Select Committee on Health Minutes of Evidence


Memorandum by the Bioindustry Association (PI 147)

I.  INTRODUCTION

  1.  The BioIndustry Association (BIA) congratulates the Committee on this inquiry and is pleased to have the opportunity to submit evidence.

  2.  The BIA is the trade association for innovative enterprises in the UK bioscience sector. We represent over 350 members, the majority of which are involved in realising the human health benefits that bioscience promises.

  3.  The UK bioscience industry is the European leader and second globally only to the US. One third of Europe's bioscience companies are in the UK.

  4.  At the end of 2002, the sector:

    —  comprised 486 companies;

    —  employed approximately 25,930 people;

    —  had 225 new drugs in clinical development or awaiting approval; and

    —  had 47 publicly quoted companies with a total market capitalisation of

    9.7 billion.[52]

  5.  The BIA defines bioscience companies as those that are developing products or services that are derived from the study of living systems, or use living systems in their research, development and/or manufacturing activities. Such companies will typically be operating in the fields of human or animal healthcare, including diagnostics, therapeutics, vaccines and nutrition; environmental protection and remediation; or will be companies providing technical services to such companies.

  6.  The BIA, in conjunction with the DTI and the DH, last year led the Bioscience Innovation and Growth Team (BIGT), whose report, Bioscience 2015—Improving National Health, Increasing National Wealth,[53] was published in November 2003.

  7.  Bioscience 2015 is the biggest policy review of the sector to date and follows months of consultation with more than 70 leading industry figures. The report, with a foreword by the Prime Minister, said the UK must act now to secure its leading position as other countries recognise the value of a vibrant bioscience sector. The recommendations in the report form the core of this written submission.

  8.  This response focuses on the following areas of the Committee's inquiry:

    —  drug innovation;

    —  the conduct of medical research;

    —  regulatory review of drug safety and efficacy; and

    —  product evaluation.

II.  EXECUTIVE SUMMARY

  9.  The BIA makes the following points in this submission:

  10.  Unmet medical needs remain high and bioscience has the potential to address them, which would not only improve health but also the economics of preventative medicine and treatment of illness.

  11.  A supportive regulatory environment, both in the UK and EU, is critical to the ability of the UK bioscience sector to deliver human healthcare benefits. A growing number of regulatory decisions are made at EU level, many of which threaten to hamper the ability of the bioscience sector to develop medicines and to disincentive innovation.

  12.  Bioscience companies need adequate funding to ensure their ability to innovate and deliver new medicines and treatments.

  13.  Improving the UK's clinical research infrastructure will help to deliver new treatments and cures for patients, give the UK the opportunity to become the world-leading location for clinical research, and attract industry, academia and investment to the UK.

  14.  Industry should work with NICE, MHRA and EMEA to improve transparency in order that MHRA, EMEA and industry engage early in the development process to discuss which patient outcomes will be important for subsequent acceptance.

  15.  More needs to be done to ensure early access to life-saving medicines for patients. The new EU pharmaceutical legislation (Regulation (EC) No 726/2004) is a helpful step towards introducing a system for provisional licensing of drugs, similar to the French Autorisations Temporaires d'Utilisation (ATU) de cohort system, which would make promising new treatments available to patients where a genuine public health need exists, often before the completion of Phase III clinical trials. However, it falls short of recognising that products supplied for compassionate use are equivalent to authorised products for the purpose of reimbursement.

  16.  A robust approval procedure for biosimilar medicines (please see definition in paragraph 65) is necessary not only to guarantee patient safety but also to protect the future of biotechnological innovation in the healthcare industry in the UK.

  17.  PPRS—price modulation across portfolios is a disincentive for innovative, emerging companies in the UK. If this and other bioscience-specific issues are to be fully discussed—for the benefit of patients, the NHS, and the taxpayer—representation of the bioscience sector needs to be ensured in future PPRS (or equivalent scheme) negotiations.

