APPENDIX 94
Memorandum from the Medical Research Council
INTRODUCTION
1. The Medical Research Council (MRC) is
a national organisation funded by the UK taxpayer. Its business
is medical research aimed at improving human health. The research
it supports and the scientists it trains meet the needs of the
health services, the pharmaceutical and other health-related industries
and the academic world. The MRC supports medical research by providing
funding for research programmes and infrastructure, and by investing
in training and employment both in universities (and medical schools)
and in MRC's own research centres. About half of the MRC's expenditure
of just over £400 million is invested in 33 of its Institutes
and Units, where it employs its own research staff.
2. MRC welcomes the opportunity to contribute
to the House of Commons Science and Technology Committee Inquiry
into Human Reproductive Technology and the Law. It is important
that the legal and regulatory framework in this area does not
hinder high quality research on human reproduction which provides
insights into basic biology, including the determinants of female
and male infertility, and informs the development of new interventions
and approaches. The legal and regulatory framework should also
seek to facilitate the assessment of existing technologies, provide
a structure for the evaluation of new assisted reproduction technologies,
and facilitate surveillance through the linkage of medical records,
particularly in relation to possible long-term adverse effects.
The ways in which these important but diverse needs can be met
and the balance between societal interests and public health and
the rights of the individual considered raise complex and difficult
issues. The legal and regulatory framework in this area also has
profound implications for the development of new therapeutic approaches
to degenerative disease and injury (eg Alzheimer's disease, Parkinson's
disease, heart disease, osteoporosis, diabetes, leukaemia, spinal
cord injury) and the prevention of some inherited metabolic diseases,
in particular those associated with mitochondrial dysfunction.
3. The main focus of MRC research support
in the field of human reproduction is the MRC Human Reproductive
Sciences Unit (HSRU) in Edinburgh. The Unit carries out basic
and applied research in a number of relevant areas including:
the formation of sperm and ova (gametogenesis), uterine biology,
the developmental determinants of reproductive health and female
and male infertility. Another important area relevant to the act
is stem cell research. In the 2002 Spending Review, Government
provided £40 million across the Research Councils for stem
cell research, £26 million of which came to MRC. This money
has now been allocated and, in addition to new high quality research,
supports the recently opened MRC/BBSRC Stem Cell Bank and training
in the form of dedicated studentships, joint MRC/BBSRC fellowships,
and a short practical course for researchers on how to work with
embryonic stem (ES) cells. MRC was also asked by HFEA and the
Department of Health to set up an independent Working Group, under
the Chairmanship of Professor Catherine Peckham, to look at the
priorities and needs for research in this area. Many of the comments
below draw on the findings emerging from that exercise.
Comments on the areas covered by the inquiry
To consider:
(c) the foundation, adequacy and appropriateness
of the ethical framework for legislation on reproductive technologies.
4. Recent figures show that about 80% of the
assisted reproduction procedures carried out in the UK take place
in a diverse range of private clinics, with the remaining activity
occurring in NHS facilities. Although this balance may change
following the February 2004 NICE Clinical Guideline on the treatment
of fertility problems in the NHS, the need for regulation, particularly
of private clinics, will remain.
5. Legislation should be based on an appropriate
ethical framework. The HFEA already monitors early outcome data,
but in developing the ethical framework consideration should be
given to the monitoring long-term health outcomes (over 20-30
years) in offspring conceived by assisted reproduction. In this
way different technologies can be evaluated fully. The level of
consent required to carry out such studies would depend on the
degree of follow-up and level of anonymisation. Obtaining consent
for such studies raises difficult ethical and practical issues.
Practical concerns include: from whom consent is sought; when
it is sought; and the duration and extent of consent. From the
research perspective, the capacity to follow up all individuals,
or at least an unbiased sample of individuals, conceived through
assisted reproduction is a prerequisite for high quality prospective
studies to evaluate different technologies. One way in which such
studies could be facilitated is through linkage with NHS records;
however, at present and in the absence of mechanisms for anonymising
the data, such studies can only take place with the consent of
the individuals involved. As a consequence, the results are likely
to be subject to sample bias. No system to facilitate the long-term
surveillance of health outcomes is currently in place in the UK
although there are international exemplars.
6. Ideally, new assisted reproduction technologies
should be introduced in the context of an evaluative framework
such as a randomized clinical trial. Only in this way will unbiased
evidence of effectiveness and risks be obtained. Such an approach
would be greatly facilitated through the granting of limited licenses
by the regulator. However, the ethical issues raised by such an
approach (including clinical equipoise, consent to randomization,
the use of cluster randomized designs) would need to be considered
carefully.
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.
To include related legislation such as the EU
human tissue directive, and law covering human rights, surrogacy,
adoption and abortion.
To include relevant declarations and statements
by international bodies.
To compare the safety and welfare provisions of
the Human Fertilisation and Embryology Act 1990 with those that
cover other areas of medical practice.
7. The HFE Act and the HFE Authority are rightly
held in high regard internationally and many other countries have
looked to emulate the UK approach to legislation and regulation.
8. In relation to monitoring outcomes consideration
should be given ways in which health outcome data, both short-term
and long-term, from international studies might be pooled to give
maximum statistical power particularly for the analysis of putative
adverse events. This would be similar to the best practice approach
adopted in international clinical trials where outcome and safety
data from similar studies is pooled to maximize the opportunity
to conclude the evaluation early and minimize any risks to participants.
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.
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.
9. The provisions of the HFE Act were amended
in 2001, in the light of recommendations in the Donaldson Report,
to facilitate therapeutic cloning and cell nuclear replacement
(CNR) as a potential treatment for inherited mitochondrial diseases.
Any further changes to should not hinder high quality research
that may be beneficial to patients and provide access to new treatments.
To consider the composition, expertise and approach
of the Human Fertilisation and Embryology Authority, its code
of practice, licensing arrangements and the provision of information
to patients, the profession and the public.
10. Through licensing, the regulator is well
placed to coordinate the introduction of new technologies in ways
that facilitate scientific evaluation—eg through a prospective
clinical trial or cohort studies—and phase out approaches
which have been shown to have safety implications or lack effectiveness.
It is essential to enhance the evidence base for reproductive
technologies in this way to maximise the benefits for patients
and reduce any risks.
11. In terms of where HFEA gets its scientific
advice, it would be important to achieve greater clarity about
the membership, remit and areas of expertise of the Scientific
and Clinical Advances Group of the and how the recommendations
of the group are arrived at and taken forward.
12. In addition it would be good to clarify the
regulators role in communication and engagement with the public,
particularly in relation to difficult ethical issues surrounding
the need for long term follow-up of new assisted reproduction
technologies. Consideration should be given to whether HFEA might
establish a citizens council to help guide such activities.
May 2004
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