PANDEMIC INFLUENZA PREPAREDNESS:

Business continuity
planning for the
global healthcare
industry
JANUARY 2007
2
Jan 2007 IFPMA
Contents
Executive Summary 4

Introduction 5

A FRAMEWORK FOR BUSINESS CONTINUITY PLANNING 6

A) Leadership and Staff Continuity 7

A-1. Leadership and Decision Making 7

A-2. Human Resource Planning 7

A-3. Remote Work and Social Distancing Planning 8

A-4. Employee Wellness Planning 9

Hygienic Measures 9
Personal Protective Equipment 10

A-5. Education Planning 11

A-6. Communication Planning 12

B) Operational Continuity 12

B-1. Mapping and Maintaining Key Business Processes 12

B-2. Critical Systems and Infrastructure 13

B-3. Physical and Information Security 13

B-4. Compliance and Drug Safety 13

B-5. Inventory and Safety Stocks 13

C) Supplier and Customer Continuity 13

C-1. Demand and Distribution Continuity 13

D) Public Health Continuity 14

Public Private Partnerships 14

Coordination of Industry Manufacturing Capabilities 15

Coordinated Funding and Regulatory Response 15

PANDEMIC BUSINESS CONTINUITY MANAGEMENT PLANNING 16

RECOMMENDATIONS AND CONCLUSIONS 18

3
 Executive Summary
Many organisations have business continuity plans in place to address the impact of
a crisis on their continuing operations. While these plans are likely to cover a variety
of scenarios, it is important that they are reviewed and updated to address the
specific case of an influenza pandemic. Unlike other crises, an influenza pandemic
could result in a peak employee absenteeism rate of 30% 50% and last for an
extended period of time. Therefore, pharmaceutical manufacturers continuity plans
must focus on maintaining the manufacture and supply of essential medicines to
patients and communities around the world during an influenza pandemic.
This paper outlines the key areas that pandemic influenza business continuity plans
should address. The IFPMA recommends that members develop detailed plans to
address the issues covered in this paper, and publish a non-confidential overview
on their websites to enhance confidence and demonstrate their preparedness
to key stakeholders: employees, governments, suppliers, customers, health care
professionals and local communities. The pandemic plans should cover four
specific dimensions.
Leadership and Staff Continuity:
Plans should ensure decision making processes are in place to handle disruptions
from a pandemic, and should ensure processes are in place to protect the health of
employees and minimise their exposure to the morbidity and mortality associated
with a pandemic. Plans should cover the array of associated Human Resource
issues, communications and education.
Operational Continuity:
Plans should ensure that company operations continue to produce and deliver
essential products and services to key customers.
Supplier and Customer Continuity:
Plans should ensure vital supplies remain available during a pandemic, and
processes for delivering and serving customers remain operational.
Public Health Continuity:
Plans must include coordination with public health providers, and appropriate public
private partnerships, to ensure critical health care needs are addressed. Due to
pharmaceutical manufacturers role in producing medicines, coordination with
governments to minimise the morbidity and mortality associated with a pandemic is
vital. Plans should cover measures that can reduce the impact of a pandemic on
essential medicines for non-influenza conditions also.
The planning process should consist of distinct phases. In the first phase managers
will assess current business continuity plans and undertake analyses of the likely
impact of a pandemic on essential business processes. These will be used in the
second phase to develop specific preparedness plans for leadership and staff
continuity, operational, supplier and customer continuity and contributing to public
health continuity. These plans will be defined and communicated to essential
leadership and staff with responsibility for their execution. The plans should be
tested for a variety of scenarios, to rehearse responses and provide assurance that
they will work. During a pandemic, and in the event of a high probability of a
pandemic in the near term, the plans will be fully rolled out and executed,
constituting the third phase of the planning cycle. Finally, with the execution of the
plan, organisations will make constant adaptations to adjust to current conditions
4 and improve their overall response.
Introduction
Pharmaceutical manufacturers play an important role in maintaining and improving
the health of societies through the manufacture and delivery of medicines.
However, like other organisations, pharmaceutical manufacturers are vulnerable to
external events and crises that can interrupt their business operations and ability to
serve their customers and communities.
Recently, one specific concern that has arisen is the possibility of a pandemic caused
by a virus related to that currently responsible for avian influenza. The World Health
Organisation (WHO) believes that such a pandemic may be imminent1 and that the
avian influenza may transition to a viral form enabling widespread human to
human transmission. While the severity and impact of such an influenza strain
remains uncertain, this transition has the potential to create a pandemic that will
massively affect society, leading to widespread illness and death and interruptions
in critical business and governmental operations. Given the likelihood of a
pandemic, pharmaceutical manufacturers would be wise to adapt their business
continuity plans to include a response to pandemics. Prior research shows that
advance preparation can help companies be less vulnerable to the negative effects
of a pandemic.
This paper provides preliminary guidelines for such a plan. It outlines four key areas
for business continuity planning and identifies critical continuity issues in each area.
It proposes a process for planning and preparation aligned to the WHO stage
model for pandemics. The IFPMA recommends that its members develop their own
detailed plans that address the key issues in this paper. IFPMA also recommends
that members provide a summary report to the association and consider publishing
a non-confidential overview on their company websites to enhance the confidence
of their key stakeholders: employees, investors, customers, suppliers and public
health professionals. The availability of a plan will assure stakeholders that steps
have been taken to ensure business continuity and stakeholder needs on a best
effort basis when confronted with a major pandemic crisis.
Pandemics
An epidemic is the increased occurrence of an infectious illness that appears for
a limited time in a limited location. In contrast, a pandemic is the widespread
occurrence of an infectious disease that occurs across multiple continents for
a limited time. This paper will focus on an influenza pandemic although the
business continuity planning issues suggested in this report may be applied
more broadly to other pandemics or other emergency situations affecting
business continuity.
Influenza pandemics which have caused unusually high levels of illness or death