III.  DRUG INNOVATION

(i)  An innovative sector addressing unmet medical need

  18.  Biopharmaceutical drugs account for 8% of total global pharmaceutical market sales, and are the fastest growing part of the market.[54] They will be an increasingly important part of the healthcare landscape over the next decade. One third of all drugs in development are now biologics.[55] While non-chemical entity (NCE)-based pharmaceutical company growth is expected to slow, due to patent expirations and pipelines of incremental innovation, biopharmaceuticals are widely expected to deliver both improved R&D productivity and strong growth.

  19.  UK bioscience companies have produced 42 marketed biotech drugs[56] with a further seven waiting for approval and at least 23 in phase III trials. The UK bioscience sector has the largest product pipeline in Europe, with 225 of the European total of 502 drugs in clinical development of awaiting approval.[57] UK companies have developed 43% of the products in late-stage clinical trials in Europe.[58]

  20.  Unmet medical needs remain high and bioscience has the potential to address them, which would not only improve health but also the economics of preventative medicine and treatment of illness. New bioscience technologies, such as genomics, proteomics, and bioinformatics, have the potential to address many medical challenges. Although tests that enable early diagnosis and highly effective innovative treatments are expensive on a per unit basis, they can reduce the total cost of care and the economic burden of disease. A good example of this is seen with diabetes. Regranex, a recombinant treatment for diabetic foot ulcers, is expensive, with one 20-week treatment costing at least £550-825. However, combined with appropriate ulcer nursing, Regranex actually reduces the cost of care and improves health (providing more healthy months and fewer amputations) compared to the alternative of ulcer nursing on its own.[59]

  21.  Bioscience has the potential to enable:

    —  earlier identification of disease risk and disease diagnosis, through genetic screening and diagnostics—eg as seen in breast cancer;

    —  development of targeted drugs, with higher efficacy (because they focus on particular patient pools or forms of disease), and improved safety (because they may reduce side effects);

    —  faster and more precise detection of pathogens;

    —  disease prevention through more effective and targeted vaccines;

    —  new modes of treatment for previously untreatable conditions, eg engineered tissue, stem cell therapies; and

    —  Faster drug development, which will enable faster delivery to patients of critical treatments.

  22.  At the same time, it should be remembered that generally accepted pharmaceutical industry data shows that it takes 10-15 years and in excess of $800 million[60] to develop a drug launched in the US or Europe and that less than half of these drugs ever repay their costs of development. Only one in nine drugs entering clinical trials will ever be launched. Most UK bioscience companies are not yet profit-making. At the start of 2003, there were 18 profitable bioscience companies in the UK.[61]

(ii)  Barriers to innovation

  23.  A supportive regulatory environment, both in the UK and EU, is critical to the ability of the UK bioscience sector to deliver human healthcare benefits. The UK has been a leader in establishing appropriate, science-based regulation in a number of areas, such as stem cell research. However, a growing number of regulatory decisions are made at EU level many of which threaten to hamper the ability of the bioscience sector to develop medicines. Often the real threat is from other EU Member States, which either do not understand the potential benefits of bioscience or do not consider its continued development to be a priority. This threat was highlighted by the Prime Minister in Prime Minister's Question Time on 18 June 2003:

  24.  "The biotech industry in this country is immensely important, and it is important for its future that decisions made by Government will be based on proper scientific evidence. It worries me that there are voices, here and in the rest of Europe, that are not prepared to give enough consideration to the potential benefits as well as the potential downsides."

  25.  Bioscience 2015 recognised that "the increasing requirement of regulation, due to heightened concern for the precautionary principle, threatens to stifle innovation."[62] The recently published Research for Patient Benefit Working Party report[63] also recognised that a review of the regulatory environment for clinical research in the UK needs to take place.

