Select Committee on Health Minutes of Evidence


Memorandum by The Association of the British Pharmaceutical Industry (PI 35)

  The Association of the British Pharmaceutical Industry (ABPI) represents more than 80 pharmaceutical companies in Britain engaged in the research, development, manufacturing and supply of prescription medicines. The ABPI brings together companies producing such medicines, whether branded or generic, many smaller organisations involved in pharmaceutical and bio-pharmaceutical R&D and those with an interest in the pharmaceutical industry operating in the UK. ABPI member companies manufacture and supply more than 80% of the medicines prescribed through the NHS and are major exporters to countries all over the world.

TABLE OF CONTENTS
Summary
1.Introduction
2.Innovation in Medicine
3.The Conduct of Medical Research
4.Provision of Medicines Information and their Promotion
5.Professional and Patient Information
6.Regulatory Review of Medicine Safety and Efficacy
7.Product Evaluation, including Assessments of Value for Money
8.Conclusion

SUMMARY

  Positive engagement between the pharmaceutical industry and the UK health system is both necessary and desirable, on all the dimensions highlighted by the Committee:

    —  On innovation, the industry is the prime innovator of new medicines. While all major companies operate research globally, it is very much in the UK's interest to attract as much research here as possible, and to ensure strong UK doctor and patient input into research priorities. A quarter of the world's top 100 medicines were discovered in Britain, and we want this success story to continue.

    —  The industry sponsors a large proportion of UK medical research. New initiatives will bring an increasing volume of clinical trials to the UK, increasing patient access to new medicines, especially if some cost and time challenges are tackled jointly by industry and the NHS. The industry spends £10 million per day on research in the UK, and we would like to see this increase further.

    —  The majority of information and in-service training and education on new medicines is provided by the industry. Responsible, regulated promotion is still the most effective way to get information into the hands of prescribers, the industry is also active to ensure comprehensive medicines information is available online to doctors, patients and their families.

    —  Stringent regulatory review is a cornerstone of the process for the development of medicines. Since the majority of safeguards are globally, not just nationally relevant, this is increasingly an international activity, but one in which the UK, through the MHRA and the UK-sited EMEA, has a prominent voice.

    —  Product evaluation for cost-effectiveness is an increasingly important activity, as the need to make difficult choices about priorities rises. In most cases, medicines represent an economically superior solution—earlier, less costly intervention than hospital procedures, for example. However, the industry has provided input to the NHS and to NICE to help reverse the continued lower access to innovative medicines in the UK than in other leading European countries.

  All the above interactions are two-way. The NHS and its doctors, patients and administrators have profound impact on the way the pharmaceutical industry operates in the UK. This partnership has helped build a UK industry that directly and indirectly employs over 300,000 people and contributes a surplus of £3.6 billion to the annual UK balance of trade. All the key points of contact between the health system and the industry are subject to regulation through UK and European laws and by mechanisms as varied as NHS ethics committees, new medicine approval processes and promotional codes of practice. There is always room for improvement, however, and the industry looks forward to the dialogue with the Committee about ways in which the two-way partnership can be further enhanced.

1.  INTRODUCTION

  1.1  Most people will take a prescription medicine at some stage of their lives. Whether commonplace interventions such as vaccination against childhood disease or an antibiotic to clear up a painful infection, through to medicines that prevent the rejection of transplanted organs or sophisticated chemotherapy that improves the life prospects of someone battling cancer, medicines are integral to health care. The gradual increases in life expectancy and quality of life over the past 50 years, with corresponding improvements in people's overall health, are due in large measure to the success of modern medicines.

  1.2  None of which happens by accident. It typically takes 12 years and £500 million of investment to bring just one new medicine to the patient. And the pathway is as precarious as it is long. For every one medicine available to prescribe, many hundreds of thousands of molecules begin the journey. Of the factors that determine those medicines that reach the patient, the health needs of the population is the most important. If there is insufficient clinical need to justify a new medicine then that medicine will not be developed. Safety is equally a key consideration since medicines with unacceptable safety or side-effect complications are worthless. Regulatory authorities rigorously and independently assess all potential new medicines for quality, safety and efficacy. The standards they demand are becoming even higher. To surmount the regulatory hurdle today, a new medicine must not merely be adequate: it must demonstrate that it is at least as good, if not better, than those already available.

  1.3  The NHS Chief Executive's 2003 report said that the increases in the prescribing of medicines "are contributing to improvements in care and, in particular to the improvements in survival rates for cancer and coronary heart disease". The pharmaceutical industry is proud of what it does. Our goal—to bring to patients life-enhancing medicines—is not only necessary but noble, and there is no reason why the industry should not use all legitimate means to advance it. We respect the fact that both Parliament and the public have the right to know that the medicines they take have been thoroughly researched, independently approved and are promoted to prescribers appropriately within clearly laid-down rules.

  1.4  Regulation is a fact of life for the pharmaceutical industry. There can be no industry more closely policed than ours. At every stage of a medicine's development and then, once it is licensed, during its commercial phase, the industry and its medicines are subject to control. So, for example, experiments involving animals (itself a regulatory requirement since it is illegal, for obvious reasons, to do basic safety tests on humans) are controlled by the Home Office and its Animals Procedures Committee. Clinical trials involving human beings must be properly authorised and require independent ethical approval. The UK is now subject to the EU Clinical Trials Directive which, among other things, bolsters internationally-agreed standards of good clinical practice and has written them into national legislation. Manufacturing is also the subject of very rigorous inspection and legislation.

  1.5  No medicine can be promoted to prescribers without a marketing authorisation, which is not granted until the regulatory authority has examined every line of a medicine's submission dossier, with documents totalling hundreds of thousands of pages. Sales and marketing activity is controlled, mainly through the industry's own ABPI Code of Practice (like the House of Commons, the pharmaceutical industry works well within self-regulation), and this is backed up in legislation, notably the European Directive 2001/83/EC, which, among other things, prohibits the promotion of prescription only medicines directly to the public. The industry is currently embarking on a further review of its Codes of Practice across Europe and hence in the UK, challenging ourselves to keep our standards high.

  1.6  Medicines are regulated for both value and cost. Increasingly, medicines must also prove their cost and clinical effectiveness to the National Institute of Clinical Excellence (and to similar bodies in Scotland and Wales). Prices are controlled through the Pharmaceutical Price Regulation Scheme (PPRS) as well as by various market pressures in an increasingly cost-aware NHS.

  1.7  The terms of reference of this inquiry are broad and themselves make the point that the industry is active across a wide range of endeavour. This response from the ABPI, on behalf of the industry, follows the headings in the terms of reference point by point. In each section we seek not only to explain the industry's approach to the subject matter in hand, but to anticipate points that the Committee will doubtless wish to explore in this inquiry. While we have tried to keep our comments as succinct as possible, the sheer breadth of ground that needs to be covered means that this submission is somewhat longer than the Committee's guideline.

  1.8  The Committee has acknowledged the contribution of the pharmaceutical industry not only to improved health, but to the economic and scientific output of the country. It is worth stressing a few salient facts:

    —  a quarter of the world's 100 most-used medicines originated in research and development carried out in the UK;

    —  pharmaceuticals is by far the largest contributor to R&D in this country (£10 million every day); and

    —  pharmaceutical companies operating here sustain 83,000 jobs directly and a further 250,000 indirectly.

  1.9  Neither the industry itself, nor those responsible for creating the environment in which it operates, can afford to rest on this record. It is an unarguable fact that the focus of innovation in medicines is shifting to the USA and while the UK has been less exposed than some other European countries, such a trend cannot be ignored. The industry is not asking for special favours; nor should we be immune from public scrutiny. However, there should be recognition that the influence of the pharmaceutical industry in this country is overwhelmingly for the good. Where the industry can get better, so we should. Where the Committee, and Parliament more generally, is able to recognise the positive contribution the pharmaceutical industry in the UK makes to health, wealth and to science, so it should. No one should be in any doubt that the benefits of having a strong and thriving pharmaceutical industry in this country are immense.

