Select Committee on Health Minutes of Evidence

Annex 3

Submission by the Medical Research Council (MRC)


  1.  The Medical Research Council (MRC) is a national organisation funded mainly by the UK tax-payer. With a total income of £480 million (in 2003-04) the Council promote research and training in all areas of medical and related science. The MRC's mission is:

    —  To encourage and support high-quality research with the aim of improving human health.

    —  To produce skilled researchers and to advance and disseminate knowledge and technology to improve the quality of life and economic competitiveness in the UK.

    —  To promote dialogue with the public about medical research.

  2.  Delivery of the mission requires close working with industry, the NHS and Health Departments, charities and consumers among other stakeholders. Many of the issues under consideration by the Committee are central to corporate policy development, business planning and decision making. This submission outlines some of the ways in which MRC works in partnership with industry.


  3.  The MRC believes that medical research requires approaches at all levels: molecules, cells and tissues, animal models, whole organs and systems, individuals and populations.

  4.  The MRC is publicly committed to giving greater priority in future to translational research at the basic/clinical interface. As a result, the Council have readily embraced the need for new approaches to partnership-working in clinical research—including working with the pharmaceutical industry—as outlined in recent reports.[1] MRC are playing an integral part in the new UK Clinical Research Collaboration (UKCRC), and have welcomed the setting-up of a new Joint MRC/DH Health Research Delivery Group in order to achieve greater strategic co-ordination of medical research between public sector funders.

  5.  Industry representatives contribute to MRC policy development and funding decisions at strategic and operational levels, for example through membership of the MRC's Council, research boards and consultative committees. This facilitates a two-way flow of information and ideas about innovative approaches in research and on commercial realities. In this way the Council are able to develop an understanding of areas where there are common goals and areas in which to work together effectively. Industry representatives do not participate in any MRC decisions relating to the companies for which they work.

  6.  The MRC believe that the pharmaceutical industry values the high quality of MRC research for its contribution to the knowledge base from which all innovation flows. The MRC's postgraduate and postdoctoral training programmes also delivers trained manpower to industry as well maintaining standards in the academic sector.

  7.  MRC's intramural research units engage in a wide range of collaborative research programmes with pharmaceutical, biotechnology and other companies, as do recipients of MRC grant support in the universities. MRC staff also offer their expertise to companies through consultancy agreements. In general, MRC does not undertake commissioned research which is wholly targeted at industry's goals, as this is not part of the MRC's mission. Collaborative research therefore reflects shared or complementary interests, or instances where MRC has particular infrastructure or technology to offer as a resource. Issues such as ownership of intellectual property and publication rights are agreed in advance with a view to ensuring that intellectual property is protected where necessary, mechanisms exist for timely exploitation, and results are published subject only to short delays when patent applications are to be filed. MRC scientists retain the ultimate control over the content and presentation of publications in order to preserve scientific integrity. This is typical of collaborations between the pharmaceutical industry and the academic science base and in general companies in this sector have substantial experience of working with academia and are aware of its particular concerns.

  8.  The MRC has some dozens of collaborations in place at any one time, ranging from basic science through to identification of drug targets, high throughput screening of potential candidate drugs, and clinical trials. A case worth highlighting is the renewal in 2003 of an existing collaboration between the MRC Protein Phosphorylation Unit, and the University of Dundee's School of Life Sciences with six of the world's major pharmaceutical companies—AstraZeneca, Boehringer Ingelheim International GmbH, GlaxoSmithKline, Merck Co, Inc. (USA), Merck KGaA (Germany) and Pfizer. The companies agreed to provide further funding of more than £15 million over five years to investigate two classes of enzymes, termed kinases and phosphatases, which have become some of the most important classes of drug target in the pharmaceutical industry. Overall the collaboration will have provided funding in excess of £21.5 million over 10 years and supported the creation of over 20 new scientific posts within the specially created Division of Signal Transduction Therapy. Novel pathways and targets have been dissected and a number of patent applications licensed by MRC to partners within the consortium and more widely.


  9.  MRC funding for clinical trials is approximately £18 million per annum. Around 170 trials are currently in progress covering all aspects of medicine from prevention and diagnosis to drug and primary healthcare treatments for a broad range of health problems. MRC trials have established, for example:

    —  the role of aspirin and of statins in protecting against heart attack and stroke;

    —  the use of magnesium sulphate in halving risk of pre-eclampsia in pregnancy; and

    —  a rise in the cure rate for childhood leukaemia to 80%.

  10.  The MRC's role in clinical trials complements that of industry: in general the Council are not concerned with trials aimed directly at licensing new drugs. A recent review[2], confirmed the MRC's commitment to promote trials in areas that may pose methodological challenges and in which the interventions studied may have an important impact on public health. In future, the MRC wishes to place emphasis on trials of complex interventions such as those aimed at behavioural or lifestyle changes; MRC also undertake trials of non-drug interventions such as surgery or radiotherapy. In the pharmaceutical field, the Council undertake a number of trials which provide an independent comparative assessment of different products, often from different companies, for example in the fields of AIDS or cancer. Companies generally welcome such studies, and frequently provide their products and the necessary trial packaging, free of charge.

  11.  Within UKCRC, MRC will continue to play a leading role in developing trials methodology, drawing for example on expertise at MRC clinical trials units in Oxford and at University College, London. The MRC's infrastructure for the conduct of trials will also be made available for use in this collaboration.