  26.  Overly restrictive regulation reduces the incentive to investigate and develop innovative drug therapies. It also lengthens the time, increases the cost, and constrains the market for innovative drugs, usually without any increased patient safety. Bioscience companies have limited financial resources and are producing innovative and expensive medicines, so these cumulative constraints weigh particularly heavily.

  27.  There is also a real risk that the health benefits of this regulatory tightening will be more than offset by significant health costs, including:

    —  loss of some drug development (due to lack of R&D);

    —  delays in drugs reaching the market;

    —  higher cost of new therapies leading to de facto rationing of supply; and

    —  weakening of competition among suppliers through inhibition of new market entry.

  28.  An example of the increasing regulatory requirements from EU legislation is the recently implemented Clinical Trials Directive, which tightens regulation, monitoring, and standards for early stage clinical trials. Bioscience 2015 expressed serious concerns that the implementation of the Directive into national legislation could have a negative impact on the attractiveness of the UK as a location for clinical research, in terms of extra costs, and bureaucracy. The report also expressed real concerns, in particular, about the requirement for all Investigative Medicinal Products (IMPs) to be Good Manufacturing Practice (GMP) compliant, and the increase in statutory time periods for regulatory and Ethics Committee approval of trials.

  29.  The MHRA's commitment to appropriate implementation of the Directive was key; it took on board industry's concerns about the possible crippling impact of the Directive on early stage research, in fact delaying implementation of the Directive to further examine these issues. The BIA believes that the implementing Regulations in the UK are as sensible as they could have been, although the impact of the Directive over time will need to be monitored.

  30.  Another recent example of EU over-regulation concerns the recent revision of the EU Technology Transfer Block Exemption Regulation (TTBER), which came into force in May 2004. The TTBER is a set of terms and principles that allows the drafting of commercially viable licensing agreements with reasonable certainty that they will not be found to be anti-competitive under competition law. The industry has operated successfully with the old TTBER but the new rules will mean that most licensing agreements—the life-blood of the bioscience industry—will lose the certainty of the TTBER regime.

  31.  To come within the new rules, companies working together must now not have a combined market share of more than 30% of either technology or products. The innovative nature of the bioscience sector means that companies can find themselves at times with a high, even a 100%, market share. Many bioscience licensing agreements will now fall outside the new Block Exemption, resulting in higher legal costs—an unnecessary and unhelpful burden for emerging, innovative companies. The BIA is monitoring the impact in practice of the revised Regulation on licensing agreements and would be happy to keep the Committee informed of results of this work.

  32.  Increased uncertainty and additional bureaucracy, of which the Clinical Trials Directive and the TTBER are but two examples, could reduce the ability of the industry to deliver new treatments for the many life-threatening and debilitating diseases that still have no cure. This flies in the face of the European Commission's own Life Sciences and Biotechnology Strategy and its recently launched consultation, "Innovate for a competitive Europe". If the regulatory environment continues to stifle innovation, the real losers will be the end-users—patients.

(iii)  Innovation—the impact of consolidation

  33.  A key driver of innovation is the ability of companies to access sufficient capital to undertake the research and product development required in order to bring life-changing/life-enhancing or life-saving drugs to the user.

  34.  In the long term, there are benefits for both patients and the NHS if pioneering drug companies are able to innovate, grow and develop products and still remain UK-based, without automatically being acquired by other, larger companies once they reach a certain size.

  35.  Currently, there are many excellent UK bioscience companies with world-class science and management, whose ability to continue to innovate from the UK is hampered because of an unequal "equity playing field". In simple terms, successful innovative UK biotech companies grow to a certain point when their capital requirements mean that they are nearly always obliged to access US capital markets in order to continue the drug innovation process, which itself often means being acquired by large companies.

  36.  We now need to ensure that UK bioscience companies are adequately funded so that innovation can benefit. We hope that the Committee will agree that we owe it to all those suffering from illness to ensure that the UK remains a world leader in bioscience. Specifically, Bioscience 2015 recommended:

    —  Amending the pre-emption Guidelines to permit UK-listed life science companies to issue up to at least 20% of their share capital on a non-pre-emptive basis.

