Code Conduct Annual Report 2007

Medicines Australia
Code of Conduct
Annual Report 2006/2007
TABLE OF
CONTENTS
Foreword
Executive Summary
Definitions
1. Medicines Australia Code Committees and Secretariat

1.1 Code of Conduct Committee
1.2 Appeals Committee
1.3 Roles and Responsibilities
1.3 Code Secretariat
8
8
9
10
11
2. Promoting Understanding of the Code

2.1 International Federation of Pharmaceutical Manufacturers &
Associations
2.2 Education in Australia
2.3 Presentations & Meetings
2.4 Continuing Education Program
2.5 Code Refresher Course
12
12
12
13
14
15
3. Complaints Process
3.1 Lodging a Complaint
3.2 Adjudication of Complaints
3.3 Sanctions
3.4 Appeals
16
16
16
16
16
4. Analysis of Complaints Data

4.1 Source of Complaints
4.2 Summary of Complaint Determinations
4.3 Code Sanctions & Principles for Determining Code Sanctions
4.3 Sections of the Code Alleged to be in Breach by Complainant
4.4 Timeframe for Finalisation of Complaints
17
17
18
19
22
23
5. Complaint Determinations
5.1 Code of Conduct Complaints Comparisons 1999 - 2007
5.2 Index of Complaints by Complaint Reference Number
24
24
25
6. Medicines Australia Monitoring Committee

6.1 Monitoring Committee
6.2 Roles and Responsibilities
150
150
151
7. Review of Materials by the Monitoring Committee

7.1 Overview
7.2 Summary of the Monitoring Committee Review of Materials
2002 - 2007
7.3 Outcomes of the Monitoring Committee Review of Materials
152
152
153
Medicines Australia Code of Conduct Annual Report 2006/2007
154
FOREWORD
MUCH OF THE
INFORMATION IN THIS
I am pleased to contribute to the Medicines Australia Code of Conduct

Annual Report for 2006/2007, which contains comprehensive information
about the activities of the Code, Appeals and Monitoring Committees and
the outcomes of all finalised complaints reviewed by the Code and Appeals
Committees.
REPORT HAS BEEN

PUBLICLY RELEASED
THROUGHOUT 2006/2007 VIA
THE MEDICINES AUSTRALIA
WEBSITE. THIS IS THE FIRST
TIME, HOWEVER, THAT THE
The Board of Medicines Australia is responsible for the oversight of the Code
of Conduct. During the past 12 months the Board has examined its
governance arrangements to ensure that it provides appropriate leadership
and direction to the Code Committees.
The Board has built on initiatives to advance these governance
arrangements by engaging with the Panel of Chairs to discuss matters of
procedural fairness, natural justice and administration issues.
DATA HAS BEEN

PRESENTED IN A
CONSOLIDATED REPORT.
MEDICINES AUSTRALIA
The introduction of the Guidelines for Determining Code Sanctions has

provided a strong platform for informed discussion when members of the
Code and Appeals Committees are considering sanctions when a company
has been found in breach of the Code.
Good governance and a Code that sets a high standard will not guarantee
good practice, but they do provide a framework around which
pharmaceutical companies can develop and implement quality processes
and compliance procedures.
CONSIDERS THAT
COMPLIANCE WITH AN
INDUSTRY CODE OF
CONDUCT SHOULD BE A
CONDITION OF PRODUCT
LICENCE.
Medicines Australia considers that compliance with an industry Code of

Conduct should be a condition of product licence for prescription medicines.
This will ensure consistency and effectiveness of a robust self-regulatory
regime for the industry.
This report is presented with a view to sharing lessons, encouraging
increased compliance by companies and providing baseline data from which
future improvements can be measured.
Ian Chalmers
Chief Executive, Medicines Australia
EXECUTIVE SUMMARY
MEDICINES AUSTRALIA IS
COMMITTEED TO
Medicines Australia is committed to enhancing and promoting the standing

and role of the Code of Conduct in Australia. To do that, we seek to
establish the highest ethical and technical standards of conduct in the
marketing and promotion of prescription medicines for all pharmaceutical
companies. Many individuals, companies and organisations have provided
advice and contributed to the process of ongoing review and continuous
improvement of the Code.
CONTINUING TO WORK
WITH ALL STAKEHOLDERS
Pharmaceutical companies marketing prescription medicines in Australia

must comply with the following Acts and Regulations:
TO ENHANCE
UNDERSTANDING AND
COMPLANCE WITH THE
CODE OF CONDUCT.
Therapeutic Goods Act 1989

http://www.comlaw.gov.au/comlaw/management.nsf/lookupindexpagesbyid/IP200401372
Therapeutic Goods Regulations 1990

http://www.comlaw.gov.au/ComLaw/Management.nsf/current/bytitle/470A4D2EDB75C67
6CA256F710006B348?OpenDocument&mostrecent=1
Trade Practices Act 1974

http://www.austlii.edu.au/au/legis/cth/consol_act/tpa1974149/
Regulations for the Advertising of Therapeutic Goods in Australia

http://www.tga.gov.au/docs/html/advreg.htm
THE CODE SECRETARIAT

STRIVES TO MAINTAIN A
FRAMEWORK THAT
SUPPORTS GOOD
GOVERNANCE AND TO
SUPPORT AND IMPROVE
MEMBERS SERVICES,
INDUSTRY COVERAGE AND
OPENNESS TO NONINDUSTRY STAKEHOLDERS.
In addition it is a condition of marketing approval for prescription medicines

issued by the Therapeutic Goods Administration (TGA) that companies
comply with the Medicines Australia Code of Conduct. Information on the
Medicines Australia Code of Conduct can be found via the website at:
http://www.medicinesaustralia.com.au/pages/page16.asp
The vast majority of pharmaceutical companies who interact with healthcare

professionals and the general public do so responsibly. Nevertheless, on
occasion a potential breach of the Code is identified and a complaint is filed
with Medicines Australia. While breaches of the Code might never be
completely eliminated from the industry, important lessons from complaints
can be used as an educational tool in company training and auditing internal
compliance procedures.
Medicines Australia is not the adjudicator of complaints. Its role is to set and
promote high standards in the advertising and promotion of prescription
medicines and to provide advice and education to members and other
stakeholders.
The Code of Conduct and Appeals Committees role is to enforce those

standards set by the Code by investigating complaints and where a breach is
found, imposing sanctions against those companies that breach the Code.
The members of the Committees bring extensive experience in trade
practices law, public health, general practice, specialist medicine, consumer
advocacy and in evaluating the utility of drugs in a variety of research and
clinical situations. The Committees review processes are fair, rigorous and
independent.
A COMPLAINT UNDER THE
CODE OF CONDUCT MAY BE
LODGED BY AN INDIVIDUAL,
ORGANISATION OR
The complaints process is open to any company, organisation or individual.

Medicines Australia does not charge a fee to make a complaint; however,
there is a fee for a company to lodge an appeal against the findings of the
Code of Conduct Committee. This fee is not applicable to non-industry
appellants.
PHARMACEUTICAL
COMPANY.
RESULTS OF THE CODE OF

CONDUCT AND APPEALS
COMMITTEE DECISIONS ARE
PUBLISHED ON THE
MEDICINES AUSTRALIA
Financial sanctions imposed by the Code of Conduct Committee are paid to

Medicines Australia and used for the following purposes:
To defray the costs of the complaints process Code and Appeals
Committee meetings;
Provide independent facilitators to assist non-industry complainants;
For education services free seminars and presentations for all
stakeholders at no cost;
Development and provision of Code of Conduct booklets;
Development and production of resources to promote compliance with
the Code; and
Public dissemination of outcomes of all complaints on the Medicines
Australia website.
Results of the Committees decisions are published on the Medicines
Australia website on a quarterly and annual basis. This helps educate
companies as well as demonstrating the transparency of the complaints
process.
WEBSITE ON A QUARTERLY
AND ANNUAL BASIS.
2006/2007
Introduction of Edition 15 of the Code of Conduct came into effect on 6
December 2006. The revised and updated edition includes a number of
enhancements such as:
Restrictions on the use of posters and abstracts as the sole source of
evidence (Section 1.2.2 of the Code);
New requirements for advertisements and printed promotional material
(Section 3.1 and 3.3 of the Code);
Restrictions on the placement of advertisements in prescribing software
(Section 3.9 of the Code);
New provisions for the supply of starter packs (Section 5 of the Code);
New requirements for Product Familiarisation Programs (Section 5.2 of
the Code);
Appeal bond to be paid by an industry appellant increased to $20,000
(Section 13.1 of the Code);
Addition of a permanent consumer representative to the Appeals
Committee (Section 13.2 of the Code);
Addition of a permanent consumer representative to the Monitoring
Committee (Section 14.2 of the Code); and
Reporting on all finalised complaints now on a quarterly basis (See
Section 16.2 of the Code).
During 2006/2007 the Medicines Australia Code of Conduct website was

further developed by providing:
New information on lodging a Code of Conduct complaint and
responding to a Code of Conduct complaint; and
Publication of the Guidelines for Determining Code Sanctions.
Medicines Australia has developed a number of initiatives to enhance the
Code and Code processes to meet our obligations within the self-regulatory
framework that governs the pharmaceutical industry such as:
Biannual meetings between the Medicines Australia Board and the
Panel of Chairs;
Enhanced information on lodging and responding to a complaint; and
Development and publication of the Guidelines for Determining Code
Sanctions.
The success of the Code of Conduct, Appeals and Monitoring Committees
can be attributed to the participation and dedication of their Chairmen and
members. Medicines Australia is very grateful to these individuals for their
continued commitment and diligence in administering the Medicines
Australia Code of Conduct.
Thanks also go to the Medicines Australia Code Secretariat who ensures
these Committees are supported in a professional, impartial, responsive and
timely manner.
Deborah Monk
Medicines Australia Director responsible for the Code of Conduct
DEFINITONS
Advertisement means any communication which promotes or discourages

the use, sale or supply of products (whether or not in conjunction with the
supply of services, and whether or not the communication identifies
particular products or services).
Australian approved name means the active ingredients or chemical
components of a medicine.
THE DEFINITIONS INCLUDED

IN THIS LIST APPLY ONLY TO
TERMS USED IN THIS
ANNUAL REPORT.
Brand name has the same meaning as proprietary name which is the
registered trade mark of the therapeutic product or the unique name
assigned to the product.
Brand name reminder (BNR) means such items of low monetary value which
are intended to remind healthcare professionals of the existence of a
product.
Complainant means an individual, organisation or company who lodges a
complaint under the Code of Conduct.
A MORE EXTENSIVE
GLOSSARY OF TERMS IS
INCLUDED IN EDITION 15 OF
THE CODE OF CONDUCT.
Consumers and the general public are persons other than healthcare
professionals.
Healthcare professional (HCP) includes members of the medical, dental,
pharmacy or nursing professions and any other persons who, in the course
of their professional activities, may prescribe, supply or administer a
medicine.
Hospitality means the provision of food and/or beverages.
Indications mean the registered therapeutic use of a medicine as approved
by the Therapeutic Goods Administration.
Medical representative means a person expressly employed by a company
whose main purpose is the promotion of the companys products to
healthcare professionals.
Member means a company holding membership of Medicines Australia.
PBS means the Pharmaceutical Benefits Scheme of the Commonwealth
Department of Health and Ageing.
Patient support program means a program run by a company, with or without
involvement from a health consumer organisation, with the aim of increasing
patient compliance and positive health outcome.
Product familiarisation program (PFP) means a program run by the company

with the aim of allowing the medical profession to evaluate and become
familiar with the product.
Product Information (PI) means a document submitted to the TGA which
includes the following information: description, pharmacology, clinical trials,
indications, contraindications, precautions, adverse reactions, dosage and
administration.
Promotional material means any representation concerning the attributes of
a product conveyed by any means whatever for the purpose of encouraging
the usage of a product.
Starter pack means a quantity of a product supplied without cost to medical
practitioners, dentists and hospital pharmacists. Starter packs are also
referred to as samples by healthcare professionals.
Subject company means a pharmaceutical company against whom a
complaint under the Code of Conduct has been lodged.
Therapeutic Goods Administration (TGA) is the Division of the
Commonwealth Department of Health and Ageing that is responsible for the
regulation of therapeutic goods in Australia.
Trade pack means a package of a product which is sold by the company.
MEDICINES AUSTRALIA
CODE COMMITTEES and
SECRETARIAT
1
1
Current Members
Brief biographies are available on the Medicines Australia website
http://www.medicinesaustralia.com.au/pages/page96.asp for current members of
the Panel of Chairs and the Code of Conduct and Appeals Committees.
PANEL OF CHAIRS
A PANEL OF SIX SUITABLY
QUALIFIED AND
EXPERIENCED LAWYERS
HAS BEEN APPOINTED BY
Conflict of Interest
A person must not have a conflict of interest with the therapeutic area/s or
company/ies against which a complaint has been lodged or with the
Complainant. This also extends to financial or perceived bias with any of the
matters being considered at the meeting which they have been invited to
attend.
BOARD.
Code of Conduct Committee Members (Edition 15)
THE CHAIRMAN FOR A

PARTICULAR CODE
COMMITTEE MEETING IS
APPOINTED FROM THE
PANEL TAKING INTO
CONSIDERATION THAT THE
PERSON HAS NO CONFLICT
OF INTEREST.
Full Members (Voting rights)

Independent Lawyer (Chairman)
Representatives nominated by:
Australian General Practice Network (AGPN)
(Formerly Australian Divisions of General Practice)
Australian Medical Association (AMA)
Australasian Society of Clinical and Experimental Pharmacologists and
Toxicologists (ASCEPT)
Consumers Health Forum of Australia (CHF)
Royal Australian College of Physicians (RACP)
Royal Australian College of General Practitioners (RACGP)
Therapeutic Goods Administration (TGA)
Medicines Australia Association Representatives (maximum 3)
Medicines Australia Medical/Scientific Directors (maximum 2)
Observers (No voting rights)
Medicines Australia member companies employees (maximum 2)
Observer nominated by Medicines Australia (maximum 1)
Advisors (No voting rights)
Secretary, Code of Conduct Committee
Medicines Australia officer responsible for Scientific and Technical
Affairs
Medicines Australia Chief Executive Officer
Code of Conduct Committee Meeting Attendance
THE PANEL OF CHAIRS

HOLD BIANNUAL MEETINGS
WITH THE MEDICINES
AUSTRALIA BOARD TO
DISCUSS STRATEGIC
ISSUES IN RELATION TO THE
ADMINISTRATION OF THE
CODE OF CONDUCT.
The following table indicates the attendance of the external (non-Medicines

Australia member company) members of the Committee. Edition 15 of the
Code of Conduct requires the participation of an ASCEPT member at each
Code Committee meeting to form a quorum.
Figure 1: Code of Conduct Committee Meeting Attendance
AGPN
AMA
ASCEPT
CHF
RACGP
RACP
TGA
1
10
11
12
Number of Meetings
Appeals Committee Members (Edition 15)

Full Members (Voting rights)
Independent Lawyer (Chairman)
The College and/or Society associated with the therapeutic class of the
product subject to appeal
The target audience to which the activity was directed eg: AMA,
RACGP, AGPN
Australasian Society of Clinical and Experimental Pharmacologists and
Toxicologists (ASCEPT)
Medicines Australia Association Representatives (maximum 2)
Medicines Australia Medical/Scientific Director (maximum 1)
Advisors (No voting rights)
Medicines Australia Chief Executive Officer or delegate
Roles and Responsibilities of the Code of Conduct and

Appeals Committee Members
The Committee members must fulfill the following roles and responsibilities.
MEMBERS MUST BE FULLY

CONVERSANT WITH ALL
PROVISIONS OF THE
CURRENT EDITION OF THE
MEDICINES AUSTRALIA
CODE OF CONDUCT.
To be fully conversant with:
All provisions of the current edition of the Medicines Australia Code of

Conduct:
Membership and nominating bodies for the Code and Appeals

Committee as set out in Sections 11.2 and 13.2 of the Code of
Conduct;
Provisions relating to the administration of the Code as set out in

Section 11 and Appendix 1; and
Provisions relating to the Appeal process as set out in Section 13.
The sanctions that can be imposed by the Committee where a breach

of the Code of Conduct has been found by the Code and Appeals
Committees:
Provisions relating to the imposition of sanctions on companies

found to be in breach of the Code by the Code and Appeals
Committees as set out in Section 12.
The Constitution of Medicines Australia, specifically those which refer to

the disciplining of members and their right of appeal as set out in
Appendix 2.
As a Committee member they must:
Establish and maintain an effective working relationship with Medicines

Australia;
Participate in the scheduled Code and Appeals Committee meetings:
Ensuring that they understand the procedures for the meeting;
Establishing the details of what is subject to complaint;
Ensuring that all the items subject to complaint are addressed;
Providing appropriate and sufficiently detailed information for

discussion by all members of the Code or Appeals Committee to
enable the minutes to reflect the decisions;
Ensuring that matters outside the scope of the Code of Conduct

or aspects not subject to complaint are not taken into account
when making a determination; and
Ensuring confidentiality is maintained until the complaint is

finalised.
Be aware of all voting procedures under the provisions of the Code of

Conduct:
All permanent members of the Code of Conduct Committee are

entitled to vote eg. observers to the meeting and members of
the Code Secretariat do not have voting rights as set out in
Section 11.2; and
Should the vote be deadlocked the deciding vote is taken by the

Chairman of the Code or Appeals Committee.
Declare any conflict or potential conflict of interest to the Code
Secretariat prior to any agenda papers being circulated and
consideration of the complaint.
10
Code Secretariat
Ms Deborah Monk
Ms Heather Jones
Ms Lara Winther
Director, Scientific and Technical Affairs

Manager, Code of Conduct
Code Administration Officer (Part time)
Role of the Medicines Australia Code Secretariat

The Code Secretariat at Medicines Australia means the staff within
Medicines Australia with responsibility for Code and related matters.
The Code Secretariat has responsibility for:
Providing advice to any healthcare professional, member of the general

public, pharmaceutical company or agency on Code related matters;
Providing educational seminars, training and briefings to companies

and other stakeholders;
Providing the administrative support to the Code, Appeals and

Monitoring Committees:
Preparing the agenda papers for the Committees;
Recording the minutes for the Committees;
Providing copies of the minutes to the Complainant and Subject

Company; and
Preparing reports for publication; and
Developing and implementing the administrative procedures for the

Code process.
11
PROMOTING
UNDERSTANDING of the CODE
International Federation of Pharmaceutical Manufacturers

and Associations (IFPMA)

CODE IS BASED ON THE
PROVISIONS OF THE IFPMA
CODE.
IN 2006 AN INTERNATIONAL
CODE COMPLIANCE
NETWORK WAS
ESTABLISHED TO BRING
TOGETHER COMPLIANCE
OFFICERS.
The IFPMA is a non-profit, non-government organisation representing

pharmaceutical companies and industry associations from both developed
and developing countries. Member companies of the IFPMA are global
research-based pharmaceutical and vaccine companies.
The Medicines Australia Code is based on the provisions of the IFPMA
Code. An updated version of the IFPMA Code of Pharmaceutical Marketing
Practices entered into force on 1 January 2007. The new Code, whose
applicability extends to every country and is required of all IFPMA members,
imposes even stricter and clearer requirements on pharmaceutical
companies, to ensure the ethical promotion of their products to healthcare
professionals.
In 2006 the IFPMA Code Compliance Network was established to bring
together compliance officers from member companies and industry
associations, to share best practice in informing company sales and
marketing people about compliance with the IFPMA Code, with an emphasis
on teaching respect for the spirit as well as the letter of the rules of the Code.
Medicines Australia is participating in this network and Ms Deborah Monk
presented at an international IFPMA Code roll out conference in Hong Kong
in January 2007 and will be a keynote presenter at a regional Asia Pacific
Code training seminar in July 2007.
Education in Australia
Educational seminars and meetings are provided by Medicines Australia
throughout the year to increase industry and stakeholder awareness of and
adherence to the Medicines Australia Code of Conduct. Presentations were
made to member and non-member companies; advertising, marketing and
public relations agencies; conference organisers and health consumer,
pharmacy and medical organisations.
Medicines Australia has also developed printed brochures to promote
awareness and understanding of the Code of Conduct and has made
available further information on the Code and Code processes via the
Medicines Australia website.
Online education programs are also available through the Medicines
Australia Continuing Education Program.
12
Presentations and Meetings

Table 1: Code Education 2006/2007
Audience
Presentations
Member Company
Non-member Company
External (Advertising/PR/Conference)
Healthcare Professional (Medical/pharmacy)
Health Consumer Organisation
Seminars
Total
2 KEYNOTE
PRESENTATIONS AT
INTERNATIONAL MEETINGS
No
Attendees
5
0
7
2
0
6
20
182
0
43
100
0
371
696
2
3
2
2
9
4
6
4
4
18
Code related meetings

Medical Software
Politicians
Companies
Others
Total
20 PRESENTATIONS IN
AUSTRALIA
696 INDIVIDUALS ATTENDED
PRESENTATIONS
Code Trade Display at Medical Conference

700 registered healthcare professionals and 300 enquiries/discussions re
the Code of Conduct
9 MEETINGS SPECIFICALLY
DEDICATED TO THE CODE
Print Materials Available

CODE TRADE DISPLAY AT
MEDICAL CONFERENCES
Code of Conduct Edition 15: Information for members of the general

public
Code of Conduct Edition 15: Information for healthcare professionals
Medicines Australia Website

Information available from the Medicines Australia website:
DOWNLOADS FROM CODE
WEBSITE
CODE OF CONDUCT 70,333
CODE GUIDELINES 21,964
CODE REPORTS 39,334
Code of Conduct Edition 15

Guidelines to Edition 15
Guidelines for Determining Code Sanctions
Code of Conduct Committee Meeting Dates
Committee Membership
Frequently Asked Questions
Lodging and Responding to a Complaint
Code of Conduct Reports
Briefing Papers
13
Continuing Education Program (CEP)

Medicines Australias Continuing Education Program (CEP) is designed to
educate company representatives to a recognised industry standard in order
to provide healthcare professionals with accurate, balanced information in an
ethical manner that will enhance the quality use of medicines.
CEP PROGRAMS
1. CODE OF CONDUCT
2. PHARMACEUTICAL AND
HEALTHCARE INDUSTRY
3. INTRODUCTION TO
PHARMACOLOGY
4. UNDERSTANDING
PRODUCT INFORMATION
5. UNDERSTANDING
CLINICAL EVIDENCE
The CEP is offered in distance learning and online modalities through UQ

Health Insitu which is the life long learning arm of the Centre for Health,
Innovation and Solutions (CHIS), a centre of the University of Queenslands
Faculty of Health Sciences. The course is tailored for adult learning and
designed to provide flexibility for participants in full time employment.
Section 4 of the Code of Conduct states:
All medical representatives entering the Australian prescription
pharmaceutical industry for the first time must enrol in the Code of Conduct
component of the endorsed Medicines Australia education program within
the first six months of employment and must complete the full program
requirements for medical representatives within two years.
Any person who is directly involved in the development, review and approval
of promotional materials and educational materials for the general public
(this includes Product Managers, medical, marketing or sales staff); or has
direct interaction with healthcare professionals for the purpose of promoting
a prescription medicine, whether part time or full time, must complete the
Code of Conduct component of the endorsed Medicines Australia education
program within the first 12 months of commencement of employment.
For more information regarding the CEP content, please contact Medicines
Australia on 02 6282 6888. For enrolment details, please visit the CEP
website at http://ma.healthinsitu.uq.edu.au
CEP in 2006/2007
Enrolments in Semester 2 2006 (some candidates may be enrolled in more
than one program in the semester eg Programs 1 and 2)
Program 1 452
Program 2 280
Program 3 251
Program 4 261
Program 5 211
Number of individuals who completed the CEP in Semester 2 2006 198
Enrolments in Semester 1 2007 (some candidates may be enrolled in more
than one program in the semester eg Programs 1 and 2)
Program 1 507
Program 2 279
Program 3 249
Program 4 207
Program 5 213
Number of individuals who completed the CEP in Semester 1 2007 207
14
CEP Awards
EACH YEAR AWARDS ARE

MADE TO INDIVIDUALS FOR
OUTSTANDING
ACHIEVEMENT IN THE CEP.
2006 Top Ten CEP achievers acknowledges outstanding medical

representatives who have completed the CEP
Jane Trotter (Boehringer Ingelheim)
Kerryn Gamble (Sanofi aventis)
Rhys Hosgood (Altana Pharma)
Kylie Myers (Novo Nordisk Pharmaceuticals)
Nicola Ruijne (Lundbeck Australia)
James Dummett (AstraZeneca)
Jill Blackwood (Merck Sharp and Dohme Australia)
Thomas Ferguson (Boehringer Ingelheim)
Theodore Holland (Solvay Pharmaceuticals)
Sean Remedios (AstraZeneca)
Module 1 Code of Conduct candidate whose work in this important module
is outstanding with demonstrated knowledge and practical application of the
Medicines Australia Code of Conduct
David Cheng (Bristol-Myers Squibb Australia)
UQ Health Insitu Active Learning Prize is based on the level and quality of
participation in group discussions and personal reflections in online tutorials
Anita Flint (Valeant Pharmaceuticals)
Andrew Corbett (Eli Lilly Australia)
CEP Evaluation
Each person enrolled in the CEP is asked to complete an evaluation form.
Medicines Australia is pleased that the majority of students undertake this
task with the overall satisfaction rate over 80%.
98% SATISFACTION RATE

WITH THE CEP
Overall Student Satisfaction

Exceeded 39%
Met 59%
Did not meet 2%
N/A 0%
Code Refresher Course
CODE REFRESHER COURSE

DOWLOADED 4,026 TIMES
This course is designed to highlight the key changes to the Medicines

Australia Code of Conduct Edition 15 and update the knowledge of staff
involved in the development, review and approval of promotional materials
for healthcare professionals and educational materials for the general public.
The course is designed to be self-directed, so each person can work at their
own pace.
The course is available in two formats:
Online accessed at:
http://ma.healthinsitu.uq.edu.au/products/MA4911/MA4911_brochure.cfm
Downloadable PDF Document accessed at:
15
COMPLAINTS PROCESS
Lodging a Complaint
In addition to intercompany complaints a non-industry Complainant (for
example a member of the general public, healthcare professional, academic,
Therapeutic Goods Administration) may lodge a complaint in relation to the
activities of, or materials developed by, the Australian sponsor of a
prescription medicine.
THE CODE OF CONDUCT

COMMITTEES
Anonymous complaints will not be accepted. However, on request of the

Complainant, the Code Secretariat will withhold the name of the
Complainant from the Subject Company and will not publish their name in
the Code of Conduct Annual Report.
A Complaints Submission Form can be found at:
DETERMINATION IS BASED
ON A REVIEW OF THE
WRITTEN SUBMISSIONS
FROM THE COMPLAINANT
AND SUBJECT COMPANY
Adjudication of Complaints
Complaints are adjudicated upon by the Code of Conduct Committee. For
membership of this Committee please refer to page 8. The Committees
determination is based on a review of the written submissions from the
Complainant and Subject Company.
Sanctions
The Code of Conduct Committee, with medical, legal and consumer
representatives, has the power to direct withdrawal of advertising, require
corrective letters or advertisements and impose fines on companies for
breaches of the Code. The Committee will take a range of factors into
consideration when determining an appropriate sanction.
The Guidelines for Determining Code Sanctions can be found at
Appeals
Under Edition 15 of the Code, an appeal may be lodged by either the
Complainant or Subject Company. Both the Complainant and Subject
Company are permitted to be in attendance at the Appeals Committee
meeting to make a presentation and hear the presentation of the other party.
The Appeals Committee is independent of the Code of Conduct Committee
no member of the Appeals Committee may have also been a member of the
Code of Conduct Committee that made the determination subject to appeal
For membership of the Appeals Committee please refer to page 9.
A complaint is not deemed finalised until the Complainant and Subject
Company have advised Medicines Australia that they will not appeal the
decision of the Code of Conduct Committee decision (following circulation of
the Code minutes) or in the case of an appeal the minutes of the Appeals
Committee meeting have been provided to both parties.
16
ANALYSIS OF
COMPLAINTS DATA
3
Summary of Complaints
This section of the Code Annual Report contains information on the source of
complaints, outcomes from the determination of complaints and sanctions
imposed by the Code of Conduct and Appeals Committees.
MEDICINES AUSTRALIA
RECEIVED 42 NEW
COMPLAINTS IN 2006/2007.
The number of complaints in 2006/2007 was 42 (27 in 2005/2006) with 55%

lodged by pharmaceutical companies. Table 2 provides information on the
source of complaints in 2006/2007. In 17.6% of new and finalised complaints
all aspects of the complaints were found to be in breach of the Code. In 41.2%
of complaints no aspect of the complaint was found to be in breach of the
Code. In the remaining 41.2% of complaints the complaints were partly found
in breach; that is some aspects of a complaint were found to be in breach
whereas other aspects were not found in breach. Table 5 provides information
on complaints considered in 2006/2007.
Appeals were lodged in relation to 12 complaints. The Appeals Committee
upheld one appeal, upheld some aspects of two appeals and did not uphold
any aspect in relation to nine appeals (that is, the Code Committees decisions
were confirmed in 9 out of 12 appeals).
Source of Complaints
Table 2: Source of complaints 2006/2007
DETAILS OF THE
DETERMINATIONS OF THE
CODE OF CONDUCT AND
APPEALS COMMITTEES CAN
BE FOUND IN SECTION 5 OF
THIS REPORT.
Complainant
Healthcare Professionals
General Practitioner
Doctor in a hospital
Physician/Specialist
Pharmacist
Nurse
Academic
4
2
2
1
2
1
Pharmaceutical Company
Medicines Australia Member Company
Non-member Company
21
2
Organisations
Therapeutic Goods Administration
Medical College/Society
Consumer Organisation
4
0
1
Others
Members of the general public
Academic (non-healthcare professional)
0
2
Total new complaints in 2006/2007
42
Number
17
Summary of Complaint Determinations

Table 3: Complaints received by Medicines Australia in 2005/2006 and
finalised in 2006/2007
Complaints finalised from 2005/2006
No.
Number of complaints held over from 2005/2006 and finalised in

2006/2007
7*
Code of Conduct Committee Decision

Where all aspects of a complaint were found to be in breach
Where some aspects of a complaint were found to be in breach
4*
100%
Where no aspects of a complaint were found to be in breach
* 4 complaints pertain to the same matter and were considered

together with one decision and sanction applied
Number of appeals pertaining to complaints held over from
2005/2006 and finalised in 2006/2007
Appeals Committee Decision

Where all aspects of an appeal were upheld
Where some aspects of an appeal were upheld
66.6%
Where no aspects of an appeal were upheld
33.3%
Table 4: Complaints received by Medicines Australia in 2006/2007

Complaints received in 2006/2007
No.
Number of complaints received by Medicines Australia
42*
100%
Complaints considered by the Code of Conduct Committee
34*
80.9%
Complaints considered by the Code of Conduct Committee subject

to appeal in 2007/2008 (not finalised)
7.1%
Complaint withdrawn
2.4%
Complaint referred to the TGA
4.8%
Complaint returned to complainant with request for further

information
2.4%
Complaint received after cut off date for June Code meeting
2.4%
Complaints not considered by the Code of Conduct Committee
* 2 complaints pertain to the same matter and were considered

together with one decision and sanction applied
18
Table 5: Outcomes of complaints received and considered in 2006/2007

Code of Conduct Committee Decision
Where all aspects of a complaint were found to be in breach
No.
17.6%
Where some aspects of a complaint were found to be in breach
14
41.2%
Where no aspects of a complaint were found to be in breach
14*
41.2%
Number of appeals pertaining to complaints received in 2006/2007
12
Where all aspects of an appeal were upheld
8.3%
Where some aspects of an appeal were upheld
16.6%
Where no aspects of an appeal were upheld
75%
* 1 outcome relates to two complaints pertaining to the same matter

which were considered together with one outcome and sanction
Code Sanctions
COMPANIES SHOULD
FOCUS THEIR EFFORTS ON
GOOD REGULATORY
COMPLIANCE RATHER THAN
RELIANCE ON THE
COMPLAINTS PROCESS.
In the context of the Code a sanction is an imposition on a company in

response to finding it has breached the Code. The three main types of
sanction are to:
Cease the activity and withdraw the materials found in breach (the
minimum sanction);
Issue a corrective letter or advertisement; and
Pay a monetary fine.
The specific purposes of sanctions are to:
Encourage compliance with the Code;
Ensure that any materials found in breach are not used again or any
activity found in breach is ceased; and
Ensure that incorrect or misleading information is corrected.
The minimum sanction that is consistently applied when a company has been
found in breach of the Code is to require the company to cease the activity or
withdraw the materials from further use. This sanction cannot be applied if the
activity found in breach was a single occurrence and not an ongoing activity.
The principles for determining a sanction should be transparent to both the
Complainant and Subject Company.
The principles are not a list of procedural rules but the foundation on which the
determination of the level of sanction is based. Sanctions should be based
upon clear principles and applied in a predictable and consistent manner
without unnecessary rigidity.
Compliance with the Code is most effective when companies develop internal
procedures for the development and approval of company activities and
materials and ensure operations are based on an explicit risk management
strategy. Companies should focus their efforts on good regulatory compliance
rather than reliance on the complaints process.
19
Principal Factors in Determining a Sanction

The following is a set of principal factors which will be taken into consideration
by the Code of Conduct and Appeals Committees in determining a sanction
following a finding of breach/es of the Code of Conduct.
THE PRINCIPLES ARE NOT A

LIST OF PROCEDURAL
RULES BUT THE
FOUNDATION ON WHICH
THE DETERMINATION OF
THE LEVEL OF SANCTION IS
BASED.
The nature and extent of the activity/material

Whether the breach should have been clearly evident to the Subject
Company;
Breadth of activity or campaign;
Length of time that the materials have been in use;
The number and type of alleged breach/es;
Circumstances in which the activity took place any explanation offered
by the Subject Company; and
Level of the breach technical, minor, moderate, serious, repeat breach,
bringing industry into disrepute.
Other considerations
Extent of breach how misleading, damaging, disparaging;
Potential for patient harm such breaches usually require corrective
action and may attract a higher sanction;
Direct to consumer advertising or misleading information to the general
public in general, activities directed to the consumer found in breach of
the Code attract a higher sanction. Direct to consumer advertising is in
breach of the Therapeutic Goods legislation;
Promotion of an unapproved indication or product also attracts a higher
sanction in recognition that this would also breach the Therapeutic Goods
legislation;
Extent of dispute resolution dialogue demonstration of significant
attempts to resolve a complaint prior to proceeding to the Code Committee
may result in a lower sanction being applied;
Potential costs to be incurred by a company for corrective action the
Committee will consider the overall monetary cost of the package of
sanctions, for example the cost of issuing a corrective letter in combination
with a fine; and
Company history.
Double Jeopardy
The Code of Conduct Committee will not rehear a complaint against a
particular section or sections of the Code in relation to the same activity or
same material irrespective of whether there was a finding of a breach of the
Code, unless there is an allegation that the material has not been withdrawn or
the activity has not ceased. If a complaint is received in relation to an activity
or material already considered by the Code of Conduct Committee the
Complainant will be referred to the outcome of the previous complaint.
20
Table 6: Frequency of sanctions imposed by the Code and Appeals

Committees on companies found in breach of the Code
Complaints
finalised
from
2005/2006
Complaints
received
and
finalised in
2006/2007
Withdraw/cease using material/activity found in

breach
21
Corrective Letter/ Corrective Advertisement
Other (eg. update internal review processes)
$0 $24,999
$25,000 $49,999
$50,000 $74,999
$75,000 $99,999
$100,000 $149,999
$150,000 $200,000
Total value of fines
$260,000
$695,000
Sanctions
Fines
Table 7: Summary of sanctions imposed by the Code and Appeals

Committees on companies found in breach of the Code
Complaints
finalised
from
2005/2006
Complaints
received
and
finalised in
2006/2007
Withdraw/cease only
Withdraw & corrective letter/advertisement
1*
Withdraw & corrective letter/advertisement & fine
Fine only
Withdraw & fine
Other & withdraw/cease & fine
Sanctions
* 1 sanction relates to four complaints pertaining to the same matter which were
considered together with one decision and sanction
21
Sections of the Code alleged by Complainants to be in

breach
One complaint may include a number of allegations of a breach of the Code
against different materials or several separate aspects of a single promotional
item under different sections of the Code. For example there may be 3 claims
in one promotional item alleged to be in breach.
Example:
Claim 1 breach of Sections 1.1, 1.2 and 1.3
Claim 2 breach of Sections 1.1, 1.2, 1.3 and 1.7
Claim 3 breach of Sections 1.1, 1.3 and 1.7
In the 34 complaints finalised during the 2006/2007 period (Table 9 excludes
the 8 complaints that were withdrawn, not heard or not finalised in 2006/2007),
217 alleged breaches were considered by the Code of Conduct and Appeals
Committees. Of these a total of 96 breaches were found.
Table 9: Alleged and Actual Breaches of Code Sections 2006/2007
This table sets out the alleged breaches and the actual breaches by section
found by the Code of Conduct and Appeals Committees.
Section of the Code
Alleged
Breach
No Breach
1.1
1.2
1.3
1.4
1.5
1.7
1.9
2.1
3.3
3.5
4.1
4.2
4.3
4.4
4.8
5.3
5.9
6.1
6.2
6.3
6.4
6.6
6.8
7.1
8.2
9.2
9.3
9.4
9.5
9.6
9.7
9.8
10
10.1
10.2
10.5
20
24
50
3
5
22
1
1
2
1
2
2
1
1
1
1
1
1
2
1
3
1
1
9
1
3
1
8
22
1
1
7
3
2
3
8
13
11
30
1
0
8
0
0
0
0
1
0
0
0
0
1
0
0
1
0
2
0
0
1
1
1
1
4
13
0
0
4
0
0
1
2
7
13
20
2
5
14
1
1
2
1
1
2
1
1
1
0
1
1
1
1
1
1
1
8
0
2
0
4
9
1
1
3
3
2
2
6
Total
217
96
121
22
Timeframe for finalisation of complaint

The time taken to consider and finalise a Code of Conduct complaint is
calculated from the date the complaint is received at Medicines Australia to the
date of the Code of Conduct Committee or Appeals Committee Meeting.
The date for each scheduled meeting and information on the cut off dates for
each months meeting can be found on the Medicines Australia website at
While the Committees deal with each complaint as expeditiously as possible
the finalisation of some complaints may be delayed due to requests by the
Code Secretariat or the Code of Conduct Committee for further information; or
delays in hearing appeals due to matters relating to finding a mutually
acceptable Appeals Committee meeting date for the Subject Company and
Complainant and the sourcing of external experts for the meetings.
The following table provides a summary of the time taken to resolve a
complaint.
Table 8: Length of time to resolve all finalised complaints
Length of time to resolve complaints
Number of
working
days
Shortest
13
Longest
101
Average
41
Average for complaints not subject to appeal
28
Average for complaints subject to appeal
66
23
COMPLAINT
DETERMINATIONS
The Code of Conduct Annual Report makes available detailed information on each complaint considered by the
Code of Conduct and Appeals Committees.
Medicines Australia is committed to continuing work with stakeholders in raising their awareness of the Code of
Conduct and how a company, organisation or individual can lodge a complaint in relation to the activities of a
pharmaceutical company marketing a prescription medicine in Australia.
Table 10: Code of Conduct Complaint Comparison 1999 2007
Year
Code
Edition
Complaints
Finalised
from
previous
year
New
Complaints
Outcomes
Withdrawn
Not
finalised
Not Heard
99/00
12 & 13
44
28
00/01
13
37
10
10
01/02
13
49
14
15
02/03
13 & 14
48
17
11
03/04
14
36
11
10
12
04/05
14
51
05/06
14
27
06/07
14 & 15
7*
42
20
16
10
10
18
13
2 complaints pertain to the same matter and were considered together with one outcome and sanction applied
* 4 complaints pertain to the same matter and were considered together with one outcome and sanction applied
A Where all aspects of a complaint were found to be in breach of the Code
B Where some aspects of a complaint were found to be in breach of the Code
C Where no aspects of a complaint were found to be in breach of the Code
24
Table 11: Code of Conduct Complaints July 2006 June 2007

This table provides a brief outline of each complaint finalised in 2006/2007. To view the detailed report on the
complaint outcome please click on the complaint number.
Information on the content of the provisions (Sections) of the Code can be accessed at:
Code of Conduct Complaints July 2006 June 2007

No.
Subject
Company
Material/Activity
Product
Complainant
Outcome
(Sections of the
Code where one
or more
breaches found)
Sanction
826
Schering
Material for the

general public
Betaferon
Biogen Idec
Australia
Breach 1.3, 1.7,

6.4, 9.4, 9.5,
9.5.1, 9.5.2,
9.5.6, 9.5.7, 9.8
Withdraw
Corrective letter
Fine - $150,000
827
Abbott
Australasia
Promotional
material
Lucrin
Mayne Pharma
Breach 1.2.2, 1.3
Withdraw
Corrective letter
Fine - $10,000
828
Bayer Healthcare
Promotional
material
Levitra
Australian
Consumers
Association
Breach 10.5
Withdraw
Corrective letter
Corrective
advertisement
829
Bayer Healthcare
Promotional
material
Levitra
Australian
Consumers
Association
See 828
830
Schering
Material for
general public
Betaferon
Sanofi Aventis
Breach 1.2.2,
1.3, 6.4, 7.1.1,
9.4, 9.5, 9.5.1,
9.5.2, 9.5.6,
9.5.7, 9.8
831
Bayer Healthcare
Promotional
material
Levitra
Australian
Consumers
Association
See 828
832
Bayer Healthcare
Promotional
material
Levitra
Australian
Consumers
Association
See 828
833
GlaxoSmithKline
Australia
Competition for
healthcare
professionals
Infanrix
Healthcare
professional
No breach/es
found
834
GlaxoSmithKline
Australia
Competition for
healthcare
professionals
Infanrix
Healthcare
professional
See 833
835
Roche Products
Hospitality
N/A
TGA
Breach 6.2, 10.2,

10.5
Dont use
materials again
Fine - $100,000
N/A
Fine - $75,000
25
No.
Subject
Company
Material/Activity
Product
Complainant
Outcome
(Sections of the
Code where one
or more
breaches found)
Sanction
836
Allergan
Australia
Promotional
material
Lumigan
Pfizer Australia
Breach 1.2, 1.3,

1.4, 1.7
837
All
pharmaceutical
companies
Relationship with
healthcare
professionals
N/A
Healthcare
professional
No breach/es
found
N/A
838
Baxter
Relationship with
healthcare
professionals
Desflurane
Healthcare
professional
No breach/es
found
N/A
839
Merck Sharp &

Dohme (Aust)
Promotional
material
Zocor
Healthcare
professional
No breach/es
found
N/A
840
GlaxoSmithKline
Australia
Promotional
material
Avandia
TGA
No breach/es
found
N/A
841
Amgen Australia
Relationship with
healthcare
professionals
N/A
Roche
Products
No breach/es
found
N/A
842
AstraZeneca
Promotional
material
Crestor
Pfizer Australia
Breach 1.3, 1.7
Withdraw
Corrective letter
Fine - $40,000
843
GlaxoSmithKline
Australia
Promotional
material
Rotarix
CSL Limited
Breach 1.1,
1.2.2, 1.3
Withdraw
Corrective letter
Fine - $25,000
844
Boehringer
Ingelheim
Promotional
material
Buscopan
Healthcare
professional
Breach 1.3
Withdraw
Fine - $10,000
845
Roche Products
Promotional
material
NeoRecormon
Amgen
Australia
No breach/es
found
N/A
846
GlaxoSmithKline
Australia
Promotional
material
Seretide
Boehringer
Ingelheim &
Pfizer Australia
Withdrawn
N/A
847
AstraZeneca
Promotional
material
Nexium
Janssen-Cilag
Breach 1.3, 1.7
Withdraw
Fine - $75,000
848
Octapharma
Promotional
material
Octanate
CSL Limited
Breach 1.3,
1.3.1, 1.7
Withdraw
Corrective letter
Fine - $10,000
849
Boehringer
Ingelheim
Promotional
material
Mobic
Pfizer Australia
Breach 1.2, 1.3
Withdraw
Corrective letter
Fine - $25,000
850
Alcon
Laboratories
Promotional
material
DuoTrav
Pfizer Australia
Breach 8.2.2
Cease program
Fine - $10,000
Withdraw
Corrective letter
Fine - $15,000
26
No.
Subject
Company
Material/Activity
Product
Complainant
Outcome
(Sections of the
Code where one
or more
breaches found)
Sanction
851
CSL Limited
Promotional
material
Biostate
Octapharma
Breach 1.3
852
GlaxoSmithKline
Australia
Promotional
material
GSK
Respiratory
Care Program
Healthcare
professional
No breach/es
found
N/A
853
GlaxoSmithKline
Australia
Promotional
material
GSK Adult
Immunisation
Healthcare
professional
No breach/es
found
N/A
854
Schering
Starter packs
Angeliq
Organon
Australia
Breach 5.3
Cease
distribution of
trade packs
855
CSL Limited
Representative
behaviour
N/A
Healthcare
professional &
Octapharma
Breach 1.1,
1.2.2, 1.3, 1.7,
4.1
Withdraw
Fine - $15,000
856
GlaxoSmithKline
Australia
Promotional
material
Twinrix
Healthcare
professional
No breach/es
found
N/A
857
Janssen-Cilag
Promotional
material
Pariet
AstraZeneca
Breach 1.1, 1.2,

1.3, 1.7
Withdraw
Fine - $100,000
858
GenRx
Promotional
material
Perindopril
Servier
Laboratories
Referred to TGA
859
Sanofi Aventis
Promotional
material
Stilnox
Healthcare
professional
Breach 1.1, 1.3
Withdraw
Fine - $5000
860
Pfizer Australia
Promotional
material
Celebrex
Boehringer
Ingelheim
Breach 1.1, 1.3
Withdraw
Fine - $100,000
861
Merck Sharp &

Dohme
Promotional
material
Fosamax Plus
Servier
Breach 1.1, 1.2,

1.3
Withdraw
862
Janssen-Cilag
Starter pack
Pariet
TGA
No breach/es
found
N/A
863
Janssen-Cilag
Promotional
material
Pariet
Altana Pharma
Breach 1.2.2, 1.3
Withdraw
Other sanctions
covered in
Pariet 857
864
CNS Pharma
Esipram
Healthcare
professional
Referred to TGA
865
Pfizer Australia
Xalacom
Alcon
Laboratories
Breach 1.1, 1.3
Withdraw
Corrective letter
Fine - $50,000
Promotional
material
Withdraw
27
No.
Subject
Company
Material/Activity
Product
Complainant
Outcome
(Sections of the
Code where one
or more
breaches found)
Sanction
866
Pfizer Australia
Information in
Readers Digest
Celebrex
Healthcare
professional
Breach 9.4, 9.5.2
Do not publish
this article again
in publication to
general public
Fine - $100,000
867
GlaxoSmithKline
Australia
Media release
and sponsorship
of a lay media
journalist
Tykerb
Roche
Products
Breach 9.2.1
868
AstraZeneca
Acronym used in
promotional
material
Symbicort
Turbuhaler
TGA
No breach/es
found
N/A
869
GlaxoSmithKline
Australia
Education event
N/A
Healthcare
professional
No breach/es
found
N/A
Provide no
media releases
until medicine
registered
Fine - $40,000
28
Betaferon (826)
Subject Company: Schering Pty Ltd (Schering)
Complainant: Biogen Idec Australia (Biogen)
Corrective letter to all members of the general

public who attended MS 2006
Corrective letter to all healthcare professionals
who received the materials found in breach of
the Code
Fine $150,000
Product: Betaferon
Consideration of the complaint:
Complaint:
Materials distributed at a MS Conference, which
was attended by members of the general public,
contained
information
about
unapproved
indications for Betaferon and that the information
was promoting a prescription medicine to
members of the general public.
Sections of the Code:
Materials alleged to be in breach of the following
1.3 False or misleading claims
1.7 Comparative statements
4.4 Medical representatives
4.8 Medical representatives
6.3 Involvement in Educational Symposia,
Congresses and Satellite meetings
Behaviour
6.4 Sponsorship or involvement in
Australasian Congresses and Satellite
Meetings
9.4 Promotion to the General Public
9.5, 9.5.1, 9.5.2, 9.5.6, 9.5.7 Patient
Education
9.8 Discredit to, and reduction of confidence
in, the industry
Code of Conduct and Appeals Committee
decision:
Unanimous breach of Sections 1.3, 9.4, 9.5,
9.5.1, 9.5.2, 9.5.6, 9.5.7 and 9.8 (Decision
confirmed by the Appeals Committee)
Breach of Section 1.7 (Decision confirmed by
the Appeals Committee)
Majority breach of Section 4.4 (Decision
Majority no breach of Sections 4.8 and 6.3
Breach of Section 6.4 (Decision amended by
the Appeals Committee no breach of Section
6.4 of the Code)
Sanctions:
(Decision confirmed by the Appeals Committee)
Cease distribution of all materials found in
breach of the Code
Recall materials found in breach of the Code
Code of Conduct Committee