  12.  The MRC is a partner in the European Developing Countries Clinical Trials Partnership (EDCTP), formally representing the UK on the governing body. The aim of this initiative (with EU funding of 200 million Euros over five years) is to accelerate development of effective, affordable and sustainable interventions against poverty-related infectious diseases such as HIIV, tuberculosis and malaria. Among other things this includes encouraging the participation of industry and developing partnerships. The focus will be on phase II and III trials of preventive interventions and treatments. Funding for research and capacity development will concentrate on Africa initially, with full involvement of the African nations. The MRC also undertake clinical trials of vaccines and potential treatments for infections and tropical diseases in our own research units in The Gambia and Uganda.

  13.  MRC helps to set standards of good practice in the conduct of clinical trials and clinical research generally through the publication of a range of guidelines in its clinical trials and ethics series. Recipients of MRC funding are expected to follow these guidelines, which are also publicly available on the web and known to be used by a variety of other organisations including industry.


  14.  MRC owns the intellectual property (IP) arising in its own research units and institutes. Management of this IP is handled by an affiliate company, MRC Technology (MRCT), whose Chief Executive, Roberto Solari, and others in the company have extensive experience of working in and with the pharmaceutical/biotech industry. Its objectives in fostering the industrial development of MRC inventions are based on the MRC mission statement and are designed to attain—in order of priority—improved healthcare products and services, national economic benefit and a financial return to MRC itself.

  15.  Over the last four years MRCT has completed over 150 licensing deals and generated £60 million in income. Much of this income derives from the sales of therapeutic antibody products using patented antibody engineering technologies developed by MRC teams in Cambridge. Products on the market include antibody-based treatments for breast cancer, leukaemia, colorectal cancer, infant respiratory disease, asthma, psoriasis, kidney transplant rejection and rheumatoid arthritis. A further 30 products are now in late stage clinical trials.

  16.  MRC has given particular attention to encouraging the formation of new companies, where appropriate, to exploit new MRC technologies. Two of the largest UK biotechnology companies, Celltech and Cambridge Antibody Technology originated as start-ups based on MRC technologies and 15 other MRC start-up companies have either merged with others prior to listing or have attracted substantial venture capital or corporate financing as private companies. MRC also created a subsidiary, MVM Ltd, to act as investment managers for funds which have raised over £150 million—all from the private sector—for seed and early stage investment in new companies based on life sciences research.

  17.  Despite these successful interactions with industry there remain some difficulties to overcome. There are massive costs and high risks involved for the pharma industry in taking potential new drugs through pre-clinical development and clinical trials to product launch. Companies are understandably reluctant to take forward results arising from the science base which, while promising, are as yet at too early a stage for commercial investment. The current depression in the biotechnology investment market, in Europe at least, exacerbates the difficulties. While the problem is particularly acute in those fields where the eventual rewards are relatively limited (eg potential treatments for tropical diseases or rare disorders) there are many other instances where initial discoveries require further validation and/or development before they can attract industrial or venture capital interest. MRC has taken a number of initiatives to alleviate this problem.

  18.  In 2003, following a successful pilot scheme, MRC approved a £4.5 million "Development Gap" fund managed by MRCT to support further investigative research and reduction to practice on initial results with commercial potential that arise in MRC Units and Institutes. The research is project-managed to deliver to commercially relevant targets. Through this mechanism, MRC is able to develop its intellectual property into more robust and commercially attractive opportunities.

  19.  MRCT has also established an Assay Development Group based at its Mill Hill site which converts MRC molecular targets and bench assays into robust high throughput screens (HTS). MRCT collaborates with MRC scientists to develop the assays and re-supplies the "hit" compounds to the scientists for target validation studies. This means that MRC can offer characterised targets with supporting biology to potential commercial partners.

  20.  For the future, Council has recently approved development of a full business case for MRCT to establish a new drug discovery capability. The Council noted that the emerging vision—of a medicinal chemistry capability within the public sector which will enhance the value of early stage biology in the drug discovery process—had drawn widespread support in the pharmaceutical industry, among venture capitalists and key global health players including MMV and the World Health Organisation.


  21.  MRC has welcomed recent opportunities to develop a partnership approach to the handling of a range of regulatory issues in medical research. A widely shared desire to maintain public trust in the governance and practice of medical research, whilst ensuring that research is not impeded by excessive regulation, has helped to develop powerful alliances across the sector on a number of regulatory issues. For example:

    —  MRC worked closely with the medical charities, the Royal Society and others to brief policy-makers on the health implications of stem cell research when the legislative framework was being developed.

    —  Similar joint briefing has been provided for drafting of human tissue legislation and in relation to the EU clinical trials directive.


  22.  MRC has taken the lead in establishing The Coalition for Medical Progress (CMP), an alliance of organisations that share the common aim to ensure the UK continues to lead advances in human and animal medicine. Through CMP, representatives from all sectors involved with biomedical research can work together nationally to explain and illustrate the need for and benefits of research involving animals, and to respond to specific issues of public interest. The majority of the UK's major pharmaceutical companies are members of CMP.

1   (Bioscience 2015-Improving National Health, Increasing National Wealth-a report to Government by the Report by the Bioscience, Innovation and Growth Team; Strengthening Clinical Science-a report from the Academy of Medical Sciences published in October 2003 and Research for Patient Benefit Working Party-a report from the Department of Health in May 2004). Back

2   Clinical trials for tomorrow-An MRC review of randomised control trials 2003. Back

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Prepared 26 April 2005