PHARMACEUTICAL DRUG PROMOTION IN

PAKISTAN: ISSUES IN ETHICAL AND

NON-ETHICAL PRACTICES

Thesis

By
RIZWAN RAHEEM AHMED

In Partial Fulfillment of the Requirements for the Degree

of Doctor of Philosophy (Ph. D.) in Social Sciences

Under the Supervision of

DR. AHMAD SAEED

Presented to

Hamdard Institute of Education and Social Sciences (HIESS)

HAMDARD UNIVERSITY KARACHI, PAKISTAN

July 2012
 CERTIFICATE OF APPROVAL

This is to certify that RIZWAN RAHEEM AHMED has completed his research thesis

entitled “Pharmaceutical Drug Promotion in Pakistan: Issues in Ethical and Non-

Ethical Practices” in partial fulfillment of the requirements for the degree of Ph. D.

(Social Sciences), under my supervision and is found to meet the prescribed standard of

the Hamdard Institute of Education and Social Sciences (HIESS), Hamdard University

Karachi.

Signature

DR. AHMAD SAEED

(Research Supervisor)

Dated:

Karachi

1
PHARMACEUTICAL DRUG PROMOTION IN PAKISTAN: ISSUES
IN ETHICAL AND NON-ETHICAL PRACTICES

ABSTRACT

Common People and government authorities are usually concerned about the unethical
pharmaceutical marketing practices in Pakistan, therefore; the researcher examines the
unethical pharmaceutical marketing practices in Pakistan, and selected Karachi City as
Case study for this purpose and analyze the impact of unethical marketing practices in
pharmaceutical industry.

This study not only evaluates the responsible variables for the unethical pharmaceutical
marketing practices but also compare who is more responsible for these unethical
pharmaceutical marketing practices in Pakistan. This study also examines, who has
initiated these unethical pharmaceutical marketing practices in Pakistan and who is
responsible for the continuation of these practices in Pakistan.

In this study researcher focuses six variables that can be a major cause of unethical
pharmaceutical marketing practices in Pakistan i.e. Pharmaceutical marketing and Sales
personnel, doctors’ community, retail and whole sales pharmacies, government and
private hospitals personnel, government officials and patients or their attendants’. All
these six variables have been taken and gathered the data through survey questionnaire,
compile and analyze through Statistical tools like descriptive and inferential Statistics
both and conclude the main cause of unethical pharmaceutical marketing practices in
Pakistan.

In the under taken study four different hypotheses were developed and tested through Z
and F test and also analyze the data through descriptive Statistics, for the descriptive
Statistics four different parameters were developed and presented in the form of graphs
and tables. The conclusion of the study was that initially pharmaceutical industry was

2
responsible to introduce the unethical marketing practices to their customers i.e. doctors
community, and hospitals and later on unethical pharmaceutical marketing practices
became the norm of the pharmaceutical industry. Now the doctors are the main cause or
reason for the continuation of these unethical pharmaceutical marketing practices in
Pakistan.

It is further concluded in the study that foreign visits are more common tools in order to
get maximum output from the doctor community and now doctors have become more
demanding and they ask themselves regarding the foreign and local tours and
conferences. Cash incentive and home appliances are another form of unethical practices
in the pharmaceutical industry. Clinic and home decoration are also the findings of
unethical pharmaceutical marketing practices in the under taken study. However, it is also
found that some demands from the doctors’ community or the offers by the
pharmaceutical companies are quite ethical genuine regarding the scientific meeting and
local & international scientific conferences.

It is further concluded that all the stakeholders are agreed that these unethical
pharmaceutical marketing practices can be stopped. They are also agreed non-qualified
doctor’s practice should be eradicated. Pharmaceutical companies should strictly abide
the rules and regulations, which are already mentioned and given in the pharmaceutical
marketing code of ethics, at the same time Pakistan Medical Association and Pakistan
Medical and Dental Association should restrict to the doctors community to practice in
the limit of ethical and moral grounds. Governmental agencies are also responsible to
enforce the prevailing laws with their true spirit on pharmaceutical companies. If any
further legislation is required in order to stop these unethical pharmaceutical marketing
practices then further legislation should be taken place and strict laws should be made
and implemented.

3
 ACKNOWLEDGEMENT

My deepest gratitude and profound admiration are due firstly to my supervisor Dr.

Ahmad Saeed for his help and cooperation in the smooth completion of my Ph. D.

studies at Hamdard University.

My special thanks go to Prof. Dr. Syed Abdul Aziz, Director, Hamdard Institute of

Education and Social Sciences, Hamdard University Karachi for his encouragement and

continuous support during the research and course work.

I am also thankful to my friends, colleagues and well wishers, who constantly pray for

my success. Special thanks to Mr. Abid & Mr. Sajid who supported me whenever they are

asked for any support and help during my research work.

I would like to express my special thanks to all those who participated in this study and

whom I could not mention the names in the list of gratitude.

In last but not lease I appreciate the encouragement and countless help of my wife during

my studies and my parents who always supported me during every step of my career.

RIZWAN RAHEEM AHMED

4
 TABLE OF CONTENTS
Certificate of Approval … … … … … … … i
Abstract … … … … … … … … … ii
Acknowledgement … … … … … … … … iv
Table of Contents … … … … … … … … v

Chapter I: INTRODUCTION 01
1.1 Background of the Study … … … … … 01
1.2 An Overview of Pakistani Industry … … 04
Pharmaceutical
1.3 Statement of the Problem … … … … 10
…
1.4 Research Hypotheses … … … … … 10
…
1.5 Purpose of the Study … … … … … 11
…
1.5.1 General Purpose … … … … … 11
…
1.5.2 Specific Purpose … … … … … 12
…
1.6 Scope of the Study … … … … … 12
…
1.7 Justification … … … … … … 13
…
1.8 Definition of Key Words & … … … 14
Phrases…
Chapter II: REVIEW OF THE LITERATURE 17
Chapter III: RESEARCH METHODOLOGY 46
3.1 Data, Sample and Methodology … … … 46
…
3.2 Total … … … … … … 46
Population
3.3 Targeted … … … … … … 47
Population
3.4 Sample Size … … … … … … 48
…
3.5 Pharmaceutical Sales & Marketing … … 49
Personnel
3.5.1 Multinational/National Pharmaceutical … … 49
Personnel
3.6 Doctors Community … … … … … …
3.6.1 General Practitioners (Both Rural & Urban) … … 49
…
3.6.2 MOs & RMOs of Public & Private … … 49
Hospitals…
3.6.3 Consultants of All Specialties… … … … 49
…
3.7 Hospitals … … … … … … … 50
3.7.1 Public … … … … … … 50
Hospitals
3.7.2 Private … … … … … … 50 5
Hospitals
3.8 Pharmacies … … … … … … 50
…
Chapter IV: DATA ANALYSIS 52
4.1 Survey Findings …. … … … … … 52
4.1.1 Gender … … … … … … … 52
4.1.2 Age … … … … … … … … 53
4.1.3 Experience … … … … … … … 54
4.1.4 Education … … … … … … … 55
4.1.5 Respondents … … … … … … … 56
4.1.6 Pharmaceutical … … … … … 57
Personnel…
4.1.7 Consultants … … … … … … 58
…
4.1.8 General Practitioners … … … … … 59
…
4.1.9 RMO / MO … … … … … … 60
…
4.1.10 Government & Private Hospitals Officials… … … … 61
4.1.11 Retail Pharmacies … … … … … … 62
4.1.12 Whole Sales Pharmacies … … … … … 64
4.1.13 Outdoor Patients … … … … … 65

…
4.1.14 Indoor Patients … … … … … 66

…
4.1.15 Government Officials (Federal & Provincial)… … … 68
4.2 Hypotheses Testing … … … … … 69
…
4.2.1 Hypothesis No. 1 … … … … … 69
…
4.2.2 Hypothesis No. 2 … … … … … 71
…
4.2.3 Hypothesis No. 3 … … … … … 73
…
4.2.4 Hypothesis No. 4 … … … … … 75
…
4.3 Qualitative Analysis … … … … … 77
…
4.3.1 Tools of Unethical Drug Practices… … … … 78
…
4.3.2 Drug Promotion to Non-qualified Doctors … … 79
Appendix – III: … of Ethics for Pharmaceutical Marketing
Code … 113
4.3.3
Appendix – Legislation for Unethical Drug Promotion … …
The New Pharma Code on Interactions with Healthcare 80
IV: …
Professionals … … … … … … 154
4.3.4 Eradication of Unethical Drug Promotion … … 81
…

Chapter V: SUMMARY, CONCLUSIONS AND RECOMMENDATIONS 82

5.1 Summary & … … … … … 82
Conclusions
5.2 Recommendations … … … … … 92
…
5.3 Suggested Areas of Further Research … … … 95
6
REFERENCES … … … … … … … … 96
 CHAPTER ONE

INTRODUCTION

1.1 BACKGROUND OF THE STUDY

Unethical marketing practices have become an essential part of the pharmaceutical

industry in Pakistan and roots are so strong that it may not be possible to reverse the same

(Parmar & Jalees, 2004). However the previous study has a limitation. It was a case study

on pharmaceutically industry in Hyderabad. In view of the findings of that study there

was a need to carry out the same on larger basis. Thus this research has been undertaken

with this objective in mind.

The phenomenon of the unethical drug practices is common worldwide but its severity is

deep rooted in developing countries. Unethical drug practices have two dimensions. One

is drug related, and other is drug promotion related. Extensive research on drug related

unethical practices has been carried out internationally. However, the author was not able

to find any empirical study on unethical drug promotion practices except the one that was

carried out by (Parmar, Jalees, 2004) in Pakistan. Parmar and Jalees (2004) in their study

observed that pharmaceutical industry spends a substantial portion of its budget on

market research but do not carry out the research on unethical drug promotion practices.

One of the reasons is that the industry itself is indulged in this practice therefore it does

not find any need to carry out the research on this issue.

1
Lack of research on the subject does not mean that unethical drug promotion practices do

not exist. The pre-survey and focus groups discussions indicate that unethical

pharmaceutical marketing practices have become an acceptable norm of the

pharmaceutical diligence, and it is also well supported by more or less all the

pharmaceutical groups with the cooperation of government hospitals, private hospitals,

doctors and health allied organizations including pharmacies on patients’ interests. All the

entities as discussed above appear to be corrupted; therefore, it may not be fair to blame

any one of them, including pharmaceutical industry.

Doctors and other entities as discussed above have become greedy; therefore, these are

vulnerable to Pharmaceutical industry for unethical drug promotion practices. The

Pharmaceutical companies fund nearly all symposiums and educational actions of

doctors; therefore, the industry uses the forum to pursue its goals, which at times may not

be the same as the purpose and objective of the conferences. Pakistan Medical Journalists

Association (PMJA) has published a few articles on this issue. But this has not affected

the prevailing unethical drug promotion practices (Zaidi et.al, 1995).

The focus of the subject study was to identify the intensity and trends of unethical drug

promotion practices in Pakistan. Ascertaining the contribution of the doctors, health

related institutions and the pharmaceutical industry in promoting such practices.

Unethical marketing practices have now an integral part of drug promotion. Unethical

practices could be classified into two segments. One is related to the medical side of the

drug i.e. the trial of the drug both on animals and the human, and registration of

indications and patent period in different countries.

2
According to the prominent scholar and eminent physician of the country, Dr Sania

Nishtar (2007), the unreliable news of bribery and dishonesty in this pharmaceutical circle

have to be given watchful investigation. Health system of Pakistan must have an effect

with these corruption practices. These practices can entail together supervisory body and

private sector. The process of registration, authorization and pricing criteria, procurement

and sales & marketing of drugs are all involve with these types of practices. These all bad

practices has their roots for the commercial safety of the pharmaceutical companies, who

pay heavy cost and struggle to avoid dealings for the enlistment of their products,

accelerate the endorsement procedure, and catch flattering prices of their products.

The astringent method for procuring medicines proffer money-spinning resource for most

of the bureaucrats and thus suppliers intend to pay bribes, and paying them through

excess in billing and invoicing. In Pakistan, we can find the similar behaviors in almost

every public hospital through unreliable data.

Consequently, healthcare prerequisite rely on a system, which proficiently joins fiscal

and individual assets to deliver system of check and balance, good management and

effective services. Conversely, in our country bad management and dishonesty in health

system are symptoms of a wider system trend. These issues need be address and entails

consent and right both inside and outside of the health sector system (Nishtar, 2007).

3
2. AN OVERVIEW OF PAKISTANI PHARMACEUTICAL INDUSTRY

There are about 650 leading Nationals and Multinational pharmaceutical companies

operating in Pakistan. Of this total 23 are multinationals and rests of companies are local

companies. The companies here could be categorized in three groups:

1. Manufacturing plant

2. Importers (bring finished medicines from abroad)

3. Franchisers

Franchisers are those companies that have all the marketing setup and facilities. These

companies obtain the rights of marketing of the drugs of other companies on profit

sharing basis. Total current market volume (March 2010) is of Rs.137.7 billion. (IMS, Q3,

2010)

GRAPH – 1
Pakistan Pharmaceutical Market (PKR in Billion)

Source: IMS – PKPI Q2 2010 (MAT)

4
In the year 2009 the industry realized a high degree of fluctuation in the growth rate. One

of the major reasons for such a trend was merger and acquisition, and glutting the market

by local pharmaceutical industry. However on an average the growth rate in the year

2009-10 was about 15.4% per annum. Comparatively the growth rate in the year 2008-09

was about 12% (IMS, Q2 & Q3, 2010).

A tough competition exists between the multinationals and nationals, day-by-day

nationals are taking up the share and in the last six years they have taken around 7%

share in value. The gap between multinationals and nationals narrows further during

2009-10 with multinationals losing another 1.7% share to nationals. At present

multinationals hold 46.9% share of the market while the nationals have captured 53.1%

of the pharmaceutical business. From around 80% share in the pharmaceutical retail

market, the MNCs have lost around 29% during the last twenty years as the nationals

continue to improve their performance in the market place. Almost an identical trend is

observed in units as well, nationals having 54.05% as compared to multinationals 45.95%

(IMS, Q1 & Q2, 2010).

GRAPH – 2
Top 10 Pharmaceutical Companies (PKR in Millions)

Source: IMS – PKPI Q2 2010 (MAT)

5
The overall market dynamics are tilted in favour of national companies as they are

continuously launching new products at a much faster rate than MNCs, a trend that is

becoming increasingly evident. In terms of new product market in value, the sales

contribution gap between multinational and national companies has also increased over

the last five years. The products launched before 1991 are dominated by the

multinationals while after 1991 it is shifting towards the nationals. However, the leading

20 products of the industry are still those products, which are launched by the MNCs

between 1970 and 1990 (IMS, Q2 & Q3, 2010).

Of the total markets size of 137.7 billion, the top 20 corporations contribute around 60%

of total business, 34% of market concentrated among the top 5 corporations. The rest

40% of the market is distributed amongst 630 corporations in Pakistan. For the purpose

of calculation in terms of value, the top 15 corporations make up 54%, top 35

corporations make up 75.09%, and top 75 corporations make up 90.91%, while the

remaining corporations are competing for approximately 9% market share (IMS, Q1 &

Q2, 2010).

The drugs prices of the national pharmaceutical companies are cheaper, as they have

choice of procuring the raw material from those countries where it is available at a

cheaper rate. The other reason for the price differential is that the national pharmaceutical

industry does not invest in research and development compare to multinationals.

Multinational companies invest a huge amount of their net profit in R & D, therefore,

when they introduce a new molecule into the market they have already invested billions

6
of dollars for a new product, therefore, the price of the new product keeps high in order to

meet the total cost of the drug in a certain time period because after patent period any

company can make its Me too or imitation at cheaper rate. So, the national companies

have twice leverage to set their prices at the lower level i.e. first they did not invest a

single penny on Research & Development and secondly they are having cheaper raw

material resources (Ahmed & Jalees, 2008).

Another, important point in price difference is that national companies are not bound to

pay certain amount of profit to any other body, whereas, multinational companies are

paying certain percentage of profit to their parent companies. Moreover, national

companies do not have huge overhead expenses; in contrast, multinational companies

allocate huge overhead expenses in different fields at the beginning of every fiscal year

for every product in a certain ratio, therefore, the cost of goods (COG) are different in

national and multinational companies. In order to maintain all these costs they are bound

to set a high price, otherwise bottom line will be very low and business would not be

feasible any more.

The connection among pharmaceutical companies, doctors and health officials is also

very significant. Commissions may be the reason behind weakness of this sector, to

prevent from corruption strict rules and regulations are needed. Heavily regulation is

indispensable toward safety and protection of peoples in opposition to inferior and

unjustly price of medicines. Another reason for such regulations is to guarantee that

industrial strategies fortify the effective economic development and improvement in the

7
pharmaceutical sector. These two intentions at times decline each other’s. If regulators

are coercing by pharmaceutical companies, healthiness can be compromised. Charitable

campaign and contributions both politically and socially by pharmaceutical companies

are instances of these demands offered to doctors for stipulating fastidious medicines and

specific brand. These behaviors are very un-ethical as well as illegal in many countries.

Most of the companies may make use of underhand procedure to masquerade such bribe

(American College of Physicians, 1990, 1995-2002).

In recent years, the problem of illegal and unethical pharmaceutical practices for

marketing of medicines has acknowledged an enormous covenant of awareness,

indicating from different pharmaceuticals and doctors association who already keep

noticing of this problem. Some of them have conceded set of codes and ethical course of

action for selling of pharmaceuticals (Ahmed & Jalees, 2008).

There is another kind of practices that reflect corruption happens during clinical trials.

Many pharmaceutical companies are paid to doctors to take patients for clinical trials.

Many universities have research assessment committees who are engaging in exposure of

strategies and actions concerning divergence of interest (Avorn & Hartley, 1982).

Furthermore, there is discussion on whether confession is adequate: must researchers

permissible to carry out studies and research for organization wherein they contain

finances?

8
Pakistani pharmaceutical industry also growing at rapid pace over last many years and

reached to Rs. 137.7 Billion in 2010 (IMS Q2 2010) in this growth major chunk came

from generic drugs manufacturer or generic drugs in Pakistan.

GRAPH – 3
Generic (Copy) Drugs (% Share of Total Market)

Source: IMS – PKPI Q2 2010 (MAT)

Above graph shows that market share of generic drugs in Pakistan in continuously

increases over the years reach to 53.1% market share and likely to cross 55% market by

the end of this year. This can also validated by the number of generic drugs making

company in top ten pharmaceutical in Pakistan Getz Pharma, Hilton Pharma, Sami

Pharma & Searle are top four generic drugs making companies listed in top 10

pharmaceutical companies in Pakistan.

9
 GRAPH – 4
Research (Branded) Drugs (% Share of Total Market)

Source: IMS – PKPI Q2 2010 (MAT)

While looking at the research drugs, market share in Pakistan continuously decreasing

compare to the local/ generic drugs making companies in Pakistan more than 53% market

share in year 2010 (IMS Q2 2010).

3. STATEMENT OF THE PROBLEM

Is unethical drug promotion practice is common in Pakistan? Who initiated unethical

drug promotion practice in Pakistan? Who is responsible for the continuation of the

same?

4. RESEARCH HYPOTHESES

Based on the theoretical framework, focus group and problem statement the following

hypotheses statements have been developed:

10
 The level of unethical drug promotion practices in pharmaceutical industry
H1o:

is high (at least 4) on the scale of (5 to 1)

The level of unethical drug promotion practices in pharmaceutical

H1A:

industry is less than 4 on the scale of (5 to 1)

The levels of unethical drug promotion practices are high in rural areas.
H20:

The levels of unethical drug promotion practices are not high in rural
H2A:

areas.

There is no significant difference on the opinions of doctor, pharmaceutics

H30:

companies, hospitals and pharmacies on who initiated unethical drug

promotion practices in Pakistan.

There is significant difference on the opinions of doctor, pharmaceutics

H3A:

companies, hospitals and pharmacies on who initiated unethical drug

promotion practices in Pakistan.

The contribution of the pharmaceutical industry in continuation of

H40:

unethical drug promotion practices is higher than the doctors.

The contribution of the pharmaceutical industry in continuation of

H4A:

unethical drug promotion practices is not higher than the doctors.

5. PURPOSE OF THE STUDY

1. General Purpose

The overall purpose of the study is to analyze the unethical pharmaceutical drug

promotion practices in Pakistan and its impact on common people of the Country.

11
2. Special Purpose

Most specifically the study will address the following questions:

1. Is there any relationship between unethical pharmaceutical drug promotion

practices & under taken stakeholders i.e. pharmaceutical companies, doctors,

hospitals and pharmacies etc?

2. Who is the most responsible for these unethical pharmaceutical drug promotions

in Pakistan?

3. How common people are affected by these unethical pharmaceutical drug

promotion practices in the Country?

4. Is there any further legislation is required by the government in order to stop these

unethical practices?

5. How different stakeholders can play their role in order to stop these unethical

practices?

1.6 SCOPE OF THE STUDY

The scope of the study will be limited to all the concerned bodies of the government,

pharmaceutical companies, doctor’s community, hospitals, pharmacies and the common

people of the Country, which provides the knowledge about the unethical drug promotion

practices in Pakistan. Moreover, it will also provide the basis to the government to take

some suitable measures to stop these unethical pharmaceutical drug promotion practices

from Pakistan and to provide ease to the common people of the Country in order to get

better health facilities at nominal cost.

12
7. JUSTIFICATION

The study is justified on the following grounds:

1. The results of the study can be used by the government and some suitable

measures and actions can be taken to improve the legislation in order to stop

unethical pharmaceutical drug promotion practices in Pakistan on the basis of the

results of the under taken study.

2. The medical facilities can be provide at nominal cost by improving the

atmosphere of unethical pharmaceutical drug promotion practices for the common

people by taking corrective measures against the responsible stakeholders of the

study.

3. To provide the knowledge of actual situation of unethical pharmaceutical drug

promotion practices to all the concerned bodies who are directly or indirectly

involved in these practices and to realize them that they should fulfill their social

responsibilities in order to improve the situation.

4. To give the awareness to the common people of the Country that in the light of

study they should play their role in order to rectify the situation.

5. The pharmaceutical ethical committees on local & multinational pharmaceutical

companies should implement the new or existing code of conduct with its true

spirit after reviewing the results of this study.

6. The concerned bodies’ of government sector should make further effective

legislation and to enforce the rules and regulations in order to stop these unethical

pharmaceutical drug promotion practices in Pakistan.

13
 7. In the light of result of this study, the Pakistan Medical & Dental Committee

(PMDC) and Pakistan Medical Association (PMA) should make some effective

code of conduct for the doctors’ community in order to stop these unethical

pharmaceutical drug promotion practices in Pakistan.

8. DEFINITION OF KEY WORDS & PHRASES

 Unethical Promotion

The promotion of pharmaceutical drugs by avoiding the set of rules & regulations,

which are given by the ethical, bodies Worldwide & the local bodies & government.

 Pharmaceutical Drugs

The medicines are being produced and sold by the pharmaceutical companies for

human beings.

 Unethical Practices

The unusual and absurd ways of marketing & selling tactics to sell the pharmaceutical

drugs.

 MNCs & Local Companies

The Multinational pharmaceutical companies, which operate more than one Country,

whereas, the companies, which are only operating in Pakistan.

14
 Whole Sales & Retail Pharmacies

The medicines shops, which procure the pharmaceutical drugs in bulk quantity from

distributors and fulfill the requirement of retail pharmacies, whereas, retail

pharmacies are those pharmacies where the consumers purchase pharmaceutical drugs

directly.

 Government Officials

The government servants who are employed in those Provincial or Federal

governments deportments, which are directly relevant to the pharmaceutical drugs,

pharmaceutical companies & the pharmacies.

