Annex 3
Submission by the Medical Research Council
(MRC)
INTRODUCTION
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.
THE MRC RESEARCH
PORTFOLIO: WORKING
WITH THE
PHARMACEUTICAL AND
OTHER INDUSTRIES
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.
MRC CLINICAL TRIALS
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.
MRC TECHNOLOGY (MRCT)
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.
REGULATORY ISSUES
IN MEDICAL
RESEARCH—WORKING
IN PARTNERSHIP
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.
PUBLIC ENGAGEMENT
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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