  1.10  As the Prime Minister has said: "A successful pharmaceutical industry is a prime example of what is needed in a successful knowledge economy. The UK's pharmaceutical industry has an outstanding tradition and has contributed very substantially to our economy and the welfare of our citizens".[17]

2.  INNOVATION IN MEDICINE

    —  The UK is a world-centre for pharmaceutical research and development.

    —  The industry has a strong record of partnership in collaborative research with universities that has brought benefits to both.

    —  Care must be taken to maintain a UK environment supportive of R&D.

    —  Innovation in pharmaceuticals takes many forms—from "wonder drugs" to steady improvements that can revolutionise a patient's quality of life.

    —  The output of pharmaceutical research is well-aligned to the priorities of the NHS.

  2.1  The UK has a long history of success in pharmaceutical research and development, with 25 of the world's leading medicines having their origins in this country.[18] This success is due to three factors above all: historically strong research; a strong academic research and clinical base; and a framework that encourages investment in R&D. The recent introduction by the Treasury of tax credits to support R&D is an example of the Government's positive attitude towards this endeavour.

  2.2  The combination of a strong history and favourable environment means that UK pharmaceutical R&D is able to "punch well above its market weight": only 3% (by value) of the world's prescription medicines are sold here; yet the UK attracts around 10% of global investment in pharmaceutical R&D. This is more than half of the total pharmaceutical R&D investment in Europe as a whole.

  2.3.  However, as figure 1 overleaf clearly illustrates, over the past 10 to 15 years, the USA has opened up a commanding lead in pharmaceutical R&D investment. This trend will continue unless a favourable environment exists in the UK, including the supply of suitably-trained scientists and removing attacks on the industry and its suppliers by animal rights extremists.

  2.4  Overall, what the pharmaceutical industry spends on R&D has tripled in the last 10 years (over the same period NHS spending has roughly doubled). The UK remains a world-leader in the development of new compounds and R&D productivity is amongst the best in the world. As a proportion of R&D spend, the UK has one of the largest numbers of first patents filed for new molecular entities. Such activity has a benefit not only to medicine, but to science. No other industry sector in the UK comes close to matching pharma's R&D spend, which represents a quarter of the overall UK total. We are the country's largest employer of science graduates: 27,000 employees are directly engaged in R&D activities.


  2.5  As figure 2 shows, the pharmaceutical industry funds more healthcare-related research in the UK than every other funder put together—six times as much as the Department of Health; five times as much as medical charities; eight times as much as the MRC.[19]


Collaborative research

  2.6  The pharmaceutical sector is also a significant supporter of academic research. Last year ABPI companies funded over 1,100 collaborations in 80 UK institutions. The Lambert report,[20] an independent review of business-industry links, commissioned by HM Treasury, noted that the UK pharmaceutical industry is an exemplar not just in research intensity, but also in its approach to collaborative research with universities.

Case study: Dundee Kinase Consortium

  Six pharmaceutical companies, GlaxoSmithKline, AstraZeneca, Pfizer, Boehringer Ingelheim, Merck & Co Inc, Merck KGaA (German company) have established a consortium collaborating with the University of Dundee to support the Division of Signal Transduction Therapies, led by Prof Sir Philip Cohen. The funding, worth £15 million over five years, brings:

Benefits for Industry

    —  Access to know-how from >70 world class scientists.

    —  Screening facility vs panel of kinases.

    —  Electronic information storage/transfer. Production of proteins and biological reagents.

    —  Custom synthesis of antibodies.

    —  Information on new drug targets.

Benefit to the University

    —  Access to the most selective chemical tools.

    —  Joint publications in top journals.

    —  Intellectual direction from industry.

    —  Increased efficiency of process through semi-industrialisation and sharing best practice.

Meeting NHS needs

  2.7  The pharmaceutical industry's input into research and development should not therefore be in any doubt. It is legitimate, however, to ask two questions about all this effort: is the end result genuinely innovative medicines; and, secondly, how aligned is pharma's research effort to health priorities, and specifically to the priorities of the NHS?

  2.8  The history of medicines research is punctuated by landmark discoveries in human health. The discovery of AZT by Wellcome in 1987, for example, was the moment when humanity first began to turn the tide of HIV/AIDS. The fact that we can now slow, or even reverse, the progression of cancer, or bring relief to people suffering from the debilitating effects of mental illness, is all due to breakthroughs made by the pharmaceutical industry. The almost complete disappearance in the UK of childhood diseases, which used to kill and cripple, could not have been achieved without vaccines the industry has developed.

  2.9  Death rates from heart disease have fallen by more than 40% in the UK over the past 10 years alone. A review of the relevant literature has shown that about 40% of this reduction is due to treatment including secondary prevention, use of thrombolysins (clot-busters), treatment of angina and treatment of hypertension. The use of statins to reduce cholesterol levels is estimated by Government to be saving 6,000 lives a year.

  2.10  Nevertheless there is still no "cure" for many cancers, no "cure" for Alzheimer's disease, no "cure" for acute psychoses, and no "cure" for arthritis. These can come in time if the pharmaceutical industry funds the necessary research and development.

  2.11  In the meantime, incremental (and important) advances are being made. The industry is working closely with the medical profession in chronic disease management—emerging as one of the most important priorities for the NHS. Conditions such as diabetes, asthma and arthritis cannot (at the moment) be eliminated. However, the quality of life of people with these conditions can be substantially improved, for example, by medicines that have fewer side-effects or provide better symptom control or that are easier to take (which in turn improves compliance). Table 1 below gives a number of examples where later medicines in a class have provided innovative advances to patients over and above those of the first medicine of their type.

  2.12  We are also now discovering why different patients respond differently to different medicines (the so-called "pharmacogenetic" effect). This knowledge is being used increasingly to choose the right medicine for the right patient and to discover even more specific therapies.

Table 1

BENEFITS OF INNOVATION


First to MarketFollower ClassBenefit of Follower

AccolateSingulairLeukotriene modifiers More convenient dosing (once a day vs twice a day
BeconaseFlixonaseIntranasal steroid Potency; fewer adverse events
ZoviraxValtrexHerpes anti-viral More convenient dosing
MevacorLipitorCholesterol lowering Potency
TagametZantacH2 antagonists More convenient dosing; fewer drug interactions
CozaarDiovanAngiotensin Receptor Block Potency


  2.13  The research output of the pharmaceutical industry is well-aligned to the priorities of the NHS. Some 43% of new medicines introduced over the past 10 years by the industry are designed to support four of the NHS's key health priorities— cancer, coronary heart disease , mental health and illnesses of the elderly.[21]

Table 2

MEDICINES LAUNCHED OVER PAST 10 YEARS


Therapy
Number launched
Proportion of total new launches

Heart disease
111
14%
Cancer
48
6%
Mental Health
119
15%
Elderly conditions excluding the above
(eg Type 2 diabetes, arthritis)
63
8%


  2.14  Hence, in the area of innovation in the UK, the NHS and the pharmaceutical industry have essentially a common cause—an ambitious role for the UK in researching and developing both "breakthrough" and "better performance" medicines.

3.  THE CONDUCT OF MEDICAL RESEARCH

    —  The UK is a world centre for clinical research which has helped to develop major innovative advances in medicines.

    —  Clinical trials are conducted ethically and safely and to the highest standards of Good Clinical Practice.

    —  All trial data are provided to the regulatory authority for its independent assessment.

    —  Publicly-funded research benefits from collaboration with industry.