have previously occurred in 1918, 1957 and 1968. Influenza pandemics pose
various challenges from a medical perspective. Vaccines are usually the most
effective way of preventing seasonal influenza infection, but have not been widely
available for previous pandemics. Vaccines against a new strain of influenza virus
can take anywhere between three to six months to develop and manufacture.
This response time could be too slow to protect people against the first wave of a
pandemic. This situation would be further exacerbated if no prototype or pre-
pandemic vaccines were available that could provide cross protection against the
pandemic strain.
Prior to the availability of effective influenza pandemic vaccines, antiviral drugs
would be the principle medical intervention for reducing morbidity and mortality
(as stated by the WHO2). In addition to treating infected patients, front line workers 5
 required to maintain public services during the pandemic (e.g. healthcare staff,
police, etc) may be protected using stockpiled antivirals or vaccines (although the
latter may not be perfectly matched to the actual pandemic strain).
Given the challenges of creating and delivering effective vaccines in response to a
pandemic, business staff and leadership may have to increase social distance or be
isolated from person-to-person contact to reduce exposure and prevent human-to-
human transmission. The likely interruptions arising from increased social distancing
or widespread disease make it imperative for pharmaceutical manufacturers to
establish a business continuity plan for the contingency of a pandemic. The plan
would help operations to continue, to promote the safety and wellbeing of
employees, and help to keep accessible and available manufacturers products that
are vital to the public interest and health.
While the impact and magnitude of a pandemic are uncertain and will vary across
companies, the impact of an influenza pandemic is expected to be significant.
Based on previous pandemics, reasonable estimates for absenteeism are between
30% and 50% with overall mortality rates between one and two percent. This can
be significantly disruptive to businesses and society in general.
A FRAMEWORK FOR BUSINESS CONTINUITY PLANNING
Most major business organisations are likely to have business continuity plans in
place to address different contingencies from both man-made and natural disasters.
These plans will have to be adapted to the specific contingency of a pandemic and
the special role of pharmaceutical manufacturers in society.
Based on an analysis of prior business continuity models, this paper proposes that
pharmaceutical manufacturers should plan business continuity along four key
dimensions in relation to a pandemic. These include:
A) Leadership and Staff Continuity i.e. ensuring leadership decision making
processes are effectively in place to handle any disruptions from a pandemic, and
ensuring processes are in place to meet the wellness needs of employees, and
minimise their exposure to morbidity and mortality from a pandemic.
B) Operational Continuity ensuring the company facilities and operational
processes can continue to produce and deliver its essential products and services to
key customers.
C) Supplier and Customer Continuity i.e. vital supplies remain available during
a pandemic and processes for delivering and serving customers remain operational
during a pandemic.
D) Public Health Continuity i.e. coordination with public health providers such
as governments and appropriate private public partnerships to ensure critical health
care needs are being addressed. Due to the special role and capabilities of
pharmaceutical manufacturers in producing medicines, coordination with
governments to minimise the disruptive primary or secondary morbidity and
mortality impacts of a pandemic remains vital. Consideration should be given to
measures that can reduce the impact of a pandemic on essential medicines for non-
influenza conditions.
When undertaking planning along each of these four dimensions, it is important to
consider not only the positive measures that must be taken to ensure continuity, but
also those areas that must be scaled down in parallel. Similarly, while the plan will
outline the steps required to maintain continuity, it should also consider the
measures required to reverse the process once the external environment permits
6 the Organisation to re-enter normal operations.
This paper expands on some considerations for planning around each of the
dimensions. Business continuity planners may also find the US CDCs Business
Pandemic Influenza Planning Checklist a useful adjunct to this document3.
A) Leadership and Staff Continuity
The leadership and staff of the manufacturing Organisation form the foundation for
creating business value. Manufacturers should prepare their pandemic plans to
address continuity of leadership and staff, and their well being.
Six key contingency plans required to achieve effective leadership and staff
continuity should be established and addressed:
1. Leadership and decision making
2. Human resources identifying critical workforce for continued operations
3. Remote work and social distancing
4. Employee wellness
5. Education
6. Communication
A-1. Leadership and Decision Making:
A pandemic crisis will create new demands, for leadership and decision-making
in the Organisation, on how to respond to the crisis. One approach for building
management resources to address this challenge is to establish a pandemic
planning and coordination unit that may or may not be part of existing business
continuity planning functions. This group will be chartered with developing overall
continuity plans for the Organisation in advance of the pandemic, and should
incorporate appropriate contingency resources to cover team members who may
become unavailable during a pandemic. As most pharmaceutical manufacturers are
multi-locational and even multi-national the unit will have to coordinate with
location leaders on how to establish continuity plans appropriate to each location
and country. In the event of a crisis local management will be called upon to assure
local continuity and execute a continuity plan. To facilitate this further local
pandemic planning and response teams may need to be specified. A pandemic plan
will further outline decision rights and delegation of spending authorities to local
managers under such a contingency, and will include the identification of backup
individuals with appropriate decision-making rights to provide interim management
in the place of colleagues who become unavailable during a crisis. Advance
allocation of critical decision rights and spending authorities can help managers
respond more quickly to such crises.
A-2. Human Resource Planning:
Human resource (HR) planning identifies strategies for coping with staff absences
during a pandemic and reviews and revises existing policies to address issues and
employee concerns that may arise in a crisis. While estimates vary, 30% to 50% of
staff may be absent during the height of a pandemic due to illness, the need to