The Committee reviewed the printed materials and
DVD provided by Schering at the Multiple Sclerosis
50th Celebration Meeting which was attended by
people with MS, families, researchers, medical
practitioners, allied health professionals, non-profit
organisations and community groups. Members
acknowledged that patients with MS and their
carers are interested in seeking further information
on the condition and available treatments; however
government legislation and the Medicines Australia
Code of Conduct prohibit advertising prescription
medicines to the general public or distributing
patient education materials containing promotional
or comparative information. Further, the promotion
of a non-approved indication to either healthcare
professionals or members of the general public is
not permitted.
The Committee also noted that there is a distinction
between materials prepared by a pharmaceutical
company and information prepared and distributed
by a health consumer organisation (HCO) such as
the Multiple Sclerosis Society.
Some members of the Committee also commented
that as Betaferon is an expensive medicine there
were significant benefits to a company in
encouraging patients to ask their doctor to switch to
this medicine. The Committee was of the view that
the presentation of the brochure Moving the
treatment goalposts in Multiple Sclerosis, with a
photo of eight experts in the field of MS could
persuade a patient to believe that this must be the
best treatment for MS. Members were also of the
view that whilst patients and their carers may be
well educated, they would not consider whether the
information was a peer reviewed report or
unpublished data or whether it was balanced.
Rather it would encourage them to ask their doctor
why arent I on this new treatment?
In relation to the argument by Schering that by
using the name interferon beta-1b 250mcg they
were not referring to a specific prescription
medicine, the Committee commented that the use
of the generic name was clearly an identifier for
Betaferon and was equivalent to the use of the
29
(Betaferon 826 contd)

brand name, particularly where this is the only
beta-1b medicine available.
The Committee considered the Moving the
treatment goalposts in Multiple Sclerosis brochure
and DVD under each section of the Code alleged
to be in breach by Biogen.
Section 1.3
The Committee noted that the approved
indications for Betaferon were:
Ambulatory patients with relapsing-remitting
multiple sclerosis (MS) characterised by at least
two attacks of neurological dysfunction over a two
year period followed by complete or incomplete
recovery. Betaferon is also indicated for the
reduction of frequency and severity of clinical
relapses, and for the slowing of progression of
disease in patients with secondary progressive
multiple sclerosis.
The expert panel discussion recorded during the
18th World Congress of Neurology, Sydney 9
November 2005, presented on the DVD and
summarised in the brochure, was discussing new
information on MS treatment, including a new trial
known as BENEFIT which was in relation to early
detection via an MRI scan and the early treatment
(after 1 episode) with interferon beta-1b 250mcg.
Members were of the view that the materials were
promoting a non-approved indication of a
prescription medicine, interferon beta 1b. The
Committee also commented that the material was
not balanced as it did not discuss the range of
treatment options available for MS but focused
solely on interferon beta 1b and was promotional
which is not permitted in information provided to
members of the general public. The Committee
highlighted the provisions in Section 1.3 of the
Code which explicitly state that companies must
not promote non-approved indications to
healthcare professionals. Healthcare professionals
may request copies of materials discussing nonapproved indications, such as a copy of
information on the BENEFIT Study. However a
company must not proactively promote availability
of this information nor initiate its distribution.
Some members of the Committee were also
concerned that should a patient ask their doctor
whether they could receive this treatment they
would have to be advised that it was not an
approved indication, therefore not listed on the
PBS, and consequently they would have to pay for
it as a private script. This contributed to the

Committees concern that Schering had not been
transparent or balanced in the information provided
to patients or carers.
The Committee did not accept Scherings defence
that it is stated in the brochure Moving the
Treatment Goalposts that interferon beta 1b is not
approved by the TGA or listed on the PBS.
Whether TGA approval or PBS listing is stated in
the material or not, it is not permissible to promote
non-approved indications for a prescription
medicine to healthcare professionals attending an
Australia congress, and it is not permissible to
provide promotional information to members of the
general public and particularly not about nonapproved indications.
In a unanimous decision the Committee found a
breach of Section 1.3 of the Code as the Moving
the treatment goalposts in Multiple Sclerosis
brochure and DVD displayed and distributed by
Schering at the MS Conference was not balanced
and was promoting a non-approved indication.
Section 4.4
In relation to the complaint that the Schering
representatives present at the stand should have
been aware of the requirements of the Code and
were advised by Biogen representatives that the
materials being distributed were in breach of the
Code, members noted that they did not remove
them and continued to distribute them to members
of the public.
Members commented that the
Schering representatives at the conference
probably did not develop or approve the materials;
however they should have been aware that the
materials were promoting a prescription medicine to
the general public which is not permitted under the
Code or therapeutic goods legislation. Members
considered the representatives should have acted
more promptly in working with senior management
within the company to consider the matter.
A few members were of the view that an individual
representative could not be held personally
responsible for materials produced by the company
and Product Managers, Marketing and Medical
Directors should be held accountable.
However should a medical representative have any
concerns in relation to their companies materials,
there should be a culture within companies which
encouraged questioning and compliance with the
Code.
30
Betaferon 826 (contd)

A minority view was expressed that it was not
appropriate to hold the representatives at the
conference responsible for the materials they were
distributing but rather responsibility lies with
Schering management. Further, senior managers
had been involved in determining whether the
materials should be removed or not.
By a majority the Committee found a breach of
Section 4.4 of the Code as the high degree of
professionalism
expected
of
medical
representatives was not discharged.
Section 4.8
The Committee was of the view that as Schering
did not consider the material was promotional they
would not have expected that they should provide
a copy of the Product Information (PI) for
Betaferon. However a minority of members were
of the view that the material distributed by
Schering was clearly promotional. A company
should be aware that if they provide information
about a non-approved indication (on request) they
must provide a clear and prominent statement to
that effect and a copy of the Australian approved
PI.
By a majority the Committee did not find a breach
of Section 4.8 of the Code as members
considered that it would not be appropriate to
provide a PI to members of the general public as
they had not been prescribed the medicine and it
would be more appropriate to give a Consumer
Medicine Information (CMI) to a patient once the
medicine had been prescribed rather than from the
conference stand.
Section 6.3
Members were of the view that this section which
refers to the conduct of company representatives
was broader than Section 4.4 which only referred
to medical representatives. As noted in the
discussion pertaining to Section 4.4, the
Committee was of the view that all medical and
company representatives should ensure that their
behaviour does not bring discredit to the industry
and should be beyond reproach and that staff
further up the line from the medical representative
should have addressed the concerns immediately.
The Committee was concerned that Schering
withdrew the materials from their stand after a
lengthy delay only to reinstate them the next day.
The materials were also taken from the Schering
stand and distributed from the MS Society stand.
By a majority the Committee found no breach of

Section 6.3 of the Code.
Section 6.4
Members emphasised that they did not have
concerns with a pharmaceutical company
sponsoring a health consumer organization (HCO)
event or other reputable educational events on the
condition that the guidelines for awarding the
sponsorship were open and transparent and within
appropriate boundaries.
The Committee also considered that it was not
relevant for Schering to claim that the MS Society
had said they had no issues with the Schering
materials. It is Scherings responsibility to ensure
its activities and materials comply with the Code of
Conduct, not the conference organisers.
Members also commented that there was a
difference between the Moving the treatment
goalposts in Multiple Sclerosis brochure and DVD
which were Schering materials and the brochure
developed by the MS Society. It was noted that the
Schering brochure and DVD were included in the
welcome bags provided to registrants at the
conference.
The Committee found a breach of Section 6.4 of the
Code as this type of activity could bring discredit to
the industry and reflect poorly on the relationship
between the industry and a HCO.
Sections 9.4, 9.5, 9.5.1, 9.5.2, 9.5.6, 9.5.7 and 9.8
breach of all of these sections of the code:
Information brochure and DVD were promoting

a prescription medicine to the general public.
Information brochure and DVD related to a nonapproved indication.
Information brochure and DVD were not
balanced and were non-compliant as patient
educational material due to the focus on a
single treatment and were promotional.
Information brochure and DVD may cause
unnecessary alarm or misunderstanding in the
community as the indication was not approved
in Australia, not available on the PBS and
therefore costly to a patient. The material may
raise expectations beyond what is deliverable in
terms of treatment outcomes and availability of
the medicine.
31

Information brochure and DVD may also
cause alarm to a newly diagnosed patient who
may expect immediate access to the new
treatment but has to wait up to 6 months to
see a neurologist.
Section 9.8
In having found a number of breaches of the Code
in relation to the provision of promotional materials
to the general public, the Committee was of the
view that these were serious breaches of the Code
and could bring discredit to and reduce confidence
in the industry.
By unanimous decision the
Committee found Schering in breach of Section
9.8.
Section 1.7
The Committee was of the view that the claim 10
years of the most prescribed MS treatment in
Australia on the Schering banner and other
materials on display at the MS Conference was a
hanging comparison and in breach of Section 1.7
of the Code which states Hanging comparatives
those which merely claim that a product is better,
stronger, more widely prescribed must not be
used.
Sanctions
Having found a number of breaches of the Code,
including a serious breach, the Committee
considered an appropriate sanction.
The Committee determined that it was its intention
through the sanctions imposed to:
Cease further distribution of the materials
found in breach.
Recall the materials from healthcare
practitioners who had been provided with the
materials; and from the MS Society or any
other organisation who may be distributing the
materials.
Issue a corrective letter to all members of the
general public who attended the MS
Conference in March 2006 and any other
member of the public who may have received
the materials from Schering or the MS Society.
Issue a corrective letter to all healthcare
professionals who attended the MS Society
Conference and any other healthcare
professional to whom the materials were
distributed by Schering or the MS Society or
used in representative detailing.
The Committee resolved that Schering should take
immediate action for the prompt withdrawal of the
material found in breach and should permit no

further appearance of it in its present form.
Schering should also recall the materials found in
breach of the Code (Moving the treatment
goalposts in Multiple Sclerosis brochure and DVD)
from the MS Society and specialist neurologists. A
letter of explanation should be provided to the MS
Society outlining the reasons for the recall. The MS
Society should be advised to remove any access to
the DVD or brochure from its website.
The Committee further resolved that Schering
should be required to distribute a corrective letter to
all participants at the MS Conference, both
members of the public and health professional, and
any general or specialist medical practitioner who
was detailed with the brochure and DVD found in
breach. The Committee recognised that the
corrective letter to consumers should differ from that
distributed to healthcare professionals. In particular
the letter to members of the public should explain
what the Code is and why the material was in found
in breach but should not cause alarm to a patient by
suggesting that there was any problem with their
medication. The corrective letters will list all of the
breaches of the Code found. The corrective letters
are to be approved by the Chairman and members
of the Code of Conduct Committee.
Recognising that it may not be appropriate, for
privacy reasons, for Schering to have access to the
names and contact details of all conference
registrants, the company should provide the
corrective letters to the conference organiser or the
MS Society and ask that they be mailed to all
registrants on the conference data base. The cost of
mailing the letters should be met by Schering.
If it is not possible to identify all members of the
public that have been provided with the brochure
and DVD found in breach of the Code, Schering
should request that the MS Society publish the
corrective letter in the next edition of the Society
newsletter.
Acknowledging that the MS Society may not be
inclined to distribute the corrective letter as
determined by the Committee, Schering shall
provide advice to the Committee confirming whether
or not the corrective information has been
distributed as directed. If it has not been distributed
by the MS Society, Medicines Australia will write to
the Society explaining the reasons for the actions
and encourage the Societys cooperation.
32

In relation to the claim 10 years of the most
prescribed MS treatment in Australia Schering
should take immediate action for the prompt
withdrawal and should permit no further
appearance of it in its present form or a manner
which conveys the same meaning.
It was agreed that a fine of $150,000 should be
imposed on Schering as there were a number of
serious breaches in relation to the promotion of an
unapproved indication for a prescription medicine
to the general public.
The Committee noted Biogens proposal that
Schering should be banned from participating in or
holding a patient focused event for one year.
Sanctions of this type are not available to the
Committee.
Appeals Committee
An appeal was lodged by Schering against the
findings of the Code of Conduct Committee.
The following summarises the main points
presented by Schering representatives in favour of
its appeal:
The material supplied at the MS Conference
was educational and not promotional.
Schering acted promptly on the concerns
raised by Biogen at the MS Conference
Schering did not display a cavalier attitude as
suggested by Biogen.
Attendees at the MS Conference were not
members of the broad general public but
patients with MS and carers. It is acceptable
to direct materials to patients with MS which is
a life long and debilitating disease.
The content of brochure is not Scherings
views but extracts from an expert panel
discussion convened at the behest of the MS
Society.
There was minimal editing of the expert panel
discussion presentation shown on the DVD
Moving the treatment goalposts.
The
A4brochure was written by Schering but
closely reflects the statements in the DVD.
The brochure and DVD were endorsed by the
MS Society.
The provision of materials at a trade display in
the setting of the MS Society meeting is
different to a normal trade display as the
attendees are more informed than members of
the general public.
The fine imposed was punitive and excessive
Schering takes the Code very seriously and
have never been found in breach of the Code.

presented by Biogen Idec representatives in
response to the Schering appeal:
The pamphlet Moving the treatment goalposts
in Multiple Sclerosis was provided in the
conference welcome bag which went to all
meeting participants. It was also freely available
on the Schering stand, with an accompanying
DVD of the same title. The pamphlet was not
simply a transcript of the panel discussion but a
summary of certain points of that discussion
which Schering elected to highlight.
Biogen considers that whilst the DVD portrays a
discussion by experts, as soon as a company
takes the expert opinions and place it on their
stand, they take responsibility for it, regardless
of who wrote it.
The generic name interferon beta-1b is
referenced on the second page of the A4
Pamphlet (the first page with substantive text)
to the title of the "BENEFIT" study on the back
page. "Betaferon" provides the foundation for
the anagram used to describe that trial.
Therefore there is a clear link to Betaferon
brand.
Interferon beta-1b appears 25 times in the
pamphlet. Schering's logo also appears
prominently on both the front and back cover of
the DVD: an obvious link between Schering and
Betaferon / interferon beta-1b.
There are two references to Betaferon by a
member of the expert panel in the DVD.
The use of the generic name interferon beta-1b
was clearly an identifier for Betaferon and was
equivalent to the use of the brand name,
particularly where there is only one interferon
beta-1b medicine available.
The A4 pamphlet International MS Research
and Management and the corresponding DVD
of the same title were also freely available on
racks on the Schering stand for conference
participants to help themselves to. The DVD
was playing on the flat screen television in the
Schering stand.
This brochure included a table comparing
Betaferon and Avonex, noting for all 3
endpoints listed that Betaferon was stronger.
Whilst these materials are identified as
produced by the MS Society, their appearance
on the Schering stand requires that Schering
takes responsibility for them.
The Moving the treatment Goalposts brochure
and DVD found in breach were not balanced
they focused on one treatment Interferon
beta-1b.
33

The indication being promoted in the materials
is not approved in Australia.
The material is unbalanced they do not
mention a product which is approved for early
use in MS Avonex for mono-focal
symptomatic MS.
Educational materials for the general public
must not be promotional or contain
comparative claims, as these materials do.
Biogen agrees that the statement Most
prescribed treatment in Australia is a hanging
comparative and a clear breach of Section 1.7.
Reaction of Schering's representatives was
inappropriate as they did not take immediate
steps to remove the materials from the stand.
Schering withdrew the materials after a
lengthy delay only to reinstate them on the
stand the next day. Biogen considers that this
was a breach of Section 4.4 and 6.3.
Material still appears on the Multiple Sclerosis
Australia ("MSA") website.
Biogen considers it irrelevant that the MS
Society was not concerned by the material.
MS Australia is not required to monitor
compliance with the Code.
Biogen Idec believes the materials to be
promotional and not educational, and focus on
one product and therefore in breach of
Sections 9.4, 9.5.1, 9.5.2, 9.5.6, and 9.5.7.
The materials may cause alarm for any patient
who had not been placed on therapy after the
first event to meet the sense of urgency
suggested in the materials.
It also raises expectations beyond what is
deliverable in terms of treatment outcomes
and availability of interferon beta-1b for the
indication which is not approved or reimbursed
The materials stimulate demand for interferon
beta-1b 250mcg which does not have TGA
approval for this indication nor PBS
reimbursement.
Biogen considers the breaches to be flagrant
and bring discredit on the industry, and
therefore in breach of Section 9.8.
Materials potentially in breach of section 22(5)
of the Therapeutic Goods Act 1989
(advertising an unapproved indication).
Biogen considers the sanctions imposed were
appropriate, and suggested that the Appeals
Committee
should
impose
additional
sanctions.
Consideration of the Appeal
The Appeals Committee agreed that patients and
carers should be able to access reliable, balanced
and non promotional information about a specific

condition or disease. However members were
cognisant that there is a difference between
company developed materials such as the Moving
the treatment goalposts DVD and pamphlet and
information that is prepared and developed by a
health consumer organisation (HCO). A HCO can
develop information on all available treatments for a
particular condition or disease and include the
brand names for the medicines. This information,
whether a pamphlet, DVD or website can be
provided by the HCO to all members of their
association irrespective of whether they have been
prescribed a specific medicine.
The Code of
Conduct does not apply to the materials or activities
of a HCO.
In contrast a pharmaceutical company cannot
develop or distribute material that focuses on a
particular product to members of the general public.
If a patient has been prescribed a medicine they
can be provided with company produced
information on that medicine, described as a
Patient Aid under the Code, which may assist in
understanding the particular condition or disease
and aiding compliance. As set out in the provisions
of the Code these materials must not include
comparative statements or promotional claims.
The Committee noted that the definition of general
public or consumers in the Code is persons other
than healthcare professionals. This definition is
broad and includes both a sub group of the public,
such as members of a HCO, or every member of
the general public. Members also commented that
not all persons registered for the MS Society
conference were patients who had been prescribed
Betaferon.
The Committee discussed whether the material
should be considered as promotional material or
non-compliant
educational
material.
Whilst
acknowledging that if it contained promotional
statements it could not be educational material as
defined in the Code, members were of the view that
the Code Committee had not been in error to review
them against the provisions of the Code as Patient
Education. It was noted that these provisions (eg.
9.5.1, 9.5.2) reflected many of the same concerns
as were covered in Section 1 of the Code (eg. 1.3,
1.7) such as whether material is balanced or
includes comparative statements. The fact that the
same material, if regarded as non-compliant
educational material under Section 9 might be found
not to comply did not mean a Member was exposed
to double jeopardy if consideration was also given
to the material under the corresponding provisions
34

of Section 1, provided this was recognised when
determining any sanction.
Section 1.3
The Appeals Committee unanimously concurred
with the Code of Conduct Committees decision
that the materials were in breach of Section 1.3 of
the Code as it is not permissible to promote nonapproved indications for a prescription medicine to
healthcare professionals attending an Australian
congress, and it is not permissible to provide
promotional information to members of the general
public and particularly not to promote nonapproved indications.
Section 1.7
Following discussion on the definitions for
hanging comparison and superlatives the
Appeals Committee did not uphold the appeal in
relation to a breach of Section 1.7 for the use of
10 years of the most prescribed MS treatment in
Australia. The Committee agreed that most
prescribed is ambiguous and could be interpreted
in several ways.
Section 4.4
The Committee discussed at length who has
responsibility for materials that are distributed at a
trade display. Members were of the view that
while having knowledge of the Code, medical
representatives would not have the authority to
remove items that had been approved by senior
company staff. The Committee acknowledged that
there was a disparity between the complainant
and respondent on the length of
time taken to
respond to Biogens concerns and the behaviour
of company representatives at the conference.
The Committee did not consider that there was a
breach of Section 4.4 of the Code.
The Committee upheld the appeal by Schering in
relation to the breach of Section 4.4 of the Code.
The Committee was of the view that Section 6.3
was more relevant to the activities of all company
representatives, including senior management,
and may have upheld a finding of a breach in
relation to this section of the Code. However, as
the Code of Conduct Committee had elected to
find no breach of Section 6.3, the Committee did
not take this into consideration when determining
the sanction.
Section 6.4
The Committee did not uphold the appeal in
relation to Section 6.4 as members were of the
view that it is the responsibility of a pharmaceutical

company to ensure that all materials that they
produce or distribute from their trade display are
compliant with the Code and can withstand public
scrutiny and are intended to support the quality use
of medicines.
Sections 9.4, 9.5, 9.5.1, 9.5.2, 9.5.6, 9.5.7
Having previously discussed whether the materials
were promotional material or non compliant patient
education, members agreed that as Schering had
argued that the intent was educational the Appeals
Committee considered that the materials did not
comply with the requirements for educational
materials and therefore did not uphold the Schering
Appeal in relation to Sections 9.4, 9.5, 9.5.1, 9.5.2,
9.5.6, 9.5.7.
The Committee did not accept Scherings argument
that the materials were not broadcast to the general
public. The definition of general public doesnt
mean all members of the public have to be exposed
to the material. Also, even if the sub-group of
patients is well-informed, a company may not
promote a particular medicine to them.
As set out in the minutes of the Code of Conduct
Committee meeting members concurred that the
information brochure and DVD Moving the
treatment goalposts were:
Promoting a prescription medicine to the
general public;
Promoting a non-approved indication;
Not balanced; and
Non-compliant as patient educational material
due to the focus on a single treatment and were
promotional.
Members also noted that the materials may:
Cause unnecessary alarm or misunderstanding
in the community as the indication was not
approved in Australia, not available on the PBS
and therefore costly to a patient. The material
may raise expectations beyond what is
deliverable in terms of treatment outcomes and
availability of the medicine.
Also cause alarm to a newly diagnosed patient
who may expect immediate access to the new
treatment but may have to wait up to 6 months
to see a neurologist.
Section 9.8
The Committee did not uphold the Schering appeal
in relation to the breach of bringing the industry into
disrepute as the Therapeutic Goods Act and the
Code clearly state that prescription medicines must
not be promoted to the general public. In addition
35

non-approved indications must not be promoted to
healthcare professionals or members of the
general public.
The provision of promotional material to members
of the general public is seen as an activity that
would bring discredit upon the industry or reduce
confidence in the industry and is treated as a
severe breach.
Sanctions
Having not upheld all but one aspect of the appeal
the Committee then reviewed the sanctions
imposed by the Code of Conduct Committee.
The Committee did not consider that the finding of
no breach of Section 4.4 mitigated the other
findings of breaches of the Code.
The Committee agreed that the sanctions as
imposed by the Code of Conduct should remain:
Cease further distribution of the materials
found in breach;
Recall the materials from healthcare
practitioners who had been provided with the
materials; and from the MS Society or any
other organisation who may be distributing the
materials;
Issue a corrective letter to all members of the
general public who attended the MS
Conference in March 2006 and any other
member of the public who may have received
the materials from Schering or the MS Society;
professionals who attended the MS Society
Conference and any other healthcare
professional to whom the materials were
distributed by Schering or the MS Society or
used in representative detailing.
The Committee agreed that the fine of $150,000
imposed by the Code of Conduct Committee
should remain.
36
Lucrin (827)
Subject Company: Abbott Australasia Pty Ltd
(Abbott)
Complainant: Mayne Pharma Limited (Mayne)
Product: Lucrin
Complaint:
Materials circulated by Abbott contained
misleading claims, hanging comparatives and
unqualified superlatives which impacted on the
understanding of clinicians prescribing Lucrin, as
well as some technical breaches.
1.2.2 Level of substantiating data
1.5 Unqualified superlatives
decision:
3 claims: Majority breach of Section 1.2.2 of
the Code x 2 and unanimous no breach of
Section 1.2.2 of the Code x 1 (Decision
3 claims: Majority breach of Section 1.3 of the
Code x 2 and unanimous no breach of Section
1.3 of the Code x 1 (Decision confirmed by the
Appeals Committee)
Majority no breach of Section 1.5 of the Code
Sanctions:
Withdraw material found in breach of the Code
Corrective letter to urologists and general
practitioners who received the material found
in breach of the Code
Fine $10,000
The Committee noted that there are currently
three marketed luteinising hormone-releasing
hormone (LHRH) antagonists available in
Australia:
Zoladex AstraZeneca
Lucrin Abbott Australasia
Eligard Mayne Pharma
Following advice from a general practitioner

member of the Code of Conduct Committee who
had received the promotional material it was
accepted that the audience for this item had not
been exclusively urologists. The Committee also
noted that the materials referred to more
convenient for you and simpler for your GPs to
administer implying that it was only for urologists.
Members noted that whilst a urologist might initiate
treatment with an LHRH antagonist, often the GP
then continues to administer the treatment.
The Committee reviewed the wording in both the
package insert and the promotional item.
Package Insert
A simpler way to administer Lucrin Depot
The Lucrin Depot PDS has been designed to
allow for:
Simpler preparation
Easier administration
Enhanced
physician
and
patient
convenience
The Lucrin Depot PDS (Prefilled Dual-chamber
Syringe) is a self contained unit dose system
designed to replace the Lucrin Depot vial and
ampoule delivery system.
Promotional Item
Lucrin PDS: Simply Responsive
The Lucrin PDS has been launched in response
to your requests for a delivery device system
that is:
More convenient for you
Simpler for your GPs to administer
Preferred by your patients
Lucrin PDS gives you the convenience of a selfcontained syringe that replaces the vial and
ampoule system
Some members of the Committee were of the view
that that the promotional item did not make it clear
that the claims were in relation to the new delivery
device in comparison with the previous Lucrin
device and not a comparison with other products
within the therapeutic class. They were also of the
view that the material was designed to create
ambiguity and encourage prescribers to change to
Lucrin from another LHRH product.
37
Lucrin 827 (contd)

Section 1.2.2
The Lucrin PDS has been launched in
response to your requests for a delivery device
system that is:
By a majority the Committee found the first and
second claims in breach of Section 1.2.2 of the
Code. In a unanimous decision, the Committee
found the third claim to be in breach of Section
1.2.2. Members were of the view that there was no
data to substantiate the claims.
Section 1.3
The Lucrin PDS has been launched in
response to your requests for a delivery device
system that is:

By a majority the Committee found the first and

second claims in breach of Section 1.3 of the
Code. In a unanimous decision the Committee
found the third claim in breach of Section 1.3.
Members were of the view that by creating
ambiguity and not including a statement that each
claim was in relation to the new delivery device
compared with the previous Lucrin device it had
the potential to mislead.
Section 1.5
Simply Brilliant
Section 1.5 of the Code in relation to this
statement. Members were of the view that Simply
Brilliant did not imply that the product was unique,
the only one or that it had special merit. Members
also commented that it did not imply that
competitor products were not equally as
efficacious. The Committee was not convinced
that the words would have an impact on a
prescribing decision.
In relation to the referencing of the claims to the
package insert, the Committee considered that the
wording in the package insert more accurately
reflected the comparison between the previous
and new product presentation. However, whilst
the package insert was likely to have been
approved by TGA, this was an insufficient basis on

which to reference the claims.
Sanctions
the Committee considered an appropriate sanction.
The Committee unanimously determined that Abbott
should take immediate action for the prompt
withdrawal of the material found in breach and
should permit no further appearance of it in its
present form.
By a majority, the Committee also determined that
Abbott should issue a corrective letter to all
urologists and general practitioners who had
received the brochure stating that Abbott had been
found in breach of the Code since the claims were
misleading with respect to the comparison with
other LHRH products and some had not been
substantiated. The corrective letter should be sent
within 30 days of finalisation of the complaint.
The sanction also included a requirement for Abbott
to pay a fine of $10,000.
Appeals Committee
An appeal was lodged by Abbott against the
presented by Abbott representatives in favour of the
Abbott appeal:
LHRH treatments are administered to patients
with non-curable prostate cancer.
Prostate cancer is a chronic condition in which
patients remain on therapy until they die.
The promotional material was designed to
introduce the new Lucrin Pre-filled Dualchamber Syringe (PDS) and was not intended
to compare different products. It was designed
to outline the mixing instructions.
The audience for the promotional material was
primarily urologists, oncologists and radiation
oncologists who initiate Lucrin therapy.
General practitioners do not initiate LHRH
therapies, nor do they switch LHRH therapies.
General practitioners continue maintenance
therapy.
Specialists rarely switch between different
LHRH therapies.
Specialists rarely switch between doses of the
same therapy.
The material included no switching protocols.
38
Lucrin 827 (contd)

If the intent was to drive LHRH switching by
the prescribing doctor there would have been
other information:
Switching instructions
Clinical information relating to the

switching process
Switching instructions for patient and his

family
Reference
to
differences
between
products recommending reasons for a
switch
All claims were referenced in accordance with
the Code requirements.
Abbott questioned why is it necessary to have
high level supporting data to say something is
more convenient.
Abbott received many
complaints from doctors about broken
ampoules and from patients who have to
return to the pharmacy to purchase another
vial and ampoule.
Abbott had offered to amend the materials to
remove any possibility of ambiguity about the
intended message but Mayne Pharma
rejected this offer.
The Code of Conduct Committee erred in not
taking into consideration Abbotts offer to
amend the material.
Website is being reviewed.
In discussion the following points were raised:
The promotional material was aimed at
doctors initiating treatment with Lucrin PDS
based on the simpler and easier to use
presentation.
Abbott asserted that the Lucrin PDS package
insert had been approved by the TGA and is
an appropriate reference for the claims.
presented by a Mayne representative in response
to the Abbott appeal:
The claims found in breach are misleading
and ambiguous due to the omission of an
explicit statement or visual that states the
claims are in reference to Abbotts products.
Abbott have not provided any further evidence
in their appeal document or presentation to
support their case.
Abbott did offer to make amendments to the
promotional materials however these still did
not clarify the matter there was no mention
that the PDS was replacing the Abbott vial and
ampoule system.
If all LHRH products are equally effective and
it is the delivery system that is the
differentiation between them, it is, therefore,

promotional to claim that one is more
convenient or easier to use and it must be
substantiated.
It can be argued that the Lucrin PDS has a
number of steps involved in administering the
injection and therefore is not simpler or easier
than the vial and ampoule system.
Broken ampoules are a manufacturing issue for
Abbott and are not relevant to the appeal.
Abbotts
proposed
amendment
to
the
promotional material had referenced the
package insert, which is not sufficient to support
the claims. It also omitted relevant text that the
PDS system was designed to replace the Lucrin
Depot vial.
Package insert should not be used as
substantiating evidence for a claim.
Mayne Pharma has written to the TGA seeking
clarification on the approval/non approval of
package inserts.
Abbott has no data to support claims.
The Lucrin Patient Support Program website
listed on the promotional piece compares Lucrin
and Zoladex delivery systems but does not refer
to Eligard which was on the market when the
website was meant to have been last reviewed.
Mayne alleged that this indicates a
disconnection between Abbotts claims of
intention for the promotional item.
An Abbott representative made a brief statement in

reply to the Mayne response. It was not Abbotts
intention to make claims relative to other LHRH
analogues, only to draw the attention of doctors to
the new presentation of Lucrin.
Members considered that the promotional material
found in breach of the Code and the proposed
amendments by Abbott did not reflect in full the
statements in the package insert. As stated in the
Code minutes the wording in the package insert
more accurately reflected the comparison between
the vial and ampoule system and the new pre-filled
dual-chamber syringe and had Abbott not wanted to
create any ambiguity they would have used this as
the basis for their promotional material.
Some members thought that the intent of the
promotional item was to encourage more specialists
to initiate patients on the new Abbott Lucrin PDS.
Some members proposed that Abbott could have
referred to or discussed the problems with broken
ampoules and the number of complaints they
39
Lucrin 827 (contd)

received and possibly used this as a lower form of
evidence to support the change to the new
system.
The Committee was of the view that not all
healthcare professionals would find one system
simpler to administer than the alternatives.
Members agreed that while some patients may
prefer the new system, a company must have
evidence to support a claim of a patient advantage
or patient preference for one product over another.
It was therefore open to the Code Committee to
make the findings it did that the claims required to
be substantiated and, in the absence of
substantiation and given the ambiguity, they were
misleading.
The Appeals Committee was not persuaded that
the Code of Conduct Committee had erred in its
findings and did not uphold the appeal against the
finding of a breach of Section 1.2.2.
In relation to the appeal against Section 1.3 the
Committee also agreed with the findings of the
Code of Conduct Committee and did not uphold
the appeal.
Members agreed with the Code of Conduct
Committee that use of the wording from the
package insert in the promotional material would
have avoided a misleading impression that the
statements were comparing Lucrin to other LHRH
analogue products. The Appeals Committee
considered the approval of the product by the TGA
did not constitute endorsement of the claims
made.
While Mayne Pharma had included the Lucrin
PDS patient support program website as an
appendix to their letter of complaint to Medicines
Australia, no complaint had been made
concerning this material and it was therefore not
taken into consideration by the Appeals
Committee when determining a sanction.
However, the Committee recommended that
Abbott should review the website and ensure that
it fully complies with the Code.
Sanctions
Having not upheld the appeal the Committee then
reviewed the sanctions imposed by the Code of
Conduct Committee. The Committee determined
that the sanctions should not be amended.
40
Levitra (828,829,831 and 832)

Subject Company: Bayer Healthcare (Bayer)
Complainants:
Australian Consumers Association;
A healthcare professional;
A community pharmacist; and
The TGA on behalf of a pharmacist
Product: Levitra
Complaint:
The complainants alleged that the money back
guarantee campaign, which included a website
component, would stimulate consumers to seek a
prescription for a particular prescription medicine
and would bring the industry into disrepute.
1.4 Good taste
3.9 Use of the Internet for Pharmaceutical
information
9.2 Product specific media statements
9.4 Promotion to the general public
9.5 Patient education
9.6 Patient aids
9.7 Patient support programs
9.8 and 10.5 Discredit to, and reduction of
confidence in, the industry
Code of Conduct Committee decision:
Unanimous no breach of Sections 9.2, 9.6 and
9.7 of the Code
Majority no breach of Sections 1.4, 9.4, 9.5
and 9.8 of the Code
Majority breach of Section 10.5 of the Code
Sanctions:
Cease offering the money back guarantee
Corrective letter to healthcare professionals
who had received the material offering the
money back guarantee
Corrective advertisement in all healthcare
professional journals where advertisement had
appeared for the money back guarantee
The Committee discussed the money back
guarantee campaign in relation to the Code of
Conduct and with reference to the Code
Guidelines. It noted that several of the
complainants considered that their confidence in the

industry was decreased due to the offer of the
money back guarantee. It discussed the elements
of
the
campaign,
which
included
the
encouragement of consumers visiting the whennow website to seek a Performance Pack that
could only be obtained through attending their
nominated GP who would have before him or her
the Levitra information and the materials to offer a
patient the money back guarantee.
The Committee discussed whether the campaign
was advertising Levitra directly to consumers. The
elements of the campaign available to consumers
prior to visiting their GP were not product specific
and may be regarded as disease awareness
information. The information on the when-now
website that is available to the general public
discussed erectile dysfunction and encouraged a
consumer to discuss the issue with their doctor.
One GP member of the Committee noted that the
average time between onset and treatment of
erectile dysfunction was seven years, indicating that
men were not seeking treatment for this condition.
Further a GP has the options of not prescribing a
medicine at all or prescribing a treatment other than
Levitra.
The Committee noted that the money back
guarantee was not mentioned on the consumer
website.
Members accepted that erectile
dysfunction is an important condition and the
information provided on the website was useful
information for consumers and was not productspecific.
The Committee considered the use of the flame
logo, which is a Levitra trademark, as a bullet point
indicator on the website and whether consumers
would see this as a link to a particular product.
Members overall did not consider that the flame
logo was so well known that it would be regarded as
synonymous with Levitra and therefore would not
link the bullet point logo with a specific product.
The Committee also considered the letter that a
consumer could print from the website to take to
their doctor, which is clearly branded with Bayer
and the flame logo. One member considered that
this would influence a consumer to request the
Bayer product. However, other members accepted
that a GP could select an alternative product that is
more suitable for the particular individual.
41
Levitra 828, 829, 831 & 832 (contd)

The Committee discussed the money back
guarantee offer, noting that the offer could be
made by either the GP or pharmacist when
prescribing or dispensing Levitra.
Members
thought that the money back guarantee may be an
incentive to doctors to select Levitra amongst the
PDE 5 medicines.
Some members were
concerned that the money back guarantee, which
is provided to the patient through a third party
independent of Bayer, the pharmacist or doctor,
interferes in the therapeutic relationship between
doctor and patient through encouraging a patient
to express their dissatisfaction with their treatment
to a third party with no encouragement to return to
the GP to discuss why the treatment was not
successful. Some members considered that the
campaign was not encouraging responsible quality
use of medicines. The Committee noted that
Bayer had provided testimonials from doctors in
support of the campaign, but some members were
also concerned that several complainants had
expressed concern at the instigation of a money
back guarantee in association with a prescription
medicine.
The Committee discussed the letters sent to
pharmacists and doctors advising them of the
money back guarantee, the letter to pharmacists
stating that the materials should now have been
received including the booklet of money back
guarantee leaflets. Members were concerned that
the language in the second letter to pharmacists in
particular did not suggest that that it was optional
to offer the money back guarantee but rather
suggested that the offer should be given to all
patients to whom a 4 tablet pack of Levitra was
dispensed. This appeared to be contrary to
Bayers argument that the offer was optional, to be
based on the doctors judgement that cost might
be a barrier to a particular patient filling the
prescription.
The Committee discussed the graphical elements
of the campaign, in which banana images were
used for consumer advertisements as well as
health professional advertisements. One member
of the Committee considered that the images of
bananas were in poor taste when used in
association with erectile dysfunction. Members
did not consider that the use of the images in both
consumer and health professional advertisements
was sufficient to be regarded as direct to
consumer advertising of a particular prescription
medicine.
The Committee then discussed the individual

allegations of breaches of the Code.
Section 1.4
Whilst a minority of members considered that the
banana images used in the advertisements were in
poor taste, by majority no breach of Section 1.4 was
found.
Section 3.9
The Committee considered that the information
provided to the general public via the when-now
website was appropriate educational information
about erectile dysfunction. The website did not
focus on or mention a specific prescription
medicine. If the flame logo on the website became
well known to consumers as being associated with,
and a representation of, the Levitra product it could
be regarded as indicating a specific prescription
medicine.
However, the Committee did not
consider that this was currently the case. By a
unanimous decision no breach of Section 3.9 was
found.
Section 9.2
The Committee accepted that there had been no
product specific media statement made. By a
unanimous decision, no breach of Section 9.2 was
found.
Section 9.4
By majority the Committee found no breach of
Section 9.4 of the Code because no specific product
was mentioned in the advertisements or on the
website available to the general public. A minority
of members considered that the advertisements to
consumers directing them to a website where they
can nominate a doctor from whom to receive a
Performance Pack, combined with Levitra
advertisements to health professionals should be
regarded as direct to consumer advertising of a
Section 9.5
By a unanimous decision no breach of Section 9.5
was found. The information contained on the
when-now website was considered to be
acceptable education. The Committee noted that
the website does focus on oral treatments for
erectile dysfunction, but non-oral treatments were
now considered not to be the standard approach
when treatment is required for erectile dysfunction.
Section 9.6
The Committee accepted that the materials should
not be classed as patient aids. By a unanimous
decision, no breach of Section 9.6 was found.
42
Levitra 828, 829, 831 & 832 (contd)

Section 9.7
The Committee accepted that the materials and
advertisements should not be classed as a patient
support program. By unanimous decision, no
breach of Section 9.7 was found.
Section 9.8
By majority no breach of Section 9.8 was found. A
majority of members considered that the
information available to consumers in the
advertisements and on the website would not
bring discredit to the industry or reduce confidence
in the industry. One member suggested that it
could be regarded as a positive outcome in terms
of patient safety if men were to stop taking Levitra
if it had been ineffective. A minority of members
considered that the campaign was not promoting
quality use of medicines and was solely intended
to encourage people to use a particular
prescription medicine and therefore brought
discredit to the industry.
advertisements, website and letters to

professionals who received the letters
concerning the money back guarantee offer
advising that promoting and making the offer of
the money back guarantee has been found in
breach of the Code of Conduct and has ceased.
The Committee considered that a consumer
that had received the offer prior to the activity
ceasing should have the offer honoured. The
health professionals should be advised to return
or destroy the money back guarantee leaflet
pads.
Publish a corrective advertisement in all health
professional
journals
in
which
the
advertisements about the money back
guarantee offer were published.
The Committee discussed whether a fine
should also be imposed, but by a majority
decision no fine was included in the sanctions.
Section 10.5
By majority the Committee found a breach of
The Committee
considered that whilst the testimonials provided by
Bayer supported the money back guarantee offer,
there was evidently concern amongst community
pharmacists and some doctors that the campaign
brought discredit to the professions and to the
industry.
The Committee was generally
concerned that the concept of a money back
guarantee should not be made for prescription
medicines, which are not normal consumer
products.
The money back guarantee was
considered to decrease the value of prescription
medicines and brought discredit to the industry.
The Committee was also concerned that the
content of the letter to pharmacists that followed
their receipt of the materials suggested that there
was no option but to offer the money back
guarantee, which exerts pressure on pharmacists
to make the offer and reduces their
professionalism.
Sanctions
Having found a breach of Section 10.5, which is
regarded as a severe breach of the Code, the
Committee considered an appropriate sanction.
The Committee determined that Bayer Healthcare
should:
Take immediate action to cease offering the
money back guarantee and its promotion to
healthcare professionals in the form of
43
Betaferon (830)
Subject Company: Schering Pty Ltd (Schering)
Complainant: The Sanofi Aventis Group (Sanofi
Aventis)
Product: Betaferon
Complaint:
Materials available at a MS Conference promoted
a non approved indication, were misleading and
directly promotional to members of the general
public. This complaint relates to materials
distributed at the same conference as Betaferon
826, some of which were considered in complaint
826 and some additional materials not previously
considered. Additional breaches of the Code were
alleged in relation to materials previously
considered under complaint Betaferon 826.
1.3.1 Unapproved products and indications
Australasian Congresses
7.1.1 and 7.1.3 Sponsorship
9.4 Promotion to the general public
9.5, 9.5.1, 9.5.2, 9.5.6, 9.5.7 Patient education
in, the industry
This complaint was considered over the July,
August and September 2006 Code of Conduct
Committee meetings.
decision:
Trade display banner breach of Section 1.7

of the Code (Decision confirmed by the
Appeals Committee)
Update leaflet no breach of Sections 1.3
and 1.7 of the Code; breach of Sections 9.4,
9.5, 9.5.1, 9.5.2, 9.5.6 and 9.5.7 of the Code
(Decision
confirmed
by
the
Appeals
Committee)
Update 2 no breach of Sections 9.4, 9.5,
9.5.1, 9.5.2, 9.5.6, 9.5.7 and 9.8 of the Code
Leaflet already found in breach of
Sections 1.3, 9.4, 9.5, 9.5.1, 9.5.2, 9.5.6,
9.5.7 and 9.8 of the Code under complaint 826

not considered by the Committee. However a
breach of Section 1.2.2 of the Code was found
Sponsorship of MS Australia breach of
Sections 6.4 and 7.1.1 of the Code (Decision
Sponsorship Guidelines breach of Sections
7.1.1 and 7.1.3 (Decision amended by the
Appeals Committee no breach)
Presentation no breach of Section 7 of the
Code
Cochrane review no breach of Sections
1.3.1, 1.7, 9.4, 9.5.2 and 9.5.6 of the Code,
breach of Sections 1.3, 9.5.1, 9.5.6 and 9.8 of
the Code (Decision confirmed by the Appeals
Committee)
Sanctions:
Cease distribution of the materials found in
breach of the Code (Decision confirmed by the
Appeals Committee)
Write to MS Australia (Decision confirmed by
Amend and expand company guidelines for
sponsorship and grants (Decision amended by
the Appeals Committee no requirement that
Schering should submit the amended guidelines
to the Code of Conduct Committee)
Pay a fine of $100,000 (Decision confirmed by
Consideration of the Complaint:
July 2006 meeting
The Committee noted that Schering had requested
that the letter from Sanofi Aventis which
accompanied the complaint and complaint summary
should not be provided to the Code of Conduct
Committee. However, it had been determined that
all materials submitted by Sanofi Aventis should be
provided to the Committee, which would give the
materials the weight they deserve.
The Committee determined to consider each item of
the complaint in the order given in the complaint
summary document provided by Sanofi Aventis. It
noted that some of the materials subject to this
complaint had already been dealt with in complaint
826. The Committee confirmed that if a complaint is
about the same conduct and in relation to the same
44

section of the Code previously complained of, it is
not open to the Committee to impose a new
sanction.
Trade display banner
10 years of the most prescribed MS treatment
in Australia.
This item was found in breach of Section 1.7 in
complaint 826. Therefore the Committee did not
make a further finding in relation to this section of
the Code.
Sanofi Aventis had also alleged this claim was in
breach of Section 9.4. The Committee considered
that the statement on the trade display banner was
a promotional statement and would encourage a
member of the general public to seek a
prescription for a particular medicine.
The
Committee acknowledged the comparative nature
of the statement as formerly found in breach. The
Committee unanimously found a breach of Section
9.4 of the Code.
Update leaflet International MS research and
Management and DVD presentation by Jack
Burks MD
The Committee noted that it had previously
considered this material in complaint 794 which
related to distribution of the materials to healthcare
professionals. In the present complaint (830) the
material had been distributed to members of the
general public at the MS 06 Conference.
The Committee discussed whether Schering
should be responsible for the opinions of an
independent third party presented in materials that
are identified as being produced by MS Victoria.
The Committee determined that Schering is
responsible for all materials it made available from
its display stand at the conference, whether
produced by it or someone else.
Sanofi Aventis had alleged that the brochure and
accompanying DVD included both favourable
comparisons of Betaferon and other treatments.
The Committee first considered the comparisons
included under the heading New direct
comparisons.
The Cochrane Review was
considered later.
The Committee considered that the materials
presented the opinion of Dr Burks, which was
favourable towards Betaferon, stating that
Betaferon was stronger than Avonex.
The
Committee considered that the provision of this
material to members of the public by Schering was
promoting Betaferon to consumers.
The Committee concluded that no breach of

Sections 1.3 or 1.7 should be found because the
Committee accepted that the statements concerning
Betaferon, Avonex and Rebif contained in the
material were Dr Burks opinion and may be
defensible.
However, with respect to Sections 9.4, 9.5, 9.5.1,
9.5.2, 9.5.6, 9.5.7 and 9.8, the Committee
considered that the provision of this material, which
provided favourable comparative statements about
Betaferon, to consumers, was promoting the
product to consumers. Whilst some of the material
was educational, it was not balanced; it focused on
a particular product, Betaferon; it may raise
unfounded hopes and may stimulate a consumer to
seek a prescription for a particular prescription
medicine. The Committee therefore, by a majority,
found that Schering was in breach of Sections 9.4,
9.5, 9.5.1, 9.5.2, 9.5.6, 9.5.7 of the Code. The
Committee considered that provision of the material
to members of the public brought discredit to the
industry and therefore found a breach of Section
9.8.
Update 2 International perspective. Progress in
MS Research and associated DVD
Sanofi Aventis had alleged that the reference to use
of Tysabri in MS in these materials was promoting
an unapproved product. The Committee did not
agree that the statements about Tysabri were
promotional because they clearly identified that this
product had caused deaths. The Committee noted
that Tysabri had been withdrawn from the market.
No breach of Section 1.3.1 was found.
The Committee considered that the brochure and
DVD were balanced, mentioned the range of
medicines and treatments available for MS and did
not focus on a particular treatment. The Committee
considered that this was acceptable educational
material. No breach of Sections 9.4, 9.5, 9.5.1,
9.5.2, 9.5.6, 9.5.7 or 9.8 was found.
Leaflet
Moving the treatment goalposts in multiple
sclerosis and accompanying DVD
The Committee noted that it had previously
considered these materials in complaint 826 in
which breaches of Sections 1.3, 9.4, 9.5.1, 9.5.2,
9.5.6, 9.5.7 and 9.8 had been found. Therefore, the
Committee did not make any further findings in
relation to these sections of the Code, including
Section 1.3.1.
45

The Committee commenced its consideration of
the allegation that medical representatives
employed by Schering had been using the
BENEFIT study in its interactions with neurologists
and promoting an unapproved indication. The
Committee determined that it had insufficient
information to reach a decision on this or the
remaining parts of the complaint and therefore
requested the Secretariat to obtain further
information.
Further Information requested
In accordance with Section 11.1.1 of the Code, the
Committee requested the Secretariat to obtain
further information in relation to a number of
matters.
It asked the Secretariat to request further
information about the BATTMAN Specialist
Promotion Monitor, which had been included in the
complaint, from both Schering and Sanofi Aventis.
Specifically the Secretariat should request
information about how the BATTMAN data is
collected in particular, what questions were
asked of the neurologists by IMS who conduct the
BATTMAN market research and what their
methodology is - and what the data represents.
In addition, Schering Pty Ltd should be asked
whether its representatives had been using the
Moving the Treatment Goalposts in Multiple
Sclerosis in their interactions with neurologists
and/or general practitioners in the field.
The Secretariat was also asked to request
information from Schering on their sponsorship
relationship with MS Australia. Section 7.1.3
requires that companies have clear guidelines for
the awarding sponsorship which are capable of
being disclosed to the Code of Conduct
Committee if required. Therefore the Schering
Sponsorship Guidelines should be requested. The
Committee further requested advice setting out the
nature and terms of Scherings long standing
sponsorship of MS Australia (excluding the
monetary amount of the sponsorship).
Sanofi Aventis and Schering had each provided a

response to the Committees request for information
concerning the methodology and interpretation of
the BATTMAN data. Schering had not provided any
information about its sponsorship of MS Australia
and had expressed some concerns about the
request for this information and the validity of Sanofi
Aventis complaint.
Leaflet
sclerosis and accompanying DVD and the
promotion of BENEFIT and tracking in
BATTMAN
Schering had also acknowledged that it had used
the Moving the treatment goalposts in Multiple
Sclerosis brochure, prior to the finding of the
Committee on 15 May 2006, in its interactions with
neurologists but not with general practitioners.
Committee Members noted that in the Schering
response to the request for information on the use
of the Moving the treatment goalposts they
advised that they had not used this material since
the finding of a breach of the Code in the previous
complaint. Members were of the view that it was not
possible to authenticate who had initiated the
discussion which resulted in comments from
specialists in the BATTMAN data. It was also noted
that it is not disclosed who has contributed their
information to the BATTMAN survey and therefore it
would not be possible to ask the neurologists
whether a representative had initiated discussion of
the BENEFIT study.
Some members of the Committee expressed a
reservation that Sanofi Aventis was relying on
comments from healthcare professionals in
BATTMAN which are not conclusive or instructive.
However other members were of the view that as
Schering had acknowledged that they had been
distributing the brochure which included claims
solely based on a poster and abstract this was a
breach of Section 1.2.2 of the Code.
After further discussion the Committee unanimously
concluded that a breach of Section 1.2.2 of the
Code should be found.
August 2006 Meeting