 Public & Private Hospitals

The public hospitals are owned and run by the federal, Provincial or district

governments, whereas, the private hospitals are owned and run by the individual or

group of people.

 Indoor & Outdoor Patients

Those patients’ who are admitted in hospitals due to their illnesses are called the

indoor patients, whereas, the walk in patients or just come to the doctor and get the

prescription and go to home or called outdoor patients.

15
 Patients & Attendants’

The person who has suffered in any illness is known as patient, whereas, those

patients who admitted in hospital and they have been taken care by their relatives’ or

friends during the treatment are called their attendants’.

 Consultants, Medical Officers & General Practitioners

The doctors who has done post graduation after their medical graduation are known

as Consultants, whereas, those doctors who has started their career as doctor after

their medical graduation in any private or government hospital, are called Medical

Officers or Resident medical doctors and finally those medical graduates who does

open their own clinics in different areas are known as General Practitioners.

16
 CHAPTER TWO

REVIEW OF THE LITERATURE

The pre-survey and focus groups discussions indicate that unethical pharmaceutical

marketing practices have become an acceptable norm of the pharmaceutical diligence,

and it is also well supported by more or less all the pharmaceutical groups with the

cooperation of government hospitals, private hospitals, doctors and health allied

organizations including pharmacies on patients’ interests.

A report on practices for pharmaceutical companies has published by Lexchin J. (1995)

in Consumer International (CI). CI scrutinized that 20 main worldwide medicines

companies of the world have developed their own codes of ethics conducts, which are

highly biased in their favor.

Pharmaceutical companies exercise immoral and dishonorable marketing devices to

persuade doctors to recommend their medicines and also delicately to convince customers

to use them. The findings are based on the marketing practice of world top most 20

pharmaceutical companies. The report contends, “Pharmaceutical companies are

advancing their medicines through patients set, student and internet chat places to avoid

the interdict on promoting excluding doctors” (Lexchin, 1995).

17
The authors of the report have also the opinions that the subject companies create

imprecise declares regarding protection and effectiveness of their medicines. Moreover,

the companies also offer enticements to stipulate and uphold medicines including bribes,

donations, expensive promotional gift items, free drug samples and conferring contracts.

The authors pointed out that several organizations encompass concerned in non-

aggressive policies (Lexchin, 1992, 1995).

In September 2009, Pfizer was fined US$2.9 billion dollars for deceitful marketing

practices. This was done because the company was promoting medicines for unapproved

uses or “off-label uses”. Pfizer deliberately encouraged doctors to prescribe four

medicines to treat symptoms the drugs were not approved by the FDA to treat. The

settlement also settles allegations that Pfizer induced doctors to promote these "off-label"

uses by paying for their meals and subsidizing their travel. This is the third settlement

that Pfizer has signed a “corporate integrity” agreement (Gibbons et al., 1998).

This is just an example of the deceitful and underhanded marketing practices that has

occurred. This wrongdoing was done due to the fact that it takes approximately US$1

billion to develop and test a new drug. In recovering their spending, the companies want

healthcare professionals to subscribe their drugs as widely as possible (Gibbons et al.,

1998).

Another example is that of Johnson & Johnson unlawfully and successfully promoted

Propulid off-label for kids regardless of inner objection complaining safety issues. The

18
side effects of this drug include serious cardiac arrhythmias including ventricular

tachycardia; ventricular fibrillations have been reported in patients taking Propulid

(generic name: Cisapride). This product is no longer available in the United States

(Sibbald H., 2004).

Other companies have gotten in trouble over off-sales promotion and withholding of

critical information. In 2004, the medicine title Vioxx manufactures by the Merck & Co.

pharmaceutical company was inhibited from the market. Merck willingly removed the

medicine by reason of serious unease on cardiovascular side effects. Allegedly the

company knew that the drug may perhaps raise the probability of heart attacks in cardiac

patients from 2000 and has been charges of engineering research outcomes to minimize

the threat. In the United States, above 6,000 court cases have been filed by public who

suffer from this medicine (Boseley, S., 2006).

Again in 2004, GlaxoSmithKline (GSK) was faced a court case for preservation off-

putting data on their medicine Paxil (Paroxetine). GlaxoSmithKline decided to an

arrangement to make public regarding results of all clinical trial reviews on its website

(Sibbald H., 2004).

The case happened following a secret GSK memorandum disclosed to press

acknowledged a clinical trial in 1998 so as to wrap up paroxetine had refusal outcome in

the handling of young people. AstraZeneca faced a class action lawsuit alleging that it

was misleading in its promotion of its top-selling ulcer treatment Nexium. The lawsuit

19
was brought on behalf of trade union healthcare providers in New York who paid for the

drug on behalf of their members. It demanded the return of profits made on Nexium,

which had sales of US$3.3bn. It claimed that Nexium is an end to useful than Prilosec,

AstraZeneca's older ulcer drug, which is considerably low price as it is no more secluded

from opposition by copyrighter (Tomlinson H., 2004).

Gifts that are given by the pharmaceutical industry to healthcare professionals are

controversial. Approximately, US$11billion is spent on promotion and marketing each

year towards doctors (Gibbons et al., 1998).

A case was inspected against GlaxoSmithKline (GSK) from Italian and German official

for supposed corruption of distributing illegal gifts to doctors and other officials, and

approximate €228m from 1999 to 2002. After that, GSK has formed marketing ethical

codes for his employees, which are compulsory to all new employees to clear an

evaluation test. In 2001, a report was public and pointed out 87 employees was

terminated or voluntarily departed after violation of these codes (Boseley, S., 2006).

Charges were implicated in opposition to AstraZeneca for unsuitable use of gifts and

promotions. In a promotional campaign they invited doctors to attend this

seminar/conference free of cost, and they bear their hotel, flights and other charges

(Boseley, S., 2006).

20
Studies were carried out to uncover the impact of relation between physician and medical

representatives of pharmaceutical industry. Doctors meeting with pharmaceutical

representatives linked with requirements by doctors to put in medicines to the hospital

formulary and there was a change in prescribing practice of the doctor (Tomlinson H.,

2004).

Overall, residents and physicians have the same attitude towards pharmaceuticals

representatives. Physicians believed that they offer precise data regarding the medicines

that they promote. They also believe that pharmaceuticals representatives may perhaps

offer precise data on recognized or substitute medicines. On the other hand, the majority

considers that representative’s precedence the promotion of product over the wellbeing of

the patient and use unethical practices to do this (Tomlinson H., 2004).

In the United States, once a medical student comes into school, the pursuance of

pharmaceutical companies is significant. Free promotional gift items, medical manuals,

journal subscription payments, lunches, and gifts are provided to the medical student.

These all are become a component of daily medical practice. The sales representatives

from pharmaceutical companies are good-looking, likeable and imminent. From an early

stage in the doctors’ career, the pharmaceutical companies have an influence on the

medical student (Sibbald H., 2004).

Another study (Zaidi et al., 1995) explores the connection involving in physicians and the

pharmaceutical industry. The author while criticizing the pharmaceutical industry

21
observed that the industry is responsible for corrupting the medical profession. The report

further indicated that this habit is very widespread in the urbanized countries as well as

developing countries.

The author further alleged that the anticipation and requisite of physicians/doctors has

increased manifold. The attitude of doctors has changed, and some of the commonly

demanded requests are presented below:

 The doctors frequently ask for free travel and hotel accommodation.

 The doctors demands donations for various issues and threaten to not entertain

Medical Representatives, if they fail to provide the same.

 Group of doctors have formed companies. The doctors do not manufacture the

medicine in this company, but they have obtained the marketing rights from the

other companies. Subsequently these doctors heavily prescribe their products.

 The liaison between doctors and chemists has increased tremendously. In this

kind of relationship the doctors prescribe those medicine that carry heavy

discounts, which are then shared by the doctor and chemist as per pre agreed

arrangement.

 It is a common practice of doctors asking cash for each recommendation of

medicines.

 Demand for renewal of hospitals and clinics.

Zaidi, et al., (1995) observed that in the 13th national psychiatric conference held at

Abbottabad in September, nine papers were read by different doctors; however, most of

22
the papers were not on the subject issue but were mainly focused on their experience of

administrating specific drugs to the patients. Incidentally, some of the foreign guests

thought that the conference was not on psychiatric issue but it was more on the specific

drug promotion activity. Two inferences could be drawn from this incidence. One, the

doctors are so much involved in the unethical drug practices that they did not realized

what was the objective of the conference. Second is that the doctors did not spend

considerable time for developing the appropriate paper for the conference.

Zaidi, et al., (1995) in the same report pointed out about an incidence of the 17th

International Gastroenterology conference held at Rawalpindi. In this conference about a

dozen of local doctors’ presentations were on a particular drug that belonged to the

pharmaceutical company that was sponsoring the event. The foreign delegates became so

frustrated with the proceeding that they left the conference by stating that their purpose of

the visit was to gain insight and share their views on the issue “gastroenterology”.

However, the conference appears to be one directional with objective of promoting the

drugs of the sponsoring company.

Zaidi et al. (1995) also pointed out that unethical drug practices was originally initiated

by multinationals as they were in the position to afford this unethical practices due to

huge resources at their possession. Subsequently, the local national companies also

followed the suit, and now it has become the norm of the industry.

23
In Nepal, a study conceded Giri, BR., Shankar, PR., (2005) also observed that doctors

recommend such drugs that are keenly promoted by representative. The authors observed

that the pharmaceutical companies use conferences and seminars for entertaining doctors,

unethical demand of traveling, and lodging etc.

According to Fisher et al., 1993, “It is immoral for research journals that issue

information on psycho-Pharmacology to recognize medicine company money for

everything. Similarly, it is unethical that the American Psychiatric Association permits

Medicines Company financially supported symposia as part of its yearly meetings”

(Fisher, Bryant & Kent, 1993).

According to the WHO Ethical Criteria for Medicinal Promotion, the nastiest

immoderation of deceptive and unprincipled promotion of drug keep on in developing

countries, where parameters for pharmaceutical industry are very weak (American

College of Physicians, 1990).

Promotion can be defined as “the information whose intention is to promote or market a

product and for itself it has an inbuilt unfairness in favor of the product in the finest

doable way. Worldwide, an enormous disparity in the funds obtainable for promotional

against existence of self-governing information (Lexchin, 1995).

Another study of Lexchin pointed out that the Companies which prop up tranquilizers

and antidepressant medicines through similes of women are nonentity to flout the agreed

product tagging, but they probably to give a well-acknowledged setback of unsuitable

stipulation of psychotropic medicines to women (Lexchin, 1992).

24
The Lexchin further concluded in the study that most of the countries rely a lot on

overseas multinational pharmaceutical companies, through exports and local production.

Promotional actions must focus to parameters according to the company’s origin country.

“Promotional materials and labeling should be required to be acceptable in both

countries, i.e. to adhere to the higher of the two standards. This would put more of an

onus on governments in industrialized countries to prevent messages with negative health

consequences from being provided overseas by multinational companies with head offices

in their country” (Lexchin, 1992).

Arun Phatak studies concluded that pharmaceutical industry is already profit taking and

intends at giving utmost profit to share owners. The pharmaceutical industry is not

worried about their consumers, or else the market would not be swamped by illogical

formulations. In United States, it obtains $9.4 million to build up a fresh medicine and

catch its approval. The only approach to give back this is through forceful promotion. An

expected 20% of drug companies’ funds are used up on marketing of drugs; and of this

amount, 20% is used up on retaining and instructing medical representatives, 30% for

publicity media, and 50% for unusual schemes which involves dinner meeting for doctors

and other medical staff, printing & publication of books and other materials (Phatak,

1998).

Arun further concluded here can be no doubt of getting a handsome profit in this

industry. The obnoxious is taking advantage by deceitful ways:

25
 Imperfect and insufficient product information provided by
medical

representatives. However, it is the solitary resource of information related to drugs

for most of the practitioners.

 Support for educational actions can be suitable if it is exclusive of filaments and

the event’s planners is the only decision making authority of each and every

portion of the event: Donations should be given to the institutions, and the charges

of speaker should be pay back by the proficient, not by the pharmaceutical

company.

 Funding should be handed to institutions and certified bodies not to individual

persons.

 The practitioners must worry about fake information and advertisements in the

media for drug injurious to the health. They prohibit on advertisements of alcohol,

child milk substitutes and feeding bottles are examples of this concern. Medicine

companies also publicize their drugs in research journals and publications. It has

to be making sure that incorrect information and messages are not given, and

ridiculous medicines are not promoted through advertisements.

 The medicine companies convince doctors to recommend specific medicines by

giving gifts or payments. In Pakistan, where poverty stripe of people is 40%, the

payments and gifts connection infringe the moral values of loyalty and non-

maleficence. Medicines companies like LOCOST, who do not involve in

unprincipled marketing and promotional activities of their medicines, are capable

to offer valuable and standard medicines under common names at half price as

compare to market rates (Phatak, 1998).

26
Daniella, & Michael studied the interaction between medicine companies’ representatives

and physician in training sitting. According to them contact with medicine companies’

representatives were widespread among locals. Most of the trainees experienced that the

connections were suitable while other think that their own prescribing could be

predisposed by gifts or relations, but were more possible to deem that others' prescribing

could be inclined. Occupant prescribing was linked with pharmaceutical representative

appointments and the accessibility of medicines samples. A range of rules and instructive

interferences come into view to sway local mind-sets toward relations with

pharmaceutical companies, though information on the durable possessions of these

interferences is inadequate. In general, locals reported deficient exercises in this area

(Daniella & Michael, 2005).

Finally they concluded that the drug industry has a noteworthy existence for the period of

placement training, has added on the whole receiving of trainees, and come into views to

control prescribing activities. Training sessions can promote from policies and curriculum

that educate residents about industry manipulate and traditions in which to gravely assess

information that they are provided.

Komesaroff and Kerridge (2002) evaluate numerous issues regarding the connection

between medical practitioners and the drug industry, highlighting that planning between

doctors and drug companies have to be transparent and obvious. They recognize the key

sources for concern and inspect ways in which unusual phases of the medical profession

are missing susceptible to sleaze. Furthermore they recommended the points, which are as

follows:

27
  Drug companies and medical practitioners serve each other interests that

occasionally overlie and clash.

 There is sturdy proof that relations between drug industry and medical

practitioners manipulate the last actions in relation to clinical decision-making as

well as carry out of research.

 Present the jeopardy of concession relationships with patients and the honesty of

the research process, physicians must work out in their communication with

pharmaceutical industry.

 The basic philosophy for the behavior of physicians with respect to drug

companies must directness and lucidity.

 Evidently uttered measures should be constructed to deal with precise problems

such as traveling expenses, delivery of gifts, funding of conferences and seminars

and enduring education activities.

According to Bodenheimer (2000) and Mathieu (1999) Doctors and the drug companies

carve up a number of common interests. For example, both are anxious with heartening

effectual and accountable utilization of accessible medicines in handling and care, their

usage monitoring, and pioneering research. But both parties have different importance

and having different center of attention. Doctors are concerned mainly in patient health

care and scientific advance, while companies are interested first and foremost in financial

benefits. The resemblances and dissimilarities between participants and their interests

generate both a requirement for dialogue and the possible for differences. The

contribution for medical knowledge and practice done by drug industry has been

28
considerable. The cost of development of a fresh medicine is between US$300 to $600

million, nearly all is provided by pharmaceutical industry. Clinical research is also

luxurious: last year, in the United States, about US$6 billion was used up on clinical

research, out of which 70% came directly from drug industry. The total amount used for

research and development is still much superior. In spite of these clear mutual benefits

and interests of cooperation, both the medical profession and the community have

expressed concerns of an ethical nature. There are three main concerns:

1. The probability of connection between physicians and medicine companies may

dole out commercial purposes of industry and greedy interests of clinicians more

willingly than lawful thinking, research and educational objectives, thus

compromising the main moral compulsion of doctors to patients, dividing the

faithfulness of physicians and discouragement the fundamental belief on which

clinical relations depend.

2. The hazard that medicines promotion will unsuitably pressurize physician’s

decisions.

3. The risk that industry participation in research and development of new drugs will

lead to deformations in scientific confirmation and stop self-governing appraisal

of information.

Parmar and Jalees, 2004, developed the distinctions between ethical and unethical drug

promotions practices based on the focus group discussions. “The acceptable norms of

promoting drugs through doctors are visiting them, giving a presentation on the merits

and demerits of the drugs. Explicitly, pointing out the side effects of drugs, giving

29
nominal quantity of drugs sample. These gifts and give away must not be highly

expensive and restricted to items such as dairies, calendar, year planner, etc.” (Parmar &

Jalees, 2004).

“The drugs thus prescribed to the patients on the merits of drugs with focus on the well

being of the patient will fall in the category of ethical drug promotion practices.”

“Comparatively, unethical drug promotion practices are prescribing drugs to the patients

based on the monetary considerations, and ignoring the well being of the patients. The

commonly used monetary rewards for unethical promotion of the drugs are discussed

below” (Parmar and Jalees, 2004).

(i) Monetary Reward

The crudest type of immoral medicine promotion is financial return. In this type, the cash

payment is associated with the quantity of the medicine prescriptions by the physicians.

The rewards are given on quarterly or monthly basis.

(ii) Visits With in Country

In this category, the drug companies manage seminars and conferences for the physicians

in those cities where doctors are not domiciled. The purpose of such arrangement may be

to keep informed physicians on the current advances in the industry, but the actual

intention is to offer effusive paid medicines. The drug companies manage the travelling

expenses, accommodation expenses in posh hotels. This paid medicine may possibly for

30
the physicians their families. Doctors travel to other cities for personal reasons. The

pharmaceutical firms entertain the doctors by arranging the air traveling with lodging &

boarding expenses of the doctors’ personal visits.

(iii) Foreign Visits

Drug companies organize overseas visits of the physicians. Like in country travelling,

these visits are managed in the setting of conferences and seminar, but again actual aim is

to offer paid medicines.

(iv) Gifts & Give away

a) Medical Equipments: Drug companies offer medical instruments

like

stethoscope, thermometers, surgical kits and other expensive medical equipments.

b) Personal Use Items: Drug companies provide personal use items such as

mobile, laptop, air-conditioned, and even cars.

(v) Chamber Decoration

In this category, the drug companies refurnish the physician’s clinics, as well as provide

air-conditioners, furniture, display boards, computers etc.

(vi) Home Decoration

The arrangements for the home display is alike to the physician’s clinics decorations as

mentioned above.

31
One author has suggested in the study (Brennan et.al, 2006), that doctors record their

attachment with medical companies. Actually, data given to the people who are most

expected to be debilitated looks most rational. Drug companies promote their medicines

to doctors, patients, and facilities for health care in turn to boost sales and reinforce sales

revenues. Literature shows many marketing models, which deal with the control

distressing: What are the conditions at which companies and peoples select medicine for

their use (Aaker & Williams; 1998, Bar-On & Parker; 2000, Curcura, 1999; Gonul et al.,

2001; Mintzes, 1998, 2002; Tutor2u, 2004; Wolfe, 2002).

In many research papers, we can easily find literature regarding the control of Medicine

Company fully funded gifts and paid education for medical students, practicing expenses

of experience and naïve doctors (Avorn et al., 1982; Curcura, 1999; Gonul et al., 2001;

Stolberg & Gerth, 2000; Wazana, 2000).

Pharmaceutical companies used approximate more than 11 billion USD per year for their

marketing and promotion budget, between 5 to 8 billion USD set off to promotion of

medicines through their sales staff (Greene, 1999, 2000), and for doctors a projected 8-13

thousand USD per year used up (Gibbons et al., 1998; Greene, 1999, 2000; Wazana,

2000; Westfall, McCabe, & Nicholas, 1997, 1998). Medical students, experience and

naïve doctors fully confessed that listeners in seminars and conferences latently fewer

incase of lack of lunch and gifts (Steiman, Shlipak & McPhee, 2001; Wazana, 2000).

32
According to an article published in New York Times, which shows the explication of

investigation by Federal Department. It engages different pharmaceutical manufacturers

for example Schering-Plough, Bristol-Myers Squibb, Johnson and Johnson, and Wyeth

(Coleman, J., Katz, E., Menzel, H., 1968)

In the course of an assessment of interrogation with doctors and managements of drug

manufacturers, the government has acknowledged unsuitable, incongruence and unlawful

promotional campaigns. It comprises of financial payback and appreciating medical

doctors to invoice intermediary payers for medicines delivered to physicians with no cost

(Harris, 2004).

In recent years, different medicines companies have pled blameworthy to elicit accuse

connecting the promotion of their medicines and even paid some fines. In 2001 TAP

Company paid 875 million USD, while in 2003 Astra Zeneca paid 355 million USD.

Beside this a multinational Pharmaceutical company Pfizer settled to pay 430 million

USD against fines. These all are beseech culpable to unlawful allegation of dishonesty for

heartening doctors to tab government against free medicines, which these companies

delivered to doctors (Harris, 2004).

A question has been lifted due to these problems related to unprincipled influence those

programs which could cover doctors’ stipulated observations (Avorn et al., 1982;

Curcura, 1999; Gonul et al., 2001; Wazana, 2000, Wolfe, 2002). A number of

investigation claimed that students and residents of at medical universities considerably

33
undervalue the control medicine organization fully funded education has on their

prescribing practices (Steinman et al., 2001; Wazana, 2000; Waud, 1992).

A research shows that 46% of doctors stated that medical company sales and marketing

persons be fairly significant in pressurizing their set down practices (Avorn et al., 1982).

Other researchers claimed that 61 percent of residents at medical universities affirmed

that marketing and promotions by pharmaceutical companies did not weight their own

selection of medicines, on the other hand the remaining 16 percent understood other

doctors to be also uninfluenced (Steinman et al., 2000).

In 2002, survey conducted by the journal Medical Economics found that 71% of doctor’s

respondents did not consider that accepting gifts, trips or hospitality weaken their

objectivity (Murray, 2002). Murray reports, “Indeed, many physicians found the

suggestion that they may be influenced insulting” (Murray, 2002).

For the treatment of hypertension “Chew & Colleagues” researched in year 2000, if the

sample was obtainable in the office to hand out a patient, over 90% of doctors would

distribute a sample that different from their chosen medicine options. According to

Industry estimate in 2000, 7.2 billion USD values of free medical samples were

distributed in 2000 (IMS Health, 2002).

Westfall et al. (1997) found that 96% of physicians and their staff had taken drug samples

for personal and family utilization in last year. The authors projected that the value of

34
these drugs is about USD 10,000. Westfall, et al. further states: “The use of whatever

medication is available on the sample shelf (usually the more expensive of several

options) is contrary to the development of good prescribing habits that will be necessary

for success in practice”.

In 1995, Hodges observed exchanges between medical company representatives and

psychiatry residents and confine in 7 teaching hospitals in Canada. Findings illustrated an

association between the receipt of promotional marketing materials and a conviction that

conversation with the medical representatives did not pressure doctor’s prescribing. The

more promotional gift items the resident or intern had received, the less likely he or she

was to consider the medical representative prejudiced his or her prescribing (Hodges,

1995).

In 1997, a team from University of Chicago studies advertising heading for medical

students and the students’ approach towards medical company’s representatives. The

study instituted that 90% of the students had received one or more medical books from

medical company’s representatives. The medical students whispered that the medical

company’s representatives to be obliging and edifying and also affirmed that they felt

compelled to take note to the medical company’s representatives informational sales

ground once they had received a free gift or meal (Sandberg, Carlos, Sandberg E., &

Roizen, 1997).

35
Wang et al. (1999) found that there was a considerable boost in doctor’s demands for

specific medicine to be placed on their hospital’s pharmacy after attending an educational

conference/program funded by the drug manufacturing company. In parallel Wazana

(2000) reported a conclusion from 29 articles found in the peer-reviewed literature linked

attitudes towards, the connection between doctors and the drug manufacturing industry

and its outcomes on the attitudes, knowledge and behaviors of doctors.

