APPENDIX 44
Memorandum by Pfizer (PI 28)
EXECUTIVE SUMMARY
Pfizer
Pfizer Inc is a research-based global pharmaceutical
company that discovers, develops, manufactures and markets leading
prescription medicines for humans and animals, and many of the
world's best-known consumer products. In the UK, Pfizer Ltd is
the largest single supplier of prescription medicines to the NHS.
Medicines Innovation
The key to Pfizer's continued investment in
the UK is the strength of the UK and European science base. High
quality science is essential to the innovation that leads to the
invention and delivery of new medicines to patients, and the improvement
of the health and wealth of the nation. Pfizer actively supports
the science base and since 1998 has invested more than £1
billion in the UK, including over £450 million on research
buildings and pilot plant facilities. Pfizer spends £10 million
on research and development in the UK every week, nearly £1,000
a minute. If the UK is to continue to attract inward investment
from global pharmaceutical companies, then it needs to remain
committed to investing in the science base.
Conduct of medical research
The implementation of the Clinical Trials Directive
ensures that all clinical trials covered by the directive conducted
in the UK, whether public or private, will be conducted to uniformly
high standards. Pfizer partners and collaborates with the NHS
in the support of both commercial and non-commercial research,
which benefits many NHS research units. Pfizer's support helps
to make up the shortfall of public sector funding within the UK.
As the UK is one of the most expensive places to conduct research,
this seriously reduces its competitiveness when competing for
the placing of research by global companies. Further government
action is required to drive down the cost of clinical research
to maintain the attractiveness of the UK as a location to conduct
research.
Provision of medicines information and promotion
A medicine's marketing authorisation includes
an obligation for the pharmaceutical company to provide information
on request to healthcare professionals. To comply with the Code
of Practice, companies are obliged to have a "scientific
service responsible for information". This obligation continues
beyond the date of loss of data and patent exclusivity, which
means that information may be requested and supplied on a generic
medicine not produced by the pharmaceutical company, which invented
the original product. The cost of running such a department to
meet this obligation involves considerable expense. Generic manufacturers
are under no obligation to provide this service and therefore
do not have to bear the costs of providing it. The overall cost
of Pfizer's medical information provision is in excess of £1
million per annum.
Professional and Patient Education
Pfizer's principal objective when providing
professional and patient education is to achieve the best outcome
for patients through appropriate use of its medicines. Pfizer
provides both professional and patient education programmes in
line with the legislation and the ABPI Code of Practice. Pfizer
can only engage in patient education through information contained
in patient information leaflets and disease awareness campaigns,
for example, the "Cholessterol" campaign, designed to
educate patients about cholesterol and coronary heart disease.
Disease awareness programmes can only communicate information
about the disease, available treatment options and advice to patients
to consult their healthcare professional. Pfizer supports the
industry's call for legislative change to allow pharmaceutical
companies to communicate scientifically reliable information directly
to patients. Pfizer shares the view of Government and regulators
that greater access to scientifically accurate, non-promotional
information about medicines will greatly improve patient concordance
and health outcomes.
Regulatory review of medicines safety and efficacy
Pfizer operates within the UK and EU legislative
frameworks to bring innovative new medicines that will deliver
health benefits to patients. Pfizer shares a common objective
with government and patients in ensuring that the MHRA's assessment
process is transparent, robust and based on a high level of scientific
evidence. This process must be efficient in order to maximise
the improvements in quality of life, or the life saving potential,
of a new medicine. Pfizer recommends that the MHRA continues to
build close working relationships with the other international
regulatory institutions and the pharmaceutical industry. This
approach will benefit patients by increasing the efficiency with
which medicines are made available to a large international community,
utilising data gathered from a heterogeneous patient population.
Pfizer suggests that transparency for licensing
decisions made by the MHRA is in the interests of patients, regulators
and industry. Current levels of interaction are not sufficient
and it could be argued that further openness in the MHRA's decision-making
process is needed. Industry could also play a more proactive role
in providing non-commercially sensitive data. Pfizer welcomes
all opportunities to work closely with the MHRA to protect public
health.