Additional information was received from Sanofi
Aventis on 9 August 2006 and from Schering on
10 August 2006, which was provided to the
Committee for its further consideration of
complaint Betaferon (830) at the 21 August 2006
meeting.
Live presentation by Jack Burks

In relation to the Jack Burks presentation, members
commented that views on alternative treatment
options should not be stifled, however it was of
concern that there was no disclosure by the
presenter of his relationship with Schering. All
members agreed that disclosure is not only a
professional responsibility it was also imperative
46

that a pharmaceutical company disclose this to
any Health Consumer Organisation (HCO)
involved in a sponsorship arrangement. The
Committee determined that this issue should be
considered in the context of the complaint
concerning Scherings sponsorship of MS
Australia.
Sponsorship of MS Australia
The Committee was disappointed that Schering
Pty Ltd had not provided the information about its
sponsorship of MS Australia as was requested
following the July 2006 Committee meeting.
The Committee was of the view that it would be a
very serious matter for a company to use a health
consumer organisation as a conduit to engage in
promotional activities directed to consumers.
The Committee noted Scherings concern stated in
its letter of 10 August 2006 that Sanofi Aventis had
not sufficiently made out their complaint.
However, the Committee considered that it had
received a valid complaint from Sanofi Aventis and
was empowered by the Code to fully investigate
the complaint and to determine whether any
breach had occurred.
Members agreed that many health consumer
organisations (HCO) receive financial support and
unrestricted
educational
grants
from
pharmaceutical companies to conduct programs
for their members. The Committee was of the
view that such relationships should comply fully
with the requirements of the Code (specifically
Section 7) and should be guided by the publication
Working Together A Guide to relationships
between Health Consumer Organisations and
Pharmaceutical Companies which was developed
following lengthy consultation between the
Consumers Health Forum, HCOs and Medicines
Australia.
The Committee did not accept that the details of a
sponsorship relationship should be held out as
being confidential from the Committee when it has
received a complaint. Section 7.1.3 of the Code
requires companies to have guidelines for
awarding sponsorship and these must be available
for public disclosure. With respect to a specific
sponsorship arrangement, the details would not be
disclosed by the Committee to any other party. It
only requires the information in so far as it is
necessary to determine the complaint.
All
permanent members of the Committee have
signed confidentiality undertakings. The rotating
members receive the agenda papers on the
undertaking that all papers are to be kept

confidential.
The Committee asked that the Secretariat draft a
further letter to Schering, to be approved by the
Chairman of the Code Committee, requesting the
following information to be provided in accordance
with Section 11.1.1 of the Code:
A copy of the Schering Pty Ltd Sponsorship
Guidelines; and
Information setting out the nature and terms of
Scherings sponsorship of MS Australia as it
existed in March 2006 at the time of the MS
Conference, including a copy of any
sponsorship agreement or other document
which sets out the nature and terms of the
sponsorship and the amount of financial support
provided in the last financial year.
Failure to provide this information would appear to
be a breach of Section 11.1.1 of the Code in these
circumstances.
September 2006 meeting
Additional information was received from Schering
on 8 September 2006, which was provided to the
Committee for its consideration at the September
meeting.
The Committee reviewed the Sponsorships and
Grants Guidelines provided by Schering. The
Committee considered this to be a fairly scant and
short document. It was expected that there would
be more detailed guidelines on the criteria for
allocation of sponsorship and the approval
processes within the company for sponsorship
grants. It was particularly noted that numbered
point 2 (first occurring) in the document omitted any
reference to conformity with professional and
community standards for ethics as is required by
clause 7.1.1 of the Code for sponsorship. This was
considered to be a significant omission. Whilst the
document states that sales and marketing
managers must adhere to the guidelines, there is no
guidance on how this might be assured or what
would or would not be appropriate sponsorship.
The Procedure and Allocation section of the
Guidelines is concerned with the internal allocation
of money and budget management, but does not
deal with appropriate criteria for allocation of
sponsorship in terms of enhancing quality use of
medicines or medical knowledge or ensuring no
discredit is brought on the industry.
47

The Committee concluded by a majority that the
Schering sponsorship and grants guidelines were
inadequate and did not adequately reflect the
requirements of Section 7.1.1 of the Code and
therefore were in breach of Section 7.1.3 of the
Code.
The Committee reviewed the information provided
by Schering about its sponsorship of MS Australia
and the MS Society State organisations. From the
information provided it appears that Schering had
contributed the significant majority of the
sponsorship for the MS 06 conference obtained
from pharmaceutical companies and was identified
as the principal sponsor. Schering was evidently
the event partner, however it was unclear from the
materials provided to the Committee what specific
activities at the conference were identified as
sponsored by Schering, such as the conference
dinner. It was also unclear from the information
provided what control or influence Schering had
over the conference program and content. It was
noted that the letter from the MS Society to
Schering inviting sponsorship identified that
Schering could sponsor one of the major
addresses at the conference. Sanofi Aventis had
also stated that as a minor sponsor of the event it
had been given the opportunity to nominate a
speaker of its choice for the event.
The Committee concluded, by a majority, that
Scherings sponsorship of the MS Conference was
not able to successfully withstand public and
professional scrutiny and therefore was in breach
of Section 7.1.1 of the Code. The Committee was
concerned that in light of the activities undertaken
by Schering at the conference, including
distribution by Schering of brochures produced by
the MS Society that had been found by the
Committee to be promoting a particular
prescription medicine to consumers, it could be
perceived that MS Australia was acting as an
agent for Schering whether or not this was actually
the case.
The Committee did not raise any concerns about
the amount of sponsorship provided to the MS
Society State organisations for different activities
and projects however it noted that the Working
Together guideline developed by CHF, Medicines
Australia and HCOs recommended that multi-party
relationships were preferable as this helps avoid
any perception that one sponsor has an undue
influence on a health consumer organisation.
The Committee discussed whether Scherings

sponsorship of the MS Society Conference in March
2006 met the requirements of Section 6.4 of the
Code, with particular reference to the Explanatory
Notes.
Whilst it could be accepted that the
conference sponsorship was to enhance medical
knowledge, the Committee considered that it did not
meet the other tests described in the Explanatory
Note to Section 6.4 Scherings activities at the
conference involved promotion of a prescription
medicine to consumers which was not consistent
with the principles of quality use of medicines;
brought discredit on the industry; and could not
successfully withstand public, professional or
community scrutiny. By a majority the Committee
determined that the sponsorship of the conference
was in breach of Section 6.4 of the Code.
The Committee noted that Schering had been found
in breach of Section 6.4 of the Code in relation to
the distribution of the Moving the treatment
goalposts in MS brochure and DVD at the MS 06
conference in complaint MS Conference 826. In the
current complaint the finding in relation to Section
6.4 was in relation to different conduct, the
sponsorship of the conference.
Presentation by Jack Burks MD
The Committee noted the document provided by Dr
Burks in which he stated his independence from
Schering and that Schering had no opportunity to
review his presentation to the MS 06 conference
before it was delivered. The Committee determined
that there was no evidence in the documentation
provided to indicate that Schering had any influence
over statements made by Dr Burks. By unanimous
decision, no breach of Section 7 was found.
Misleading use of Cochrane review of glatiramer
acetate
The Committee noted that the brochure Update
International MS Research and Management was
published following the 2004 MS Conference and
included a section on the Cochrane MS Review and
findings concerning Schering's product Copaxone.
It further noted that new data had subsequently
become available and, whilst there had been some
debate in the medical literature concerning the
original Cochrane Review, there had been an
opportunity to incorporate the new information in a
revised brochure.
The Committee noted that Schering had distributed
the Update brochure from its stand, although the
Committee understood that MS Victoria was
identified as the publisher.
The Committee
determined that Schering is responsible for all
48

materials it made available from its display stand
at the conference, whether produced by it or
someone else. The Committee considered that
the 2004 Update brochure was not up to date and
was not balanced. By a majority decision, the
Committee found Scherings distribution of this
information was a breach of Section 1.3.
By unanimous decision, no breach of Section
1.3.1 was found. The Committee did not consider
that the statements concerning Copaxone were
comparative.
No breach of Section 1.7 by
unanimous decision.
The Committee did not agree that the statements
in the brochure in relation to Copaxone were
promoting the product to consumers.
By
unanimous decision, no breach of Section 9.4 was
found.
The Committee considered the brochure in terms
of the requirements for patient education
materials.
The Committee unanimously
determined that the brochure was not current or
balanced and was therefore in breach of Section
9.5.1.
The Committee did not agree that the brochure
focused on a particular product. By unanimous
decision, no breach of Section 9.5.2 was found.
The Committee considered that patients taking
Copaxone could be alarmed by the statements
contained in the brochure. By majority decision, a
breach of Section 9.5.6 was found.
By unanimous decision, no breach of Section
9.5.7 was found as it did not consider that the
statements in relation to Copaxone would raise
unfounded hopes of successful treatment or
stimulate demand for prescription of Copaxone.
Because Schering had distributed this brochure to
consumers at the MS 06 conference, in relation to
the statements contained therein on Copaxone
which were not current or balanced, the
Committee considered that this brought discredit
to the industry. By majority decision, a breach of
Section 9.8 was found.
The Committee noted that Schering had alleged
that Sanofi Aventis should be found in breach of
Section 12.3 (Abuse of the Code). In light of the
range of other matters alleged in this complaint
and upheld by the Committee, it did not consider
that the complaint was frivolous or vexatious.
Sanctions
including Section 9.8 which is regarded as a severe
breach of the Code, the Committee considered an
appropriate sanction.
It determined that Schering should cease
distribution of the brochures, DVDs found in breach
and cease use of the trade display banner found in
breach.
The Committee debated at length whether a
corrective letter should be sent to healthcare
professionals and consumers who attended the MS
06 Conference. It concluded that it would be more
appropriate for Schering to write to MS Australia
advising that Schering has been found in breach of
the Code and to request that the MS Society update
the information that has been identified as being not
accurate or balanced. This letter is to be approved
by the Code of Conduct Committee Chairman.
The Committee also determined that Schering
should amend and expand its Guidelines for
sponsorship and grants to ensure that these comply
with the Code. These updated Guidelines should
be provided to the Committee for its review within 3
months of receiving the minutes of the meeting.
By unanimous decision, the Committee determined
that a fine of $100,000 should also be imposed.
In its consideration of this complaint the Committee
ensured that it was not rehearing matters that had
already been considered in complaints 794 and
826. No matters determined in complaint 830 were
a repeat of a previous breach.
Appeals Committee
An appeal was lodged by Schering against the
The Appeals Committee was advised that Schering
had sent an email to Medicines Australia as follows:
I wish to advise that no one from Schering P/L will
be in attendance at today's Appeals Subcommittee
meeting. We will let our written commentaries speak
for themselves.
presented by Sanofi Aventis representatives in
response to the Schering appeal:
Sanofi Aventis agrees with the findings of the
Code of Conduct Committee.
49

The materials subject to the complaint breach
the Code because they:
Involve direct to consumer advertising of a

prescription medicine;
Give misleading and biased information,

that is out of date, misleads by omission
and is not reflective of the body of
evidence;
Promote unapproved indications to

healthcare professionals and consumers;
and
Rely on unpublished study data.

Schering seeks to avoid the Code through
inappropriate sponsorship of MS Australia.
Sanofi Aventis finds it hard to understand that
Schering continues to maintain that the
material is educational and not promotional.
The trade display banner is obviously
promoting Betaferon.
The Update Leaflet 1 includes a disparaging
discussion of Copaxone which relies on
material that does not reflect the data for the
approved indications. Further, there was no
mention of the Cochrane review of interferons,
which is misleading by omission.
The Moving the treatment goalposts brochure
promoted an unapproved indication and dose
for Betaferon to MS patients and healthcare
professionals and relies on unpublished data
a poster and panel discussion.
Update Leaflet 2 includes a discussion on
Tysabri which is focussed on patient deaths
this amounts to fear mongering and is
unsuitable for the general public.
Scherings activities do not withstand public
and professional scrutiny.
It does not matter that some of the materials
were produced by MS Australia.
It is irrelevant that comments about
unapproved uses were provided by experts
It is irrelevant that Betaferon was not named
as the specific drug in all cases.
It is of concern that Schering maintains that
the materials are educational and that the
content of the materials distributed by
Schering is not their responsibility but that of
MS Australia.
Sanofi Aventis emphasised that their
complaint is against Schering, not MS
Australia.
Sponsorship must be appropriate, transparent
and withstand scrutiny.
Sponsors must take responsibility for their
sponsorship or cease that relationship.
Promotional material is easy to distinguish from

educational material.
The frequent and consistent use of materials
produced by MS Australia, funded by Schering,
which routinely favour Schering and Betaferon,
is unprecedented.
Sanofi Aventis rejects the assertion that the
outcome of this complaint will affect the
continued sponsorship provided to patient
groups by pharmaceutical companies.
Sanofi Aventis considers that the Appeals
Committee should uphold the Code of Conduct
Committees decision and maintain the
sanctions.
The Chairman asked Sanofi Aventis representatives

whether Schering was responsible for the opinions
expressed by experts. Sanofi Aventis responded
that experts can state their own personal views
which cant be controlled by a company, but the
responsibility lies with a company if it then chooses
to distribute these opinions to patients and
Sanofi Aventis also noted that other companies had
been concerned at the possibility that the Code
might be breached as they had become aware of
what had been presented and offered to members
of the general public at the MS Conference in New
Zealand which was held the week before the
Australian conference. Sanofi Aventis had raised
their concern regarding the speakers and materials
with Schering prior to the MS Conference in
Australia but Schering had chosen to proceed and
to distribute the materials. Sanofi Aventis stated
that in the hierarchy of evidence an expert opinion is
at level 5 which is the lowest level of evidence.
Sanofi Aventis advised the Committee that all
companies with MS treatments had been offered
the opportunity to sponsor a session and nominate
the keynote speaker for the plenary session on
each of four days of the conference. The remainder
of the program was put together by an organising
committee. He advised that Sanofi Aventis had not
taken the opportunity to nominate a speaker as they
knew that members of the general public would be
present.
The Chairman asked whether MS patients or
carers, who may have knowledge of alternative MS
treatments, would have a degree of scepticism
about any of the products for MS. Sanofi Aventis
responded that this would be true of any patient
group, but the Code does not allow for them to be
treated any differently. Unless a person has been
prescribed a specific medicine, they cannot be
50

provided with materials discussing particular
prescription medicines, only items of general
information about the disease. The Code is there
to protect the public from the promotion of
prescription medicines.
Sanofi Aventis acknowledged that the MS patient
support group may be more discriminating and
aware than the average member of the general
public, and they had chosen to attend the
conference. However Sanofi Aventis asserted that
it was not possible to know which patient was on
which treatment and therefore Schering should not
have been providing information favourable to
Betaferon from their trade display at a conference
where members of the general public were
present. Sanofi Aventis also commented that
patients and carers were also more vulnerable
because of the nature of the disease and it was
particularly important that they were not provided
with unbalanced or misleading information or
promotional material in relation to any treatments
for MS.
A member of the Committee enquired as to
whether there was public disclosure of
sponsorship prior to the presentation by Dr Burks.
Sanofi Aventis responded that there was no public
statement that the session and speaker were
sponsored by Schering although Scherings
sponsorship of the day of the conference was
acknowledged in the program.
Another member of the Committee asked whether
Sanofi Aventis considered these activities had led
to a reduction in prescriptions for Copaxone.
Sanofi Aventis responded that it was not possible
to say this was the case. However, the feedback
from patients who were concerned that having
heard the presentation and read the materials they
should switch to Betaferon as other treatments
were not effective was the most disturbing factor in
this case. Sanofi Aventis stated that some patients
had asked the speaker after his presentation
whether they should remain on their current
treatment.
A member of the Committee asked Sanofi Aventis
whether their complaint was about the speaker or
the materials. Sanofi Aventis stated that the
complaint outlined in their written submission was
about the distribution and use of the materials by
Schering to the general public. These materials
were not balanced, were misleading, discussed
unapproved indications and doses and were
promotional rather than educational. There is a

history of production of materials DVDs and
brochures - by the MS Society that favoured
Betaferon which amounts to inappropriate
sponsorship.
In responding to another question on whether any
part of the sponsorship was appropriate, Sanofi
Aventis stated that companies can provide
unrestricted educational grants to health consumer
organisations.
However this process must be
transparent and if the sponsoring company
becomes aware that materials or programs
developed through their sponsorship were not
balanced and educational they should make the
organisation aware of the issues or withdraw their
sponsorship. It was not appropriate for a company
to continue to provide sponsorship to a patient
group or health consumer organisation where the
materials they develop favour one treatment or are
disparaging to competitor products.
Following further questions from the Committee
about what control a sponsoring company has on
the recipient of an unrestricted educational grant,
Sanofi Aventis responded that a company should
be aware of what they are sponsoring,
communicate its responsibilities under the Code to
the recipient but should not interfere with the
content. A company is accountable for the materials
it distributes.
Sanofi Aventis stated that it did not consider that
MS Australia was complicit in the production of the
materials, however material which is not balanced
or is misleading should not be distributed by a
company to members of the general public or
patients. Sanofi Aventis stated that other companies
at the MS Conference had supplied materials which
contained general information about MS but were
not product specific. Sanofi Aventis did not provide
materials for inclusion in the conference satchel
because it knew that members of the public would
be at the conference.
For the record the Chairman requested confirmation
of the dates of the materials distributed from the
Schering stand. The Committee confirmed that the
brochures and DVDs distributed by Schering at the
MS Conference in 2006 were from presentations
given at meetings held in 2004 and 2005.
The Chairman thanked the representatives from
Sanofi Aventis and asked that they retire from the
meeting to allow the Committee to deliberate on the
matters before them.
51

The Appeals Committee discussed the comments
made by Schering in paragraphs 3 and 4 of its
appeal submission. The Committee considered
that the minutes of the Code of Conduct
Committee meeting were adequate and provided
sufficient information concerning the findings. The
minutes of a Code Committee meeting never
attempt to provide a verbatim report or transcript
of what occurred in the Committee deliberations.
The Appeals Committee considered that the Code
of Conduct Committee had been careful to avoid
finding a breach in relation to the Code for conduct
that had been already considered in complaint
826. There was no foundation to Scherings
assertions that this had occurred. The Appeals
Committee did not agree that there had been a
denial of procedural fairness as asserted by
Schering.
A different complainant may raise other issues in
relation to the same material or activity if it had not
been considered by the Committee in a previous
complaint. Where conduct is found in breach in
relation to overlapping sections (and it is not
infrequent that this occurs) the outcome is
reflected in the sanctions. The Code of Conduct
Committee makes its determination and applies
sanctions related to each complaint as a whole.
The Committees also consider the factors outlined
in the Guidelines for determining Code sanctions
which is available on the Medicines Australia
website.
Members discussed the issue of cascading
complaints and whether this was an issue
Medicines Australia should address. The
Committee noted that it was an infrequent
occurrence that two complaints were received
about the same item or activity. However, where a
complaint is received that is identical to a
complaint already considered by the Code of
Conduct Committee, the complainant is provided
with this advice and referred to the Code reports
available on the Medicines Australia website. In
the event that a subsequent complaint is received
in relation to the same activity or material but
different sections of the Code are alleged to have
been breached, the Committee will consider each
aspect on its merits and apply any sanction
accordingly.
In relation to matters of procedural fairness the
Appeals Committee considered that Schering had
been offered the same opportunity to respond to a
complaint and make an appeal as any other
Subject Company in accordance with the provisions

of the Code.
Trade Display Banner
Ten years of the most prescribed MS treatment
in Australia
Members referred to Scherings statements in
paragraph 8 of its Appeal submission, asserting that
because it had been found in breach of Section 1.7
in complaint 826 it was not appropriate for the
Committee to find a breach of 9.4 and impose a
sanction in relation to the same conduct.
The
Committee was of the view that sections 1.7 and
9.4 of the Code are quite independent and the Code
of Conduct Committee was correct in considering
the allegation of a breach of Section 9.4 and making
a determination. If Biogen Idec had raised a
complaint under Section 9.4 in its complaint (826)
the Code of Conduct Committee would not have
considered this matter in complaint 830. It would
not be practicable for Medicines Australia to
disallow complaints that raise new issues in relation
to conduct that has already been considered by the
Code Committee, and would not afford
complainants natural justice.
The Appeals Committee considered that the claim
Ten years of the most prescribed MS treatment in
Australia leads to the identification of a particular
product supplied by Schering. Patients and carers
who were knowledgeable about treatments would
associate the claim with a particular product, and
those less knowledgeable would be encouraged to
enquire which product.
The Committee considered that the claim was a
promotional statement to which members of the
public were directly exposed.
The Appeals
Committee was of the view that it was inappropriate
to display this claim to members of the general
public and concurred with the findings of the Code
of Conduct Committee. The Appeals Committee
did not uphold the appeal in relation to the breach of
Update leaflet International MS research and
management and DVD presentation by Jack Burks
MD
The Committee referred to the Schering submission
paragraphs 10 to 21. In relation to the statement in
paragraph 10 of the submission, that Schering
should not be found responsible for the material, the
Committee considered that Schering is responsible
for the information it distributes to health
professionals and members of the public from its
display stand whether or not it had any editorial
control over their content.
52

The Appeals Committee agreed with the Code of
Conduct Committees assessment that the Update
leaflet and DVD communicated a favourable
comparison between Betaferon and other
treatments and were promoting Betaferon to
consumers.
The Committee did not accept
Scherings assertions that the materials were
educational, but agreed with the Code
Committees conclusion that the materials were
unbalanced
and
may
cause
alarm
or
misunderstanding. Members also referred to the
tone of the messages which were emotive and
suggested that certain treatments approved for
use in Australia do not work. The Committee was
not persuaded that the Code Committee had erred
in its findings.
The Appeals Committee discussed the finding of a
breach of Section 9.8 of the Code in light of
Scherings arguments presented in paragraphs 20
and 21 of its submission. The Committee also
referred to Section 9.8 of the Code which refers to
both activities with and materials provided to
members of the general public. The Committee
considered that a breach of Section 9.8 does not
exclusively follow from a finding of a breach of
Section 9.4, although it may do so.
The
Committee considered that Section 9.8 was
relevant to an overall view of a course of conduct
undertaken by a company which may bring
discredit to or reduce confidence in the industry.
The Committee noted that Schering had been
found in breach of Section 9.8 of the Code in
relation to distribution of the Moving the treatment
goalposts brochure and DVD in complaint 826.
The Committee considered that if the distribution
of the Update leaflet International MS research
and management at the MS06 conference were
dealt with in isolation of any other conduct, it
would bring discredit to the industry. Therefore
the Committee did not consider that the finding of
a breach of Section 9.8 should be overturned.
However, it accepted that there should not be a
double or multiple penalty applied for each finding
of a breach of Section 9.8 in relation to Scherings
conduct at the MS06 conference.
relation to the breach of Sections 9.4, 9.5, 9.5.1,
9.5.2, 9.5.6, 9.5.7 and 9.8 of the Code.
Leaflet
sclerosis and accompanying DVD
Members concurred with the findings of the Code of

Conduct Committee that claims cannot be based
solely on posters or abstracts. It was noted that the
Benefit Study had not been through a peer review
process or published. The brochure included a
promotional statement taken from the Benefit trial:
Thus the benefits of early interferon beta-1b
250mcg treatment seem clear at least throughout
the two year duration of the BENEFIT trial, as was
identified in the letter of complaint. The Committee
did not accept the arguments presented by
Schering in paragraph 24 of its submission that the
experts opinion presented in the DVD and brochure
overcame the Code Committees objection to the
inadequacy of the substantiating data.
The Committee did not uphold the appeal in relation
to the breach of Section 1.2.2 of the Code.
Sponsorship Guidelines
The Appeals Committee accepted Scherings
arguments that the Code Committee had not
sufficiently justified its findings.
The Appeals
Committee
considered
that
the
Schering
sponsorship guidelines are very scant and probably
inadequate to meet the spirit of the Code embodied
in section 7.1.1. However, there is no industry
standard for such guidelines against which the
Schering document can be evaluated. The Appeals
Committee also considered the omission of any
reference to ethics in the Schering sponsorship
guidelines to be significant.
The Appeals
Committee further noted that the remaining text of
Section 7.1.1 had been transcribed almost
verbatim.
The Appeals Committee strongly recommended
that Schering should revise its sponsorship
guidelines to better reflect both the letter and spirit
of Sections 7.1.1 and 7.1.3 of the Code. Medicines
Australia and the Consumers Health Forum of
Australia have produced guidelines for both industry
and health consumer organisations which would
inform the revision of the Schering document.
The Committee upheld the appeal in relation to the
findings of a breach of Sections 7.1.1 and 7.1.3 of
the Code in relation to Scherings sponsorship
guidelines.
The Appeals Committee agreed with the Code
Committees finding that Scherings conduct at the
MS06 conference was not consistent with Quality
Use of Medicines, involved promotion of a
prescription medicine to members of the public and
some of the materials distributed by Schering that
53

were produced as a result of its sponsorship did
not present balanced information about treatments
for MS. The Committee had also agreed with the
finding that Scherings conduct at the MS 06
conference, of which it was the major sponsor,
would bring discredit to the industry and could
therefore not successfully withstand public and
professional scrutiny. The Appeals Committee
agreed that the fact of sponsorship of MS Australia
was not wrong, but rather the obligations on
companies that engage in sponsorship of health
care professional activities and congresses had
not been fulfilled.
relation to the breach of Sections 6.4 and 7.1.1 of
the Code in relation to Scherings sponsorship of
MS Australia.
Cochrane review material in the brochure and
DVD Update International MS research and
Management
The Appeals Committee noted the arguments
presented in paragraphs 38 to 40 of the appeal
submission.
The Committee did not accept
Scherings assertion that it was not their
responsibility to ensure that the brochure is
accurate and includes updated information.
Similarly to previous decisions, the Committee
considered that Schering is responsible for
materials that it chooses to distribute.
The
Appeals Committee agreed with the Code
Committees decisions with respect to finding
breaches of sections 1.3, 9.5.1, 9.5.6 and 9.8. In
relation to the finding of a breach of Section 9.8,
the Committees earlier comments similarly apply that there should not be a double or multiple
penalty applied for each finding of a breach of
Section 9.8 in relation to Scherings conduct at the
MS06 conference.
as having been applied in relation to the findings of

breaches of Section 9.8 of the Code under
complaint 830.
The Appeals Committee confirmed the following
sanctions:
Schering should cease distribution of the
brochures and DVDs found in breach and
cease use of the trade display banner found in
breach.
Schering should write to MS Australia advising
that Schering has been found in breach of the
Code and to request that the MS Society
update the information that has been identified
as being not accurate or balanced. This letter is
to be approved by the Code of Conduct
Committee Chairman.
Pay a fine of $100,000.
The Committee overturned the requirement that
Schering should amend and expand its Guidelines
for awarding sponsorship and grants to ensure that
these comply with the Code. However, Schering
should note that the Appeals Committee strongly
recommended that the company should revise its
sponsorship guidelines to better reflect both the
letter and spirit of Sections 7.1.1 and 7.1.3 of the
Code.

relation to the breaches of Sections 1.3, 9.5.1,
9.5.6 and 9.8 of the Code.
Sanctions
Having confirmed the Code of Conduct
Committees determination finding a number of
breaches of the Code and upholding only two
aspects of the appeal, the Appeals Committee
considered the sanction imposed by the Code of
Conduct Committee. The Appeals Committee
considered that the sanctions applied by the Code
Committee were appropriate to the additional
breaches of the Code found in complaint 830. No
additional or multiple sanction should be construed
54
Infanrix Immunisation Awards (833 and

834)
Subject Company: GlaxoSmithKline Australia
(GSK)
Complainant:
Healthcare professionals (nurses and pharmacist)
Product: Infanrix
Complaint:
It was alleged that the Infanrix Immunisation
Awards, offered by GSK for programs or initiatives
by immunisation providers implemented over the
previous five years, were unethical and blatant
bribery as doctors should not be encouraged to
use a medicine in order to win a substantial cash
prize.
Competition alleged to be in breach of the
following Sections of the Code.
7.1.1, 7.1.2, 7.1.3 Sponsorship
in, the industry
Unanimous no breach of Sections 7.1.1, 7.1.2,
7.1.3 and 10.5 of the Code
awards to ensure the process would withstand

public and professional scrutiny. This panel
consisted of representatives from the Royal
Australian College of General Practitioners, the
Australian Divisions of General Practice, Public
Health Association of Australia the Rural Doctors
Association, one paediatrician and general
practitioner. The Panel determined the number of
awards, determined the monetary value of the grant
and provided input into the content of the
application form. The criteria against which the
applications were judged and the selection of the
winning and commended programs was undertaken
solely by the panel.
The Committee unanimously found no breach of
7.1.1, 7.1.2, 7.1.3 or 10.5 of the Code as the award
was open to practitioners in all States and
Territories regardless of the choice of vaccine brand
in that jurisdiction and the process was robust and
independent with professional input.
The
Committee did not agree with the complainants that
the awards should be regarded as paying people to
prescribe particular prescription medicines.
Members considered that the purpose of the
awards in trying to raise the immunisation rates in
Australia was commendable.
However, the
Committee suggested that it may be more
appropriate to rebrand the award as the GSK
Immunisation Awards rather than using a specific
product name.

The Committee noted that general practitioners
and immunisation providers do not select the
brand of vaccine to be given to a patient unless a
specific vaccine is not suitable for the individual.
Members were advised that the Australian
Government funds vaccines through the National
Immunisation Program and that State and
Territory governments decide which vaccine will
be used in their jurisdiction.
General practitioners on the Committee indicated
that the government was working with healthcare
professionals to raise the immunisation rates in
Australia. The current rate of immunisation for
children between 2 and 6 years was 79% - 87%
depending on the State in which the child lived.
The government target is 90%. It was noted that
there are also Hard to Reach target groups such
as indigenous Australians.
Members noted that GSK had convened an
independent panel of experts in developing the
55
Roche Sponsored Hospitality (835)

Subject Company: Roche Products (Roche)
Complainant: Therapeutic Goods Administration
(TGA)
Product: N/A
Complaint:
Haematology and Oncology Targeted Therapies
(HOTT) a two day educational symposium and
LyFE LyNE, a one and a half day workshop style
meeting. It was alleged that hospitality provided in
association with these meetings may not be
compliant with the requirements of the Medicines
Australia Code of Conduct
members of the Committee expressed concern that

the complaint was based on a newspaper article
with the source being a person who was reported
as having attended the evening functions and who
could not be described as disinterested. However
the Committee concluded that there was sufficient
substance to the allegation to require investigation.
Roche had provided a full response to the complaint
and had outlined the educational program for the
meetings, the venues and cost of the hospitality.
In considering the provisions of the Code in Section
10.2 and the Explanatory Notes for this section,
members agreed that there was a different
meaning, or at least a perception of a different
meaning, between the provisions and Explanatory
Notes.

Hospitality alleged to be in breach of the following
6.2 Hospitality
6.6 Venue selection
6.8 Travel
10.1 Entertainment
10.2 Hospitality
in, the industry
Provisions of the Code Section 10.2 Hospitality

Any hospitality offered by Companies to health care
professionals should be simple, modest, secondary
to the educational content and provided in an
environment that enhances education and learning.
The venue and location at which a company
provides hospitality to health care professionals
must be conducive to education and learning and
must not be chosen for its leisure or recreational
facilities.

Majority breach of Sections 6.2, 10.2 and 10.5
of the Code
No breach of Sections 6.6, 6.8 and 10.1 of the
Code
A Company must not subsidise or pay for the costs

of family or companions of attendees at educational
meetings.
Sanctions:
Fine $75,000
Prior to discussing this complaint the TGA
representative on the Code of Conduct Committee
raised the matter of the perception of a conflict of
interest with the TGA lodging this complaint. The
representative advised the Committee that he had
no prior knowledge of the complaint before
receiving the papers. Members were of the view
that while they did not consider this to be a
conflict, in the interest of avoiding any perception
of conflicting interests, the TGA representative
should not participate in reviewing this complaint.
The Committee accepted the decision that while
the letter from the TGA may not have clearly
stated that it was a complaint to the Code of
Conduct Committee, the concern raised by the
TGA should be dealt with as a complaint. Some
Explanatory Notes 10.2 Hospitality

Meals or any other hospitality provided by
companies at an educational meeting should
not differ to that expected at any professional
business meeting and should reflect the
professional standing of the audience.
Examples of activities that would be seen as
acceptable include: Medical education in conjunction with a simple
lunch meeting in a surgery at which the catering
could include the provision of sandwiches or
takeaway food or what the health care
professional would normally consume at a
working lunch
Medical education given in conjunction with a
meal outside a practice consistent with the
quality expected by a professional attending a
business meeting.
In relation to companions and family members it is
unacceptable for a Company to pay for, subsidise
or reimburse a health care professional for any
costs, including but not limited to:
Travel costs to and from any meeting;
56
Roche Sponsored Hospitality 835 (contd)

Their accommodation costs at the meeting; or
Any meals or hospitality they may consume at
the meeting.
The Committee concluded that the descriptors
simple and modest that are included in the
provisions of the Code take precedence over the
explanatory notes which state that that expected
at any professional business meeting and
reflect the professional standing of the audience.
To clarify the perceived inconsistency between the
provisions of the Code and the Explanatory Notes
the Committee recommended that the matter
should be considered by the Code Review Panel.
Having reviewed the academic programs for the
LyFE LyNE and HOTT meetings the Committee
was unanimously of the view that the scientific
content was unquestionable, indicated by the high
quality of international speakers and a substantial
breadth and depth of topics. Members commented
that the meetings had much to offer Australian
healthcare professionals and presented much
needed opportunities for access to important new
and valuable information.
Section 6.2 Hospitality
As there are no financial limits on hospitality
imposed in the Code, the Committee found the
determination of an appropriate level for hospitality
to be difficult as it would vary from state to state,
city to country location and the type of educational
meeting that was being provided varying
between a 4 day international conference for
specialists in a major capital city to the lunch time
meeting in a GP practice or hospital setting. While
a minority of members of the Committee did not
consider the hospitality provided to the
professional and highly skilled group of
oncologists, haematologists and pathologists to be
excessive, a majority of members considered that
for at least two of the evening functions the
hospitality could not be described as simple or
modest and was more extravagant than would
normally be expected at a professional
educational meeting. By a majority the Committee
found a breach of Section 6.2 of the Code.
Section 6.6 Venue Selection
The Committee was of the view that the venue for
the educational meetings did comply with the
provisions of the Code as it was selected on the
basis of being able to accommodate several
hundred attendees, it offered a range of theatres
and rooms for the educational sessions a large
auditorium for plenary sessions and smaller

meeting rooms for breakout sessions; and
infrastructure and support for audiovisual systems.
In relation to the venues for the evening meals,
members were of the view that it was not the venue
that caused raised concern but the level of
hospitality that was provided at several of the
dinners.
For the reasons above the Committee found no
Section 6.8 Travel
The Committee was of the view that there was no
concern with the travel arrangements provided by
Roche for meeting attendees. Roche had advised
attending healthcare professionals that any
accompanying persons would not be paid for by the
company.
The Committee found no breach of Section 6.8 of
the Code.
Section 10.1 Entertainment
As no entertainment was provided to healthcare
professionals the Committee found no breach of
Section 10.2 Hospitality
For the reasons outlined in the discussion in relation
to Section 6.2, in a majority decision the Committee
found a breach of Section 10.2 of the Code.
Section 10.5 Discredit to and reduction of
confidence in the industry
A majority of the Committee members were of the
view that the overall perception was that the
hospitality provided exceeded what may be
considered by the public to be simple and modest
and thereby brought the industry into disrepute.
In relation to partner payments the Committee
recommended that a company should always make
it clear on the registration form that any travel,
additional accommodation or meals must be paid in
full prior to the event. Members acknowledged that
a company is put in a difficult position when a
partner arrives with a registered delegate at a
function without having completed the partner
registration form or paid for the event.
57
Roche Sponsored Hospitality 835 (contd)

Sanctions
Having found breaches of the Code the
The Committee noted that in finding a breach of
Section 10.5 of the Code in relation to this
complaint it would be classified as a severe
breach where the activity has ceased which may
attract a fine of up to $200,000.
It was agreed that a fine of $75,000 should be
imposed on Roche.
In making a determination in relation to the fine the
Committee noted that the issues determined to be
in breach were balanced by other factors such as
the high quality and substance of the education
provided. Further, Roche had been asked to
respond to a number of allegations, the majority of
which were not found in breach. Had it not been
for these balancing considerations the sanction
would have been higher.
58
Lumigan (836)
Subject Company: Allergan Australia (Allergan)
Complainant: Pfizer Australia (Pfizer)
Product: Lumigan
Complaint:
Statements in the promotional material were
misleading, inadequately substantiated and in
poor taste.
The material was alleged to be in breach of the
following Sections of the Code:
1.4 Good taste
in, the industry
decision:
Breach of Sections 1.2.2, 1.3 and 1.7 of the
Code (Decision confirmed by the Appeals
Committee)
No breach of Section 10.5 of the Code
Sanctions:
Withdraw materials found in breach of the
Committee)
who received the material found in breach of
Committee)
Fine $15,000 (Decision confirmed by the
Appeals Committee)
with Xalacom. In reviewing the referenced papers

members noted the following:
Paper 1 compared bimatoprost once daily with
an unfixed combination of latanoprost
(administered in the evening) and timolol
(administered in the morning);
Paper 2 was a switching study which included a
small number of patients being treated with a
beta blocker (not necessarily timolol);
Paper 3 was designed to evaluate bimatoprost
in clinical practice;
Paper 4 was a poster presentation and did not
compare Xalacom (fixed combination of
latanoprost and timolol) and Lumigan; and
Paper 5 was an abstract which examined
switching from Xalacom to bimatoprost in 50
patients.
Section 1.2.2
The Committee was of the view that there was
insufficient evidence to substantiate the claim of
equivalent efficacy (equivalent efficacy requires
stricter criteria than no significant difference) and
therefore a breach of Section 1.2.2 was found.
Section 1.3
As there was insufficient evidence to support the
claim made in the promotional material members
were of the view that this resulted in misleading
information
being
provided
to
healthcare
professionals. The Committee found a breach of
Section 1.7
For the reasons outlined above the Committee
considered the comparative claim was not factual or
capable of substantiation and therefore was in
Section 10.5
In a unanimous decision the Committee found no
Statement: Dont be fooled
Claim: Switch dont add Lumigan eye drops

are just as effective at lowering IOP as the
combination treatment Xalacom (latanoprost
50g/ml and timolol 5mg/mL) to be listed on
April Fools day.
The Committee commented that while five
references were cited by Allergan there were no
head to head studies directly comparing Lumigan
Section 1.4
Members were of the view that while the words
dont be fooled could be considered a silly play on
words it was ambiguous and confusing. It was
unclear who might be fooled and implied that a
doctor is foolish to add a beta blocker to a treatment
regimen, which is acceptable therapy in certain
patients with raised intraocular pressure.
Section 1.4 of the Code as the words were in poor
59
Lumigan 836 (contd)

taste and did not recognise the professional
standing of recipients.
Sanctions
The Committee resolved that Allergan should take
immediate action for the prompt withdrawal of the
material found in breach and should permit no
further appearance of it in its present form. This
sanction also applies to any other advertisement
or item of printed promotional material that
contains the same claims as those found in breach
of the Code.
The Committee further resolved that Allergan

should be required to distribute a corrective letter
to all healthcare professionals who had received
this item. The corrective letter is to be approved by
the Chairman and members of the Code of
Conduct Committee.
In considering whether to also impose a fine, the
Committee referred to the Table of Complaints
and Fines spreadsheet and the Guidelines for
determining Code sanctions provided in the
agenda papers. It was agreed by a majority
decision that a fine of $15,000 should be imposed
on Allergan which was consistent with past
sanctions.
Appeals Committee
An appeal was lodged by Allergan against the
presented by Allergan representatives in support
of the Allergan appeal:
All three actives contained in Lumigan
(bimatoprost) and Xalacom (latanoprost and
timolol) have potent ocular hypotensive activity
and are therefore indicated for open angle
glaucoma and ocular hypertension. The aim
of glaucoma treatment is to lower IOP as
much as possible.
The South East Asia Glaucoma Interest Group
(SEAGIG) and the European Glaucoma
Society (EGS) Guidelines recommend to
switch rather than add if one agent doesnt
achieve the required reduction in IOP.
The intent of the Lumigan mailer was to
reinforce the message to ophthalmologists
from the SEAGIG and EGS Guidelines on best
practice, to Switch dont add.
The Code Committee did not take into

consideration two important facts:
It is of no clinical consequence if
latanoprost and timolol are administered as
a fixed combination (i.e. Xalacom) or
unfixed; and
Recent work by Rosetti has demonstrated

in a head to head study that bimatoprost is
equivalent to Xalacom.
The peak effect on IOP is usually measured in
the morning, which generally represents the
highest IOP of the day.
Night time dosing of latanoprost and
bimatoprost provides lower daytime IOP.
Morning dosing of timolol is most effective.
The body of evidence currently comprises five
published articles plus one poster with all
references either directly proving or supporting
the claim of equivalent efficacy between
bimatoprost and the combination of latanoprost
plus timolol. At the time of publication of the
mailer, three published articles were available
and two posters.
Pfizer has contended that there are design
flaws in these studies. Allergan contends that
the number of patients in the studies were
adequate.
The dosing of timolol in the morning and
latanoprost in the evening in the Manni study is
the optimal efficacy dose regimen and
bimatoprost was found to be equivalent to the
unfixed combination.
Whether timolol and latanoprost are dosed in a
fixed or unfixed manner is not clinically relevant.
Switch studies are appropriate in the
investigation of treatment for a stable, chronic
condition.
Brittain et al concluded that the use of Xalacom
in patients who may have been experiencing blocker drift may result in unnecessary dual
therapy, when a simple switch of medications
would be more appropriate.
Dirks et al, which is a poster presentation, is
acceptable to use as secondary supporting
evidence because it is consistent with other
data. The fact that the poster is 4 years old is
irrelevant.
Allergan believe that the Rossetti paper
(available in abstract in April 2006 and now
accepted for publication) should be taken into
account since it is now part of the body of
evidence and further supports the claim. This
study had 200 enrolled patients and at week 12,
mean day time and night time IOPs were similar
and there was no statistically significant
difference between the two groups.
60
Lumigan 836 (contd)

There is not one reference which refutes the
fact that all six references either directly prove
or support the claim of equivalent efficacy.
The Appeals Committee Chairman asked Allergan
whether they were appealing the decision in
relation to the statement Dont be fooled which
was found to be in breach of Section 1.4 of the
Code. An Allergan representative advised that
Allergan considered that this matter had been
resolved through intercompany dialogue and had
previously agreed to send a corrective letter to
ophthalmologists stating that there had been no
intention to mislead them in relation to the listing of
Xalacom on the PBS on April Fools Day. Allergan
were surprised that Pfizer had raised this matter in
their complaint. Allergan still undertakes to send
the corrective letter. Allergan agreed that this
matter did not need to be considered by the
Appeals Committee.
presented by a Pfizer representative in response
to the Allergan appeal:
Allergans appeal is on the basis that they do
not agree with the Code of Conducts
Committees decision.
No procedural issues have been raised by
Allergan or any objection to the sanctions.
The claim Lumigan eye drops as just as
effective at lowering IOP as the combination
treatment Xalacom (latanoprost 50g/mL and
timolol 5mg/mL) is a direct, major,
comparative claim between Lumigan and
Xalacom which Pfizer believes has not been
adequately substantiated.
The Pfizer representative referred to the Code
of Conduct Guidelines that state that a
comparative claim must be supported by
unequivocal supporting evidence.
None of the references used to support the
claim (Manni, Bournias, Dirks and Rait)
involved a direct comparison between
Lumigan and Xalacom.
Patient numbers in the trials were low and not
conducted over a sufficient length of time
The dose regimen in Manni et al was different
to the dose regimen for Xalacom.
Bournias et al relies on a sub-analysis of 5%
of subjects who used latanoprost plus one
other beta-blocker, but it is unknown which
drug this was.
Rait et al was a comparison with an unfixed
combination and was therefore inadequate in
design to support the claim. Dirks et al was a
switch study of an unfixed combination of
latanoprost and timolol.

The new reference provided by Allergan,
Rosetti et al, was not published until after the
promotional mailer was produced and therefore
cannot be used to support the claim.
The claim of equivalent efficacy between
Lumigan and Xalacom is false and misleading
and is not supported by adequate substantiating
data.
The claim switch dont add was misleading as
it could not be established that Lumigan was as
effective as Xalacom
The Appeals Committee should uphold all
findings of a breach and the sanctions should
remain.
In consideration that Allergan had stated that the

switch dont add claim had been in use for some
24 months, a Committee member inquired why
Pfizer had waited so long before lodging a
complaint in relation to the promotional materials. In
response a Pfizer representative commented that
Pfizer had not been aware of the materials until
recently.
In response to a question from a Committee
member, an Allergan representative stated that
Allergan were of the view that the duration of the
cited trials was adequate.
In response to a question from a Committee
member about whether it is correct to switch or use
some other therapy if you cant use timolol (because
of contraindications), a Pfizer representative stated
that it is up to the ophthalmologist. The RANZCO
representative on the Appeals Committee
commented that there are many factors that
determine whether to switch rather than add a
second drug, not just the IOP.
The Appeals Committee Chairman also referred to
a statement from a Pfizer representative that a
company cannot appeal simply because it
considered that the Code of Conduct Committee
made the wrong decision. He advised the
Committee and the company representatives that
an appeal may be lodged if in the view of the
Subject Company the Committee may have not
understood all the relevant issues or perhaps did
not consider the evidence provided and therefore
erred in their decision.
The RANZCO representative commented that from
the perception of an ophthalmologist there must be
some trust that what a pharmaceutical company
61
Lumigan 836 (contd)

states in their promotional materials is true and
that they are acting in the public interest. He also
stated that each healthcare professional does not
always have the time to read each referenced
study and to critically evaluate the veracity of any
claim. Many ophthalmologists will want to see the
evidence of the degree of improvement offered by
a new treatment before changing therapeutic
approaches.
Healthcare
professionals
will
consider the effectiveness and any potential side
effects for the patient when making a prescribing
decision. The RANZCO representative also stated
that compliance with treatment is a very important
issue when determining a treatment for an
individual patient i.e. if there are more frequent or
unacceptable side effects, such as red eyes,
overgrowth of eyelashes, hyperpigmentation of the
skin, a patient may not continue to use the
treatment.
The RANZCO representative noted that most
ophthalmologists would not have a standard
treatment approach if a patient was not controlled
on their current therapy. When reviewing options
for a patient who is not controlled an
ophthalmologist would need to consider whether
to switch or add and factors such as side effects
of a different or additional drug, cost of treatment
and possible compliance issues were all
important.
Sanctions
Having not upheld the appeal the Committee
reviewed the sanctions imposed by the Code of
Conduct Committee. Members noted that Allergan
had not specifically appealed against the sanctions.
The Committee determined that Allergan should:
Take immediate action for the prompt
present form.
professionals
who
had
received
this
promotional item. The Committee discussed the
proposed corrective letter that Allergan had
undertaken in intercompany dialogue with Pfizer
to send to healthcare professionals in relation to
the Dont be fooled statement. Members were
of the view that this information should be
incorporated into the corrective letter to be
approved by the Chairman of the Code of
Conduct Committee. The corrective letter shall
be sent within 30 days of finalisation of the
complaint.
Pay a fine of $15,000
The Committee discussed whether the Rossetti

paper could be used as supporting evidence for
the claims. Members were of the view that as it
was not published even in abstract form at the
time of publication of the promotional item subject
to complaint it could not be used to support the
claim made at that time. However this did not
mean that it could not be used to support claims in
promotional materials subsequently developed.
In reviewing the referenced papers the Committee
were of the view that they were not sufficient to
support such a bold comparative claim. None of
the studies were direct head to head comparisons
between Lumigan and the fixed dose combination
Xalacom.
The use of indirect comparisons
increases the uncertainty of the result and
therefore cannot support a definitive claim of
equivalent efficacy. Some members were also of
the view that the SEAGIG Guidelines are just a
guideline and need to be considered in the context
of what is best for an individual patient. The
Appeals Committee concluded that there was
insufficient evidence to substantiate the claims
which were therefore misleading.
62
Relationships with healthcare

professionals (837)
Subject Company: All Medicines Australia
member companies and non-member companies
which market prescription medicines in Australia.
Complainant: Healthcare professional
Product: N/A
Complaint:
It was alleged that unless companies had
undertaken public consultation to determine what
level expenditure on meals would withstand public
and professional scrutiny, had a written policy for
staff on such expenditure and published this policy
and information on their actual expenditure, they
were in breach of the Code.
The healthcare professional alleged that all
companies were in breach of the following
10 Relationship with healthcare professionals
10.2 Hospitality
in responding to the complaint, it would have been

inappropriate not to accept the complaint. It was
noted that the Secretary had requested more
specific information from the complainant but who
declined to provide this.
The Committee commented that the complaint
lacked the specificity required by conventional due
process and the provisions of the Code. It also
adopted a particular form of circular reasoning that
was ultimately misleading and unfair. The
complainant made a series of generalised
assertions in which the principles and standards
embodied in the Code were replaced with a series
of highly specific interpretations of how these
principles and standards might be implemented in
practice. In effect, the complainant deemed a
particular interpretation of the Code provisions to be
the Code and then found all companies (without
naming any) had failed to comply irrespective of
how those companies may in fact comply with the
provisions set out in the Code.
The Committee concluded that the complaint was
not sufficiently made out and found no breach of
Sections 10 or 10.2 of the Code by any company.