Haxby (1995) inspects medicines samples circulated by drug manufacturing companies to

the Oregon Health Sciences family medical clinic more than 14 months and found that

the medical clinic received a total of 1117 separate visits, ensuing in 331 different

medicine samples from 43 different drug manufacturing companies. A good number of

the clinic’s health care providers confessed they didn’t know in fact what was distributed

when they signed for drug samples. A lot of the medicine samples delivered were found to

be medicines that were not stocked by the clinic’s pharmacy and even not an approved

drug at the clinic (Haxby, Rodriguez, Zenchnich, Schuff, & Tanigawa, 1995).

These results have lead to the progress of numerous nonprofit companies focusing the

importance of doctors and drug manufacturing company’s representative contact and on

any unsuitable marketing and promotional activities. An internal medicine doctor

Goodman from New York founded one such company, No Free Lunch. The company’s

message is “Our quarrel is not with the pharmaceutical industry, but with pharmaceutical

industry promotion. The time has come to eliminate its influence from our practices” (No

Free Lunch, 2002a). The supporters and membership of ‘No Free Lunch’ are listed as

“physicians, pharmacists, dentists, nurses, physician assistants, medical ethicists and

36
others” (No Free Lunch, 2002a). The company provides indication lists from main

pharmaceutical-physician studies, a forum for concerned health care professionals and a

power point presentation, which is also downloadable on the topic of drug manufacturing

company’s influence, gifts and promotions. The site sells paraphernalia such as tee shirts

and coffee mugs to hoist income for its effort. The web site also encloses a pledge that

physicians may take if they are dedicated to being free of pharmaceutical company

influence. The pledge states:

“I, , am committed to practicing medicine in the best interest of my

patients and on the basis of the best available evidence, rather than on the basis of

advertising or promotion. I therefore pledge to accept no money, gifts, or hospitality from

the pharmaceutical industry; to seek unbiased sources of information and not rely on

information disseminated by drug companies; and to avoid conflicts of interest in my

practice, teaching, and/or research” (No Free Lunch, 2002b).

In 1999, a research was conducted by Kessenich and Westbrook focused on the

relationship of nursing and pharmaceutical sales persons’ and other reason that could

create impact on prescribing practices by taking interview from 6 Nurse Practitioners in

the New England area. According to Kessenich and Westbrook, the Nurse Practitioners

were asked about:

1. Medicine data from drug manufacturing company sales persons.

2. Basis of upcoming medicines,

3. Approval of medicines samples,

4. Providing gratis medicines samples,

37
 5. The professed pressure medicines samples their selections,

6. Approval of hand-outs

7. Attendance at pharmaceutical company sponsored events,

8. Concentration to drug manufacturing organization marketing campaigns

Of the sample population, 100% of the Nurse Practitioners had participated drug

manufacturing company’s funded educational programs and all of them had taken free

sample medications for their patients. 4 out of 6 Nurse Practitioners i.e. 67% had get

verbal or written communication about pharmaceutical products during pharmaceutical

company encounters for example office lunches, they believed the accessibility of sample

medications might have influenced their prescribing choices. All 6 Nurse Practitioners

had read medicine’s advertisements in medical professional journals and 100% of the

Nurse Practitioners believed that drug manufacturing companies influenced their

prescribing behaviors, “even in a subliminal manner” (Kessenich & Westbrook, 1999).

New technique of marketing is to target the patient consumer rather than the MD, NP, or

PA. Since the early 1990’s, drug manufacturing’s companies have been publicity directly

to the consumer (DTC) through different media advertisement such as television

advertisements, billboards and gifts, mass market publications that attract the patient to

ask for specific medicine when they see their healthcare provider (Manning & Masia,

2001). A lot of the advertisements hire popular media personality to pitch their medicines

including Olympic Gold Medalist ice skater Dorothy Hamill advertising for the arthritis

medication Celebrex and Senator Bob Dole extolling the virtues of Viagra. These

38
advertisements lean to show the medicine as the most excellent, effective and latest for

the complaint. Many conclude that if the patients’ doctor is not prescribing this

medication for them, they are not receiving the best possible recovery of their illness

(Ingelfinger, 1972; Mintzes, 1998; Mixed Reaction to Consumer Advertising, 2003).

These tactics encourage the patient to request the medical doctor or Nurse Practitioners

about the medicine and occasionally to point out the advertised medicine instead of

besides their current medications (Mintzes, 1998; Wolfe, 2002). Patient asks for precise

medicine has been acknowledged to impinge on doctor’s choice of prescription for the

patient (Mixed Reaction to Consumer Advertising, 2003; Steinman et al., 2001). Wolfe

notes, “There is evidence that many drug advertisements are not balanced or accurate and

duped gatekeepers may not adequately resist patients’ exhortations to write a

prescription” (2002, p. 525).

In general, budget for promotion on prescription medicines mounted to 15.7 billion USD

in 2000, rise from 13.9 billion USD in 1999 and only 9.2 billion USD in 1996 (National

Institute for Health Care Management, 2001, 2002). An anticipated 2.5 billion USD were

used up on direct to consumer advertising in 2000 up from 1.8 billion USD in 1999 and

791 million USD in 1996 (National Institute for Health Care Management, 2002). Sales

amplify of 50 medicine most profoundly advertised to consumers were conscientious for

almost 47.8% (Half) of the 20.8 billion USD rise in spending in 2000 (National Institute

for Health Care Management, 2002). In 2000, a pharmaceutical company Merck spent

161 million USD on promotion and advertising for Vioxx, a new medicine for respite of

arthritis pain. Explicitly over Anheuser-Busch spent advertising Budweiser beer (146

39
million USD) or Pepsico spent advertising its soft drink, Pepsi Cola (125 million USD).

The boost in Vioxx sales in 2000 accounted for 5.7% of the one-year rise in medicine

spending in the United States (National Institute for Health Care Management, 2001,

2002).

In the beginning of 1990, apprehension arose by American College of Physicians related

to persuasion by drug manufacturing unit’s funded institutional events and offering for

doctors and students’ recommended observations (American College of Physicians, 1990;

American Medical Association, 1991; Wazana, 2000). According to their research they

pointed out prospective persuasion from drug manufacturing organizations might affect

doctors recommended observations. Regardless the report from past more than 10 years,

and American Medical Associations and the American College of Physicians’ suggestions

so it subsist conversed among residents & students, and after the discussion the studies

demonstrated that merely 23 - 50 percent of medical residents familiar with current

statement (Gibbons et al., 1998). The information related to the manipulation that drug

manufacturing organization fully funded edification has on the recommended

observations of students and residents has consequence in a recent American College of

Physicians position statement released on March 5, 2002 (Coyle, 2002a; 2002b).

According to this, restated the necessitate in support of consciousness of the insinuation

of drug manufacturing organization fully funded edification and its control on

recommended observations and suggested that the entire doctors, student and residents

has to get teaching on this matter (Coyle, 2002b). In 2002, the existing declaration

exclusively spoken to conscientiousness who have completed their education and who

40
have not, universities have to make sure that neutral edifying substance has offered and

universities course of actions be primed to recognize suitable & deplorable connections

with the drug manufacturing organizations equally for practicing doctors and for medical

students (Coyle, 2002a; 2002b).

Similar guidelines are formed from different professional medical associations regarding

relations of doctors and sales persons of pharmaceutical companies and are recognized by

Royal College of Physicians and Surgeons of Canada, Canadian Medical Association,

Academy of Medicine and American College of Physicians and United State Medical

Association (Wazana, 2000). Despite their position regarding the influence of drug

manufacturing companies, the American Medical Association persists headed for 20

million USD in a year by advertising comprehensive professional and personal data on all

physicians working in US for utilizing medical company’s doctors prescribing databases

(Stolberg & Gerth, 2000).

Different researches have explained, and direction from U.S. Department of Health,

professional medical associations, Human Services’ Office of Inspector General (OIG)

and different industry trade associations mirrors distress that, the prospective that the

promotional efforts by pharmaceutical companies could have a unswerving and

thoughtful consequence on doctors prescribing practices, which may brunt medical

finding (Hemminki, 1975). This conflict of interest is not only receiving substantial

concentration in the media but it is also making news in the form of enforcement actions

and legislation. In consideration of the surprising costs linked with these marketing

41
practices approx. 90% of the 21 billion USD marketing finances of the drug

manufacturing industry are heading for doctors, in spite of a staged augment in direct-to-

consumer advertising (Holmer, 1999). The apparent incapability to manage increasing

healthcare costs, it is not shocking that pharmaceutical company’s gift-giving and other

promotional and marketing practices have get nearer under strict scrutiny and interest by

federal and state enforcement agencies and also self regulation by the pharmaceutical

companies, doctors and hospitals (Catlin et al., 2007).

Current study focused the suggestion of JAMA article’s related the association between

drug manufacturing companies and medical doctors and related professionals. In April

2007, a nationwide research published in the New England Journal of Medicine

(Campbell et al., 2007) set up that in United States about 94% of physicians stated a

number of relationships with the pharmaceutical industry, and 78% receiving free

medicines samples while 83% of these connections concerned getting food in the place of

work.

The investigation finally concluded that drug companies were expected to offer payments

and gifts to doctors who were recurrent recommended those companies’ medicines as

compare to those who were less prescriber (PhRMA, 2002a, 2002b).

Ahmed & Jalees (2008) have conducted a study on the same topic and concluded that

both doctors and pharmaceutical companies are equally responsible for unethical drug

promotion practices in Pakistan. But most important and interesting findings were,

42
"basically pharmaceutical companies are responsible for initiating these unethical drug

practices in Pakistan but now in continuation of these practices the doctor’s community is

actually responsible for these unethical drug promotion practices in Pakistan. Now the

doctors have become demanding and pharmaceutical companies are responsible to fulfill

their ethical and unethical demands. Now, this has become an acceptable norm of the

pharmaceutical industry and doctor’s community for the promotion of drugs in unethical

ways. The monetary rewards, local and foreign visits in the name of scientific activities

offered by the pharmaceutical companies for unethical promotion of the drugs are

extensively used as a tool of promotion of their drugs".

The study further concluded, the focus groups discussions and survey findings suggest

that strong legislation must be developed, implemented and enforced by the government.

However, the regulations and legislation actually works when they are supported by the

norms and values of the society (Ahmed & Jalees, 2008).

In this particular case, these unethical practices are considered as the norms of the

pharmaceutical industry and the doctor’s community; therefore, it could only be

addressed by educating both the segments for realizing their social responsibilities with

the focus on the patients’ well being. Furthermore, there must be strong check and

monitoring by the Ministry of Health both on pharmaceutical industry and the doctors

(Ahmed & Jalees, 2008).

43
According to Nishtar Sania (2007), immoral practice can engage private sectors as well

as authorizing bodies and could involve drug supply chain process, which starts from

registration, licensing and official approval of prices, sales and marketing of medicines

with procurements. This sector involved in corruption from its base in the profitable

benefits of the non-genuine drug companies, who uncover observance with set of laws

pricey and attempt to avoid rules and procedures to obtain registration of their products,

accelerate endorsement method, and obtain own choice rates of their products.

The further conclusion of this research stated that the process of contracting for purchase

of medicines offers a well-paid supply of income for dishonest bureaucrat and contractor

through kickbacks and excess invoicing. During procurement, the most actively

fraudulent practices include conspiracy among bidders, kickbacks from drug suppliers and

bidders to minimize contest, and bribes to government officials. They also involved in

procuring below standard medicines and get money for the suitable drugs. It is also

reported that a number of medicines and other supplies are stolen from hospital stores and

are abstracted for resale. The reason behind this is to encourage commission and

corruption, which engage a lot of medical practices such as wrong documentation, supply

of medicines to ‘ghost patients’, embed and stuffing of bills, witty book observance,

additional payment for medical supplies, extra billing and over invoicing. There is other

form of mismanagement and fraud crop up due to inadequate check and balance system;

e.g. supplies do not congregate demanding standards, partial delivery, or selling poor

standard, over date, fake and injurious medicines at lower cost. The process of registering

pharmacies can also be besmirched. Above all, the most important problem is violent

44
medicines promotional and marketing strategies, which can show the way to the unethical

promotional activities.

In Pakistan, above 450 drug companies manufacture registered approximately 45,000

drugs. Such huge competition joined with hospitality based strong marketing can lead to

unprincipled marketing practices, which have the prospective influence on medical

practice and handling doctors decisions (Nishtar Sania, 2007).

A report Bowman (1988) put into noticed that drug companies are infringing moral

regulations when they test their drugs in emerging countries. Manufacturer

GlaxoSmithKline has unethically tested a breast cancer drug in India, says the Wemos

Foundation, an Amsterdam-based lobbying organization on international health issues.

According to Bowman, M. A., & Pearle, D. L. (1988), GSK has tested an untried

medicine for breast cancer on women in India, which is also available in the Netherlands.

According to WEMOS this performance flout ethical standards. WEMOS is initiating a

campaign to encourage principled exploration in developing countries such as India. Non

developing countries are extensively used for researching and testing products that are

eventually inspired in Western countries. GlaxoSmithKline (GSK) is tinted as the main

perpetrator in a report published today by the Centre for Studies in Ethics and Rights,

based in Mumbai, India (Bowman & Pearle, 1988).

45
 CHAPTER THREE

RESEARCH METHODOLOGY

3.1 DATA, SAMPLE AND METHODOLOGY

The total population, and targeted population has been given as under and on the basis of

targeted population researcher has selected sample size which has also been elaborated as

under, moreover, following research methodology will be adopted in order to conduct this

research study.

2. TOTAL POPULATION

The total population of undertaken study is the following:

 All Sales & Marketing Personnel of all Pharmaceutical Companies, which are

operating in Pakistan including Multinational & National Companies.

 All the doctor community whether they are General practitioner in rural or urban

area or Medical Officers & Resident Medical Officers of Government & Private

hospitals or the Consultants of all specialties whether they are working in

Government or Private Hospitals.

 All the Retail Pharmacies' of the Country.

 All the whole sales pharmacies of the Country.

 All the Public & Private Hospitals of the Country.

 All the indoor & outdoor patients & their attendants' during the data collection

time period.

46
  Government Offices & Officials, which are directly or indirectly involved in order

to implement & ensure the law enforcement which are related to the subject

matter of undertaken study.

3. TARGETED POPULATION

The targeted population of undertaken study is the following:

 Sales & Marketing Personnel of top 10 (according to IMS) Pharmaceutical

Companies, which are operating in Pakistan including Multinational & National

Companies. These top 10 players have more than 80% share of total

pharmaceutical volume, which include GSK, Abbott, Sanofi-Avantis, Novartis,

Pfizer, Merck-Serrano, Buyer-Schering, Getz, Hilton, and Bosch Pharmaceuticals.

 The undertaken study is a case study of Karachi city; therefore, the data has been

collected from peripheral and urban areas of Karachi City. General practitioner in

rural (peripheral) and urban areas, Medical Officers & Resident Medical Officers

of Government & Private hospitals or the Consultants of all specialties whether

they are working in Government or Private Hospitals have been taken for this

study. According to IMS Karachi city is contributing more than 35% of total

pharmaceutical market of Pakistan.

 Karachi city will be taken for the data collection of the Retail Pharmacies' of the

study. According to IMS, Karachi city is contributing more than 40% of total

pharmacies of the country.

47
  Karachi city will be taken for the data collection of the wholesale Pharmacies' of

the study. According to IMS, Karachi city is contributing more than 50% of total

wholesale pharmacies of the country.

 Karachi city will be taken for the data collection of the public and private

hospitals for this study. According to IMS, Karachi city is contributing more than

28% of total public and private hospitals of the country.

 Karachi city will be taken for the data collection of the indoor and outdoor

patients & their attendants during the data collection time period, which cater

more than 20% of total market.

 Karachi city will be taken for the data collection of government offices &

Officials, which are directly or indirectly involved in order to implement and

ensure the law enforcement, which are related to the subject matter of the

undertaken study.

3.4 SAMPLE SIZE

Probability sampling technique will be used because the research study based on

quantitative analysis. For the sampling purpose the Cluster sampling technique will be

used, another reason to use this sampling technique is, the overall population is very

much scattered and spread in a larger geographical area of the city, moreover, the overall

population is heterogeneous. Therefore, for sampling purpose different clusters will be

collected from different areas of Karachi city. Researcher has used following six variables

in order to conduct the undertaken study and to draw statistical analysis &

48
conclusions. The total sample of 300 has been extracted from following six different

variables.

5. PHARMACEUTICAL SALES & MARKETING PERSONNEL

1. Multinational / National Pharmaceuticals Personnel

Since 10 MNCs will be taken and total 60 samples have been drawn from sales and

marketing teams of these companies, so, in this way the total 60 personnel will be taken

randomly.

6. DOCTORS COMMUNITY

1. General Practitioners (Both Rural & Urban)

Total 30 General Practitioners have been taken from different areas of Karachi city for

sampling purpose randomly.

3.6.2 Medical Officers & Resident Medical Officers of Public & Private Hospitals

Total 30 samples of MO & RMO have been recruited randomly.

3.6.3 Consultants of All the Specialties of Public & Private Hospitals

Total 30 consultants from Public hospitals & Private hospitals of different specialties will

be recruited randomly.

Therefore, the sample size of doctors' community will be of 90 respondents'.

49
7. HOSPITALS

1. Public Hospitals Including Provincial & Federal Hospitals

The sample of 10 has been taken from Provincial & Federal hospitals from Karachi City.

3.7.2 Private Hospitals

Total 15 private hospitals have been taken randomly for this study from Karachi City.

Therefore, the sample size of Hospitals will be of 25 hospital respondents'.

8. PHARMACIES

1. Retail Pharmacies

Total 25 retail pharmacies have been selected from different areas of Karachi City.

3.8.2 Whole Sales Pharmacies

Total 25 wholesale pharmacies have been selected from different areas of Karachi City.

Therefore, the sample size of total pharmacies will be of 50 respondents'.

9. GOVERNMENT OFFICIALS

1. Federal / Provincial Government Officials

Total 15 government officials have been taken from Karachi City.

Therefore, the sample size of Government officials will be of 15 respondents'.

50
10. PATIENTS OR THEIR ATTENDANTS'

1. Outdoor Patients & Their Attendants'

Total 30 Outdoors patients or their attendants' from Public hospitals and private hospitals

have taken randomly from different areas hospitals.

3.10.2 Indoor Patients & Their Attendants'

Total 30 Indoor patients or their attendants' from Public hospitals and private hospitals

have taken randomly from different areas hospitals.

Therefore, the sample size of Patients or their attendants' will be of 60 respondents'.

3.11 PLAN OF DATA ANALYSIS

Both descriptive and inferential statistical techniques will be used through SPSS and

Megastat. The data will be presented in tables and charts. The statistical hypothesis will

be tested with the help of z-test (involving two groups) and F-test (involving more than

two groups) of significance. The graphical analysis will also be presented wherever it is

needed.

51
 CHAPTER FOUR
DATA ANALYSIS

1. SURVEY FINDINGS
The survey findings were analyzed linearly, cross sectionally in order to have a better

comprehension and understanding between the relationship of dependent and independent

variables, moderating, and intervening variables. The empirical results or the survey

findings and interpretations of the study are discussed as below. The total sample of 300

has been extracted from following six different variables. The demographic information

of these 300 respondents as follow:

1. Gender
TABLE 1
FEMALES MALES TOTAL
88 212 300

Major samples collected from Male respondents (Total 212, 70.67%) total samples size

responded to the research while Female doctors (Total 88, 29.33%) of sample size.

GRAPH – 5
Gender

52
The above graphical representation shows the gender recruitment of respondents in the

under taken study, which clearly demonstrate that the overwhelming majority of

respondents are male.

Following table shows the age brackets of different respondents who have participated in

the study.

4.1.2 Age
TABLE 2
< 30 30-40 40-50 > 50 TOTAL
81 76 78 65 300

It is clearly indicated from the above table the majority of respondents belongs to the age

group of less than 30 years and then followed by between 40-50 years and so on.

Following is the graphical representations of different age groups of were participated in

the study.

GRAPH - 6
Age (In Years)

53
4.1.3 Experience
TABLE 3
<5 5--10 10—15 > 15 TOTAL
47 57 67 129 300

Major respondents i.e. 129 fall under the category of more than 15 years experiences &

then followed by 67 respondents have 10-15 years of experience in their field. 57

respondents belong to 5-10 years experience and 47 respondents have less than 5 years

experience. Moreover, following graph shows the distribution of experiences according to

their ages of all the respondents who have participated in the under taken study.

GRAPH - 7
Experience (In Years)

4.1.4 Education
TABLE 4
Post Graduates Graduates Intermediate Metric
105 140 33 22

54
The above table shows that 140 respondents were graduates and 105 respondents were

post-graduates, whereas, only 33 respondents have received intermediate education and

22 have obtained Matriculation certification. So, it is concluded that majority of

respondents i.e. 245 were graduate or post-graduate. Following graph shows the pictorial

diagram of this data.

GRAPH - 8
Education of Respondents

4.1.5 Respondents
TABLE 5

Consultan RMO/M Govt. Pharma. Govt. Hosp

t O GPs Officials Personnel Personnel
30 30 30 15 60 10

If we analyze the whole respondents then we come to know that there were 30

consultants and 30 MO/RMOs, & 30 general practitioners who have participated in that

study. Whereas, 60 pharmaceutical personnel have been recruited for the under taken

55
study. The pharmaceutical personnel were either from sales or from marketing.

Moreover, 15 government officials were also taken as respondents for this study and 10

hospital employees were participated in the study as well.

TABLE 6
Private Hosp. Retail Wholesale Outdoor Indoor
Personnel Pharmacies Pharmacies Patients
Patients
15 25 25 30 30
Moreover, 15 private hospitals personnel were also taken as respondents for this study

and 25 each retail and wholesale pharmacies taken randomly for the undertaken study.

Outdoor and indoor patients were taken 30 each. Following is the graphical

representation of the above data.

GRAPH – 9
RESPONDENTS

4.1.6 Pharmaceutical Personnel

TABLE 7
Gender Age Experience
Male Female < 30 30 - 40 40 - 50 > 50 <5 5--10 10--15 > 15
37 23 29 20 8 3 16 16 18 10

The pharmaceutical personnel who were taken as sample for the under taken study the

further break up was as:

56
There were 37 males and 23 females who were participated for the study and age bracket

of less than 30 were 29 participant and 20 between 30-40 years. Only 8 respondents were

of age between 40-50 years. Whereas, the experience was less than 5 years between 5-10

years for 16 respondents each, 18 respondents have 10-15 years experience and 10

respondents have more than 5 years experience.

TABLE 8
Education
Graduate Post Graduate
25 35

As far as education was concerned all the respondents from pharmaceutical industry were

well educated, in which 25 were graduates and 35 were post-graduates. Following is the

graphical representation of all above data & tables.

GRAPH – 10
Pharmaceutical Personnel

57
4.1.7 Consultants
TABLE 9
Gender Age (Yrs) Experience (Yrs) Education
Male Female > 50 40 - 50 > 15 10--15 Post Graduates
28 2 16 14 27 3 30

The consultants who were taken as sample for the under taken study the further break up

was as:

There were 28 males and 2 females only who were participated for the study and age

bracket of less than 50 years were 16 participant and 14 between 40-50 years. Whereas,

27 respondents have more than 15 years experience and only 3 were have 10-15 years

experience. Moreover, all the 30 respondents were post-graduates who were participated

in the under taken study.

