The Government has published a command paper detailing proposals for revision of the law on assisted reproduction and embryo research, including the proposed Regulatory Authority for Tissue and Embryos (RATE), which will replace existing regulatory bodies (the Human Fertilisation & Embryology Authority, and the Human Tissue Authority).
The report is published by the UK Department of Health (DH) by command of Her Majesty and can be downloaded from their website: www.dh.gov.uk
Dr Stephen Minger, Director of the Stem Cell Biology Laboratory, Kings College London, said:
“Whilst I am happy to see that the Review continues to support the use of donated embryos for stem cell derivation, I am very disappointed that the Government’s position is to ban the use of non-human oocytes for the derivation of cloned human embryonic stem cell lines. Given the large number of human eggs that are likely to be required for therapeutic cloning, it seems very short-sighted to not allow a readily available alterative that could be used to generate disease-specific cell lines that could be used for the development of new therapies.”
Professor Lord Robert Winston, Emeritus Professor Of Fertility Studies at Imperial College London (Hammersmith Hospital), said:
“It is highly disappointing that the thinking in the Department of Health is so impoverished that they could not see the need to reduce the regulation of routine IVF, which is no longer an experimental procedure and should not be subject to additional regulation. The current regulatory mechanism does nothing to limit the exploitation of women. History has shown that this form of regulation is inadequate to protect real people.”
Dr Allan Pacey, British Fertility Society (BFS) Secretary, said:
“As a first reaction, I’d say that this is a reasonable set of proposals, although there is a sense that the Government has been quite conservative and has missed an opportunity to be more radical and forward thinking.
As we now work to a very high standards of clinical governance, there’s a good case for regulations being less strict than they were when the laws were first drafted. The Government’s proposals are largely in keeping with the BFS view as expressed in our response to the consultation process. There are areas of the White Paper where we will have specific concerns, but there are also areas where we can support the proposals without reservations. For example, we’re pleased with the proposals on confidentiality relating to access to data for research purposes, and the regulation of internet sperm services. The British Fertility Society represents a wide body of opinion, and we will need some time to digest the proposals to allow us to give a more considered view. Of course we will discuss the proposals fully before responding on behalf of the whole membership.”
James Lawford-Davies, a solicitor specialising in reproductive and genetic technology at Bevan Brittan LLP in London, said:
“The proposals are very limited: cell nuclear replacement, tissue typing, mitochondrial disease research, and IVF for single and lesbian women are all currently licensed or provided within the existing legal framework. The proposals may seek to clarify the law in these areas but specific legal provisions are often more vulnerable to challenge than general terms.”
“There are good reasons to revisit the basis for regulation in this area, particularly in relation to IVF which is no longer experimental or unpredictable in the way it was seen in the 1980s. The government have proposed some sensible and long-overdue improvements to areas such as confidentiality and the parenting provisions but overall, the proposals do little to move forward from the status quo.
“The HFEA has indicated it could licence the creation of hybrids for research purposes under the existing law, and the Science and Technology Committee said that the law should only be amended to explicitly allow such research. In contrast, the government is suggesting this should be banned – presumably to avoid headlines.
“I am yet to hear a convincing reason for the merger of the HFEA and the HTA. It appears to be based solely on cost-cutting. One organisation cannot effectively regulate IVF, museum displays, stem cells, organ transplants and cloning.
“Though similar, the HFEA and HTA have adopted very different styles of regulation to date. It would be very damaging if critical areas such as organ transplantation become swamped with the sort of administrative burdens borne by IVF clinics as a result of the merger.”
Professor Peter Braude, Director of the Centre for Preimplantation Genetic Diagnosis, Guy’s and St Thomas’ Foundation Trust, said:
“I am pleased to see that the government has finally seen the need to support the training of embryologists under licence by judicious use of embryos not needed in, nor suitable for treatment. It is imperative that we seek to train our embryologists to the highest standard of clinical practice and that eventually requires refinement of their techniques (such as embryo biopsy for PGD) using human embryos not destined for clinical purposes.
I welcome the intended change in the confidentiality restrictions to allow linkage of national databases which will facilitate follow up of children born as a result of assisted conception, so that we can at last investigate the safety of new assisted conception technologies in the UK.”
Anna Smajdor, researcher in medical ethics at Imperial College London, said:
“This document clarifies many areas which were previously hazy or uncertain. However, there are still problems in relation to the Welfare of the Child clause, which has been retained. While the removal of the specific reference to a need for a father is on balance a good thing, it still remains utterly bizarre that fertility clinicians should be responsible for making judgements about the suitability of people to be parents. The criteria by which these judgements are now entirely open, leaving scope for clinics to pick and choose the parents of the next generation according to their own whims. If these judgements are to be made, the criteria need to be specific, and the people responsible for making the judgements should not be those who stand to profit from the treatment.”
Ann Furedi, Chief Executive of British Pregnancy Advisory Service (BPAS), said:
“As a reproductive healthcare charity, we welcome the opportunity for Parliament to update the 1990 law on IVF and embryo research in the light of social and clinical developments. The reproductive technologies involved in ending a pregnancy have also changed- just as much as the technologies now involved in creating pregnancies.
“Abortion is now even safer, much more widely requested and more socially acceptable than it was in the 1960s. The law should be changed to reflect this.”