No breach of Sections 10 and 10.2 of the
Code
Members of the Committee considered that the
complaint was an expression of a personal
interpretation of the way companies should act to
comply with the Code rather than an allegation
that a particular activity or activities did not comply
with the Code. The complaint did not provide any
precise information or allegation which the Code of
Conduct Committee could evaluate.
The Committee noted that the Code does not
include any provisions limiting expenditure in
specific monetary terms or requiring companies to
disclose the levels of expenditure on hospitality for
healthcare professionals. The Code does require
hospitality to be simple, modest and secondary to
the educational content provided.
The Committee acknowledged that the healthcare
professional was entitled to lodge a complaint with
Medicines Australia and it was the role of the
Code of Conduct Committee to determine whether
the complaint was made out. Whilst considerable
time and effort had been expended by companies
63
Desflurane (838)
Subject Company: Baxter Healthcare (Baxter)
Product: Desflurane
Complaint:
It was alleged that the company had acted in a
careless and irresponsible manner by not
servicing a vaporizer on loan to the hospital.
The activity was alleged to be in breach of the
following Section of the Code:
in, the industry
that Baxter purchased the vaporizers and made

them available to hospitals under a loan
arrangement. In reviewing the loan agreement it
was noted that it specifically stated The customer
undertakes at their expense to have the vaporizers
serviced to the manufacturer's recommendations
and will be responsible for any loss or damage.
the Code as it was clearly stated in the loan
agreement that it is the hospitals responsibility to
maintain and service the item. Members also
commented that it is the responsibility of healthcare
professionals using a piece of equipment to make
sure it is in working order and properly serviced.
Members recommended that if the complainant had
concerns about the servicing or maintenance of the
vaporizer he should report it to the hospital
management.

Prior to considering the complaint the Committee
debated whether the Medicines Australia Code of
Conduct had jurisdiction over the issue raised in
the complaint. Some members were of the view
that the complaint was specifically in relation to the
device and therefore did not fall under the Code.
One member commented that the Committee
would consider a complaint concerning a
prescription medicine administered by a needle
and syringe, which are classified as devices,
under the Code therefore it was appropriate that it
considered
this
complaint.
The
TGA
representative advised that the TGA regulates
medical devices and prescription medicines in
different branches of its organisation. TGA would
consider the maintenance of a device as a
separate matter to the administration of a
prescription medicine with a device. However the
majority of members were of the view that as the
device was used to administer a prescription
medicine the complaint could reasonably be
considered under the Medicines Australia Code of
Conduct.
Members commented that the Medical Industry
Association of Australia (MIAA) is the body
representing the medical devices sector and
recently introduced a Code of Conduct.
The Committee noted that the manufacturer and
sponsor of the vaporizers is GE Healthcare and
64
Zocor (839)
Subject Company: Merck Sharp & Dohme
(Australia) [MSD]
Product: Zocor
Complaint:
It was alleged that an advertisement for Zocor was
misleading.
The advertisement was alleged to be in breach of
the following Section of the Code:

Section 1.3 of the Code. Whilst the first statement
in the advertisement might be misleading by itself,
the clarifying and qualifying statements below the
picture and at the left did explain the claim.
The Committee commented that whilst it found no
breach of the Code, MSD should consider more
clearly communicating the meaning of the NNT and
placing the full clarification or qualification under the
claim.
In considering this complaint, the Committee
discussed the derivation of the number 17. Several
members had found it difficult to calculate the figure
from the referenced source and questioned whether
it was correct. The Committee recommended that
MSD should endeavour to convey the valuable
information of the NNT more clearly and its
derivation.

Write 17 scripts. Rewrite a diabetics life.
The Committee commented that the concept of
the number needed to treat (NNT is the number of
patients who need to be treated to prevent one
bad outcome) was important information to
communicate to prescribers and it is important to
communicate this information clearly. Some
members noted that the correct interpretation of
NNT is the number of patients needed to be
treated for a period of time to gain the associated
benefit rather than the number of prescriptions
written. The heading claim in the advertisement
refers to the number of scripts in relation to the
NNT.
Members acknowledged that the clarifying
statement under the picture in the advertisement
partially explained the claim, with a further
qualifying statement at the top of the text on the
left side of the advertisement. The Committee
considered it would be preferable not to split the
full explanation between the statement directly
below the picture Based on the Heart Protection
Study: Diabetes Sub-Study, in diabetics with
cholesterol, 5.0mmol/L, you only need to treat 17
patients with Zocor 40mg to prevent one event
and the further qualifying statement on the left
hand side of the advertisement Based on
treatment with Zocor 40mg over 5 years to prevent
first major vascular event.
65
Avandia (840)
(GSK)
(TGA)
Product: Avandia
Complaint:
That the references in the promotional material
were insufficient to support the advertisement as
the data were only sufficient to generate a
hypothesis for the proposed use of Avandia and
the advertisement suggests an indication that has
not been established by clinical trial data or the
evaluation of these data in the conventional
registration process.
from case to case depending on the quality of the

study. Members also noted comments in GSKs
response to the complaint that two of the cited
references were primary endpoints and the
secondary endpoints were consistent with the
published literature.
The Committee commented that animal evidence
with respect to effect on beta-cell function was
included in the Avandia Product Information.
Published clinical evidence is available that the
thiazolidinediones improve beta-cell function, which
is a mechanism of action for this class of drugs
used to treat type 2 diabetes.

Material alleged to be in breach of the following
1.1 Responsibility
1.2 Substantiating data
No breach of Sections 1.1 and 1.3 of the Code
Avandia, alone and in combination, provides
sustained improvement in beta-cell function
The Committee was of the view that the statement
in the advertisement concerning beta-cell function
was supported by adequate evidence as the basis
for the claim. The Committee unanimously found
no breach of Section 1.2 of the Code.
Members considered that this statement did not
imply that improvement in beta-cell function is an
indication for Avandia. There is sufficient evidence
that beta-cell dysfunction is a pathophysiological
cause of type 2 diabetes. The Committee did not
consider that the statement concerning Avandias
effect on beta-cell function was false or misleading
and was not suggesting an additional indication for
Avandia. By unanimous decision, no breach of
Sections 1.1 or 1.3 of the Code was found.
In relation to the arguments presented in the
complaint about use of secondary endpoints from
studies to support claims, members commented
that the acceptability of such evidence would vary
66
Amgen Hospitality (841)

Subject Company: Amgen Australia (Amgen)
Complainant: Roche Products (Roche)
Product: Not applicable
Complaint:
It was alleged that Amgen hosted two dinners in
association with the ANZ Society of Nephrology
(ANZSN) and Renal Society of Australia (RSA)
conjoint conference for nephrologists and renal
nurses at which there was no educational
component. The complainant also identified
concerns in relation to Amgen hosting an event at
the same time as educational events occurring at
the conference.
Hospitality was alleged to be in breach of the
6.2 Hospitality
Australasian congresses
in, the industry
Majority no breach of Sections 6.2, 6.4 and
10.5 of the Code
The Committee was of the view that the most
important issue was whether there was a
relationship between Amgen and the ANZSN and
RSA conference. Members were advised that
Amgen had been a Platinum sponsor of the event.
The Committee also noted the letters from the
Chair and a member of the Organising Committee
stating that evening dinners were an extension of
the conference scientific program, offered as part
of the meeting sponsorship. The letters also stated
that the free evening in the conference program
was offered to members of the trade as an
opportunity for the trade to host an event of their
choice and their venue.
Members also noted Amgens comments in their
submission that the invitations to the dinners had
been mailed to the relevant healthcare
professionals prior to the finalisation of the
program.
Therefore it was unknown to the
company that one evening event would be held at
the same time as the trade seminars. Amgen also
had commented that a healthcare professional

could choose which of the three events offered on
the night they would attend.
Section 6.2
The Committee carefully reviewed the wording of
both the provisions of the Code and the Explanatory
Notes. Members of the Committee all agreed that if
the two dinners had been offered on an occasion
where there was no association with education the
company would be in breach of the Code. However
as the dinners were offered during a conference
they could be regarded as being associated with
education. The Committee considered that the
ANZSN and RSA conference offered three days of
quality education for healthcare professionals.
Members discussed whether education should also
be provided at a conference dinner. Some members
commented that having participated in six to eight
hours of scientific and educational sessions in a day
a further session in the evening was not necessary
nor an educationally sound practice.
On the matter of a conflict with two other company
symposiums held at the same time as one of the
dinners, the Committee did not consider that this
was a critical issue and noted that it was up to an
individual healthcare professional to decide which
event they would attend.
Section 6.2 of the Code as the hospitality was
provided in association with the conference and to
conference delegates. The dinners were secondary
to the conference and no entertainment had been
provided. A minority of Committee members were
concerned that the connection between the Amgen
dinners and the conference was not sufficiently
clear as they were not identified on the conference
program provided in the agenda papers and that
one of the dinners was held at the same time as a
session in the conference program sponsored by
two other companies.
Section 6.4
For the reasons outlined above, by a majority
decision the Committee found no breach of Section
6.4 of the Code.
Section 10.5
In finding no breach of Sections 6.2 and 6.4 of the
Code the Committee was of the view that the
hospitality was associated with and secondary to
education and would not bring the industry into
disrepute.
67
Amgen Hospitality 841 (contd)

Members were of the view that greater clarity is
required in the Code and Guidelines to assist
companies and third party conference organisers
to understand what is acceptable sponsorship
from pharmaceutical companies. The Committee
recommended that there should be clarification of
the need for a clear connection with an
educational meeting if hospitality is offered and
that the hospitality should only be provided to
conference delegates (in addition to the current
requirements with respect to hospitality being
secondary to education etc). The Committee
requested the Code Secretariat to refer this matter
to the Code Review Panel for clarification in future
editions of the Code and Guidelines.
Section 12.3
Amgen had asked that the Committee consider
the timing and likely motivation of Roches actions
under the provisions of Section 12.3 of the Code.
The Committee advised that each complaint is
reviewed on its merits and not whether there were
other complaints under consideration between two
companies. Having spent considerable time
debating the facts of this complaint the Committee
did not consider that Roche should be required to
respond to the allegation that its complaint was in
68
Crestor (842)
Subject Company: AstraZeneca Pty Ltd
(AstraZeneca)
Product: Crestor
Complaint:
It was alleged that
overstated the benefits
false and misleading
profile, ease of use
doses.
the promotional items

of Crestor and created a
impression of its safety
and appropriate starting

decision:
Claim 1: Breach of Sections 1.3 and 1.7 of the
Committee)
Claim 2: Breach of Section 1.3 of the Code
and no breach of Section 1.7 of the Code
(Decision amended by the Appeals Committee
no breach)
Claim 3: Breach of Section 1.3 of the Code
and no breach of Section 1.7 of the Code
no breach)
Claim 4: Breach of Sections 1.3 and 1.7 of the
Committee)
Sanctions:
Committee)
who had received the material found in breach
of the Code (Decision confirmed by the
Appeals Committee)
Fine $75,000 (Decision amended by the
Appeals Committee fine reduced to $40,000)
The Committee decided to consider the complaint
following the four issues raised in the Pfizer letter
of complaint.
Claim 1: Crestor is the most effective statin at

lowering LDL-C (With footnote on a mg per mg
basis when compared to other currently
marketed statins)
The Committee considered the Crestor Product
Information. Whilst there is a table in the PI
comparing the effectiveness in lowering of LDL-C
for the different statins, this does not indicate that
Crestor is more effective than other statins in
lowering LDL-C. Whilst rosuvastatin may be more
potent on a mg for mg basis, this does not equate to
it being more effective than another statins.
The Committee noted that AstraZeneca had
referred to studies that are not included in the PI
which it contended support the claim of better
efficacy of Crestor in lowering LDL-C. These
studies were open label controlled studies and
appear to be appropriately designed. However,
they are not fully consistent with the PI and
apparently have not been evaluated by the TGA.
Further, with reference to the study by Jones et al,
the reduction in LDL-C was not statistically different
between the 40mg rosuvastatin dose and 80 mg
atorvastatin. The superior lowering of LDL-C in the
later studies cited by AstraZeneca apparently
included the full dose range of up to 80mg of
rosuvastatin, which is not approved in Australia.
The Committee concluded that there was evidently
an evolving body of evidence which was not strong
enough at this time to support the strong claim that
Crestor is more effective than other statins.
The Committee made a unanimous decision that
the claim that Crestor is the most effective statin at
lowering LDL-C was in breach of Sections 1.3 and
1.7 of the Code as it did not adequately reflect the
body of evidence and made a comparison with
other statins that could not be substantiated.
Claim 2: Crestor 10mg Simply right from the
start
The Committee noted that the front page of the
promotional item emphasised a starting dose of
10mg while the table inside the item Initiating
Crestor listed both 5mg and 10mg starting doses.
The PI recommends either a 5mg or 10mg starting
dose. Some members of the Committee proffered
the view that it is not in the best interests of the
industry or quality use of medicines to promote the
highest starting dose for a medicine and not make
balanced reference to both the 5mg and 10mg
starting doses.
Section 1.3 of the Code as prescribers could be
69
Crestor 842 (contd)

misled that 10mg was the most appropriate
starting dose. By a unanimous decision no breach
of Section 1.7 of the Code was found as the
statements about the starting dose were not
comparative.
Claim 3: Crestor is simple to initiate and use
Members of the Committee were of the view that
although the promotional item referred to once
daily, any time of the day and with or without food
the term simple to initiate was understating all of
the PI contraindications and precautions for
initiation and continuation therapy with Crestor.
The Committee noted that doses above 20mg
daily required specialist supervision.
Section 1.3 of the Code because doctors could be
misled by the statement that treatment with
Crestor is simple. In a unanimous decision no
breach of Section 1.7 of the Code was found.
Claim 4: Crestor - The confidence of a
favourable risk/benefit profile
The Committee considered the claim that Crestor
had a favourable risk benefit profile which
appeared at a trade display at CSANZ 2006.
Although acknowledging that a medicine must
have an acceptable risk/benefit profile in order to
be registered for use in Australia, members were
of the view that the juxtaposition of the statement
with the graphs was an implied comparison
between Crestor and other statins that suggested
that Crestors risk/benefit profile was superior to
that of the other statins which could not be
substantiated. The Committee was also of the
view that this statement was a hanging
comparative.
Members commented that the graphs adjacent to
the claim were difficult to interpret there were no
error bars or numbers of patients treated to assist
in interpretation and evaluation of the claim.
Members were also of the view that the referenced
source, Davidson, was not easily accessible or
critically reviewable by prescribers and the graphs
appeared to be selective presentation of evidence.
Some members commented that they had
concerns over the use of data from several older
studies for other statins in the composite graph
and it was not clear that the information presented
came from several sources.
breach of both Sections 1.3 and 1.7 of the Code.
Sanctions
It determined that AstraZeneca should cease
distribution and use of the materials found in breach
of the Code. The Committee determined that a
corrective letter should be sent to all general
practitioners in Australia who had been detailed
with, or mailed the promotional material, all doctors
enrolled in the Crestor Early Access Program and to
all attendees at the CSANZ 2006 conference at
which the trade display appeared. The Committee
also determined that a fine of $75,000 should be
imposed.
Appeals Committee
An appeal was lodged by AstraZeneca against the
findings of the Code of Conduct Committee
The following summarises the main points in the
AstraZeneca appeal:
An AstraZeneca representative emphasised the
seriousness with which AstraZeneca takes the
complaint which concerns the new statin
product Crestor.
Pfizer is currently the statin market leader with
Lipitor. Crestor threatens this market position.
The Code of Conduct Committee minutes are
brief and do not contain sufficient information. It
appears from the minutes that the Code of
Conduct Committee did not consider all of the
evidence submitted by AstraZeneca.
The Committees findings are flawed and
should be overturned and the sanction revised
or removed.
The safety profile of Crestor has been
exhaustively studied.
Crestor patient experience in the clinical
development program was approximately equal
to the patient numbers in all of the other statin
clinical development programs.
lowering LDL-C
The claim Crestor is the most effective statin at
lowering LDL-C should be read together with
the footnote on a per mg per mg basis
compared to other currently marketed statins.
The statement and footnote comply with the
Code and AstraZeneca is entitled to assume
that doctors read footnotes.
The Code
Committee appears to have assumed that
doctors would not read the footnote.
A mg per mg comparison is clinically important
for prescribers to determine equipotent doses.
70
Crestor 842 (contd)

It is common practice by TGA, PBAC, NPS
and industry to make mg per mg
comparisons in this therapeutic class.
Pfizer had acknowledged that the statement
and footnote is accurate during intercompany
dialogue.
The Code Committee did not take into account
the qualifying statement. If the Code of
Conduct Committee did take into account the
qualifying statement, then it made a decision
which was not reflective of the provisions of
the Code.
TGA required AstraZeneca to include a mg
per mg comparison in the Crestor Product
Information, indicating it considers this
comparison is legitimate.
Even if the footnote were not taken into
account, the claim is still accurate that Crestor
is the most effective statin.
The Crestor Product Information figure and
table reflects Crestors greater LDL-C
reductions compared on a mg per mg basis
with other statins.
The PBAC, considered to be one of the most
rigorous reviewers of scientific data in the
world,
concluded
that
the
rosuvastatin:atorvastatin equivalent dose was
greater than 1:2 but less than 1:4, so
approximately 1:3.
Of the 20 studies listed in the references to the
claim, the Code of Conduct Committee only
considered four: Jones et al, Wolfenbuttel et
al, Jukema et al and Leiter et al.
The Code Committee has erred in its
statement in the minutes where it states
the later studies cited by AstraZeneca
apparently included the full dose range of up
to 80mg of rosuvastatin There was no
reliance on 80mg dose data which is not
approved in Australia.
There was head to head comparison of
Crestor 40mg versus 80mg Lipitor in all four
studies. Three of these showed a statistically
significant difference in favour of Crestor; the
fourth didnt. The Code Committee appears to
have placed undue emphasis on Jones et al,
but the body of evidence is much broader.
The Code Committee stated that there is an
evolving
body
of
evidence
whereas
AstraZeneca believe the evidence is
conclusive and compelling in favour of Crestor
being the most effective statin.
The Code of Conduct Committee raised issues

that were not part of the Pfizer complaint,
thereby denying AstraZeneca the opportunity to
respond.
The Code of Conduct Committees conclusion
was incorrect. General Practitioners will not be
misled by the claim either in part or with the
footnote.
Claim 2: 10mg Simply right from the start

The PI states that the starting dose is 5mg or
10mg.
The dose card conveys this information through
balanced reference throughout the card to both
5mg and 10mg starting doses.
10mg is an appropriate starting dose to allow
the majority of patients to achieve their LDL
goal.
There is no difference between the 5mg and
10mg dose safety and tolerability profile, so
there is no reason to believe there are patient
safety concerns arising from the dose card.
Claim 3: Simple to initiate and use
The statements simple to initiate and use
relate
to
initiation.
Reference
to
contraindications and precautions is not
relevant.
Discussion about initiation doesnt relate to
continuation therapy and this is where the Code
of Conduct Committee erred.
Claim 4: The confidence of a favourable
risk/benefit profile
The Code of Conduct Committee failed to
identify that the statement in isolation is not
comparative.
The claim is simply quoting the conclusions of
the TGA evaluation and ADEC. AstraZeneca
tabled in confidence the extract of the ADEC
minutes relating to Crestor, which refer to
Crestor having a favourable risk benefit profile.
Crestor data has been subject to intense
scrutiny and review. In light of the cerivastatin
withdrawal, it is important to convey the risk
benefit profile of statins.
Cardiologists present at CSANZ would not be
misled and would understand the claim refers to
a risk:benefit comparison.
The association of the claim with the graph is
not disparaging to Lipitor. The graph is faithfully
reproduced from the Davidson article. It shows
that all the statins are well tolerated and have
similar risk benefit profiles.
71
Crestor 842 (contd)

Sanctions
According to the Guidelines for determining
sanctions, the principal factors in determining
sanctions include nature and extent of the
material, level of the breach and any potential
patient harm. The sanctions imposed by the
Code Committee are unduly severe.
Between August and October 2006 Crestor
was only available under an early access
program with 1000 patients in Australia.
The early access program is well documented
with strict guidelines for doctors. The potential
for patient harm is minimal.
The requirement for AstraZeneca to send a
corrective letter stating that a favourable risk
benefit profile could not be shown for Crestor
would
cause
irreparable
damage
to
AstraZeneca and Crestor and is a false
statement.
A fine is to deter behaviour that could cause
patient harm, but AstraZeneca denies this
promotional material could cause harm.
The materials in question have been
withdrawn and new materials developed which
have fulfilled the purpose of the sanctions.
AstraZeneca concluded by stating:
The Code Committee didnt rule on the claims
considered in their totality.
The Committees findings are inconsistent with
science.
Crestor is an effective statin.
AstraZeneca does not accept that doctors
could be misled by the materials.
The confidence of a favourable risk benefit
profile is endorsed by the Australian regulator.
The sanctions imposed are unreasonable.
In response to a question from the Appeals
Committee Chairman concerning the sanctions
being related to perceived patient harm and
whether commercial harm should be considered,
an AstraZeneca representative commented that
Pfizers motivation in lodging the complaint was
purely commercial with great sensitivity to a new
product in the marketplace.
In response to subsequent questions about the
materials for Crestor, AstraZeneca representatives
stated that all materials found to be in breach had
ceased to be used and new materials had been
produced in time for the PBS launch on 1
December 2006. However, these amendments do
not indicate a change to AstraZenecas view that

the science supports its position.
The following summarises the Pfizer response to
the AstraZeneca appeal:
The Code of Conduct Committee rulings and

sanctions should be upheld. AstraZeneca has
not advanced any argument that should
overturn the Code Committees findings.
Crestor is a new drug and clinician knowledge
is limited. Lasting impressions are formed early
and inappropriate treatment decisions may
result. AstraZeneca has overstated the efficacy
of Crestor. Errors must be drawn to clinicians
attention to avert inappropriate treatment
decisions.
Claims have been widely disseminated since
April 2006. Using CAM data between July and
September some 12,000 doctor calls have been
made by AstraZeneca representatives.
The Code of Conduct Committees views were
unanimous in relation to claims 1 and 3 being
found in breach of sections 1.3 and 1.7.

lowering LDL-C (on a mg for mg basis when
compared to other currently marketed statins)
Mg for mg comparisons are irrelevant,
misleading and associated with significant
limitations.
Across their dosage ranges, Crestor provides
no significant advantages over Lipitor in
lowering LDL-C.
Similar doses of different drugs are not
assumed to be equivalent.
AstraZeneca
asserted that the doses of Lipitor and Crestor
are similar, but this is not correct. There is no
5mg dose of Lipitor (as there is for Crestor) and
no approved dose of 80mg of Crestor (as there
is for Lipitor).
The Crestor PI states that the usual maximum
dose is 20mg and that a dose of 40mg should
only be considered in patients still at high CV
risk This may particularly apply to patients
with familial hypercholesterolemia. and that
specialist supervision should be considered
when the dose is titrated to 40mg.
A note in the Crestor Public Summary
Document (PSD) released in October 2006
states that a note must be included in the PBS
listing, indicating that 40mg should be
prescribed with caution; that the NPS should
consider developing a RADAR article on this
product; and AstraZeneca should develop a
QUM strategy to address the issue.
72
Crestor 842 (contd)

(AstraZeneca later advised that this note will
be removed from the PSD in January 2007.)
Pfizer agrees with the Appeals Committees
previous ruling in relation to complaint 820 that
Some statements subject to complaint may
be factual in isolation, but the manner in which
they are portrayed in the promotional material,
and the impression created, are misleading.
The data are not conclusive enough to permit
a claim of unequivocal superiority of one drug
over another. In light of the limitations of
comparisons on a mg for mg basis, the drugs
need to be assessed across the full range of
available doses to assess superior efficacy.
The 40mg dose is rarely used for Crestor.
The pivotal study, Jones et al, found there was
no significant difference between Crestor
40mg and Lipitor 80mg, indicating there is no
advantage of Crestor over Lipitor. The FDA
has ruled against using this study in support of
the superiority claim.
AstraZeneca has presented three other
studies Leiter et al is an abstract of an
interim analysis; Wolffenbuttel et al and
Jukema et al are both open label studies
which introduces the potential for bias. These
studies are insufficiently robust to base the
claim of superiority. Law et al, a metaanalysis of 15 trials shoed a 55% reduction of
LDL-C with Lipitor, which is at odds with the
48% see in the two open label studies.
Pfizer considers that the body of evidence is
not conclusive. The four studies cited give
slightly different results.
The differences
between the drugs at the top end of the dose
ranges are not sufficiently conclusive to allow
a comparative claim of superiority.
Pfizer consider that the claim is in breach of
sections 1.3 and 1.7 as it is a misleading
comparison.
Claim 2: Simply right from the start
The question is whether the statement
accurately reflects the PI. Pfizer considers
that AstraZeneca has overemphasised 10mg
over 5mg as the starting dose.
The Crestor PI gives equal emphasis to 5mg
and 10mg as starting doses.
AstraZeneca asserts that because selected
groups of patients must start on 5mg,
everyone else can start on 10mg. This is
misleading.
The 5mg start dose was only introduced at the
behest of regulatory authorities, subsequent to
the 10mg start dose being approved. Pfizer
referred to information on the regulatory history

of Crestor where the EMEA and ADEC had
recommended that 5mg should be the start
dose for all patients. The data presented by
AstraZeneca on the number of people taking
10mg of Crestor would naturally be greater than
those taking 5mg due to the later introduction of
the 5mg start dose.
Treating with the lowest effective dose is a
cornerstone of cholesterol treatment and of
QUM.
Pfizer agrees with the Code of Conduct
Committee that Claim 2 is in breach of section
1.3 of the Code.

There are important restrictions that complicate
rather than simplify Crestor initiation, including
requirements for liver function tests, use with
fibrates or niacin, precaution in patients with
predisposing factors for myopathy.
Also
consideration of race to determine the starting
dose.
The use of simple is unjustified and misleading
when all considerations taken into account.
The dosage card also omits important
precautions which appear in the Crestor PI.
Pfizer supports the Code Committees decision
that Claim 3 is in breach of section 1.3.
AstraZeneca argued that the claim is not
comparative, but it is referenced to comparative
studies.
Crestor does not have a favourable risk/benefit
profile versus Lipitor. The Crestor PI contains
important information on safety issues unique to
Crestor such as the 5mg start dose and
recommendations associated with the 40mg
upper dose.
There have not been any clinical outcome
benefits demonstrated with Crestor. All Crestor
benefits relate to surrogate endpoints only
(lipoprotein levels).
The use of the graph is unacceptable and
comparative as it combines uncontrolled data
from multiple studies with data from different
time points.
Pfizer considers that Claim 4 is in breach of
sections 1.3 and 1.7 of the Code.
In summary, Pfizer asserted that if left
uncorrected the misleading claims have the
potential to compromise patient care
inappropriate switching to or initiation on
Crestor to achieve perceived better LDL-C
73
Crestor 842 (contd)

outcomes, or perceived better cardio vascular
outcomes which are unsubstantiated.
In response to questions from the Appeals

Committee, the following further issues were
discussed with Pfizer representatives:
Pfizer agreed that the safety profiles of Lipitor
and Crestor are very similar, but Pfizer does
not claim Lipitor has a more favourable profile
than other statins.
A Committee member asked why Pfizer
thought that corrective action was necessary if
the safety profiles were similar.
Pfizer
responded that statins are not simple to use
the doctor needs to perform liver function tests
prior to treatment, for example, and there are
populations where people need to start on
5mg of Crestor. It was accepted that there is
no demonstrable difference in tolerability
between 5mg and 10mg of Crestor, except for
the special populations. Pfizer stated that
there is no reason to start at the 10mg dose.
It is important to start at the lower 5mg dose
and titrate up. The Crestor PI states to start at
5mg or 10mg. With Lipitor you can start at
any dose. Titration is not described in the
Lipitor PI.
In relation to effect on HDL, Pfizer agreed that
statins dont affect HDL much and an issue
with respect to a claim concerning effect on
HDL had been resolved with AstraZeneca
during intercompany dialogue.
An AstraZeneca representative was offered the

opportunity to respond to any matters raised and
to provide a final summary of AstraZenecas
appeal.
AstraZeneca is interested in the appropriate

use of all its products and challenge the
accuracy of the statistics on the early
marketing of Crestor, which are fraught with
potential inaccuracies.
Pfizer
had
provided
a
disingenuous
interpretation of the PBAC summary with
respect to Crestor.
Crestor had a positive effect on HDL that is
maintained across the dose range, which is
unique to Crestor.
Any reference to complaint 820 is outside the
scope of this Appeals Committee.
In relation to other jurisdictions, such as
Japan, a 2.5mg dose of Crestor is in the
process of being registered but this does not
indicate any lack of patient safety.
Outcomes data is not available at the time of

launch with any statin. This does not reflect
safety, just that the studies havent been
completed.
The Note in the PBS listing referred to by Pfizer
is being withdrawn in January 2007 evidence
can be provided to the Appeals Committee.
All evidence supports the safety profile and
efficacy of Crestor.
Committee members asked the AstraZeneca

representatives
how
the
original
doctors
participating in the Early Access Program (EAP)
would get the revised Crestor dose card information
produced following the Code Committees decision.
An AstraZeneca representative responded that the
new materials were in addition to the EAP materials.
The EAP materials didnt cover any of the issues
subject to this complaint. The new materials cover
the PBS listing and have corrected the information
as required by the Code Committee. The
Committee was not shown the new materials or
given clear and precise information about what
changes had been made.
The Chairman sought clarification regarding Claim 1
as to why the footnote was not included with the
actual claim as it would appear that this was an
attempt to downplay the qualifying words in the
footnote.
An AstraZeneca representative responded that this
was a subjective view and that other companies
have used mg per mg statements, citing Vytorin
and Lipitor examples. Further, AstraZeneca believe
that the claim is defensible even without the
footnote.
The Chairman also sought clarification on
AstraZenecas allegations that it had been denied
procedural fairness in relation to being able to
respond to the sanctions imposed by the Code of
Conduct Committee, noting that this could have
been addressed by AstraZeneca in its original
response to the complaint. It was not usual practice
for a Subject Company to be asked to make a
further submission to the Code of Conduct
Committee on the sanctions. The Chairman drew
the distinction between a clear breach of procedural
fairness if the Committee is invited to consider a
breach of section 1.3 but finds a breach of section
1.7 at one extreme, and alternatively where an
argument arises in the debate by the Committee as
the rationale for finding a breach, which would not
be considered a breach of procedural fairness.
74
Crestor 842 (contd)

He suggested that most of AstraZenecas
concerns regarding procedural fairness appeared
to fall into the latter category and invited comment
on whether AstraZeneca felt any issues fell into
the former category.
An AstraZeneca
representative responded that he had no further
comments beyond those in the written submission.
perspective because the member considered that

one cannot assume that a general practitioner
would not read the footnote, and if read in totality
the statement was correct.
A Pfizer representative commented that while HDL

was important it was not part of the complaint by
Pfizer. He also re-iterated that the activity found in
breach under complaint 820 was relevant as it
demonstrated a similar pattern of behaviour. In
relation to the PBAC Note on the PBS listing, the
Pfizer representative asserted that at the time the
Crestor materials subject to complaint were
published, the Note was in the PBS Book. An
AstraZeneca representative responded that this
was not correct as the PBS listing had not
occurred at that time. Rather, he had written to
the Pfizer Managing Director, informing him that
the Note is being removed.
Claim 2: 10mg Simply right from the start

The Committee agreed that the Product Information
states that both 5mg and 10mg are approved
starting doses for Crestor. While expressing some
concern as to apparent emphasis on the 10mg dose
by use of larger print size, the Committee was of the
view that the claim was not misleading and
therefore upheld the appeal in relation to a breach
of Section 1.3 of the Code.
A Pfizer representative stated that Pfizer was of

the view that the reason AstraZeneca had
withdrawn the materials was that new materials
were already being prepared for the PBS launch
on 1 December 2006. The Pfizer representative
rejected the allegations by AstraZeneca that they
were aggressive in lodging a complaint in relation
to Crestor.
lowering LDL-C
The Appeals Committee was of the view that the
statement when read in association with the
footnote was technically correct. However the
impression given by the claim read in isolation of
the footnote is that Crestor was the most effective
statin
which
could
not
be
adequately
substantiated. The body of literature indicates that
you cannot obtain better control over LDL-C with
Crestor than with equi-effective doses of other
statins. While agreeing that it is permissible to use
qualifying statements under the Code, the
Committee was of the view that where a claim can
only be correctly interpreted with the footnote or
qualifying statement, as in this case, it was
misleading to separate the claim from the footnote.
A majority of the Committee considered that it was
misleading to make the claim with separate
presentation of the important qualifying statement.
One member of the Committee dissented from this
By a majority decision the Committee did not uphold

the appeal in relation to Sections 1.3 and 1.7 of the
Code.

The Committee considered that it was routine that
all patients being prescribed a statin should have a
liver function test and evaluation of their risk of
myopathy. It was agreed that the bullet points
directly under the claim made it clear what it was
referring to. Members agreed that the claims in
relation to once daily and any time of day were
commensurate with the Product Information and
therefore upheld the appeal in relation to a breach
The Appeals Committee was of the view that in
isolation there was no issue with the claim of
Crestor having a favourable risk/benefit profile.
However, when made in association with the graph,
which was based on comparative studies, it
incorrectly implied that Crestor had a more
favourable risk/benefit profile in comparison to other
statins. Members agreed that the graph compiled
datasets from a range of studies in a comparative
manner which, when combined with the claim made
a misleading comparison.
The Appeals Committee did not uphold the appeal
in relation to a breach of Sections 1.3 and 1.7 of the
Code.
Sanctions
Having upheld two aspects of the appeal the
Committee considered the sanctions imposed by
the Code of Conduct Committee.
The Committee agreed that the materials found in
breach should be withdrawn.
75
Crestor 842 (contd)

Members also agreed that the requirement for a
corrective letter should remain as the materials
had been heavily marketed outside the Early
Access Program.
The Committee agreed that the fine should be
reduced to $40,000 in consideration that the
appeal had been partly upheld.
76
Rotarix (843)
(GSK)
Complaint: CSL Limited (CSL)
Product: Rotarix
Complaint:
It was alleged that claims in relation to Rotarix and
protection for rotavirus strains G4P[8] and G2P[4]
were inaccurate and misleading and could not be
supported by the Product Information (PI).
The material was alleged to be in breach of the
1.1 Responsibility
decision:
Breach of Sections 1.1, 1.2.2 and 1.3 of the
Committee)
Sanctions:
Committee)
who received the material found in breach of
Committee)
Fine $25,000 (Decision confirmed by the
Appeals Committee)
Claim 1: Protective trend against G2P[4]
Members of the Committee questioned the use of
protective trend and how it would be understood
by a general practitioner and were also of the view
that to use trend in a claim would require very
good supporting data.
The Committee concurred that the claim in relation
to G2P[4] went beyond the scope of the PI which
stated that in clinical trials protective efficacy had
been demonstrated against rotavirus of types
G1P[8], G3P[8] and G9P[8]. In relation to the
evidence provided by GSK, members commented
that the data were not sufficient to support the
claim.
The supporting study did not achieve
statistical significance and there were very wide
confidence intervals for G2P[4] reflecting the very
small number of subjects with this strain.
breach of Sections 1.1 and 1.3 and by a majority a
breach of Section 1.2.2 of the Code.
Claim 2: Rotarix provides cross protection
against G4P[8]
The Committee similarly found that the claim that
Rotarix provides cross protection against the G4P[8]
strain was not supported by the PI and the other
supporting references were inadequate to
substantiate the claim. One reference, the Vesikari
paper, is only available as an abstract.
The
Committee unanimously found a breach of Sections
1.1, 1.2.2 and 1.3 of the Code.
Sanctions
Having found a number of breaches of the Code the
It determined that GSK should cease distribution
and use of all materials found in breach.
The Committee was concerned to correct the
misleading impression about the strains covered by
Rotarix and determined that a corrective letter
should be sent to all general practitioners in
Australia.
The Committee also determined that a fine of
$25,000 should be imposed.
Appeals Committee
An appeal was lodged by GSK against the findings
of the Code of Conduct Committee.
The following summarises the GSK presentation to
the Appeals Committee:
GSK maintain that it relied on scientific data of
the highest quality in the promotional material
and was guided by scientific convention in the
way the data was presented.
GSK communicated in the most accurate and
appropriate language to its audience (general
practitioners) within the parameters of the Code
of Conduct.
GSK was conscious of their obligation and is
fully committed to ensuring that patients will
benefit from a vaccine that is both safe and
efficacious.
Basis
for
protection
against
rotavirus
gastroenteritis by rotavirus vaccines:
77
Rotarix 843 (contd)
Protection against natural rotavirus

infection has been observed to be
determined by both the G type and P type
proteins on the outer surface of the virus.
The combination of these proteins defines
the virus strain.
Rotavirus vaccines may confer protection

that depends on either the G-protein, Pprotein, or both
Protection against rotavirus strains with

the same P-protein as the vaccine but
different G-protein is referred to as
heterotypic or cross-protection.
Rotarix contains a single human G1P[8]

strain. The idea of the vaccine is to confer
broad protection by using a human
derived rotavirus strain; i.e. by heterotypic
protection.
Data shows statistically significant
cross-protection
against
P[8]containing strains irrespective of the
G-type, i.e. G1P[8], G3P[8], G4P[8]
and G9P[8]
Cross-protection has historical foundations
and multiple precedents in vaccinology:
Jenner (1798) used cowpox to prevent

smallpox heterotypic protection examples:
BCG vaccine and tuberculosis
7-valent pneumococcal vaccine has
demonstrated cross-protection against
vaccine-related serotypes.
The promotional claim in question:
Rotarix provides cross-protection against
G4P[8] is fully supported by the PI:
The Indication states: ROTARIX is

indicated for the prevention of rotavirus
gastroenteritis (see Clinical Trials).
The Clinical Trials section clearly

presents, in table form, efficacy against
all strains with P8 genotype (which
includes G4P[8]) as being 90.9%, with
95% confidence interval of 79.2 - 96.8.
The claim is further supported by RuizPalacios et al (NEJM, 2006) and Vesikari

(ESPID 2006). All references were cited
in the promotional material.
G2P[4] Protective Trend claim
Two meta-analyses have demonstrated

the protection against G2P[4] to be
statistically significant
Meta-analysis is needed to address the

low incidence of G2P[4] rotavirus
gastroenteritis in study populations.
However, all clinical trials used the same
methodology.
The methodology has been reviewed by an

independent expert biostatistician, whose
expert opinion was accepted by the EMEA.
The data demonstrating protection against

G2P[4] is sufficient and of adequate quality
and fully supports vaccination of infants and
young children with Rotarix.
However, GSK has conservatively used the
term protective trend in promotional material.
Protective derives from protective efficacy
which is synonymous with vaccine efficacy.
Trend means a positive point estimate
observed in several studies, none of which was
statistically significant.
Notwithstanding this, GSK have used the term
protective trend which inherently denotes data
that was not statistically significant in one single
study. The term is appropriate and accessible
language for the GP audience.
In relation to the allegations that the GSK
appeal is frivolous and vexatious, and GSK
are abusing the Code.
GSK is exercising its process rights under

the Code.
GSK hold strongly and sincerely that claims

are scientifically valid and justified.
GSK has withdrawn all relevant materials and
has
not
promoted
to
non-healthcare
professionals.
The G4P[8] claim is consistent with the
Approved Product Information.
GSKs major concern is the requirement for a
corrective letter to be sent to all GPs. Given the
current state of the evidence, this has the
potential to be misleading to these healthcare
professionals.
GSK requests reconsideration of the $25,000
fine, should any or all of this Appeal be upheld
The following summarises the CSL response to the

appeal:
The claims breach the Code in relation to
sections 1.1, 1.3 and 1.2.2 and CSL considers
that the Code Committees decisions should be
upheld.
A CSL representative noted that the claim for
cross-protection against G4P[8] and protective
trend against G2p[4] in the promotional material
were placed under the heading proven
efficacy. This is a breach of section 1.1 as the
claims are inconsistent with the Rotarix PI.
The stated Indication is Rotarix is indicated for
the prevention of rotavirus gastroenteritis (see
Clinical Trials).
78
Rotarix 843 (contd)
Protective efficacy has been demonstrated

against rotavirus of types G1P[8], G3P[8]
and G9P[8].
Specific data against G4P[8] are not

presented in the PI, notwithstanding P8
cross-protection.
G2P[4] efficacy: 41% with very wide 95%

confidence interval: -79.2% to 82.4%.
The data are not adequate to support the
claims.
Rotarix PI no efficacy data for G4P[8]

and Ruiz-Palacios et al G2P[4] data is not
statistically significant.
Vesikari et al is an abstract and therefore

cannot be used as the sole supporting
evidence.
The data for G4P[8] are
supportive but not the G2P[4] data which
are not statistically significant.
Perez-Schael et al is also an abstract of a

meta-analysis of G2P[4] results.
Cross protection:
Concept
of
cross-protection
is
predominantly theoretical and needs to be
supported by sound clinical evidence.
The available supporting evidence is

limited and not sufficient to extrapolate to
clinical practice.
There must be clinical data to support any

claim for clinical efficacy.
Vaccine PIs are no different from those of

pharmaceuticals.
GSK has presented no new data of relevance
to persuade the Appeals Committee that it
should uphold the appeal.
The De Vos meta-analysis and CHMP

opinion are nevertheless in conflict with
Australian PI. It is a breach of the Code to
use a foreign PI. Further, this information
post-dates the release of the promotional
claims.
Significance of G2P[4] disease in Australia:
The strain is less frequent, but can and

has caused significant disease.
There have been outbreaks in 1993, 1994,

2001 and 2004
In the 1994 outbreak approximately 100

children were admitted to hospital in Alice
Springs and 43 hospital admissions in
Darwin.
It is not appropriate to downplay the need

to justify a claim on the basis that the
occurrence of G2P[4] is much lower.
Either it is sufficiently important to make
the claim, or if not, no claim should be
made.
CSL submit that:
The Code of Conduct Committees

decisions should be upheld.
No new information has been presented by

GSK to change the outcome.
Neither claim is supported by the Rotarix PI.
The
medical
profession
relies
on
promotional material to be accurate and
balanced.
The supporting data is not of sufficient

quality and is in breach of section 1.2.2.
Consideration should be given to increasing

the sanctions, including requiring a
corrective advertisement in trade media and
a corrective letter to immunisation
coordinators.
Financial sanctions should remain.

In response to a question from the Committee, CSL
explained that efficacy of a vaccine is a statistical
difference when compared with placebo, but doesnt
have to reach a particular threshold level.
In relation to a question about access to the
rotavirus vaccines and the role of State vaccine
coordinators, CSL explained that the companies
were currently waiting the outcomes of a recent
PBAC meeting which will recommend inclusion on
the National Immunisation Schedule. Once the
vaccines are listed on the Schedule, State
immunisation coordinators will decide which vaccine
will be administered based on tender arrangements.
However, this will take some time to be put in place,
and in the interim GPs are selecting which vaccine
to use as a private prescription.
In response to a question as to whether there was a
difference in the CSL and GSK vaccines, CSL
responded that Rotateq is a pentavalent vaccine
including five serotypes G1, G2, G3, G4 and G9.
A GSK representative provided a final closing
statement in support of the GSK appeal. He
acknowledged that this was a very complex and
technical area. GSK believed that because of the
complex nature of the complaint the Code of
Conduct Committee may not have fully understood
the scientific evidence. The option to appeal a
decision of the Code of Conduct Committee gave a
company the opportunity to explain the scientific
data and evidence in person and that the Appeals
Committee meeting included an expert in the field of
the complaint. GSK did not consider its appeal to
be vexatious. GSK also vehemently deny that they
have provided materials to members of the general
public, as has been suggested by CSL.
79
Rotarix 843 (contd)

The Committee sought clarification from GSK in
relation to whether it was appealing against a
finding of a breach of section 1.3 of the Code for
the protective trend against G2P4 claim. The
Chairman referred to the GSK letter of appeal
which stated that GSK may have breached
Section 1.3 of the Code. A GSK representative
responded that GSK would not be appealing
against Section 1.3 of the Code in relation to the
protective trend claim.
Claim 1: Protective trend against G2P[4]

relation to Sections 1.1 and 1.2.2 for the following
reasons:
The basis for the claim is pooled data due to
the low incidence of G2P[4] strain.
It can be observed from naturally occurring
strains of rotavirus that the commonly
occurring G1P[8] strain offers some crossprotection against G2P[4]. However, at the
time of publication of the claim, this had not
been demonstrated at a level of statistical
significance of protection against G2P[4] in
appropriate clinical trials.
Term protective trend would imply to a
general practitioner reader some level of
actual clinical protection, which had not been
proven and was therefore misleading.
Whilst there now may be published studies
demonstrating protection against the G2P[4]
strain, these studies were only available in
abstract form at the time the promotional
materials were disseminated.
At the time of dissemination of the promotional
material there was insufficient evidence to
support the claim which implied actual
protection against the G2P[4] strain.
The data used to support the claim has not
been published in a peer-reviewed form.
Whilst the study may have been evaluated by
the CHMP, this opinion was released after the
publication of the claims.
abstract (Vesikari et al) and a published paper

Ruiz-Palacios et al.
In relation to the Ruiz-Palacios et al paper
published in the New England Journal of
Medicine, the data concerning G4P[8] is
compiled with G3P[8] and G9P[8] and therefore
cross-protection against G4P[8] specifically
could not be demonstrated from this study.
The Appeals Committee did not agree that the
general statement in the Rotarix PI concerning
all strains with the P8 genotype was sufficient
on which to base a specific claim of crossprotection against G4P[8].
There was therefore insufficient data of
adequate quality to support the claim at the time
of its publication.
Sanctions
Having not upheld the appeal, the Appeals
Members agreed that GSK should cease
distribution and use of all materials found in breach.
Following
considerable
discussion
on
the
requirement for a corrective letter, the Appeals
Committee determined that a corrective letter
should be sent to all general practitioners in
Australia and any other person who had received
the materials found in breach of the Code. The
corrective letter will advise that at the time the
claims were published there was insufficient data to
support them and they were therefore misleading.
The Appeals Committee further determined that the
fine of $25,000 should remain.
Claim 2: Rotarix provides cross protection

against G4P[8]
relation to Sections 1.1, 1.2.2 and 1.3 for the
following reasons:
At the time of dissemination of the promotional
materials containing the claim of crossprotection there was insufficient evidence to
support the claim. The claim relied on an
80
Buscopan (844)
Subject Company: Boehringer Ingelheim
Complaint: Healthcare professional
Product: Buscopan
Complaint:
The complainant alleged that the company used
the name of the Australian and New Zealand
Society of Palliative Medicine (ANZSPM) without
authority and listed the organisations website on a
Buscopan promotional brochure without
permission from the Society. The material made
reference to the ANZSPM conference.
The Committee was of the view that the design of

the promotional mailer clearly associated the
ANZSPM conference and Buscopan by the colocation of the statements:
Be aware of Australian and New Zealand
Society of Palliative Medicine Conference,
Newcastle 4 6 October 2006
Be aware of Buscopan for the relief of colicky
abdominal pain
Through the use of the conference tagline be
aware of and the conference image of pelicans
in association with Buscopan, it was agreed that
this gave a misleading impression of an association
with the conference and some implied endorsement
of Buscopan by the Society.