    —  Government action is required, however, to ensure that the cost of clinical research in the UK is not prohibitive or it will be driven abroad.

  3.1  The UK is acknowledged as a world centre for clinical research involving medicines. The basis of this success is collaboration between the industry, the NHS and academic institutions. And the contribution of industry is vital. Industry funding of research in the UK has helped many research units within NHS Trusts to continue functioning at a high level. Industry sponsored clinical trials made up about 40% of all applications to the London Multi-Centred Research Ethics Committee in 1997-2000, easily the largest grouping of research applications involving clinical trials.[22]


  3.2  In April 2000, the Prime Minister set up the Pharmaceutical Industry Competitiveness Task Force (PICTF), a joint Government/Industry task force examining the competitiveness of the UK with regard to the pharmaceutical industry. One of its work streams related to clinical research. The group continues to meet to foster collaboration between the industry and the NHS.[23] Among its outputs is a partnership agreement[24] published in March 2002. It sets out guidance for partnership between the NHS and industry both for commercially sponsored research and the role of industry in supporting non-commercial research.

  3.3  Clinical trials in Britain will receive a major boost from the recent establishment of the UK Clinical Research Collaboration (UKCRC). The new body aims to speed up the development of new medicines from the laboratory to the patient by expanding the number and range of clinical trials.[25] It has been developed as a direct result of recommendations from reports of the Biosciences Innovation and Growth Team[26] and the Academy of Medical Sciences.[27] The ABPI welcomes the fact that the pharmaceutical industry is recognised as a partner in the UKCRC and looks forward to working to improve the competitiveness of the UK in global medical research for the benefit of patients, the NHS and, ultimately, the industry in the UK.

The Development Process

  3.4  Following discovery and laboratory research, new chemical entities (NCEs) undergo toxicological and animal testing. Animal research is conducted under strict regulation and licensing by the Home Office and is only conducted when there is no practicable alternative available. These pre-clinical phases take about three years but with a high attrition rate.

  3.5  Only those compounds that have a positive benefit/risk ratio go into clinical studies. These begin with healthy volunteer studies (phase I) involving people, usually under 45, during which data on how the medicine works and its effects on human systems are collected. Some early safety data and information about likely dosage are also collected.

  3.6  If the benefit/risk ratio remains positive and there have been no severe adverse effects, the medicine will now be given to patients with the disease it has been designed to treat (phase II) to determine that the medicine works as expected. If this is confirmed and there are again no major safety issues, the medicine is used in large phase III trials of up to several thousand patients to determine its efficacy (that it works) and safety. A clinical trial will often have two arms, one containing the investigative medicine and the other a comparator, either a placebo or current best treatment. Patients entering the trial are randomly allocated to one arm or other. In a single blinded trial, the patient doesn't know which arm they are in and in a double blinded trial, neither the investigator nor the patient knows, thus eliminating bias. At the end of the study, the blind is broken and the data analysed. If the outcome of all the clinical studies together is positive with a good safety record, then a marketing authorisation is sought from the relevant regulatory authorities. At the end of the clinical trial process, several thousand patients will have volunteered to take part in the clinical trials.

The Governance of Medical Research

  3.7  All clinical studies involving medicines are conducted ethically and safely and the high standards of Good Clinical Practice (GCP). Standards are international, based upon the Principles and Guidelines for Good Clinical Practice (ICH GCP) developed by the International Conference on Harmonisation and launched in 1997.[28] Both the ABPI and the UK regulatory authorities are fully signed up to the standards and there is little or no chance of a product being licensed if its trials have not complied with them. Before 1997, other guidelines were in place, including those developed by the ABPI itself.

  3.8  On 1 May, 2004, the UK implemented the European Clinical Trials Directive, which introduced in the UK the Principles of ICH GCP into legislation.[29] This means that all clinical trials, both commercial and non-commercial, covered by the Directive will be performed to an equally high standard.

  3.9  The Directive means that all industry trial protocols will be scrutinised by both the MHRA and, as previously, an independent ethics committee before approval will be given. In addition in the UK, trials involving secondary care and many involving primary care also have their protocols assessed within the relevant NHS Trust. The timelines for scrutiny are laid down in the legislation for the MHRA and ethics committees but not for the NHS Trusts, which have now become the major time-limiting factor in clinical trial start-up. Delay in the NHS Trust process makes the UK less competitive in comparison with its European neighbours. As a result, the ABPI and Department of Health jointly launched a Model Clinical Trial Agreement (MCTA) in January 2003 with the specific aim of speeding up the contracting process at NHS Trust level and thus speeding up start-up times for trials.[30]

  3.10  The ABPI has recognised for many years the importance of publication of clinical trials. In 1996, the ABPI published its guideline on Good Clinical (Research) Practice and stated: "The investigator must agree a publication policy with the sponsor before the start of the study". The Model Clinical Trial Agreement, published by the ABPI and Department of Health contains a section on publication of the trial and makes this a contractual duty.

  3.11  In May 2003 the ABPI launched its Clinical Trial Register (https://www.cmrinteract.com/clintrial), which is a voluntary register of completed phase III trials involved in a marketing authorisation application three months after launching the new medicine in its first major market. A number of individual pharmaceutical companies have also announced proposals to make public details of their clinical trials.

  3.12  In a small minority of cases, standards full below those required. The ABPI has been at the forefront of prosecution of research misconduct in the UK. Since 1988, it has reported 26 doctors to the General Medical Council (GMC) for research misconduct and 25 of these have been found guilty of serious professional misconduct and about half have been erased from the Medical Register.

The cost of research

  3.13  The UK is one of the most expensive places, in the world, to undertake research. An international annual assessment of cost comparisons of clinical trials, FastTrack for 2002, showed that of our major competitors, the UK was second most costly in both the trials monitored.

  3.14  These facts seriously reduce the competitiveness of the UK. The key factors for a company in placing its research are the speed, quality and cost of the research. The Clinical Trials Directive has had a positive impact with regard to speed in the UK as the MHRA is one of the most efficient regulatory authorities in Europe for processing clinical trial applications and plans to approve 80% of its applications within 30 days (14 days for healthy volunteer studies). As outlined above, the key factor in timing is now NHS Trust approval. Equally, government action is required to ensure that the cost of clinical research in the UK is not prohibitive with regard to the application of general overheads and payment for standard care.

Research and Paediatric Medicine

  3.15  One of the priorities for the UKCRC, referenced above, is children's medicines. Millions of children receive medicines every day that are safe and effective. But many older medicines have not been tested on children, although experience over many years provides a sound evidence base for their continuing and safe use. Children may respond differently from adults to medicines so it is necessary to conduct proper clinical trials in children of different ages.

  3.16  For many medicines, it would be ethically inappropriate to carry out experimental trials in children of different ages from new born babies to toddlers to teenagers, before its effect is well established in the more robust adult population. Parents have been understandably reluctant to allow their sick child to participate in the clinical trial of a medicine that is, to a degree, "experimental". The UK-based pharmaceutical industry, through the ABPI, has been at the forefront of trying to improve the situation.

  3.17  The pharmaceutical industry is the leading sponsor of UK clinical trials for children.[31]


  3.18  The introduction of a new European Regulation on Paediatric Medicines in 2006 will require more medicines to be licensed for use in children. This will mean that more clinical trials will need to involve sick children in order to ascertain the safety and efficacy of new medicines that will have potential benefit for those children. The pharmaceutical industry will inevitably fund the majority of paediatric trials and we therefore welcome the principle of incentives in the draft regulation.

  3.19  In the UK, paediatric centres that are experienced in carrying out clinical trials in children are at present few and far between. Although paediatricians are well versed in managing the clinical and psychosocial problems that children have, and have an understanding of the difference in physiology between children and adults, some of these potential investigators may be inexperienced in running a clinical trial and there may be a lack of necessary resource and staffing. The pharmaceutical industry is keen to work with the Government and regulatory authorities in developing a better research environment for children.