    —  Strongly supporting efforts to create a more accessible and liquid capital market for technology companies, through harmonisation of listing rules and through a LSE-led pan-European technology exchange.

  37.  These measures would have a positive impact on innovation and bring direct benefits to patients and procuring public bodies.




IV.  THE CONDUCT OF MEDICAL RESEARCH

(i)  Building a mutually advantageous collaboration between the NHS and Industry for patient benefit

  38.  The BIA would like to bring to the Committee's attention one of the key recommendations in the Bioscience 2015 report in which the BIA is closely involved in taking forward.

  39.  Improving the UK's clinical research infrastructure will help to deliver new treatments and cures for patients, give the UK the opportunity to become the world-leading location for clinical research, and attract industry, academia and investment to the UK.

  40.  The report recognised the need to ensure that UK patients must not be left behind in their access to innovative treatments. Tapping the full potential of the NHS patient pool was seen as a way of building sustainable competitive advantage in clinical research, and in bioscience, for the future. The power of this asset will grow over the coming 10 years, as new technologies such as genetics, transcript profiling, proteomics and metabonomics start to be used more frequently in clinical development and practice.

  41.  Bioscience companies find it challenging to access patients for clinical trials in the NHS. There is a lack of transparency regarding trials capacity; lack of simple co-ordination mechanisms for dealing with multiple trusts or research centres; lack of standard practices when it comes to collaborating with industry—though progress is being made in this area; and lack of the business mentality required to conduct these trials swiftly and to high quality standards. Medical consultants in some of the existing trials units express frustration at the need (as they see it) to solicit business personally and assist NHS Trust R&D offices handling contract negotiations. There are also clear infrastructure constraints: particularly a lack of clinical research facilities and the necessary research staff to support high quality execution.

  42.  The EU Clinical Trials Directive, which came into force in May 2004, will substantially increase the managerial burden of conducting trials, as regulatory measures that previously applied only to late stage trials will now affect all clinical trials of investigated medical product including Phase I trials. Importantly, in an increasingly decentralised NHS, there is no single organisation to champion clinical research and address the challenges above. Bioscience 2015 recommended the creation of a new organisational entity to fund and lead clinical research in the UK, together with the creation of a national network for clinical trials.

  43.  The Government responded to this recommendation by setting up the Research for Patient Benefit Working Party (RPBWP), under the Chairmanship of Professor Sir John Pattison, then Director of Research and Development at the Department of Health. The BIA welcomed the recommendation in the RPBWP's Report that a UK Clinical Research Collaboration (UKCRC) be established, and the Secretary of State for Health's subsequent announcement during the health budget debate on 22 March 2004 of the Government's plan to implement this, involving the NHS, patients, the Medical Research Council, the Wellcome Trust, the medical charities and industry. The Secretary of State has also announced that a network of paediatric centres is to be established, that the mental health research network be expanded, and an infrastructure is to be developed to facilitate research into diabetes, Alzheimer's and stroke.

  44.  The BIA represents the bioscience sector on the UKCRC Steering Group and values this opportunity to work with Government and other stakeholders to develop the opportunity presented by the creation of the UKCRC, current and future research networks for the benefit of patients. Industry involvement in the Steering Group is important in order to reflect the position of industry as a leader in research and a prime sponsor of high quality research.

  45.  It was also very positive that the Budget earlier this year explicitly recognised this recommendation to strengthen clinical research in the UK, and that funding has been earmarked to take this forward. In direct recognition of the Bioscience 2015 recommendation, the Chancellor announced that NHS funding for R&D will be increased by £100 million by 2008 and the combined budget for medical research and for R&D within the NHS will rise to around £1.2 billion a year by 2007-08.

(ii)  Access to information on clinical trials

  46.  In order to ensure safety, efficacy and quality of licensed medicines, it is reasonable that all clinical trial data should be made available to the licensing authorities.

