APPENDIX 25
Memorandum from the BioIndustry Association
EXECUTIVE SUMMARY
— The focus of the BIA's response to
this inquiry concerns the use of embryonic stem cells in medical
research and cell nuclear replacement.
— The BIA is fully supportive of the
ban on human reproductive cloning. It should be remembered that
reproductive cloning is completely different to cell nuclear replacement
or "therapeutic cloning".
— The main challenge to the HFE Act
is to adapt at the rate that technological and scientific developments
are occurring and impacting on ethical and societal attitudes.
— The BIA supports continued scrutiny
of the Act so that rapid developments in this field of technology
can be absorbed and ethical considerations accounted for.
— It is essential that open discussion
of these issues takes place and involves all groups in society,
and that this is underpinned by appropriate and regularly reviewed
regulation.
— There are continuing concerns that
national delegations in the UN Ad Hoc Committee for International
Convention Against Reproductive Cloning of Human Beings will continue
to push for the Committee to adopt a more conservative line, to
ban both reproductive and therapeutic cloning.
— In the context of international legislation
and regulation, it is essential that the principle of subsidiarity
is maintained, ie that individual countries retain the right to
decide whether or not to allow embryonic stem cell research to
take place.
— With the development of new areas
of research, treatments and interventions it is increasingly important
that this is not hindered by unnecessary burdens of cost and unwieldy
bureaucracy.
— Failure to ensure an efficient application
process for HFEA licence fees and imposition of unrealistic cost
and bureaucracy would have a negative impact on the UK's position
as a world leader in this field of research.
INTRODUCTION
1. Significant progress has been made in
the fundamental science underpinning the biosciences in the last
decade and this has been accompanied by extensive debate and consultation
within the public, regulatory and scientific domains, with a view
to identifying and addressing all relevant scientific and ethical
issues. 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's bioscience sector. The BIA
has over 350 members, the majority of which are involved in healthcare
bioscience.
3. Our aim is to ensure that the UK maintains
its position as a leader in the field of biomedical research within
a framework of controls and procedures that provide public confidence
that human reproductive technology will be handled in a responsible,
respectful and ethical manner.
4. The BIA's interest in the House of Commons
Science and Technology Inquiry into Human Reproductive Technologies
and the Law concerns the use of embryonic stem cells in medical
research and cell nuclear replacement. Embryonic stem cells have
an unlimited ability to divide and the capability to turn into
virtually all cell types and tissues in the body. They all have
a vital role in research into diseases and conditions such as
Alzheimer's, Parkinson's Disease, heart disease, leukaemia, strokes
and spinal cord injuries. The BIA's evidence therefore seeks to
bring to the Committee's attention the UK bioscience sector's
views on these technologies and ensure that ethical considerations
are fully addressed while at the same time not restricting the
development of treatments by unwieldy and unnecessary bureaucracy.
The technologies referred to above are the predominant focus of
this evidence; assisted reproduction technologies such as IVF
are outside the remit of the BIA.
To consider (a) the balance between legislation,
regulation and reproductive freedom; (b) the role of Parliament
in the area of human reproductive technologies; and (c) the foundation,
adequacy and appropriateness of the ethical framework for legislation
on reproductive technologies
5. Having a full debate in both Houses of
Parliament has led to an appropriate legislative and regulatory
environment that has allowed the UK to become a world leader in
embryonic stem cell research.
6. UK scientists are at the forefront of
research into stem cell therapies, and have an international reputation
for excellence in the field. In addition, the UK has adopted a
pioneering and internationally respected stance on the regulation
of research on human embryos.
7. The BIA is totally opposed to human reproductive
cloning, which is rightly banned in the UK and most other parts
of the world. We would fully support any additional legislation
to strengthen the UK's existing ban on human reproductive cloning,
and we call on governments across Europe to do the same.
8. The BIA supports the Human Fertilisation
and Embryology Authority (HFEA), in its position as regulating
the use of stored embryos in research projects aimed at generating
embryonic stem cells. The BIA also supports the fact that in all
cases Ethics Committee approval and fully informed written consent
are required.
9. By contrast, the position taken by the
United States government, which has taken a restrictive stance
on the availability of federal funding for embryonic stem cell
research, has led in the US falling behind in this important area.
A leading scientist in this field, Roger Pedersen, moved from
the US to the UK as a result of the restrictions imposed by the
US government.
10. It is clearly desirable to develop new
treatments for degenerative diseases that are effective and for
which manufacturing scale-up can be cost-effectively achieved
whilst using as few embryos and embryo-derived materials as possible.