Product evaluation, including assessments of value
for money
Pfizer recognises that it has a responsibility
to develop medicines that are clinically effective and represent
an efficient use of NHS resources. Many innovative new medicines
deliver significant and obvious improvements in patient outcomes
at the point of approval. However, it must be recognised that
some produce incremental improvements in patient care that are
only demonstrated after several years use by the NHS.
Pfizer recognises that it needs to collaborate
with Health Technology Assessment (HTA) organisations effectively
and early in the medicine's development process to agree which
data are required to conduct value for money assessments. HTA
organisations, when planning to introduce additional data requirements
for medicines approval, must recognise that pharmaceutical research
and development programmes are planned in advance and can take
up to 10 years. There should therefore be a gradual phasing in
of planned changes to ongoing research and development programmes.
HTA organisations should establish a formal process for ongoing
dialogue with companies from the second phase of clinical trials
of a medicine in human beings onwards. This would promote better
understanding of the medicines and its potential impact on the
condition as well as its value to the NHS. These organisations
should work more closely with the appropriate regulatory authorities
to reduce duplication of effort and to accept regulatory evidence.
Pfizer is keen to see the end of post-code prescribing
and believes that patients should have access to the same high
quality of care, irrespective of where they live.
1. INTRODUCTION
1.1 Pfizer Inc is the world's largest research-based
global pharmaceutical company. The company discovers, develops,
manufactures and markets many leading prescription medicines for
humans and animals as well as many of the best-known consumer
medicines.
1.2 Pfizer's medicines help millions of
people in the UK manage conditions or alleviate symptoms in areas
such as cardiovascular disease, diabetes, respiratory disease,
oncology, central nervous system disorders, chronic pain, mental
health, ophthalmology, urology, sexual dysfunction and endocrinology.
Every month over 2 million people in the UK take a Pfizer medicine.
Pfizer is dedicated to producing medicines that improve patient
care, add value to healthcare and represent good value for money
to the NHS.
1.3 Pfizer Ltd is the largest single supplier
of prescription medicines to the NHS and also provides a wide
range of over-the-counter medicines. The company is also a leading
pharmaceutical partner of the NHS in areas such as smoking cessation
and chronic disease management, and operates under the principle
that the pharmaceutical industry has the potential to do more
good for more people than any other sector through the discovery,
development and distribution of innovative medicines.
1.4 Pfizer is one of the largest inward
investors into the UK and has around 6,985 employees throughout
the country. Of these approximately 3,600 work for Pfizer's European
Headquarters for Research and Development based at Sandwich in
Kent. A further 700 employees work in the new award winning UK
Business Headquarters at Walton Oaks in Surrey. There are four
regional offices in Birmingham, Edinburgh, Manchester and Watford
and a field force based throughout the UK.
1.5 Throughout the course of Pfizer's presence
in the UK, it has supported and worked in partnership with government;
the NHS; the Royal Colleges and other healthcare professional
and trade bodies; educational and research institutions; NGOs;
parliamentarians; patient groups; and the local communities where
it is based. The company has provided assistance and resources
to support a diverse range of projects and programmes, and has
always endeavoured to be in open and reciprocal partnerships,
governed by mutually agreed and transparent guidelines.
2. MEDICINES
INNOVATION
2.1 Pfizer Global Research and Development
(PGRD), the company's research and development division, is the
largest private biomedical research operation in the world, and
employs 15,000 scientists worldwide. In 2003, Pfizer spent more
than $7 billion globally on research and development (R&D),
more than any other private organisation.
2.2 Although Pfizer's investment is an important
contributor to the company's success in the UK, the key to continued
investment here is the strength of the British and European science
base. As a research-based organisation, Pfizer recruits talented,
innovative scientists from around the world who want to apply
their knowledge and energies to discover and develop new medicines
for conditions such as HIV/AIDS, neuropathic pain, chronic obstructive
pulmonary disease and asthma. The company's state-of-the-art laboratories
and access to the latest technologies give bio-medical research
scientists the tools to make a difference to the health of patients
worldwide, and the working environment provides a broad range
of opportunities for them to grow and develop their careers.