  47.  In addition, the BIA's Code of Best Practice (please see next page for further details) points out that Companies must establish their own formal procedures for handling unpublished information which, if it were made public, would be likely to have a significant effect on the price of its listed or publicly traded shares or securities.

  48.  It is essential for the management of these companies to build and maintain the confidence of investors who rely upon projections and information about potential future revenues from the research and development pipeline in valuing the companies. Investors rely heavily upon these companies to communicate information in a way that they can understand. Investors also rely on analysts who interpret information emanating from companies. It is therefore of the utmost importance that companies constantly seek to apply best practice in their communications policies and activities.

  49.  It is very important, however, that the obligations a company has to release "financially sensitive" information is handled in confidence where it arises. It is also important that legal rights of companies are protected if misrepresentation of data via the Internet or the media has taken place.

(iii)  The BIA Code of Best Practice

  50.  The BIA's Code of Best Practice is mainly concerned with how companies publish and communicate information, particularly in relation to the development and commercialisation of products, technologies and services. The Code applies to bioscience companies that are members of the BIA.

  51.  The Code does not attempt to prescribe in detail how companies should operate and it would be impractical to try to do so. The Code contains general principles that BIA members should observe. Member companies that are expected to comply with the Code must report in the Directors' Report in their annual report and accounts on how the principles have been applied. They must also report on compliance with the provisions of the Code and provide the reasons for any non-compliance.

  52.  The BIA wishes to act as a forum for establishing and developing best practice. The Code does not replace or override legal or regulatory requirements. It is designed to supplement and reinforce the London Stock Exchange's rules and guidance—the Continuing Obligations Guide and the Guidance on the Dissemination of Price Sensitive Information.

V.  REGULATORY REVIEW OF DRUG SAFETY AND EFFICACY

(i)  Making the case for innovation

  53.  The impact of overly restrictive regulation has been covered already in this submission. There is a real risk that this could adversely affect the health benefits that bioscience products have the potential to deliver.

  54.  The introduction of novel therapeutic approaches can lead to improved outcomes as well as reduced cost of patient care for healthcare providers such as the NHS. Newly launched products penetrate the UK market slowly relative to other countries slowly as it is—in 2000, only 16% of expenditure on medicines in the UK was on new medicines (of those launched between 1996 and 2000), compared with 25% in Germany, and over 33% in the US. The UK ranks above only Japan on this innovation index. It also lags Italy, France, Australia, Switzerland, Spain, and Canada.[64]

  55.  Bioscience 2015 stressed that the case for innovation needs to be made, to signal the UK's receptiveness to innovation and more assertively promote the advantages of technological research and scientific progress. The report highlighted the weakness of the precautionary principle that it does not allow account to be taken of what constitutes an acceptable risk. Society is generally poor at calibrating risk, eg patients suffering from acute disease usually have a different view of safety thresholds than healthy people. While innovation inevitably involves risk and cost, it also offers huge potential benefit.

(ii)  Creating a collaborative relationship

  56.  Bioscience 2015 highlighted the need to create a collaborative relationship between the EU and UK drug approval regulators and the bioscience and biopharmaceutical industry.

  57.  The report recommended that industry should work with NICE, MHRA and EMEA to improve transparency in order that MHRA, EMEA and industry engage early in the development process to discuss which patient outcomes will be important for subsequent acceptance. This should take place along the lines of FDA-industry interaction.

  58.  It went on to recommend that MHRA and EMEA should seek to at least match the FDA's target of reducing drug approval times by 10%, and that the FDA, EMEA and MHRA should also be encouraged to work closely together to ensure shared process and protocols.

(iii)  Research Ethics Committee approval

  59.  A thorough but efficient ethics review process is central to the competitiveness in attracting clinical research. The new system was simplified on 1 March 2004, but is still slow.