As it is not yet clear, however, to what extent such treatments
can be developed from adult stem-cells, it is critical that research
on all types of stem-cell should be encouraged. This is why both
the UK Houses of Parliament voted in favour of amending the Regulations
of the 1990 Human Fertilisation and Embryology Act to allow cell
nuclear replacement to take place for research into serious diseases.
The BIA supports continued close scrutiny of the Act so that rapid
developments in this field of technology can be absorbed and ethical
considerations accounted for.
11. It is essential that open discussion
of these issues takes place and involves all groups in society,
and that this is underpinned by appropriate and regularly reviewed
regulation. It is important to address public concerns about advances
in science and medicine, and to ensure that the ethical debate
keeps pace with such developments. However, it is also important
that research is allowed to continue into technology that could
provide treatment for many presently untreatable illnesses and
conditions. Introducing unnecessary bureaucracy could hinder the
UK's position as a world leader in this important field of research.
Patients—the end users—would ultimately be the losers.
To consider the provisions of the Human Fertilisation
and Embryology Act 1990 in the context of other national and international
legislation and regulation of medical practice and research
12. The BIA supports the regulatory requirements
for the use of embryonic stem cells set by the Human Fertilisation
and Embryology Act 1990 which provide the necessary safeguards
for this type of medical research. We also welcomed the introduction
of the Human Reproductive Cloning Bill 2001, which "prohibited
the placing in a woman of a human embryo which has been created
otherwise than by fertilisation".
13. In the context of international legislation
and regulation, it is essential that the principle of subsidiarity
is maintained, ie that individual countries retain the right to
decide whether or not to allow embryonic stem cell research to
take place.
To include related legislation such as the EU
human tissue directive, and law covering human rights, surrogacy,
adoption and abortion
14. The EU Tissues and Cells Directive aims
to set standards of quality and safety for the donation, procurement,
testing, processing, storage, and distribution of human tissues
and cells for human application. At the European Parliament Committee
and plenary stages, attempts were made to use the Directive as
a vehicle to ban embryonic stem cell research, which, as an ethical
issue, is not within the legislative remit of the EU institutions
and as such is subject to the principle of subsidiarity.
15. The BIA ensured that the UK industry's
voice was clearly heard in the European Parliament. We also led
and coordinated a campaign with other National Bioscience Associations.
We were delighted that the remaining amendment on embryonic stem
cell research was rejected in European Parliament plenary by 503
votes to 42, allowing embryonic stem research in the UK to progress.
16. The Technical Annexes of the Directive
are currently in the process of being developed and the BIA is
maintaining a watching brief on this to ensure that no measures
are introduced that would compromise this important research.
To include relevant declarations and statements
by international bodies
17. The BIA continues to take a close interest
in the work of the UN Ad Hoc Committee for International Convention
Against Reproductive Cloning of Human Beings. There are
continuing concerns that some national delegations, most notably
the US, will continue to push for the Committee to adopt a more
conservative line, to ban both reproductive and therapeutic cloning.
18. Although the UK would not be legally
bound to adopt such a Treaty, it would send a negative message
not only about this important research, but also about individual
countries' right to decide whether to allow it to take place.
The BIA welcomes the firm position taken by the UK delegation
and urges this to continue.
To consider the challenges to the Human Fertilisation
and Embryology Act 1990 from (a) the development of new technologies
for research and treatment, and their ethical and societal implications
and (b) recent changes in ethical and societal attitudes
19. The main challenge to the HFE Act is
to adapt at the rate that technological and scientific developments
are occurring and impacting on ethical and societal attitudes.
The opening of the UK Stem Cell Bank will bring about a large
increase in medical research involving embryonic stem cells that
will involve various ethical issues and views from different parties
and the general public. It is the responsibility of Government
to ensure that the Act considers these new and evolving issues
so that academia, business, Government and the public are comfortable
with this type of research.
20. In 2003, a MORI poll found that 70%
of the British public support the use of human embryos for medical
research to find treatments for serious diseases and for fertility
research. Open dialogue and debate is essential to ensure public
understanding of the benefits of embryonic stem cell research
and confidence that it is conducted to the highest ethical standards.
Communication from Government and those involved in the research
is an important factor in facilitating such debate.
To include new areas of research, treatments and
interventions, such as cloning, cell nuclear transfer, transplants
of ovarian and testicular tissue, embryo splitting, selection
of genetic characteristics (including sex selection), stem cell
therapy and the use of immature gametes
21. With the development of new areas of
research, treatments and interventions it is increasingly important
that this is not hindered by unnecessary burdens of cost and unwieldy
bureaucracy.