2.3 High quality science is essential to
the innovation that leads to the invention and delivery of new
medicines to patients, and the improvement of the health and wealth
of the nation. Pfizer actively supports the science base, and
since 1998 has invested more than £1 billion in the UK, including
over £450 million on new research buildings and pilot plant
facilities at the Sandwich Laboratories. Pfizer spends £10
million on research and development in the UK every week, nearly
£1,000 per minute. In addition, to ensure the continuing
strength of research in the UK more than £5 million was spent
funding science education in the last year alone. Projects ranged
from raising the standard of science teaching in primary schools,
through to financial grants for young scientists and funds for
research projects.
2.4 This massive investment in the UK has
returned a significant dividend in terms of innovative new medicines
for patients. Over the last 20 years the Sandwich laboratories
have discovered and developed many novel medicines such as:
Amlodipine (Istin™), calcium
antagonist for the treatment of high blood pressure and disease
caused by the inadequate supply of blood to the heart.
Fluconazole (Diflucan™) and voriconazole
(Vfend™), therapies for the treatment of life threatening
systemic fungal diseases.
Sildenafil (Viagra™), the
world's first oral therapy for the treatment of erectile dysfunction.
Doxazosin (Cardura™), to treat
high blood pressure and benign swelling of the prostate gland.
2.5 This success in producing innovative
medicines continues today. For example the Sandwich laboratories
have recently unveiled a significant new approach to the treatment
of HIV with a new class of medicines, known as CCR5 antagonists.
For the first time, this treatment will enable doctors to prevent
the access of virus into human cells, thereby reducing the threat
of viral resistance, an enormous problem in treating this disease.
2.6 In summary, Pfizer has invested and
continues to invest large sums in the UK to fund its own research
and to support the science base. The innovations resulting from
this investment have lead to world-class medicines for the treatment
of many cardiovascular and infectious diseases.
2.7 Pfizer welcomes the work begun by Government
in partnership with the industry through the Pharmaceutical Industry
Competitiveness Task Force to support and develop the UK science
base, and is working in partnership with the Government to deliver
the ten-year strategic plan for the future funding of the science
base in order to put the value of excellence in science and innovation
onto the balance sheet of UK plc.
2.8 However, the past successes and current
excellence of the science base give no room for complacency if
the UK is to remain competitive for the future. Medicines discovery
and development is becoming increasingly complex and challenging
and the war for talent in a competitive global environment, coupled
with ever-tightening and increasing regulation, all pose threats
to Britain's past excellent record in this area.
3. CONDUCT OF
MEDICAL RESEARCH
3.1 The primary aim of medical research
is to develop safe, effective and innovative medicines for the
benefit of patients by treating and preventing disease. Studies
are conducted in a safe and ethical manner to the highest standards.
All data are presented to the regulatory authorities for their
independent assessment and consideration as to whether a marketing
authorisation can be provided. All safety data generated from
studies and normal clinical use are regularly submitted to the
regulatory authorities.
3.2 Post-licensing studies are conducted
to identify further indications, investigate, develop and validate
clinical assessments and demonstrate the health economic value
of our medicines.
3.3 The outcome of important studies improves
medical practice and delivers better patient outcomes. The pharmaceutical
industry generates the majority of the corpus of research that
serves to make evidence based medicine possible. In the UK alone
with regard to funding of healthcare related research and development
by resource in the year 2000, the pharmaceutical industry funded
65% of research.[117]
3.4 The implementation of the European Clinical
Trials Directive now ensures that all clinical trials covered
by the directive conducted in the UK, whether public or private,
will be conducted to uniformly high standards.
3.5 Pfizer partners and collaborates with
the NHS in the support of both commercial and non-commercial research
to the benefit of many research units within the NHS and can now
do so without becoming the sponsor of the research. The company's
support also helps to make up the shortfall of public sector funding
in the UK.
