APPENDICES TO THE MINUTES OF EVIDENCE
APPENDIX 1
Memorandum submitted by Professor Robin Lovell-Badge, National Institute for Medical Research
HFEA
The HFEA does a very good job given the level of funding they receive. There is some criticism of the length of time they can take to review an application or an amendment. There is also some worry that there is not enough basic science represented on the HFEA. I have been told that dealing with the HFEA is sometimes very frustrating for an applicant, because the submission is often done blind, so there are inevitably a lot of changes that need to be made. This is different, for example, to Project Licence Applications for research on animals, where the Home Office Inspector often meets with the applicant at an early stage and at times throughout the writing process, which helps to speed things up and ensures that the submitted application is free of significant problems. However, I can quite understand that the HFEA cannot do this, without substantially more personnel and funding.
Many other countries look to the UK and the HFEA to see how research and practice in this area can be regulated. Japan, for example, seems to be largely modelling its regulatory system on the HFEA, although there are some differences, eg how consent is granted, which are perhaps not well thought through, but I suspect this is line with other consent issues there. China is also modelling its guidelines on embryonic stem cells on the UK system (although these may well be a set of rules, rather than an HFEA type regulatory system).
Again, coming back to the financial situation of the HFEA, their level of under-funding could be seen as embarrassing if other countries are looking to us as a model of how work in this area should be regulated. It is clearly not sufficient money for the HFEA to be doing all they would want to do, and probably should be doing, to both regulate and inform the public, etc, about their business. In addition, I am not sure how well the HFEA is informed about scientific developments or about what is going on in other countries in terms of regulation, etc, but I strongly suspect this is inadequate. There is a huge amount going on.[1] More funding would enable them to attend meetings, as they themselves suggest. Again, it would be embarrassing if they are not well informed, especially if other countries are looking to us to set the lead.
HGC
The HGC does an excellent and very important job. It seems much less in the limelight than the HFEA and is consequently less well known as a body. It too seems very under-funded for its remit.
STEM CELLS
The HFEA certainly could not, and in my opinion should not, be regulating work with stem cells. Nor do I think the HGC should be doing this. Both of these are really quite specialised in their area of expertise. Work with stem cells involves knowledge of several disciplines in addition to knowledge of reproductive biology and genetics. These include embryology, stem cell biology, perhaps tissue engineering and a wide range of clinical disciplines. Any body set up to regulate research and therapeutic use in this area would have to have to incorporate specialists in all of these areas, in addition to people who can cover ethical and legal issues. For the clinical aspects such a body would have to have a list of experts who could be called upon.
Both the HFEA and HGC could (and probably should) have an input into setting up such a body, but this would also need to involve the Research Councils (especially MRC and BBSRC), medical research charities, the NHS, etc. The problems will first be getting everyone to agree on how it should be set up and what its remit is, and then to create a body that is not too cumbersome, which can make sufficiently rapid decisions.
(N.B. This would be more similar to the HFEA, in that it would be making decisions, and less like the HGC, with its advisory role.)
STEM CELL BANK
The MRC is making good progress on setting this up. A stem cell regulatory body could oversee this, but it could also run independently.
June 2002
1 I know of others who are trying to gather information with respect to the legal system and regulation of research on embryos, etc, in various countries. It is not easy, especially as laws are constantly changing. In theory these people could advise the HFEA, but they may be funded only for a short-term project, whereas it almost needs a permanent group. Back
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