APPENDIX 23
Memorandum by The Wellcome Trust (PI 93)
The Wellcome Trust is pleased to respond to
this inquiry into the influence of the pharmaceutical industry.
The Trust is a major funder of biomedical research, with a mission
"to foster and promote research with the aim of improving
human and animal health". Biomedical research fenders cannot
work in isolation: we see the pharmaceutical industry as a
key partner in the process of translating research into healthcare
benefits.
The Wellcome Trust aims to support the translation
process by providing "pump-priming" funding for promising
early-stage projects, and access to key advice on intellectual
property and product development. The aim of this support is to
maximise the likelihood that an invention will be suitable for
further development by either a start-up company or the pharmaceutical
industry. We therefore see our role as funding basic research
and supporting the development of this research to a point where
it will be taken up by industry or by venture capitalists (VCs).
This is mainly achieved through our translation funding programmes[80]
and support for international public private partnerships such
as the Medicines for Malaria Venture (MMV).[81]
This response concentrates on the influence of the pharmaceutical
industry on the conduct of medical research and on the development
of new drugs, as this is our main area of experience. It is in
this context the Trust suggests that as part of its inquiry the
Committee should consider a number of issues which I have set
out below.
Market failure
It is well documented that for a large number
of diseases there is little or no commercial research and development
being undertaken. These so-called orphan diseases include
those that are the biggest killers in the developing world such
as malaria and tuberculosis. It is clear that the market fails
to provide the pharmaceutical industry with the necessary environment,
predominantly financial return, to become involved with developing
drugs for these orphan and developing world diseases. The
Trust considers that it would be interesting to explore whether
there are aspects of the regulatory environment which could
be adapted so that it is more "fit for purpose"
and as such reduce the financial burden in developing drugs for
these areas.
There have already been a number of other initiatives,
such as tax incentives, to encourage greater commercial R&D
in these areas but the Trust is not aware if the effectiveness
of these schemes has been evaluated as yet and the Committee could
usefully explore with the pharmaceutical industry what their
minimum requirements are to invest in a particular area.
Is there a widening gap between basic research
and industry take up?
The Lambert Review of Business-University Collaboration
(published December 2003)[82]
illustrated that there has been a general decline in industrial
investment in UK R&D over the last 20 years. Whilst the
pharmaceutical industry, and particularly new biotechnologies
do better than other areas, the Trust feels there is an increasing
trend for the pharmaceutical industry to licence research in,
either from academia or more commonly from spinout companies,
rather than develop in-house basic research. It might well be
unlikely and in fact inappropriate for academic research to be
drawn further along the product development pipeline in an attempt
to fill this requirement. Eventually a gap may develop between
what academia can deliver and what the pharmaceutical industry
is prepared to invest or licence-in. It would be very useful if
the Committee could explore whether this is an apparent or real
trend.
Private Public Partnerships
Public private partnership are a new, but as
yet unproven, model for bringing together public, charitable and
industry money to both share risk and produce research which is
mutually beneficial. This has been particularly successful in
areas where the research creates pre-competitive information and
the SNPs consortium is a very good example of this.
Product development public-private partnerships
are one model trying to address the market failure in new drug
and vaccine production particularly for those diseases most prevalent
in the developing world. However, to date the Trust considers
many of these PPPs have not been equal partnerships and particularly
in international efforts such as MMV, the level of government
support does not appear to match the commitment of the charitable
foundations. PPPs will not be able to meet all future public
health needs without significantly increased and equal levels
of investment. It is worth noting that whilst these PPPs might
improve the product development aspect of the pipeline there will
still be many other areas such as product manufacture, marketing
and distribution which will need addressing to eventually
have an impact on the burden of disease itself. This will also
require similar innovative ways of working between public and
private stakeholders.
80 Further details about Technology Transfer at the
Wellcome Trust can be found at http://www.wellcome.ac.uk/en/1/biottd.html Back
81
Further details about MMV can be found at http://www.mmv.org/pages/page_main.htm Back
82
http://www.hm-treasury.gov.uk/consultations_and_legislation/lambert/consult_lambert_index.cfm Back
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