Clinical Pharmacology

  3.20  In the mid-1990s, the ABPI recognised that there was an increasing shortage of clinical pharmacologists in the UK, who are vital in the early clinical development of a medicine. The UK has traditionally led the world in clinical pharmacology research—half of European healthy volunteer studies are done in the UK. Following negotiations involving the Department of Health, the Royal College of Physicians of London and the ABPI, a joint training programme has been set up in Clinical Pharmacology with the industry partner funding half of the trainees' salary. So far, 20 trainees are undertaking or have completed the course at a total cost to industry of over £2 million. Two of the supported trainees are in Paediatric Clinical Pharmacology.

4.  PROVISION OF MEDICINES INFORMATION AND THEIR PROMOTION

  Information and promotion are necessary and valid activities for the pharmaceutical industry:

    —  Informing doctors of new medicines and new indications for existing medicines for the benefit of patients.

    —  Ensuring that health professionals are aware of the medicine dosage, side effects etc, allowing them to optimise their use of medicines for the benefit of patients.

    —  Encouraging value for money and better patient outcomes.

    —  Strictly regulated by the ABPI Code of Practice.

  4.1  Medicines information and promotion are strictly regulated by UK and European law as well as by the ABPI's own Code of Practice. Promotion of prescription only medicines (POMs) to the general public is prohibited in the UK. The provision of accurate information through marketing to health professionals is an essential element of a successful pharmaceutical business and is conducted in an ethical, responsible and professional manner.

  4.2  Doctors, pharmacists and other health professionals need to keep up to date with scientific understanding and new developments in treatments to ensure that patients can benefit from advances. Pharmaceutical companies know more about their own products than anyone else, so the industry has an important role to play in providing information for prescribers and dispensers, including about potential side effects to help ensure their proper use of medicines.

  4.3  A recent Taylor Nelson study[32] of 205 GPs showed that family doctors consistently rated representatives amongst their top three sources of information:

    —  First as most effective source of awareness of new medicine information.

    —  First as most effective source supporting educational or medical meetings for GPs.

    —  Second most effective source of medicine information (withdrawals, dosage etc).

    —  Third most effective source of clinical trial results.

  4.4  The ABPI Code of Practice is drawn up in consultation with the British Medical Association, the Royal Pharmaceutical Society and, importantly, the Medicines and Healthcare Products Regulatory Agency. It reflects the legal requirements controlling the advertising and promotion of medicines and extends well beyond them.

  4.5  It is a condition of membership of the ABPI that companies abide by both the letter and the spirit of the Code. Observation of the Code is a priority for pharmaceutical companies. Any breaches have a damaging impact on the company concerned in terms of both sanctions and company reputation. Companies also have to divert valuable resources, often over several months, into investigating every complaint in detail.

  4.6  Self-regulation has proved effective for well over 40 years. The industry's own vigilance in observing the Code results is reflected in the fact that nearly half the complaints made to the Prescription Medicines Code of Practice Authority emanate from pharmaceutical companies themselves. The overall number of complaints (upheld or not) is some 125 a year over the past decade. This is a modest level, given the scope of the Code and the fact that it covers relationships and activities with more than 90,000 GPs and hospital doctors and 40,000 pharmacists as well as other health professionals.

  4.7  The pharmaceutical industry worldwide holds the ABPI Code of Practice in high esteem and actively promotes its use. In the UK the ABPI and its member companies routinely explain to health professionals how the Code operates and welcomes comments on how it could be improved. The ABPI is publishing in September 2004 guidance notes on the Code for health professionals that will be distributed to all Primary Care and Hospital Trusts.[33]

  4.8  All national codes in Europe are currently being reviewed by the European Federation of Pharmaceutical Industries and Associations (EFPIA). As part of this the ABPI is carrying out its own review of the Code and its operation. This will involve external consultation and the conclusions of the Health Select Committee inquiry will be taken into account.

Industry representatives—training and qualification

  4.9  There are approximately 8,000 pharmaceutical company medical representatives operating in this country, a number which has remained fairly stable over the past five years. The medical representative plays a key role in promoting medicines to health professionals. Representatives traditionally have scientific or health-related backgrounds, and receive intensive training within their own company. All training material has to be approved on behalf of the company by an employee who is a registered doctor and one other senior person to ensure that it complies with the ABPI Code of Practice.

  4.10  Company representatives have to pass the ABPI medical representatives exam within two years of being employed in such a role. The ABPI course and exam covers:

    —  Basic physiology and anatomy.

    —  In-depth education on their relevant disease area.

    —  Understanding of the NHS and how it operates.

Visiting health professionals

  4.11  Health professionals need to balance the responsibilities of dealing with patients' needs together with administrative and managerial duties. In addition they need to set aside time to keep up to date with the latest medical innovations. Information learnt from visits by medical representatives helps health professionals to be aware of the latest changes in treatment regimes in a very time-efficient manner.

  4.12  The number of visits by a representative to a doctor during any year is controlled by the Code and should not normally exceed three. The primary care medical representative calls on GPs, usually through a well-managed appointment system. This may sometimes be with a single GP or a larger group of doctors. Nurses are increasingly included in such meetings as their involvement, including prescribing decisions, has grown in recent years.

  4.13  During the discussion the representative will use detailed material to explain the appropriate use of the medicine, provide data on clinical trials and relevant comparative information. Promotional material must also contain prescribing information which states the cost of the medicine and be consistent with the medicine's marketing authorisation. All material is checked for factual accuracy and must comply with the Code.

  4.14  Secondary care representatives use material especially designed for this level of care. A discussion about cost benefit or cost effective data allows health professionals to quantify the potential effect of a new or different medicine on their budgets.

  4.15  The Code permits promotional aids to be given to health professionals provided they are both relevant to the recipient's work and inexpensive (costing no more than £6).



Wider promotional activities

  4.16  Companies regularly advertise in medical journals to create awareness of a medicine and its role within effective therapy. All information and comparisons must be accurate, balanced, objective and unambiguous. They must not mislead and must be capable of substantiation. Direct mailing is used, often to inform the profession of changes to prescribing information, new medicines or new clinical data.

Further improvements

  4.17  In providing information to the medical profession it is becoming increasingly clear that:

    —  there is greater pressure than ever on doctors' workloads;

    —  the benefits that increased prescribing can bring in better patient health and lower overall costs to the NHS need more emphasis alongside the steady feedback to doctors on prescribing costs alone; and

    —  more efforts are also required to widen patient access to many newer medicines.

  The pharmaceutical industry believes it has a powerful role to play in partnership with the NHS in delivering better healthcare for patients.

5.  PROFESSIONAL AND PATIENT EDUCATION

    —  No one knows more about a medicine than the people who discovered, developed and made it available.

    —  Our principal objective is to provide factual information for professional and patient education to achieve the best outcome for patients.

    —  The UK-based pharmaceutical industry funds more than half of all further education and training for NHS doctors.

    —  Industry collaboration with patient groups under agreed "rules of engagement" can result in real benefits for patients.

    —  Patients' own search for more information about their medicines could be met in part by industry, given some relaxation of current communication restrictions.

Information Requirements and Offerings

  5.1  Professional and patient education is vital to achieving the best outcome for patients from the most appropriate use of medicines. As in other areas, in the provision of education and information, the pharmaceutical industry operates in a highly regulated environment.

  5.2  Pharmaceutical companies are required to provide information about their medicines, on request, to health professionals under the terms of the ABPI Code of Practice. Companies are obliged to have a "scientific service responsible for information" (Clause 13 of the Code). Over the course of a year, large pharmaceutical companies in the UK each deal with between 15-26,000 requests for information directly from health professionals and administrative staff and some 12,000 indirectly through sales representatives. This obligation to provide information continues beyond the end of data and patent exclusivity.