tend to family members and community needs, or due to a greater perception of
safety at home. HR plans must consider the potential impact of schools closing,
should account for large absences, and identify who are the essential employees
required to be available to maintain essential operations and plants. In addition, it
should outline any incentives to be provided to essential employees and any impact
on the remuneration and benefits of those requested to stay at home. The plan will
identify which critical staff are required onsite and how to best make them available 7
 and minimise risk to them on and offsite, as well outlining any sites that may need
to be closed and associated policies for requiring staff to work from home. It will
identify work related risk groups to enable rapid diagnosis and treatment for those
who become ill. Furthermore it will identify alternatives if key staff are unavailable
due to illness and prepare in advance to ensure key skills and people are available to
continue operations including within the HR function, which may require additional
resources during a crisis that results in added demands on HR processes. The plans
will establish leave of absence policies related to the crisis, and policies covering
travel, medical insurance and life cover, support for ex-patriot employees and
employee assistance/counselling support. In addition, plans should consider any
impact on these policies if authorities were to place restrictions on travel or the
crossing of borders. HR plans will also establish guidelines for company routine
internal operations, meetings and events so that opportunities for person-to-person
transmission of illness are minimised as a pandemic emerges.
When developing the continuity plan, HR should not be the sole source of
absenteeism planning. HR should work closely with each area likely to be impacted,
such as Supply Chain, Manufacturing, Commercial, Public Affairs, Finance,
Administration, Information Technology, Research and Development, Legal,
Security, Facilities and Environmental Health and Safety to identify business
continuity critical functions and appropriate staffing requirements, including the
potential for outsourcing.
A-3. Remote Work and Social Distancing Planning:
Remote work and social distance planning is vital as illness is usually spread through
person-to-person contact. Some social distancing measures may be mandated by
governments. A key corollary of the human resource plan will be to establish
capabilities for as many staff as possible to contribute through remote work. This
may be done through the use of computer networks such as the Internet, which
enables work from home. Remote work planning must involve Information
Technology departments to address capacity issues that will be faced by a significant
increase in home working. Capacity issues are likely to extend beyond the direct
control of the Organisation, to networks that rely on telecommunication and
internet service providers, as well as infrastructure limitations at employees homes.
Within the work place it is also important to increase social distance and discourage
large group meetings during the course of the pandemic. This again will reduce the
likelihood of transmission. A pandemic plan would identify how workers can best
contribute through remote work and assure the availability of infrastructure to
support this. It will also provide employees with guidelines for social distancing
during the course of the pandemic.
Guidelines on social distancing include:
Avoid any non-essential travel including calls by sales representatives and clinical
trials monitors. Travel will be restricted/cancelled as per the recommendations of
the WHO and the relevant local and national public health authorities.
Avoid meeting people face-to-face, use the telephone, video conferencing and
the internet to conduct business as much as possible, even when participants are
in the same building.
If a face-to-face meeting with people is unavoidable, minimise the meeting time,
choose a large meeting room and sit at least one meter away from each other if
possible; avoid shaking hands or other greetings involving contact.
If possible, arrange for employees to work from home or work variable hours to
8
avoid crowding at the workplace.
 Avoid public transport: walk, cycle, drive a car or go early or late to avoid rush
hour crowding on public transport.
Bring lunch and eat at your desk or away from others (avoid the cafeteria and
crowded restaurants). Introduce staggered lunchtimes so numbers of people in
the lunch room are reduced.
Do not congregate in tearooms or other areas where people socialite. Do what
needs to be done and then leave the area.
Set up systems where clients/customers can pre-order/request information via
phone/email/fax and have the order/information ready for fast pick-up or delivery.
Encourage staff to avoid recreational or other leisure classes/meetings etc. where
they might come into contact with infectious people.
A-4. Employee Wellness Planning:
Employee wellness planning should involve close coordination with local and
national authorities to enhance the safety and health of staff in partnership with the
communities in which they operate. The plans advise employees on strategies to
minimise the risk of infection, including advice for those travelling in affected areas
in pre-pandemic stages. Furthermore, it will review healthcare options for
employees and identify how to provide appropriate critical medical care during the
course of the pandemic, in co-ordination with local authorities. This may include
household quarantine as appropriate and access to antivirals for treatment and to
vaccines for prophylaxis. In the context of influenza pandemics some organisations
may choose to acquire a security supply of antivirals for treatment or prophylaxis
(post-exposure or during a pandemic as appropriate). The WHO proposes that
strong consideration be given by all stockpile-controlling authorities to include
antiviral drugs in their stockpile
It may also include providing materials that may reduce risk of infection by the use
of gloves, masks or respirators. Policies for acquiring and making these resources
available need to be specified in advance, and may apply for instance to limited
cases such as health centre workers. Policies for the provision of specialist
equipment should also consider the practicalities of such provision. For instance,
wearing masks may be uncomfortable and achieving a good fit difficult,
arrangements for eating and drinking should be considered, and the disposal of
clinical waste associated with used equipment should be addressed.
Hygienic Measures
Personal Hygiene
Basic personal hygiene measures should be reinforced and people should be
encouraged to practice them to minimise potential influenza transmission:
Wash hands frequently with soap and water.
Cover your mouth and nose with a tissue when you cough or sneeze.
Put used tissues in a wastebasket.
Cough or sneeze into your upper sleeve if you dont have a tissue.
Clean your hands after coughing or sneezing. Use soap and water or an alcohol-
based hand cleaner.