3.6 However, the UK is still one of the
most expensive places to undertake research, which seriously reduces
its competitiveness with regard to the placing of research in
a global company. FastTrack for 2002, an international annual
assessment of cost comparisons of clinical trials, showed that
the UK was the second most expensive country to undertake research.
Further government action is required to drive down the cost of
clinical research if further research is not to be placed abroad
in more competitive countries where cost is lower, speed is faster
and quality at least equivalent.
3.7 Pfizer supports the recommendations
of the American Pharmaceutical Group in respect of the development
of a publicly available registry of late-stage clinical trials
in order that patients should have the benefit of more information
about their medicines.
4. PROVISION
OF MEDICINES
INFORMATION AND
PROMOTION
4.1 Information about medicines, and the
way in which pharmaceutical companies promote them is regulated
by both statutory controls, and market constraints. In addition,
a voluntary Code of Practice exists to ensure that medicines are
promoted in an ethical way in the United Kingdom.
4.2 The Marketing Authorisation of a medicine
includes an obligation for the pharmaceutical company to provide
information on request to healthcare professionals (HCPs). The
Code of Practice (The Code) of the Association of the British
Pharmaceutical Industry (ABPI) states that:
"Upon reasonable request, a company must
promptly provide members of the health professions and appropriate
administrative staff with accurate and relevant information about
the medicines which the company markets." (Clause 7.1 of
the Code).
4.3 To achieve this, companies are obliged
to have a "scientific service responsible for information"
(Clause 13 of the Code).
4.4 This obligation continues beyond the
date of loss of data and patent exclusivity. This means that information
may be requested by healthcare professionals on off-patent Pfizer
medicines now being produced by generic manufacturers. These "generic
companies" are under no similar obligation, and therefore
do not have to bear the costs or providing this service.
4.5 The employment, training and equipment
of a department to meet this obligation involves considerable
expense. Over a financial year, the Medical Information Department
of Pfizer Ltd receives approximately 26,000 requests for information
directly from Health Care Professionals and administrative staff,
and 12,000 indirectly through Sales Representatives. This equates
to about 150 requests per day. The responses to these requests
can range from a simple telephone call or a written answer, to
the provision of detailed data either in written form or even
as a presentation from a suitably qualified member of Pfizer's
Medical Department. The overall cost of Pfizer's medical information
provision is in excess of £1 million per annum.
4.6 As approximately 97% of prescriptions
are supplied by the NHS, it is clearly appropriate that statutory
controls exist to ensure that the promotion of medicines is conducted
in an acceptable way. These controls include The Medicines Act
(1968), the Medicines Advertising Regulations (1994) and amendments
and the Control of Misleading Advertisements (1988) and amendments.
The Code of Practice of the ABPI was introduced in 1958 and now
virtually all the pharmaceutical companies in the UK accept its
jurisdiction. The Code is regularly revised in consultation with
the British Medical Association, the Royal Pharmaceutical Society
of Great Britain and the Medicines and Healthcare products Regulatory
Agency (MHRA) of the Department of Health. "The Code reflects
and extends well beyond the legal requirements controlling the
advertising of medicines" (The Code, 2003, Introduction,
p 4).
4.7 The Code covers all aspects of the promotion
of medicines, including advertisements, Representatives' activities,
meetings, the provision of education and hospitality and the provision
of medical information, as discussed above.
4.8 The Code accepts complaints from competitor
companies, healthcare professionals and members of the public.
The Director of the Prescription Medicines Code of Practice Authority
(PMCPA) is also obliged to scrutinise advertisements in the medical
press, which provides another check on the quality of this medium
of promotion. Most significantly, the outcomes of the Code's proceedings
are made public and are available to the statutory body. Moreover,
the MHRA undertakes its own surveillance of pharmaceutical companies'
advertisements. This surveillance is becoming increasingly active.