  5.3  The industry provides information about medicines in a variety of other ways as well. It contributes to both the British National Formulary and the Monthly Index of Medical Specialities, the two most important and commonly used UK reference works on licensed medicines. The industry also supports the development of the Medicines Compendium and its electronic edition, which provides, via the internet (www.medicines.org.uk), comprehensive, up-to-date, government-approved technical data on individual medicines, including safety and dosage information, and patient information leaflets on individual medicines. This service delivers over 2.5 million documents about medicines per year to health professionals and to members of the public. The electronic Medicines Compendium is being incorporated into the National Electronic Library of Medicines and is widely used throughout the NHS as a primary and definitive source of medicines information.

  5.4  Medicines Guides produced by the industry, both electronic and in print, are now being developed as additional sources of information for the general public via NHS Direct.

Professional Education

  5.5  Professional education is largely provided through regulated medical education programmes conducted in various partnership activities between the industry, academia, health professionals and their professional bodies, medical publishers, the Government and the NHS. Such education is directly supported by the industry, whether by donation, unrestricted educational grants or partnership programmes, and is of considerable value to the NHS. Without this high quality educational support from the industry, an additional heavy burden will be placed on NHS resources.

  5.6  In fact, the UK-based pharmaceutical industry funds more than half of all further education and training for doctors in Britain and of a quality standard at least as good as non-sponsored education.[34] This provides an essential role in helping to build a culture of innovation and medical knowledge to help the NHS deliver a modern health service. Internationally, the industry supports symposia that bring together leading experts from the UK with their counterparts around the world.

Patient Education

  5.7  The industry is prohibited from providing information, directly to patients, outside the relevant clause in the Code (Clause 20). This does permit the tightly regulated and formulaic information available in the summary of product characteristics, the patient information leaflet inserted in the pack and information on the packaging of the medicine itself.

  5.8  However, under current legislation and guidelines, pharmaceutical companies can run, partner or sponsor certain kinds of regulated and strictly non-promotional public health education and disease awareness activities. This helps make people aware of the availability of treatment options for a condition and advises them to seek the advice of a health professional. Any such communications cannot speak solely about the availability of a specific medicine or encourage patients to ask their doctors for a specific brand. Guidelines agreed between the industry and the MHRA mean that these communications must clearly have public or patient education about a disease and treatment options for it as their objective.[35]

  5.9  This kind of education usually involves partnership with public and or voluntary sector bodies and informal but wide consultation with interested stakeholders. Successful public health education and disease awareness programmes in the UK have covered subjects such as: allergies, cancer, cardiology, central nervous system diseases, dermatology, epilepsy, glaucoma, men's health, multiple sclerosis, respiratory disease, urology and women's health. The ABPI has produced a CD ROM with examples of such successful collaborations. A copy is being submitted to the Committee. Patients often benefit through these disease awareness programmes by having previously unidentified and sometimes serious conditions diagnosed and treated in good time.

Working with Patient Groups

  5.10  Relationships and partnerships with patient groups, voluntary sector and other stakeholders are governed by the prohibition in UK law on advertising prescription only medicines to the public. Furthermore, they are conducted in accordance with strict published guidelines or operating principles, such as the Long-term Medical Conditions Alliance's guidelines for voluntary health organisations working with pharmaceutical companies.[36] Many pharmaceutical companies also have in-house rules for working with patient groups. Above all, companies wish to avoid either the reality or the perception of improper or undue influence.

  5.11  Pharmaceutical companies and patient groups share a common interest in wanting patients to receive the most effective, evidence-based treatments, and to do so without unnecessary delay. It is desirable for patient groups and pharmaceutical companies to work together towards this end and to educate and inform their members or a wider public, about particular chronic medical conditions, their prevention, and new developments in therapy. This co-operation can take the form of funding by way of donation or unrestricted educational grant, administrative and technical or logistical support, advice and consultancy in specific areas of business or healthcare expertise etc. Two examples are given below.

  Arthritis Care has been supported by Pfizer in raising awareness of the availability of treatments and methods for the management of arthritis with materials which are comprehensive and go well beyond the availability of medicinal interventions, looking at diet and lifestyle etc. A "state of the nation" report to quantify and provide evidence of the extent of the problem of arthritis in the UK and a programme to assist in the implementation of NICE guidelines have also been delivered.

  Eleven pharmaceutical companies have worked with CancerBACUP over the last year to utilise their oncology representatives to help raise awareness of the new CancerBACUP information and support line phone number by distributing cards and posters to oncology centres across the UK.

Working with the NHS

  5.12  The relationship between the NHS and the pharmaceutical industry is constantly changing. To support these changes teams within pharmaceutical companies work with NHS management to develop NHS partnership activities.

  5.13  The ABPI and the NHS Alliance have recently produced a suggested framework for joint working between the pharmaceutical industry and the NHS. Among its provisions are:

    —  The interests of individual patients should be protected.

    —  Clinical aspects of care should be under NHS control, although industry input is legitimate and offers benefits to patients and the NHS.

    —  Joint working should not be seen as an endorsement or promotion of a specific medicine or technology.

  5.14  The framework also includes a selection of case studies of successful partnership working in a variety of different areas, ranging from educational support to the implementation of National Service Frameworks.[37] A copy is being supplied to the Committee but an example is extracted overleaf.

http://medicines.mhra.gov.uk/inforesources/publications/gn26.pdf).

www.lmca.org.uk/docs/pharmgds.htm.

  In 2003 Lilly launched the "Well-being Support Programme" as a pilot scheme for mental health services in the UK. Organisers from various PCTs will seek to enrol a total of 1,200 patients over two years at eight sites across the UK. The programme will aim to improve the lifestyles of patients suffering with a serious and enduring mental illness. These objectives comply with the recommendations made by the National Institute for Clinical Excellence and the NSF for Schizophrenia. Lilly's programme addresses these issues by concentrating on three key areas:

    —  Lifestyle assessments and interventions—eg smoking, weight management and physical activity.

    —  Side effect assessment and management—eg understanding the impact of side effects and helping patients manage them.

    —  Physical health assessment—providing a basic physical health check including blood pressure, weight, height and pulse rate.

  The outcome—by the end of 2003, eight national sites had enrolled over 1,000 patients. Each trust has set up groups for weight management and physical activity. Over 100 patients are now benefiting from these groups each week.

Areas for development and improvement

  5.15  The Government recognises that better health outcomes are generated when patients are entrusted with responsibility for their own healthcare. Through initiatives such as the Expert Patient Programme or NHS Direct, it is promoting policies that focus on increasing patient choice and advancing the self-care agenda. At the same time, the desire of patients for reliable and balanced information about their health needs and the options available for treatment has never been greater. Health-related subjects are at the top of the list of the most searched for items on the Internet. It is in this context that the debate about whether the pharmaceutical companies should be allowed to communicate directly with patients becomes significant.

  5.16  The ABPI's Informed Patient Initiative Task Force,[38] believes that pharmaceutical companies could help patients be better informed if current restrictions on industry providing scientifically reliable information on healthcare, medicines and treatments directly to patients were relaxed.

  5.17  This position is supported by many patient groups and is consistent with the position of the MHRA on the provision of health information to consumers. The UK government does not support direct to consumer advertising of prescription medicines but is supportive of the provision of information to patients. This shows that there is common ground between regulators, Government, and industry.

  5.18  An opinion survey conducted by MORI[39] last year asked the general public if they thought it was valuable to have a range of different types of information about medicines from different sources. An overwhelming 81% agreed with the statement.