9
 Ensure that adequate supplies of hand hygiene products are available. This is a
high planning priority as there may be interruption to the supply or shortages of
hygiene products.
Workplace Cleaning
Cleaning of environmental surfaces with a neutral detergent followed by a
disinfectant solution is recommended to minimise the transmission of the virus
through environmental sources. Surfaces that are frequently touched with hands
(e.g. sinks, handles, railings, mirrors, phones, objects and counters) should be
cleaned often, preferably daily.
To avoid possible re-aerosolisation of influenza virus, damp, rather than dry
dusting or sweeping should be performed, whenever possible. Wet-dust
horizontal surfaces by moistening a cloth with a small amount of disinfectant.
During wet cleaning, cleaning solutions and equipment soon become
contaminated; clean less heavily contaminated areas first and change cleaning
solutions, cleaning cloths, and mop heads frequently.
Equipment used for cleaning and disinfection must be cleaned and dried
between uses.
Mop heads should be laundered daily and dried thoroughly before storage
or reuse.
For carpeted surfaces, a vacuum cleaner with HEPA filtration4 should be used.
If such a vacuum cleaner is not available, vacuuming should be avoided, or the
floors should be vacuumed when no persons are present, and the cleaning staff
must be equipped with an FFP3 mask5 or equivalent.
Cleaning staff that empty wastebaskets must wear gloves and an FFP2 mask6 or
equivalent. Employees should be encouraged to close waste bags into which they
have placed materials with increased infectious risk such as used masks and
respirators, hygiene paper towels and tissues.
Air Conditioning
There is scientific and medical evidence that influenza can spread in inadequately
ventilated internal spaces. All internal spaces should be well ventilated, preferably by
fresh air via opening windows, or otherwise by properly designed and maintained
air conditioning systems. In spaces without central air conditioning, consider the use
of natural ventilation (open windows in isolation rooms/areas) if weather permits,
keeping the door closed.
Personal Protective Equipment
Respirators (Face masks)
Currently, neither WHO nor any national government is recommending the use of
respirators by the general public for the virus that causes Avian Influenza H5N1 (Bird
Flu) or any other influenza virus. Nevertheless, people in the general public might
want to make a personal decision to use some form of respiratory protection to
help reduce their exposure to airborne influenza virus. Therefore, plans should
determine whether face masks should be offered to all employees remaining on site
for self protection, in addition to special cases such as health centre workers.
Measures to avoid inhalation of infectious aerosols must be seen as a continuum,
with social distancing as a simple yet effective measure. The choice of the measure
is driven by the degree of protection deemed necessary, and secondary factors such
as the acceptance of the mask (comfort) may also play a role in the choice. Some
10 respirators with certified protection factors are sold with or without exhalation
valves. Masks with such valves are much more comfortable to wear, especially in the
long run, but provide no protection of the environment from the aerosol emissions
of the wearer.
WHO and other bodies have recommended that health care workers exposed
during certain procedures to patients with confirmed or suspected Avian Influenza
use certified respiratory protection equipment. If face masks are used then it is
important that instructions for use are available that include information regarding
the risk of re-use of masks, particularly if the employee has been in contact with
infected individuals. Masks should be immediately disposed into a waste container
after use and not laid on any working surface. Hands should be washed
immediately after removing and disposing of the mask as the surface of a used
mask can be a source of infection. It is also important that masks do not lead to
a false sense of security i.e., should not replace other defined containment and
distancing measures or encourage infected individuals to venture out of their
contained environment.
Examples of disposable particulate respirators acceptable for high risk
situations include:
U.S.: NIOSH-certified N95 (95%), N99 (99%), N100 (99.7%)
Australia/New Zealand: P2 (94%), P3 (99.95%)
China: II (95%), I (99%)
Japan: 2nd class (95%), 3rd class (99.9%)
Korea: 1st class (94%), Special (99.95%)
EU: FFP2, FFP3
Note: The percentage figures indicate the filtering capability in a standardised
laboratory test setting for the material used to manufacture the masks.
The actual protection factors for viruses have not been determined but are certainly
much lower.
Personal Protective Equipment (for Health Care Workers)
As per WHO, the use of Personal Protective Equipment, for instance gloves, gowns,
respirators/masks, eye protectors etc, is mandatory for Health Care Workers if direct
close contact with the patient is anticipated and when entering the room where
aerosol-producing procedures in influenza-infected patients are being performed.
Ensure that adequate supplies are available and refer to WHO guidelines for details.
This is a high planning priority as there may be interruption to the supply or
shortages of personal protective equipment.
For further details refer to WHO Guideline Avian Influenza, Including Influenza A
(H5N1), in Humans: WHO Interim Infection Control Guideline for Health Care
Facilities (last update April 26 2006).
A-5. Education Planning:
Education planning develops programs to educate employees about business
continuity planning, and includes good personal hygiene and work place cleaning
practices in advance, to ensure the spread of avian influenza virus is minimised
during the course of the pandemic. Education can cover seasonal influenza
vaccination and advice for travellers and those residents in affected areas prior to a
pandemic. In addition, it can cover what employees may do from a personal
hygiene perspective and in work interactions to minimise infection. Education may
also cover how employees may prepare for a pandemic at home to minimise public 11
 interactions and to outline general household emergency planning. This may
include information for equipment they may use, such as masks etc, which may
provide a measure of protection against the pandemic. It can also cover how
employees may access healthcare and other facilities, and outline care measures for
employees in the event healthcare provision is overwhelmed. Education can be
provided through multiple channels and formats: meetings that build awareness
prior to a pandemic, through paper and/or digital format documents, online
briefing kits, etc. It is important that education is delivered through credible sources
such as Medical, Human Resources or Environmental Health and Safety
departments, and where appropriate dovetails with the work of external experts
such as WHO, the American CDC, and other local authorities. Planners may also
wish to identify a coordinator in each country.
A-6. Communication Planning:
Communication Planning identifies how leadership can effectively communicate
with staff, partners, suppliers, customers and other stakeholders before, during,
and right after a pandemic. It develops channels and assures their availability during
the course of a pandemic. It ensures communication of key response plans to all
relevant stakeholders, such as employees,, partners, suppliers and customers, in
advance of the pandemic. Again a multi-channel communication strategy should