4.9 A fundamental review of the Code is
imminent in the face of an ongoing review of the European Code
of Practice for the Promotion of Medicines, which is administered
by the European Federation of Pharmaceutical Industries and Associations
(EFPIA). The preliminary draft of this EFPIA Code closely mirrors
the UK Code. This is in keeping with our understanding that the
regulations and the Code governing medicines promotion in the
UK are widely considered to be as stringent as those of any other
country in the world.
4.10 Since 1994, the Association of Information
Officers in the Pharmaceutical Industry (AIOPI) has convened a
working party to create an industry standard for medical information
functions. The purpose of this initiative was to provide a reference
against which medical information departments could monitor and
improve their performance in line with customer requirements.
4.11 The working party consists of representatives
of medical information departments from a range of pharmaceutical
companies, both small and large, and from hospital-based information
pharmacists (the UK Medicines Information Pharmacists Group, UK-MIPG).
Endorsements for successive revisions of the guidelines are sought
from the AIOPI committee, UK-MIPG membership, and the ABPI. All
pharmaceutical company representatives have to achieve standards
in qualifications set by the PMCPA within two years of joining
the industry.
5. PROFESSIONAL
AND PATIENT
EDUCATION
5.1 Professional and patient education is
tightly regulated by UK and European law, and is supported by
a voluntary, enforceable and transparent ABPI Code of Practice.
The principal objective of Pfizer's effort to provide professional
and patient education is to achieve the best outcome for patients
from the most appropriate use of its medicines.
5.2 Pfizer provides professional education
in regulated medical education programmes and partnership activities
with healthcare professionals; their professional bodies and trade
associations; educational institutions; medical societies and
publishers; the government and the NHS. New partnerships initiated
in the past 12 months include an initiative with Brighton and
Sussex Medical School, where there is to be a Pfizer staff member
on the Clinical Research Unit management team to give expert input.
Another example is a partnership with the Royal Colleges of Physicians
and General Practitioners, working with their education unit at
the University of Bath, in support of their existing Medical Education
efforts for specialists in training and General Practitioners.
5.3 The promotion of prescription-only-medicines
to the public is not permitted. Pfizer can only engage in patient
education about prescription-only-medicines through information
contained in medicines packaging. Communication with the public
is therefore limited to information about disease awareness and
must not be considered to be an inducement to request a specific
medicine. Pfizer has launched several educational disease awareness
campaigns in a variety of disease areas. There can now be little
doubt that such campaigns are contributing hugely to the nation's
understandings of health and disease. They can provide valuable
support to the successful attainment of targets set out in National
Service Frameworks and the General Medical Services contract.
The "Cholessterol" campaign, designed to educate
patients about cholesterol and coronary heart disease, is ongoing
and is an excellent example of such an initiative. These programmes
can only communicate information about the disease, available
treatment options and advice to patients to consult their healthcare
professional. They cannot in any way be brand-specific or speak
only about a medicinal intervention. These public health campaigns
are carried out a significant cost to Pfizer.
5.4 Pfizer's relationships and partnerships
with patient groups, voluntary sector and other stakeholders are
governed by its published guidelines. Many stakeholders are of
great importance in ensuring the delivery of good quality cost-effective
healthcare, including healthcare providers, patient groups and
political organisations.
5.5 The establishment of collaborative working
relationships with shared objectives between Pfizer and patient
groups can result in real benefits for those affected by the disease
or condition who are represented by the patient group, especially
where there are shared objectives, common goals, and mutual benefits.
5.6 Support for patient groups can be provided
in different ways, for example, financial sponsorship; donations;
project funding or core funding. It can also be delivered through
other benefits in kind, for example, resources to support internal
and external communication; education and external policy initiatives.
5.7 It is important that such partnerships
and collaborations are based on the understanding that all activities
should be conducted within a clearly understood and mutually accepted
set of key operating principles, in order to avoid both the reality
and the perception of improper or undue influence.
5.8 The principles of Pfizer's guidelines
state that there should be transparency at all times in any activities
between Pfizer and the patient group. Confidential information
about members of the patient group, individuals associated with
it, or other confidential information should remain the property
of the patient group and should not be made available to Pfizer.