  5.19  There are still understandable concerns about the regulation of patient information on the Internet. The Times reported (3 August 2004) a study warning that thousands of cancer patients are risking their health by following the advice of websites promoting bogus cures.[40] The industry could play an important role here, working in conjunction with the regulators, health professionals and patients.

  5.20  This greater public demand for information about their health is also reflected in increasing coverage of healthcare issues by the press and broadcast media. Everything that the industry says to the media about medicines is governed by the Code. The media has a genuine interest in reporting health news and producing features on healthcare and related advice. However, editorial control rests with the media organisations and companies have no control over final headlines, content or slant.

  5.21  Given the above, a key issue facing the industry is how best to legitimately (and legally) participate in the healthcare information revolution. Industry and Government are therefore in active discussion to explore ways to improve public access to good quality information on licensed medicines.

  5.22  For example, within the NHS Strategy Document "Pharmacy in the Future—Implementing the NHS Plan", the Government has established a joint task force to lead the implementation of a national strategy on partnership in medicine taking. There is pharmaceutical industry representation on the task force and its working groups. For the first time last year this partnership supported a very successful "Ask About Medicines Week" campaign for the general public. The ABPI and individual pharmaceutical companies participated in this event, which will be repeated later this year (November 1-6, 2004).

  5.23  We would support changes to allow pharmaceutical companies to communicate scientifically reliable information directly to the ultimate consumers of its medicines and would welcome the opportunity to explore this in further work with regulators, policy makers and other stakeholders. No one knows more about a medicine than the people who discovered, developed and made it available.

6.  REGULATORY REVIEW OF MEDICINE SAFETY AND EFFICACY

    —  The pharmaceutical industry operates within one of the most complex and stringent regulatory frameworks of any industry.

    —  Good communication between regulators and companies is essential to ensure the regulatory system is efficient and effective.

    —  Companies are legally required to monitor continually the use of a medicine throughout its lifetime to maintain a positive benefit/risk balance.

    —  Future funding models for the MHRA must ensure that the agency can continue to operate as a European Centre of Excellence.

Regulatory Framework

  6.1  Public health and medicine safety are important issues around the world. Governments have responded by placing requirements on manufacturers to obtain marketing authorisations before placing medicines on the market and to monitor them closely thereafter.

  6.2  All aspects of activities in these areas are tightly regulated and legally controlled, and the European and international regulatory framework is constantly updated to reflect new scientific and medical progress. The amount of pharmaceutical regulation has increased significantly over the past 20 years with greater international exchange of medicines information to increase the protection of patients.

  6.3  The pharmaceutical industry, medical community, patients and government all have a common interest in ensuring that the regulatory system in the UK is transparent, efficient, meaningful and robust, and bases its decisions on a high standard of scientific evidence. The aim should be to regulate effectively but efficiently: over-regulation is a disadvantage to both to patients and industry. The regulatory system should provide timely access for patients to effective medicines, while ensuring patient safety and stimulating research into new treatments.

Marketing Authorisation Application

  6.4  Before a company can market a medicine in the UK, it must be approved by expert committees within the Medicines and Healthcare Products Regulatory Agency (MHRA) or the European Medicines Evaluation Agency (EMEA). Before a marketing authorisation is issued, the agencies will carry out close scrutiny of all the technical reports that must be generated by a pharmaceutical company during the development of the medicine. They will also review the proposed manufacturing methods, quality control procedures and evidence of pharmacological activity, clinical safety and efficacy.

  6.5  The average regulatory submission for a new medicine consists of several hundred volumes of technical and scientific reports and data, including details of animal research, clinical trials and manufacturing processes.

Role of Independent Experts and Industry in the Provision of Advice

  6.6  The MHRA is assisted by advisory committees in making licensing decisions and in reviewing the safety of marketed medicines. It is in the interest of all stakeholders to make sure that the highest level of medical and scientific expertise and excellence is available to the MHRA through these committees.

  6.7  There is, however, only a limited pool of experts in any given area at any given time. Industry seeks their expertise during the development process for a new medicine and the MHRA benefits from their advice during the regulatory assessment. Consequently, it is essential to have in place a robust, transparent and effective system to avoid any potential conflicts of interest for experts in relation to a specific medicine. The MHRA operates just such a system, whereby committee members are subjected to a high level of transparency and rigorous declaration of personal interest, to ensure that their expert scientific opinion is independent and unbiased. Independent experts with a declared personal interest in a particular pharmaceutical company are excluded from assessments involving that company's medicines.

Financial Structure of the MHRA

  6.8  The Evans-Cunliffe report[41] recommended that the full cost of the then Medicines Directorate should be charged to the pharmaceutical industry. Therefore, the Medicines Control Agency (the predecessor of the MHRA) was established as a Trading Fund that had to be self-sufficient and recoup its costs through fees charged to the industry for its assessment and control activities. The pharmaceutical industry has no choice but to pay the fees levied by Government.

  6.9  The ABPI is supportive of the MHRA being properly funded so that it can operate efficiently and effectively as a centre of regulatory excellence in Europe. There are sufficient checks and balances in place to ensure independence from industry. Fee levels are set by the Treasury, following public consultation, and are detailed in the relevant UK statutory instruments.[42] However, the pharmaceutical industry has asked for greater transparency from the MHRA on how income from fees is allocated. This is particularly important since the merger of the MCA and Medical Devices Agency, as most of MDA's activities were previously funded by the Government. Fees for the control of medicines should not subsidise activities related to medical devices.

  6.10  The industry would welcome any proposal to review the financing of the MHRA if this would help dispel any perception of undue influence.

Post Marketing Authorisation Phase

  6.11  If a medicine is approved and obtains a licence to be marketed, this does not mean that the assessment of the medicine is finished. It marks the beginning for the applicant company of a legal obligation continuing throughout the lifetime of the medicine to provide the MHRA with information about the medicine both at regular intervals and on an ad hoc basis. The benefit/risk assessment of a medicine is a continuous process.

  6.12  At the time of approval there will be extensive clinical data on the use of the medicine. However, companies have pharmacovigilance systems in place to monitor and assess the safe use of the medicine in the wider population after its launch and risk management plans to deal with any problems.

  6.13  Newly approved medicines and significant changes to existing medicines are subject to intensive monitoring by the MHRA as part of the Committee on the Safety of Medicines (CSM) Yellow Card/Black Triangle scheme. This scheme allows rapid monitoring of potential new risks as medicines become more widely used in patients. The CSM is currently considering the introduction of direct reporting by patients of side effects through the Yellow Card scheme. Whilst the ABPI supports any improvements to strengthen the scheme, the reporting of side effects by patients without validation by a health professional could inundate the MHRA with reports of side effects that all require validation by the MHRA, and make accurate signal detection of actual ADRs difficult. Patient reporting has been introduced in the US, but required a significant increase in resource at the FDA in order to collect, analyse and validate the increased numbers of reported side effects.

  6.14  Pharmaceutical companies and the MHRA continuously monitor Adverse Drug Reaction reports which companies submit expeditiously to the MHRA and also summarise regularly in Periodic Safety Update Reports (PSURs) submitted to the MHRA for in-depth review. Changes to the approved product information or labelling have to be based on evaluated scientific evidence, which involves open interaction between the relevant parties. The aim of this is to ensure that the medicines are used as safely as possible, without restricting access to patients who could benefit from the medicine. The requirement for pharmacovigilance is embodied in the pharmaceutical legislation and there are severe penalties for non-compliance. MHRA also conducts regular inspections and has enforcement powers if serious non-compliance is found.