The activity was alleged to be in breach of the
1.1 Responsibility
1.9 Medical ethics
The Committee also commented on the mailing

cover sheet which gave the impression that the
contents were from the conference organisers and
contained information pertaining to the conference,
which gave further weight to the contention that
readers would be misled into understanding that the
ANZSPM endorsed Buscopan.

decision:
Unanimous breach of Section 1.3 of the Code
(Decision
confirmed
by
the
Appeals
Committee)
Majority no breach of Sections 1.1 and 1.9 of
the Code
While acknowledging that Boehringer Ingelheim

may have undertaken to produce this brochure to
advertise the conference and also offer support to
healthcare professionals wishing to attend the
conference, this action was not well considered and
could potentially bring the industry into disrepute.
Sanctions:
Committee)
Members of the Committee initially questioned
whether the complainant was acting on behalf of
the Society or conference organisers. The
Committee concluded that the complainant had
framed his complaint as a member of ANZSPM
and he was aware that permission had not been
granted for Boehringer Ingelheim to use the
Societys name in association with promotional
material for a specific medicine. However some
members commented that it did not matter
whether the complainant was lodging the
complaint as an individual or on behalf of the
Society.
The Committee unanimously found a breach of

Section 1.3. By a majority no breach of Sections 1.1
or 1.9 of the Code was found as a majority of
members considered that these sections were not
applicable to the complaint.
In relation to the statements by Boehringer
Ingelheim that there had been some internal
procedural issues resulting in Boehringer Ingelheim
not being an official sponsor of the conference,
members recommended that Boehringer should
conduct an internal review of its approval processes
for sponsorship arrangements and promotional
material.
Sanctions
Having found a breach of Section 1.3 of the Code
It determined that Boehringer Ingelheim should
cease distribution and use of any materials found in
breach.
The Committee determined that a fine of $25,000
should be imposed.
81
Buscopan 844 (contd)

Appeals Committee
An appeal was lodged by Boehringer Ingelheim
against the findings of the Code of Conduct
Committee.
The following summarises the Boehringer
Ingelheim appeal:
Boehringer Ingelheim had been surprised at
the Code Committees decision and was
disappointed the Complainant was not in
attendance.
Buscopan injection is a small niche product.
Buscopan was first registered in 1958. The
ampoules were listed on the PBS in February
2004 as a result of a request from the
Palliative Care Working Group.
Buscopan ampoules sales volume is less than
100 units per month.
The mailer in question was part of an
awareness campaign about the PBS listing.
Three mailers with a nature theme were to be
sent to Palliative Care physicians and relevant
GPs in 2006.
Mailer 1 was sent in March 2006 to 9,500 GPs
and
specialists,
offering
Therapeutic
Guidelines as a competition prize. The
publisher gave permission to use an image of
the Guidelines on the brochure.
Mailer 2 was sent in July 2006 using the
tagline Be aware of PBS listing. The mailer
offered a donation of $2 to Daffodil Day for
each response. Boehringer Ingelheim had
offered this donation to Palliative Care
Australia for National Palliative Care Week,
but this had not been approved and therefore
did not proceed. The mailer therefore referred
to Daffodil Day and provided a link to the
website, as agreed with organisers.
Mailer 3 was sent to 5,000 GPs and
specialists in September 2006. It offered a
competition prize of a $500 assistance
package to attend the Australian and New
Zealand Society of Palliative Medicine
Conference.
Background to development of Mailer 3:
In July 2006 ANZSPM invited sponsorship

from Boehringer Ingelheim, but this
request was sent to a person within
Boehringer Ingelheim who was unaware of
the Buscopan listing for palliative care who
declined sponsorship.
An employee from Tactical Health

developed the brochure concept and was
responsible
for
obtaining
external
approvals.
According to a statutory
declaration, the employee obtained verbal
approval from the ANZSPM to offer

sponsorship to delegates via a competition.
There was no written agreement, but
ANZSPM verbally advised that it did not
approve use of their logo, images or colour
theme for the conference.
A copy of the mailer was sent to the

ANZSPM office in Cheltenham Victoria and
Boehringer
Ingelheim
received
a
conference kit in response.
As a result of these communications the

agency formed the view that ANZSPM had
no concerns about the brochure or the offer
of a $500 assistance package to the
conference, but it was understood
Boehringer Ingelheim could not use the
conference colours or logo.
The Be aware of tagline was not used by the
ANZSPM in promoting its conference. Pelicans
were not part of the conference images.
Boehringer Ingelheims intention was to provide
GPs and specialists with information on the
PBS palliative care listing for Buscopan and to
let them know about the conference.
Boehringer Ingelheim did not intentionally infer
that it or Buscopan were associated with the
ANZSPM conference.
Boehringer Ingelheim had no reason to think
that drawing attention to the conference and
offering sponsorships to attend would not be
regarded positively by ANZSPM.
The rejection of the invitation to sponsor the
conference was unfortunate and was a
breakdown in communication within Boehringer
Ingelheim. This has led to improvements and
new arrangements within the company.
Boehringer Ingelheim is of the view that the
reference to the conference website and
inclusion of the definition of palliative care from
the Society website was useful information for
GPs and specialists and these are not protected
by copyright.
Boehringer Ingelheim does not accept that a
breach of Section 1.3 should be found because
it does not agree that the average person who
received the brochure would think there was an
association between Boehringer Ingelheim and
the Society and its conference. Boehringer
Ingelheim agrees that some aspects could have
been managed better, but the level of fine was
very high.
In response to questions from the Appeals

Committee a Boehringer Ingelheim representative
agreed that the first two mailers had received
written approval and in the case of the third mailer it
had been advised by the advertising agency that
82
Buscopan 844 (contd)

there was only verbal approval. The representative
stated that this would not occur again and
Boehringer Ingelheim had introduced new
procedures to improve such approval processes.
A Boehringer Ingelheim representative also
advised the Committee that following the draw of
the competition only one person had taken up the
$500 assistance package as the conference was
held on a weekday and other doctors were unable
to attend. Boehringer Ingelheim had offered to
donate the remaining funds to the ANZSPM.
The Appeals Committee agreed with the Code
Committee that people who viewed the mailer
would believe that there was an association
between Boehringer Ingelheim and Buscopan
ampoules and the ANZSPM conference, which
was not the case.
The Appeals Committee
considered that it was inadequate for the agency
and company not to have ensured it obtained
written approval from the ANZSPM prior to making
reference to that organisation or its conference.
The agency acting for Boehringer Ingelheim had
assumed too much as a result of having received
the conference package from ANZSPM.
The Appeals Committee referred to the Working

Together Guide which had been developed by
Medicines Australia, the Consumers Health Forum
of Australia and other consumer groups. While this
document does not make specific reference to
medical Colleges or Societies it does give some
guidance on developing agreements between
companies and third parties.
Sanctions
While not upholding the appeal, the Committee
considered that the breach was not as severe as
judged by the Code of Conduct Committee. One
member dissented from this view.
By a majority decision, the fine was reduced to
$10,000.
While acknowledging that the Be aware of tagline

and the pelican images were not proprietary to the
ANZSPM, members were concerned that the
mailer cover sheet gave the impression that it had
been sent by the conference organisers rather
than Boehringer Ingelheim, which was misleading.
Members agreed that there was probably minimal
commercial gain and the complaint did not expose
overt abuse of the Code.
The Committee
accepted that had the company been made aware
of the concerns first expressed by the conference
secretariat about not using the Society logo or the
conference theme colours and images, the
company was likely to have ensured approval was
obtained in the proper form. This complaint had
highlighted some internal problems at Boehringer
Ingelheim and the Committee noted that the
Boehringer Ingelheim representative had advised
that new processes were now in place.
The Committee did not uphold the appeal and
confirmed the finding of a breach of Section 1.3.
The Appeals Committee noted that permission to
use a third partys name or refer to a third party
conference must be in writing and should clearly
describe the arrangements between the parties.
83
NeoRecormon (845)
Subject Company: Roche Products (Roche)
Complainant: Amgen Australia (Amgen)
Product: NeoRecormon
Complaint:
It was alleged that the claims in the promotional
materials were based on a poster presentation
that is the sole source of evidence which is not
permitted by the Code.
The materials were alleged to be in breach of the
1.1 Responsibility
Majority no breach of Sections 1.1 and 1.2.2 of
the Code
Unanimous no breach of Section 1.3 of the
Code.
Minimal Injection Pain
The Committee was of the view that there was a
sufficient body of evidence in the field to support
this claim.
In relation to the use of healthy patients in the
referenced study, the Committee noted that there
was evidence provided by Roche of other studies
that had used real patients with similar outcomes.
The Committee discussed the use of the two pain
scales Visual Analogue Scale (VAS) and Verbal
Rating Scale (VRS), and agreed that whilst pain
assessment can be subjective and variable the
cross over design would minimize this impact.
Sections 1.1 and 1.2.2 of the Code and by a
unanimous decision no breach of Section 1.3 of
the Code.
concerns that the company was using a poster to

substantiate a claim, members were of the view that
there was a body of evidence that also supported
the claim, including direct comparisons between
NeoRecormon and Aranesp. Members also noted
that the respective Product Information documents
refer to injection site pain.
In reviewing the study references Choukroun et al
and Berthoux et al members noted that both the
poster and abstract referred to the same study.
While the study has not been published in a peer
reviewed journal, the majority of members were of
the view that it did not conflict with the body of
evidence and the poster included sufficient detail to
enable evaluation of the study and the study used a
well-validated methodology and the results are
reproducible.
Further, the study was not a
comparison with another product but with normal
saline.
A member noted that the primary claim of minimal
pain at the injection site was referenced to
published studies - Weiss et al and Locatelli et al.
The claim of equivalent pain at injection site to
normal saline is a secondary claim and may be
referenced to an abstract.
The Committee also commented that under Edition
14 of the Code posters could not be used as the
sole evidence to support major claims. Members
noted Edition 15 of the Code will state that posters
could not be used as the sole supporting evidence
for any claim.
Sections 1.1 and 1.2.2 of the Code and in a
unanimous decision no breach of Section 1.3 of the
Code.
Section 12.3
In their response to the complaint Roche had
argued that Amgen had been mischievous and
frivolous in their actions by making accusations that
are unfounded and unsubstantiated.
In consideration of the considerable debate that
arose during consideration of this complaint, the
Committee did not consider that Amgen should be
required to respond to the allegation of being in
Injection site pain equivalent to normal saline

The Committee was of the view that the claim was
comparative to physiological saline only and not
the Amgen product Aranesp. While having
84
Nexium (847)
Subject Company: AstraZeneca
Complainant: Janssen-Cilag
Product: Nexium
Complaint:
Janssen-Cilag alleged that AstraZeneca used
clinical information inappropriately in the
promotion of Nexium 40mg and promoted Nexium
40mg outside the approved indications which
resulted in misleading information and a
disparaging comparison being communicated to
1.2 Substantiating Data
1.3 False and Misleading Claims
1.7 Comparative Statements
Response:
AstraZeneca denied any breach of the Code.
AstraZeneca strongly rejected the allegations that
Nexium was promoted outside the approved
indications.
AstraZeneca considered that the
evidence supports the claims. AstraZeneca also
stated that the complaint was about a minor
technical argument about study design (erosive vs
non erosive disease).
Code of Conduct Committee Decision:
A4 piece Based on the Miner et al Study
Unanimous decision - no breach of Section
1.2 of the Code
Majority decision - breach of Sections 1.3 and
1.7 of the Code
Advertisements
Reflux symptoms under control
1.2 of the Code
Majority decision - breach of Section 1.3 of the
Code
Majority decision - no breach of Section 1.7 of
the Code
Superior acid control
1.2 of the Code

Code
the Code
Reflux oesophagitis healed

Unanimous decision - no breach of Section 1.2
of the Code
Code
the Code
Sanctions:
Withdraw materials found in breach
Fine $75,000
A4 piece Based on the Miner et al Study
In reviewing the Miner et al paper the Committee
commented that there was no issue with the trial
design or methods, however noted that the trial
excluded patients with past or present endoscopic
evidence of esophageal erosions, ulcer, or other
significant upper GI pathology. In addition the trial
compared doses of drugs that were not comparable
in terms of standard doses in the Australian context.
Whilst noting that the Product Information for
Nexium states 40mg for treatment for erosive reflux
oesophagitis, members also commented that there
is no longer a requirement for endoscopy in
prescribing a PPI therefore a doctor is not in a
position to determine whether a patient has erosive
lesions. Nevertheless the 40mg dose is only
indicated for erosive disease and care should be
taken by the Sponsor to market the dose
accordingly.
Members also commented that because healthcare
professionals prescribe outside the Product
Information a company must always ensure that
promotional material does not make claims which
may fall outside the Product Information.
In a unanimous decision the Committee raised no
concerns with the Miner et al paper and did not find
a breach of Section 1.2 of the Code.
By a majority decision the Committee found a
breach of Section 1.3 of the Code in relation to the
conclusion Nexium at the standard dose (40mg
once daily). Members were of the view that in
translating the results of the paper there was a
disconnect between the results in the trial and the
85
Nexium 847 (contd)

approved Product Information. The standard
dose used in the paper was not the standard
dose used in Australia.
breach of Section 1.7 of the Code as the basis of
comparison was not reflective of the doses in the
Product Information.
Advertisements
The Committee was concerned about the use of
claims which are subsequently qualified with
statements in the mandatory text stating clinical
significance yet to be established.
Some members commented that the use of the
word sustained implied that a patient should
remain on 40mg.
Sanctions
The Committee determined that AstraZeneca
should:
present form.
Following discussion of the requirement for a
corrective letter members noted that the campaign
had been running for a considerable length of time
with no complaints and that the cost of withdrawal
and redesign of the promotional materials would be
expensive. The Committee also stated that by not
asking for a corrective letter to be sent out this
resulted in a higher monetary penalty.
The Committee considered this to be a moderate

breach as there was a disconnect between the
clinical findings and acid suppression and the
materials gave the impression of using 40mg
always.
These comments led to the following decisions in
relation to the Nexium advertisements:
Reflux symptoms under control
1.2 of the Code
Unanimous decision - breach of Section 1.3 of
the Code
the Code
Superior acid control
1.2 of the Code
Code
the Code
Reflux oesophagitis healed
1.2 of the Code
Code
the Code
86
Octanate (848)
Subject Company: Octapharma Australia

(Octapharma)

Prior to consideration of the complaint the
Committee referred to the statement by
Octapharma that the Committee does not have
jurisdiction with respect to the complaint because
Octapharma is not a member of Medicines
Australia. The Code of Conduct Committee was of
the view that the TGA letter of marketing approval
required all companies to comply with the
provisions of the Code and that the Code of
Conduct is recognised by the TGA, ACCC and
Department of Health as applying to all companies.
Complainant: CSL Bioplasma (CSL)

Product: Octanate
Complaint:
CSL alleged the representation of an indication for
Immune Tolerance Induction (ITI) was outside the
approved Product Information for Octanate and a
comparative statement in relation to purified factor
VIII was misleading and deceptive and constituted
a disparaging comparison of products.
1.3.1 False and Misleading Claims
Response:
Octapharma acknowledged that they do not have
a separate indication for ITI in Australia, however
were of the view that the approved indication
encompasses the treatment of Haemophilia A
patients who develop inhibitors and therefore
statements in relation to use in ITI were not
outside the approved Product Information in
Australia. Octapharma denied that the claim in
relation to unwanted protein was in breach of the
Code.
Decision:
Representation of indication for ITI
Majority decision - breach of Section 1.3.1
(Decision
confirmed
by
the
Appeals
Committee)
Less unwanted foreign protein
1.7 of the Code (Decision confirmed by the
Appeals Committee)
Sanctions:
(Decisions confirmed by the Appeals Committee)
Withdraw material found in breach
Fine $10,000
Corrective letter to the recipients of the
material found in breach
Members were also of the view that all companies

take the Code process seriously and ensure internal
compliance procedures are in place.
The Committee also noted that court proceedings
could be undertaken by any company in relation to
misleading advertising.
The Committee agreed to review the complaint as
submitted by CSL.
Representation of indication for ITI
Members noted Octapharmas statement in their
initial response to CSL in conceding that Octanate
does not have a separate indication for ITI in
Australia, but had asserted that It was
Octapharmas view that the treatment and
prophylaxis of bleeding in patients with Haemophilia
A (congenital factor VIII deficiency), Octanates
approved indication, encompasses the treatment of
Haemophilia A patients who develop inhibitors.
The Committee commented that they were
cognisant that a physician may use a product for an
off label indication, however a company should not
promote outside the approved indications for their
product. Some members commented that clinical
practice may outdate the Product Information. A
company should provide clinical data to the TGA for
an updated indication if they wish to promote that
specific indication.
Some members also
messages should be
promotional.
commented
educational
that
and
the
not

Section 1.3.1 of the Code.
87
Octanate 848 (contd)

Comparative statement Purification
The advantage of purified factor VIII is that
the patient receives less unwanted foreign
protein about 1/10 of the amount, compared
to preparations stabilised with albumin.
The Chairman referred to the Octapharma letter to
the TGA of 28 October 2003 in which they state
Octanate is purer than Biostate as the specific
activity of Biostate in the absence of added
albumin is 50IU/mg of protein compared to the
specific activity of Octanate, which is 128IU/mg of
protein. Given the higher specific activity of
Octanate the amounts of proteins other than factor
VIII should theoretically be lower in Octanate.
The Committee noted that in applying to the TGA
for approval Octapharma had made three claims
of superiority over the local product. The TGA may
have approved Octanate on the basis of accepting
all claims of superiority or only one or two. It was
implied in the submission to the Code of Conduct
Committee that the claims of superiority by
Octapharma had been accepted by the TGA, but
no evidence for this was produced to the Code of
Conduct Committee.
Members were of the view that given there was
only one other product on the market (Biostate,
CSL) that there was an implied comparison and
the
words
used
by
Octapharma
were
unnecessarily emotive. The Committee was also
of the view that the words unwanted foreign
protein lacked context, made claims that were
unsupported by appropriate refereeing (if such
information is extant) and was not in the spirit of
the Code.
breach of Sections 1.3 and 1.7 of the Code.
Sanctions
the Committee considered an appropriate
sanction.
It was noted that Octapharma had agreed to
withdraw materials prior to the complaint being
forwarded to Medicines Australia.
The Committee determined that Octapharma
should:
withdrawal of the material found in breach.
By a majority decision it was determined that
Octapharma should issue a corrective letter to
all healthcare professionals who had received
the materials found in breach. The corrective

letter shall be sent within 30 days of finalisation
of the complaint. The corrective letter shall be in
a form that does not result in the further
promotion of claims found in breach of the
Code.
Appeals Committee
Octapharma lodged an appeal on the following
grounds:
There is no separate indication for ITI in
Australia. The approved indication for Octanate
encompasses the treatment of Haemophilia A
patients who develop inhibitors.
Albumin has no role in the therapeutic effect or
indication for factor VIII in the treatment of
Haemophilia. The comparison in relation to
unwanted albumin is factual and verifiably
correct.
The following summarises the main points of the
Octapharma
presentation
to
the
Appeals
Committee:
The Code Committee had misunderstood
Octapharmas response and misdirected itself
on finding a breach.
Background - timeline
8/9/06
Octapharma received
complaint
from CSL
8/9/06
Octapharma ceased distribution of
brochure
(all
copies
later
destroyed)
22/9/06 Octapharma notified CSL that
distribution
had
ceased
and
remaining copies destroyed
23/11/06 Teleconference held dealing with
multiple issues. At the conclusion
of this conference the companies
agreed
on
a
protocol
of
intercompany dialogue if one
thought the other was in breach
and to put a complaint squarely to
the other and try and resolve it. If
the conduct in question was not
ceased, a complaint would be
lodged with Medicines Australia.
24/11/06 Complaint lodged by CSL with MA
Octapharma had already provided an
undertaking to CSL that the brochure would not
be further distributed.
Approved indication for Octanate is the
treatment and prophylaxis of bleeding in
patients with haemophilia A (congenital factor
VIII deficiency).
88

Haemophilia A patients with inhibitors are
given higher dose (10%-30% of patients).
Octapharma has not represented that it has a
separate indication for treatment of patients
with inhibitors.
Octanate brochure does not represent
Octanate as separately indicated for Immune
Tolerance Induction (ITI) or promote an
unapproved off label indication.
Suitability of Octanate for patients with
inhibitors is within the approved indications
and product information.
The Code
Committee made the incorrect assumption
that there was a different indication involved
for treating people with inhibitors.
Less unwanted foreign protein statement is
factually correct and capable of verification:
Albumin
Is only added for its stabilising effect
Has no role in the clinical effect or
indication of factor VIII products
Is unnecessary in the treatment of
haemophilia and therefore unwanted
Is technically an impurity with capacity
to cause additional adverse events
The statement does not compare Octanate
with Biostate.
In a global context other factor VIII products
contain albumin eg Haemate, so the statement
could not be comparing Octanate with
Biostate.
The Code Committee had
incorrectly assumed that the statement was
comparing Octanate and Biostate.
Australian Guidelines for the Registration of
Prescription Medicines, Appendix 19 requires
a demonstrably significant clinical advantage
over the local product. Octapharma had to
demonstrate clinical advantage over the local
product and the only clinical advantage
presented to TGA was the absence of
albumin.
The fact of gaining registration
demonstrates that they had met the Guideline
requirements.
The Code Committee had
misunderstood the issue and seemingly had
not accepted that the TGA had accepted the
clinical advantage.
In answer to a question from a Committee
member, it was established that no
documentation could be provided to
demonstrate that the TGA had accepted, as
the basis for registering the product, that the
one clinical advantage of Octanate was its
lack of albumin.
Findings of the Code Committee do not
support a breach. They are expressed as
finding the statement in question
unnecessarily emotive, lacking in context,

unsupported by appropriate refereeing and not
in the spirit of the Code. These are not words
used in Sections 1.3 or 1.7 of the Code and
therefore cannot be the basis for finding a
breach.
The comparison wasnt disparaging, was
factual, fair and capable of substantiation and
referenced to the body of evidence.
No evidence that Code Committee took into
account the Guidelines for Determining Code
Sanctions 2006.
Octapharma had immediately ceased using the
brochures once the complaint was received.
Gave an undertaking that the brochure would
not be further distributed.
Copies of the brochure were destroyed.
Octapharma attempted to resolve the complaint
with CSL.
No likelihood that healthcare professionals
would be misled.
No likelihood of patient harm.
Jurisdiction of the Code Committee:
Australia.
Condition of marketing approval requires
that promotional material (other than
Product Information) must comply with the
requirements of the Code of Conduct of
Medicines Australia.
Octapharma had invited the Code
Committee to rule on whether there was a
breach on the basis that it is a condition of
marketing approval for promotional material
to comply with the Code. It does not
require compliance by Octapharma as an
entity.
Does not require compliance with Code
provisions other than those relating to
promotional material (Section 3).
Octapharma reserved its position but invited
to the Code Committee to find no breach. It
did not invite the Committee to deal with a
sanction, but to express a non-binding
opinion.
Medicines Australia has no authority to find
a company in breach of their letter of
marketing approval.
The following summarises the CSL presentation
to the Appeals Committee in response to the
appeal:
Intercompany dialogue resolved 6 of the 8
issues
raised
with
Octapharma.
Octapharma did not agree not to promote
Octanate for Immune Tolerance Induction
89

(ITI) in future and would not desist in using the
reference to unwanted foreign protein.
ITI is a different therapeutic use of a factor VIII
product a different intent from controlling or
prophylaxis of bleeding.
ITI treatment is repeated high doses of factor
VIII to tolerise the immune system to factor
VIII and reduce inhibitor titres.
Supported by CPMP Note for Guidance on
the clinical investigation of human plasma
derived factor VIII and IX products, which
has been adopted by TGA. This states
that any request for an indication of
induction of immune tolerance in
haemophilia A patients with inhibitors
should be accompanied by clinical data
The Octanate PI makes no reference to
ITI in any section dosage, indication or
clinical trial data.
If promotion of unapproved indications is
allowed, CSL considers that this has very real
potential to open the floodgates.
In relation to the unwanted foreign protein
statement, albumin is not foreign as it is the
most common protein in human plasma.
Unwanted implies that albumin is a
contaminant protein which is not removed
during the purification.
But albumin is
deliberately added to the formulation of
Biostate in order to stabilise the factor VIII.
It is used as an excipient that serves a
particular purpose and cannot be said to be
unwanted.
There is no evidence that the TGA has
approved any statement that not including
albumin is a clinical advantage.
The decision of the Code Committee is
correct. Resolution could not be reached in
inter-company dialogue and CSL had no
choice but to submit the complaint to
Medicines Australia.
It is a serious breach to promote an
unapproved indication.
Octapharma should not be able to have it both
ways - to avail themselves of the process to
make complaints against CSL but at the same
time argue that they are not subject to the
Code.
In answer to questions from the Appeals
Committee, the following issues were raised:
Biostate is used for ITI in Australia, but it is not
promoted for this use by CSL. No factor VIII
products are approved for this use in Australia.
The Octanate brochure is a global brochure that

was adapted for Australia. The version subject
to complaint was only distributed in Australia.
Biostate and Octanate are the only two plasmaderived factor VIII products available in
Australia. There is a factor VIII recombinant
product.
Octapharma made the following points in its

response to CSLs presentation:
Octapharma is not promoting Octanate for
anything more than how doctors are using
Biostate and Octanate for ITI.
There is no suggestion that a sponsor has to
obtain a separate approved indication for use in
ITI. Use in ITI is wholly subsumed within the
current approved indication for Octanate.
Albumin in factor VIII products is not required to
replace something in which the patient is
deficient and therefore the word unwanted is
correct and is not used in a disparaging sense.
There is a clinical significance to the absence of
albumin in Octanate. A higher rate of adverse
reactions is reported for products containing
albumin compared with those without albumin.
Octapharma responded to this assertion stating that
you cant compare adverse reactions on the basis of
independent single arm studies that are reported in
the Product Information. There is no difference in
adverse reactions between factor VIII products
stabilised with albumin and those without albumin
and there is no clinical difference. Octapharma also
stated that when there are more unwanted proteins
present this does lead to greater adverse reactions
generally, but it is not possible to relate this directly
to the presence of albumin.
The Committee discussed the procedural issues
raised by Octapharma in relation to the complaint:
Lodgement of complaint by CSL
In relation to the request to make a determination
that CSL had breached an agreement with
Octapharma, the Appeals Committee cannot
deliberate on whether the companies had achieved
an agreement or whether an agreement they say
they had has been breached, irrespective of
whether there may be evidence of these matters in
the minutes of the inter-company dialogue.
Members also commented that there no provisions
in the Code which prevent a company from lodging
a complaint unless previously complained of
conduct was repeated.
90

Jurisdiction of the Medicines Australia Code and
Appeals Committees
In relation to Octapharmas assertion that the
Committee technically does not have jurisdiction
with respect to the complaint because
Australia, the Appeals Committee referred to
Section 11.4 of the Code. The Committee was of
the view that as Octapharma had responded to the
complaint in terms which suggested it was willing
to have the matter determined by Medicines
Australia, it should accept the decision and also
comply with any sanctions imposed. Should a nonmember company decline to have a complaint
considered by the Committee Medicines Australia
may refer the matter to the TGA or ACCC for
appropriate action.
Members of the Appeals Committee were also
concerned with Octapharmas allegation that the
Code Committee had misdirected itself with
respect to having jurisdiction where a company
may have breached the terms of marketing
approval. Members were of the view that the Code
and Appeals Committees were not putting
themselves in the position of the TGA with respect
to marketing approval but are entitled to interpret
and apply the provisions of the Code of Conduct
insofar as they reflect the provisions of the
Therapeutic Goods Act.
Merit of Appeal
relation to Section 1.3.1 for the following reasons:
The Committee considered that use of purified
factor VIII products for immune tolerising
therapy was very different to their use to
control bleeding or prophylaxis against
bleeding. In the first instance factor VIII is
being replaced to restore normal coagulation,
where for ITI large doses of factor VIII are
used to manipulate the immune system.
The Product Information for Octanate does not
include an indication for Immune Intolerance
Induction (ITI) and there is no information
elsewhere in the Product Information such as
dosage or in the clinical trials section. The
promotional material therefore included
reference to a non-approved indication.
The Committee did not accept the assertion
that the Octanate approved indication
encompasses ITI.
The words less unwanted foreign protein were

emotive and disparaging to factor VIII products
containing
albumin,
if
not
specifically
mentioning Biostate. The statement is about
purified factor VIII products, of which only
Octanate and Biostate are available in
Australia.
The brochure was specifically adapted for the
Australian market and by Octapharmas
admission that version was only distributed in
Australia.
Inappropriately implies that albumin is an
unwanted contaminant.
No evidence that adverse events were
attributable to the presence of albumin. There
is no information in the Product Information for
Octanate to show that there are less adverse
reactions.
The statement implies that Octanate is better
than similar products containing albumin
whereas a clinical advantage of Octanate had
not been demonstrated.
No evidence that the TGA supported this claim.
Whilst Octapharma may have submitted three
arguments in its application for registration in
support of its superiority to Biostate, no
evidence had been provided to support the
assertion that TGA had approved the product
on the basis of clinical superiority due to the
absence of albumin.
Sanctions
Having not upheld the appeal, the Appeals
The Appeals Committee was of the view that it was
appropriate that the material found in breach should
be withdrawn and not used again in a manner that
conveys the same or similar meaning. This applies
to any other items where the same claims or
information may appear.
Following discussion on the requirement for a
corrective letter, the Appeals Committee determined
that a corrective letter should be sent to all
haematologists.
fine of $10,000 should remain.

relation to Section 1.3 and 1.7 for the following
reasons:
91
Mobic (849)
Subject Company: Boehringer Ingelheim (BI)
referenced to a published paper, it was not a repeat

breach of the Code.
Product: Mobic
Promotion of superior GI safety of Mobic

compared to traditional NSAIDS
The Committee referred to the following statement
in the Mobic Product Information:
Complaint:
Pfizer alleged that one claim was a repeat breach
of the Code and the other claim was misleading in
terms of the safety profile of Mobic compared to
other traditional NSAIDS at all doses.
In clinical trials, meloxicam has been shown to

cause fewer GI adverse events (including
dyspepsia, abdominal pain, nausea, vomiting etc)
than other NSAIDS with which it has been
compared (Table 2).

1.2 Substantiating Data
Members noted that the measurements had been

taken at 4 and 12 week and 6 months of treatment
using Meloxicam 7.5mg and 15mg.
Response:
BI denied any breach of the Code. BI strongly
denied the allegations and stated that the efficacy
and safety of Mobic have been deemed
acceptable by the TGA, PBAC and overseas
regulatory agencies. Additionally none of the
material referred to as part of the complaint is
currently in use.
Repeat breach
Unanimous decision - no breach
Promotion of superior GI safety of Mobic
compared to traditional NSAIDS
Unanimous decision - breach of Sections 1.2
and 1.3
Majority decision - no breach of Section 1.7
Sanctions:
Withdraw
Corrective letter to all general practitioners
Fine $25,000
Repeat Breach
The Committee was of the view that as the claim
low incidence of GI perforations, obstructions and
bleeding was no longer used in isolation as in the
previous material found in breach in 2003 and was
Members also reviewed the referenced Singh paper

which analysed pooled data from clinical trials of
meloxicam at doses of 7.5 or 15 mg/d and noted the
conclusion:
.. the risk of serious gastrointestinal complications
was generally lower with meloxicam than with
diclofenac, naproxen and piroxicam and that this
risk was dose dependent.
The Committee also noted that the Singh paper
described the limitations of comparing products
across studies with different designs, interpretations
of end points and differing durations, which would
have increased the uncertainty when making
extrapolations/conclusions
about
long
term
use/safety. It was also noted that there was a
difference in the number of patients and in the data
presented from the poster submitted in 2001 to the
final paper published in 2004 with the latter
presenting the more accurate and sound data from
the Singh analysis.
Members commented that whilst the claim appears
to be misleading it was difficult to make the
complaint when the Product Information includes a
reference to lower rates of GI events. Nevertheless,
the Committee was of the view that the claim was
not sufficiently qualified in terms of the different
doses and the duration of the studies. The
information in the brochures would need to be
presented in full with information on the dose and
duration to ensure prescribers are not misled.
The majority of the Committee was of the opinion
that the material was not disparaging of the
comparator products and therefore not in breach of
Section 1.7.
92
Mobic 849 (contd)

breach of Sections 1.2 and 1.3 of the Code. By a
majority decision the Committee found no breach
Sanctions
the Committee considered an appropriate
sanction.
The Committee determined that Boehringer
Ingelheim should:
withdrawal of the materials found in breach.
Send a corrective letter to all general
practitioners
93
DuoTrav (850)
Subject Company: Alcon Laboratories (Alcon)

As the DART Program was actioned prior to the
introduction of Edition 15 of the Code members
advised that it would be heard under Edition 14 of
the Code and statements in relation to compliance
with Edition 15 by Pfizer would not be adjudicated
upon.

Product: DuoTrav
Complaint:
Pfizer alleged that Alcon did not accurately reflect
the differences between the TGA approved
indication
and
the
indication
for
PBS
reimbursement. Pfizer also asserted that the
DuoTrav as Replacement Therapy (DART)
Program was a hybrid post marketing surveillance
study (PMS) and a product familiarisation program
(PFP) and did not comply with the requirements of
the Code for either program.
sections of the Code:
8.2.2 Product Familiarisation Programs
9.8 Discredit to, and Reduction of, Confidence
in, the Industry
10.5 Discredit to, and Reduction of,
Confidence in, the Industry
Response:
Alcon denied any breach of the Code. Alcon
stated that they believed that the DART Program
was compliant with the Code.
decision:
DART Program
Majority decision - breach of Section 8.2.2
(Decision
confirmed
by
the
Appeals
Committee)
10.5 (Decision amended by the Appeals
Committee no breach)
Sanctions:
Severe breach (Decision amended by the
Appeals Committee minor breach)
Cease using program (Decision confirmed by
Corrective letter to all ophthalmologists
no requirement for a corrective letter)
Prior to reviewing the complaint the Committee

noted the indications listed in the approved Product
Information and the PBS.
Product Information
Reduction of elevated intraocular pressure in
patients with open angle glaucoma or ocular
hypertension for whom single therapy provides
insufficient intra-ocular pressure reduction.
PBS
Reduction of elevated intra-ocular pressure in
patients with open angle glaucoma who are not
adequately controlled with timolol maleate 5mg
(base) per mL (0.5%) eye drops or travaprost eye
drops.
Reduction of elevated intra-ocular pressure in
patients with ocular hypertension who are not
adequately controlled with timolol maleate 5mg
(base) per mL (0.5%) eye drops or travaprost eye
drops
The Committee also considered the requirements
for PFPs and PMS Studies under the Code. It was
noted that Alcon had asserted that the DART
Program was a PFP and Pfizer had accepted this
premise.
TGA Indication vs PBS Restriction
The Committee was of the view that there was a
difference between the two indications and that this
was not clearly identified in the materials for the
DART Program. Members were of the view that a
company had a responsibility to provide full details
to patients enrolled in a PFP and not leave it
exclusively to the healthcare professional.
The Committee considered that this action may
leave some patients out of pocket and could be
disruptive to a patients long term treatment. Such
patients may have benefited from the new treatment
but then found they were unable to afford to
continue. Members concurred that it was more
appropriate to switch monotherapy first before
moving to a fixed combination treatment. Some
members also expressed concern about a potential
for PBS leakage.
94
DuoTrav 850 (contd)

While noting that there was no harm likely to result
from a change to this medication, members found
a breach of the Code as the DART Program was
poorly executed and not in line with the quality use
of medicines, as stated in the preceding
paragraph.
from one treatment to that of the Subject Company.

Further, failure to adequately explain the financial
consequences to the patient had the potential to
either compromise the patients treatment and/or
the potential to cause financial hardship for the
patient and this had brought the industry into
disrepute.
Payment to doctors
Members noted Alcons comment that it was not
correct that a doctor would not be paid if a patient
withdrew from the program or failed to return for
the second visit. Doctors only needed to record a
NO in answer to the question of whether the
patient was discontinued.
The Committee also commented that where a

company provided information to patients that did
not clearly outline all relevant information,
particularly in this case in relation to the differences
between the approved indication and those for PBS
reimbursement, that this could reduce confidence in
the pharmaceutical industry.
However members were more concerned with the

actual payment to the doctors as part of the DART
Program and referred to Section 8.2.2 which
states:
Companies should not offer any monetary or
other type of reward to healthcare professionals,
their families and/or employees for taking part in
PFPs.

Sections 9.8 and 10.5 of the Code.
The majority of members were of the view that the

Code Section identified in the previous paragraph
could be interpreted as there should be no
payment to healthcare professionals for enrolling
patients or collecting data, while a minority of
members considered that the payment should not
be an incentive to take part, however it was
acceptable to pay healthcare professionals for
their time in completing the data/questionnaires.
Several members were also of the opinion that the
payment could be seen as an inducement to
switch patients to this product.
The Committee noted that Alcon relied on their
consultation with staff at Medicines Australia as to
the appropriateness of a reimbursement regime.
However, the Committee was unclear as to the
basis or context of the consultation, but in any
event determined that any payment whatsoever
was in breach of section 8.2.2.
Section 8.2.2 of the Code as the information on
the PBS reimbursement to patients enrolled in the
PFP was not sufficiently clear and payment should
not be made to healthcare professionals
participating in a PFP.
Sections 9.8 and 10.5 - Bringing Industry into
Disrepute.
Members were concerned that the structure of the
payments was simply designed to change patients
Sanctions
Having found a number of breaches, including
Sections 9.8 and 10.5 which are severe breaches of
the Code, the Committee considered an appropriate
sanction.
The Committee determined that Alcon should:
Take immediate action for the cessation of the
DART Program found in breach.
Send a corrective letter to all ophthalmologists
Appeals Committee
An appeal was lodged by Alcon on the basis that
they had sought advice from Medicines Australia
and were of the view that the company was not
paying healthcare professionals to take part in a
PFP but remunerating them for their time in
completing the forms and that it was not an
inducement to switch products.
The following summarises the Alcon presentation to
There are no explanatory notes to Section 8.2.2
in the Code or the Guidelines.
Alcon took advice from the Director, Scientific
and Technical Affairs at Medicines Australia.
Any suggestion that Alcons description of the
dialogue that took place is not correct is
unfounded.
The advice indicated a difference between a
reward and remuneration for services.
Alcon acted in good faith on this advice in the
absence of anything else.
Alcon acknowledges that this advice is not
binding.
Any PFP for DuoTrav, whether or not it included
remuneration for services, would involve
switching patients from monotherapy as the
95
DuoTrav 850 (contd)

TGA indication for use is second line (for
patients with inadequate control on single
agent).
Whether or not a doctor decides to switch
monotherapy (or in fact already had) is a
clinical decision and not in Alcons control.
Payment of $50 per patient per visit was
reasonable for the amount of time and work
required by the doctor.
Alcon only paid doctors for the actual visits
and patients if the doctor did not have ten
patients. It is not correct to state that Alcon
would not pay for time taken if a patient
dropped out or a doctor did not complete 10
patients.
10 patients was chosen as a reasonable
number to allow the doctor to form a clinical
opinion of the usefulness (or not) of DuoTrav.
There was no inducement to the doctors to
prescribe DuoTrav as payments were totally
unrelated to the outcome of patients on the
program.
Contrary to Pfizers allegation and the Code
Committees finding, the DART documentation
clearly lays out the TGA indication and the
PBS restrictions.
All doctors were personally attended by Alcon
Medical
Representatives
who
clearly
explained the PBS restrictions.
A DuoTrav sales aid was used to demonstrate
clinical studies and included PBS restrictions.
Doctors also received 2 letters from Alcon
reiterating the TGA indications and the PBS
restrictions.
Based on these five forms of communication,
it is clear that Alcon took every opportunity to
ensure the PBS information was adequately
communicated to participating doctors.
Alcon does not agree there was a breach of
Section 8.2.2:
The payment was payment for services,
not a reward
There was no inducement to prescribe
DuoTrav each doctor was limited to a
maximum of 10 patients
The only guidance available from
Medicines Australia was verbal advice as
no guidelines available
Alcon at all times acted in good faith
If Medicines Australia intent was for no
payment to be permitted then surely this
should be clearly stated in the Code.
Alcon does not believe there was a breach
of Section 10.5 (bringing industry into
disrepute):
If there is no breach of Section 8.2.2, then

there are no grounds for finding a breach of
Section 10.5 as the industry was not
brought into disrepute with doctors.
Alcon does not believe there was a breach of
Section 9.8 (bringing industry into disrepute
General Public):
Doctors were adequately informed of PBS
restrictions, and it is usual practice for
doctors to discuss PBS restrictions with
patients, there is no basis for finding a
breach of Section 9.8 (General Public).
Alcon contends that the PBS information
was clearly communicated via DART
materials, Alcon representatives and two
letters
Patients were not misled in the patient
information leaflet.
If Appeal Committee decides to uphold the
breaches then Alcon requests consideration of
the following:
Alcon at no time intended to bring the
industry into disrepute.
Alcon acted in good faith based on the
advice of a Senior Officer of Medicines
Australia believing, in the absence of any
other guidance, that the advice was good.
There is no evidence to suggest or
demonstrate otherwise.
Based on the above facts Alcon requests
relief on:
The severity of the breach;
The severity of the penalty; and
If a corrective letter is required it should
be limited to DART participants as
these are the only people affected.
The following summarises the Pfizer presentation to

Agree with the Code of Conduct Committees
findings that it is not appropriate to pay doctors
as part of a PFP.
There was inadequate disclosure of critical
information to doctors and patients with
possible compromise to the patients treatment
and/or potential to cause financial hardship.
Concern that payment was simply designed to
change patients from one treatment to DuoTrav.
Adequate information was not provided to
patients relating to the significant differences
between the TGA approved indication and the
PBS restriction.
Fewer patients would be eligible for PBS funded
drug than those who fulfil TGA indication.
DART entry criteria were broad and encouraged
enrolment of patients who may not ultimately
qualify for PBS funded drug.
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DuoTrav 850 (contd)

Implications of this (out of pocket expense
and/or compromise of long term treatment)
were not adequately disclosed to patients or
doctors.
Some patients who have benefited from
DuoTrav will find themselves in a situation
where they will have to incur an out of pocket
expense of $43.21 per month or discontinue
the medication that has clearly worked in
lowering their intraocular pressure (IOP).
Alcon had a number of instruments it might
have used including a PFP or Post Marketing
Surveillance Study (PMS).
Intent of Section 8.2.2 is clear: to ensure that
payment
to
healthcare
professionals
participating in PFPs cannot be perceived as
an inducement or reward.
Payment of $500 for ten patients who have
been switched from monotherapy to DuoTrav
can reasonably be perceived as a reward or
an inducement to doctors to switch and
maintain patients on DuoTrav.
Alcon claims that DART is not about switching.
However without switching to DuoTrav
patients are not eligible to participate in the
Program. Therefore switching to DuoTrav is
central to the DART Program.
Alcon failed to adequately communicate the
difference between the TGA indications and
PBS restrictions. In the patient information it
is stated that at the end of the program a
patient can get DuoTrav on the PBS as a
restricted benefit.
Alcon claims that they have complied with
Section 8.2.3 which states that PFPs should
only involve patients being treated for the
approved indications.
To shift the responsibility to doctors to ensure
that a patient was made aware of the PBS
indication
and
likely
ramifications
is
irresponsible and avoiding the duty a company
has to doctors and their patients. The DART
materials failed to adequately explain to
doctors the difference between the TGA
indication and PBS restriction.
The purpose of a Patient Information Leaflet
(PIL) is to communicate all pertinent
information that might bear on a patients
decision to participate in a PFP.
The PIL should have clearly provided
information on any expense a patient may
incur if they are not eligible for PBS funded
medication.
Failure to disclose this information in the PIL

and the consequent difficulty this may present
to patients and their doctor is likely to bring
discredit to the industry.
The intent of Sections 9.8 and 10.5 is to ensure
that member companies do not engage in
activities or behaviour that has the potential to
bring the industry into disrepute and that
material evidence of discredit is not required to
find a breach.
The design and execution of the DART
Program has the potential to reduce confidence
in the industry.
Pfizer called on the Appeals Committee to
uphold all findings by the Code of Conduct
Committee of a severe breach of the Code and
to uphold all sanctions:
Payment should not be made to healthcare
professionals participating in a PFP;
The payment in DART was simply designed
to change patients from one treatment to
that of DuoTrav; and
Inadequate information was provided to
patients relating to the difference between
the approved indication and those for the
PBS, with possible compromise to the
patients treatment and/or potential to cause
financial hardship.
In response to questions from members of the

Committee Alcon provided the following comments:
Doctors were paid for completing the forms
irrespective of reaching the target number of
patients if only 5 patients enrolled in DART
Program and the doctor completed the form for
each patient they were paid $50 per completed
form.
Target was 150 patients in the PFP actual
number at time of ceasing the program was
115.
Doctors could charge the patient for the
consultation time as per a normal visit.
There is no data on how many patients
remained on DuoTrav after the expiry of the
PFP.
The purpose of paying the ophthalmologists
was recognition of the time it would take to
complete the forms which was outside their
normal patient consultations - $50 was
considered reasonable and relevant to the time
involved to explain the program to patients and
complete the forms and is not considered
excessive for the time required.
Alcon chose PFP rather than a PMS as there
was no plan to actively collect safety data.
97
DuoTrav 850 (contd)

In response to a question from a member of the
Committee, the RANZCO representative advised
that the accepted guidelines for treatment of
glaucoma would be a step by step approach.
Patient
initiated
on
monotherapy
(prostaglandin analogue).
If inadequate switch to another prostaglandin
monotherapy or add a beta blocker (fixed or
unfixed combination).
Potentially add a third medicine.
Laser treatment.
Surgery.
Committee, Pfizer provided the following
comments:
Pfizer dont have any data as to whether
DuoTrav or the DART program has impacted
on Pfizers market share.
Three quarters of patients with glaucoma will
be on a health benefit card. Therefore the out
of pocket expense may be significant.
There are alternatives that will not leave the
patient out of pocket if they do not meet the
PBS criteria.
The Code is clear that you cannot make any
payments to doctors for involvement in a PFP.
No evidence that any patients have suffered or
that a doctor would consciously do anything to
impact on the patient in terms of expense or
inappropriate treatment.
The information on the difference between the
TGA and PBS indications should have been
more clearly laid out for the doctor and patient.
relation to Section 8.2.2 for the following reasons:
In a unanimous decision the Committee was
of the view that it was strictly a breach of
Section 8.2.2 to pay a healthcare professional
whether as recompense for work undertaken
or as an incentive to become involved in a
PFP. Whilst agreeing that Sections 8.1 and
8.3 are separately self contained, the
Committee noted the difference in expression
between sections 8.1.7 and 8.3.2 which clearly
envisaged allowing payment commensurate
with work involved and section 8.2.2 which
does not make such an allowance.
In this case Alcon took advice from Medicines
Australia that there was a difference between
payment as a benefit or incentive and as
recompense for work undertaken and
developed a program that paid the
ophthalmologist for the time to complete a
form on each patients response to DuoTrav.

Members considered that the payment of $50
per patient per visit for two visits was unlikely to
have influenced ophthalmologists in relation to
prescribing.
Therefore the severity of the
breach is at the lower end of the scale and
should be downgraded from a severe breach.
The Committee upheld the appeal in relation to
Sections 9.8 and 10.5 for the following reasons:
The Committee was of the view that
ophthalmologists were well informed healthcare
professionals and would have been aware of
the differences between the TGA and PBS
indications for DuoTrav. It was noted that
several forms of communication had also been
employed
by
Alcon
in
informing
ophthalmologists of this difference. Members
agreed that company initiated materials must
always include a reference to the TGA and PBS
indications. The Committee was also of the
view that healthcare professionals in the normal
course would communicate information to a
patient about any program in which they were
enrolling them and how it may impact on their
treatment and any potential costs that may be
incurred. This would include a PFP, surgery etc.
The Committee was of the view that while there
was some information in the Patient Information
Leaflet in relation to the difference between the
TGA and PBS indications and possible out of
pocket expenses should the patient not qualify
for PBS subsidised medicine, the message
could have been made more explicit. However
the Committee was of the view that this was not
sufficient to find a breach of Section 9.8 which
is considered a severe breach.
Sanctions
Having partially upheld the appeal, the Appeals
As previously determined by the Code of Conduct
Committee members agreed that Alcon should
advise doctors to cease enrolling patients in the
DART Program.
Following
considerable
discussion
on
the
requirement for a corrective letter, the Appeals
Committee determined that no corrective letter
should be sent to ophthalmologists.
fine of $100,000 should be reduced to $10,000 to
reflect the fact that the only breach remaining was a
minor one.
98
Biostate (851)
Subject Company: CSL Bioplasma (CSL)
Complainant: Octapharma Australia
(Octapharma)
Product: Biostate
Complaint:
Octapharma alleged that a Hong Kong Product
Information for Biostate was provided to an
Australian
healthcare
professional
at
an
international
meeting
held
in
Australia.
Octapharma also alleged that CSL gave the
impression that Biostate had a haemostatic
function and therefore could be used to treat von
Willebrands Disorder. Octapharma were also of
the view that other statements in the Australian
CSL brochure were misleading.
1.3.1 False or Misleading Claims
3.3.1.2(d) Printed Promotional Material
6.1.7 Trade Displays
Response:
CSL noted that the complaint was in relation to
two CSL publications. One of these publications
has not been made available since August 2005
and the other is approximately three years old and
has not been actively disseminated for some time.
CSL also maintained that the Australian Product
Information
was
available
for
Australian
prescribers and that the Octapharma complaint in
reference to von Willebrands Disorder (VWD) was
selective and incomplete. CSL also rejected the
allegations of a breach of the Code in relation to
the Australian brochure.
Decision:
Absence of Product Information majority
decision - no breach of Sections 6.1.7 or
3.3.1.2(d)
References to Von Willebrands Disorder
majority decision - no breach of Section 1.3.1
Viral Inactivation majority decision - breach
of Section 1.3
High Purity unanimous decision - no breach
of Section 1.3
Absence of inhibitors majority decision breach of Section 1.3
Sanctions:
Withdraw
Fine $5,000 (Decision amended by the Appeals
Committee fine removed)
The Committee made a number of general
comments in relation to this complaint.
Intercompany Dialogue
The Committee noted that intercompany dialogue
was undertaken through the respective company
legal advisors. Members commented that, in their
view, non-legal representatives of the two
companies should be prepared to engage directly in
constructive dialogue. The Committee felt that both
teams of lawyers complicated the issues with each
successive exchange of correspondence.
The
Committee considered that a genuine attempt by
the company representatives to resolve the
complaint may have led to a more constructive
outcome and/or a clearer position of difference for
the Committee to consider.
The Guidelines in the Code of Conduct require an
exchange of letters and face to face or
teleconference dialogue between the parties with
intercompany correspondence having the written
endorsement of the Association Representative.
Preparation of documentation for submission to the
Members noted that the CSL response included
extensive reference to a previous CSL/Octapharma
complaint. The Committee was of the view that the
Subject Company must respond to the complaint at
hand as it is the role of the Committee to consider
only the matter subject to complaint.
International CSL Brochure
Absence of Product Information
The Committee noted that it was acceptable under
Section 6.1.7 of the Code to display or supply
educational material for a product not approved for
registration in Australia or a non approved indication
of a product registered in Australia, provided that
any display material or educational material used
clearly identifies that it refers to a product or
indication not approved in Australia, and that the
product or indication, as appropriate, is approved
overseas.
99
Biostate 851 Contd

Members noted the statement in the CSL
response that the Hong Kong Monograph included
a statement to the effect Please review country
specific approved Product Information before
prescribing and that the Australian Product
Information
was
available
for
Australian
prescribers.
Australian Brochure was not sufficiently clear.