  60.  A review is needed to look into actions that could be taken to improve NHS Trust approval. Delays caused by the R&D offices within NHS Trusts are probably the single cause for most of the delays and the reason why industry conducts trials abroad.

(iv)  Making promising new treatments available

  61.  Drugs take 10-15 years to progress from initial research through to on-market sale, and spend at least three years in Phase III clinical trials and pre-registration. In some markets, pricing and reimbursement decisions further lengthen those timelines. Getting safe, innovative drugs to the patients who need them, quickly, is a shared objective of both industry and Government. However, more needs to be done to ensure early access to life-saving medicines for patients.

  62.  The BIA would like to bring to the Committee's attention a key BIGT recommendation to introduce a system for provisional licensing of drugs, similar to the French Autorisations Temporaires d'Utilisation (ATU) de cohort system. This would make promising new treatments available to patients where a genuine public health need exists, often before the completion of Phase III clinical trials.

  63.  The system was introduced under the French Social Security Code in 1994. It is an exceptional measure for compassionate use of medicines, allowing the sale of drugs that have not yet been granted a marketing authorisation. The aim of ATUs is to provide early access to new promising treatments where a genuine public health need exists—where there is no alternative available. The diseases most frequently concerned are cancers, infectious diseases such as AIDS, and neurological disorders. ATUs are typically granted for drugs where there is a strong presumption of efficacy against an acceptable safety profile. This typically occurs at an advanced stage of clinical development when, for example, a marketing authorisation application is in the course of production or registration.

  64.  Drugs that received ATU status from the French regulatory authority AFSSAPS are included in the list of medicinal products approved for hospital use, thus permitting reimbursement. Pharmacies of healthcare establishment are authorised to purchase the ATU approved products.

  65.  The new EU pharmaceutical legislation (Regulation (EC) No 726/2004) is a helpful step towards this, laying the foundation for an EU-wide framework for compassionate use of medicinal products in advance of authorisation and providing the opportunity for Member States to implement a fast-track registration procedure, conditional marketing authorisations. However, it falls short of recognising that products supplied for compassionate use are equivalent to authorised products for the purpose of reimbursement; pricing and reimbursement fall within the national competence.

(v)  Regulation of biosimilar medicines

  66. A biologic is a medicine that can be made only by using a living system/organism. Biologics have large, complex, inherently diverse molecular structures. A so-called similar biological medicinal product (a "biosimilar") is a product that purports to be similar to a reference biological medicinal product manufactured by an innovative biopharmaceutical company.

  67.  Since biological medicinal products are inherently different and more complex than small chemical molecules, they must be approved under strict conditions to guarantee patient safety. With the adoption of the EU pharmaceutical review package earlier this year, the EU has established a regulatory and legislative pathway for the approval of such medicines, together with other, earlier adopted Directives and supporting EMEA guidelines. In short this pathway states that contrary to what is required for generics, the application for a marketing authorisation for a biosimilar medicine must include appropriate pre-clinical and clinical data, to establish safety and efficacy, on a case-by-case basis.

  68.  Biosimilar medicines are not identical or "substitutable" to the original product the way generic drugs can be substituted, because they are not made from the same parent cell or via the same manufacturing process, and thus cannot be an exact copy or "generic".

  69.  Small differences in the production process of biological medicines can yield vastly different products. A faulty or imprecise "copy" of a biologic might appear to be the same as the original product, but can cause extreme side effects in patients and could raise serious safety concerns. It is therefore right that the legitimate attempts to make and market biosimilars should not compromise patient safety. The field of biopharmaceuticals is a very new one. The first biopharmaceuticals will be coming off patent very soon, paving the way for other companies to copy these products and sell them. Now is the time to get the definitions and the conditions right to ensure that the products offered to patients are as safe, as efficacious and of as high quality as the original products.