Communication between Industry and Regulatory Authorities throughout the Lifecycle of a Medicine

  6.15  There are clearly defined legislative requirements, which necessitate communication, dialogue and the submission of data from industry to the MHRA during the life-cycle of a medicine. Such regular dialogue is in the public interest to ensure that effective and safe new medicines reach the patient as quickly as possible. It is essential that this integral part of the regulatory framework is continued throughout the various regulatory processes, including pharmacovigilance.

  6.16  It takes an average of 12 years to develop a new medicine and various issues of a technical or scientific nature might arise during this process where written guidance is not available. It is important to ensure that the right development programme is carried out to enable registration of safe and effective new medicines in the most efficient way and avoid unnecessary clinical trials or delays in getting new medicines to the patients.

  6.17  During the regulatory review of a new medicine, or a change to an existing medicine, there is an on-going dialogue between the applicant company and the MHRA. The applicant company explains the data, provides clarifications and answers questions based on the scientific evidence provided. Through such dialogue, the MHRA is able to make decisions on the safety, quality and efficacy of the medicine based on the totality of the evidence available and the proposed usage.

  6.18  Good communication channels between the MHRA and the company are also essential when the MHRA requires information from companies, often at very short notice (eg the safety review on TSE[43]).

  6.19  Input from the industry and other stakeholders during the drafting of guidelines on issues such as clinical trials and manufacturing standards is essential to highlight the practical implications of such guidance particularly given industry's knowledge of future likely scientific developments.

Future improvements

  6.20  Not only is a strong, efficient and effective UK regulatory agency necessary for ensuring the safety of public health, it is also fundamental to drive a competitive UK-based pharmaceutical industry that will develop innovative medicines for the benefit of patients. The impact of the establishment of the European Medicines Evaluation Agency on the EU regulatory environment has been significant. Companies now have the possibility to select any one of the 25 Member States to assess their medicines. Experience shows that companies select European regulatory agencies that not only provide high scientific excellence, but also consider customer service and efficient performance. In order to be selected by companies the MHRA must promote their specialist expertise in particular therapeutic areas in order to distinguish themselves from the other leading regulatory agencies.

  6.21  The MHRA is considered to be one of the top five leading regulatory agencies in Europe. Findings in the National Audit Office Report on the MCA[44] (the MHRA's predecessor) indicated that the Agency would be looking to improve the quality of the services it provides to industry in order to attract more business. The ABPI strongly supports the ongoing development of the MHRA as the leading regulatory agency in Europe but this will require dedicated high-quality staff who are sufficiently senior and experienced to chair key European scientific committees.

  6.22  The Medicines Commission has appointed individuals to its membership who have expertise in the pharmaceutical industry since it was formed in 1968 and the industry has also provided advice to the previous MCA Executive Board on the Agency's performance through representation on the Ministerial Advisory Board. The ABPI believes that the presence of such persons on these advisory bodies has been essential in providing information about the practical implications of medicines regulation policy and feedback on the Agency's performance from one of its major stakeholders. The continued presence of people with industry expertise on the MHRA's Board and the Medicines Commission, or its replacement, is recommended.

7.  PRODUCT EVALUATION, INCLUDING ASSESSMENTS OF VALUE FOR MONEY

    —  Industry's participation in NICE health technology assessments are vital in developing effective guidance for the NHS.

    —  NICE has itself sought the participation of industry in various consultative groups.

    —  Lack of implementation of NICE recommendations remains a major issue.

    —  Faster patient access to clinically and cost-effective technologies would be promoted by a number of initiatives.

    —  Industry should be engaged as a full partner both in these initiatives and in implementation activities more generally.

    —  Varying processes in England, Scotland and Wales need to avoid duplication to achieve best outcome for patients.

Introduction

  7.1  The pharmaceutical industry is committed to ensuring equitable access to clinical and cost-effective treatments and to achieving faster uptake of new technologies. Through partnership and constructive engagement and with appropriate probity, the contribution of the pharmaceutical industry to Health Technology Assessment (HTA) is vital to the production and dissemination of robust, evidence-based guidance for the benefit of both patients and the NHS. The following comments relate principally to NICE but separate sections have been included on industry engagement with HTA bodies in Scotland and Wales.

The pharmaceutical industry as a NICE stakeholder

Submission of evidence

  7.2  The ABPI welcomes NICE's collaborative approach towards HTA. Company submissions are considered by the independent Appraisal Committees of NICE alongside those of patient/carer groups, health professional groups and NHS organisations.

  7.3  NICE itself recognises the value of the industry submission in the appraisal process. NICE has declined to adopt the WHO's recommendation[45] that NICE should be presented with a single set of analyses (incorporating manufacturers' input via consultation rather than separate submissions).

Partnership

  7.4  The pharmaceutical industry is represented on the group which helps to develop NICE's work programme (the Advisory Committee on Topic Selection). Industry contributes specialist knowledge and expertise helping to ensure that the most appropriate, suitable and relevant topics are referred.

  7.5  NICE welcomes the contribution of pharmaceutical industry consultees on the Appraisal Committees, as they share experience which enhances the depth and quality of the appraisal. The probity of industry representation on both of these committees is assured by the Department of Health's procedures with regard to conflicts of interest.

Constructive engagement

  7.6  Industry has worked with NICE to achieve a more efficient, fair and transparent appraisals process, through regular dialogue between NICE and the ABPI's National Health Technology Assessment/Clinical Guidelines (NHTA/CG) User group.

  7.7  A good example of this constructive engagement has been the development of a framework on the use of confidential data, in response to the Health Select Committee's concerns in 2002[46] about the transparency of the appraisal process. The framework sets out guidelines on what company data should be made public during a technology appraisal.

Further improvements

Ensuring quality and maintaining standards

  7.8  The Health Select Committee's 2002 report raised the issue of the quality of the work undertaken by the independent academic groups which produce the Health Technology Assessment (HTA) reports. This remains an issue, with variability in performance between the groups, and one on which the ABPI will collaborate further with NICE and the National Coordinating Centre for Health Technology Assessment.

  7.9  There is a need for a common framework to improve consistency and quality control. The industry shares the Health Select Committee's concerns with regard to the resourcing of the HTA centres.

  7.10  There is also a need for the appeals process to be independent, robust and transparent. In particular by the nomination of an independent share of the appeals committee (which is currently chaired by the chairman of NICE). The appropriately constituted appeals committees are also restricted in the evidence they can consider by narrow and limiting criteria. This means that they cannot reach a fully informed decision on the issue at hand.




Clinical Guidelines

  7.11  The development of NICE's clinical guidelines programme, which industry supports, has helped to shift the focus in the direction recommended by the Health Select Committee. However, further clarity is necessary in the relationship between technology appraisals and clinical guidelines and the criteria for choosing between them.

  7.12  The pharmaceutical industry has not been treated equitably by NICE in the development of NICE Clinical Guidelines. It is the only stakeholder that does not have access to or membership of the Guideline Development Groups which are responsible for compiling the guidelines. Approaches to NICE to improve this situation have been repeatedly rejected.

  7.13  Increasingly, HTA guidance is being put into guidelines rather than going through the rigorous HTA development process which includes an opportunity for appeal. The process by which these decisions are made is opaque and of considerable concern to industry.

Implementation

  7.14  The most important measure of the work of HTA bodies is their ultimate impact on patient access to new technologies. Industry has worked with patient groups and NICE to develop the evidence base which has identified inconsistent take-up of NICE guidance around the UK (see, for example, the relevant papers linked to the NICE website),45,[47] 46,[48] 47,[49] [50] and has contributed to Professor Richards's report on cancer services.[51] A significant portion of this extensive evidence base was not available to the NHS without the contribution from the industry.

  7.15  The UK still lags behind most other major countries in the adoption of new medicines. Industry looks forward to collaborating with NICE, the Health Care Commission, the Department of Health and NHS organisations to promote greater consistency between different parts of the country in patient access to clinically effective and cost effective technologies.