GRAPH – 11
Consultants

58
4.1.8 General Practitioners
TABLE 10
Gender Age Experience
Male Female < 30 30 – 40 40 - 50 > 50 <5 5--10 10--15 > 15
23 7 1 10 14 5 1 2 10 17

General Practitioners who were taken as sample for the under taken study the further

break up was as:

There were 23 males and 7 females only who were participated for the study and age

bracket of less than 30 years was only 1 participant and 10 between 30-40 years, and

there are 14 respondents of age bracket 40-50 years. Whereas, 5 respondents have more

than 50 years age group. As far as experience was concerned there were two participants

who have 5-10 years experience, only 1 respondent who has less than 5 years experience.

There were 10 respondents who had 10-15 years experience and 17 participants had more

than 15 years experience.

TABLE 11

Education
Graduation Post Graduation
28 2

There were 28 respondents who had graduation and 2 general practitioners were post

graduated who participated in the under taken study. Following is the graphical

representation of the above data.

59
 GRAPH – 12
General Practitioners

4.1.9 RMO / MO
TABLE 12
Gender Age Experience Education
Male Female < 30 30 - 40 < 5 5--10 10—15 Graduation
12 18 25 5 15 12 3 30

RMOs / MOs who were taken as sample for the under taken study the further break up

was as follows:

There were 12 males and 18 females who were participated in the study and age bracket

of less than 30 years were 25 participants and 5 between 30-40 years. As far as

experience was concerned there were five participants who have more than 5 years

experience, only 3 respondents who have between 10-15 years experience. All 30

participants were graduated who participated in the study.

60
 GRAPH – 13
RMO / MO

4.1.10 Govt. & Private Hospitals Officials

TABLE 13
Gender Age Experience
Male Female < 30 30 - 40 40 - 50 > 50 < 5 5--10 10--15 > 15
19 6 3 6 11 5 2 1 8 14

Government and private hospitals officials who were taken as sample for the under taken

study the further break up was as follows:

There were 19 males and 6 females who were participated in the study and age bracket of

less than 30 years were only 3 participants and 6 between 30-40 years, 11 participants

were between 40-50 years of age and 5 respondents were more than 50 years. As far as

experience was concerned there were only two participants who have less than 5 years

experience, only 1 respondent who has between 5-10 years experience, 8 respondents

have between 10-15 years experience and 14 participants have more than 15 years of

experience.

61
 TABLE 14
Education
Intermediate Graduation Post graduation
1 14 10

One respondent was intermediate only, 14 were graduated and 10 respondents were post

graduated who have participated in the under taken study.

GRAPH - 14
Government and Private Hospitals Officials

4.1.11 Retail Pharmacies

TABLE 15
Gender Age Experience
Male Female < 30 30 - 40 40 - 50 > 50 < 5 5--10 10--15 > 15
7 18 9 10 4 2 6 8 6 5

Retail pharmacies personnel who were taken as sample for the under taken study the

further break up was as follows:

62
There were 7 males and 18 females who were participated in the study and age bracket of

less than 30 years were 9 participants and 10 between 30-40 years, 4 participants were

between 40-50 years of age and 2 respondents were more than 50 years. As far as

experience was concerned there were five participants who have less than 5 years

experience, eight respondents who have between 5-10 years experience, 6 respondents

have between 10-15 years experience and 5 participants have more than 15 years of

experience.

TABLE 16
Education
Metric Intermediate Graduation Post Graduation
3 1 15 6

Three participants were matriculated, one respondent was intermediate only, 15 were

graduated and 6 respondents were post graduated who have participated in the under

taken study.

GRAPH – 15
Retail Pharmacies

63
4.1.12 Wholesales Pharmacies

TABLE 17
Gender Age Experience
Male Female < 30 30 – 40 40 - 50 > 50 <5 5--10 10--15 > 15
25 0 2 4 11 8 1 2 5 17

Wholesales pharmacies personnel who were taken as sample for the under taken study

the further break up was as follows:

There were 25 males and none of female who were participated in the study and age

bracket of less than 30 years were 2 participants and 4 between 30-40 years, 11

participants were between 40-50 years of age and 8 respondents were more than 50 years.

As far as experience was concerned there was only one participant who has less than 5

years experience, 2 respondents who have between 5-10 years experience, 5 respondents

have between 10-15 years experience and 17 participants have more than 15 years of

experience.

TABLE 18
Education
Intermediate Graduation Post Graduation
13 10 2

There were 13 respondents who were intermediate, 10 were graduated and 2 respondents

were post graduated who have participated in the under taken study.

64
 GRAPH – 16
Wholesale Pharmacies

4.1.13 Outdoor Patients

TABLE 19
Gender Age Experience
Male Female < 30 30 - 40 40 - 50 > 50 < 5 5--10 10--15 > 15
23 7 11 8 6 5 6 10 5 9

Outdoor patients or their attendants who were taken as sample for the under taken study

the further break up was as follows:

There were 23 males and 7 females who were participated in the study and age bracket of

less than 30 years were 11 participants and 8 between 30-40 years, 6 participants were

between 40-50 years of age and 5 respondents were more than 50 years. As far as

experience was concerned there were 10 participants who have between 5-10 years of

experience, 5 respondents have between 10-15 years experience and 9 participants have

more than 15 years of experience.

65
 TABLE 20
EDUCATION
Matric Intermediate Graduation Post graduation
8 12 4 6

There were eight respondents who were Matriculated, 12 respondents who were

intermediate, 4 were graduated and 6 respondents were post graduated who have

participated in the under taken study.

GRAPH – 17
Outdoor Patients

4.1.14 Indoor Patients

TABLE 21
Gender Age Experience
Male Female 30 - 40 40 – 50 > 50 5--10 10--15 > 15
23 7 8 8 14 2 7 21

Indoor patients or their attendants who were taken as sample for the under taken study the

further break up was as follows:

66
There were 23 males and 7 females who were participated in the study and age bracket

between 30-40 years were 8 participants and 8 between 40-50 years, and 14 respondents

were more than 50 years. As far as experience was concerned there were 2 participants

who have between 5-10 years of experience, 7 respondents have between 10-15 years

experience and 21 participants have more than 15 years of experience.

TABLE 22
Education
Metric Intermediate Graduation Post Graduation
11 6 6 7

There were 11 respondents who were Matriculated, 6 respondents who were

intermediate, 6 were graduated and 7 respondents were post graduated who have

participated in the under taken study.

GRAPH – 18
Indoor Patients

67
4.1.15 Govt. Officials (Provincial & Federal)
TABLE 23
Gender Age Experience
Male Female < 30 30 - 40 40 - 50 > 50 5--10 10--15 > 15
13 2 1 5 2 7 4 2 9

Provincial and Federal government officials who were taken as sample for the under

taken study the further break up was as follows:

There were 13 males and 2 females who were participated in the study and age bracket

between 30-40 years were 5 participants and 2 between 40-50 years, and 7 respondents

were more than 50 years, whereas, less than 30 years were only one participant. As far as

experience was concerned there were 4 participants who have between 5-10 years of

experience, 2 respondents have between 10-15 years experience and 9 participants have

more than 15 years of experience.

TABLE 24
Education
Graduation Post Graduation
8 7

There were eight respondents who were graduated and 7 respondents were post graduated

who have participated in the under taken study.

Following is the graphical representation of Provincial and Federal government officials

who were participated in the study:

68
 GRAPH – 19
Government Officials (Provincial & Federal)

4.2 HYPOTHESES TESTING

Four different hypotheses were developed and tested using Z-test, simple ANOVA and F-

test. The result and interpretation of the four developed hypotheses are presented below:

4.2.1 Hypothesis No. I

The level of unethical drug promotion practices in pharmaceutical industry

H1o:

is high (at least 4) on the scale of (5 to 1)

The level of unethical drug promotion practices in pharmaceutical

H1A:

industry is less than 4 on the scale of (5 to 1)

The statistical representation of the above hypothesis is presented below:

69
 H10: µ ≥ 4

µ˂4
H1A:

The above hypothesis was tested through Z-test and the summarized result is presented

below:

TABLE 25

Level of Unethical Drug Promotion Practices

Mean 4.220
Standard Deviation 0.887
Hypothesized mean 4.00
Confidence level 0.95
Critical value one tail 1.645
Critical value two tail 1.96
Z-Calculated value 4.29
N 300
confidence interval 95.% lower 4.120
confidence interval 95.% upper 4.320
p-value (two-tailed) 1.76E-05
std. error 0.051
half-width 0.100

The hypothesis relating to high level of unethical drug promotion practices (at least 4 on

the scale of 5-1) was substantiated. At 95% confidence level, Z critical value is -1.645,

and Z-calculated value is 4.29 that fall in the non-critical region.

So, it is concluded that the null hypothesis is accepted because 4.29 lies in non critical

region and it is further concluded that the level of unethical pharmaceutical marketing

practices is high (at least 4) on the scale of (5 to 1).

70
4.2.2 Hypothesis No. 2

Focus group discussions indicate that the level of unethical drug promotion practices is

high in rural areas. Therefore the hypothesis developed in this context is presented below:

The levels of unethical drug promotion practices are equally higher in

H20:

rural areas as compared to the urban areas.

The levels of unethical drug promotion practices are not equally higher in
H2A:

rural areas as compared to the urban areas.

The statistical representation of the above hypothesis is presented below:

H20: µ1 ≥ µ2

H2A: µ1 ˂ µ2

Above test was carried out through by Z-two samples variables analysis, and the

summarized result is presented below:

TABLE 26

Level of Unethical Drug Promotion Practices In Rural Area

Rural Urban
Mean 4.03 3.50
Standard Deviation 1.01 1.21
Observations 300 300
Hypothesized Mean Difference 0
Z 5.81
p-value (one-tailed, lower) 1.0000
z Critical one-tail 1.645
P(Z<=z) two-tail 0
z Critical two-tail 1.95
difference (Rural - Urban) 0.527
standard error of difference 0.091

71
The hypothesis relating to higher level of unethical drug promotion practices in rural

areas was substantiated. At 95% confidence level the Z-critical value taken from table is -

1.645 and Z-calculated value is 5.81 that fall in the non-critical region. Therefore, it is

further concluded that the levels of unethical drug promotion practices are higher in rural

areas as compared to the urban areas.

TABLE 27

Unethical Practices (5 to 1)
Common in Karachi Higher in Rural areas Equally higher in Urban areas
4.22 4.03 3.5

Following is the graphical representation of unethical pharmaceutical marketing practices

in overall Karachi and Urban & Rural areas, which clearly demonstrate that according to

the respondents, unethical marketing practices are more common in rural areas as

compared to the urban areas.

GRAPH – 20
UNETHICAL MARKETING PRACTICES IN KARACHI

72
4.2.3 Hypothesis No. III

An important aspect is who was responsible for initiating the unethical drug promotion

practices in Pakistan. Doctor, pharmaceutical companies, hospitals, pharmacies, Govt.

Officials and Patients all have different opinions. In view of this disparity the developed

hypothesis is presented below:

There is no significant difference on the opinions of doctor, pharmaceutics

H30:

companies, hospitals, pharmacies, Govt. Officials and Patients on who

initiated unethical drug promotion practices in Pakistan.

There is significant difference on the opinions of doctor, pharmaceutics

H3A:

companies, hospitals, pharmacies, Govt. Officials and Patients on who

initiated unethical drug promotion practices in Pakistan.

The statistical representation of the above hypothesis is presented below:

H30: µ1 = µ2 = µ3 = µ4 = µ5 = µ6

H3A: µ1 ≠ µ2 ≠ µ3 ≠ µ4 ≠ µ5 ≠ µ6

The above hypothesis was tested through simple ANOVA, and the summarized results

are presented below:

73
 TABLE 28

Opinion on Who Initiated the Unethical Drug Promotion Practices

Groups Count Sum Average Variance

Pharmaceutical company 300.00 439.00 3.59 2.62
Doctors 300.00 294.00 2.39 3.16
Hospitals 300.00 148.00 1.19 0.49
Pharmacy 300.00 140.00 1.11 0.19
Govt. Officials 300.00 140.00 2.11 1.29
Patients 300.00 140.00 2.29 2.31

Source of SS df MS F P-value F crit

Variation
Bt. Groups 521.56 5.00 178.95 106.24 0.00 2.62
Within Groups 747.93 476.00 1.67

Total 1,269.48 479.00

The hypothesis relating to no significant difference of opinions on who initiated unethical

drug promotion practices in Pakistan was rejected. At 95% confidence level and (5, 476)

df the calculated F value of 106.24 is greater than F- critical values of 2.62.

TABLE 29

Unethical Practices (5 to 1)
Groups Average Variance
Pharmaceutical companies 3.59 2.62
Doctors 2.39 3.16
Hospitals 1.19 0.49
Pharmacies 1.11 0.19
Govt. Officials 2.11 1.29
Patients 2.29 2.31

74
 GRAPH – 21
LEVEL OF UNETHICAL PRACTICES

The above analysis also indicates that the pharmaceutical industry were found to be the

entity that has initiated unethical drug promotion practices in Karachi with a mean of

3.59, followed by doctors with a mean of 2.39.

4.2.4 Hypothesis No. IV

In the previous hypothesis, it was found out that the pharmaceutical industry initiated

unethical drug promotion practices, in Pakistan. However, an important issue is that who

is more responsible for the continuation of this practice. Based on the previous

hypothesis the following hypothesis was developed.

The contribution of the pharmaceutical industry in continuation of

H40:

unethical drug promotion practices is equal or higher than the doctors.

The contribution of the pharmaceutical industry in continuation of

H4A:

unethical drug promotion practices is not equal or higher than the doctors.

75
The statistical representation of the above hypothesis is presented below:

H40: µ1 ≥ µ2

H4A: µ1 ˂ µ2

Above test was carried out through by Z-two samples variables analysis, and the

summarized result is presented below:

TABLE 30

Opinion on Who Continued the Unethical Drug Promotion Practices

Pharmaceutical Company Doctors

Mean 2.94 3.81
Known Variance 3.52 2.61
Observations 300.00 300.00
Hypothesized Mean 0
Difference
Z (4.39)
P(Z<=z) one-tail 0.00
Z Critical one-tail 1.645
P(Z<=z) two-tail 0.00
Z Critical two-tail 1.96

The hypothesis relating to a higher contribution of pharmaceutical industry in unethical

drug promotion practices was rejected. At 95% confidence level, the Z critical value is

-1.645 and Z-calculated value is -4.39 that falls in the critical region. So, it is further

concluded that the doctor community is more responsible for the continuation of

unethical pharmaceutical practices.

76
 TABLE 31

Pharmaceutical companies Doctors

Mean 2.94 3.81
Known Variance 3.52 2.61

GRAPH – 22

CONTINUATION OF UNETHICAL PRACTICES

Therefore, it is further concluded that the pharmaceutical companies do not have more

contribution than the doctors in order to continue the unethical pharmaceutical marketing

practices. In other words doctors’ community is more responsible for the continuation of

unethical marketing practices in the industry.

4.3 QUALITITVE ANALYSIS

The qualitative analyses of determinants such as (a) tools of unethical drug promotion

practices (b) drug promotion to the non-qualified doctors (c) Legislation for unethical

drug promotion (d) eradication of unethical drug promotion is given as below:

77
4.3.1 Tools of Unethical Drug Practices

As was discussed in the literature survey that the commonly used tools for unethical drug

practice was, monetary rewards, local visits, and foreign visits etc. The summarized

results are presented below:

TABLE 32

Monetary Local Foreign Personalized Chamber Home

Rewards visits Visits gifts decoration decoration
4.24 4.33 4.59 3.88 2.77 1.31

GRAPH 23

It was discussed in earlier section that the doctors are the ones that are responsible for the

continuation of unethical drug promotion practices. The above table and graphs shows

that foreign visits with a mean of 4.59 are more in demand and local visits being the

second. The reasons for high preferences for local visits and foreign visits are that

pharmaceutical industry could justify these expenses by linking it with the conference.

78
4.3.2 Drug Promotion to Non-Qualified Doctors

Opinions on drug promotion to non-qualified doctors were obtained. Ethically, the firms

should not promote their drugs through them. The respondents’ opinions are presented

below:

TABLE 33

Pharma Personnel Doctors Hospital Pharmacies Govt. Officials Patients

3.29 4.45 3.53 3.11 3.23 3.44

GRAPH 24

Majority of respondents’ of all the segments such as doctors, Pharmaceutical companies,

hospitals, pharmacies, Govt. Officials and Patients were strongly against drug promotion

to the non-qualified doctors. However, despite their opinions it is a fact that the drugs are

being promoted through non-qualified doctors.

79
4.3.3 Legislation for Unethical Drug Promotion

Respondents’ opinions were obtained on the prospects of strong legislation against

unethical drug promotion practices. The respondents’ opinions are presented below:

TABLE 34

Pharma Govt.
Personnel Doctors Hospital Pharmacies Officials Patients
3.96 3.91 4.12 4.35 3.34 3.72

GRAPH 25

Inference could be drawn from the above that the majority of respondent are strongly in

the favor of making some strong legislation against the unethical drug promotional

practices in Pakistan. Although some legislation is already available but this research

showed there is no implementation of that legislation, therefore, majority of respondent

demanded that there must be strong legislation to stop this unethical drug promotion in

Pakistan.

80
4.3.4 Eradication of Unethical Drug Promotion

Opinions on eradication of drug promotion in Pakistan were obtained from the

respondents’. The respondents’ opinions are presented below:

TABLE 35

Pharma Govt.
Personnel Doctors Hospital Pharmacies Officials Patients
1.98 2.12 1.77 1.91 2.91 2.22

GRAPH 26

Above graph shows that the majority of the respondents’ i.e. doctors, pharmaceutical

personnel, hospitals, pharmacies, Govt. Officials and Patients strongly disagree about the

opinion that the unethical drug promotion practices cannot be stopped now. Majority of

respondents’ agreed upon that these unethical practices can still be stopped.

81
 CHAPTER FIVE

SUMMARY, CONCLUSIONS AND RECOMMENDATIONS

The major findings and recommendations are discussed below:

5.1 SUMMARY & CONCLUSIONS

The researcher has concluded the overall results and found that both doctors and

pharmaceutical companies are equally responsible for unethical drug promotion practices

in Pakistan. But most important and interesting findings are, basically pharmaceutical

companies are responsible for initiating these unethical drug practices in Pakistan but

now in continuation of these practices the doctor’s community is actually responsible for

these unethical drug promotion practices in Pakistan. Now the doctors have become

demanding and pharmaceutical companies are responsible to fulfill their ethical and

unethical demands. Now, this has become an acceptable norm of the pharmaceutical

industry and doctors community for the promotion of drugs in unethical ways. The

monetary rewards, local and foreign visits in the name of scientific activities offered by

the pharmaceutical companies for unethical promotion of the drugs are extensively used

as a tool of promotion of their drugs. The entire above conclusion is evident from the four

hypotheses that were tested through Simple ANOVA, F-tests and Z-tests.

The results of tested hypothesis and their conclusions are presented below:

82
 1. The hypothesis relating to high level of unethical drug promotion practices (at

least 4 on the scale of 5-1) was substantiated. At 95% confidence level, Z critical

value is -1.645, and Z-calculated value is 4.29 that fall in the non-critical region.

So, it is concluded that the null hypothesis is accepted because 4.29 lies in non

critical region and it is further concluded that the level of unethical pharmaceutical

marketing practices is high (at least 4) on the scale of (5 to 1).

It may be pointed that the level of unethical drug promotion practices as was

ascertained by (Parmar and Jalees, 2004) in their research was 3.56. The reason

could be that the study of (Parmar and Jalees) was case study of Hyderabad,

where as this study is Karachi based, and the sample drawn was a more

representative sample.

The above data clearly shows that the severity and intensity of unethical pharmaceutical

marketing practices have grown intensively in Pakistan. Now, it has become an

acceptable norm for both pharmaceutical industry and doctors’ community.

Unfortunately, pharmaceutical companies are very much active in these unethical

practices; some how national and multinational companies are competing each other in

order to do these illegal and unethical pharmaceutical marketing practices. These

companies are just bothering for their profits and expansion of businesses. These

companies are least bother about the patients’ well-being and their economic burden and

care.

83
At the cost of the patient these companies are offering every kind of social or scientific

activities, local and international CMEs and Conferences and doctor’s personal

obligations in the form of cash, local or foreign trips, home or clinical appliances. The

doctors’ community is equally responsible for these unethical pharmaceutical marketing

practices across Pakistan by accepting all sorts of activities whether these are ethical or

unethical. So, because of both parties cooperation the level of unethical practices has

escalated beyond imagination and crossed all limits and subsequently patients are

suffering enormously.

2. The hypothesis relating to higher level of unethical drug promotion practices in

rural areas was substantiated. At 95% confidence level the Z-critical value taken

from table is -1.645 and Z-calculated value is 5.81 that fall in the non-critical

region. Therefore, it is further concluded that the levels of unethical drug

promotion practices are higher in rural areas as compared to the urban areas.

In above hypothesis it is clearly demonstrated the level of unethical pharmaceutical

marketing practices are very high in rural areas as compared to urban areas. It does not

mean the level of unethical practices is very low in urban areas but comparatively it is

more severe in rural areas. The reason is very simple, in rural areas there is almost zero

check and balance by the regulating and law enforcing agencies. Therefore, the

pharmaceutical companies are free to offer anything to the doctors community in rural

and suburb areas, even in slum areas of big cities the level of unethical pharmaceutical

marketing practices are very high as compared to the main city areas. The doctors who

84
are practicing in rural or suburb areas are very much greedy and taking cash incentives

for every prescription of medicine. They have their attached Pharmacies with their clinics

and it is very convenient to prescribe and consume all unknown, substandard,

unregistered and counterfeit drugs. The reason is simple there is very low check and

balance of regulating and law enforcing agencies of medicines in rural and slum areas.

The government drug inspectors are also very much involved in for corruption for those

areas as well.

The sale of free sample is also very common in rural and suburb areas, whereas, the sales

of free samples is illegal but due to these attached pharmacies samples are being

prescribed and sold to the patients. Another horrible fact is that almost 80% fake doctors

who do not have medical degree and medical license; they also do illegal practice in these

areas. So, there is two-dimension problem in rural areas, the fake medicines and the fake

doctors. This could be a strong reason for more unethical practices in the rural areas as

compared to the main cities. Ironically, both pharmaceutical companies and doctors are

playing with the health of poor people in all those rural, suburbs and slum areas.

An important aspect is who was responsible for initiating the unethical drug promotion

practices in Pakistan. Doctor, pharmaceutical companies, hospitals and pharmacies all

have different opinions. In view of this disparity the developed hypothesis is presented

below:

85
 3. The hypothesis relating to no significant difference of opinions on who initiated

unethical drug promotion practices in Pakistan was rejected. At 95% confidence

level and (5, 476) df the calculated F value of 106.24 is greater than F- critical

values of 2.62.

The above analysis also indicates that the pharmaceutical industry were found to

be the entity that has initiated unethical drug promotion practices in Pakistan with

a mean of 3.59, followed by doctors with a mean of 2.39.

The result of above hypothesis clearly demonstrated that the pharmaceutical industry was

the responsible for the cultivation of these unethical norms in Pakistan. Actually, initially

multinational companies have started these practices in big cities with international

conferences. Multinational companies have provided the opportunities to the consultants

for abroad trips in the name of international conference and subsequently national

conferences and personalized activities as well. After emergence of national companies,

the unethical practices span has increased many folds because national companies have

targeted family physicians and comparatively junior doctors at mass level.

Another reason for phenomenal increase of unethical practices was the margin of profits.

Since the national companies have more margins and these companies have larger field

force and coverage of doctors is tremendous across Pakistan. These national companies

have diversified product portfolios and commonly used products; therefore, their reach is

also very vast to the doctors. So, they spread these unethical pharmaceutical marketing

86
practices rapidly to every corner of the Country. They also introduced new dimensions of

unethical practices like cash incentives, family trips, home appliances and foreign trips

with family as well.