  70.  The system needs to ensure that what the patients are getting is safe, but it also needs to ensure that the emerging biopharmaceutical sector can develop. Safety issues that might arise due to inadequate approval regulations for biosimilars would damage the development of bioscience in the UK and Europe. We therefore believe that a strict approval procedure is necessary not only to guarantee patient safety but also to protect the future of biotechnological innovation in the healthcare industry in the UK.

VI.  PRODUCT EVALUATION, INCLUDING ASSESSMENTS OF VALUE FOR MONEY

(i)  NICE

  71.  As outlined in Bioscience 2015, there are concerns about how quickly drugs can be effectively marketed in the UK after approval. Particular difficulties are foreseen with new bioscience products. NICE has an emphasis on mainstream drugs, whereas the bioscience industry often has niche products where the patient numbers involved falls below NICE's economic threshold. As a review by NICE of a new drug comes after approval of that drug through the MHRA or EMEA and before its availability to the NHS, it can be a barrier to diffusion. In addition, nothing has been done so far to rectify the "postcode prescribing", which is widely publicised, especially in the oncology area.

  72.  Bioscience 2015 recommended that: industry should work with NICE, MHRA and EMEA to improve transparency in order that NICE is aware of clinical trials data at the earliest appropriate moment for each individual company. NICE and industry should engage in mutual education—about, for example, which drugs NICE will look at, NICE criteria for niche medicines/therapies, and the best framework for evaluating total cost of care. In addition, NICE should take full account of the wider economics of health and social care when making decisions about the cost-effectiveness of therapies.

(ii)  PPRS

  73.  The PPRS is an agreement for the purposes of Section 33 of the Health Act 1999. The objectives for the scheme are that it should continue to:

    —  secure the provision of safe and effective medicines for the NHS at reasonable prices; and

    —  promote a strong and profitable pharmaceutical industry capable of such sustained research and development expenditure as should lead to the future availability of new and improved medicines.

  74.  An issue that has been raised with the BIA by several bioscience companies in the context of the PPRS is that of price modulation across portfolios. This related to a mechanism whereby companies with portfolios are able to maintain prices on individual products, providing that sufficient price cuts are made on other products in the portfolio. The problem that this presents for bioscience companies is that they are likely to have a small portfolio—often one or two products.

  75.  Consequently, the option of making price cuts across the portfolio is not open to them, putting them at a significant disadvantage to larger companies with larger portfolios. This is a definite disincentive for innovative, emerging companies in the UK.

  76.  Moving forward, as more bioscience products reach the market, not only will this issue affect a greater number of bioscience companies, it is also likely that more issues specific to the bioscience sector will become pertinent to the PPRS negotiations. If these issues are to be fully discussed—for the benefit of patients, the NHS, and the taxpayer—representation of the bioscience sector needs to be ensured in future PPRS (or equivalent scheme) negotiations.





52   All data from Critical I. Back

53   www.bioindustry.org/bigtreport Back

54   Biopharmaceutical drugs includes vaccines, all figures at ex-manufacturer prices. CAGR (compound annual growth rate) for biotech drugs 15% between 1997 and 2002 (Evaluate Pharma) vs 8% for total pharmaceutical market (IMS Health). Forecast biopharmaceutical drug growth: 17% CAGR 2002-07 (estimated from IMS Health 2003, Evaluate Pharma 2003, and analyst reports) www.evaluatepharma.com. Back

55   "In development" means Pre-clinical through Phase III. Source: Pharmaprojects, March 2003 www.pharmaprojects.co.uk. Back

56   PharmaProfiles2003. Back

57   Critical I. Back

58   E&Y 2003. Back

59   Bioscience 2015, p 11, www.bioindustry.org/bigtreport. Back

60   Tufts. Back

61   Critical I. Back

62   Bioscience 2015, p 50. Back

63   http://www.dh.gov.uk/assetRoot/04/08/26/75/04082675.PDF. Back

64   ABPI, cited in Parexel's Pharmaceutical R&D Statistical Sourcebook 2002. Back


 
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