be considered.
To provide a coherent structure to Communication Planning, manufacturers may
want to align their plans with the WHO Pandemic Phases as messages and themes
are likely to change with the transition through the various pandemic phases and
on to recovery.
B) Operational Continuity
Operational continuity focuses on the key business processes, plant and equipment
for continuing operations, manufacturing and supplying of products during the
course of a pandemic. Many of these categories of planning may already exist in
the context of existing business continuity plans. As a complement of leadership
and staff continuity plans, these plans focus on continued operations. The plan
should also address areas which may impact continued operations, such as contract
provisions and insurance coverage.
Five recommended areas of focus include:
1. Mapping and maintaining key business processes
2. Maintaining critical systems and infrastructure such as information technology
3. Managing physical and information security
4. Managing for compliance and drug safety
5. Maintaining inventory
B-1. Mapping and Maintaining Key Business Processes:
Successful operations are often predicated on the execution of key business
processes. While these may already be documented, the processes should be tested
against the hypotheses of a reduced workforce to implement the processes.
Plans should identify and prioritise key lifesaving and life sustaining products, and
the entire supply chain should be mapped. At risk supplies, such as those from
single sources, should be identified along with mitigation strategies (for example
hedge inventories) to reduce risk of supply chain disruption.
12
B-2. Critical Systems and Infrastructure:
Key business processes are usually supported by a series of essential system and
technology infrastructures. These may be critical manufacturing equipment and
plant or information systems. A key requirement for continued operation of plant
and critical equipment will be to ensure that available staff have the necessary
knowledge to safely operate systems. Furthermore as delays can be expected for
spare parts and other equipment, companies will be wise to ensure their plants are
in good working order, and that they have critical parts stored in advance of a
pandemic as appropriate.
B-3. Physical and Information Security:
While it is difficult to predict the impact of the pandemic on workforces and
operations, the companys physical plants or information systems or even key
employees may be targeted more actively during a pandemic. This may be the case
especially if the company is manufacturing scarce essential products such as a
vaccine or a treatment targeted to the pandemic. Security plans should be reviewed
and adapted for the context of a pandemic. If necessary, physical security needs to
be coordinated with law enforcement or other public authorities. Consideration
should be given to security throughout the entire supply chain.
B-4. Compliance and Drug Safety:
Compliance and drug safety is another source of business risk that must be
addressed in a pandemic plan. It is important that critical safety requirements and
other critical compliance requirements are met during the pandemic period. Any
legal or regulatory waivers likely to be required due to reductions in the available
workforce are best evaluated and applied for in advance of a pandemic.
B-5. Inventory and Safety Stocks:
Pandemics can vary in duration and may consist of several waves. An influenza
pandemic is therefore expected to be disruptive in any specific area ranging from a
few weeks to several months. During this period it is likely that regular deliveries of
essential manufacturing inputs may be disrupted. Furthermore in the event of
production disruptions, inventories of finished goods may also become depleted.
In anticipation of these disruptions it is best where feasible that companies maintain
a higher level of inventories or safety stocks in anticipation of a pandemic. This can
be at the supply chain end as well as the distribution end.
C) Supplier and Customer Continuity
As noted above, a key to operational continuity is the availability of essential
supplies and alignment of the supply chain between manufacturers and their
suppliers. In addition to maintaining safety stocks of critical inputs, it is important
to assess the vulnerability of the supplier to a pandemic. Will the supplier be able to
operate and continue past a pandemic? Assessments of supplier continuity plans
can help to increase confidence in specific suppliers. This can be based on the
sharing of continuity plans between the supplier and the manufacturers seeking
sustained supply.
C-1. Demand and Distribution Continuity
A pandemic may not only disrupt the supply chain but also disrupt the distribution
chain and logistics processes. Furthermore, payment and other systems may be
compromised. Manufacturers should review their capacity to distribute products,
and where appropriate identify alternative distribution and logistics systems, and
the capacity of key buyers to receive, store and further distribute products directly 13
to customers.
 D) Public Health Continuity
An influenza pandemic will result in significantly increased demand for healthcare
products directly involved in the prevention and treatment of influenza and
secondary bacterial infections (notably pneumonia). These include:
Antivirals
Antibiotics
Face masks, disinfectants
Vaccines and syringes
In addition, demand for other essential healthcare products and services will
continue during the pandemic and potentially accelerate, requiring more production
of essential medicines something the manufacturers of select items should be
aware of. It is important to agree in advance with governments what will be
considered essential medical products.
For public health continuity it is important to increase coordination:
Between manufacturers and government agencies for the timely development,
manufacture and supply of essential medicines through public private
partnerships. Coordination between government and industry, establishing what
is required of both parties before and during a pandemic is essential.
Manufacturers and their relevant associations should press for dialogue to further
develop this coordination.
Among manufacturers, to identify and overcome barriers to achieving such
supply, in advance of the pandemic.
Public Private Partnerships
In most countries governments have established pandemic plans including antiviral
stockpiles, which they will control. Government funded antiviral stockpiles have
been established in around 75 countries, with different levels of coverage, as WHO
has advised that stockpiling drugs in advance is presently the only way to ensure
that sufficient supplies are available at the time of a pandemic. However, many
developing countries have only a small stockpile of antivirals, which is likely to limit
their supply in the event of the pandemic.
Where healthcare provision has transitioned from the public to the private sector
in recent years, governments are including the private sector in their plans for
distribution and administration of vaccines, antivirals and other pandemic supplies.
Often the patient prioritisations will be established by the government.
The IFPMA Influenza Vaccine Supply international task force has advocated
the establishment of a public-private partnership to increase access
to prototype or pandemic vaccines to developing countries
(see http://www.ifpma.org/Influenza/index.aspx?45 position statement on
Pandemic Vaccines Supply and Allocation).