In the previous hypothesis, it was found out that the pharmaceutical industry initiated

unethical drug promotion practices, in Pakistan. However, an important issue is that who

is more responsible for the continuation of this practice.

4. The hypothesis relating to a higher contribution of pharmaceutical industry in

unethical drug promotion practices was rejected. At 95% confidence level, the Z

critical value is -1.645 and Z-calculated value is -4.39 that falls in the critical

region.

Therefore, it is further concluded that the pharmaceutical companies do not have

more contribution than the doctors in order to continue the unethical

pharmaceutical marketing practices. In other words doctors’ community is more

responsible for the continuation unethical marketing practices in the industry.

The result of above hypothesis clearly shows that after initiation of pharmaceutical

marketing practices by the pharmaceutical companies, now it has become an acceptable

norm. Now, the doctors’ community thinks, this is the right of doctor to ask their share of

the profit from the pharmaceutical companies. Therefore, now, they have become more

demanding and bluntly ask for different obligations without any hesitation.

87
Pharmaceutical companies also fulfill their demands happily without asking any question,

even there is a competition amongst the companies to fulfill their demands. So, now, the

doctors are asking for cash incentives for per prescription and other lucrative incentives

from the pharmaceutical companies themselves.

Doctors clearly ask from the pharmaceutical companies, if they prescribe their products

then what sort of benefits they will be getting. They dictate and blackmail to the

pharmaceutical companies, if companies will not fulfill their demands then they will stop

their prescription and make deals with other companies. They totally forget the patients’

stakes and their economic burden and their well-being.

The qualitative analyses of determinants such as (a) tools of unethical drug promotion

practices (b) drug promotion to the non-qualified doctors (c) Legislation for unethical

drug promotion (d) eradication of unethical drug promotion is given as below:

a) As was discussed in the literature survey that the commonly used tools for

unethical drug practice was, monetary rewards, local visits, and foreign visits

etc. The summarized results are presented below:

It was discussed in earlier section that the doctors are the ones that are

responsible for the continuation of unethical drug promotion practices. The

Qualitative analysis shows that foreign visits with a mean of 4.59 are more in

demand and local visits being the second. The reasons for high preferences for

88
 local visits and foreign visits are that pharmaceutical industry could justify

these expenses by linking it with the conference.

The above qualitative analysis clearly demonstrated that the foreign visits are the most

common practice, which is being used by the pharmaceutical industry in order to please

and oblige the doctors. Whereas, the local visits are the second one tool to oblige the

doctors. Foreign and local visits are the most demanding and practicing by the

pharmaceutical industry to please or to oblige doctors for unethical marketing practice.

Initially, the multinational companies in the name of international conferences have

started foreign visits and they selected consultants from the main cities of the Country.

They were not only providing boarding, lodging, air tickets and registration but also

arrange sight seeing as well. After entrance of national companies the quantum of foreign

and local visits have increased substantially. Local companies have also offered these

visits to family physicians and junior doctors as well. Mainly, national and multinational

companies are linking these local and foreign tours with national and international

conferences. Local companies have forwarded one step ahead and they started

Continuing Medical Education (CMEs) and in the name of CMEs these national

companies arrange international tours for doctors and their families. In those international

tours these companies are providing all sort of recreational activities to the doctors and

families that is why the international tours are in more demand by the doctors community.

89
 b) Opinions on drug promotion to non-qualified doctors were obtained.

Ethically, the firms should not promote their drugs through them. The

respondents’ opinions are presented below:

The Qualitative analysis shows that the majority of respondents’ of all the

segments such as doctors, Pharmaceutical companies, hospitals, pharmacies,

govt. officials or Patients were strongly against drug promotion to the non-

qualified doctors. However, despite their opinions it is a fact that the drugs are

being promoted through non-qualified doctors.

The above opinion is very logical and interesting which is obtained from doctors,

pharmaceutical companies, hospitals and pharmacies. All the respondents are very much

agreed upon that the promotion of pharmaceutical drugs should be prohibited to the non-

qualified doctors. However, the ground realities are entirely different than their opinions

because most of the pharmaceutical companies are promoting their drugs to non-qualified

doctors in order to boost up their sales, especially in rural, suburbs, and slum areas

because the major chunk of doctors are non-qualified in all these areas. Patients’ of those

areas also visit non-qualified doctors because of unviability of qualified doctors and for

economic reasons as well. All the pharmacies of those areas freely selling their medicines

to the patients on the prescription of non-qualified doctors. Only qualified doctor’s

opinion could be taken validated because these non-qualified doctors are competitors of

degree holder doctors.

90
 c) Respondents’ opinions were obtained on the prospects of strong legislation

against unethical drug promotion practices. The respondents’ opinions are

presented below:

Inference could be drawn from the Qualitative analysis that the majority of

respondents are strongly in the favor of making some strong legislation

against the unethical drug promotional practices in Pakistan. Although some

legislation is already available but this research showed there is no

implementation of that legislation, therefore, majority of respondent demanded

that there must be strong legislation to stop this unethical drug promotion in

Pakistan.

The above qualitative analysis clearly shows that all the respondents are agreed upon,

further legislation should be taken place in order to stop these unethical pharmaceutical

marketing practices. However, prevailing laws are more than sufficient for the eradication

of these practices, but the problem is true implementation of these laws. The laws and

code of conduct is already there for ethical marketing practices for pharmaceutical

companies. There are numerous government bodies and agencies who are supposed to

implement these laws on pharmacies, pharmaceutical companies and doctors community

but unfortunately government officials are indulged themselves in the corruption. So, if

there will be made any new law, then who will implement that law.

91
 d) Opinions on eradication of drug promotion in Pakistan were obtained from the

respondents’. The respondents’ opinions are presented below:

The Qualitative analysis shows that the majority of the respondents’ i.e.

doctors, pharmaceutical personnel, hospitals, pharmacies, govt. officials and

Patients strongly disagree about the opinion that the unethical drug promotion

practices cannot be stopped now. Majority of respondents’ agreed upon that

these unethical practices could still be stopped.

Above qualitative analysis shows that these unethical practices could be stopped, but

there is a big question how? Who will take the responsibility to stop these practices? The

pharmaceutical companies? These are busy in making huge profits from these practices.

The doctors’ community? They are getting unmatched and enormous benefits from the

pharmaceutical companies. Government officials are taking bribery in order to support all

these unethical practices. Actually, everybody is involved in that unethical practice;

therefore, everybody should realize their moral responsibility and take their own part in

order to stop these unethical practices from the society. Otherwise, hundreds of thousands

laws and regulations could not be stopped these unethical practices.

5.2 RECOMMENDATIONS

The focus groups discussions and survey findings suggest that strong legislation must be

developed, implemented and enforced by the government. However, the regulations and

92
legislation actually works when they are supported by the norms and values of the

society.

In this particular case, these unethical practices are considered as the norms of the

pharmaceutical industry and the doctors community; therefore, it could only be addressed

by educating both the segments for realizing their social responsibilities with the focus on

the patients’ well being.

Furthermore, there must be strong check and monitoring by the Ministry of Health and

other monitoring agencies both on pharmaceutical industry and the doctors.

It is also strongly recommended that there should be strong legislation by the healthcare

authorities and government agencies to stop or at least minimize these unethical

pharmaceutical marketing practices both by the doctor community and the

pharmaceutical industry.

There must be strong enforcement of existing rules and regulations by the relevant

government departments and autonomous bodies whom responsible to implement and

ensure these rules and regulations both on pharmaceutical industry and the doctors’

community.

93
It is also recommended to the doctors’ community that this is also their prime and ethical

responsibility to avoid getting unethical benefits from pharmaceutical companies while

they are prescribing their products.

The pharmaceutical industry should also restrict itself up to ethical marketing offers and

discourage healthcare professionals if they would ask any thing, which is unethical

according to the ethical pharmaceutical practices guidelines.

Most importantly every stakeholder should realize their responsibility and take their own

part in order to stop these unethical pharmaceutical practices from the society.

Pharmaceutical companies should abide the prevailing laws and regulations for marketing

their drugs to the doctors and draw a thick line between ethical and non-ethical

pharmaceutical marketing practices and do not cross that line at any cost.

Doctors’ community should also realize their moral and ethical responsibility and do not

demand for unethical benefits from the pharmaceutical companies and restrict themselves

within the ethical limits. Doctors’ community is known as the most sophisticated and

literate group of people of the society; therefore, they have a more responsibility to

behave seriously in order to stop these unethical practices. They should discourage

pharmaceutical companies if they offer some unethical benefits because if they accept

then they would also be expected to be unethical some point. They should care their

patients and their well-being and do not put economical burdens on their shoulders at the

expense of their own benefits.

94
Government should increase check and balance on their agencies and employees and

reprimand those officials who are involved in bribery and corruption. If government will

keep on checking and giving punishments then eventually prevailing laws and regulations

will be started to work and quantum of these unethical practices will be diminishing and

one day these unethical practices will completely be eradicated from the society.

5.3 SUGGESTED AREAS OF FURTHER RESEARCH

 Since the under taken study was a case study of Karachi City only, therefore, it

could not be concluded that the result of the study if which would be conducted on

country-wide would be the same as, therefore, further research can be conducted

on Pan-Pakistan basis for more representative sample.

 Another dimension is to segregate the specialties and then could be conducted the

study in order to analyze whether the results of different specialties are same or

different.

 Since in this study only promotional or the marketing aspect of pharmaceutical

industry is been covered, other areas of pharmaceutical industry like medical,

production and procurement could also be covered.

 In this study few variables have been incorporated whereas, in further research

more variables can be incorporated in order to have more clear and accurate

results.

95
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 APPENDIX - I

Annexure – A

Pharmaceutical Drug Promotion in Pakistan: Issues in Ethical

and Non-Ethical Practices
QUESTIONNAIRE
Unethical pharmaceutical marketing PRACTICES:
It means to promote the product by ignoring the ethical values and principles of
PHARMACEUTICAL marketing & SALES:

Q1. Gender
 Male  Female
Q2. Age? (in years)
 Less than 30  30-40  40-50  More than 50
Q3. Professional Experience? (in years)
 Less than 5  5-10  10-15  More than 15
Q4. Respondent?
 General  Govt. Official  Consultant  Patient or
Practitioner Attendant
 Pharmacy  MO or RMO  Hospital  Pharmaceutical
Personnel
Q6. Education?
 Primary  Secondary  Metric  Intermediate
 Graduate  Post Graduate  Ph.D.  Others
Q7. Income? (in Thousands)
 Less than 5  6 to 10  11 to 15  16 to 20
 21 to 25  26 to 50  51 to 100  More than 100
Q8. Affiliated Institute or Organization?*
 Govt. Office (F/P)  Govt. Hospital  Private Hospital  GP
(Urban/Rural)
 Pharma. (MNC)  Pharma.  Pharmacy (W.  Pharmacy
(Local) Sale) (Retail)
 Private Service   Self Employed  Any Other
Govt.
E
mploye
e

103
 Annexure – B

Please Rate the following questions on the scale of 5 to 1 (5 being high and 1 being
low) as described follows:

Strongly Agree = 5
Agree = 4
Do not Know = 3
Disagree = 2
Strongly Disagree = 1

Q9. Unethical drug promotion practice is common in Pakistan 5432 1

5 4 3 2 1
Q10. Unethical drug practices are higher in Rural areas:
5 4 3 2 1
Q11. Unethical drug practices are equally higher in Urban areas:

Q12. The unethical drug practices was initiated by:

(a) Pharmaceutical Companies 5 4 3 2 1
(b) Doctors 5 4 3 2 1
(c) Hospitals 5 4 3 2 1
(d) Pharmacies 5 4 3 2 1

Q13. Who are the responsible for the continuation of unethical drug practices?
(a) Pharmaceutical Companies 5 4 3 2 1
(b) Doctors 5 4 3 2 1
(c) Hospitals 5 4 3 2 1
(d) Pharmacies 5 4 3 2 1

Q14. Tools which are being used in unethical drug promotion:

(a) Monetary Rewards 5 4 3 2 1
(b) Local Visits 5 4 3 2 1
(c) Foreign Visits 5 4 3 2 1
(d) Precious Personalized Gifts 5 4 3 2 1
(e) Chamber’s Decoration 5 4 3 2 1
(f) Home Decoration 5 4 3 2 1
(g) Specify if any
5 4 3 2 1
Other

104
 Q15. Do you support to promote the drugs to Non-Qualified Doctors?
(a) Pharmaceutical Companies 5 4 3 2 1
(b) Doctors 5 4 3 2 1
(c) Hospitals 5 4 3 2 1
(d) Pharmacies 5 4 3 2 1
(e) Govt. Official 5 4 3 2 1
(f) Patients or Attendants’ 5 4 3 2 1

Q16. Should it be any strong legislation by the government to stop this malpractice?
(a) Pharmaceutical Companies Personnel 5 4 3 2 1
(b) Doctors 5 4 3 2 1
(c) Hospital's Influencer 5 4 3 2 1
(d) Pharmacy's Spokesperson 5 4 3 2 1
(e) Govt. Official 5 4 3 2 1
(f) Patients or Attendants’ 5 4 3 2 1

Q17. Is it difficult to stop unethical promotion practices in Pakistan?

(a) Pharmaceutical Companies Personnel 5 4 3 2 1
(b) Doctors 5 4 3 2 1
(c) Hospital's Influencer 5 4 3 2 1
(d) Pharmacy's Spokesperson 5 4 3 2 1
(e) Govt. Official 5 4 3 2 1
(f) Patients or Attendants’ 5 4 3 2 1

Abbreviations:

F = Federal
P = Provincial
Pharma = Pharmaceutical Company
MNC = Multinational
Local = National Pharmaceutical Company
W. Sale = Whole Sale Pharmacies
GP = General Practitioner
MO = Medical Officer
RMO = Resident Medical Officer
Consultant = Post Graduate in any Specialty

Thank you very much for your valuable time and Cooperation

105
 APPENDIX - II

CROSS-TABULATION
i. AGE
TABLE
Age (Years) Respondents’
< 30 81
30-40 76
40-50 78
> 50 65
TOTAL 300

TABLE

Cross-tabulation Respondents’ 81 76 78 65 300 Total

Age Observed 1 1
Expected 0.17 0.17 0.17 0.17 0.17 0.17 1.00
O-E 0.83 -0.17 -0.17 -0.17 -0.17 -0.17 0.00
(O - E)² / E 4.17 0.17 0.17 0.17 0.17 0.17 5.00
% of chi sq 13.9% 0.6% 0.6% 0.6% 0.6% 0.6% 16.7%
% of row 100.0% 0.0% 0.0% 0.0% 0.0% 0.0% 100.0%
% of column 100.0% 0.0% 0.0% 0.0% 0.0% 0.0% 16.7%
% of total 16.7% 0.0% 0.0% 0.0% 0.0% 0.0% 16.7%
< 30 Observed 1 1
Expected 0.17 0.17 0.17 0.17 0.17 0.17 1.00
O-E -0.17 0.83 -0.17 -0.17 -0.17 -0.17 0.00
(O - E)² / E 0.17 4.17 0.17 0.17 0.17 0.17 5.00
% of chi sq 0.6% 13.9% 0.6% 0.6% 0.6% 0.6% 16.7%
% of row 0.0% 100.0% 0.0% 0.0% 0.0% 0.0% 100.0%
% of column 0.0% 100.0% 0.0% 0.0% 0.0% 0.0% 16.7%
% of total 0.0% 16.7% 0.0% 0.0% 0.0% 0.0% 16.7%
30-40 Observed 1 1
Expected 0.17 0.17 0.17 0.17 0.17 0.17 1.00
O-E -0.17 -0.17 0.83 -0.17 -0.17 -0.17 0.00
(O - E)² / E 0.17 0.17 4.17 0.17 0.17 0.17 5.00
% of chi sq 0.6% 0.6% 13.9% 0.6% 0.6% 0.6% 16.7%
% of row 0.0% 0.0% 100.0% 0.0% 0.0% 0.0% 100.0%
% of column 0.0% 0.0% 100.0% 0.0% 0.0% 0.0% 16.7%
% of total 0.0% 0.0% 16.7% 0.0% 0.0% 0.0% 16.7%
40-50 Observed 1 1
Expected 0.17 0.17 0.17 0.17 0.17 0.17 1.00
O-E -0.17 -0.17 -0.17 0.83 -0.17 -0.17 0.00
(O - E)² / E 0.17 0.17 0.17 4.17 0.17 0.17 5.00
% of chi sq 0.6% 0.6% 0.6% 13.9% 0.6% 0.6% 16.7%

106
 % of row 0.0% 0.0% 0.0% 100.0% 0.0% 0.0% 100.0%
% of column 0.0% 0.0% 0.0% 100.0% 0.0% 0.0% 16.7%
% of total 0.0% 0.0% 0.0% 16.7% 0.0% 0.0% 16.7%
> 50 Observed 1 1
Expected 0.17 0.17 0.17 0.17 0.17 0.17 1.00
O-E -0.17 -0.17 -0.17 -0.17 0.83 -0.17 0.00
(O - E)² / E 0.17 0.17 0.17 0.17 4.17 0.17 5.00
% of chi sq 0.6% 0.6% 0.6% 0.6% 13.9% 0.6% 16.7%
% of row 0.0% 0.0% 0.0% 0.0% 100.0% 0.0% 100.0%
% of column 0.0% 0.0% 0.0% 0.0% 100.0% 0.0% 16.7%
% of total 0.0% 0.0% 0.0% 0.0% 16.7% 0.0% 16.7%
TOTAL Observed 1 1
Expected 0.17 0.17 0.17 0.17 0.17 0.17 1.00
O-E -0.17 -0.17 -0.17 -0.17 -0.17 0.83 0.00
(O - E)² / E 0.17 0.17 0.17 0.17 0.17 4.17 5.00
% of chi sq 0.6% 0.6% 0.6% 0.6% 0.6% 13.9% 16.7%
% of row 0.0% 0.0% 0.0% 0.0% 0.0% 100.0% 100.0%
% of column 0.0% 0.0% 0.0% 0.0% 0.0% 100.0% 16.7%
% of total 0.0% 0.0% 0.0% 0.0% 0.0% 16.7% 16.7%
Total Observed 1 1 1 1 1 1 6
Expected 1.00 1.00 1.00 1.00 1.00 1.00 6.00
O-E 0.00 0.00 0.00 0.00 0.00 0.00 0.00
(O - E)² / E 5.00 5.00 5.00 5.00 5.00 5.00 30.00
% of chi sq 16.7% 16.7% 16.7% 16.7% 16.7% 16.7% 100.0%
% of row 16.7% 16.7% 16.7% 16.7% 16.7% 16.7% 100.0%
% of column 100.0% 100.0% 100.0% 100.0% 100.0% 100.0% 100.0%
% of total 16.7% 16.7% 16.7% 16.7% 16.7% 16.7% 100.0%

30.00 chi-square
25 df
.2243 p-value
2.236 Phi coefficient
.913 Coefficient of Contingency
1.000 Cramér's V
Fisher Exact Probability can only be calculated for a 2 x 2 table.

ii. EXPERIENCE
TABLE

Experience (Years) Respondents’

<5 47
5--10 57
10—15 67
> 15 129
TOTAL 300

107
 TABLE
Cross-tabulation Respondents’ 47 57 67 129 300 Total
Experience Observed 1 1
Expected 0.17 0.17 0.17 0.17 0.17 0.17 1.00
O-E 0.83 -0.17 -0.17 -0.17 -0.17 -0.17 0.00
(O - E)² / E 4.17 0.17 0.17 0.17 0.17 0.17 5.00
% of chi sq 13.9% 0.6% 0.6% 0.6% 0.6% 0.6% 16.7%
% of row 100.0% 0.0% 0.0% 0.0% 0.0% 0.0% 100.0%
% of column 100.0% 0.0% 0.0% 0.0% 0.0% 0.0% 16.7%
% of total 16.7% 0.0% 0.0% 0.0% 0.0% 0.0% 16.7%
<5 Observed 1 1
Expected 0.17 0.17 0.17 0.17 0.17 0.17 1.00
O-E -0.17 0.83 -0.17 -0.17 -0.17 -0.17 0.00
(O - E)² / E 0.17 4.17 0.17 0.17 0.17 0.17 5.00
% of chi sq 0.6% 13.9% 0.6% 0.6% 0.6% 0.6% 16.7%
% of row 0.0% 100.0% 0.0% 0.0% 0.0% 0.0% 100.0%
% of column 0.0% 100.0% 0.0% 0.0% 0.0% 0.0% 16.7%
% of total 0.0% 16.7% 0.0% 0.0% 0.0% 0.0% 16.7%
5—10 Observed 1 1
Expected 0.17 0.17 0.17 0.17 0.17 0.17 1.00
O-E -0.17 -0.17 0.83 -0.17 -0.17 -0.17 0.00
(O - E)² / E 0.17 0.17 4.17 0.17 0.17 0.17 5.00
% of chi sq 0.6% 0.6% 13.9% 0.6% 0.6% 0.6% 16.7%
% of row 0.0% 0.0% 100.0% 0.0% 0.0% 0.0% 100.0%
% of column 0.0% 0.0% 100.0% 0.0% 0.0% 0.0% 16.7%
% of total 0.0% 0.0% 16.7% 0.0% 0.0% 0.0% 16.7%
10—15 Observed 1 1
Expected 0.17 0.17 0.17 0.17 0.17 0.17 1.00
O-E -0.17 -0.17 -0.17 0.83 -0.17 -0.17 0.00
(O - E)² / E 0.17 0.17 0.17 4.17 0.17 0.17 5.00
% of chi sq 0.6% 0.6% 0.6% 13.9% 0.6% 0.6% 16.7%
% of row 0.0% 0.0% 0.0% 100.0% 0.0% 0.0% 100.0%
% of column 0.0% 0.0% 0.0% 100.0% 0.0% 0.0% 16.7%
% of total 0.0% 0.0% 0.0% 16.7% 0.0% 0.0% 16.7%
> 15 Observed 1 1
Expected 0.17 0.17 0.17 0.17 0.17 0.17 1.00
O-E -0.17 -0.17 -0.17 -0.17 0.83 -0.17 0.00
(O - E)² / E 0.17 0.17 0.17 0.17 4.17 0.17 5.00
% of chi sq 0.6% 0.6% 0.6% 0.6% 13.9% 0.6% 16.7%
% of row 0.0% 0.0% 0.0% 0.0% 100.0% 0.0% 100.0%
% of column 0.0% 0.0% 0.0% 0.0% 100.0% 0.0% 16.7%
% of total 0.0% 0.0% 0.0% 0.0% 16.7% 0.0% 16.7%
TOTAL Observed 1 1
Expected 0.17 0.17 0.17 0.17 0.17 0.17 1.00
O-E -0.17 -0.17 -0.17 -0.17 -0.17 0.83 0.00
(O - E)² / E 0.17 0.17 0.17 0.17 0.17 4.17 5.00
% of chi sq 0.6% 0.6% 0.6% 0.6% 0.6% 13.9% 16.7%
% of row 0.0% 0.0% 0.0% 0.0% 0.0% 100.0% 100.0%

108
 % of column 0.0% 0.0% 0.0% 0.0% 0.0% 100.0% 16.7%
% of total 0.0% 0.0% 0.0% 0.0% 0.0% 16.7% 16.7%
Total Observed 1 1 1 1 1 1 6
Expected 1.00 1.00 1.00 1.00 1.00 1.00 6.00
O-E 0.00 0.00 0.00 0.00 0.00 0.00 0.00
(O - E)² / E 5.00 5.00 5.00 5.00 5.00 5.00 30.00
% of chi sq 16.7% 16.7% 16.7% 16.7% 16.7% 16.7% 100.0%
% of row 16.7% 16.7% 16.7% 16.7% 16.7% 16.7% 100.0%
% of column 100.0% 100.0% 100.0% 100.0% 100.0% 100.0% 100.0%
% of total 16.7% 16.7% 16.7% 16.7% 16.7% 16.7% 100.0%