The independence of internal policy making, political judgement
and other activities of the patient group are be assured at all
times. Copies of our operating principles are attached.
5.9 Pfizer has been working closely with
patient groups and think tanks to understand and address growing
concerns for patient safety because of threats to the integrity
of the European pharmaceutical supply chain. Constructive relationships
have been built with groups such as Depression Alliance and the
Patients Association to better understand patients' concerns.
5.10 As a member of the ABPI, the company
supports the Association's Informed Patient Taskforce's objectives
and the industry's call for legislative change to allow pharmaceutical
companies to communicate scientifically reliable information more
directly to the ultimate consumers of its medicines. In common
with the Government and the regulators, Pfizer believes that a
greater access to scientifically accurate non-promotional information
about medicines will greatly improve patient concordance and health
outcomes.
6. REGULATORY
REVIEW OF
MEDICINES SAFETY
AND EFFICACY
6.1 In common with other research-based
companies that invent new medicines, Pfizer operates within a
legislative framework that is enforced by UK and EU regulatory
authorities. This legislation is frequently updated and revised
to reflect new medical outcomes and scientific advances. Medicines
are either approved through the Mutual Recognition Procedure (MRP)
or the Centralised Procedure (CAP).
6.2 The MHRA evaluate the safety, efficacy
and quality of each medicine and will only approve it for use
in the UK if satisfied that the benefits of a medicine outweigh
any risks associated with it. Pfizer submits a comprehensive dossier
containing all research and development data when applying for
a licence for a new medicine. This comprises on average around
60,000 pages. Pfizer's responsibility does not end at that point,
as there is a legal requirement to inform the MHRA of any information
that may affect the risk-benefit profile of the medicine. This
is something the company takes very seriously and to which it
commits a significant proportion of resource involving a team
of around 50 people within the UK who co-ordinate globally with
colleagues in similar functions.
6.3 As is routine amongst companies that
invent new medicines, Pfizer complies with the normal standards
of Good Manufacturing Practice (GMP), Good Clinical Practice (GCP)
and Good Laboratory Practice (GLP). The MHRA's inspection enforcement
group can inspect for these practices. The MHRA has also recently
introduced Pharmacovigilance inspections.
6.4 Pfizer shares a common objective with
government and patients in ensuring that the MHRA's assessment
process is transparent, robust and based on a high level of scientific
evidence. Pfizer's purpose is to invent innovative new medicines
that will deliver much needed health benefits to patients. It
is important that this process is as efficient as possible in
order to maximise the improvements in quality of life, or the
life saving potential, of a new medicine.
6.5 There is a need for the existing ongoing
dialogue between the MHRA and Pfizer throughout the development
of a new medicine. This is essential in order to ensure that the
requirements of the regulators are fully met to address areas
within new indications that have not been previously investigated
and generally to ensure that the proposed pre-clinical or clinical
trial programme is appropriate. Advice sought can be diverse,
including ascertaining the most appropriate regulatory procedure
to use for registration purposes in Europe, defining the criteria
for a new indication, the scope and design of the clinical trials,
and the recommended risk management programme. Advice can also
be sought on how best to design the trial so that the data required
by the regulatory authorities can be obtained. Both a Clinical
Trial Application (CTA) approval from the MHRA, and independent
local and national ethics committee approvals are needed to conduct
a clinical trial.
6.6 Pfizer cooperates closely with regulators
and other stakeholders (eg patient groups and consumers associations)
during the drafting of new guidelines. These provide guidance
on the implementation of European law. Pfizer plays a critical
role in highlighting the practical implications of these proposals,
ensuring that they are actually able to deliver the benefits sought.
This can be achieved through a consultation process or through
the setting up of advisory committees on which there is industry
representation. Successful examples in which MHRA has engendered
a particularly productive engagement with all stakeholders including
Pfizer are: the pan European review of medicines' legislation;
the labelling best practice guidance issued by the MHRA devised
to reduce medication errors; and the Committee on the Safety in
Medicine's review of Patient Information Leaflets, currently in
progress, to improve the quality of patient leaflets supplied
with medicines.