HTA in Wales and Scotland

All Wales Medicines Strategy Group (AWMSG)

  7.16  The ABPI Cymru Wales Therapeutic Development Assessment (TDA) User Group has begun to meet regularly with the Welsh Medicines Partnership (WMP) in order to develop a more effective and workable assessment process. These changes in process are then considered by the All Wales Medicines Strategy Group (AWMSG)—Steering Committee "in camera", before final public consideration by AWMSG.

  Specifically the industry is working in Wales on the need:

    —  for early clarification of the scope of the assessment;

    —  to establish a means of treating "in confidence" material;

    —  to ensure retention of a transparent and robust appeals process; and

    —  for clearer timelines for the assessment process.

Scottish Medicines Consortium (SMC)

  7.17  The SMC's process for appraising new medicines has been developed in consultation with industry through constructive dialogue and active industry participation from its inception.

  7.18  The SMC operates to the highest standards of probity, basing its policy on declaration of interests (in common with NICE) on that of the Medicines Commission, and publishes a register of interests for SMC members.

Future developments

  7.19  Constructive engagement between industry and HTA agencies has helped to shape and establish fair and robust processes which are open to the sometimes conflicting views of a variety of stakeholders.

  7.20  Faster patient access to clinically and cost effective technologies would be promoted by a number of initiatives:

    —  The Department of Health, in conjunction with NICE, the Health Care Commission, the NHS and industry, should actively promote NICE's implementation support plan and act on the recommendations of Professor Richards's report. Industry should be engaged as a full partner both in these initiatives and in implementation activities more generally.

    —  The Department of Health and local NHS organisations should work with industry to investigate instances of "NICE blight" and continue to develop mechanisms to address this issue in order to maintain and increase access to new medicines.

    —  The Department of Health and NICE, in conjunction with the National Coordinating Centre for Health Technology Assessment, should ensure that the HTA groups have sufficient professional capability to complete their work for NICE to the highest standard. Collaborative working between industry and the HTA groups should be promoted to ensure that NICE's Appraisal Committees focus on the most important aspects of the decisions they are required to make.

    —  Multiple technology appraisal processes have developed as a result of devolution. The Department of Health, Welsh Assembly Government and Health Department of the Scottish Executive should review these processes and devise a mechanism for sharing best practice across the three separate technology appraisal systems to avoid duplication of effort and achieve the best outcome for patients.

    —  The Department of Health should periodically review the operation of NICE, as recommended by the 2002 Health Select Committee report on NICE, at least every three years.

    —  Official documents referring to technology appraisals should highlight the value of industry submissions in assembling the evidence on which appraisals are based.

8.  CONCLUSION

  8.1  We trust this submission has highlighted to the Committee the indispensable nature of the partnership between the NHS and the pharmaceutical industry that serves it. Each needs the other. Interactions between the two are subject to stringent regulation in a wide variety of respects. However, it is critical for both the NHS's effectiveness and the performance of this vital industry that the partnership be continuously enhanced to develop and deliver optimum treatment for the benefit of patients. We therefore look forward to discussing this with the Select Committee.

August 2004






17   Pharmaceutical Industry Competitiveness Task Force report, March 2000. Back

18   ABPI analysis of global sales and historical information on R&D pipelines. Back

19   ABPI estimates. Back

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

21   IMS Dataview. Back

22   Boyce M. Observational study of 353 applications to the London multicentre research ethics committee 1997-2000. International Journal of Pharmaceutical Medicine 2002. Back

23   Pharmaceutical Industry Competitiveness Task Force Report www.abpi.org.uk. Back

24   Partnership Agreement-Annex 1 to the Pharmaceutical Industry Competitiveness Task Force Clinical Research Report March 2002 www.dh.gov.uk/assetRoot/04/05/71/54/04057154.pdf. Back

25   Formation of UKCRC-DH Press Release 29/6/04. ABPI welcome www.abpi.org.uk/press/press_releases_04/040629.asp. Back

26   Bioscience 2015: Improving National Health, Increasing National Wealth, DTI, November 2003. Back

27   Strengthening Clinical Research, Academy of Medical Sciences, October 2003. Back

28   ICH GCP-hhttp://www.ich.org click on E6. Back

29   Statutory Instruments 2004 No 1031 The Medicines for Human Use (Clinical Trials) Regulations 2004 HMSO www.legislation.hmso.gov.uk/si/si2004/20041031.htm. Back

30   The Model Clinical Trial Agreement www.abpi.org.uk. Back

31   Boyce M. Observational study of 353 applications to the London multicentre research ethics committee 1997-2000. International Journal of Pharmaceutical Medicine 2002. Back

32   Taylor Nelson study, "The Value of the Representative", April 2004. Back

33   Controls on the Promotion of Prescription Medicines in the UK-guidance notes for health professionals, ABPI, September 2004. Back

34   Survey of PGEA Approved Meetings: J Pharm Med (1995) vol 5, 177-179. Back

35   Disease Awareness Campaigns Guidelines, MHRA Guidance Note No 26, June 2003, Back

36   Working with the Pharmaceutical Industry, Long Term Medical Conditions Alliance, Back

37   NHS and Pharmaceutical Industry Working Together for Patients, joint publication of ABPI and NHS Alliance, July 2004. Back

38   The remit of the IPTF is to work with the Association of the British Pharmaceutical Industry (ABPI) to make recommendations to the Medical and Healthcare Products Regulatory Agency (MHRA) on patient information. Back

39   MORI survey of 2,000 adults, July 2003. Back

40   Fatal dangers of alternative "cancer cures" on the web, Times, page 3, August 3, 2004. Back

41   Evans N J B, Cunliffe P W. Study of Control of Medicines, December 1987. Back

42   Medicines for Human Use (Marketing Authorisations, etc.) Regulations 1994. Back

43   Review of all medicines to minimise the risk of transmission of Transmissible Spongiform Encephalopathies. Back

44   Safety, quality, efficacy: regulating medicines, report by the Comptroller and Auditor General, HC 255 Session 2002-03, 16 January 2003, p 14-15. Back

45   Hill S, Garattini S, van Loenhout J, O'Brien B J, de Joncheere K. Technology appraisal programme of the National Institute for Clinical Excellence: a review by WHO. Copenhagen: World Health Organization; 2003. Back

46   House of Commons Health Committee. National Institute for Clinical Excellence: second report of session 2001-02. London: The Stationery Office Limited; 2002. Back

47   Brickwood D. Implementation of NICE guidance: an ABPI perspective [monograph on the internet]. London: Association of the British Pharmaceutical Industry; 2004 [cited 2004 Jul 15]-www.nice.org.uk/pdf/ABPI-Perspective.pdf. Back

48   Catchpole P. Audit into the implementation of NICE guidance for Roche drugs [monograph on the internet]. Welwyn Garden City: Roche; 2004 [cited 2004 Jul 15] Available from: www.nice.org.uk/pdf/Roche-Drugs.pdf. Back

49   Howard S, Harrison L. NICE guidance implementation tracking: data sources, methodology & results [monograph on the internet]. Bicester: Abacus International; 2004 [cited 2004 Jul 15]-www.nice.org.uk/pdf/Abacus-report.pdf. Back

50   Rawlings S. NICE implementation: the patient organisation perspective [monograph on the internet]. London: Breakthrough Breast Cancer; 2004 [cited 2004 Jul 15]-www.nice.org.uk/pdf/BREAST-CANCER.pdf. Back

51   Department of Health. Variations in usage of cancer drugs approved by NICE: report of the review undertaken by the National Cancer Director. London: Department of Health; 2004. Back


 
previous page contents next page

House of Commons home page Parliament home page House of Lords home page search page enquiries index

© Parliamentary copyright 2005
Prepared 26 April 2005