30.00 chi-square
25 df
.2243 p-value

2.236 Phi coefficient

.913 Coefficient of Contingency
1.000 Cramér's V
Fisher Exact Probability can only be calculated for a 2 x 2 table

iii. INCOME
TABLE

Income (in thousands)

Income (Thousands) Respondents’

<5 8
6--10 12
11—15 21
16—20 44
21—25 59
26—50 49
51—100 51
> 100 56
TOTAL 300

109
 TABLE

Cross-tabulation

Respondents’ 8 12 21 44 59 49 51 56 300 Total

Income Observed 1 1
(Thousands)
Expected 0.10 0.10 0.10 0.10 0.10 0.10 0.10 0.10 0.10 0.10 1.00
O-E 0.90 -0.10 -0.10 -0.10 -0.10 -0.10 -0.10 -0.10 -0.10 -0.10 0.00
(O - E)² / E 8.10 0.10 0.10 0.10 0.10 0.10 0.10 0.10 0.10 0.10 9.00
% of chi sq 9.0% 0.1% 0.1% 0.1% 0.1% 0.1% 0.1% 0.1% 0.1% 0.1% 10.0%
% of row 100% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 100%
% of column 100% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 10.0%
% of total 10.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 10.0%
<5 Observed 1 1
Expected 0.10 0.10 0.10 0.10 0.10 0.10 0.10 0.10 0.10 0.10 1.00
O-E -0.10 0.90 -0.10 -0.10 -0.10 -0.10 -0.10 -0.10 -0.10 -0.10 0.00
(O - E)² / E 0.10 8.10 0.10 0.10 0.10 0.10 0.10 0.10 0.10 0.10 9.00
% of chi sq 0.1% 9.0% 0.1% 0.1% 0.1% 0.1% 0.1% 0.1% 0.1% 0.1% 10.0%
% of row 0.0% 100% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 100%
% of column 0.0% 100% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 10.0%
% of total 0.0% 10.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 10.0%
6—10 Observed 1 1
Expected 0.10 0.10 0.10 0.10 0.10 0.10 0.10 0.10 0.10 0.10 1.00
O-E -0.10 -0.10 0.90 -0.10 -0.10 -0.10 -0.10 -0.10 -0.10 -0.10 0.00
(O - E)² / E 0.10 0.10 8.10 0.10 0.10 0.10 0.10 0.10 0.10 0.10 9.00
% of chi sq 0.1% 0.1% 9.0% 0.1% 0.1% 0.1% 0.1% 0.1% 0.1% 0.1% 10.0%
% of row 0.0% 0.0% 100% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 100%
% of column 0.0% 0.0% 100% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 10.0%
% of total 0.0% 0.0% 10.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 10.0%
11—15 Observed 1 1
Expected 0.10 0.10 0.10 0.10 0.10 0.10 0.10 0.10 0.10 0.10 1.00
O-E -0.10 -0.10 -0.10 0.90 -0.10 -0.10 -0.10 -0.10 -0.10 -0.10 0.00
(O - E)² / E 0.10 0.10 0.10 8.10 0.10 0.10 0.10 0.10 0.10 0.10 9.00
% of chi sq 0.1% 0.1% 0.1% 9.0% 0.1% 0.1% 0.1% 0.1% 0.1% 0.1% 10.0%
% of row 0.0% 0.0% 0.0% 100% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 100%
% of column 0.0% 0.0% 0.0% 100% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 10.0%
% of total 0.0% 0.0% 0.0% 10.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 10.0%
16—20 Observed 1 1
Expected 0.10 0.10 0.10 0.10 0.10 0.10 0.10 0.10 0.10 0.10 1.00
O-E -0.10 -0.10 -0.10 -0.10 0.90 -0.10 -0.10 -0.10 -0.10 -0.10 0.00
(O - E)² / E 0.10 0.10 0.10 0.10 8.10 0.10 0.10 0.10 0.10 0.10 9.00
% of chi sq 0.1% 0.1% 0.1% 0.1% 9.0% 0.1% 0.1% 0.1% 0.1% 0.1% 10.0%
% of row 0.0% 0.0% 0.0% 0.0% 100% 0.0% 0.0% 0.0% 0.0% 0.0% 100%
% of column 0.0% 0.0% 0.0% 0.0% 100% 0.0% 0.0% 0.0% 0.0% 0.0% 10.0%
% of total 0.0% 0.0% 0.0% 0.0% 10.0% 0.0% 0.0% 0.0% 0.0% 0.0% 10.0%
21—25 Observed 1 1
Expected 0.10 0.10 0.10 0.10 0.10 0.10 0.10 0.10 0.10 0.10 1.00

110
 O-E -0.10 -0.10 -0.10 -0.10 -0.10 0.90 -0.10 -0.10 -0.10 -0.10 0.00
(O - E)² / E 0.10 0.10 0.10 0.10 0.10 8.10 0.10 0.10 0.10 0.10 9.00
% of chi sq 0.1% 0.1% 0.1% 0.1% 0.1% 9.0% 0.1% 0.1% 0.1% 0.1% 10.0%
% of row 0.0% 0.0% 0.0% 0.0% 0.0% 100% 0.0% 0.0% 0.0% 0.0% 100%
% of column 0.0% 0.0% 0.0% 0.0% 0.0% 100% 0.0% 0.0% 0.0% 0.0% 10.0%
% of total 0.0% 0.0% 0.0% 0.0% 0.0% 10.0% 0.0% 0.0% 0.0% 0.0% 10.0%
26—50 Observed 1 1
Expected 0.10 0.10 0.10 0.10 0.10 0.10 0.10 0.10 0.10 0.10 1.00
O-E -0.10 -0.10 -0.10 -0.10 -0.10 -0.10 0.90 -0.10 -0.10 -0.10 0.00
(O - E)² / E 0.10 0.10 0.10 0.10 0.10 0.10 8.10 0.10 0.10 0.10 9.00
% of chi sq 0.1% 0.1% 0.1% 0.1% 0.1% 0.1% 9.0% 0.1% 0.1% 0.1% 10.0%
% of row 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 100% 0.0% 0.0% 0.0% 100%
% of column 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 100% 0.0% 0.0% 0.0% 10.0%
% of total 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 10.0% 0.0% 0.0% 0.0% 10.0%
51—100 Observed 1 1
Expected 0.10 0.10 0.10 0.10 0.10 0.10 0.10 0.10 0.10 0.10 1.00
O-E -0.10 -0.10 -0.10 -0.10 -0.10 -0.10 -0.10 0.90 -0.10 -0.10 0.00
(O - E)² / E 0.10 0.10 0.10 0.10 0.10 0.10 0.10 8.10 0.10 0.10 9.00
% of chi sq 0.1% 0.1% 0.1% 0.1% 0.1% 0.1% 0.1% 9.0% 0.1% 0.1% 10.0%
% of row 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 100% 0.0% 0.0% 100%
% of column 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 100.0% 0.0% 0.0% 10.0%
% of total 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 10.0% 0.0% 0.0% 10.0%
> 100 Observed 1 1
Expected 0.10 0.10 0.10 0.10 0.10 0.10 0.10 0.10 0.10 0.10 1.00
O-E -0.10 -0.10 -0.10 -0.10 -0.10 -0.10 -0.10 -0.10 0.90 -0.10 0.00
(O - E)² / E 0.10 0.10 0.10 0.10 0.10 0.10 0.10 0.10 8.10 0.10 9.00
% of chi sq 0.1% 0.1% 0.1% 0.1% 0.1% 0.1% 0.1% 0.1% 9.0% 0.1% 10.0%
% of row 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 100% 0.0% 100%
% of column 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 100% 0.0% 10.0%
% of total 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 10.0% 0.0% 10.0%
TOTAL Observed 1 1
Expected 0.10 0.10 0.10 0.10 0.10 0.10 0.10 0.10 0.10 0.10 1.00
O-E -0.10 -0.10 -0.10 -0.10 -0.10 -0.10 -0.10 -0.10 -0.10 0.90 0.00
(O - E)² / E 0.10 0.10 0.10 0.10 0.10 0.10 0.10 0.10 0.10 8.10 9.00
% of chi sq 0.1% 0.1% 0.1% 0.1% 0.1% 0.1% 0.1% 0.1% 0.1% 9.0% 10.0%
% of row 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 100% 100%
% of column 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 100% 10.0%
% of total 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 10.0% 10.0%
Total Observed 1 1 1 1 1 1 1 1 1 1 10
Expected 1.00 1.00 1.00 1.00 1.00 1.00 1.00 1.00 1.00 1.00 10.00
O-E 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00
(O - E)² / E 9.00 9.00 9.00 9.00 9.00 9.00 9.00 9.00 9.00 9.00 90.00
% of chi sq 10.0% 10.0% 10.0% 10.0% 10.0% 10.0% 10.0% 10.0% 10.0% 10.0% 100.0%
% of row 10.0% 10.0% 10.0% 10.0% 10.0% 10.0% 10.0% 10.0% 10.0% 10.0% 100.0%
% of column 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100%
% of total 10.0% 10.0% 10.0% 10.0% 10.0% 10.0% 10.0% 10.0% 10.0% 10.0% 100.0%

111
 90.00 chi-square
81 df
.2313 p-value

3.000 Phi coefficient

.949 Coefficient of Contingency
1.000 Cramér's V
Fisher Exact Probability can only be calculated for a 2 x 2 table

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 APPENDIX - III

CODE OF ETHICS FOR PHARMACEUTICAL MARKETING

Governing pharmaceutical marketing and relations with pharmaceutical professionals and

healthcare professionals as well as relations between the pharmaceutical industry and
patient organisations applicable to companies engaged in pharmaceutical marketing in
Lithuania

Approved by IFPA and VGA (2012 revision)

Approved at the general meeting of VGA members on 31 May 2012

Approved at the general meeting of IFPA members on 7 June 2012

INTRODUCTION

The Code for Pharmaceutical Marketing has been adopted at the will and upon common
agreement of IFPA and VGA – associations of companies engaged in pharmaceutical
marketing in Lithuania. It seeks to ensure that member pharmaceutical companies engage
in an ethical promotion, restraining from deceitful practices and potential conflicts of
interest with healthcare professionals, whilst complying with applicable laws and
regulations. Thus the Code seeks to enable an environment where the general public may
be sure that the choices regarding their medicinal products are made based on the merit of
each product and the patients’ clinical needs. This Code does not aim at restraining the
promotion of medicinal products in such a way as to hinder free competition or limit
interaction with healthcare professionals.

Lithuanian Association of Innovative Pharmaceutical Industry (hereinafter referred to as

IFPA) is the association of companies engaged in the development and/or marketing of
medicines in Lithuania. IFPA is member of the institution representing the

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pharmaceutical industry in Europe, the European Federation of Pharmaceutical Industries
and Associations (EFPIA).

The Pharmaceutical Manufacturers’ Association (hereinafter referred to as VGA) is the

association of companies which develop, produce and/or are engaged in the marketing of
medicines and their representatives in Lithuania.

Both associations (IFPA and VGA) contribute to EFPIA mission – to promote

pharmaceutical research and development and the best conditions in Europe for
companies to bring to patients new medicines that improve human health and the quality
of life around the world.

Members of IFPA and VGA are aware of the importance of providing accurate, fair and
objective information about medicinal products enabling people to make informed
decisions about the use of specific medicinal products. Building upon this goal, IFPA and
VGA approved the Code of Ethics for Pharmaceutical Marketing, which governs
pharmaceutical marketing and relations with pharmaceutical professionals and healthcare
professionals as well as relations between the pharmaceutical industry and patient
organisations (hereinafter referred to as Code). The Code has been developed according
to the Code of Ethics adopted in Lithuania in 2004 in compliance with the provisions of
the EFPIA code and general ethical principles as amended on 24 June 2010 and on 14
June 2011. It also reflects the requirements of the EU Council Directive 2001/83/EC, as
amended, (hereinafter referred to as Directive) concerning the use of medicinal products
for human use. The Code is consistent with the general provisions of the Directive, which
acknowledge voluntary control over promotion of medicinal products implemented
through organisations/institutions, which represent the pharmaceutical industry sector by
providing the opportunity to apply to such organisations when complaints occur. In
addition, the Code incorporates the principles set out in the Law on Pharmaceutics of the
Republic of Lithuania (Official Gazette, 2006 No. 78-3056), the Law on Advertising of
the Republic of Lithuania (Official Gazette, 2000, No. 64-1937, 2002, No. 123-5508) and
the Law on Provision of Information to the Public of the Republic of Lithuania (Official
Gazette 1996, No. 71-1706, 2000, No. 75-2272, 2006, No. 82-3254).

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SCOPE OF THE CODE OF ETHICS FOR PHARMACEUTICAL MARKETING

This code for pharmaceutical marketing (hereinafter referred to as Code) covers the
marketing of medicines (both prescription-only and over-the-counter) and relationships
between healthcare professionals and pharmaceutical companies as well as relationships
between the pharmaceutical industry and patient organisations. The Code applies to
companies engaged in pharmaceutical marketing in Lithuania and to their representatives
(hereinafter referred to as companies).

Companies shall be liable for their obligations under the Code even when they contract
other parties (e.g. companies providing sales services, consultants, market research
companies, advertising agencies) to design, implement and conduct the activities covered
by the Code on their behalf. Furthermore, companies must take reasonable steps to ensure
that any other parties that they commission to design or implement the activities covered
by the Code but which do not act on behalf of the company (e.g. joint ventures, licensees)
comply with the Code.

The Code covers all methods of promotion, including but not limited to oral and written
promotion activities, co-operation, advertising in specialised journals for healthcare
professionals and direct mail advertising, the activities of medical sales representatives
(defined in section 17.1), advertising over the Internet and other electronic media using
audio and video systems, e.g. films, video recordings, data storage services and the like,
as well as the supply of free drug samples, distribution of gifts and hospitality events.

The Code also applies to relations between companies and healthcare professionals to
govern, including but not limited to, relations emerging from research and contracts
(including clinical trial studies, non-interventional studies and advice, as well as
consultations). Furthermore, this Code governs relations between companies and patient
organisations, which are subject to the requirements set out in Annex C hereto – “The
Code of Ethics on the Relations between the Pharmaceutical Industry and Patient
Organisations “ (Annex C).

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The Code does not aim to restrain or govern provision of non-promotional medicinal,
scientific or factual information.

The Code does not apply to:

- the labelling on medicinal products and accompanying package leaflets which are
subject to Title V of the Directive;
correspondence,
- possibly accompanied by non-promotional material, required to answer
to a specific question on a specific medicinal product;
factual,
- informative announcement and reference material relating, for example, to pack
changes, adverse reaction warnings, trade catalogues and price lists, provided they
include no product characteristics;
non-promotional
- information regarding human health and diseases;
non-promotional,
- general information about companies (such as information
directed to investors or to current/prospective employees), including financial
data, descriptions of research and development programs, and discussion of
regulatory developments affecting the company and its products.

Attached to the Code are: Annex A − “Implementation and Procedure Rules”, which is
binding upon and obligates members of the association and other committed companies
as well as those with specific guidelines in place to implement the Code to examine
complaints and administrate sanctions which may be applied to pharmaceutical
companies; Annex B − “Guidelines for Internet Websites Available to Healthcare
Professionals, Patients and the Public in the EU”, which provide guidance for
pharmaceutical companies with respect to the content of their websites containing
information on medicinal products, and Annex C − “Code of Ethics on the Relations
between the Pharmaceutical Industry and Patient Organisations”.

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APPLICABILITY OF THE CODE

The Code sets out the key ethical standards, which are considered binding upon the
companies. IFPA and VGA must comply and ensure their members’ compliance with the
Code and legislative provisions. IFPA and VGA must have specific procedures in place
to ensure compliance with all the codes referred to above by both their member
companies and other companies.

Provisions of the Code must be followed both in spirit and by letter. For example,
companies should follow consistent standards while interacting with healthcare
professionals, in particular as far as gifts and hospitality are concerned. IFPA and VGA
also encourage, on a needs basis, to adhere to the Code of Pharmaceutical Marketing
Practices of the International Federation of Pharmaceutical Manufacturers and
Associations (IFPMA).

The Code for Pharmaceutical Marketing, its content, structure and order may be revised
only upon common agreement between RFA and VGA associations. The Ethics
Committee may recommend revisions of the Code, its content, structure and order based
on its experience. The Code shall be reviewed and revised at the initiative of the Ethics
Committee, IFPA and VGA, also following revisions of the effective Lithuanian laws and
regulations (where in conflict with provisions of the Code) or in the EFPIA Code.

To avoid ambiguities, the term “company” for the purposes of this Code means any legal
entity that organises or sponsors promotion or, within the limits of the Code, maintains
relationships with healthcare professionals or patient organisations in Lithuania whether
such entity be a parent company (e.g. the headquarters, principal office or controlling
company of commercial enterprise), subsidiary company or any other form of enterprise
or organisation.

To ensure proper compliance with the provisions of the Code, IFPA and VGA must inter
alia introduce appropriate procedures for the lodging and examination of complaints as
well as a procedure for imposing sanctions for violations of the Code. Furthermore, the
relevant local subsidiary of the company must be notified in advance of all international

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events organised abroad (as provided in Section 9.2 of the Code) or must be consulted
locally.

TERMS EMPLOYED

Participation in an international conference is understood as arrival of the healthcare

professional to the venue of the conference not earlier than one day before the conference
starts and departure not later than one day after the event, registration and payment of the
fee, participation in scientific meetings and acquisition of a participant’s certificate.

Extravagant venues means venues, which are lavish and deluxe, and the visiting of which
could be prejudicial to the image of healthcare professionals/patient organisations or of
the pharmaceutical industry.

Medical Sales Representative means a person appointed by a pharmaceutical or any other

company engaged in the marketing of medicinal products in Lithuania for the promotion
of medicinal products, provision of relevant, precise and evidence-based information
about medicinal products and medical aids and about innovations of the medical and the
pharmaceutical industries, including personnel retained by way of contract with third
parties, any other company representatives who call on healthcare professionals,
pharmacies, hospitals or other healthcare facilities aiming to provide relevant, precise and
evidence-based information about medicinal products and medical aids and about
innovations of the medical and the pharmaceutical industries and to promote medicinal
products. The qualification and competence of the Medical Sales Representative to carry
out the above-listed functions falls within the responsibility of the company they
represent.

Company means pharmaceutical or any other company engaged in pharmaceutical

marketing in Lithuania.

Entertainment venues means places for leisure and entertainment which advertise their
entertainment facilities on promotional leaflets, also publicly in the press or on the
Internet and which are intended primarily for recreation and/or entertainment, i.e.
entertaining activities rather than professional/business meetings.

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Promotion for the purposes of this Code is consistent with the definition provided in the
Law on Pharmaceutics.

Healthcare professionals for the purposes of this Code means general practitioners,
including other members of the medical, dental, pharmacy or nursing profession or any
other persons who in the course of their professional activities may prescribe, purchase,
supply or administer any medicinal products.

Medicinal product for the purposes of the Code shall bear the meaning defined in Article
1 of the Directive: (a) any substance or combination of substances presented for treating
or preventing disease in human beings; or (b) any substance or combination of substances
which may be administered to human beings with a view to making a medical diagnosis
or to restoring, correcting or modifying physiological functions in human beings.

Provisions of the Code of Ethics for Pharmaceutical Marketing

Article 1. Marketing Authorisation

1.A medicinal product must not be promoted prior to the grant of the marketing
authorisation, which permits its sale, or placing on the market, also when promotion of
medicinal products does not meet the approved indications for medicinal products.

2.Promotion of a medicine must be consistent with the particulars listed in its summary of
product characteristics.

Article 2. Information that should be Made Available

2.1. Subject to relevant Lithuanian laws and regulations, all promotional materials must
include the following basic information clearly and legibly:

a) essential information consistent with the summary of product characteristics,

indicating the date on which such essential information was generated (if the text was not
revised) or last revised;

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b)the classification of the medicinal product placed on the market (prescription-only or
over-the-counter medicinal product);

c)when appropriate, the selling price or indicative price of the various presentations and
the conditions for reimbursement by social security bodies.

2.Requirements for the information provided in the advertisement of medicinal products

are set out in Lithuanian laws and regulations governing promotion of medicinal
products.

3.Subject to relevant Lithuanian laws and regulations, where an advertisement is

intended only as a reminder, the requirements of Section 2.1 above need not be complied
with, provided that the advertisement includes no more than the name of the medicinal
product or its international non-proprietary name, if any, or the trademark.

Article 3. Promotion and Its Substantiation

4.Promotion must be accurate, balanced, fair, objective and sufficiently complete to

enable the recipient to form his or her own opinion of the therapeutic value of the
medicinal product concerned. It should be based on an up-to-date evaluation of all
relevant evidence and reflect that evidence clearly. It must not mislead by distortion,
exaggeration, undue emphasis, omission or in any other way.

5.Promotion must be capable of substantiation, which must be promptly provided in

response to reasonable requests from pharmaceutical professionals or healthcare
professionals. In particular, promotional claims about side effects must reflect available
evidence or must be capable of substantiation by clinical experience. Substantiation need
not be provided, however, in relation to the validity of elements approved in the
marketing authorisation.

6.Promotion must encourage the rational use of medicinal products by presenting them
objectively and without exaggerating their properties. Claims must not imply that a
medicinal product, or an active ingredient, has some special merit, quality or property
unless this can be substantiated.

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4. When promotion refers to publish studies, clear references should be given.

5.Any comparison made between different medicinal products must stem from relevant
and comparable aspects of the products based on published scientific evidence.
Comparative advertising must not be misleading or disparaging.

6.All artwork, including graphs, illustrations, photographs and tables taken from
published studies included in promotional material should:

a) clearly indicate the source(s) of the artwork;

b)be faithfully reproduced; except where adaptation or modification is required in order

to comply with any Applicable Code(s), in which case it must be clearly stated that the
artwork has been adapted and/or modified.

Particular care must be taken to ensure that artwork included in promotion does not
mislead about the nature of a medicine (for example whether it is appropriate for use in
children) or mislead about a claim or comparison (for example by using incomplete or
statistically irrelevant information or unusual scales).

7.The words “safe” must never be used to describe a medicinal product without proper
substantiation.

8.The word “new” must not be used to describe any product or presentation which has
been generally available or any therapeutic indication which has been generally
promoted, for more than one year.

9.It must not be stated that a product has no side effects, toxic hazards or risks of
addiction or dependency.

Article 4. Use of Quotations in Promotion

4. 1. Quotations from medical and scientific literature or from personal communications

must be faithfully reproduced (except where adaptation or modification is required in
order to comply with any Applicable Code(s), in which case it must be clearly stated that
the quotation has been adapted and/or modified) and the precise sources identified.

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Article 5. Acceptability of Promotion

5.1. Companies must comply with high ethical standards at all times. Promotion must: a)
never be such as to bring discredit upon, or reduce confidence in, the pharmaceutical
industry; b) always be of a nature which recognizes the special nature of medicines and
the professional standing of the recipient(s); c) never cause offence to the competitors.

Article 6. Distribution of Promotion

1.Promotion should only be directed at those persons whose need for, or interest in, the
particular information can reasonably be assumed.

2.Promotional mailing lists must be kept up-to-date. Requests by healthcare

professionals to be removed from promotional mailing lists must be complied with.

