Submission from the Department for Trade
"THE IMPACT OF THE PROPOSALS UPON STEM
CELL RESEARCH IN THE UK"
The Prime Minister in his speech to the Royal
Society on 3 November 2006 said that "I am glad to say that
the UK biotechnology sector remains the most successful in Europe
and is second globally only to the US". He has also said
previously "Biotechnology is the next wave of the knowledge
economy, and I want Britain to be its European hub".
2. The realisation of the Prime Minister's
vision is dependent upon a regulatory environment in the UK that
promotes innovation by both industry and the academic research
base. Accordingly, DTI is keen that regulation supports and encourages
both universities and companies to remain at the leading edge
in the particularly important area of stem cell research and development.
3. The strength of our current regulation
is that it balances both the opportunities for advancement of
the science underpinning improvements in health care with consideration
for ethical implications. Both objectives must continue to be
4. The UK permits and supports financially
stem cell research using cells from all sourcesadult, foetal,
and embryonic. As a result, the UK has been at the forefront of
stem cell research for a number of years. Key advances such as
nuclear transfer have been developed in the UK, and the Government's
objective is that the UK retains its position as a world leader
in stem cell research. The 2005 Budget announced the launch of
a UK Stem Cell Initiative (UKSCI) to help shape the future of
stem cell research in the UK.
5. The UK Stem Cell Initiative (UKSCI) was
a high-level review, chaired by Sir John Pattison, and included
the Wellcome Trust, MRC, BBSRC, DTI, DH and the UK Stem Cell Foundation.
The UKSCI report, published in December 2005, provides a clear
vision for maintaining the UK's position as a world leader in
stem cell research, and provides a pathway to translate this research
into new therapies to benefit patients.
6. The Government accepted the recommendations
in the report, which have been used to inform the development
of the UK's investment and regulatory strategy for stem cell research.
The Government announced that £100 million will be made available
for UK stem cell research over the 2006-08 period through its
funding of Research Councils, DTI Technology Programmes, the NHS
R&D programmes and Regional Development Agencies. Although
the exact amount the Research Councils will spend on stem cell
research in this period will depend on the number of high quality
applications received, it is anticipated that this will be in
the order of £50 million.
7. The implementation of the recommendations
from the UKSCI is progressing well. Funding for the Stem Cell
Bank has been agreed and the Stem Cell Network established. A
task force led by the Association of the British Pharmaceutical
Industry has backed the recommendation to establish a Public Private
Partnership. The Government will work in partnership with industry
to establish a consortium which will develop the use of stem cells
in the production of safer medicines, and begin work with a series
of pilot projects in 2007.
8. The UK Stem Cell Bank is responsible
for storing, characterising and supplying ethically approved,
quality controlled stem cell lines for research and ultimately
for treatment The Bank relies on researchers producing new stem
cell lines. Much of the stem cell research being carried out in
the UK relates to understanding stem cells themselves and understanding
the production of stem cell lines, which will lead to better techniques
and research tools. Many researchers consider that this type of
research may benefit from the use of hybrid stem cells.
9. There is a very strong commercial interest
in the applications of stem cell research, in particular for regenerative
medicine. This is reflected in the high level of support for industry-driven
R&D awarded through the Government's Technology Programme.
This Programme is investing directly in new and emerging technologies,
and has been designed to help businesses work collaboratively
with each other or with academic partners to develop technologies
that will underpin products and services of the future. Nine major
industry-led projects developing stem cell technology with a total
value of £17 million, which are taking forward various aspects
of stem cell research to clinical translation and commercial exploitation,
are currently being supported with public funding from DTI and
the Research Councils of over £10 million. Thirteen companies
are participating in these projects, which cover a range of potential
applications of stem cell research such as:
Therapeutic stem cells for neurology
applications (eg Parkinson's Disease);
Delivering differentiated cells for
therapeutics and screening applications, focusing on bone, lung
and liver cells;
Developing a system for producing
dermal stem cells in commercial quantities for wound healing,
particularly the treatment of large area burns;
Creating a cardiovascular stent with
a stem-cell derived coating.
10. DTI has also provided other support
for the commercial exploitation of stem cell technology, including:
Stem cell-derived products for therapeutic
purposes are classed as "cell-based therapies". DTI's
discussions with industry and researchers developing cell-based
therapies indicated that guidance on relevant regulations and
Codes of Practice for this areafrom research lab to clinical
translationwould be useful. A guidance document was commissioned
from BSI and published in November 2006
identifying relevant regulations, codes of practice and standardised
methods and linking them to the lifecycle of cell based therapy
Overseas missions for UK stem cell
companies to North America, Asia and Australia to identify key
developments, benchmark UK industry and establish contacts with
overseas players have also been supported over the past few years.
11. In January the Scottish Executive announced
a £59 million investment in a Scottish Centre for Regenerative
Medicine (SCRM) at Edinburgh University. This will bring basic
scientific research, clinical development and commercial application
together in one building and provide state-of-the-art research
facilities, manufacturing capacity and commercialisation facilities.
12. The Government's support for stem cell
research and the UK's current regulatory framework have encouraged
inward R&D investment in UK. For example, Cellartis, a Swedish
Company, has recently announced it will be setting up a development
and manufacturing facility for stem cell technology in Dundee
with the creation of 75 new jobs and investment of £9.5 million
in the UK. The attractiveness of inward investment will diminish
if the UK is not able to offer the most relevant and internationally
competitive research under a clear and up to date regulatory framework.
13. The Research Councils are working with
the DTI's Sciencewise initiative on a programme of public dialogue
and engagement on stem cell research. The Chief Executives of
both MRC and BBSRC have agreed to lead a public dialogue on stem
cell research under an RCUK umbrella and supported by a DTI grant.
shape public expectations about the
opportunities offered by stem cells;
enable scientists to understand public
values and ethics related to stem cell research and use;
involve key organisations, such as
the UK Stem Cell Network, the UK Stem Cell Communications Coalition
and the emerging stem cell "club"; and
produce a plan for a longer-term
programme of public dialogue, engagement and social research around
14. The use of hybrid embryos potentially
provides a valuable new source of the material needed if stem
cell research is to continue to move forward. Hybrids could potentially
contribute to drug development particularly in areas such degenerative
diseases where the global market is enormous. They could also
enhance the potential of stem cells to be used in toxicity testing.
In addition hybrids will provide a valuable resource for research
into degenerative diseases, where relatively large quantities
of stem cells will be required, and where the current shortage
of good quality human embryos is restricting research. The use
of hybrid embryos may in addition speed up testing the capacity
of embryonic stem cells to differentiate into a range of bodily
cell types as part of research into the treatment of serious disease.
The joint MRC/Wellcome Trust submission (published as memorandum
35) to the Committee on this issue puts forward a strong analysis
of the scientific case for the use of hybrid stem cells in research,
and DTI endorses that submission.
15. DTI has received strong views from industry
that a regulatory ban on the use of hybrids for research may harm
the climate for both company and academic research, This may damage
the widespread international view that the UK has one of the best
regulatory systems in relation to stem cell research.
16. DTI supports the view that, with appropriate
regulation, the creation of hybrid stem cells for research purposes
should be permitted.
70 BSI Publicly Available Specification (PAS 83) "New
guidance on codes of practice, standardized methods and regulations
for cell-based therapeutics, from basic research to clinical application". Back