Select Committee on Health Written Evidence


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

ABPIAssociation of the British Pharmaceutical Industry
ADRAdverse Drug Reaction
AIOPIAssociation of Information Officers in the Pharmaceutical Industry
CAPCentralised procedure
Code of PracticeThe ABPI Code
CSMCommittee on Safety of Medicine
CTAClinical Trial Application
EFPIAEuropean Federation of Pharmaceutical Industries and Associations
GCPGood Clinical Practice
GLPGood Laboratory Practice
GMPGood manufacturing practice
HCPHealthcare professionals
HTAHealth Technology Assessment
MHRA Medicines and Healthcare products Regulatory Agency
MRPMutual Recognition Procedure
NICENational Institute for Clinical Excellence
PGRD Pfizer Global Research and Development
PMCPAPrescription Medicines Code of Practice Authority
PSURPeriodic Safety Update Report
R&D Research and development
RMSReference Member State
SMCScottish Medicines Consortium
UK MIPGUK Medicines Information Pharmacists Group





117   Lambert Review of Business-University Collaboration, Final Report, December 2003. Back


 
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