3.Subject to the relevant Lithuanian laws and regulations, the use of fax, e-mail,
automated calling systems, text messages and other electronic data communication for
promotion of prescription-only medicinal products is allowed only upon obtaining prior
consent of the healthcare professional.

Article 7. Transparency of Promotion

4. Promotion must not be disguised.

5.Clinical assessments, post-marketing surveillance and experience programmes, post-

authorisation studies (including those that are retrospective in nature) must not be
disguised promotion. They must be conducted with a primarily scientific or educational
purpose.

6.When a pharmaceutical company pays for, or otherwise secures or arranges the

publication of promotional material in journals, such material must not resemble
independent editorial matter.

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7.4. Materials supported by the company referring to its medicinal products and their use,
no matter if they are or not of promotional nature, must clearly indicate that the company
sponsored the materials.

Article 8. Limitations Regarding the Advice on Personal Medical Matters

8.1. In the case of requests from individual members of the general public for advice on
personal medical matters, the enquirer should be advised to consult a healthcare
professional.

Article 9. Events and Hospitality

1.All promotional, scientific or professional meetings, congresses, conferences,

symposia, and other similar events (including but not limited to advisory board meetings,
visits to production sites or research laboratories, planning meetings, education (courses)
or investigator meetings for clinical or non-interventional studies), hereinafter referred to
as events, organised on behalf of or sponsored by the company must be held in an
appropriate venue that is conducive to the main purpose of the event and may only offer
hospitality when such hospitality is appropriate and otherwise complies with the
provisions of any Applicable Codes. The term “appropriate” is understood as compliant
with the provisions of Sections 9.5 and 9.6 of this Code and not in conflict with the
relevant Lithuanian laws and regulations.

2.No company may organise or sponsor an event that takes place in another country,
unless provided in Section 13.2 of this Code.

3.Promotional material which is displayed or provided as hand-out materials at

international events may, unless prohibited or otherwise regulated by local laws and
regulations, refer to medicinal products (or their use) which are not registered in the
country where the event takes place, or which are registered under different conditions,
so long as: (i) any promotional material (excluding promotional aids) is accompanied by
a suitable statement indicating countries where the product is registered and making clear
that the product is not registered or used locally, and (ii) any such promotional material
which refers to the prescribing information (indications, warnings, etc.) authorised in a

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country or countries where the medicinal product is registered must be accompanied by
an explanatory statement indicating that registration conditions differ internationally.

4.The provision of hospitality is limited to the healthcare professionals attending the

event who are true (registered) participants of the event (where registration is required). It
may not extend to the persons accompanying the healthcare professionals attending the
event.

5.All forms of hospitality offered to healthcare professionals shall be reasonable in level

and strictly limited to the main purpose of the event. Hospitality costs should not exceed
those allocated to the scientific part of the event. At promotional events of medicinal
products hospitality must be strictly limited to the main purpose of the event and must
not extend beyond participating healthcare professionals and/or pharmaceutical
professionals. Payment of travel, accommodation and other costs for those professionals
is prohibited. The term of promotional events is understood as defined in the relevant
Lithuanian laws and regulations. At professional/scientific events hospitality must be
secondary to the main purpose of the event. The cost reimbursement of healthcare
professionals attending such events shall be limited to travel, accommodation, catering
and/or registration fee.

6.Hospitality must not extend to sponsorship or organising of any entertainment (e.g.

sporting or leisure) events. Companies should avoid venues known as “entertainment
venues” or which are “extravagant”. “Entertainment venues” are understood as places for
leisure and entertainment which advertise their entertainment facilities on promotional
leaflets, also publicly in the press or on the Internet and which are intended primarily for
recreation and/or entertainment, i.e. entertaining activities rather than
professional/business meetings. “Extravagant venues” are understood as places, which
are lavish and deluxe, and the visiting of which could be prejudicial to the image of
pharmaceutical professionals, healthcare professionals, patient organisations or of the
pharmaceutical industry.

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9.7. Companies should follow the guideline relating to the term “appropriate” in the
meaning used in Article 9 hereof or subject to the provisions of any of the Applicable
Codes.

Article 10. Gifts

1.Companies are prohibited to supply, offer or promise to healthcare professionals

gifts, any kind of pecuniary advantage or benefit in kind as an inducement to prescribe,
recommend, supply, sell or buy a medicinal product.

2.Subject to Section 10.1 above, when medicinal products are being promoted to
healthcare professionals, objects intended for reminder advertising may be supplied,
offered or promised to such persons only if they are inexpensive and relevant to the
practice of medicine or pharmacy. The term “inexpensive” means that the item cost the
company not more than 35 litas, including VAT, the attached logo and other extra costs.
Section 10.2. does not govern giving of medical literature to healthcare professionals.

3.Except where they carry all the information stipulated in Section 2.1 above, objects
intended for reminder advertising may bear no more than the name and logo of the
company and the name of the medicinal product, or its international non-proprietary
name, if any, or the trademark.

4.Gifts for the personal benefit of pharmaceutical professionals or healthcare

professionals (such as tickets to cultural events or of other entertainment media) are
prohibited.

5.Companies should follow the guideline relating to the term “inexpensive” in the
meaning used in Article 10 hereof as indicated in the provisions of any of the Applicable
Codes or related instruments.

Article 11. Sponsorship and Charity for Healthcare or Research Purposes

11.1. The provision of sponsorship and charity to institutions, organisations or

associations that are comprised of pharmaceutical professionals or healthcare
professionals and/or that provide healthcare or conduct behavioural research (that are not

125
otherwise covered in the Code on the Relations between the Pharmaceutical Industry and
Patient Organisations) is only allowed if: (i) they are made for the purpose of supporting
healthcare or research; (ii) they are documented and kept on record by the company; (iii)
they do not constitute an inducement to recommend, prescribe, buy, supply, acquire or
administer any medicinal product. Sponsorship and charity to individual healthcare
professionals based on this section are not allowed. Companies’ sponsorship of
healthcare professionals attending international events is governed in Article 13 of the
Code. Companies are encouraged to publicize information about provided sponsorships
and charity as defined in this Section 11.1.
Article 12. Fees for Services

12.1. Contracts between companies and institutions, organisations or associations of

pharmaceutical professionals or healthcare professionals under which such institutions,
organisations or associations provide any type of services on behalf of companies (or any
other type of funding by the company not otherwise covered by Article 11 or the Code)
are only allowed is such services (or other funding): (i) are made for the purpose of
supporting healthcare or research; (ii) do not constitute an inducement to recommend,
prescribe, buy, supply, acquire or administer any medicinal product.

Article 13. Sponsorship of Healthcare Professionals

13.1. Companies must comply with criteria governing the selection and sponsorship of
healthcare professionals to attend trainings or events as provided in the provisions of any
Applicable Codes or related instruments. Funding must not be offered to compensate
merely for the time spent by healthcare professionals in attending events. In the case of
international events funded by the company, where attended by the healthcare
professional and if any kind of funding is provided to that particular healthcare
professional under the provisions of this Section 13.1, such funding shall be subject to the
procedure of the jurisdiction where the said healthcare professional is engaged in his/her
practice otherwise than the jurisdiction of the location of the event. For the avoidance of
doubt, Section 13.1 of this article is not intended to prohibit the extension of hospitality
to healthcare professionals in accordance with Article 9 hereof.

126
2.A company may sponsor participation of healthcare professionals in international
scientific events arranged by Global, European, North American, Scandinavian and
Baltic professional organisations of healthcare professionals and scientific institutions.

3.When deciding whether or not to sponsor participation of healthcare professionals in

international scientific events in Europe, it is recommended to check the preliminary
evaluation of the corresponding event in the EFPIA database at www.efpia-e4ethics.eu. It
should be noted that the said EFPIA review shall in no instance be interpreted as an
evaluation of the event’s scientific content or qualification of lecturers. Each company
shall decide independently whether or not to sponsor participation of healthcare
professionals in international professional events, but the decision should take account of
the relevant rules and references of the Code of Ethics.

4.The company must report such sponsorship of healthcare professionals to the

Pharmaceutical Marketing Ethics Committee within 30 calendar days following the end
of events, indicating:

a) name, venue and time of event;

b) speciality and number of sponsored pharmaceutical professionals or
healthcare professionals;
c) full names of sponsored pharmaceutical professionals or healthcare
professionals.
Information about the sponsorship of association members will be announced publicly on
the website of the Pharmaceutical Marketing Ethics Committee. The term “sponsorship”
includes sponsorship through healthcare facilities, pharmaceutical or medical trade
unions, specialty societies, company subsidiaries operating in other countries, etc.

Article 14. The Use of Consultants

14.1. Healthcare professionals may be used as consultants and advisors, whether in

groups or individually, for services such as speaking at and chairing meetings,
involvement in scientific/medical studies, clinical trials or training services, participation
at advisory board meetings, and participation in market research where such participation
involves remuneration and/or travel. The arrangements, which cover these genuine

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consultancy or other services, must, to the extent relevant to the particular arrangement,
fulfil all the following criteria:

a.A written contract or agreement must be agreed in advance which specifies the nature
of the services to be provided and, subject to condition (g) below, the basis for payment
of those services.

b.A legitimate need for the services must be clearly identified in advance of requesting
the services and entering into arrangements with the prospective consultants.

c.The criteria for selecting consultant must be directly related to the identified needs and
the persons responsible for the selecting of consultants must have the expertise necessary
to evaluate whether the particular healthcare professionals meet those criteria.

d.The number of pharmaceutical professionals or healthcare professionals retained must

not be greater than the number reasonably necessary to achieve the identified need.

e.The contracting company must maintain records concerning and make appropriate use
of, the services provided by consultants.

f.The hiring of the healthcare professional to provide the relevant service must not be an
inducement to recommend, prescribe, buy, supply, acquire or administer any medicinal
products.

g.The compensation for the services must be reasonable and reflect the fair market value
of the services provided. In this regard, token consultancy arrangements must not be used
to justify compensating healthcare professionals.

14.2. In their written contracts with consultants, companies are strongly encouraged to
include provisions regarding the obligation of the consultant to declare that he/she is a
consultant to the company whenever he/she writes or speaks in public about a matter that
is the subject of the agreement or any other issue relating to that company. Similarly,
companies that employ, on a part-time basis, healthcare professionals that are still
practising their profession are strongly encouraged to ensure that such persons are
obliged to declare their employment arrangement with the company whenever they write

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or speak in public about a matter that is the subject of the employment or any other issue
relating to that company. The provision of Section 14.2 of this article also apply to
general information of non-promotional nature about companies which does not fall
under the scope of the Code.

3.Limited market research, such as one-off telephone interviews or mail/email/Internet

questionnaires is excluded from the scope of this Article 14, provided that the healthcare
professional is not consulted in a recurring manner (either with respect to the frequency
of the calls to the same healthcare professional generally or of calls relating to the same
research) and the compensation for such consultations is minimum (i.e. does not exceed
the level of what a doctor would earn doing his/her primary job within the time scale
he/she spent doing market research).

4.If a healthcare professional attends an international event in a consultant or advisory

capacity the relevant provisions of Article 9 and the declaration procedure in Section 13.2
apply.

Article 15. Non-interventional Studies of Marketed Medicines

5.A non-interventional study of a marketed medicine is a study where the medicine is

prescribed in the usual manner in accordance with the terms of its marketing
authorisation. The assignment of the patient to a particular therapeutic strategy is not
decided by a study protocol but falls within current practice and the prescription of the
medicine is clearly separated from the decision to include the patient in the study. No
additional diagnostic or monitoring procedures are applied to the patients and
epidemiological methods are used for the analysis of collected data.

6.Non-interventional studies that are prospective in nature and involve the collection of
patient data on behalf of a healthcare professional or a group of healthcare professionals
for a scientific purpose must comply with all the following criteria:

a. The study is conducted for scientific purposes.

b.(i) There must be a written protocol and (ii) written contract between the healthcare
professionals and/or the institutes at which the study will take place, on the one part, and

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the pharmaceutical company sponsoring the study, on the other part, which specify the
nature of the services to be provided and, subject to section (c) below, the basis for the
payment for those services.

c. Any remuneration must be reasonable and reflect the fair market value of the work.

d.The study protocol must be submitted to the ethics committee for review as prescribed
by Lithuanian laws and regulations.

e.Applicable Lithuanian laws and regulations on the protection of personal data

(including collection and use of personal data) must be complied with.

f.The study must not constitute an inducement to recommend, prescribe, buy, supply,
acquire or administer a medicinal product.

g.The company’s scientific service must approve the study protocol and must supervise
the conduct of the study as described in Section 17. 2 (a).

h.The study results must be analysed by the contracting company or any other entity
acting on its behalf and summaries must be made available within a reasonable period of
time to the company's scientific service (as described in Section 17.2 (a)), which service
shall maintain records of such reports. The company must send the summary reports to
the ethics committee which reviewed the study protocol (where requested by the
committee or required by law) and to the healthcare professionals who participated in the
study, and make them available to industry self-regulation bodies and/or committees
responsible to the supervision of Applicable Codes, at their request. If the study results
are important for the assessment of benefit-risk, the summary report should be
immediately forwarded to the State Medicines Control Agency.

i.Medical sales representatives may only be involved in an administrative capacity and

such involvement must be under the supervision of the company’s scientific service
which will also ensure that the representatives are adequately trained. Such involvement
must not be linked to the promotion of any medicine or product for medical use.

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In Lithuania, non-interventional studies involving compensated medicines are allowed
only if this does not contravene applicable Lithuanian laws and regulations.

15.3. Companies are encouraged to follow the same principle in applying Section 15.2 to
all other types of studies that are subject to Section 15.1, including epidemiological
studies and registries and other studies of retrospective nature. Whatever is the case,
Section 12.1 applies to such studies.

Article 16. Samples

1.When promoting medicinal products to healthcare professionals qualified to prescribe

medicinal products, promoters of medicines may use samples of medicinal products
which are not intended for sale. A sample of the medicinal product not intended for sale
must correspond to the smallest package of the medicinal product of the same title, form
and strength and the package must bear the sign “Free medical sample – not for resale”.
Leaving of samples of medicinal products not intended for sale with healthcare
professionals, distributing them to pharmaceutical professionals and to the general
public and using them for healthcare purposes are prohibited.

2.Companies must have adequate systems of control and accountability for samples of
medicinal products not intended for sale handled by their representatives.

Article 17. Staff of the Pharmaceutical Company

17.1. Medical Sales Representatives must ensure that the frequency, timing and duration
of visits aiming to meet just one or two pharmaceutical professionals or healthcare
professionals and to pharmacies, hospitals or other healthcare facilities, together with the
method of presentation used by Medical Sales Representatives, do not cause
inconvenience to healthcare professionals or patients.

Each company shall ensure that its representatives, including personnel retained by way
of contract with third parties, and any other company staff who call on healthcare
professionals, pharmacies, hospitals or other healthcare facilities in connection with the
promotion of medicinal products (hereinafter referred to as “Medical Sales
Representatives”) are familiar with the relevant requirements of Applicable Codes and

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with the provisions of all relevant Lithuanian laws and regulations, and are adequately
trained and have sufficient scientific knowledge to be able to provide precise and
complete information about the medicinal products they promote.

a)Medical Sales Representatives must comply with the requirements of all Applicable
Codes, and all relevant laws and regulations. Heads of companies are responsible for
ensuring their compliance.

b) Medical Sales Representatives must approach their duties responsibly and ethically.

c)During each visit, having regard to the provisions of applicable laws and regulations,
Medical Sales Representatives must hand to visited persons, or have available for them, a
summary of the product characteristics for each medicinal product they represent.

d)Medical Sales Representatives must transmit to the medical department of their

companies forthwith any information they receive in relation to the use of their
company's medicinal products, particularly reports of side effects.

e)Medical Sales Representatives must ensure that the frequency, timing and duration of
visits to healthcare professionals, pharmacies, hospitals or other healthcare facilities,
together with the manner in which they are made, comply with the procedure laid down
by law.

f)Medical Sales Representatives must not use any inducements or subterfuge to gain a
call. In an interview, or when seeking an appointment for an interview, Medical Sales
Representatives must, from the outset, take reasonable steps to ensure that they do not
mislead a healthcare professional they are addressing as to their identity or that of the
company they represent.

g)The provisions of Section 15.2(i) also apply to the activities of Medical Sales
Representatives.

17.2. All members of the company’s staff, and any personnel retained by way of contract
with third parties, who are concerned with the preparation or approval of promotional

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material or activities must be fully conversant with the requirements of all Applicable
Codes and relevant laws and regulations.

a)Each company must establish a scientific service in charge of information about the
company’s medicines and products for medical use, as well as of approval and
supervision of non-interventional studies. Companies may decide by themselves about
the best way to organise these services according to Section 17.2 (i.e. whether a single
service will be responsible for both duties or whether two services will be established
with clearly defined responsibilities), taking into account their resources and structure.
This department must include at least one doctor or, where appropriate, a pharmacist who
will be responsible for approving any promotional material before release. Such person
must certify that he/she has examined the final form of the promotional material and that
in his/her belief it is in accordance with the requirements of all Applicable Codes and
advertising laws and regulations, is consistent with the summary of product
characteristics and is fair, equal and truthful representation of the proofs about the
medicinal product. Furthermore, the scientific service must include a doctor or
pharmacist in charge of the supervision of any non-interventional studies (including
supervision of any responsibility in connection with such studies, particularly where such
responsibility is undertaken by Medical Sales Representatives). Such a person must
confirm that he/she examined the protocol of non-interventional studies and that in
his/her belief the protocol is consistent with the requirements of this Code and of other
Applicable Codes.

b)Each company must appoint at least one senior employee who shall be responsible for
the supervision of the activities of the company and its subsidiaries to ensure compliance
with the standards of all Applicable Codes.

17.3. Companies engaged in pharmaceutical marketing in Lithuania cannot employ

healthcare professionals who work simultaneously at healthcare facilities.

Article 18. Enforcement

18.1. IFPA and VGA must, within current applicable rules and legislation, enforce the
provisions of this Code. In the event that a breach is established pursuant to the

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procedures of the National code, each IFPA, VGA or any other company which has
joined enforcement of the Code shall require from the offending company an immediate
cessation of the offending activity and a signed undertaking by the company to prevent
recurrence.

18.2. The procedure for the examination of violations of this Code and sanctions for
violations of the Code are set out in Annex A hereto.

Article 19. Awareness and Education

19.1. IFPA and VGA must, within current applicable rules and legislation facilitate
companies’ awareness of and education about the Code, including by providing guidance
to companies in order to prevent breaches of the Code.

Annex A

Pharmaceutical Marketing Ethics Committee

INTRODUCTION

Supervision of the Code of Ethics for Pharmaceutical Marketing, which governs

pharmaceutical marketing and mutual relations with pharmaceutical professionals and
healthcare professionals as well as relations between the pharmaceutical industry and
patient organisations (hereinafter referred to as the Code) is performed by the
Pharmaceutical Marketing Ethics Committee (hereinafter referred to as Committee). The
names of reporting individuals outside the pharmaceutical industry are kept confidential.
In special cases the company specified in the report to the Committee needs to know the
identity of the reporting person to be able to examine the case adequately. Even in such
cases the identity of the reporting person shall be disclosed only after obtaining his/her
consent. The Committee shall submit the number of processed violation reports to
members of IFPA and VGA on a quarterly basis.

The Committee shall ensure that industry and non-industry complaints are processed in
the same manner, without regard to who has made the complaint.

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STRUCTURE AND RESPONSIBILITY

1. The Pharmaceutical Marketing Ethics Committee is responsible for:

1.Organisation of the Committee’s procedures and selection of the required technical

staff, resources and consultants;

2.Supervision of the Code, including advice, comments and guidance related to the
application and enhancement of the Code;

3. Examination of reported violations of the Code;

4. Imposition and enforcement of sanctions for violations of the Code;

5. Supervision of the Committee’s website.

2. Structure of the Pharmaceutical Marketing Ethics Committee

1.The Committee is accountable to IFPA and VGA. On an annual basis the Committee
shall generate its operational report, which the Chairperson of the Committee shall
present separately at the general meetings of IFPA and VGA members. The Committee’s
annual report shall be posted on its website.

2. IFPA and VGA each delegate 3 members to the Committee.

3.The Committee shall be elected for the period of one year. Within at least one month
before expiration of this term, IFPA and VGA shall approve members of the Committee
for the next term of office. The Committee is composed of 7 members, including the
Chairperson. If a member of the Committee in person or the company he/she represents
violates the CEPM more than once over one year, the Chairperson of the Committee may,
at the Committee’s decision, file a proposal to the association to replace the Committee
member concerned.

4.The Committee shall be chaired by an individual outside the pharmaceutical sector.

The Chairperson of the Committee shall be approved by IFPA and VGA upon common
agreement.

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5.Decisions shall be adopted by majority voting. The votes of the Chairperson (or in the
absence of same, his/her deputy) and three members shall form the quorum. At least one
member must represent VGA or IFPA. In the event of equal distribution of votes, the
vote of the Chairperson (or in the absence of same, his/her deputy) shall be decisive.

6.The deputy to the Chairperson of the Committee shall be elected by rotation from
Committee members representing IFPA or VGA for the entire term of office of the
Committee.

7.The Committee shall have the right to obtain the material required for the
examination of the reported violation of the Code from pharmaceutical companies
suspected of violating the Code. The company may refuse to provide the information
which constitutes its commercial secret.

3.Operating and Funding Procedure of the Pharmaceutical Marketing Ethics

Committee

1.The Committee shall hold meetings upon receiving violation reports or whenever
intending to address any other matters in connection with the Code or the Committee’s
area of responsibility. Each Committee member shall have the right of initiative to
convene a Committee meeting. Committee meetings shall be convened at the decision of
the Chairperson of the Committee (or in the absence of same, his/her deputy).

2.At meetings of the Committee minutes shall be taken. The draft minutes shall be
emailed to members of the Committee for information and comments. The minutes shall
be signed by the Chairperson and Secretary of the meeting. The Chairperson of the
Committee shall be responsible for storage of minutes and other materials of the
Committee.

3.The Committee may seek assistance from experts. Advising experts may be invited to
attend Committee meetings without the right to vote.

4.To prevent conflicts of interest it is required that prior to examination of the violation
members of the Committee name all interests related to the violation. The Chairperson
(deputy) shall then determine whether such a member can participate in the examination

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of the reported violation. Where a member of the Committee is related to the complainant
or to the respondent, he/she shall suspend himself/herself (the Committee shall decide
which parties may attend the meeting) from the adoption of the relevant decision as long
as the Committee examines that particular violation report.

5.While the Committee examines the violation report, both the complainant and the
respondent may be invited to attend or be represented at its meeting. At a Committee
meeting, the company may not be represented by the same individual who is member of
the Committee, even if he/she has suspended himself/herself from the case.

6.Where it is impossible to adequately identify the circumstances of the violation report

between the complainant and the respective company based solely on the report, the
Committee shall have the right to invite directly related persons to attend the meeting as
well as to provide and receive information in oral form.

7.The costs of the Committee shall be covered from the IFPA and VGA budget in
equal contributions which ensure the activities of the Committee. When compiling the
budget, IFPA and VGA must include funds on a separate line according to the planned
cost estimate provided in advance by the Committee.

8.The Committee may incur costs in connection with the remuneration of the
Committee member outside the pharmaceutical industry and with the hiring of experts
whose opinions are reasonably required to examine specific reports, but without
exceeding the estimated budget funds. The Committee shall report its expenditure to
IFPA and VGA Boards in the form of a financial statement.

PROCEDURE FOR LODGING AND PROCESSING VIOLATION REPORTS

4. Lodging of Violation Reports

1.Reports of potential violations of the Code may be lodged by representatives of

pharmaceutical companies, pharmaceutical or healthcare professionals, representatives of
patient organisations, representatives of legal entities and natural persons. After receiving
information about a potential violation(s) of the Code, the Committee may initiate ex-
officio investigations.