14
Coordination of Industry Manufacturing Capabilities
The pharmaceutical industry is also undertaking a number of measures to
increase the supply of products required to prevent or treat pandemic influenza;
these include:
Significant increases in the manufacturing capacities for the principal antiviral
drugs, including sub-licensing arrangements7.
Development of pandemic vaccines; all IFPMA Influenza Vaccine Supply
international task force member companies are in the process of developing
prototype pandemic vaccines. Some have already filed license submissions (see
http://www.ifpma.org/Influenza/index.aspx?42 for list of clinical trials).
Seasonal influenza vaccine manufacturing capacity is estimated to double by
2010. Coupled with the use of antigen sparing approaches (i.e. inclusion of novel
adjuvants in the vaccine, enabling significantly lower antigen doses to be
employed) and development of pandemic LAIV vaccines, the output of pandemic
influenza vaccines should become several times that of seasonal vaccines.
Manufacturers are developing pre-pandemic vaccines based on current strains, with
the potential to offer a level of cross protection against an actual pandemic strain.
This could open up the possibility of routine vaccination of the population against
potential pandemic strains before a pandemic occurs. This would overcome the
delay in provision of a vaccine against the actual pandemic strain, and spread the
huge workload in manufacturing and administering pandemic vaccines over several
years, rather than the several months that would be required if vaccination occurred
only after a pandemic struck. As the availability and manufacturing surge capacity
of other medicines, such as antibiotics to treat secondary bacterial infections, differ
from country to country, this paper cannot address each individual case. However,
manufacturers are encouraged to work in advance with governments to plan the
supply of essential medicines during a pandemic.
Coordinated Funding and Regulatory Response
The pharmaceutical industry is investing heavily in the research, development and
manufacturing of pandemic influenza vaccines and antivirals despite the fact that
there is no guarantee of a significant commercial return, due to the unpredictable and
sporadic timing of pandemics (once every 20 to 40 years, on average). The industry
has requested governments assist with funding support for the above activities, and
also the streamlining of regulatory processes to ensure that pandemic vaccines can be
developed, licensed and supplied as quickly as possible come the pandemic.
The US government has been most forthcoming in funding terms, having already
allocated in excess of $1 billion to pandemic vaccine development and
manufacturing investments, for both egg and cell culture based vaccines. Its goal is
to ensure that there is sufficient domestic production capacity to enable vaccination
of the total population in the event of a pandemic.
Other governments have provided lower levels of funding support to these
activities; examples include Australia, Japan, France, and the UK.
On the regulatory front, EMEA has developed a simplified regulatory process to
facilitate the licensure of pandemic influenza vaccines, called the Mock-Up File
process. Several companies have already made submissions under this process (see
http://www.ifpma.org/Influenza/index.aspx?42 for a list of clinical trials).
Similarly, the FDA has issued guidelines for approval of pandemic vaccines.
The IFPMA urges manufacturers and relevant industry associations to continue
dialogue with governments around the world to maintain progress in this field.
15
 PANDEMIC BUSINESS CONTINUITY
MANAGEMENT PLANNING
Business Continuity Management (BCM) for pandemics anticipates how a pandemic
will impact the essential functions and processes of the Organisation and provides a
planned and rehearsed organisational response to the event. The purpose of BCM
is the continued availability of key processes, to mitigate the negative effects of the
pandemic, and to maintain business operations as efficiently as possible.
When planning, manufacturers will outline the business priorities and objectives
for the pandemic period, determine the scope and magnitude of risks from a
pandemic, when and how to effectively deploy different stages of the BCM plan,
and who will be responsible for BCM planning and implementation.
Current estimates of the impact of an influenza pandemic vary. Reasonable
planning assumptions include:
If avian influenza adapts fully to humans, the disease will spread worldwide in
a few weeks
The pandemic will circle the globe in 2-3 waves, recurring after 4-6 months
25% of the population will become ill in the first wave, decreasing in
subsequent waves
Creating a peak absentee rate between 30-50% (about 20% are ill at
the same time, and the remainder are absent due to care giving and other
personal reasons)
A fatality rate of 3-5% of those who are ill, resulting in about 1% mortality
across the entire population
Most commercial flights will be grounded during the first wave
Although restricting cross-border travel (car, train, bus, air) for a period may not
be particularly effective at preventing the spread of a pandemic virus it should be
assumed for planning purposes that restrictions will be introduced
Cargo transport will be restricted to land and sea, except for critical supplies
(e.g. vaccines)
Cargo transport of certain goods (e.g. food) will be restricted or forbidden
Given the highly infectious nature of pandemic viruses, existing healthcare
systems and infrastructure will be overwhelmed
Vaccines against the exact pandemic strain will not be available until
4 6 months after the first wave arrives
In the next 1 2 years, most governments will not have sufficient stockpiles of
antiviral agents to treat those infected.
While the timing of the influenza pandemic is hard to predict, manufacturers should
assess risks and prepare along the multiple dimensions identified in this paper. This
can be done through a four stage model to: plan, prepare, respond/restore, and
adapt stages as illustrated opposite.