Members were of the view that any future wording
should use the exact words from the Product
Information or a paraphrased statement that
accurately reflected the Product Information.
The Committee also commented on the

discrepancy between the two companies on what
actually happened at the international meeting.
High Purity
A high purity factor VIII that has a normal
specific activity of 50IU/mg total protein with
footnote without the addition of albumin.
Whilst finding no breach of Sections 3.3.1.2(d) and

6.1.7 of the Code, the Committee was of the view
that CSL should have taken more care and shown
greater diligence to ensure that there was no
accidental distribution of the wrong Product
Information to an Australian attendee and that
documents for distribution were clearly labelled.
References to von Willebrands Disorder
The Committee again referred to the Explanatory
Notes under Section 6.1.7 of the Code that it is
possible to display or supply educational material
for a product not approved for registration in
Australia or a non approved indication of a product
registered in Australia, provided that any display
material or educational material used clearly
identifies that it refers to a product or indication not
approved in Australia, and that the product or
indication, as appropriate, is approved overseas.
Whilst finding no breach of Section 1.3 of the
Code, the Committee was of the view that CSL
should have taken more care and shown greater
diligence to ensure that documents for distribution
were clearly labelled that they referred to
indications not approved in Australia.
The Committee were of the opinion that the
information provided was not contrary to the
approved Product Information, the product was not
promoted as a treatment for von Willebrand
Disease and that the material was educational in
nature and therefore did not constitute a breach.
Australian CSL Brochure
Viral Inactivation
Dry heat at 80C for 72 hours is Effective
against enveloped viruses and also provides
protection against non-enveloped viruses such
as hepatitis A virus (HAV) and parvovirus B19
(B19).
The Committee was of the view that this is an
important area and the information in the CSL

The Committee was of the view that this statement

was sufficiently qualified with the footnote and found
no breach of Section 1.3 of the Code.
Absence of inhibitors
No inhibiting antibodies were detected
The Committee found a breach of Section 1.3 of the
Code as the statement was misleading in that it did
not provide qualification in terms of treated or
untreated patients. Members also noted CSLs
statement that they would qualify this statement in
any future materials. The Committee noted that the
presence or absence of inhibiting antibodies is a
safety issue and therefore this information should
have been clearly stated in the brochure.
Sanctions
Members noted CSLs comments that the brochures
have been withdrawn.
The Committee determined that CSL should:
withdrawal of the materials found in breach.
Appeals Committee
CSL lodged an appeal in relation to the sanctions
imposed by the Code Committee. CSL argued that
the Code Committee did not give adequate
consideration to action already taken by CSL prior
to the complaint submission by Octapharma.
The following summarises the CSL presentation to
CSL had taken the following action after receipt
of Octapharmas letter of 22/9/06:
Distribution of brochure formally ceased
(although it had not been in active
distribution for some time) and remaining
copies destroyed (4 October 2006).
100
Biostate 851 Contd

Reference to CSL brochure removed from
CSLs inventory tracking system by
marketing administrator (4 October 2006).
Advised Octapharma that brochure no
longer being distributed.
In respect of the two issues where CSL
had been found in breach,
written
assurance was provided to Octapharma
that future publications will be consistent
with PI in respect of viral inactivation and
an appropriate qualification will be
included in respect of absence of
inhibitors (6 October 2006).
Confirmed in writing again (23 October
2006).
CSL acknowledged that the statement subject
to the complaint was inconsistent with the PI.
CSL notes that directly underneath the
offending statement there was a table that
provided further and more detailed information
about the level of viral inactivation.
CSL notes that Octapharma did not provide
written confirmation in relation to future
conduct for Octanate whereas CSL had
provided written confirmation in relation to
Biostate.
Healthcare professionals would not be misled
because:
Biostate is typically used in previously
treated patients who have had previous
plasma product exposure and not in
Previously Untreated Patients (PUPs)
where the standard treatment is
recombinant factor VIII and not plasma
derived factor VIII concentrate (eg
Biostate).
Clinicians are aware that a significant
percentage of PUPs treated with factor
VIII concentrates will develop inhibitors as
a response to treatment.
Clinicians are aware that because
Previously Treated Patients (PTPs) have
been exposed to the factor VIII molecule,
it is uncommon for them to develop
inhibitors.
The sanctions were unjustified in light of
the prompt and effective action taken by
CSL.
The following summarises the Octapharma
presentation to the Appeals Committee:
Background
22 September 2006 Octapharma alerted
CSL that it is in breach of the Code.
15 December 2006 Octapharma submitted

a complaint to the Code Committee.
Between these dates correspondence
between the parties failed to resolve the
dispute.
The fact that there has been a breach of the

Code is not in dispute.
The sanctions were too lenient the Code
Committee did not adequately take into account
the Medicines Australia Guidelines for
determining sanctions when making their
determination.
A fine is necessary to encourage compliance
with the Code, to ensure that materials are not
incorrect or misleading. $5,000 is inadequate
and is not sufficient to encourage a company of
CSLs size to comply.
There is potential for patient harm the claim
could result in PUPs being treated with Biostate
and patients being given a virus infected
product in situations where the treating
professional believes it to be virus free.
The claim will affect prescribing practice of
practitioners.
CSL brochure had been in use for 3 years and
existed in the market as late as September
2006.
The breach should have been clearly evident to
CSL.
According to Section 12.1.2, corrective action is
required for moderate or severe breaches.
Statements in relation to viral inactivation are
inconsistent with PI, were not qualified and
were grossly misleading.
Statement in relation to the absence of
inhibitors is misleading and has safety
implications for patients.
There is an increased mortality rate in inhibitor
patients.
Appeals Committee should increase the fine to
$20,000 and require a corrective letter.

The Committee upheld the appeal in relation to
sanctions imposed by the Code of Conduct
Committee for the following reasons:
The CSL assessment of the likely clinical

impact of the statements is accurate.
Breach by CSL in relation to viral inactivation
was perhaps questionable, but the Committee
agreed it was not sufficiently clear. However,
the log reductions in viral load are very good
(meeting national and international standards)
and the risk to patients was minimal, if any. This
101
Biostate 851 Contd

was made very clear to physicians in the
product information table of viral inactivation.
Only a limited number of physicians can
prescribe these treatments through designated
Haemophilia treatment centres and product
use is monitored by the Department of Health
(National Blood Authority). They would be
very familiar with the product, risk of the
development of inhibitors and their clinical
importance.
The Committee noted that recombinant
products were released in Australia in 1994.
Since then all children diagnosed with
Haemophilia would have been started on
recombinant products and most adults
previously on plasma-derived products before
1994 may have been changed to recombinant
products. Therefore there is no clinical risk
that PUPs would be commenced on Biostate.
The promotional material was an out of
circulation item.
Concern about the timing of the complaint
only made following the CSL complaint
against Octapharma.
While CSL conceded that the materials could
have been better, it did provide written
confirmation that CSL would not use the
materials again.
The Committee considered this was a minor
breach.
Sanctions
Having upheld the appeal, the Appeals Committee
considered the sanctions imposed by the Code of
Conduct Committee.
The Appeals Committee determined that the fine
of $5,000 should be removed.
In relation to Octapharmas request that a
corrective letter should be sent to haematologists,
members noted that the Code states that it is a
general rule but not mandatory that a corrective
letter be sent where breaches of the Code are
found.
The Appeals Committee was of the view that this
was not a severe breach and that the physicians
to whom the material had been provided had a
high level of understanding of the field and would
not be misled or misinformed. Members also
commented that the clinical risk was non existent
and particularly in relation to children, as they
would not be prescribed one of the plasma-derived
products.
102
GSK Respiratory Care Program (852)

(GSK)
Complainant: Healthcare Professional

Complaint:
Incorrect
and
inappropriate
recommendations and information provided by
GSK sponsored nurses to general practitioners in
their practices
The Secretariat had requested GSK to respond to
the complaint with reference to the following
7.1.1 Sponsorship
7.1.2 Sponsorship
7.1.3 Sponsorship
10 Preamble Relationship with healthcare
professionals
10.5 Discredit to and reduction of confidence
in the industry
By a majority decision no breach of Sections
7.1.1, 7.1.2, 7.1.3, 10 (Preamble) and 10.5
The Committee referred to Section 11.1.1 of
Edition 14 of the Code which states The Subject
Company and complainant will provide the
Association with whatever references or
information is deemed by the Chief Executive
Officer or his or her delegate to be necessary to
fully investigate the complaint. The information
and response shall be provided to the Code of
Conduct Committee.
Members of the Code of Conduct Committee
considered that it had insufficient evidence to
determine the complaint. The Committee
requested that the complainant be asked to
provide additional information to the Committee
and that GSK be given the opportunity to respond
to any further submissions from the complainant.
For this reason the complaint was adjourned to the
next meeting.
Additional information to be requested from the
Complainant:
a copy of the extensive data which allegedly
shows that nurses are making incorrect and
inappropriate recommendations about asthma

treatments
a copy of a written report by a GSK sponsored
nurse stating that an inspiratory flow greater
than 60 litres/minute is required to use a
Turbuhaler (de-identified of any patient details)
This information shall be provided within 10
working days from receipt of formal advice of
this request
This information will be forwarded to GSK to
allow them to make a further written response
to the Code of Conduct Committee within 10
working days from receipt of the further
information.
The Committee also requested that the Code

Secretariat write to the National Asthma Council
seeking written advice on the NAC endorsement of
the program. This information will also be provided
to the Code of Conduct Committee for their
consideration.
The Committee agreed that the final hearing of this
complaint should again be deferred to the next
meeting to enable further information to be obtained
from GlaxoSmithKline Australia (GSK) in response
to the information received from the complainant
and the National Asthma Council.
Additional information to be requested from GSK:
Is the version of the program submitted in
response to the complaint the same version as
was originally reviewed and approved by the
National Asthma Council?
Why is there a difference in the data collection
sheet provided by the complainant and the
proforma submitted by GSK?
Why is the Symbicort tagline total control being
used in the material?
Clearly define who is responsible for the
program?
Consideration of complaint including the
additional information:
It was noted that the National Asthma Council
supported the concept and had participated in the
planning for the Respiratory Care Program when it
was first developed and were happy to have their
support for the program recognised through the
inclusion of their logo on the documents provided to
Committee members were supportive of the
concept of a program to enhance the care of
asthma patients and to support the delivery within
general practice of the National Asthma Council
Guidelines and support general practitioners in
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GSK Respiratory Care Program 852 (contd)

delivering this government funded initiative.
Members agreed with the views expressed by a
range of stakeholders that optimal asthma
management can be assisted by a comprehensive
assessment by appropriately trained allied health
staff.
The Committee agreed that programs of this
nature must be open and transparent and be able
to withstand public and professional scrutiny. It
was noted that GSK had contracted Innovex to
recruit and train the nurses who review patients
identified by a GP participating in the Respiratory
Care Program. There appeared to be training
provided to the nurses from a range of individuals,
including the GSK Medical Director on adverse
events reporting obligations and the Code of
Conduct, reference to the Code of Professional
Conduct for Nurses in Australia, and, for the first
intake of nurses, the NAC medical advisor.
The Committee noted GSKs assertion that the
function of the Respiratory Care nurse is to
comprehensively evaluate a patients asthma
control through a review of the patients history
and a number of respiratory tests including
spirometry. On the basis of the information
provided to the Committee, all actions of the nurse
are undertaken with the full knowledge and
endorsement of the general practitioner, who is
required to sign a Document of Understanding
upon agreeing to participate in the Program. The
general practitioner is made aware that GSK is
sponsoring the program. No data identifying
individual patients is made available to the
company, although de-identified aggregated data
can be provided by Innovex to GSK. Committee
Members commented that a well structured
program could have positive benefits for patients.
The respiratory care nurses have the time to assist
with aspects of asthma management such as
proper device use.
of the nurse on potential device changes is only one

piece of information the doctor will use to assist in
the ongoing asthma management.
In relation to the inspiratory flow rates of 60 litres
per minute (60L/min) members noted that one of the
references submitted by GSK stated For the
Turbuhaler device, it has been reported that
60L/min is the most desirable rate and in vitro
studies have demonstrated high variability of
emitted dose below this inhalation rate. However it
could be argued that some clinical response is
obtained between 30 and 60L/min, through this
device, but the clinical effect of the intra-individual
variability of inhalation rates is not known.
Therefore, it is not an absolute contraindication to
successful use of a Turbuhaler with flow rates below
60L/min, but this is one of a number of factors that a
GP should consider when evaluating the nurses
report and whether a change in asthma therapy is
necessary for a particular individual. It was noted
that in the Respiratory Care nurse report provided to
the Committee it was also recommended that the
patient receive education about proper use of their
inhaler.
In summary members were of the view that overall
the GSK Respiratory Care Program had benefits for
asthma patients and there was no evidence that the
Program systematically encouraged or offered
inducement to the nurses to make a
recommendation to GPs to switch devices in favour
of GSKs products. The general practitioner is
ultimately responsible for making a decision on
treatment for a patient, taking into account a range
of information that they have requested the
Respiratory Care nurse to provide. By a majority
decision, no breach of the Code was found. One
member of the Committee abstained from voting.
The majority of members agreed that the complaint
in relation to inducement, bribery or pressure was
not made out on an evidentiary basis.
The Committee commented that if a general

practitioner agrees to be part of the Program and
he or she requests the nurse to do a
comprehensive assessment of a patient whose
asthma is not currently well controlled, the report
is provided to the GP and it is up to them to make
a decision on whether any change to
medication/device or dosing is required. Members
stressed that a nurse can only make a
recommendation to the GP and should be
providing education for a patient on the
management of their asthma and can assist in the
optimal use of their device. The recommendation
104
GSK Adult Immunisation (853)

(GSK)
Complaint:
The Healthcare professional alleged that there
was inadequate supporting evidence in relation to
the claim Adult Immunisation. Boost your bodys
force field and imagery on the poster promoting
immunisation was misleading.
1.2.2 Substantiating Data
1.3 False and misleading claims
Response:
GSK responded that the federally funded vaccine
advisory committee had assessed the body of
data relating to the adult/adolescent booster and
found it sufficient to recommend the booster for
use. GSK also stated that the poster subject to
complaint would not be misinterpreted and is a
health initiative intended to increase awareness
regarding weakening immunity and the need for
adults to boost their immunity against certain
diseases.
Members also considered that adult infectious

disease is increasing; a view supported by
government advisory groups, and did not consider
that the poster was misleading or the evidence of
the
effectiveness
of
vaccination
was
unsubstantiated. Members considered that it was
correct statement that vaccination increased a
persons immune response.
The Committee was also of the view that it was an
important public health initiative to promote the
importance of immunisation of adults against
preventable diseases.
Some members were of the view that the
statements referring to boosting your bodys field
force and improves ones well being were
hyperbole and might not be able to be
substantiated, but if so, would only be a minor
beach as there is well documented evidence to
support the efficacy of vaccines.
Sections 1.2.2 or 1.3 of the Code.

1.2.2 and 1.3 of the Code was found
What is the evidence that immunisation improves
immune resistance?
The imagery suggests that Adult immunisation is
akin to helping one reach Nirvana
What is the evidence that any vaccination
improves ones well being or boosts your bodys
field force?
The Committee acknowledged that Boostrix is
indicated for booster vaccinations against
diphtheria, tetanus and pertussis of individuals
aged 10 years and older. For the TGA to approve
a vaccine in Australia the company was required
to submit evidence of its efficacy.
105
Angeliq (854)
Subject Company: Schering Limited
Complainant: Organon Australia
Product: Angeliq
Complaint:
Inappropriate use of trade packs as starter packs.
5.3 Product Starter Packs
Decision:
By a majority decision a breach of Section 5.3
of the Code was found (Decision confirmed by
Sanction:
Cease distribution of trade packs of Angeliq to
healthcare professionals as starter packs.
The Committee reviewed Section 5.3 of the Code,
the Explanatory Note and Code of Conduct
Guidelines, which state as follows:
Section 5.3
Starter Packs should not exceed 1/3 of the PBS
primary quantity for each strength of a product
Where it is not practical to produce a 1/3 pack, the
smallest trade pack may be used.
Explanatory Note
Examples of products where 1/3 may not be
practical would include ear and eye drops, small
aerosols, ampoules, products taken in a specific
order where pack presentation dictates the order
of taking of the product and packs of 15g or less of
ointments and creams. Reasons such as cost or
availability will not be accepted as being
impractical.
Code of Conduct Guidelines
the Code Committee has expressed the view
that if it was in the best interest of patients this
could be justification for providing sufficient tablets
in the starter kit to achieve a quality use of
medicine outcome.
Some members strongly expressed the view that it

was not appropriate to only give a 10 day supply
(equal to the 1/3 trade pack size) starter packs for a
HRT treatment. These members concurred with the
two expert opinions included in the response to the
complaint, that due to HRT being monthly cyclical
treatment there is a risk of a woman experiencing
breakthrough bleeding if she ceased taking the
medicine prematurely when the 10 day supply ran
out, however other members were also strongly of
the view that similar arguments could be used for
many other therapeutic areas. These members
noted that all tablets in the Angeliq pack were the
same, unlike some forms of HRT that require
different tablets to be taken at different times in the
monthly cycle. Members suggested that this didnt
support the argument of the importance of the
cyclical treatment. These members noted that a
doctor could provide a patient with sufficient small
starter packs for one month to avoid any potential
cycle disturbance, or could write a prescription for a
months therapy.
By a majority the Committee found a minor breach
The Committee requested that the Code Review
Panel (or its equivalent) should be asked to
consider whether the Code should be amended to
allow trade packs to be distributed as starter packs
for HRT therapies. The Committee noted that such
a change would need to take into account a range
of stakeholders views.
Sanction
Having found a breach of the Code, the Committee
considered an appropriate sanction.
The Committee determined that Schering should:
Take immediate action to cease distribution of
trade packs of Angeliq to healthcare
professionals for use as starter packs.
Appeals Committee
Bayer Schering Pharma (Bayer Schering) lodged an
appeal in relation to the findings of the Code
Committee on the basis that the Code Committee
did not give adequate consideration to the view
expressed by healthcare professionals that Angeliq
should not be discontinued prior to six weeks of
therapy.
Organon responded to the appeal by Bayer
Schering noting that starter packs could still be used
in accordance with the Code to provide women with
sufficient medicine to address their needs.
106
Angeliq 854 (contd)

Members of the Committee considered the appeal
process outlined in Section 13 of Edition 14 of the
Code noting that an appeal should not be a rehearing of the original complaint. A company
appealing a decision or a sanction imposed by the
Code of Conduct Committee must convince the
Committee that the Code of Conduct Committee
had erred in its findings based on the information
then available to them. Members also reviewed
the provision (5.3) under which the complaint had
been lodged.
The Bayer Schering and Organon representatives
were invited to join the meeting.
The following summarises the Bayer Schering
appeal:
Angeliq is a hormone replacement therapy
(HRT) containing an oestrogen, oestradiol,
and a synthetic progestogen, drospirenone,
available in 4 pack sizes 28, 56, 84 and 112
tablets.
Angeliq is a non-PBS medicine.
Section 5.3 Explanatory Notes provide
examples of where it may not be practical to
use a trade pack size for a starter pack
small ear drops, ampoules, products taken in
a specific order.
The section on Starter packs in the Code
Guidelines (Edition 14, Version 4) also refers
to the quality use of medicines as a
justification for providing more tablets in a
starter pack than of the trade pack.
Angeliq is a continuous combined Hormone
Replacement Treatment (HRT) and is
prescribed for the treatment of climacteric
symptoms.
There is evidence to support the view that
Angeliq should not be discontinued prior to
four weeks and up to six weeks of therapy to
allow a full trial of the medicine before
evaluating its effect in a particular woman.
Use of 10 day starter packs may create
confusion due to not remembering when to
take the medicine.
Angeliq has a modest effect on lowering blood
pressure; sustained lowering of blood
pressure is known to lower risk of stroke and
cardiovascular events, which is a further
reason to give more than 10 days treatment.
It is inconvenient and less professional to
expect doctors to bundle starter packs
Use of a trade pack as a starter pack is in the
best interests of the patient.
Provision of a 28 day trade pack is consistent

with the spirit, intent and letter of the Code and
Guidelines.
The following summaries the Organon response to

the Appeal:
Organon supports the quality use of medicines
(QUM) and is in agreement with the views of
Bayer Schering in relation to QUM. However
companies must comply with the Code which
states that only a trade pack size should be
used as a starter pack.
Angeliq does not have to be taken in a specific
order therefore it is possible to bundle starter
packs to ensure the patient has a sufficient
quantity for a months treatment.
Organon has starter packs for HRT treatment
which are only of the trade pack size.
Should the Committee make an exception for
the use of trade packs for Angeliq, exemptions
would also have to be granted to companies
manufacturing
anti-depressants,
antihypertensives, anti-psychotics and antibiotics,
which all have a titration period and require
some time before an effect is demonstrated.
To remove the requirement for a trade pack
size for starter packs would require a change to
the Code.
The decision of the Appeals Committee has
wide ranging implications for the industry.
Committee, Bayer Schering provided the following
comments:
A longer trial period with starter packs is
required as evidence shows that 25% of women
never actually fill their prescription at the
pharmacy. If a trade pack is provided there is
more chance of resolving a clinical issue and
demonstrate a benefit to the woman that would
therefore encourage her to continue treatment
with a prescription.
Use of starter packs has changed over the past
30-40 years. Previously access to pharmacies
was more restricted in terms of opening times
and number of sites. However doctors now use
starter packs to familiarise a patient with a
medicine; to show benefit and encourage them
to fill their prescription.
Modern HRT is lower dose therapy than in the
past and may take longer to see an effect.
Usually at least a month of therapy is required,
and perhaps longer.
The expert advisor advised that he usually gave
a months supply of starter packs and a
prescription for another month before assessing
the patient.
107
Angeliq 854 (contd)

Organon also commented that many companies
may argue that it is economically preferable not to
have starter packs as the cost is often as much as
a trade pack. However companies are signatories
to the Code of Conduct and should adhere to the
provisions.
The Committee commented that it is not in a
position to debate the merits of starter packs
versus trade packs only to assess whether a
breach of the Code had occurred.
relation to Section 5.3 for the following reasons:
No practical reason had been given for why
trade pack size starter packs for Angeliq could
not be supplied.
Product Familiaristion Programs only allow for
the use of starter packs in the first 12 months
therefore there is no justification for use of
trade packs to familiarise healthcare
professionals.
The Code is in place and companies have had
the opportunity to discuss this issue when the
Code was reviewed the restriction on size of
starter packs to trade pack size was
retained in the new Code, Edition 15.
Angeliq is not taken sequentially. Each tablet
in the pack has the same constituents and
strength. Therefore the use of a trade pack
does not comply with the provisions or the
Explanatory Notes for Section 5.3.
The argument that you need to use a months
supply to allow time for a demonstrated effect
could apply to many chronic conditions.
Sanction
The Committee unanimously confirmed that the
sanction imposed by the Code of Conduct
Committee should not be changed to cease
distribution of trade packs of Angeliq to healthcare
professionals
as
starter
packs.
108
Complainants:
Healthcare professional
Octapharma Australia
Sanctions:
y Determined to be a moderate breach
y Withdraw and do not use the training tool cost
comparison table in the same or similar form
unless it fully complies with the Code
y Fine of $15,000
Products: Intragam P
Complaint:
Misleading statements by a CSL representative to
healthcare professionals in a hospital on two
occasions

The Committee referred to Section 11.1.1 of Edition
14 of the Code which states: The Subject Company
and complainant will provide the Association with
whatever references or information is deemed by
the Chief Executive Officer or his or her delegate to
be necessary to fully investigate the complaint. The
information and response shall be provided to the
CSL Representative Behaviour (855)

Subject Company: CSL Limited (CSL)

1.1 Responsibility
1.2.1Provision of Substantiating Data
1.2.2 Level of Substantiating Data
1.5 Unqualified Superlatives
1.10 Distinction of Promotional Materials
2.1.2 Full disclosure of Product Information
3.3.1.1 Printed Promotional Material
4.1 Medical Representatives
10 Relationship with healthcare professionals
in the industry
15 Compliance Procedures
Decision:
In relation to the use of the cost comparison
table alone the Committee found a breach of
Sections 1.1, 1.2.2, 1.3, 1.7, 1.10 and 4.1
(Decisions confirmed by the Appeals
Committee)
The Committee found no breach of the
remaining sections of the Code alleged by
Octapharma to be in breach with respect to
the cost comparison table.
In relation to the alleged claims and
statements made by the CSL representatives
the Committee found no breach of the Code.
Members of the Code of Conduct Committee were

of the view that there was insufficient information
provided to them on which to determine the
complaints and considered that in the interest of
procedural fairness further information should be
sought from the complainants and a further
response sought from CSL in order to elucidate
more clearly the alleged conduct by the CSL
representative.
For this reason the complaint was adjourned to the
next meeting without any decision being made by
the Committee.
Further information requested from the healthcare
professional
Any additional information that would assist the
Committee to establish more clearly the
statements made by the CSL representative as
alleged
The forum in which the alleged conduct
occurred, including whether there were any
other people present at the meeting between
the healthcare professional and the CSL
representative who might corroborate the
allegations
This information should be provided to the Code
Secretariat within 10 working days from receipt
of formal written advice of this request
Any additional information provided by the
healthcare professional will be provided to CSL
(without identifying the healthcare professional
by name or the hospital at which he or she
works) for its response.
The CSL response to the additional information
provided will be provided to the healthcare
professional for comment.
109
CSL Representative Behaviour 855 (contd)

Further information requested from Octapharma
Restate the complaint in the form required as
stated in Appendix 1 (page 128) of Edition 14
of the Code, in particular identifying the
specific sections of the Code alleged to be in
breach.
The complaint should include any additional
information from the healthcare professional,
whose statement was included in the
Octapharma complaint, that would assist the
Committee to establish more clearly the
statements made by the CSL representative
as alleged, including the forum in which the
alleged conduct occurred and whether there
were any other people present at the meeting
between the healthcare professional and the
CSL representatives who could corroborate
the allegations. This information should be
preferably provided by the healthcare
professional in the first person not through the
words of an intermediary.
This information should be provided to the
Code Secretariat within 10 working days from
receipt of formal written advice of this request
The restated complaint and any additional
information will be provided to CSL (without
identifying the healthcare professional by
name or the hospital at which he or she works)
for its further response.
Further information requested from CSL
Provide a statutory declaration from the
medical representative, stated in the words of
the representative and preferably not through
any intermediary, providing details of what
occurred at the meetings with the healthcare
professionals and what statements the
representative made to the healthcare
professionals.
CSL will be given 10 working days to review
the additional information provided by both
complainants and to provide a written
response.
The CSL response to the additional
information provided by the healthcare
professional complainant will be provided to
the healthcare professional for comment.
Adjourned to the next meeting without any
decision being made by the Committee.
At the next Code of Conduct Committee meeting,
the Committee noted that although Octapharma
had been given the opportunity to provide further
information to support the complaint (see below),
other than specifying the

alleged to be in breach
evidence provided from the
through Octapharma to
allegations.
sections of the Code

there was no further
healthcare professional
support the breach
Members commented that the CSL Representatives

had provided statutory declarations which were
declared to be true in the presence of an authorised
witness. There are significant penalties for a person
who willfully makes a false statement in a statutory
declaration including being fined or jailed, or both.
The Committee considered that it must give weight
to these declarations of what had occurred in the
interactions between the healthcare professionals
and the CSL representatives in the absence of
statutory declarations made by either healthcare
professional making their complaints one directly
to Medicines Australia and the other through
Octapharma. The Committee further noted that
because neither healthcare professional wished to
be identified to CSL, the statements from the CSL
representatives were made on the basis of certain
assumptions about which specific interactions with
healthcare professionals were the subject of the
complaints.
The Committee found the complaints about verbal
statements made by the CSL representatives to the
healthcare professionals were not sufficiently made
out. Members stated that their decision does not
reflect a lack of concern regarding the healthcare
professionals
perceptions
of
what
the
representatives may have communicated at the
meetings.
In relation to the following claims the Committee
stated that the complaint was not made out. The
use of these claims in the form or context as alleged
had been denied by the CSL representatives in their
statutory declarations.
In addition CSL had
provided information about the training provided to
representatives in relation to the matters subject to
complaint, including use of the Australian Red
Cross Blood Service IV Immunoglobulin Clinicians
Guide, which is an independently prepared
reference.
Alleged statements by CSL Representative:
Octagam was not safe to use because the
manufacturing process does not inactivate nonenveloped viruses.
Octagam has to be stored in the fridge
otherwise the product is unusable.
Intragam P has higher efficacy than Octagam
because of its manufacturing process.
110

The viral inactivation steps used by CSL in the
production of Intragam P are safer than the
viral
inactivation
processes
used
by
Octapharma.
Australia sourced unpaid plasma donations
are safer that imported paid plasma.
Hospitals that specifically request Intragam P
will receive it, whereas hospitals that do not
will receive mainly Octagam. The CSL
representative told Dr X that the hospital in
question does not receive Intragam P and it
therefore receives more Octagam in its IVIg
allocations.
Intragam P is simply a better product than
Octagam.
In relation to the following two statements:
85% of Intragam P is used in Australia and
Octapharma got the remaining 15% put to
contract. However, CSL believes this will
change and CSL will distribute more
Sandoglobulin in Australia in the future.
The CSL plant is not currently running at
capacity and if the Government gave more
money to ARCBS to collect more plasma, CSL
could supply all of Australias needs.
The CSL representatives had stated in their
statutory declarations that they did not make the
statement in the form or context as alleged by the
complainant. The Committee further considered
that the statements in relation to the proportion of
intravenous immunoglobulin supplied by CSL and
Octapharma and CSLs ability to increase its
supply capacity were factual and therefore not
misleading.
The Committee did not consider that it had been
provided
with
any
evidence
that
CSL
representatives were inadequately trained or that
the company did not have internal procedures to
ensure compliance with the Code. The Committee
noted that the CSL representative had stated in
the statutory declaration that Product Information
for Intragam P had been provided to the
healthcare professionals whom, it was conjectured
by CSL, had made the complaints.
In relation to the use of the training material which
compared the cost of Intragam P and Octagam
(the cost comparison table), members agreed that
this material did not comply with the Code. All
materials prepared by a company, whether for
internal or external use should be current,
accurate and balanced and not misleading and if
used externally must include

information specified in the Code.
all
mandatory
The Committee was of the view that this material

evidently had not been through the appropriate
vetting process for an item for use with an external
audience and should not have been used by the
CSL representatives, albeit to answer a question
from a healthcare professional. Some members of
the Committee noted that healthcare professionals
in the hospital (particularly haematologists and the
manager of the hospital pharmacy) should be able
to access information on the cost comparison of the
products because cost is a critical matter. However
members were also of the view that such costing
information should be capable of verification and
should describe how the costs were derived, which
was not the case for the cost comparison table used
by the CSL representatives.
The Committee considered the allegations of
breach of specific sections of the Code:
Sections 1.1, 1.2.1, 1.2.2, 1.3, 1.5, 1.7, 2.1.2, 4.1,
4.2, 4.3, 4.4, 4.8, 4.10, 4.11, 4.12, 10, 10.5 and 15 no breach in relation to the statements made by the
CSL representatives, for the reasons stated above.
Sections 1.1, 1.2.2, 1.3, 1.7, 1.10 and 4.1 - breach
in relation to the use of the cost comparison table
because CSL had failed to ensure that the table
was accurate and the information verifiable. An
internal training aid had been used inappropriately
as a promotional item in an interaction with a
healthcare professional.
Section 1.2.1 no breach in relation to either the
statements by the CSL representatives or the use of
the cost comparison table.
The Committee
considered that this section of the Code did not
apply in the circumstances described by
Octapharma. There was no evidence that CSL had
failed to respond to a request from either healthcare
professional to provide information.
Section 3.3.1.1 no breach. The Committee was
satisfied that the Product Information for Intragam P
had been provided by the CSL representatives.
Sanctions
Having found several breaches of the Code, the
The Committee considered that this constituted a
moderate breach of the Code. Whilst there was no
suggestion of potential patient safety issues, the
use of the cost comparison table may have
influenced prescribers in their choice of product.
111

The Committee determined that CSL should:
Take immediate action to withdraw the training
tool cost comparison table and do not use it
again in the same or similar form unless it fully
complies with the Code.
The Committee stated that there
requirement for corrective action.
was
no
The Committee considered CSLs allegation that

this complaint was an abuse of the Code and in
breach of Section 12.3.
Members referred to the wording in this section of
the Code prior to considering what action should
be taken.
Section 12.3
If, in the Code Committees view, a complaint by a
company is considered frivolous or vexatious the
Code Committee may request the Complainant
company to show cause why the Committee
should not impose a fine of a maximum of
$200,000 for abuse of the Code of Conduct.
Explanatory Note:
A company may be found to breach this Section if
a single complaint is considered to be frivolous or
vexatious or, following a series of complaints
against a single or number of competitors within a
therapeutic class by a single Complainant.
A complaint or series of complaints may be found
to be frivolous or vexatious regardless of whether
or not the complaint or complaints are sustained.
The Committee considered that Octapharma had
alleged breaches of a number of sections of the
Code without submitting any evidence to support
the allegations. The Committee had requested
that Octapharma provide further information but no
further information had been provided to support
the allegations. The Committee determined that
Octapharma should be asked to respond to the
allegation of a breach of Section 12.3 of the Code.
It noted that a complaint or series of complaints
may be found frivolous or vexatious regardless of
whether or not the complaint or complaints are
sustained. This matter was deferred until the
outcome of the appeal was known to both parties.
Following the outcome of the appeal CSL
withdrew the complaint.
Appeals Committee
CSL lodged an appeal against some of the findings
of the Code Committee. CSL submitted that the
Code Committee had erred in finding that the
content of the cost comparison table (CCT) was not
accurate or capable of verification (appeal against
findings of breach of Sections 1.1, 1.2.2, 1.3 and
1.7). CSL did not appeal the Committees findings
in relation to the form of the CCT or its use by CSL
representatives in discussions with healthcare
professionals (Sections 1.10 or 4.1).
In its written response to the appeal, Octapharma
re-iterated that the cost comparison tables present
an inaccurate, unfair and unbalanced comparison
and that there was insufficient detail provided to
enable the reader to properly evaluate the material
which is presented to them.
In the course of the discussion members made the
following observations:
That it is irrelevant that the cost comparison
table was meant for internal training purposes
and not for use as promotional material with
Training materials must also be accurate and
not misleading so that a medical representative
can present information and data that is
consistent with the Code to a healthcare
professional.
CSL appeal:
CSL is appealing the Code of Conduct
Committees decision that the content of the
Cost Comparison Table (CCT) was not
accurate or capable of substantiation.
The Australian Healthcare Environment in 2006
included:
A review of Australias plasma fractionation
arrangements and whether Australia should
be open to global fractionators.
Increased awareness among healthcare
professionals of availability of alternative
products.
Considerable misinformation in the market
about price of alternative products.
Price of Intragam P was being misquoted at
$100 per gram.
The CCT was developed as an internal training
tool because CSL representatives had been
asked questions about price.
The CCT is balanced, correct, factual and
accurately reflects prices paid by the National
Blood Authority (NBA) at that time for
intravenous immunoglobulin (IVIg).
112

The CCT is capable of substantiation on the
basis of the Plasma Products Agreement and
the National Blood Authority Deed of Standing
Offer for overseas sourced IVIg Products.
The CCT contains sufficient detail to allow
evaluation of the cost of the different products.
It had extensive footnotes that clearly identify
that plasma cost is not included in the
tabulated cost of Intragam P. It was also
accompanied by explanation by a CSL
representative.
The CCT is not misleading or disparaging to
another product.
There is ongoing confusion about product
pricing in the market place.
CSL requests that the finding of a breach of
Sections 1.1, 1.2.2, 1.3 and 1.7 be overturned,
the level of breach of Sections 1.10 and 4.1 be
downgraded and that the fine of $15,000 be
set aside because it is not in proportion to
other decisions, such as Octanate (848) which
was for promotion of an unapproved indication
and attracted a fine of $10,000.
The following summarises the main points of
Octapharma in response to the CSL appeal:
The Octapharma representative presented a
graphical illustration of Intragam P and Octagam
funding. This showed that the National Blood
Authority (NBA) funds 100% of the cost of IVIg
both the plasma and the fractionation costs for
both products.
Hospitals do not pay for IVIg. Therefore there
was no legitimate context for CSL to be
discussing price of products with hospitals or
prescribers.
It is impossible to compare cost of Intragam P
with Octagam unless the cost of plasma is
included. However, the asterisked footnote to
the CCT, against Intragam P alone, states that
the cost in the table excludes the cost of
plasma collection. The cost of plasma is not
zero.
The footnote is inadequate to enable
meaningful comparison of cost of Intragam P
and Sandoglobulin with other commercial IVIg
available in Australia.
The CCT is not
comparing like with like because the cost of
plasma collection is excluded from Intragam P
costs and is therefore flawed.
In the saving part of the CCT, which is
evidently intended for prescribers because it is
about choice of product, the misleading
comparison is magnified. This part of the CCT
does not include an asterisk to the footnote.
It implies that when Intragam P is prescribed

there is a saving of $5380.36 per patient per
year, but the prescriber or hospital isnt making
any saving at all because the products are paid
for through the NBA.
The proper comparative cost for Intragam P is
approximately $100 per gram based on 45
percent of the cost being the plasma cost. The
claim of dollar saving is illusory because the
table is not comparing like with like.
CSL had failed to ensure that the tables were
accurate. It is an internal training aid used
inappropriately.
The fact that there was a complaint from a
healthcare professional meant they had been
misled.
The fine should be increased to $50,000
because the table is calculated to affect
prescribing practices.
In response to questions from the Committee, CSL

representatives provided the following responses:
The NBA manages the supply and price of
blood products including IVIg.
Plasma has a value when collected
commercially but plasma in Australia has no
commercial value; it cant be sold. It is a biproduct from blood donations and there are
multiple products taken from plasma, not just
IVIg. CSL disagrees with the Octapharma
estimated price of $100.
The NBA purchases the products and provide
to the hospitals. But clinicians do have choice
of which brand they use, so cost is directly
relevant to them.
In Victoria, South Australia, Western Australia
and Queensland the products are provided by
the government
In New South Wales there is price signalling
being used to control which product is being
used.
CSL also commented that the CCT was
developed because its representatives received
a lot of questions from healthcare professionals.
The specialist member of the Committee further
explained the process for a doctor obtaining IVIg
based on his experience:
A haematologist will ring the Red Cross Blood
Service (RCBS) when they require the blood
product.
The Red Cross will tell the healthcare
professional what brand they can have most
haematologists will accept what is offered.
113

However some haematologists may request a
particular brand of product.
Whilst the cost is borne by government,
hospitals are aware of the high cost of
supplying the product out of the state budget.
When requesting IVIg from the RCBS, the
patient receiving the product must meet
clinical criteria in order for the hospital to
receive the product at no cost.
If the patient does not meet the clinical criteria
and the haematologist is nevertheless of the
opinion that the patient should receive the
product, the hospital must pay the full cost.
It is unusual that a patient does not meet the
clinical criteria approximately 5% of patients.
The chief hospital pharmacist can choose
which product they have in stock for those
patients who do not meet the clinical criteria.
Members confirmed that in this context
compliance with the Code requires that:
All materials used by companies must be
current, accurate and balanced and must not
mislead.
Comparisons must be relevant and fair.
Any qualifying statement should provide
sufficient information to ensure the material is
not misleading.
A qualifying statement should be on the same
page as the table, in close proximity to the
source to ensure that it is clear to a reader.
whom the stated savings would apply. Although the

CCT was not intended to be used directly by
medical representatives in a promotional context, it
was intended to inform representatives as the basis
for explaining costs to prescribers. When the CCT
was translated into oral information it was
considered it could be even more misleading.
The Committee considered that there was no
patient harm arising from the CCT.
The Committee did not uphold the appeal and
confirmed the findings that the CCT was in breach
of Sections 1.1, 1.2.2, 1.3 and 1.7 of the Code.
Sanctions
Having not upheld the appeal the Appeals
the Code of Conduct Committee. The Committee
confirmed those sanctions, namely:
Take immediate action to withdraw the training

tool cost comparison table and do not use it
again in the same or similar form unless it fully
complies with the Code.
Members discussed the issue of the savings

section of the CCT and noted that it is not clear for
whom the savings are relevant whether to the
NBA or a particular hospital. It was also noted that
there was no footnote associated with this part;
only with the costs part of the CCT. The Appeals
Committee concluded that the table was too vague
in relation to a proper interpretation of what
saving means and to whom. It was observed that
the explanations provided by the respective
companys representatives made it clear that any
comparative statement based around cost would
need to be very carefully worded and qualified to
satisfy the Code requirements.
The Committee was unanimously of the view that
the Code of Conduct Committee had not erred in
their findings of several breaches of the Code.
Members stated that the training document Cost
Comparison Table as presented to a healthcare
professional did not make it sufficiently clear on
the same page as the table that it was comparing
products some of which included plasma collection
costs and others did not. It was also not clear to
114
Twinrix (856)
(GSK)
Product: Twinrix
Complaint:
The Healthcare professional alleged that a
misleading impression had been created by
sending promotional material entitled Hepatitis B
test card enclosed to a healthcare professional,
which could be interpreted that the addressee was
required to have a Hepatitis B test.
misleading in the context of Hepatitis A and B risks

in travellers.
The Committee noted that GSK had received one
other complaint of a similar nature and the
companys apology to that person was included in
the response to the complaint. Committee members
were of the view that the mailing had not caused
serious or widespread offence as described in
Section 1.4 of the Code and found no breach of that
Section of the Code.
The Committee did not find a breach of Section
3.6.5 (Mailings) as the exposed material did not
make any reference to a prescription medicine, nor
did it include promotional claims and the statement
was not considered unsuitable for public view.