6.7 The applicant is not present, even as
an observer, at the review of a new medicine by the independent
Committee on Safety of Medicines. It is therefore imperative that
the applicant continues to have an opportunity to explain the
data, provide clarification and answer questions in the lead up
to this meeting. The MHRA seeks independent scientific advice
through their advisory committees, including the CSM. Declaration
of interests by Committee members ensures that scientific opinion
is independent and unbiased.
6.8 In common with other pharmaceutical
companies, Pfizer pays fees to the MHRA for the assessment of
the marketing authorisation application and subsequent variations.
Fee details and levels are published and revised by the MHRA on
a yearly basis.
6.9 Pfizer informs the MHRA of the evolving
safety and adverse event profile of all medicines. Pfizer and
the MHRA update the product information and labelling to reflect
such changes so that healthcare professionals and patients have
access to the latest information.
6.10 At the time of licensing there will
be extensive clinical data on the use of the medicine. However
Pfizer has pharmacovigilance/risk management systems in place
to monitor and assess the use of the medicine by patients in the
post-marketing phase. The Pharmacovigilance team reviews Adverse
Drug Reaction (ADR) reports, expediting their reporting to the
MHRA where appropriate, and summarising all the data received
in a regular Periodic Safety Update Report (PSUR). The MHRA periodically
conducts pharmacovigilance inspections of ADR reporting systems
and have enforcement powers including company closure if serious
non-compliance is found. The requirement for Pharmacovigilance
is heavily embodied in legislation and there are severe penalties
for non-compliance, both for the company and the individuals held
accountable. Pfizer works closely with the MHRA to ensure full
compliance with pharmacovigilance obligations.
6.11 Newly approved medicines are subject
to intensive monitoring by the MHRA as part of the CSM Yellow
Card/Black Triangle (adverse event reporting) scheme. This scheme
allows rapid monitoring of new safety signals as medicines become
available on prescription. The MHRA publish all significant conclusions
drawn from this safety surveillance system in "Current problems
in Pharmacovigilance". Pfizer considers this scheme to be
of tremendous value for patients, doctors and the research based
industry and shares the MHRA's aspiration that the current review
will only introduce changes that enhance its integrity and effectiveness.
6.12 Good communication channels between
the MHRA and pharmaceutical companies are also essential when
the MHRA requires information at very short notice, for example,
paediatric data summaries.
6.13 The benefit-risk assessment for each
medicine is a continuous process based on quality, safety and
efficacy. It is important to have dialogue with the MHRA, or indeed
other regulatory agencies, prior to, during and post approval.
This ensures rapid delivery of a rigorously evaluated medicine
to the patient, accompanied by the appropriate advice on how it
should be used. Pfizer supports any initiative that enhances the
quality of that communication.
6.14 Pfizer suggests that transparency for
licensing decisions made by the MHRA is in the interests of patients,
regulators and industry. Current levels of interaction are not
sufficient and it could be argued that further openness in the
decision-making process by the MHRA is needed. Industry could
also play a more proactive role in providing non-commercially
sensitive data to patients.
6.15 The MHRA, along with the pharmaceutical
industry, aspires to have an assessment process that is transparent,
robust and based on a high standard of scientific evidence. It
is recommended that the MHRA continues to build close working
relationships with the other international regulatory institutions
and the pharmaceutical industry. This approach will benefit patients
by increasing the efficiency with which medicines are made available
to a large international community, utilising data gathered from
a heterogeneous patient population.
6.16 Pfizer welcomes all opportunities to
work closely with the MHRA to protect public health.
7. PRODUCT EVALUATION,
INCLUDING ASSESSMENTS
OF VALUE
FOR MONEY
7.1 Pfizer recognises that it has a responsibility
to develop medicines that are clinically effective and represent
an efficient use of NHS resources.
7.2 Faster patient access to clinically
effective and cost-effective new medicines is an important means
of improving health outcomes in the UK. Pfizer fully supports
the National Institute for Clinical Excellence's (NICE) objective
of faster and consistent access to innovative, new technologies
across England and Wales.