16
 PLAN PREPARE RESPOND
Analyse Develop Implement

Leadership/Staff
Current State Continuity Communications
Assessment Communications and Training
Communications & Technology
Operational, Roll-out of
Stakeholder, operational plans
Public Health and remote work
Business Impact Continuity
Analysis of
Pandemic Test select
responses and Evaluate Rollout
capabilities

ADAPT
Improve response quality and
adapt to current conditions

In the first phase managers will assess the current state of business continuity plans
and undertake business impact analyses of the likely impact of a pandemic on
essential business processes. These will be used to develop specific preparedness
plans for leadership and staff continuity, operational, supplier and customer
continuity and contributing to public health continuity. In the second phase these
preparedness plans will be defined and communicated to the essential leadership
and staff of the Organisation with responsibilities for executing the plans. Specific
responses and capabilities should be tested for a variety of scenarios in this phase
to rehearse responses and assure management they will work. During a pandemic,
and in the event of a high probability of a pandemic in the near term, the plans
will be fully rolled out and executed. This will prepare most staff and focus on
maintaining essential operations as a pandemic interrupts normal business
operations. Once the plans are rolled out managers are likely to have to adapt the
plans to unforeseen contingencies and situations.
The World Health Organisation has created a six-phase model for the development
of a pandemic. In the context of an influenza pandemic we are currently in phase 3
as illustrated below:

Phase Description

Interpandemic Stage
No new influenza virus subtypes have been detected in humans. An influenza virus subtype that has caused human
1 infection may be present in animals. If present in animals, the risk of human infection or disease is considered low.
No new influenza virus subtypes have been detected in humans. However, a circulating animal influenza virus subtype
2 poses a substantial risk of human disease.
Where
we are
Pandemic Alert Period now

Human infection(s) with a new subtype but no human-to-human spread, or at most rare instances
3 of spread to a close contact.
Small cluster(s) with limited human-to-human transmission but spread is highly localised, suggesting that the virus
4 is not well adapted to humans.
Larger cluster(s) but human-to-human spread still localised, suggesting that the virus is becoming increasingly better
5 adapted to humans but may not yet be fully transmissible (substantial pandemic risk).