1.4 Poor taste
3.5.6 Mailings
Response:
GSK stated that the mailing of the promotional
material would not mislead, nor was intended to
cause embarrassment for the recipient. The card
was designed to raise awareness with GPs about
the risks of Hepatitis B and Hepatitis A. The card
was not intended to appear as an actual test card
for Hepatitis B. GSK also stated that the mailing
of the promotional material was not targeted at the
general public and therefore was not in breach.
1.3, 1.4 and 3.5.6 of the Code was found
Some healthcare professional members of the
Committee agreed that there was a small
possibility that a staff member in a medical
practice could have been confused by the labelling
of the material with Hepatitis B test card, and one
member noted that they personally had received
the material in question but were not concerned by
the statement.
Members were of the view that the material may
have been mildly insensitive and would have been
better if worded differently, but it was not
intentionally designed to offend a prescriber or
practice staff. The Committee did not find a breach
of Section 1.3 of the Code as the material was not
115
Pariet (857)
By a majority decision breach of Section 1.7

of the Code
Subject Company: Janssen-Cilag

Complainant: AstraZeneca Pty Ltd
Product: Pariet
Complaint:
AstraZeneca alleged that promotional claims in
two posters and a promotional brochure for Pariet
represented an integrated and sustained
campaign of misinformation and deception to
healthcare
professionals
and
were
not
representative of the body of evidence.
In
addition, a starter pack enclosed in an outer
container with other materials did not comply with
TGA labelling requirements.
1.1 Responsibility
1.5 Unqualified superlatives
5.9 Starter packs
Response:
Janssen-Cilag stated that the data provided to the
prescriber was not inconsistent with the body of
evidence as it incorporated a realistic patient
population commonly seen in clinical practice.
Janssen-Cilag had no intention to mislead
prescribers and had used the latest published
data. Janssen-Cilag was of the view that the
metal container enclosing the starter pack was
were not the actual starter pack and that the
sample pack inside complied with the TGA
guidelines and it was the doctors decision if the tin
was given to patients.
Claim 1: Heals 97% of patients at 8 weeks
By a unanimous decision - breach of Sections
1.1, 1.2 and 1.3 of the Code
By a unanimous decision - no breach of
Sections 1.5 and 1.7 of the Code
Claim 2: Erosive oesophagitis healing rates
with other PPIs by Week 8, with comparative
table of PPI healing rates
Claim 3: Complete symptom relief from

heartburn with Pariet, with graphical depiction
of Daytime 64% day 1, 85% day 28, Night time
69% day 1, 88% day 26
By a majority decision - no breach of Section
1.2 of the Code
By a unanimous decision - breach of Section
1.3 of the Code (not a repeat breach)
Claim 4: Pariet 20mg: The strength to provide 24
hour symptom control from 1st dose
1.2 and 1.3 of the Code
Claim 5: Pariet 20mg provides 7 out of 10
patients complete night time symptom relief
from first dose
By a majority decision - no breach of Section
1.2 of the Code
By a unanimous decision - breach of Section
1.3 of the Code
Claim 6: Pariet is tough on reflux symptoms
By a unanimous decision - no breach of
Sections 1.3 or 1.7 of the Code
Pariet Starter Pack
By a unanimous decision - no breach of Section
5.9 of the Code
Sanctions:
Withdraw materials found in breach of the Code
Fine $100,000
Claim 1: Heals 97% of patients at 8 weeks
The Committee commented that to make an
efficacy claim the intention-to-treat analysis should
be used rather than per-protocol used in the Pace
et al paper, which was designed as an equivalence
study.
The claim therefore could not be
substantiated by the Pace et al paper. Members
were also concerned that the claim was not
qualified with advice that many of the patients in the
study had mild oesophagitis which would heal faster
than those with Gastro-oesophageal reflux disease
(GORD) of grade of 2-4. Further, the claim is
associated with the heading above it, which states
heals erosive oesophagitis, which implies that the
97% healing rate was in patients with erosive
116
Pariet 857 (contd)

oesophagitis whereas the high healing rate in the
Pace study could be attributed to the high
percentage of subjects with mild oesophagitis.
The claim was therefore misleading.
misleading as it did not qualify or fully explain the
study on which it was based, including that the
analysis was per protocol, and was not reflective
of the body of evidence as only this new study had
demonstrated such high healing rates.
found a breach of Sections 1.1, 1.2 and 1.3 of the
Code but no breach of Sections 1.5 and 1.7 of the
Code because the Committee did not consider
that the claim implied a unique quality or property
for Pariet or that it was comparative.
Claim 2: Erosive oesophagitis healing rates
with other PPIs by Week 8, with comparative
table of PPI healing rates
The Committee was concerned that the table
included results from a number of different studies
which did not have the same design, primary
endpoints or population for analysis (some being
per protocol and some intention to treat
population analyses) and was therefore not an
accurate reflection of the evidence. Members also
noted that Pariet was placed at the top of the list
and there appeared to be no rationale for listing
products in a particular order.
The Committee was of the view that the data did
not reflect the body of evidence and that JanssenCilag had been selective in their comparison with
other PPIs, which was misleading. The claim
implied at least equivalence, and possibly
superiority, of Pariet when compared with other
PPIs, which had not been adequately
substantiated.
The Committee noted that their comments in
relation to Claim 1 were also applicable to this
claim.
For the reasons outlined above, by a unanimous
decision the Committee found a breach of
Sections 1.1, 1.2 and 1.3 of the Code and by a
majority decision a breach of Section 1.7 of the
Code
The majority of members were of the view that the

qualifying statement open-label, community-based
multicentre trial was insufficient information to
ensure the reader was fully informed of the nature
of the study, which was an unblinded, open label,
uncontrolled post marketing surveillance study.
Members also noted that the two references
referred to the same study with Jokubaitis et al
being a preliminary analysis of the Robinson et al
final paper. It was considered misleading to cite two
references, which gave the impression that there
were two independent studies to the support the
claim when in fact both related to a single study. In
considering Janssen-Cilags explanation that
Jokubaitis et al had been included as a reference
because it contained additional numerical data for
week 1, however the Committee considered that the
data presented in the graph for day 1 (64% daytime
and 69% night time) were readily identifiable in
Robinson et al paper. The day 28 data in the graph
was not included in the Jokubaitis abstract, only in
the Robinson et al paper. The Committee therefore
considered that the inclusion of the Jokubaitis
reference was misleading.
For the reasons outlined above, by a unanimous
decision the Committee found a breach of Section
1.3 of the Code. No breach of Section 1.2 of the
Code was found because the Committee accepted
that the data presented in the graphs had been
correctly derived from the Robinson et al paper and
could therefore be substantiated.
The Committee did not find a repeat breach of the
Code as the claim previously found in breach
(complaint Pariet 788) was not the same as the
current claim and the reference to the Robinson
study had been qualified, although not to the level
required by the Committee.
Claim 4: Pariet 20mg: The strength to provide 24
hour symptom control from 1st dose
The Committee was of the view that strength did
not have a clinical meaning in the context of the
claim, which was about speed of onset of action,
rather than overall efficacy.
The Committee
considered that the claim was misleading and could
not be substantiated as the referenced studies do
not refer to strength. By a unanimous decision the
Committee found that the claim was in breach of
Claim 3: Complete symptom relief from

heartburn with Pariet, with graphical depiction
of Daytime 64% day 1, 85% day 28, Night time
69% day 1, 88% day 26
117
Pariet 857 (contd)

Claim 5: Pariet 20mg provides 7 out of 10
patients complete night time symptom relief
from first dose
The Committee noted that the claim was
referenced to the Robinson et al paper and the
Jokubaitis abstract. The Robinson study, which is
the same study described by Jokubaitis et al, was
an open labelled, uncontrolled study. Members
noted that another study, Holtmann et al, which
was a randomised, double blind comparative study
between rabeprazole (Pariet) and omeprazole,
also found that rabeprazole achieved better
symptom control at 24 hours after the first dose,
however the percentage of subjects that achieved
marked night time relief of symptoms was not as
high as described in the Robinson et al paper.
Therefore, any conclusion from the Robinson et al
data should be qualified by considering the study
design.
By a unanimous decision the claim was found in
breach of Section 1.3 of the Code because, as
discussed in relation to Claim 3, the reference to
both Robinson and Jokubaitis implied that there
were two independent studies, but these were
actually the same study. Further, the majority of
members considered that the qualifying statement
open-label, community-based multicentre trial
was insufficient to ensure a reader was fully
informed of the nature of the study which was an
unblinded, open label, uncontrolled post marketing
surveillance study.
By a majority decision no breach of Section 1.2 of
the Code was found as the claim could be
substantiated by the quoted reference.
The Committee did not find a repeat breach of the
Code as the claim previously found in breach
(complaint Pariet 788) was not the same as the
current claim and the reference to the Robinson
study had been qualified, although not to the level
required by the Committee.
Pariet Starter Pack

The Committee noted Janssen-Cilags comments
that the tin was a protective cover for the starter
pack, which was labelled in accordance with the
Therapeutic Goods Order on labelling of medicines,
and educational materials for the patient.
Members were of the view that there was no breach
of the Code as the starter pack was correctly
labelled.
One member of the Committee expressed some
concerns about the material included with the
starter pack in the tin for the doctor to provide to the
patient. This member was concerned that the
materials may not be acceptable patient aids or
patient education material. Whilst no complaint had
been made by AstraZeneca in relation to these
materials, the Committee recommended that
Janssen-Cilag should carefully review all the
accompanying materials to ensure they fully comply
with the Code.
By a unanimous decision the Committee found no
Sanctions
The Committee determined that Janssen Cilag
should:
withdrawal of the material found in breach of the
Code and should permit no further appearance
of it in its current form or in a manner that
convey the same or similar meaning.
Claim 6: Pariet is tough on reflux symptoms

The Committee commented that this claim was a
meaningless, non-scientific descriptor and was
valueless to a prescriber. However, in terms of
whether it breached the Code of Conduct,
members were of the view that it was acceptable
as Pariet does work on reflux symptoms, as do all
proton pump inhibitors.
The claim was not
considered to be comparative with other
medicines in this class.
breach of Sections 1.3 or 1.7 of the Code.
118
Stilnox (859)
Subject Company: Sanofi Aventis
Product: Stilnox
Complaint:
An advertisement for Stilnox was alleged to be
confusing and possibly deliberately misleading.
The complainant was of the view that in light of
information about Stilnox in the current ADRAC
Bulletin,
manufacturers
have
an
added
responsibility to not mislead prescribers when
promoting this medicine.
The Medicines Australia Secretariat had invited
Sanofi Aventis to respond to the complaint in
relation to the following Sections of the Code:
1.1 Nature and availability of claims
Response:
Sanofi-aventis advised that the ADRAC Bulletin
was issued after the advertisement for Stilnox was
published. The advertisement conformed to the
Code of Conduct Edition 15 and was not
misleading. The advertisement was withdrawn
after the last expected appearance in the
October/November MIMS and was not intended to
be published in the December/January MIMS,
however the advertisement was included without
approval from sanofi-aventis.
Majority Decision breach of Sections 1.1, 1.3
and 1.7 of the Code
Sanctions:
Determined to be a minor breach
Withdraw and do not use the advertisement
again and do not use the claim found in
breach in the same or similar form
y Fine of $5,000
y
y

The Committee noted the Sanofi Aventis
statement that the company had not approved the
advertisement
for
publication
in
the
December/January 2006 edition of MIMS. Industry
representatives on the Committee also commented

that this was not an unusual occurrence and
expressed concern that the advice of the agency
working on behalf of the company to MIMS had
been seemingly ignored by the publishers. However
members were of the view that the companies must
implement strict protocols for any advertising
program and that any variation from this program
should not be accepted by the Code Committee as
an excuse. Companies and their agencies must
keep all communications and the detailed advice
relating to advertising dates. The Committee asked
that the Code Secretariat write to the publishers
providing feedback from the Code Committee and
seeking their support in adhering to company
programming advice and not publishing any
advertisement without written authority. This advice
should also be provided to other publishers and
organisations
which
include
pharmaceutical
company advertising in their business.
The Committee also noted that publication deadline
for advertisements for the December/January edition
of MIMS would have been several weeks prior to the
publication date and was prior to the publication of
the February 2007 ADRAC Bulletin. The Committee
was of the view that the complainants allegation that
the advertisement was misleading as it did not make
reference to the uncommon adverse events for
Stilnox outlined in the February 2007 ADRAC
Bulletin could not be sustained.
Members were of the view that although a
qualification had been included in the advertisement
in relation to what is meant by sleep performance
and that the comparison was with placebo, many
viewed the advertisement as a comparison between
Stilnox and Stilnox CR through use of the words
Switch to new Stilnox CR. Members considered
that a comparison between placebo and Stilnox
would be expected to show a benefit, otherwise the
drug would not have been approved by the TGA.
The Committee was of the view that whilst the claim
was qualified the overriding perception is that the
advertisement advocated to switch from Stilnox to
Stilnox CR which had not been substantiated. It was
noted that there was an abstract which compared
12.5mg Stilnox CR to 10mg Stilnox. Members
commented that it would be expected for the higher
dose to be more effective, however the abstract
reported no significance difference in the results.
By a majority the Committee found a breach of 1.1
and 1.3 of the Code and no breach of 1.7 of the
Code. Members agreed that this was a minor
119
Stilnox 859 (contd)

breach and noted that the advertisement was no
longer in use.
Sanctions
Having found a minor breach of the Code, the
The Committee determined that Sanofi Aventis
should:
y Take immediate action for the prompt
withdrawal of the promotional materials found
in breach of the Code and permit no further
appearance of any item in its current form or in
a manner that conveys the same of similar
meaning
y Pay a fine of $5,000
120
Celebrex (860)
Subject Company: Pfizer Australia
Complainant: Boehringer Ingelheim
Product: Celebrex
Complaint:
Promotional material for Celebrex alleged to make
two major safety related claims which are
unsubstantiated and misleading to prescribers.
1.1 Nature and availability of claims
1.5 Unqualified Superlatives
in the industry
Response:
Pfizer maintained that the current complaint is not
the same as previous complaints against Celebrex
(779 and 783) and therefore is not a repeat
breach. Pfizer also commented that even with the
revised position of most Health Authorities,
including the TGA, with regard to the relative
cardiovascular risks of coxibs and traditional nonsteroidal anti-inflammatory drugs (NSAIDS), it is
arguable whether either complaint would have
been found in breach of the Code today.
Claim 3: Unsurpassed record of effectiveness

and GI tolerability in arthritis in item
PF108105/CJB
(Decisions confirmed by Appeals Committee)
Unanimous decision breach of Sections 1.1,
Majority decision no breach of Section 1.5 of
the Code
Unanimous decision no breach of Section 1.7
of the Code
Claim 4: Promotional letter/Faxback
PF10753/CJB
Majority decision breach of Sections 1.1, 1.2
and 1.3 of the Code
Unanimous decision no breach of Sections
Sanctions:
Considered to be a severe breach (Decision
confirmed by Appeals Committee).
Withdraw materials and do not use again and
do not use the claims found in breach in the
same or similar form (Decision confirmed by
Appeals Committee).
y Corrective letter to all General Practitioners and
anyone else who was detailed using the
promotional materials or who received the
Faxback letter. (Decision amended by the
Appeals Committee requirement for corrective
letter removed).
y Fine $100,000 (Decisions confirmed by Appeals
Committee)

Decision:
Claim 1:Unsurpassed record of effectiveness,
upper GI safety and tolerability in arthritis in
item PF10788CJB
Unanimous decision breach of Sections 1.1,
Majority decision no breach of Sections 1.5,
Claim 2:
Representation of SUCCESS-1
and accompanying statements in item
PF10788CJB
Unanimous decision breach of Sections 1.1
and 1.3 of the Code
Claim 1:Unsurpassed record of effectiveness,

upper GI safety and tolerability in arthritis in
item PF10788CJB
very broad in terms of being relevant to all forms of
arthritis and both short term and long term use.
Members were also of the view that in this item of
promotional material there was no evidence
provided or referenced that Celebrex has an
unsurpassed record in comparison with all nonsteroidal anti inflammatory drugs (NSAIDS) or
disease modifying anti-rheumatic drugs (DMARDS)
or across all forms of arthritis. The Committee also
concurred that unsurpassed implied better or
equal to other treatments. If the definition proposed
by Pfizer of unsurpassed (not surpassed, not
exceeded) was correct, members remained of the
view that the claim was too broad and not
121
Celebrex 860 (contd)

adequately qualified in relation to the duration of
use that the claim related to or the type of arthritis.
Whilst osteoarthritis (OA) is mentioned on other
pages of the brochure, the claim is not qualified as
being restricted to use in osteoarthritis and
therefore could be interpreted as applying to both
rheumatoid and osteoarthritis.
Members were of the view that while there are
trials that demonstrate equivalence or nonsuperiority studies that support GI safety and
tolerability of Celebrex, however there is also
considerable information on GI side effects in the
Celebrex PI.
The Committee was of the view that there was no
specific comparison to Mobic.
The Committee did not agree that unsurpassed
was an unqualified superlative. It also considered
that sections 4.1 and 4.2 were applicable to the
complaint. Section 4.1 requires that promotional
material must comply with Section 3 of the Code,
and there is no suggestion that the item did not
comply. Further there was no evidence that the
training of medical representatives who distributed
the promotional material was lacking.
In a unanimous decision members found a breach
of Sections 1.1, 1.2 and 1.3 of the Code. By a
majority decision the Committee found no breach
of Sections 1.5, 1.7, 4.1 and 4.2 of the Code.
Claim 2: Representation of SUCCESS-1 and
accompanying statements in item PF10788CJB
It was noted that the SUCCESS -1 Study
compared celecoxib 100mg and 200mg twice daily
(BID) against diclofenac 50mg BID or naproxen
500mg BID for 12 weeks in patients with
osteoarthritis, but this is not clear to a reader.
Whilst there is a description of the Singh et al
study below the graph showing 87.5% reduction,
the text is faint grey on a light background which is
almost illegible.
It was further noted that the SUCCESS-1 Study
does not compare Celebrex to placebo as implied
by the second dot point Celebrex does not
increase the risk of serious upper GI events
compared to placebo under the heading New
Data 2006. SUCCESS-1 Study.
The second qualifying statement under the graph
was also confusing and potentially misleading to
readers. It referred to serious upper GI events
being defined as endoscopically determined
gastroduodenal ulcers and ulcer complications, but

this qualifier does not relate to the SUCCESS-1
study but to another placebo controlled study.
Some members were surprised that there was no
reference to the cardiovascular risks of Celebrex, in
consideration of the concern in relation to coxibs.
One member also commented that whilst the claims
in the brochure were in some cases limited to
osteoarthritis many of the references cited were in
relation to rheumatoid arthritis and it is not clear that
you can apply findings from an RA study to use in
OA.
Members were of the view that GI sparing was too
strong a claim. Having reviewed the referenced
study by Singh et al, members raised a number of
concerns. The claim GI sparing suggests a better
result for Celebrex with respect to all forms of GI
complications, but the SUCCESS-1 study only
showed a better outcome for Celebrex patients with
respect to ulcer complications, and this only
reached statistical significance for the patients not
taking concomitant aspirin.
For example, for
gastritis there was no statistically significant
difference between Celebrex and NSAIDs, but this
was not disclosed to the reader.
The Committee considered that the graphical
representation of the reduction in rate of upper GI
complications was inadequate. The reduction was
in relative risk, but this was not clear to a reader,
and the confidence intervals stated in the Singh
paper were not included. Also, the page conveying
the SUCCESS-1 information is not qualified as
being related to a study in osteoarthritis.
Further, the reduction in rate of upper GI
complications reported as 87.5% related to only 7
subjects in the NSAID Group and 2 in the Celebrex
Group, which are very small patient numbers on
which to base a broad claim.
The Committee also commented on the
presentation of the SUCCESS -1 study in the other
brochure, PF108105/CJB, which does identify that
the study was in OA patients, but the claim that
Celebrex does not increase the risk of serious
upper GI events compared to placebo could not be
adequately substantiated. The studies referenced
by this claim were not sufficiently powered to make
the claim against placebo in relation to serious GI
effects.
breach of Sections 1.1 and 1.3 of the Code in
relation to representation of the SUCCESS-1 study.
122

Claim 3: Unsurpassed record of effectiveness
and GI tolerability in arthritis in item
PF108105/CJB
For the reasons outlined in relation to the first
claim above, the Committee found a breach of
Sections 1.1, 1.2 and 1.3 of the Code by a majority
decision. In a majority decision the Committee
found no breach of Section 1.5 of the Code and by
a unanimous decision no breach of Section 1.7 of
the Code.
The Committee also noted that the PBS box on
this item was smaller than required by the Code
Guidelines, but did not make any finding with
respect to a breach of the Code or take it into
account when determining sanctions.
Claim 4: Promotional letter/Faxback
PF10753/CJB
The promotional letter/faxback included very
similar claims with respect to unsurpassed relief
of arthritic pain and superior upper and lower
GI safety compared to traditional NSAIDs. These
claims were not qualified in relation to the type of
arthritis (RA or OA), or duration of treatment that
these claims reflect.
found a breach of Sections 1.1, 1.2 and 1.3 of the
Code by a majority decision. In a unanimous
decision the Committee found no breach of
Members were of the view that these Celebrex
promotional materials would have an impact on
prescribing and gave a false impression that
Celebrex has superior GI safety compared with
NSAIDs and thereby had the potential for patient
harm and were therefore regarded as severe
breaches.
Sanctions
Having found severe breaches of the Code the
Committee determined that Pfizer should:
y take immediate action for the prompt
withdrawal of the promotional materials found
in breach of the Code and permit no further
meaning
y send a corrective letter to all General
Practitioners and anyone else who was
detailed using the promotional materials or
who received the Faxback letter.
y pay a fine of $100,000
The Committee noted Pfizers allegation that the

complaint from Boehringer Ingelheim was
vexatious. Having found a severe breach of the
Code the Committee was of the view that this
complaint was not vexatious.
Appeals Committee
Pfizer lodged an appeal against the findings of the
Code of Conduct Committee. Pfizer stated that the
minutes contained a number of clinically inaccurate
statements and conclusions, in particular in relation
to comparative gastrointestinal safety.
Pfizer
considered that the Committees conclusions in
relation to gastrointestinal safety were unfounded.
Boehringer Ingelheim did not submit a written
response to the Pfizer appeal but advised
Medicines Australia that they would make a
presentation at the Appeals Committee meeting.
One member of the Committee raised the matter of
dispute
resolution/mediation
between
pharmaceutical companies and asked whether
Medicines Australia had offered to act as a mediator
as described on page 128 of Appendix 1 of the
Code (Edition 14).
A Medicines Australia
representative advised that members of the Code
Secretariat were of the view that it would not be
appropriate for them to act in this capacity although
the Chief Executive had on occasions met with
companies to discuss ongoing intercompany
disputes. Members were of the view that the use of
a mediator could be of value to companies.
Members also discussed whether the term
unsurpassed should be defined and added to the
glossary in the Code to ensure there was clarity
around its use in promotional material.
The
Secretariat undertook to refer this recommendation
to the Code Review Panel when the Code is next
under review. All members of the Committee
concurred that the use of unsurpassed was subject
to differing interpretations and what is understood in
common parlance is not necessarily the dictionary
meaning.
Members agreed that in reviewing the data there
was defendable evidence of the efficacy and safety
of Celebrex and were concerned that the comments
from the Code of Conduct Committee gave the
impression that COX-2s did not have a generally
favourable GI toxicity profile compared to nonselective NSAIDs.
123

presented in favour of the Pfizer appeal:
Pfizer expressed concern that BI had not
provided a written response to the Pfizer
appeal. Pfizer was therefore unable to review
BI arguments and supporting data/references.
Celebrex history:
Launched in 2000 with PBS listed
premium over all NSAIDS for osteoarthritis
and rheumatoid arthritis on the basis of
gastrointestinal (GI) safety. The PBAC
accepted Celebrex had additional cost
effectiveness over other NSAIDs.
2003/2004 two major resubmissions to
PBAC were made and re-confirmed the
cost-effectiveness of Celebrex over all
NSAIDS including meloxicam, due to its
GI safety profile.
Late 2004 Vioxx was withdrawn and
questions raised over the cardiovascular
(CV) safety of Cox-2s.
Mid 2006 TGA accepted that Celebrex has
a CV safety risk similar to all other
NSAIDS.
Mid 2007 all NSAIDS required to include a
class warning statement on CV safety.
Celebrex was recognised as having CV
safety similar to all other NSAIDs.
There is no basis for the Code of Conduct
Committee to find a breach in relation to the
claims for the superior GI safety of Celebrex,
whether a severe breach or otherwise. The
reason Celebrex was developed was because
it has a GI safety benefit over NSAIDs based
on the following evidence. Pfizer elaborated
on each of the following points:
Body of clinical evidence 15 studies
including the SUCCESS-1 study.
Celebrex PI statements reflect superior GI
safety.
Basis for listing of Celebrex on PBS.
NPS RADAR and other Review articles
endorse it.
GI expert opinion.
Pfizer argued that if the Code of Conduct
Committees finding in relation to the GI safety
of Celebrex were accepted and Pfizer was
required to issue a corrective letter, this could
have perverse safety implications for patients
and could result in an increased rate of GI
bleeds if people were not using Celebrex as a
result.
Pfizer
considered
that
the
Celebrex
promotional material could not be found in
breach of Section 1.1 of the Code because
there is evidence that it is GI sparing.
In relation to representation of the results of the

SUCCESS-1 study, Pfizer disputed the
Committees finding that the study had
insufficient patient numbers on which to base
the claims. There are at least four other studies
that support the claim GI sparing.
The representation of SUCCESS-1 data was
not misleading. However Pfizer conceded that
the description of the study in the text
immediately under the graph could have been
more legible. Also, Pfizer accepted that the
bullet points that were referenced to other
studies would have been better located under
the graph.
In relation to the claim of unsurpassed record
of effectiveness, Pfizer argued that the claim is
a summary statement and must be interpreted
in the context of the whole promotional item.
Effectiveness is a utility descriptor an
amalgam of efficacy and tolerability.
The body of evidence for Celebrex supports the
claim of effectiveness at least similar to all
traditional NSAID comparators in both OA and
RA and for short and long term use.
All claims were either specifically or contextually
qualified.
In relation to the definition and interpretation of
unsurpassed, Pfizers definition of it meaning
not surpassed or nothing better is widely
accepted. Pfizer has never claimed superior
efficacy for Celebrex over other NSAIDS in OA
or RA; only that nothing is better than Celebrex.
A precedent was set with the Fosamax
complaint (705) decision by Code of Conduct
Committee which supported the interpretation
proposed by Pfizer.

presented by the expert gastroenterologist:
All traditional NSAIDS are capable of causing
serious GI complications (bleeding, perforation
and hospitalisation) as well as other symptoms.
4,500 hospitalisations per annum in Australia
this is a major problem.
COX-2 selective inhibitor class of drugs (coxibs)
were developed to reduce this problem.
The professor described a population study in
Australia over four years which demonstrated a
fall in general acute hospitalisation of 29% and
GI bleeding by 19% since the introduction of the
coxibs. Other countries have shown similar
trends.
Studies to assess GI safety have been
comprehensive. 15 informative studies (mainly
randomised controlled trials) with validated
design and study endpoints.
124

Celecoxib has demonstrated superior GI
safety compared with traditional NSAIDS.
Background rates of GI complications do
occur on celecoxib contributing factors
include
population
background
rate,
unmeasured use of low dose aspirin, and
higher risk of peptic disease in those
prescribed celecoxib.
The professor concluded that celecoxib has
demonstrated superior GI safety compared
with traditional NSAIDs.
In response to a question about the concerns

expressed by the Code of Conduct Committee
about the small numbers of patients, a subgroup
of the total SUCCESS-1 study population, that
were represented in the graph and whether these
results in a total of seven study subjects were
generalisable to the general population, the
professor responded that there were four or five
different measures, all of which showed a
significant benefit including a decrease in serious
upper GI complications with celecoxib.

presented by Boehringer Ingelheim in response to
the Pfizer appeal:
BI did not provide a written response to the
Pfizer appeal as there was no new evidence
or information presented in the appeal
document. BI stands by its arguments in the
original complaint.
Clearly there is a great deal of evidence
supporting
Celebrex
against
some
comparators,
especially
over
shorter
timeframes. However, this is not primarily a
technical debate about the data.
The fundamental issue is whether the safety
profile of Celebrex was clearly and accurately
communicated to prescribers in line with TGA
approved PI and the guidance contained in the
Code of Conduct.
The central issue is the broad sweeping
statement about unsurpassed record of
effectiveness, upper GI safety and tolerability
in arthritis. Every doctor who receives the
material or fax will be exposed to the
messages it is the manner in which
information is presented that can be
misleading.
Each item must stand on its own and not
mislead.
There is a range of definitions for
unsurpassed including better or greater
than any other, not surpassed, not
exceeded and not capable of being improved
on. Where there is a real risk that a prescriber

will interpret unsurpassed as better or
superior, the statement becomes misleading
and unsupported.
The use of unsurpassed implies superiority of
Celebrex which is unsubstantiated and
misleading.
Use of the word similar would
remove such a risk.
Precedent referred to by Pfizer in relation to
complaint Fosamax (705) was in a very detailed
comparison, using specified endpoint and
referenced to a specific set of data, which is not
similar to the case at hand.
Acceptance of unsurpassed in this context
could set precedent for widespread, nonspecific use of such terms in the absence of
head to head comparative data.
The available data is only against some
NSAIDs, which Pfizer calls traditional NSAIDs,
which represent only about half of NSAID use.
Half patients taking NSAIDs are taking Cox-2
selective NSAIDs.
BI believes the Celebrex promotional material is
disparaging to other arthritis medicines,
including Mobic.
Arthritis is not defined clearly in the
promotional materials and is not specific to OA
some pieces define whether they are referring
to OA or RA; others dont.
Drugs in other classes than NSAIDs are used in
RA, such as disease modifying agents
(DMARDS) with which Celebrex has not been
compared.
However the claim could be
interpreted as including this comparison.
Any reference to GI complications with
Celebrex being no different to placebo is
misleading and in conflict with the TGA
approved PI.
Representation of the SUCCESS-1 study
without balancing information about pivotal GI
safety studies referred to in the PI, such as the
CLASS study, and providing sufficient details
about doses, duration and effects of
concomitant aspirin use is misleading and
inconsistent with the TGA approved PI.
Broad statements like unsurpassed efficacy
and safety in arthritis are misleading, including
by omission; unsubstantiated and disparaging
to products with which Celebrex has not been
adequately compared, including Mobic.
Positive head to head data comparison is only
available in the short tem studies; longer term
comparison shows no positive trend for
Celebrex.
125

Pfizer has a history of misrepresenting the true
safety profile of Celebrex.
BI cited two
previous complaints 779 and 783.
The
Committee
agreed
that
the
term
unsurpassed can be interpreted in many ways.
Members commented that it was loose language
and as such did not have a specific or tightly
defined meaning and therefore can be
misinterpreted. Members were of the view that
words that dont have a defined or specific
meaning (where readers may interpret the
meaning differently) should be used with extreme
caution or not used at all when presenting
scientific information. The Committee concluded
that the use of the term had the potential to be
misleading.
The Committee made it clear that it was not
making a finding against the record of efficacy or
safety of Celebrex as this had been established
and was supported by the data evaluated in
approving the use of this product in Australia.
However the Appeals Committee was of the view
that the manner in which the information was
presented was misleading, including misleading by
omission:
Unfair reflection of comparators implied
comparison against all NSAIDs, which could
not be substantiated.
Statements comparing Celebrex to placebo
based on other studies were positioned under
the heading and claim related to the
SUCCESS-1 Study, which was not a
comparison against placebo, which was
therefore misleading. A reader may be left
with the impression that these claims were
based on the SUCCESS-1 study data, which
is not correct.
The promotional material did not clearly
identify the type of arthritis statements and
claims related to one promotional item
included a reference to the SUCCESS-1 Study
in OA patients whereas other materials did not
make this qualification.
There appeared to be a selective use of more
favourable data from the studies, which was
therefore not balanced. The selection of one
subgroup
analysis
from
SUCCESS-1,
reduction in rate of serious upper GI
complications, that involved less than ten
patients of thirteen thousand enrolled in the
study. Whereas other subgroup analyses,
representing the common adverse events with
NSAIDs where the differences, while present,

were not as striking, would be a more balanced
representation of the data.
The qualifying statement immediately under the
graph, which described the SUCCESS-1 study
was almost illegible, as was conceded by
Pfizer. The use of a pale grey text colour in
contrast to the background made it difficult to
read and therefore did not provide clear and
easily viewed information.
Members were of the view that the Code of Conduct

Committee had partly erred in its rationale for
finding that the Celebrex promotional materials
were in breach of the Code.
The Appeals
Committee accepted that there was a body of
evidence that supported a favourable comparison
between Celebrex and traditional NSAIDs with
respect to GI safety.
However, the Appeals
Committee concurred with the Code Committee that
it was the manner in which this information had
been presented in the Celebrex promotional
material and the use of the word unsurpassed that
should be found in breach of the Code.
The Appeals Committee did not uphold the appeal
in relation to any of the decisions of the Code
Committee.
The Appeals Committee considered that the
promotional materials found in breach of the Code
did not have any safety implications for patients and
therefore the findings should not be considered to
be severe breaches. The promotional material may
have an impact on how the product is prescribed
and therefore should be classified as moderate
breaches.
Sanctions
Having not upheld the appeal the Appeals
Members agreed that the requirement to cease
using and withdraw the materials found in breach
should remain.
However members were of the view that the
requirement for a corrective letter should be
removed. Members were cognisant that a corrective
letter as required by the Code Committee may imply
that there were efficacy or safety concerns with
Celebrex which is not correct. Members were also
of the view that in this instance it would be difficult
to construct a corrective letter without also giving
Pfizer an opportunity to make positive statements in
relation to efficacy and safety of Celebrex. Two
126

members of the Committee, however, were of the
view that a carefully constructed corrective letter
could be possible.
By a majority decision the requirement for a
corrective letter was removed.
Members agreed that the fine of $100,000 should
remain.
127
Fosamax Plus (861)

Subject Company: Merck Sharp & Dohme
(Australia) [MSD]
Complainant: Servier Laboratories
Product: Fosamax Plus
Complaint:
It was alleged that the promotional material which
suggests that treatment with Fosamax Plus
increases the deposition of new bone tissue
(bone building) is misleading, is not supported by
any data and could potentially influence
prescribers.
1.1 Responsibility
1.3 False or Misleading Claims
Response:
MSD maintained that the use of the statement
bone building conforms with the Code of
Conduct as Fosamax Plus does cause an
increase in bone mineral density.
Serviers
complaint gives a greater significance and
meaning to the statement which is unjustified
given the context in which it occurs.
the statement in the Fosamax /Fosamax Plus

Product Information under Pharmacodynamic
properties that bone formation is also reduced but
less so than bone resorption when a patient is
treated with alendronate, However, the majority of
members were of the view that this was a very
minor breach and would have no potential for
patient harm.
Members also noted that the expert opinions
provided by Servier were anonymous. Whilst there
was no view expressed that these opinions were
any less valuable, it would be preferable to have
experts who could be identified as to their
professional standing and independence.
By a majority decision the Committee found a minor
breach of Sections 1.1, 1.2 and 1.3 of the Code.
Sanction
Having found a minor breach of the Code, the
Committee determined that MSD should:
withdrawal of the advertisement found in breach
of the Code and should permit no further
appearance of it in its current form or in a
manner that conveys the same of similar
meaning.
The Committee determined that as this was a minor
breach and there was no potential for patient harm,
no fine or corrective action was required.

Majority decision breach of Sections 1.1, 1.2
and 1.3 of the Code
Sanction:
y Withdraw advertisement and do not use again
in the same or similar form
The Committee accepted that bisphosphonates
and Vitamin D are good for bone health and
increase bone mineralisation but do not have a
bone building effect. While noting the MSD
response that the complex process involving cells
within bone that continuously lay down
(osteblasts) and resorb bone (osteclasts) and
Vitamin D medicated deposition of calcium could
be considered to align with dictionary definitions of
build and build up, the Committee was of the
view that increased bone mass was not the same
as bone building. The Committee also referred to
128
Pariet (862)
Product: Pariet
Complaint:
It was alleged that the starter pack contained in a
hinged tin box containing, in addition to the
product, a small recipe book and a survey from
which the patient could win a prize were promoting
the product to the general public. Although it was
argued that the contents of the tin were supposed
to be taken out by the doctor and the tin would be
given to the patient as a convenient container, the
complainant stated that the tin and its contents
were clearly intended to be a marketing tool to
consumers.
Members commented that should a patient choose

to use the tin outside their home it should not be
viewed as promotion to the general public as it is
permissible to include a brand name (only) on an
envelope being sent through the mail.
In a unanimous decision the Committee found no
breach of Sections 9.4 or 9.5 of the Code.
There was some concern expressed by members of
the Committee that this complaint had been raised
by the TGA, which suggested a particular
perspective on inclusion of a brand name (alone) on
any materials provided to patients as a patient aid.
The Committee asked that the Code Secretariat to
reconsider this matter in consultation with the TGA
when next revising the Code of Conduct.

9.5 Patient Education
Response:
The starter pack, including the tin, recipe book and
survey, is only handed out to a patient by the
doctors own prerogative after the patient has
been prescribed to Pariet. The tin was not
intended to promote Pariet to the general public
but to give better protection to the starter pack.
The recipe book was included as it contains
disease state information and dietary suggestions
for better health. The survey was a voluntary
opportunity to give feedback regarding symptom
relief and, by winning a prize, gain further
educational materials in the form of a CD.
The Committee was of the view that the tin
containing the starter pack and educational
material was only provided to a patient who had
been prescribed Pariet and was therefore not
promotion to the general public or patient
education (general educational information which
may be provided to members of the general public
who have not been prescribed that particular
prescription medicine).
129
Pariet (863)
Complainant:
Australia
ALTANA
Pharma
and
Pfizer
Product: Pariet
Complaint:
Claim 1: Comparative graphs
The complainant alleged that misleading
information had been presented on graphs which
have been placed next to each other
comparatively and that the data has been
extracted in order to present Pariet favourably.
Response:
Janssen Cilag considered that it is reasonable to
provide best available evidence to clinicians even
if the data do not represent the highest level of
evidence as long as the study data is adequately
qualified.
decision:
Unanimous decision breach of Sections
1.2.2 and 1.3 of the Code
Majority decision breach of Section 1.7 of
the Code
Complaint:
Claim 2: Comparative table
It was alleged that the table compares efficacy
rates for PPIs by inappropriately placing response
rates from different studies together and uses a
mixture of intention-to-treat and per-protocol
results without qualification.
Response:
Janssen Cilag highlighted that this table was
considered by the Committee in complaint 857
and was found in breach of Sections 1.1, 1.2, 1.3
and 1.7 of the Code resulting in instruction to cease

distribution and a $100,000 fine was imposed.
Janssen Cilag has accepted this decision and has
advised Medicines Australia that they will not be
appealing the decision and have given an
undertaking not to use the table in any future
materials.
1.7 decision already made in complaint Pariet
(857)
Complaint:
Claim 3: Pariet = the only PPI with B1
pregnancy rating
It was alleged that the claim that Pariet is the only
PPI safe to use during pregnancy is misleading as it
makes it appear that Pariet is safer during
pregnancy than other PPIs and that it is safe to use
during pregnancy without having any supporting
data.
Response:
Janssen Cilag was of the view that this was a
factual statement and cannot be a breach of the
Code
as
the
pregnancy
categories
are
independently determined by the TGA and ADEC.
Majority decision no breach of Sections 1.2.2,
Sanctions relevant to claims 1 and 2:
y Withdraw the materials and do not use again in
the same or similar form
y Sanctions otherwise adequately covered under
complaint Pariet 857
Claim1: Comparative graphs
The Committee was of the view that the
juxtapositioning of the graphs when detailed by a
representative in either the double page spread
displaying the Pariet 20mg graph or as a single
130
Pariet 863 (contd)

page with esomeprazole, omeprazole and
pantoprazole was making a cross trial comparison.
clarification and advice from the Appeals Committee

on how scientific data can be used and presented
so as to prevent any further related breach.
Members noted that that there was some

description of the studies under the graphs,
however were of the view that as the studies were
in different patient groups and there were different
primary and secondary outcomes for the two
Richter papers, it was inappropriate to place them
side by side in a manner that implied the data
related to direct head to head comparison.
Altana responded to the appeal stating that the

Code of Conduct already offers adequate guidance
on how this type of data can be used and presented
in promotional material.

breach of Sections 1.2.2 and 1.3 and by a majority
a breach of Section 1.7 of the Code.
Provision
13.1.1 A Subject Company who has been found in
breach of the Code and had a sanction
imposed under Section 12 of the Code may
lodge an appeal against the findings and/or
sanction that has been imposed.
Claim 2: Comparative table

The Committee was of the view that this was the
same information as was subject to complaint
under Pariet 857 and was therefore not
reconsidered as part of this complaint.
In view of this unusual appeal, members considered

the provisions of Section 13.1 of Edition 14 of the
Code.
Claim 3: Pariet = the only PPI with B1

pregnancy rating
The Committee was of the view that it was factual
that Pariet was the only Proton Pump Inhibitor
(PPI) with a B1 pregnancy rating as determined by
the TGA and ADRAC.
Explanatory Notes
13.1.1 The Subject Company may appeal the
findings where it has been found to be in
breach of the Code and/or any sanction that
has been imposed on it under Section 11 of
the Code. The Appeals Committee has the
power to affirm, set aside or vary the
findings and/or any sanction which has
been imposed by the Code Committee.
In relation to the allegation that the inclusion of this

statement on the page headed Pariet 20mg.
Safety in Patients, members were not of the view
that this was inappropriate as the use of a PPI in a
pregnant woman could have safety implications.
The Appeals Committee shall not uphold an appeal

unless it is persuaded that the findings of the Code
Committee or the sanction imposed by it involved
an error on the basis of which they should be set
aside or varied.
By a majority decision the Committee found no

breach of Sections 1.2.2, 1.3 or 1.7 of the Code.
Some members questioned whether this appeal

should have been accepted by the Code Secretariat
as it was not an appeal against a finding rather
seeking clarification of an issue by the Appeals
Committee. A member of the Code Secretariat
explained that the Secretariat did not consider it had
the authority to not accept an appeal.
Sanctions
Committee determined that Janssen Cilag should:
withdrawal of the promotional material found in
breach of the Code and should permit no
further appearance of any item in its current
form or in a manner that conveys the same of
similar meaning.
y Sanctions otherwise adequately covered
under complaint Pariet 857.
Appeals Committee
Janssen-Cilag lodged an appeal in relation to the
Code Committees decisions on Claim 1.
However Janssen-Cilag stated that it was not its
intention to have the decision or resultant sanction
arising from 863 reversed or modified, but to seek
Having received the appeal and response

documentation, it was agreed by all members that
the appeal should proceed.
The Committee considered where information on
the evidence comparing all the available treatments
in a therapeutic area would most appropriately be
used. Members were of the view that presentation
of all the evidence in a comparative manner was
very difficult in a short visit by a medical
representative and was probably more appropriate
in an education setting such as CME, peer to peer
131
Members commented that in a 5 -10 minute

(sometimes as little as 2 3 minutes) interaction
between a busy general practitioner (GP) and a
medical representative there is insufficient time to
discuss all the relevant data and explain the level
of evidence of the referenced studies. Members
also noted that the GP would not have immediate
access to the data in the referenced studies to
enable any evidence based medicine decision.
Members noted Janssen-Cilags reference to the
minutes of Pariet 788 Appeals Committee meeting
and the Pariet 857 complaint and agreed with the
principal tenet of each that sufficient information
must be provided to a prescriber to ensure that
any claim is sufficiently qualified and the reader is
made aware of the level of evidence, study design
and outcomes measured to enable appropriate
assessment of the veracity of a claim.
The following summarises the main points in
favour of the Janssen-Cilag appeal:
It was not Janssen-Cilags intention to have
the Code Committee decision or resultant
sanction arising from complaint Pariet 863
reversed or modified, but to seek clarification
and advice as to how scientific data can be
used and presented so as to avoid any
possible future breaches.
Janssen-Cilag believe the decision of the
Code of Conduct to veto the comparative use
of differing levels of evidence in the selection
of a therapeutic agent is philosophically at
odds with what is widely accepted in evidence
based medicine (EBM) as it is currently
applied in clinical practice for the following
reasons:
Pharmaceutical company promotional
materials are evidence-based and should
comply with the same rules and guidelines
as
other
EBM
therapeutic
recommendations.
There are many
examples of therapeutic guidelines that
are based on evidence other than level 1
data. The level of evidence is transparent
and disclosed in these guidelines.
NH&MRC recognises need for flexibility in
the application of the hierarchy of
evidence.
For proton pump inhibitors (PPIs), like
Pariet, there is no Level 1 evidence head
to head comparative data) to allow direct
comparison across the full range of PPI.s
Janssen-Cilag considers that their materials

do assist a GP in making an informed
choice. The material is based on the best
available evidence used in an unbiased
way.
GPs are trained in EBM and critical review
and can interpret data and claims based on
them.
Janssen-Cilag believes it is appropriate to
present best available evidence to allow the
prescriber to make an informed judgement even
when this evidence is from different levels in the
NHMRC hierarchy.
Janssen-Cilag would like to propose some
principles to the use of data:
Disclosure/transparency
is
appropriate
when comparative evidence is of different
levels.
Prescribers should be aware of low level of
confidence in making comparisons between
trials of different designs.
The level of evidence should be disclosed
for each trial.
Bold comparative claims should not be
made unless evidence is of the highest
level.
Pariet 863 (contd)

doctor training rather than in a detail aid for a
specific medicine.

Altana presentation in response to the JanssenCilag appeal:
Material found in breach because of the
juxtaposition of the graphs was making a crosstrial comparison. The different colour used for
the graph for Pariet and those for other PPIs
was noted.
Code of Conduct and Guidelines already offer
adequate advice on how differing levels of
evidence can be used and presented.
The results of the three trials depicted on the
two pages cannot be compared because:
They have different study designs;
The populations studied are different;
The primary objectives of the studies are
different:
To evaluate timing and degree of
symptom relief;
To compare efficacy (healing rates) ;
The safety of esomeprazole and
omeprazole and dose response study.
The outcomes reported on are significantly
different:
% of patients reporting absence of
daytime heartburn on Day 1 (Pariet);
daytime or night time heartburn on Day
1 (esomeprazole/omeprazole);
132
Pariet 863 (contd)

daytime heartburn on Day 1 or any
subsequent day (pantoprazole).
There are other studies that provide more
positive results for pantoprazole yet these
were not cited.
Rapidity of onset is important but the
sustainability of effect is equally important.
Sustained symptom relief from Day 1 onwards
would be a more appropriate endpoint.
The absence of higher level of evidence with
one product does not mean that a company
can use lower level evidence to support a
comparative claim.
Results and their presentation were biased in
favour of Pariet.
While GPs have skills in assessing quality of
data, Altana do not believe that short medical
representative visits allow for this not able to
make informed judgement on the merits of the
data without all the evidence which was not
provided by Janssen-Cilag
The Janssen-Cilag representative summarised the
appeal stating that in the real world healthcare
professionals have to make choice between
different treatment options based on what
information is available. From a purist view only
Level 1 evidence should be used; however this
does not always exist and companies must use
the best evidence available. Materials should be
clear about the level of evidence used. While the
Code does contain guidance it could be improved
and should include more information for the
industry about levels of evidence and how
evidence of different levels can be used and used
together.
While agreeing with the principles of EBM
members were of the view that EBM is a skill that
needs to be constantly practiced to be maintained
and it is not reasonable to assume that an average
GP is trained and able to assess this information
in a 5 10 minute detailing by a medical
representative. Members also noted that company
materials did not always provide sufficient
information to allow a prescriber to evaluate the
data and make an informed decision. If materials
were truly educational there would be information
provided about the different study designs,
objectives, population groups and outcomes.
If there are differing level of available evidence
and a company considers they have provided to
best data available (for all products), the
information is presented in manner that does not

misrepresent any study and does not generate an
unbalanced impression it may be possible for a
company to provide such representations and
information in a detail aid or leave behind.
While guidance on levels of evidence is important,
members also noted that two level 1 studies could
also have different study designs and objectives
which need to be clear to a reader. For example,
one study could have a study population of patients
with severe symptoms while another only included
patients with mild to moderate symptoms.
The Committee did not agree with Janssen-Cilags
interpretation that the Code of Conduct Committee
had vetoed (Janssen-Cilags emphasis) the
comparative use of differing levels of evidence.
Extract from Code minutes pertaining to Pariet 863
Members noted that that there was some
description of the studies under the graphs,
however were of the view that as the studies were
in different patient groups and there were different
primary and secondary outcomes for the two
Richter papers, it was inappropriate to place them
side by side in a manner that implied the data
related to direct head to head comparison.
The Committee considered that there is nothing in
the Code of Conduct Committee minutes that
suggests a veto on the comparative use of studies
at differing levels of evidence. It is the context of
how any data is used, and presented, including any
explanation or qualification that is important. It may
not be possible to include a sufficient level of detail
in a brief promotional item to adequately inform a
reader of all the information relevant to each cited
study if the study design, population, primary
endpoints and outcome measures are very
different, and therefore it may not be appropriate to
use data that requires such qualification or
explanation. Any complaint will be determined on
how data or claims are used and how the data to
support the claims is presented.
The Committee commented that the fundamental
issue with the Pariet detail aid was not the level of
evidence used but the manner in which the
evidence was presented the lack of sufficient
detail provided to allow a reader to appropriately
interpret the data; juxtapositioning of different
studies in a way that suggests a direct comparison;
the lack of qualification that the severity of disease
for subjects entering the trials was different; lack of
explanation that the outcome measures were
different.
133
Pariet 863 (contd)

Some members were of the view that company
promotional material cannot claim to be equivalent
to therapeutic guidelines or other similar
educational material. If a company wants to
provide quality educational material (as opposed
to promotional material) with detailed information
on all the relevant data for all products in a
therapeutic area and of a standard that allowed a
reader to assess the comparability of the studies,
this would be appropriate and useful for healthcare
professionals.
The
Appeals
Committee
confirmed
the
findings/sanctions of the Code of Conduct
Committee in relation to complaint Pariet 863.
134
Xalacom (865)
Complainant: Alcon Laboratories
Product: Xalacom
Complaint:
Claim 1: that combination products for
glaucoma are more effective than concomitant
use of the components
Alcon alleged that the claim that a fixed
combination product such as Xalacom is more
efficacious than combination use of the
components is inaccurate and misleading.
1.1 Responsibility
Response:
Pfizer stated that Alcon had ignored the context in
which the statements were made.
Greater
efficacy can be demonstrated and Pfizer believe it
has been documented and referenced to
appropriate reference material.
decision:
and 1.3 of the Code
Complaint:
Claim 2: Selective use of a single study more
favourable than the body of clinical evidence
Alcon alleged that a single study was presented,
the results of which were not in line with those
from other studies, and this selective data was
used in favour of Xalacoms promotion.
1.1 Responsibility
Response:
Pfizer stated that the piece included trials relating
to the new PBS listing of Xalacom. Pfizer also
claimed that the PBAC had evaluated the Konstas
et al data as appropriate.