7.3 "Innovative new medicines"
should not be restricted only to those that deliver significant
and obvious improvements in patient outcomes at the point of approval.
It must be recognised that many new medicines produce incremental
improvements in patient care, the full impact of which may only
be demonstrated after use by the NHS for some years.
7.4 Pfizer has invested heavily in developing
capabilities in health technology assessment in order to meet
the information needs of NICE, All Wales Medicines Strategy Group,
Scottish Medicines Consortium (SMC), and the NHS.
7.5 Health Technology Assessment (HTA) organisations
must recognise the significant time and financial investment made
by pharmaceutical companies engaged in the research and development
(R&D) of new medicines. Pharmaceutical research and development
programmes are planned in advance and can take up to 10 years
or more.
7.6 The introduction of additional HTA data
requirements for product approval should therefore be phased in
gradually to enable the required changes to ongoing R&D programmes.
In the interim, HTA organisations will need to recognise and accept
the difficulties associated with providing some of the data they
request.
7.7 Pfizer recognises that it needs to collaborate
with HTA organisations effectively and early in the medicines
development process to agree what data are required to conduct
value for money assessments.
7.8 Pfizer is committed to sharing new product
information with the National Horizon Scanning organisations to
inform early understanding of the medicine.
7.9 HTA organisations should establish a
formal process for ongoing dialogue with companies from the second
phase of clinical trials of a medicine in human beings onwards.
This would promote better understanding of the medicine and its
potential impact on the condition as well as its value to the
NHS.
7.10 These actions should inform appropriate
topic selection and timing of HTA appraisal. They should also
provide for expert information to inform the development of appropriate
evidence of the medicine during the third phase of clinical trials
in humans, and to reduce uncertainty regarding the outcome of
a future HTA appraisal. The model for consultation used in the
regulatory process is recommended for this purpose.
7.11 HTA organisations should work more
closely with the appropriate regulatory authorities to reduce
duplication of effort and to accept regulatory evidence.
7.12 Pfizer actively participates in the
development of working processes for HTA organisations via formal
consultation processes, in the appraisal process for its medicines
and in the monitoring of the uptake of HTA guidance, and is keen
to see the end of post-code prescribing. Pfizer believes that
patients must have access to the same high quality of care, irrespective
of where they live.
7.13 NICE and the SMC have made some progress
in addressing postcode prescribing but large variations in use
still remain.
7.14 Implementation of HTA guidance is a
complex process and places a significant burden of work on health
organisations like Primary Care Trusts. Pfizer is committed to
developing partnerships with these organisations, professional
and patient groups and with HTA groups to support implementation
of guidance of mutual interest.
Glossary of terms
| ABPI | Association of the British Pharmaceutical Industry
|
| ADR | Adverse Drug Reaction
|
| AIOPI | Association of Information Officers in the Pharmaceutical Industry
|
| CAP | Centralised procedure
|
| Code of Practice | The ABPI Code
|
| CSM | Committee on Safety of Medicine
|
| CTA | Clinical Trial Application
|
| EFPIA | European Federation of Pharmaceutical Industries and Associations
|
| GCP | Good Clinical Practice
|
| GLP | Good Laboratory Practice
|
| GMP | Good manufacturing practice
|
| HCP | Healthcare professionals
|
| HTA | Health Technology Assessment
|
| MHRA | Medicines and Healthcare products Regulatory Agency
|
| MRP | Mutual Recognition Procedure
|
| NICE | National Institute for Clinical Excellence
|
| PGRD | Pfizer Global Research and Development
|
| PMCPA | Prescription Medicines Code of Practice Authority
|
| PSUR | Periodic Safety Update Report
|
| R&D | Research and development
|
| RMS | Reference Member State
|
| SMC | Scottish Medicines Consortium
|
| UK MIPG | UK Medicines Information Pharmacists Group
|
117
Lambert Review of Business-University Collaboration, Final
Report, December 2003. Back
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