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2.Violations of this Code (unless the Committee initiates an ex-officio investigation) shall
be reported in writing to the Chairperson of the Committee. The Committee Secretary
shall register the received report and notify members of the Committee thereof.

3. A report of a potentially committed violation of the Code must include:

1.The full name, postal address, email address (if any) and phone number of the
reporting person;

2. The institution, company or organisation represented by the reporting person;

3.Information about the violation and available evidence (place, time, circumstances and
persons involved);

4.The articles and sections of the Code whose provisions were violated under the
circumstances specified in the Report. A violation report lodged by a pharmaceutical
company must be signed by the company’s manager or his/her authorised person
indicating the clauses of the Code which in the company’s belief have been breached;

5.The Report shall be accompanied by documentation and other evidence which

substantiate the circumstances named in the Report.

4.Reports of potential violations of the Code may be provided in writing, by email or

through the section “Write us” on the Committee’s website.

5. Anonymous reports shall not be processed.

5. Actions upon Receiving a Violation Report

1.Suspected violations of the Code must be reported in writing accompanied by all

information about the violation and with the available evidence. Upon receipt of a report
of a potential violation, the Chairperson of the Committee shall within 10 (ten) business
days following receipt convene a Committee meeting to review the received material and
to establish whether the report of a violation of the Code falls within the scope of the
Code. The matter may be settled by an email voting by members of the Committee. If no
responses “AGAINST” are received within 5 business days, the Committee shall be

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deemed to have agreed that the report falls within the scope of the Code. After deciding
that the violation report falls within the scope of the Code, the Committee shall notify the
complainant and respondent thereof.

2.Where the Committee decides that the report of a violation of the Code does not fall
within the scope of the Code, the reporting person shall be notified thereof.

3.The Committee shall apply to the manager of the relevant company suspected of
breaching the respective provisions of the Code in writing (the letter must be faxed,
emailed or posted by registered mail to the company’s headquarters) asking to comment
on the material stated in the report and shall establish the term for providing responses
and comments.

4.Upon receipt of the Committee’s appeal regarding a potential violation, the relevant
company shall furnish the Committee with a written response within 5 business days
following dispatch of the Committee’s letter by fax or email. Where the response is
posted by registered mail, on the sending date it must also be faxed or emailed to the
Committee. Failing to receive the company’s response within 5 business days following
dispatch of the appeal, the Committee shall examine the violation without waiting for the
response.

5.In the process of examining the report, the Commission may apply to public
authorities requesting information available to them required to investigate the
circumstances stated in the report or ask those authorities to carry out an investigation
within their purview and to provide the obtained information to the Committee.

6.After the Committee has collected sufficient information about the potential violation,
but not later than within 6 (six) weeks following receipt of the violation report, a
Committee meeting shall be convened to adopt a decision regarding the violation of the
Code. Where the meeting fails to adopt a decision, another meeting must be arranged
within 2 (two) weeks to arrive to the final decision.

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7.The violation report must be examined in substance and the final decision must be
adopted within not more than 8 (eight) weeks following receipt thereof.

8.The Committee’s decision may be appealed against to a competent court of the

Republic of Lithuania in accordance with the law within 15 (fifteen) calendar days. The
Committee’s decision shall come into effect only following expiry of the defined appeal
term. During the said appeal term implementation of the Committee’s decision and
enforcement of imposed sanctions shall be suspended.

9.The Committee and its members undertake to protect any information received from
companies during the examination of the violation as confidential information and to
refrain from using it for any purposes other than its primary purpose.

6. Decisions of the Pharmaceutical Marketing Ethics Committee

1.Where the Committee decides that the Code was breached, this shall be communicated
to the complainant and the respondent indicating causes for adopting such a decision.

2.Where the Committee decides that the Code was breached, it may impose on the
relevant company one or more (depending on the severity of the violation) sanctions:

a) a written warning;
b) notifying the company’s principal office;
c) notifying IFPA and VGA members;
d) reporting the violation to EU member associations;
e) proposing to the general meeting of IFPA or VGA members to exclude the breaching
company from the association;
f) forwarding the case for further examination by public authorities;

6.3. The Committee shall publish effective decisions on its website:

1) in the case of severe or recurrent violations, indicating the company’s name and details
of the violation;

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2) in the case of minor violations, providing details of the violation without indicating the
company’s name.

3.Where the Committee finds that no breach occurred, such a decision of the
Committee shall not be announced subject to informing only the complainant and the
respondent companies.

Annex B

Guidelines for Internet Websites Available to Healthcare Professionals, Patients and

the Public in the EU

The Guidelines for Internet Websites Available to Healthcare Professionals, Patients and
the Public in the EU set forth herein are intended as a supplement to the provisions of the
Code for Pharmaceutical Marketing (hereinafter referred to as the Code).

Section 1. Transparency Of Website Origin, Content And Purpose

Each website shall clearly identify:

a) the identity and physical and electronic addresses of the sponsor(s) of the website;
b) the source(s) of all information included on the website, the date of publication of
the source(s) and the identity and credentials (including the date credentials were
received) of all individual/institutional providers of information included on the
website;
c) the procedure followed in selecting the content included on the website;

d) the target audience of the website (e.g. healthcare professionals, patients

and the general public, or a combination thereof); and;
e) the purpose or objective of the website.

Section 2. Content of Websites

a) Information included in the website shall be regularly updated and shall clearly
display, for each page and/or item, as applicable, the most recent date as of which such
information was updated.

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b) Examples of the information that may be included in a single website or in multiple
websites are: (1) general information on the company; (2) health education information;
(3)information intended for healthcare professionals (as defined in the Code); (4) non-
promotional information intended for patients and the general public about specific
medicinal products marketed by the company.

1) General information on the company

Websites may contain information that would be of interest to investors, the news media
and the general public, including financial data of the company, description of research
and development programmes, discussion of regulatory developments affecting the
company and its products, information for prospective employees, etc. The content of this
information is not regulated by these guidelines or provisions of the medicines
advertising law.

2) Health education information

Websites may contain non-promotional health education information about the

characteristics of diseases; methods of prevention and screening and treatments, as well
as other information intended to promote public health. They may refer to medicinal
products, provided that the discussion is balanced and accurate. Relevant information
may be given about alternative treatments, including, where appropriate, surgery, diet,
behavioural change and other interventions that do not require use of medicinal products.
Websites containing health education information must always advise persons to consult
a healthcare professional for further information.

3) Information for healthcare professionals

Any information on websites directed to healthcare professionals that constitutes

promotion (as defined in the Code) must comply with the Code and Lithuanian law. Such
information must be clearly identified as information for healthcare professionals. In
addition, access to such information must be technically restricted for patients and for the

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general public and shall be made available only subject to request from a healthcare
professional.

4) Non-promotional information for patients and the general public

Subject to any national laws and regulations, websites may include non-promotional
information for patients and the general public on products distributed by the company
(including information on their indications, adverse effects, interactions with other
medicines, proper use, reports of clinical research, etc.), provided that such information is
balanced, accurate and consistent with the approved summary of product characteristics.
For each product that is discussed, the website must contain full, unedited copies of the
applicable summary of product characteristics and patient leaflet. These documents
should be posted in conjunction with other information about the products or be
connected with that discussion by a prominent link advising the reader to consult them. In
addition, the website may provide a link to the full, unedited copy of any public
assessment report issued by the Committee for Medicinal Products for Human Use or the
State Medicines Control Agency. Brand names should be accompanied by international
non-proprietary names. The website may include links to other websites containing
reliable information on medicinal products, including websites maintained by
government authorities, medical research bodies, patient organisations, etc. The website
must always advise persons to consult a healthcare professional for further information.

Section 3. Email Enquiries

A website may invite electronic mail communications from healthcare professionals and
patients or the general public seeking further information regarding the company’s
products or other matters (e.g., feedback regarding the website). The company concerned
may reply to such communications in the same manner as it would reply to enquiries
received by post, telephone or other media. In communications with patients or members
of the general public, discussion of personal medical matters must be avoided. If personal
medical information about the specific individual’s health problems is revealed, it must

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be held in confidence and not published. Where appropriate, replies shall recommend that
a healthcare professional be consulted for further information.

Section 4. Links from Other Websites

Links may be established to a company-sponsored website from websites sponsored by

other persons, but companies should not establish links from websites designed for the
general public to company-sponsored websites that are designed for healthcare
professionals. Based on the same principle, links may be made to individual websites,
including websites sponsored by the company or other persons. Links should ordinarily
be made to the home page of a website or otherwise managed so that the reader is aware
of the identity of the website.

Section 5. Website Addresses on Packaging

Subject to any applicable national laws and regulations, the addresses of company-
sponsored websites that comply with these guidelines may be included in packaging of
medicinal products.

Section 6. Scientific Review

Companies should ensure that scientific and medical information prepared by them for
inclusion in their websites is reviewed for accuracy and compliance with the relevant
code(s). The scientific service established within the company pursuant to those
provisions of the Applicable Code that adapt the Section 13.2 of the Code may perform
this function, or it may be entrusted to other appropriately qualified professionals.

Section 7. Privacy

The website must conform to legislation and Applicable Codes of conduct governing the
privacy, security and confidentiality of personal information.

Annex C

Code of Ethics on the Relations between the Pharmaceutical Industry and Patient
Organisations

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INTRODUCTION

The pharmaceutical industry recognises that it has common interests with patient
organisations, which represent and/or support the needs of patients and/or caregivers.

In order to ensure that relationships between the pharmaceutical industry and patient
organisations are ethical and transparent, IFPA and VGA have adopted the Code of
Ethics on the Relations between the Pharmaceutical Industry and Patient Organisations,
which is considered as an integral part of the Code of Ethics for Pharmaceutical
Marketing governing pharmaceutical marketing and relations with healthcare
professionals as well as relations between the pharmaceutical industry and patient
organisations (hereinafter referred to as the Code).

The present Code builds upon the following principles:

1. The independence of patient organisations, in terms of their political judgement,

policies and activities, shall be assured.
2. All partnerships between patient organisations and the pharmaceutical industry
shall be based on mutual respect with the views and decisions of each partner
having equal value.
3. The pharmaceutical industry shall not request, nor shall patient organisations
undertake, the promotion of a particular prescription-only medicine.
4. The objectives and content of any partnership shall be transparent. Financial and
nonfinancial support provided by the pharmaceutical industry shall always be
clearly acknowledged in a proper way.
5. The pharmaceutical industry welcomes funding of patient organisations from
multiple sources.
Scope

The provisions of this Code shall apply to relations between IFPA and VGA member
companies operating in Lithuania and their affiliates or hired third parties as well as to
other parties acceded to this Code and patient organisations.

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Patient organisations are defined as any non-profit organisation (including the umbrella
organisations that integrate patient associations), composed of patients and/or caregivers,
the main activity and objectives of which are expressed in supporting the needs of
patients and/or caregivers.

Application

Pharmaceutical companies must comply with this Code and any laws and regulations that
apply to them; and:

(a) In the case of partnerships or other mode of joint activity with a patient
organisation in Lithuania, this Code and Lithuanian laws and regulations shall
apply;
(b) In the case of cross-border partnerships and activities, the industry code of the
country where the patient organisation has its principal headquarters shall apply.
In the event of discrepancies between the codes, more stringent provisions of a
code shall apply.
Activity as referred to above shall mean any interaction between a pharmaceutical
company and a patient organisation, including financial support.

Provisions

Article 1 Non-promotion of prescription-only medicines

Promotion of prescription-only medicinal products to the general public is prohibited,

unless permitted by Lithuanian law.

Article 2 Written agreements

Any financial support, significant indirect support and/or other forms of significant non-
financial support from a pharmaceutical company to a patient organisation shall be
provided basing on written agreement. The agreement must specify the amount of
funding/non-financial support as well as its purpose (e.g. unrestricted grant, specific
meeting or publication, etc.). In addition, a description of significant indirect and
significant non-financial support (e.g. time allocation for a public relations campaign and

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the nature of participation) must be provided. When support is provided to a patient
organisation in another country, the agreement must specify the codes of ethics that apply
to cooperation relations in the home countries of the pharmaceutical company and of the
patient organisation. Each pharmaceutical company must have an approval process in
place for such agreements.

An example of a written agreement is provided in Annex I.

Article 3 Use of logos and proprietary materials of patient organisations

The public use of patient organisation’s trademark (logos and/or its proprietary materials)
by a pharmaceutical company requires written permission from the patient organisation.
The provision of such permission shall be based on a written statement of the specific
purpose and the way the trademark (logo) and/or the proprietary materials will be used.

Article 4 Editorial control

Companies must not influence the reference materials made by a patient organisation
they sponsor in a manner favourable to their own commercial interests. This prohibition
does not preclude companies from correcting factual inaccuracies in materials.

Article 5 Transparency

a. Each company must make publicly available a list of patient organisations to

which it provides financial support and/or significant indirect/non-financial
support. This should include a description of support that is sufficiently complete
and clear to enable an average reader to gain an understanding of the meaning of
support. The description must include the monetary value of financial support and
of invoiced costs. For significant non-financial support that cannot be assigned a
meaningful monetary value the description must clearly describe the non-
monetary benefit that the patient organisation receives. This information shall be
provided on a national and European level. In Lithuania information about
financial support and/or significant indirect/non-financial support shall be
provided to the Pharmaceutical Marketing Ethics Committee once per calendar
year before February 1 of the following year.

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 b. Companies must ensure that their sponsorship is always clearly acknowledged
and apparent from the outset.
c. Each company must make publicly available a list of patient organisations that it
has engaged to provide significant contracted services. This should include a
description of services provided that does not disclose confidential information
but is sufficiently complete to enable the average reader to gain an understanding
of the nature of the arrangement. Each company shall also make public the total
amount paid per patient organisation over the reporting period in accordance with
the procedure and timeframe described above.

Article 6 Contracted Services

Contracts between companies and patient organisations where under the latter provide
any type of services to companies are only allowed if such services are provided for the
purpose of supporting healthcare or research.

Members of patient organisations may be invited to deliver presentations or to provide

expert or advisory services for a compensation at company-sponsored events or advisory
boards. Arrangements that cover consultancy or other services must, to the extent
relevant to the particular arrangement, meet each of the following criteria:

a. A written contract or agreement is agreed in advance specifying the nature of the

services to be provided, and, subject to clause (g) below, the basis of payment for
those services;
b. A legitimate need for the services has been clearly identified and documented in
advance of requesting the services and entering into the agreements;
c. The criteria for selecting services are directly related to the identified need and
persons in charge of selecting the service have the expertise required to evaluate
whether the particular experts and advisors meet those criteria;
d. The scope of the service is not greater than is reasonably necessary to meet the
identified need;

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 e. The contracting company keeps records of and makes appropriate use of the
services;
f. The engaging of patient organisations into paid activities is not an inducement to
recommend a particular medicinal product;
g. The compensation for the services is reasonable and does not exceed the fair
market value of the services provided. In this regard the payment of compensation
to patient organisations may not be justified with symbolic or formal agreements
for consulting and other services;
h. In their written contracts with patient organisations companies are strongly
encouraged to include provisions regarding an obligation of the patient
organisation to declare that they have provided paid services to the company
whenever they write or speak in public about a matter than is the subject of the
agreement or any other issue relating to that company;
i. Each company must make publicly available a list of patient organisations that it
has engaged to provide paid services – please refer to Article 5(c) above.

Article 7 Single company funding

No company may demand the conditions of being the sole sponsor of the respective
patient organisation or any of its major programmes.

Article 8 Events and hospitality

All events sponsored or organised by a company must be held in an appropriate venue

that is conductive to the main purpose of the event, avoiding those that are renowned for
their entertainment facilities or are extravagant“. “Entertainment venues” are understood
as places for leisure and entertainment which advertise their entertainment facilities on
promotional leaflets, also publicly in the press or on the Internet and which are intended
primarily for recreation and/or entertainment, i.e. entertaining activities rather than
professional/business meetings. “Extravagant venues” are understood as places which are

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lavish and deluxe and the visiting of which could be prejudicial to the image of patient
organisations or of the pharmaceutical industry.

All forms of hospitality of the pharmaceutical company offered to patient organisations

and their members must be “reasonable” and must not override the principal purpose of
the event whether organised by a patient organisation or a pharmaceutical company.

Hospitality must be limited to the funding of return travel to the event, catering,
accommodation and registration fees.

Hospitality may only be extended to persons who are invited to and participate in an
event in their right of a participant. In exceptional cases, in case of apparent health needs
(e.g. disability), travel, catering and accommodation expenses and the registration fee of
the accompanying person considered a carer can be covered.

All forms of hospitality offered to patient organisations and their representatives shall be
adequate and related to the purpose of the event.

Hospitality shall not include sponsoring or organising entertainment (e.g. sporting or

leisure events).

No company may organise or sponsor an event that takes place outside its country of
incorporation, unless:

a) most of the invitees are from other countries (other than the state of registration of the
company organising the event) and, given the countries of origin of most of the
invitees it makes greater logistical sense to hold the event in another country;

b) given the location of the relevant resource or expertise that is the object or subject
matter of the event, it makes greater strategic/logistical sense to hold the event in
another country.

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Article 8 Enforcement and implementation

Ensuring supervision over the Code of Ethics on the Relations between the
Pharmaceutical Industry and Patient Organisations and compliance with the provisions of
this Code respectively shall be controlled by the Pharmaceutical Marketing Violation
Committee, as defined in Annex A of the Code. The procedure for lodging and
examining violation reports shall be the same as that of the Code of Ethics for
Pharmaceutical Marketing (Annex A).

Annex I

201.... Declaration of Interest

of member of the Pharmaceutical Marketing Ethics Committee

......................................................................(full name)

1. Have you been engaged in any kind of financial relationships with pharmaceutical
manufacturers other than your represented company (employment relations, the
pharmaceutical manufacturer paid for your participation in a conference, congress,
consultation, symposium, etc., paid you a honorarium for a presentation, copyright work,
letter, advice or studies, you were involved in clinical trails conducted by the
pharmaceutical manufacturer or received gifts the value of which exceeded 1 MSL and
the like) in the past 5 years?

YES

NO

If “YES”, please provide more detailed information specifying the nature of

interest, name of the pharmaceutical manufacturer, etc.
.
……………………………………………………….................................................
.........
................

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2.Are there any other circumstances that could affect your objectivity and integrity of
decision-making as member of the Code of Ethics for Pharmaceutical Marketing
Violation Committee?

YES

NO

If “YES”, please provide more detailed information specifying the nature of

interest, name of the pharmaceutical manufacturer, etc.
……………………………………………………….....................................
......................
................

3. If your answer to at least one of the questions was “YES”, due to a potential
conflict of interest the Committee may propose that you do not participate in the
consideration of related matters or voting.

I confirm that the above is true and complete information. Should any of the
details provided in this declaration change, I commit to provide changes within 20 days.
I agree that my declaration is communicated to IFPA or VGA members.

(signature and full name of the person who completed the declaration and
completion date)

The declaration is completed once a year before 1 March of the current year and
is provided to the Chairperson of the Committee.

(signature and full name of the person who accepted the declaration and date)

Annex II

Template of a written agreement between the pharmaceutical industry and patient

organisations

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Any financial support, significant indirect support and/or other forms of significant non-
financial support from a pharmaceutical company to a patient organisation shall be
provided basing on written agreement.

Below please find the key elements of a written agreement. The agreement must directly
indicate its subject, i.e. what the parties agree about, consistent with the requirements of
the Code of Ethics on the Relations between the Pharmaceutical Industry and Patient
Organisations.

 Name of activity
 Name of partnering organisations (pharmaceutical company, patient organisation
and, where applicable, third parties that will be brought in to help , as agreed
between both the pharmaceutical company and the patient organisation)
 Type of activity (e.g. whether agreement relates to unrestricted grant, specific
event, publication, etc.)
 Objectives
 Envisaged role of the pharmaceutical company and the patient organisation
 Time-frame
 Amount of funding
 Description of significant indirect/non-financial support (e.g. the donation of
public relations agency, free courses)
 Country codes valid in the home countries of the pharmaceutical company and of
the patient organisation that apply to cross-border cooperation relations between
patient organisations and pharmaceutical companies.
All parties must be well aware that support must be clearly indicated and known from the
onset.

Applicable Code(s) of ethics:

Contracting parties:

Contract date:

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 APPENDIX - IV

THE NEW PHRMA CODE ON INTERACTIONS WITH HEALTHCARE

PROFESSIONALS

(Effective January 1, 2009)

The recently released PhRMA Code scheduled to take effect January 1, 2009 is an
extension and amplification of the Code that became effective July 1, 2007. The Codes
are remarkably similar, and focus on perceived abuses of pharmaceutical industry
interactions with healthcare professionals (HCPs).

In both cases, there is a clear distinction between legitimate pharmaceutical

promotion and possible inappropriate interactions with HCPs. Traditional product
promotion is not addressed in either of the Codes, but gifts from pharmaceutical
manufacturers, their representatives, and other manufacturer interactions with HCPs are
covered in detail.

Both the 2002 Code and the 2009 Code can be seen as influenced by the anti-
kickback statutes issued by the OIG. The new Code is designed to eliminate
inappropriate inducements to HCPs to prescribe specific products. In general, outright
gifts lacking medical relevancy may be correctly viewed as improper inducements. On
the other hand, advertising placed in traditional medical advertising media (medical
publications, prescription forms, patient record services, etc.) is designed to persuade
through education.

Items that are obviously intended for the personal benefit of HCPs “…such as
floral arrangements, artwork, music CDs, or tickets to a sporting event…” are deemed
unacceptable in both the 2002 and 2009 Codes. (See Item 7.c in the 2002 Code and Item
10 in the 2009 Code.)

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 The major difference between the Codes that occurs with regard to promotional
items (i.e., gifts) comes in the change from the previous Code where “Items of minimal
value may be offered by a company if they are primarily associated with the HCP’s
practice (pens, notepads, and similar ‘reminder’ items bearing a corporate or brand
logo).” (These items have been routinely referred to as “medically relevant.”)

The new Code places a more restrictive boundary in this area, relegating items of
“medical relevance” that provide neither professional nor patient education to the level of
unacceptability. The new Code requires that brand presentations (via personal and/or
non-personal media) have an HCP or patient education component.

Both Codes refer specifically to interactions between pharmaceutical companies

and HCPs in terms of what may be “offered” or “given” to HCPs by pharmaceutical
representatives. Personal and/or non-personal media must have a HCP or patient
education component. Both Codes seek to eliminate any appearance of impropriety in
the interaction between pharmaceutical representatives and physicians (and their staffs).
Replacing “medically relevant” with “items of an educational nature” is one way to
circumscribe the types of materials individual pharmaceutical companies may
appropriately provide to physicians.   

It is useful to note the first paragraph from Item #10 of the new Code (emphasis
added): “Providing items for HCPs’ use that do not advance disease or treatment
education—even if they are practice-related items of minimal value (such as pens, note
pads, mugs and similar “reminder” items with company or product logos)—may foster
implications that company interactions with HCPs are not based on informing them about
medical and scientific issues. Such non-educations items should not be offered to HCPs
or members of their staff, even if they are accompanied by patient or physician
educational materials.”

The 2009 Code expands the definition of inappropriate “gifts to physicians” as it

was initially outlined in the 2002 Code.

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 A distinction may also be made between gifts to physicians and the inclusion of
traditional product promotion in services to which they may subscribe. This includes
prescription forms, patient record services, and similar services physicians request to
receive (and expect to receive) regardless of support from any given company or brand.
Medical publications and third-party services provided to physicians are not initiated by
any particular company or brand, and constitute usual and customary promotion activity.

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