Complaint:
Claim 3: Xalacom vs unfixed combination
Alcon alleged that a single source was used to
make claims that were not consistent with the body
of evidence that has compared Xalacom with the
unfixed combination, ignoring the findings of less
favourable studies.
1.1 Responsibility
Response:
Pfizer re-iterated that all previous Xalacom data was
evaluated by the PBAC and it was their
determination that Xalacom is non-inferior to the
unfixed combination.
Complaint:
Claim 4: Misrepresenting Guidelines switching
vs adding
Alcon alleged that the promotional claims which are
designed to encourage moving from one single
agent to Xalacom without switching to another
single agent first are not consistent with the body of
clinical evidence or the Asia Pacific Glaucoma
Guidelines.
1.1 Responsibility
Response:
Pfizer maintained that Alcon have selectively taken
one aspect of the Asia Pacific Glaucoma Guidelines
2003 that refers only to those with a response
inadequate and not the relevant section which
relates to patients who have demonstrated efficacy
but insufficient to reach target.
Unanimous decision, no breach of Sections 1.1
and 1.3 of the Code
135
Xalacom 865 (contd)

Complaint:
Claim 5: Changing from one prostaglandin to
another is unlikely to yield a different outcome,
because
equivalent
efficacy
between
prostaglandins has been demonstrated
Alcon alleged that this claim is misleading as it is
inconsistent with clinical practice guidelines and
does not represent the body of clinical evidence.
1.1 Responsibility
Response:
Pfizer maintained that a recent Code of Conduct
Committee decision (Lumigan 836) supported their
position.
decision:
Majority decision breach of Sections 1.1 and
1.3 of the Code
Complaint:
Claim 6: that Xalacom should be considered
for new patients
Alcon alleged that this recommendation is not
consistent with Xalacoms TGA approved
indication that Xalacom should not be used to
initiate therapy.
Materials alleged to be in serious breach of the
1.1 Responsibility
Response:
Pfizer considers that it had highlighted the
statement that Xalacom is not for initiation
therapy, and that the statement in fact indicates
that Xalacom should be considered earlier in the
management plan for those patients after
monotherapy proves to be unsuccessful.
decision:
and 1.3 of the Code
Sanctions:
y Considered to be a moderate breach
y Withdraw materials, and dont use again in the
same or similar form
y Corrective letter to all ophthalmologists
y Fine $50,000
The Committee noted that the promotional brochure
was conveying information and opinions expressed
by a specialist ophthalmologist, who had also
written to Medicines Australia explaining his
perspective on the complaint.
The Committee was of the view that a healthcare
professional is entitled to express a personal view.
However when a pharmaceutical company
incorporates this opinion into a promotional piece
and distributes it to healthcare professionals, it is
the responsibility of the company to ensure that it
fully complied with the provisions of the Code.
Members considered that Pfizer had taken
responsibility for communicating the specialists
opinions and therefore must ensure that the
statements or claims were accurate, balanced and
could be supported or substantiated.
Whilst appreciating the correspondence from the
specialist whose opinions were conveyed in the
brochure, the letter was not relevant to the
complaint before the Committee.
The Committee considered that the claim that
combination products were more effective than
concomitant use of the single components had not
been adequately substantiated.
Claim 2: Selective use of a single study more
favourable than the body of clinical evidence
Members were of the view that the Konstas et al
data had been accepted by the PBAC in terms of a
cost minimisation application for PBS listing and
considered that the data presented were acceptable
to show equivalent clinical effects. The data was not
claiming that Xalacom was better, only that it works
as well and this was adding to the body of evidence.
136
Xalacom 865 (contd)

Claim 3: Xalacom vs unfixed combination
The Committee considered that the claim that
Xalacom is no worse than the unfixed combination
could be substantiated by reference to the cited
study, and therefore by unanimous decision found
no breach of Sections 1.1 or 1.3 of the Code.
Claim 4: Misrepresenting Guidelines
switching vs adding
The Committee was of the view that physicians
can review and select from a range of consensus
guidelines. It is not the role of a company to
decide which is the most appropriate. All may be
useful, and some physicians may make reference
to more than one set of guidelines.
Members noted that a company should not reword
published consensus guidelines in promotional
material. If reference is to be made to guidelines
they should include the actual text from the
document or quote the section in its entirety.
Interpretations or added nuances can lead to
misrepresentation
of
guidelines.
Members
commented that treatment of glaucoma was a
specialised field and were of the view that
ophthalmologists would be aware of the various
guidelines and are aware of emerging information
on whether to switch to another single agent or to
introduce a second agent.
The Committee
accepted that the US guidelines had not been
mentioned at the meeting which was summarised
in the promotional material and therefore it was
acceptable to not refer to them.
The Committee considered that the reference to
the consensus guidelines in the promotional
material was not misleading or misrepresenting
the guidelines. In a unanimous decision the
Committee found no breach of Sections 1.1 or 1.3
of the Code.
because
equivalent
efficacy
between
The Committee members considered that the
statement that changing from one prostaglandin to
another is unlikely to yield a different outcome was
inconsistent with the Asia Pacific and European
Glaucoma Guidelines recommendation that
switching to another class of medicine may be
useful. Even if the specialist ophthalmologist had
stated this in his presentation, it was Pfizers
responsibility to ensure that the promotional

material did not misrepresent the guidelines.
By majority decisions the Committee found a breach
of sections 1.1 and 1.3.
Claim 6: that Xalacom should be considered for
new patients
The Committee considered that there was no
explanation or qualification of the specialists
statement to consider Xalacom for new patients to
explain that this was not an approved indication for
Xalacom and was not listed on the PBS for initiation
of treatment. The Committee was of the view that in
distributing the material Pfizer had actively
promoted a non-approved indication. This aspect of
the complaint was considered to be the most
serious as there is no safety or efficacy data for the
off-label use.
The several breaches of the Code found in relation
to the promotional material were considered to be
moderate and members were of the view that there
was no potential for patient harm arising from the
promotional material.
Sanctions
Having found moderate breaches of the Code the
Committee determined that Pfizer should:
y take immediate action for the prompt withdrawal
of the promotional material found in breach of
the Code and should permit no further
meaning.
y send a corrective letter to all ophthalmologists
in Australia
y pay a fine of $50,000
Appeals Committee
Pfizer lodged an appeal claiming that the Code of
Conduct Committee made erroneous findings in
determining breaches of Sections 1.1 and 1.3 of the
Code with respect to Claims 1, 5 and 6. Pfizer also
requested that the Appeals Committee take into
consideration the correspondence provided by the
healthcare professional to the Code of Conduct
Committee as relevant to the complaint as it
provides a clinical opinion and contributes to the
body of evidence relevant to clinical practice.
Alcon responded to the appeal by stating that Pfizer
had relied heavily in their appeal on the fact that this
137
Xalacom 865 (contd)

promotional piece reflects the views of the
presenter.
However, in representing these
opinions in promotional material Pfizer takes full
responsibility for them. Alcon agreed with the
Code of Conduct Committees (COCC) decisions
and argued that the correspondence from the
health professional, whose presentation to an
educational meeting were summarised in the
promotional material, was not relevant to the
complaint.
The following summarises the arguments
presented by Pfizer in support of their appeal:
Code of Conduct Committee has made its
assessment and determination based on an
incorrect claim that was stated by Alcon.
Nowhere in the promotional material was the
statement That combination products for
glaucoma are more effective that concomitant
use of the components made or implied.
The alleged statement assumes that all fixed
combinations (FC) are better than the unfixed
combination (UFC) of its components.
Pfizer believes that the claim to be assessed
should be That combination products for
glaucoma may provide greater efficacy in
practice as a result of improved patient
compliance and/or less washout (emphasis
added by Pfizer).
Efficacy claims must be taken in context of the
whole piece which discusses the better
efficacy of fixed combination products on the
basis of better patient compliance and less
washout effect.
Evidence to support the claim is available for
equal or better efficacy Konstas et al,
Fechtner et al and Gugleta et al which all
refer to either better compliance or eliminating
the washout effect. Therefore the claim of
equal or better efficacy of FC products can be
substantiated.
Pfizer referred to Exhibit 4, stated to be an
extract of the DuoTrav (Alcon Laboratories)
European Public Assessment Report, which
states that in clinical practice it has been
shown that switching from an UFC to a FC has
provided additional intraocular pressure (IOP)
reduction owing to improved compliance.
Pfizer also referred to a statement in Alcons
response to the appeal that a single dose,
once a day product, is likely to provide better
compliance with no washout than two products

used concomitantly.
because
equivalent
efficacy
between
The Code of Conduct Committee made a
determination based on reference to the wrong
sections of the Asia Pacific and European
Glaucoma Society Guidelines.
The section that needs to be referred to in the
Asia Pacific Glaucoma Guidelines should be:
Use more than one agent only if each has
demonstrated efficacy but insufficient to
reach target: Apply this principle also to
fixed combinations.
The section that should be referred to in the
European Guidelines is:
If first choice monotherapy is well tolerated
and effective, but not sufficient to reach
target IOP, then adjunctive therapy in the
form of any other topical agent can be
initiated.
The Code Committee considered the claim out
of context. The claim in question is relevant to a
patient
responding
to
prostaglandin
monotherapy but not achieving target IOP.
Pfizer had clearly outlined in the promotional
piece, in the figure on page 5, when adding a
second drug and changing monotherapy may
be appropriate which is consistent with the
second line indication for Xalacom and the
European Guidelines.
Claim 4: Misrepresenting Guidelines switching
vs adding in this complaint - an allegation that
Pfizer had misrepresented the consensus
guidelines in the same paragraph as that in
which Claim 5 occurs - was not found in breach.
Therefore Claim 5 should also not be found in
breach.
The Code Committee made its determination
without any supporting evidence from Alcon.
Evidence supplied by Alcon to Pfizer lacks
rigour and robustness and was inadequate in
design and scope whereas the evidence
supplied by Pfizer is from a randomised,
masked and multicentre trial comprising a three
way comparison between the available 3
prostaglandins (Parrish et al).
Table 3 in the promotional piece indicates that
there is no clinical efficacy difference between
the prostaglandins.
138
Xalacom 865 (contd)

for new patients
At no stage did Pfizer intend for Xalacom to be
promoted as a first line agent.
The item contains 3 statements referring to the
second line indications for Xalacom Pfizer
referred to the sections highlighted in Exhibit
5.
Context is critical The Code of Conduct
Committee made a determination based on a
singular, isolated statement and not in context
of the entire piece.
There is no material damage to competitors or
benefit to Pfizer in promoting Xalacom as first
line.
To do so would negatively impact
Pfizers brand Xalatan, which is illogical from a
business perspective.
Pfizer argued that the claim suggests that in a
patient with very high IOP and short term
treatment with monotherapy suggests that it
isnt going to reach target, consider Xalacom.
Pfizer had acknowledged (without prejudice) in
intercompany dialogue that they would clarify
this statement. This implied removal until
corrected, however Alcon refused.
If the Appeal Committee does not uphold
Pfizers appeal on this claim, then the finding
should be reduced to a minor breach and the
sanction amended to remove the requirement
for a corrective letter, reduce the fine and
require clarification of the statement in future
materials.
Pfizer recognises its responsibility in relation
to statements made by third parties. However
Pfizer requests that the correspondence
provided by the specialist ophthalmologist to
the Code of Conduct Committee be
determined as relevant to the consideration of
the complaint by the Appeal Committee:
It provides important clinical opinion in
glaucoma management.
The specialist ophthalmologist is an
experienced clinician in the field of
glaucoma his statements should be
considered.
The statement contributes to the body of
evidence relevant to clinical practice.
It provides the framework in which Pfizer
evaluated
statements
for
Code
compliance.
The following summarises the Alcon appeal:
Alcons complaint concerns the Pfizer printed
promotional material; the complaint is not
about the specialist ophthalmologist.
The letter from the specialist ophthalmologist

can be considered, but being a personal
opinion, does not contribute to the discussion.
The promotional material must stand alone and
be assessed against the requirements of the
Code.

Pfizer has stated that the claim as alleged
doesnt appear in the promotional material.
Alcon identified three places in which the claim
appears.
The claim is not adequately substantiated.
The claim conflicts with the Xalacom Product
Information Alcon referred to two statements
from the Xalacom PI where it is stated that it is
unknown
whether
patients
adequately
controlled on UFC with timolol dosed twice daily
will be as well controlled on Xalacom (FC) once
daily; and recommending reverting to twice
daily timolol (UFC) if there is inadequate
response to Xalacom once daily.
In the promotional material Pfizer has cited
references (Fechtner et al) which used a
different product Cosopt (twice daily dosing
which is not the Holy Grail of once daily
dosing)
Alcon questioned whether the Cosopt data can
be generalised to Xalacom and other
combination products.
The context of the promotional material is
Xalacom, not fixed combination eye drops in
general there are no supporting data relevant
to Xalacom and the claim remains in conflict
with the Product Information.
Concerning the relevance of better compliance
to improved efficacy, it is necessary to establish
that this is the basis for better efficacy before
the claim is made.
because
equivalent
efficacy
between
The claim effectively says dont switch.
The statement must be taken in context of the
whole paragraph in which it appears, which
refers to both options when there is no
response to monotherapy and an inadequate
response to monotherapy. The claim is false,
both for when first line monotherapy fails, and
for when there is a good but inadequate
response.
139
Xalacom 865 (contd)

The claim directs prescribers to add rather
than switch which is inconsistent with the
Guidelines.
The claim conflicts with data supporting
switching (Przydryga et al and Law et al)
Pfizer has provided no data to support that
switching is not effective.
The claim is falsely referenced. Whilst large
randomised trials of individual agents have
shown that the prostaglandins are equally
effective overall, there are no trials in
switching from one prostaglandin to another.
Different patients respond differently to
different drugs some may do better, some
may do worse after switching.
Alcon has submitted two switch studies that
show most patients IOP control changes
when treatment changed, which supports that
switching is worth trying
Another complaint referred to by Pfizer is not
relevant to this complaint.
for new patients
Alcon has no issue with the specialist
ophthalmologists personal viewpoint.
Alcon considers that this is the most serious of
the three breaches.
The claim has been printed and distributed
without qualification as to what Pfizer claims is
its proper context.
Pfizer has actively promoted a non-approved
indication for Xalacom as first line therapy.
If Pfizer did not intend for Xalacom to be
promoted as first line agent why is the same
statement highlighted on a slide presented by
a Pfizer staff member at ANZGIG in August
2006.
Pfizer made no offer to modify this section in
the original letter of response to Alcon.
At the intercompany meeting Pfizer said they
would consider removing this from future
printings.
Alcon considered and stated that immediate
withdrawal was required.
Consideration of the appeal
The Chairman sought members advice on the
request from Pfizer that the letter from the
specialist ophthalmologist be considered as
relevant to the complaint. Members reiterated the
views expressed by the Code of Conduct
Committee that a healthcare professional is
entitled to express a personal view. However
when a pharmaceutical company incorporates
this opinion into a promotional piece and distributes

it to healthcare professionals, it is the responsibility
of the company to ensure that it fully complied with
the provisions of the Code. Members considered
that
Pfizer
had
taken
responsibility
for
communicating the specialists opinions and
therefore must ensure that the statements or claims
were accurate, balanced and could be supported or
substantiated.
Whilst appreciating the correspondence from the
specialist whose opinions were conveyed in the
brochure, the letter was not relevant to the
complaint before the Committee.
The Appeals Committee unanimously determined
that the specialist ophthalmologists letter should not
be considered in determining the appeal but that the
promotional piece should be considered on its own
merit.
Members were of the view that the claim does state
that combination fixed products are more effective
than the concomitant use of the individual
components. As this promotional item is for
Xalacom, the overall intent is to convey that
Xalacom is more effective than an unfixed
combination of prostaglandin and timolol, which
cannot be supported by the evidence. The
Committee noted that the box on page 4 of the
piece headed Fixed-dose combinations states
Advantages equal or better efficacy with
compliance as a separate point and reduced
washout affect as another separate point. This did
not support Pfizers argument that better efficacy
was due to better compliance and less washout
effect. It was also noted that in Figure 3 Relative
efficacy of fixed and unfixed combinations of
latanoprost and timolol which is stated to show the
FC is as effective as the UFC, not greater efficacy
of the FC. However the boxed statements on page
4 relating to Fixed-dose combinations states equal
or better efficacy which is not consistent.
The Committee noted that reduction in IOP is one
(important) measure of treatment success, but an
ophthalmologist will be considering loss of visual
field as the real test of efficacy. There is some
debate concerning dosing timolol at night rather
than in the morning due to the reduction in blood
pressure it causes at night and whether this might
negatively impact on perfusion of the optic nerve,
contributing to loss of visual field. Whilst this issue
was not raised in the complaint, it points to the need
140
Xalacom 865 (contd)

for careful consideration of when to add a second
drug and whether this should be as a fixed
combination or unfixed.
In a unanimous decision the Committee did not
uphold the appeal in relation to the finding of
breaches of Sections 1.1 and 1.3 of the Code with
respect to Claim 1.
because
equivalent
efficacy
between
Members expressed the view that the impression
the promotional piece gives to a prescriber is that
changing from one prostaglandin to another is not
going to make any clinical difference to patients.
The Committee discussed the quality of the
evidence the head to head trial by Parrish et al
comparing the three prostaglandins and the switch
studies proposed by Alcon.
The Committee
considered that the Parrish study does show that
the prostaglandins are similar in efficacy overall,
but not on an individual treatment basis. Members
agreed that the evidence and the consensus
Glaucoma Guidelines recommend switching
monotherapy before adding a second drug,
whereas the promotional piece conveys the
message that all prostaglandins are the same and
switching wont make a difference.
The Committee further noted the inclusion of the
word only in the Asia Pacific Glaucoma
Guidelines statement highlighted by Pfizer as the
relevant section of the Guidelines: Use more than
one agent only if each has demonstrated efficacy
but insufficient to reach target(emphasis added).
The Committee considered that the advice
provided by Pfizer in the promotional item to move
to combination therapy if monotherapy achieves a
response but inadequate to reach target was
inconsistent with the Guidelines statement.
In relation to the Pfizer argument that as Claim 4
and the misrepresentation of the Guidelines was
not found in breach by the Code of Conduct
Committee, Claim 5 should not be in breach
either, Members were of the view that both Claims
4 and 5 were in breach. However, only a ruling by
the Appeals Committee in relation to Claim 5 was
possible as an appeal in relation to the Code
Committees decision in respect of Claim 4 was
not before the Appeal Committee. In a unanimous
decision the Committee did not uphold the appeal
in relation to breaches of Sections 1.1 and 1.3 of
the Code with respect to Claim 5.
Claim 6: that Xalacom should be considered for

new patients
With respect to the section headed Xalacom: what
place in clinical practice members of the Appeals
Committee were of the view that while it is
acceptable for a healthcare professional to express
their personal view of a treatment regimen at a
conference, once a company translates this view
into a company promotional piece and proactively
distributes the item to healthcare professionals they
must accept responsibility for the content.
Members noted that the approved indications for
Xalacom were stated in three places elsewhere in
the promotional piece. However, on page 5 it was
recommended that Xalacom be considered as first
line therapy in new patients which is outside the
approved indications in Australia. The Committee
was not convinced by Pfizers argument that the
intended interpretation was consider after a trial of
monotherapy.
The Committee was of the view that while these
personal views were expressed in the Pfizer
promotional piece there was no potential for patient
harm. In a unanimous decision the Committee did
not uphold the appeal in relation to breaches of
Sections 1.1 and 1.3 of the Code with respect to
Claim 6.
Sanctions
Having confirmed the Code of Conduct Committees
determination finding a number of breaches of the
Code, the Appeals Committee considered the
sanction imposed by the Code of Conduct
Committee.
The Appeals Committee reviewed the definitions of
minor and moderate breach and determined that
there was no potential for patient harm arising as a
result of the promotional material but there was a
likelihood of it having an effect on how a health
professional may prescribe the product.
The
breaches were therefore considered to be
moderate.
The Appeals Committee considered that the
sanctions applied by the Code Committee were
appropriate. It confirmed the following sanctions:
Pfizer should:
withdrawal of the promotional material found in
breach of the Code and should permit no further
meaning.
141
Xalacom 865 (contd)

y Send a corrective letter to all ophthalmologists
in Australia. The corrective letter should state
that the Glaucoma Guidelines had not been
correctly communicated and clarify the correct
interpretation with respect to switching
between monotherapies and adding a second
agent and acknowledge that Pfizer had
promoted an unapproved use for Xalacom and
clarify the approved indications.
y Pay a fine of $50,000
142
Celebrex (866)
Complainant: Non-healthcare professional
Academic
Product: Celebrex
Complaint:
The complainant alleged that an article in the
Readers Digest included information on arthritis
treatments, specifically Cox-2 inhibitors, and
referenced the information to the Celebrex Product
Information and Consumer Medicine Information
which therefore inappropriately focused on a
particular prescription medicine and constituted
promotion of Celebrex to the general public.
9.5.2 Patient Education
Response:
Pfizer stated that while it does not believe they
have breached the Code, it acknowledged the
inference that the referencing to Celebrex PI and
CMI may imply. The article was written in direct
response to healthcare professional requests for
information following recent media about the antiinflammatory class and resulting confusion within
the general community.
and 9.5.2 of the Code
Sanctions:
y Withdraw and do not use or publish the article
again in any publication directed at the general
public
y Fine of $100,000
Members of the Committee noted the wide
circulation of Readers Digest and also the length
of time that many editions remain in circulation
and particularly are often left in doctors waiting
rooms. Thereby the exposure to members of the
general public potentially could be wide ranging.
One healthcare professional also commented that

general practitioners were also being offered copies
of the particular article subject to complaint for use
in their waiting room.
The Committee noted the statements in Pfizers
response to the complaint that the article was
written in direct response to healthcare professional
requests for information following recent media
about the anti-inflammatories and resulting
confusion within the general community based on
sensationalist reporting by the media. However
Pfizer also commented that the article had originally
been drafted for a healthcare professional audience
and it was an unfortunate oversight that in this
instance the referencing had not been adequately
changed for distribution to the general public. The
Committee was concerned that this oversight
demonstrated a lack of risk management
procedures within the company and sought
confirmation in writing that Pfizer will ensure
appropriate procedures for vetting/approving
materials for the general public are in place.
Members were of the view that the article was not
written in terms that were intended for healthcare
professionals and was therefore clearly designed
for a general public audience.
The Committee also agreed that the content was
not balanced, with the main emphasis on newer
anti-inflammatory
medicines;
older
antiinflammatories were barely mentioned in the article
and then only in relation to the side effects. It was
also noted that the article included four references
to the Celebrex Product Information and another
reference to the Celebrex Consumer Medicine
Information.
breach of Sections 9.4 and 9.5.2 of the Code.
Sanctions
Having found several breaches of the Code, the
The Committee determined that Pfizer should:
Take immediate take action to withdraw the
article from circulation and not use it again in
any publication directed at the general public.
In determining the sanction, the Committee
considered that this was a moderate breach and a
seemingly flagrant disregard of the Code.
143

The Committee expected that companies such as
Pfizer should have risk management and
compliance mechanisms in place to prevent the
publication of such material to the general public.
The Committee reiterated its request that Pfizer
provide an assurance to the Committee that its
internal mechanisms will be reviewed and
improved.
The Committee determined that no
corrective action should be undertaken as this
would offer another opportunity to advertise to the
general public.
144
Tykerb (867)
(GSK)
Complainant: Roche Products
Product: Tykerb
Complaint:
Roche alleged that GSK had initiated a media
release to the lay media for an unapproved cancer
medication, lapatinib (Tykerb) and had sponsored
a media journalist to attend a breast cancer
conference in the US in 2006.
9.2.1 Product Specific Media Statements
9.2.2 Product Specific Media Statements
9.3 General Media Articles
Response:
GSK responded that the media release was purely
educational and non-promotional and in response
to publication in the New England Journal of
Medicine of a landmark clinical trial involving
Tykerb. Further, GSK stated that the majority of
media articles submitted by Roche and alleged to
be the result of GSK initiation pre-dated the GSK
media release.
Unanimous decision breach of Section 9.2.1

of the Code
Unanimous decision breach of Sections
9.2.2 or 9.3 of the Code
Sanctions:
y Fine of $40,000
The Committee noted the intense intercompany
dialogue between the two companies in relation to
treatments for breast cancer. Members of the
Committee also commented that any emotive
argument in relation to treatment in this field
should not influence the Committees decision as
the complaint must be considered on its merits
against the provisions of the Code.
The Committee noted that several of the media
articles provided in the complaint pre-dated the
GSK media release and had no information before it

that would explain how this information found its
way into the Australia media.
The Committee was of the view that the media
release issued by GSK referred to an unapproved
product was promotional and did not include a
balanced representation of the product because it
omitted any reference to the side effects,
precautions or contraindications for Tykerb.
While noting that television and radio media
regularly include stories on breakthrough medicines
and devices, the Code states that pharmaceutical
companies should not initiate stories on unapproved
products or promote prescription medicines to the
general public.
In relation to the GSK assertion that there is a
difference between the provision of the Code and
the Explanatory Note in Section 9.2, members
noted that the provision states the purpose of a
media release is to provide current, accurate and
balanced information about medicines available in
Australia and the Explanatory Note states this
provision does not restrict companies from
responding to key international developments such
as landmark clinical trials but any response must be
current, accurate and balanced and must not be
promotional.
The Committee supported the position taken at the
21 August 2006 Code of Conduct Committee
meeting where members concluded that the
provisions of the Code take precedence over the
Explanatory Notes where the wording is in potential
conflict.
The Committee commented that the media would
have access to published information on landmark
clinical trials through Reuters and other media wire
services and may contact a company for
information or write an article based solely on an
article published in a scientific journal. Any
response from a company must not embellish upon
the original article or seek to promote a prescription
medicine. Members queried the inclusion of the
1800 number for GSK Medical Information in the
article in the Cootamundra News (14 February
2007) which apparently would have been provided
by the company. Members stated that there is a
clear difference between a pharmaceutical
company and another independent entity initiating a
media release about a new or unapproved
145
Tykerb 867 (contd)

Members were of the view that as GSK had
engaged a public relations consultant to manage a
campaign in relation to the medicine, including the
publication of a media release and sponsoring a
journalist to attend a medical conference where
the results of the trial were discussed, there
appeared to be a concerted effort to get
information about the unapproved medicine out to
the general public. Members were in agreement
that the purpose of a media release is evidently to
initiate stories in the media.
The Committee determined that GSK should:

Not provide any further media releases to the
media in relation to Tykerb until the medicine
was registered in Australia.
The Committee stated that there was no corrective
action should be undertaken as this would offer
another opportunity to advertise to the general
public.
The Committee noted that there was no complaint

under Section 7 of the Code, although the
complainant referred to sponsorship of a lay media
journalist to attend the breast cancer conference in
the US.
breach of Section 9.2.1 of the Code as the media
release initiated by GSK was considered to be
promotion of an unapproved medicine. The
Committee also took into account the Explanatory
note to this Section which requires that any
response provided by a company to an inquiry to
be educational and not promotional. The Code of
Conduct Committee did agree to refer Sections
9.2.1, 9.2.2 and 9.3 to the next Code Review
Panel for consideration of consistency between
the provisions and Explanatory Notes and whether
there is any need for explanation in the Guidelines
or revision in the next edition of the Code in
relation to initiation by companies and what is
meant by other media release.
Members did not find a breach of Section 9.2.2 as
there was no evidence that any other media
release had been distributed by GSK.
the Code as there was no evidence that that GSK
had taken any action to initiate a general media
article other than by issuing the media release
subject to complaint. Members were of the view
that the complainant had not provided evidence
that GSK had done anything other than issue one
media release.
Sanctions
Having found a breach of the Code, the
146
Symbicort Turbuhaler (868)

Subject Company: AstraZeneca
(TGA)
Product: Symbicort Turbuhaler
Complaint:
The complainant alleged that the use of the
acronym SMART (Symbicort Maintenance And
Reliever Therapy) in promotional materials was
misleading and that it was not approved for use in
the Product Information for Symbicort.
The
complainant also alleged that the acronym is a
hanging comparative.
Sections of Edition 15 of the Code:
1.1 Nature and Availability of Claims
Response:
AstraZeneca stated that the SMART acronym
was consistent with the Symbicort Product
Information. The acronym was not misleading as
AstraZeneca had ensured that the literal meaning
of smart was not used in any promotional
material. In addition, in all cases where the
acronym is used in promotional material, its
definition
was
clearly
and
accurately
communicated. AstraZeneca also stated that the
acronym was not a hanging comparative and was
not used in a comparative manner in any
promotional material.
Symbicort Turbuhaler is indicated for the treatment

of asthma where use of a combination (inhaled
corticosteroid and long acting -agonist) is
appropriate. This includes:
Patients who are symptomatic on inhaled
corticosteroid therapy
Patients who are established on regular long
acting -agonist and inhaled corticosteroid
therapy
There are two alternative treatment regimens:
Symbicort maintenance and reliever therapy
Symbicort maintenance therapy
It was noted that the term Symbicort maintenance
and reliever therapy was used in a number of
places in the PI, although the acronym did not
appear. The Committee did not consider that the
acronym was inconsistent with the Product
Information and was therefore not in breach of
Section 1.1 of the Code by a unanimous decision.
The Committee considered that the use of the
acronym in promotional materials was a completely
different issue to whether the TGA had approved its
use within the Product Information.
Members were of the view that the SMART
acronym was not false and misleading as it was not
identifying an indication or dose that was not
included in the Product Information. The acronym
did not convey any meaning that was false or
misleading. By a unanimous decision no breach of
Section 1.3 of the Code was found.
Members of the Committee did not consider the use
of the acronym to be a hanging comparator as
there was no comparison to any other asthma
treatment and it could not be inferred to mean that
only doctors who prescribe Symbicort were smart
in the normal meaning of the word or that it was
smart to prescribe Symbicort in comparison to
other asthma treatments. By a unanimous decision
no breach of Section 1.7 of the Code was found.

Members commented that SMART was not a
forced or contrived acronym as is sometimes
found in catchy clinical study titles; it is simply a
fortunate acronym formed between the product
name and the new use of a single inhaler for both
maintenance and reliever therapy for asthma. It
was noted that the name was originally devised by
an Australian respiratory physician who has no
association with AstraZeneca.
147
GSK Education Event (869)

(GSK)
Product: Seretide
Complaint:
The complainant alleged that the venue for a
GlaxoSmithKline Australia educational event was
not modest and the cost of meals did not conform
to the guidelines which state that meals should not
be extravagant.
Sections of Edition 15 of the Code:
10.1 Relations with Healthcare Professionals Entertainment
10.2 Hospitality
Response:
GSK responded that the educational event was
not in breach of the Code as it was an event of
medical significance and the hospitality was
clearly secondary to the content. GSK also stated
that the venue is often used as a location for
education meetings for healthcare professionals
and that the meals and hospitality provided was
not extravagant and did not exceed acceptable
standards according to the Code.
The Committee was of the view that the quality of
the education was not in doubt and that the focus
of the invitation had been on the educational
component and not the hospitality provided in
association with the education.
The Committee welcomed the transparency with
which GSK had responded to both media
enquiries and the Code of Conduct Committee in
providing full details of the hospitality provided in
association with the educational meeting.
In relation to the alleged breach of Section 10.1
Entertainment members determined that no
entertainment had been provided by GSK either in
an organised or informal manner in association
with the event. In a unanimous decision the

Committee found no breach of Section 10.1 of the
Code.
Members debated the various aspects of Section
10.2 of the Code in relation to the venue for the
event, the cost of the meal and the perception from
a public and professional perspective.
Some members expressed a strong view that
doctors should be treated as professionals and
when attending education events after work hours
be provided with a reasonable meal. While
acknowledging the possible perception from some
members of the public and the media that either no
hospitality be provided or a meal costing less than
$40, and in some peoples view less than $10 per
head, members of the Committee were of the view
that in terms of the Code of Conduct the hospitality
provided in association with GSK education event
was not extravagant and would not differ from that
expected at a professional meeting (Explanatory
Note Section 10.2), particularly where an
international expert was presenting.
Members of the Committee debated the issue of
perception and what is appropriate for a
professional audience. One question posed by
members was What if a well known three hat
restaurant offered meals at $40 per head
compared to an unremarkable hotel where the meal
was $90 per head does this make a difference?
Is the test the perceived prestige of the restaurant
or the cost of the meal? Members of the Committee
were able to raise examples where either
theoretical situation may or may not be in breach.
While the Committee is cognisant that the industry
would like absolute guidance on cost and venue
choice, it is not possible for Medicines Australia to
provide this. A decision regarding a breach of the
Code in relation to hospitality that has many
dimensions beyond the absolute cost of the meal
(for example). There are other factors which include
but are not limited to, the quality of the speaker and
the nature of the meeting. Industry should note that
the current description which is that meals provided
at an educational meeting should not be
extravagant or exceed standards which would meet
professional and community scrutiny.
The venue for this educational event and the
associated dinner was a private dining room within
Silks restaurant which is in the large, multifunctional
Crown Towers complex located adjacent to the
Melbourne CBD. Members noted that the Crown
148
GSK Education Event 869 (contd)

Casino was within this site, although the
restaurant is not inside or adjacent to the Casino.
However some members were concerned that in
selecting a venue associated with, or next to a
casino creates a perception that healthcare
professionals
are
being
provided
with
entertainment and the venue is inappropriate for
an educational event hosted by a pharmaceutical
company. Other members were of the view that
this complex provides purpose designed
conference and meeting facilities which are used
by various organisations throughout the year.
Although the complex offers suitable facilities for
education and business meetings a few members
suggested that it would be more appropriate to
select a venue that was not associated with a
casino in any way. However, the majority of
members commented that in line with the Code
the venue was conducive to education and
learning and was an appropriate venue for this
meeting.
In summary, all members agreed that while some
members of the general public may consider the
Silks restaurant to be a prestigious venue, the
education provided was of an appropriate quality,
the hospitality was not extravagant and the venue
was conducive to learning and education. On this
basis by a unanimous decision no breach of
Section 10.2 of the Code was found.
149
MEDICINES AUSTRALIA
MONITORING COMMITTEE
To support compliance with the Medicines Australia Code of Conduct, the

Medicines Australia Monitoring Committee proactively monitors selected
promotional material and activities of member companies on a regular and
ongoing basis.
Monitoring Committee Members (Edition 15)

MEMBERS MUST BE FULLY
CONVERSANT WITH ALL
PROVISIONS OF THE
CURRENT EDITION OF THE
MEDICINES AUSTRALIA
CODE OF CONDUCT
Permanent Members
Consultant with industry experience in marketing and knowledge of the

Code of Conduct (Chairman)
Royal Australian College of General Practitioners (RACGP)
Australian Medical Association (AMA)

Rotating Members
One representative of the College and/or Society from the therapeutic

class being reviewed
Medicines Australia Medical/Scientific Director (maximum 1)
Medicines Australia Marketing Director (maximum 1)

Advisors
Medicines Australia officer responsible for Scientific and Technical

Affairs
Conflict of Interest
A Committee member must not have a conflict of interest with the
therapeutic area/s or company/ies who are subject to review by the
Monitoring Committee. This also extends to financial interest or perceived
bias with any of the matters being considered at the meeting to which they
have been invited to attend.
In addition to the requirement to disclose a direct or indirect pecuniary
interest in a matter about to be considered in a meeting of the Monitoring
Committee, members should also disclose a conflict of interest if a
reasonable third party would conclude that there was a likelihood that a
member of the Monitoring Committee may be influenced in reaching a
decision, by factors other than the merits of the case.
150
Roles and Responsibilities of the Monitoring Committee

Members
The Committee members must fulfil the following roles and responsibilities:
To be fully conversant with:
All provisions of the current edition of the Medicines Australia Code of

Conduct:
Membership and nominating bodies for the Monitoring Committee

as set out in Section 14 of the Code of Conduct; and
Role of the Monitoring Committee as set out in Section 14 of the

Code.
As a Committee member they must:

Participate in the scheduled Monitoring Committee meetings
Ensure that they understand the procedures for the meeting;
Establish the details of what is subject to review;
Adhere to the processes established by the Chairman of the

Committee to ensure an efficient and effective review process;
Contribute to the discussion in respect of their specific area of

expertise and experience; and
Provide appropriate and sufficiently detailed information for

discussion to enable the minutes to reflect the decisions.
The minutes of the Monitoring Committee will be prepared by the Medicines
Australia Code Secretariat and will be approved by the members of the
Monitoring Committee prior to distribution to the companies. The minutes
may make recommendations and/or seek further information from a
company. The Monitoring Committee cannot find a company in breach of the
Code. However if the Committee has significant concerns about any material
or activity it may lodge a formal complaint may be lodged with the Code of
Conduct Committee for review.
151
REVIEW OF MATERIALS
BY THE MONITORING
COMMITTEE
Overview
During each reporting period the Monitoring Committee will review three
types of promotional material (For example: advertisements, printed
promotional material, brand name reminders) across three different
therapeutic classes (For example: cardiovascular, respiratory and
immunology); and three different promotional activities covered by the Code
across all therapeutic classes.
The review of promotional material will be according to the Therapeutic
Class Index:
Alimentary System
Cardiovascular System
Central Nervous System
Analgesia
Musculoskeletal System
Endocrine and Metabolic Disorders
Genitourinary System
Infections and Infestations
Neoplastic Disorders
Immunology
Respiratory System
Ear, Nose and Oropharynx
Eye
Skin
Contraceptive Agents
The Monitoring Committee may also review materials or activities across all
therapeutic classes in any review.
Member companies are required to submit to the Monitoring Committee
copies of the selected type of promotional material used during the threemonth period under review. For example, the Monitoring Committee may
review journal advertisements in the cardiovascular therapeutic class in one
review, items of printed promotional material in the analgesia therapeutic
class in the second review and brand name reminders across all therapeutic
classes in the next review.
Table 13 provides a summary of materials reviewed between 2002 and 2007
and Table 14 provides a summary of the materials reviewed by the
Monitoring Committee in 2006/2007.
152
Table 13: Summary of the Monitoring Committee Review of Materials 2002- 2007
Therapeutic Area
Year
2002/2003
2003/2004
2004/2005
2005/2006
2006/2007
Company
Websites
Educational
Meetings
Press Releases
Competitions
Educational
Meetings
Market
Research
Prescribing
Software
Educational
Meetings
Websites
Patient
Education
Patient Support
Programs
Educational
Meetings
Brand Name
Reminders
Websites
Alimentary System
Cardiovascular System
Central Nervous System
Analgesia
Muscular Skeletal System
Endocrine and Metabolic Disorders
Genitourinary System
Infections and Infestations
Neoplastic Disorders
Immunology
Respiratory System
Allergic Disorders
Ear, Nose and Oropharynx
Eye
Skin
Contraceptive Agents
Review across all therapeutic
classes*
* The Therapeutic classes are derived from the Therapeutic Class Index used by MIMS Australia
153
Outcomes of the Monitoring Committee Review of Materials

In the 2006/2007 reporting period the Monitoring Committee held 12
meetings and reviewed a total of 2723 items.
The Committee reviewed materials in the Analgesia; Endocrine and
Metabolic Disorders; Contraceptive Agents; and Skin therapeutic classes. In
addition the Committee reviewed invitations to educational meetings, patient
support programs, brand name reminders and websites (which will be
finalised in the 2007/2008 reporting period) across all therapeutic classes.
Table 14: Summary of the materials reviewed by the Monitoring

Committee in 2006/2007
Therapeutic
Class
Type of
materials
subject to
review
Number of
Companies
Number of
Items
Number of
meetings to
complete
review
Infections and
Infestations
Advertisements
14
1*
Analgesics
Advertisements
62
All therapeutic
classes
Invitations to
company
sponsored
educational
meetings
28
2128
All therapeutic
classes
Patient Support
Programs
20
48
Endocrine
and Metabolic
Disorders
Advertisements specifically
insulin
preparations and
hypoglycaemic
agents
80
Contraceptive
Agents
Printed
promotional
material
32
Skin
Advertisements
17
All therapeutic
classes
Brand Name
Reminders
15
239
All therapeutic
classes
Websites
26
103
2723
13
* Reviewed in 2005/2006 and finalised in 2006/2007

One meeting held in 2006/2007 with second meeting in 2007/2008
154
Outcomes of the Monitoring Committee Review of Materials

Patient Support Programs (across all therapeutic classes)
Over two meetings the Monitoring Committee reviewed 48 patient support
programs undertaken by 20 different member companies. Overall members
of the Committee were impressed by the array of quality materials available
to patients. The Committee requested further information in relation to seven
company programs. Following responses from the companies concerned the
Committee did not forward any matters to the Code of Conduct Committee.
The Committee advised that where patient testimonials or patient stories
are used it should be stated whether these are real patients or actors. If
actual patients the company should ensure that consent was obtained for
their names, photos and information to be used.
Members recommended that information going to healthcare professionals
and recipients of the patient support materials should clearly state the length
of time that the program will last.
The Committee also commented that references used in patient materials
should be easily accessible to patients or include a statement to the effect
that they are available from the company and include a telephone number or
email address.
The Committee was of the view that information available to the general
public should always recommend that the patient also Talk to your doctor.
Websites (across all therapeutic classes)

The Monitoring Committee was of the view that a company should not use
the product name as the password for a site restricted to healthcare
professionals as this would probably be the first word a member of the
general public would use to try and gain access to the restricted site.
The Committee noted that a few companies made available a list of doctors
names on a company website. Members were advised that after discussion
at a Code of Conduct Committee meeting which considered a complaint in
which one aspect was the provisions of doctors names on a company
website the Code of Conduct Committee asked Medicines Australia to meet
with the AMA Therapeutics Committee to discuss this issue.
The members of the AMA Therapeutics Committee were of the view that
companies should not include lists of doctors names on their website or a
search tool for doctors or clinics on a company website. Should a third party,
for example a College or Society, have a list of clinics or doctors on their
website and formally agree to the company providing a link from the
company website to the College of Society website this would be acceptable.
Medicines Australia has written to all companies to provide this advice.
The review of websites will be finalised in July 2007.
155
Advertisements for Infections and Infestations, Analgesia, Endocrine

and Metabolic Disorders, and Skin Therapeutic Classes
Over four meetings the Monitoring Committee reviewed 173 advertisements
placed by 17 member companies. The Monitoring Committee requested
further information from nine companies. Following responses from the
companies concerned the Committee did not forward any matters to the
The Committee requested that in future all advertisements should be
submitted in the original size to enable assessment of compliance with letter
size requirements for specific aspects of an advertisement and to ensure
readability by members.
Members were of the view that there should be a consistent system of
referencing within an advertisement which was not always the case.
The Committee discussed whether teaser advertisements should refer to
the Product Information as this links the advertisement to a product which
includes a claim. The Committee was of the view that this matter should be
considered by the Code Review Panel when the Code is next revised.
The Committee was of the view that any advertisement in a reference
manual for a product which has a Boxed Warning should make reference to
the Boxed Warning within the body of the advertisement. For example
Before prescribing, please review Product Information, Boxed Warning and
PBS Information in Section 6(e).
Members also questioned the use of the acronyms in promotional materials
and whether all the terms are regularly used and understood by general
practitioners. Some members were of the view that in the interest of quality
education it would be better if all acronyms were spelt out in full or at least
used in full on the first occasion and subsequently by the acronym.
Educational Meetings (across all therapeutic classes)

The Monitoring Committee reviewed 2128 invitations to educational
meetings from 28 member companies at four Committee meetings. The
Committee commented that the design and the level of information on the
educational component of the meeting had improved since the previous
review and also noted that most companies had a template which medical
representatives must use when providing invitations for educational
meetings to healthcare professionals.
While not a breach of the Code members noted that some invitations to
educational meetings did not include a level of information on the
educational component of the meeting that would allow the reader to be
assured of the duration of the presentations, information on the speakers
and an approximate finish time for the event.
The Monitoring Committee was also of the view that it is good policy to
include the name of the sponsoring company and some form of contact
details on an invitation.
The Committee requested further information in relation to 27 invitations to
educational meetings with 17 requests relating to venue selection, hospitality
or entertainment and 10 invitations where the Committee sought further
156
information on the program or agenda. Following responses from the

companies concerned the Committee did not forward any matters to the
The following cases detail aspects that raised concern in relation to venue
selection, hospitality or entertainment.
Meeting 1
Members commented that the invitation to the meeting A New Approach to
Persistent Non-Cancer Pain at the Pettavel Winery and Restaurant included
good reference to the educational component of the meeting but the
Committee expressed some concern over the choice of a winery as a venue
and sought clarification from the company on this matter.
The company responded that the reason for selecting this venue was its
geographic convenience for the doctors from surrounding towns. The venue
is the only facility within the area that caters to the numbers which had been
invited (30) and that has a private room to ensure members of the general
public would not be exposed to any component of the educational
presentation. The cost was $80 per head and there was no wine tasting
component to the evening.
Having reviewed the response from the company the Monitoring Committee
agreed not to refer this matter to the Code of Conduct Committee.
Meeting 2
Members commented that the invitation to the 3rd Haemostasis Update
weekend was an example of a weekend meeting with quality education over
the two days. Members noted that the invitation referred to wine tasting with
the case presentations and sought clarification from the company on this
matter.
The company responded that the session was entirely clinical and did not
include any formal wine tasting course or lectures nor was there any specific
presentation from the winery. What occurred was that 3 different wines were
available and offered during the clinical case sessions. The arrangement
allowed them to combine a rather intensive clinical case series (7 in total)
with what would normally be classed as pre-dinner drinks and so extended
the educational component of the meeting. The cost was $12 per head.
Meeting 3
Members commented on the invitation to the meeting Understanding
Complicated Cardiovascular Disease at the Palazzo Versace Hotel and
expressed some concern over the choice of venue and sought clarification
from the company on this matter.
The company responded that the event was held on a Thursday evening
and no overnight accommodation for any healthcare professional was
provided. The hospitality was $74.52 for 42 confirmed attendees. The
educational event comprised peer oriented clinical case discussions led by a
cardiologist for 1.5 hours followed by a 30 minute presentation and
discussion of the ACTION Trial.
157
Meeting 4
Members commented on the invitation to the meeting Vytorin Get the Latest
News which was held at Jupiters Casino and expressed some concern over
the choice of venue and sought clarification from the company on this
matter.
The company responded that Jupiters Casino was chosen as a suitable site
for the Vytorin dinner primarily because a RACGP meeting was being held
immediately prior to the Vytorin dinner allowing doctors to attend both events
easily. In addition the availability of secure parking on site and facilities for
electronic presentations in a private room made the venue suitable for
educational events. Jupiters was not chosen for its entertainment purposes,
rather for its superior package deal for venue hire in comparison to other
venues. The company confirmed that no entertainment or accommodation
was provided at the meeting.
Meetings 5 - 12
Members commented on a number of invitations to educational meetings
and expressed some concern over the choice of venues and sought
clarification from the company on these matters and whether wine tasting or
information on available wines was provided to attendees.
Dead reckoning, Demystifying the Forensic Autopsy Sheraton Noosa
Anxiety & Depression in Adolescence, Exploring the Mindset Concord
Golf Club
Anxiety in General Practice: A Problem Focused Approach Palandri
Winery
Real Life Management Strategies for Anxiety Disorders Perugino
Treatment & Management of Peri & Postnatal Depression Bacash
Substance Abuse, Mental Disorders & Violent Offending Pettavel Winery
and Restaurant
Assessment & Management of Anxiety Disorder: A Practical Approach to
General Practice Dealing with Challenging Psychiatric Problems in
General Practice Chesser Cellars
Disorders of Passion: Jealousy & Violence Henry Jones Art Hotel
The company responded that there was no wine tasting or entertainment
provided and at each venue a private function room was used.
Meetings 13 16
Members commented on a number of invitations to educational meetings
and expressed some concern over the choice of venue and sought
clarification from the company on this matter and whether wine tasting or
information on available wines was provided to attendees.
158
Auge (50 attendees)

Assagio (70 attendees)
Magill Estate (80 attendees)
Fremantle Golf Club (50 attendees)
The company responded that there was difficulty in finding a suitable venue
in Western and South Australia to accommodate the number of doctors that
attend their educational programs. The venues were chosen as they were
within appropriate costs, $80-$100 per head, and provided private rooms
away from the public. Wine was supplied with meals in accordance with cost
constraints; however no wine tasting or further information about wines were
available to attendees.
Invitation 17
Members commented on the invitation to the educational meeting ACD
2006 Melbourne and expressed some concern that the invitation made
reference to wine tasting and sought clarification from the company on this
matter.
The company responded that the wine tasting was clearly outlined as being
secondary to the educational event and optional for all attendees. A broad
selection of wines was supplied for attendees who preferred to drink wine
with dinner.
CPD Points
The RACGP representative suggested that Medicines Australia meet with
the College to discuss the level of information required when submitting an
application for CPD points to determine if collaboration on this matter would
be suitable. Medicines Australia has held one meeting with RACGP
approved education providers to discuss this issue. Additional meetings will
be held in the second half of 2007.
Printed Promotional Material (Contraceptive Agents Therapeutic Class)

Over one meeting the Monitoring Committee reviewed 32 items from four
member companies. The Monitoring Committee requested further
information in relation to seven items. Following responses from the
companies concerned the Committee did not refer any matters to the Code
of Conduct Committee.
Brand Name Reminders (across all therapeutic classes)

The Monitoring Committee reviewed 239 brand name reminders at one
meeting. The Monitoring Committee requested further information in relation
to 17 items. Following responses from the companies concerned the
Committee did not refer any matters to the Code of Conduct Committee.
159
The Committee raised the following general issues.

Use of the company name and/or contact details on a Brand Name
Reminder
The Committee debated whether it was permissible to include a company
name and contact details (such as a website address) on a Brand Name
Reminder. Members of the Code Secretariat advised that during discussions
at the Code Review Panel meetings a deliberate decision had been made to
limit what could be included on a Brand Name Reminder. This decision
followed general debate and a Code complaint relating to advertising in
prescribing software which alleged this was advertising to the general public.
Following the review of Edition 14, Edition 15 specifically removed any
reference to therapeutic category or indication.
The Monitoring Committees consensus view was that as the provisions do
not include any reference to the use of a company name and/or contact
details these should not be included. The Committee asked the Code
Secretariat to refer this matter to the Code of Conduct Committee for their
comments and also to the next Code Review Panel.
Inclusion of product strength on a Brand Name Reminder
The Committee also referred this matter to the Code of Conduct Committee
for their comments and also to the next Code Review Panel.
Use of confectionary as a Brand Name Reminder
Some members of the Committee considered that confectionary should not
be placed in packaging which in any way resembles or is similar to the
medicine packaging, such as for use as a Brand Name reminder where the
packaging includes a medicine brand name. If confectionary is used it
should be in clear jars or containers that could not be confused with
medicine packaging and particularly not in packaging of similar colour and
design to the actual medicine.
160
Medicines Australia is located at:

Level 1
16 Napier Close
DEAKIN ACT 2600
Tel 02 6282 6888
Fax 02 6282 6299
www.medicinesaustralia.com.au
Business hours: 8.30am 5.00pm
This report can be downloaded from

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Medicines Australia

1. Medicines Australia Code Committees and Secretariat

2. Promoting Understanding of the Code

4. Analysis of Complaints Data

6. Medicines Australia Monitoring Committee

7. Review of Materials by the Monitoring Committee

Medicines Australia Code of Conduct Annual Report 2006/2007

I am pleased to contribute to the Medicines Australia Code of Conduct

REPORT HAS BEEN

DATA HAS BEEN

The introduction of the Guidelines for Determining Code Sanctions has

Medicines Australia considers that compliance with an industry Code of

Medicines Australia Code of Conduct Annual Report 2006/2007

Medicines Australia is committed to enhancing and promoting the standing

Pharmaceutical companies marketing prescription medicines in Australia

Therapeutic Goods Act 1989

Therapeutic Goods Regulations 1990

Trade Practices Act 1974

Regulations for the Advertising of Therapeutic Goods in Australia

THE CODE SECRETARIAT

In addition it is a condition of marketing approval for prescription medicines

The vast majority of pharmaceutical companies who interact with healthcare

Medicines Australia Code of Conduct Annual Report 2006/2007

The Code of Conduct and Appeals Committees role is to enforce those

The complaints process is open to any company, organisation or individual.

RESULTS OF THE CODE OF

Financial sanctions imposed by the Code of Conduct Committee are paid to

Medicines Australia Code of Conduct Annual Report 2006/2007

During 2006/2007 the Medicines Australia Code of Conduct website was

Medicines Australia Code of Conduct Annual Report 2006/2007

Advertisement means any communication which promotes or discourages

THE DEFINITIONS INCLUDED

Medicines Australia Code of Conduct Annual Report 2006/2007

Product familiarisation program (PFP) means a program run by the company

Medicines Australia Code of Conduct Annual Report 2006/2007

Code of Conduct Committee Members (Edition 15)

THE CHAIRMAN FOR A

Full Members (Voting rights)

Medicines Australia Code of Conduct Annual Report 2006/2007

Code of Conduct Committee Meeting Attendance

THE PANEL OF CHAIRS

The following table indicates the attendance of the external (non-Medicines

Appeals Committee Members (Edition 15)

Secretary, Code of Conduct Committee

Medicines Australia Chief Executive Officer or delegate

Medicines Australia Code of Conduct Annual Report 2006/2007

Roles and Responsibilities of the Code of Conduct and

MEMBERS MUST BE FULLY

To be fully conversant with:

All provisions of the current edition of the Medicines Australia Code of

Membership and nominating bodies for the Code and Appeals

Provisions relating to the administration of the Code as set out in

Provisions relating to the Appeal process as set out in Section 13.

The sanctions that can be imposed by the Committee where a breach

Provisions relating to the imposition of sanctions on companies

The Constitution of Medicines Australia, specifically those which refer to

Establish and maintain an effective working relationship with Medicines

Participate in the scheduled Code and Appeals Committee meetings:

Ensuring that they understand the procedures for the meeting;

Establishing the details of what is subject to complaint;

Ensuring that all the items subject to complaint are addressed;

Providing appropriate and sufficiently detailed information for

Ensuring that matters outside the scope of the Code of Conduct

Ensuring confidentiality is maintained until the complaint is