Pandemic Period

6 Pandemic: increased and sustained transmission in general population. 17

 Given that the timing of disease progression across phases is highly uncertain,
companies should aggressively plan for a pandemic as soon as possible.
Preparedness plans should be developed and components tested as soon as phase
four is recognised. If phase five is recognised key components of the business
continuity plan should be rolled out in the regions most vulnerable to the spread of
the illness. If the disease transitions to a pandemic version full plans need to be
rolled out and executed. While this alignment with WHO phases provides a practical
reference for planners, the plans should recognise that certain actions may require
more fine-tuned trigger points.
Depending on the size of the manufacturers, the Organisation, preparation and
execution of the plan will be highly varied. BCM planning for the pandemic may be
a central effort out of corporate headquarters, or localised to countries and regions,
or a combination of both. In some cases most of the work will be done in-house, in
other cases companies will turn to third parties to access additional capabilities to
develop plans. Ultimately as key responses have to be local, senior management in
different locations must be enlisted early in the planning process to either develop
or prepare for the execution of the companys continuity plans. This will be vital to
the effective deployment of pandemic continuity plans and their effective
adaptation to different local contexts.
RECOMMENDATIONS AND CONCLUSIONS
This white paper provides a framework that identifies essential business continuity
elements to be considered in a pandemic plan. Different companies will consider
these elements and choose to design and execute a plan appropriate to their
context, based on their values, available resources and perceived level of risk.
The IFPMA recommends that all pharmaceutical manufacturers set up a pandemic
plan that addresses most of the topics raised in this report. The IFPMA also
recommends that pharmaceutical manufacturers share high level plans, planning
templates and communications and recommendations to employees and the public
for their safety during a pandemic. This will provide consistent approaches and
reduce the costs of planning and executing business continuity plans in the event of
a pandemic.

18
References:
Business Continuity Guide for Australian Businesses (by the government of
Australia, June, 2006)
Business Continuity Planning Guide (by the government of New Zealand,
October 2005)
Continuity Planning Guide for Canadian Business (by Canadian Manufacturers
and Exporters, March 2006)
Health Advice on Prevention of Avian Influenza in Workplace (Government of the
Hong Kong Special Administrative Region (HKSAR) August 2005)
National Influenza Pandemic Plans (Submitted to and compiled by the WHO)
National Strategy for Pandemic Influenza: Implementation Plan (by US Homeland
Security Council, May 2006)
Pandemic Influenza Checklist for Businesses (by UK Cabinet Office)
Schutz von Beschftigten vor der Vogelgrippe (Jointly prepared by the
Hauptverband der gewerblichen Berufsgenossenschaften HVBG, Bundesverband
der Unfallkassen BUK, Bundesverband der landwirtschaftlichen
Berufsgenossenschaften BLB)
What Employers/Enterprises Should Know about Influenza Preparedness
(Government of the Hong Kong Special Administrative Region (HKSAR))
1. Ref: WHO/CDS/CSR/GIP/2005.8 (page 2):
http://www.who.int/csr/resources/publications/influenza/WHO_CDS_CSR_GIP_05_8-EN.pdf
2. Avian influenza: assessing the pandemic threat (page 49):
http://www.who.int/csr/disease/influenza/H5N1-9reduit.pdf
3. http://www.pandemicflu.gov/plan/pdf/businesschecklist.pdf
4. The High Efficiency Particulate Arrestor (HEPA) is a 99.97% effective filter that is commonly used in hospital
operating rooms and other sites where particle- and bacteria-free air is mandatory.
5. An FFP3 mask offers the highest level of protection (99% particle filtration efficiency) in the European Union grading
system for disposable Air Purifying Respirators in the EN149 class.
6. The FFP2 mask offers only 95% particle filtration efficiency and is the EUs close equivalent to the American
NIOSH N95.
7. Sub-licenses to local manufacturers in India, China and South Africa for the production of generic oseltamivir and
to local manufacturers in China for the production of generic zanamivir.

19
About the IFPMA (www.ifpma.org):
The International Federation of Pharmaceutical Manufacturers & Associations is the global non-
profit NGO directly representing twenty-six research-based pharmaceutical, biotech and vaccine
companies and sixty national industry associations in developed and developing countries.
The industrys R&D pipeline contains hundreds of new medicines and vaccines being developed
to address global disease threats, including cancer, heart disease, HIV/AIDS and malaria.
The IFPMA Clinical Trials Portal (www.ifpma.org/clinicaltrials) and the IFPMA Health Partnerships
Survey help make the industrys activities more transparent. The IFPMA strengthens patient safety
by improving risk assessment of medicines and combating their counterfeiting. It also provides
the secretariat for the International Conference on Harmonisation of Technical Requirements for
Registration of Pharmaceuticals for Human Use (ICH).
About the IFPMA Influenza Vaccine Supply International Task Force:
The IFPMA Influenza Vaccine Supply International Task Force (IVS ITF), established in February
2002, brings together research-based influenza vaccine manufacturers from around the world,
which are conducting the R&D necessary to develop safe, effective, high-quality vaccines against
avian and pandemic influenza threats. The IVS ITF works within the constraints of anti-trust law
to address the advocacy, communication, policymaking, regulatory, scientific and technical issues
related to interpandemic and pandemic influenza vaccines. IVS ITF members are committed
to make their unique expertise in R&D, logistics, manufacturing, safety and regulatory issues
available to help governmental and intergovernmental bodies in pandemic planning and
decision-making. For more information, see: www.ifpma.org/influenza.

Dr Ryoko Krause
Director, Biologicals and Vaccines, IFPMA
Ch. Louis Dunant 15, P.O. Box 195
1211 Geneva 20, Switzerland
Tel: +41 22 338 3200 Fax: +41 22 338 3299
Web: www.ifpma.org Email: r.krause@ifpma.org