22. The BIA has consulted with members further
to the HFEA's consultation on human embryo research licence fees
and proposed changes in the application process. Members have
raised concerns that an increase in the level of fees could present
problems particularly for smaller organisations working in this
field.
23. Members have also flagged concerns that
the HFEA is properly staffed in order to be able to process applications
without unnecessary delay. Failure to ensure an efficient application
process and imposition of unrealistic cost and bureaucracy would
have a negative impact on the UK's position as a world leader
in this field of research. This would mean that the research would
move elsewhere—to the detriment of UK patients and the science
base.
CLONING
24. The BIA is fully supportive of the ban
on human reproductive cloning. It should be remembered that reproductive
cloning is completely different to cell nuclear replacement or
"therapeutic cloning".
25. Aside from the ethical debate, there
is considerable doubt about whether it would even be possible
to clone humans using the techniques used to produce Dolly. The
cell nuclear replacement technology that produced Dolly is still
in its early stages. Dolly was the only lamb born from 276 similar
attempts and similar procedures aimed at human reproductive cloning
would likely carry similar "wastage" rates and uncertainties
about malformations. This would expose large numbers of embryos/foetuses
and surrogate mothers to unacceptable medical risks without any
compelling clinical benefit.
26. There are, however, genuine potential
benefits in the research into animal reproductive cloning. Since
Dolly the sheep was created in 1997, clones have been generated
in a number of different animal species, including mice, rats,
cattle, pigs and cats. Animal cloning has obvious applications
in areas such as animal breeding, both in farming and in conservation,
but could also have major applications in human therapeutics.
The field of research known as transgenics—combining cloning
with genetic modification—is being used to generate animals
such as cattle that produce therapeutic proteins in their milk.
Cloning transgenic animals such as pigs could also address the
shortage of human organs for transplantation by generating a new
source of organs that would not be rejected by a human recipient.
CELL NUCLEAR
TRANSFER
27. Understanding the genetic control of
processes in the human body is fundamental to the development
of therapies and treatments for conditions that have yet to be
successfully treated. Cell nuclear replacement (CNR) is an important
research aid in improving this understanding of the underlying
mechanisms of disease and in helping to develop new therapeutic
methods.
28. Examples could include the development
of new skin for burns patients, the culturing of tissue to help
repair diseased organs, the alleviation of paralysis by repairing
injured spinal cord tissue and the development of healthy bone
marrow cells for cancer patients. Ongoing research into cloning
in this area may also contribute to improved treatments for illnesses
such as leukaemia, strokes, Parkinson's disease, spinal cord injuries
and heart disease. It could also provide important information
about reproduction in humans and animals.
29. Although much of the research needed
to understand the reprogramming of cells can be carried out in
laboratory animals, studies using CNR with human eggs will be
needed to confirm that our understanding of the processes involved
in the reprogramming of animal cells also hold good for human
beings. We will also need to conduct studies to confirm that human
pluripotent stem cells (hPSCs) really can be transformed into
various differentiated cell types needed for treatment of particular
diseases and to demonstrate that hPSCs can be derived from patients
with a wide range of genetic backgrounds.
30. Given the significant social consequences
of degenerative disease in our ageing population, the BIA believes
it is important to encourage such research to proceed. It is also
appropriate, however, that further debate takes place to establish
suitable frameworks for clinical development and commercialisation.
This debate should be conducted in parallel with the research
required to confirm whether or not this technology can really
deliver its promised benefits and whether alternative reprogramming
technologies can be successfully developed.
STEM CELL
THERAPY
31. Stem cell therapy offers huge potential
for major developments in medical research into a wide range of
debilitating and life-threatening diseases and conditions.
32. The establishment of the recently launched
UK Stem Cell Bank will offer a substantial resource to support
the advancement of this research and will cement the UK's position
as a world leader in this field. At the same time it will put
in place important safeguards, by ensuring that cell lines which
could ultimately provide the basis for clinical treatment are
appropriately characterised and also handled and stored under
conditions that are properly controlled. This will not only provide
high quality starting materials to facilitate the development
of stem cell therapy, but, in providing a centralised resource
for researchers, should also reduce the use of surplus embryos
for the development of stem cell lines by individual teams.
33. It is important, however, that the value
of this resource is not undermined by unwieldy bureaucracy. The
BIA has consulted with members on the recent consultation on the
draft MRC Code of Practice for the Use of Human Stem Cell lines.
BIA member companies involved in this field of research have raised
concerns that the draft Code of Practice, if implemented as currently
drafted, would result in unwieldy bureaucracy both in terms of
accessing the stem cells lines and importing stem cell lines for
research in the UK. We would be happy to provide a copy of our
response to this consultation at the Committee's request.
May 2004
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