Thank you for your letters of 7 and 9 February asking follow up questions to the oral evidence session held with Ms Shirley Harrison, Ms Angela McNab and Professor Neva Haites on the 31 January 2007.

  I have grouped your questions together where relevant. Taking these in order, you asked for:

1)   A statement on our reasons for not disclosing the legal opinion the HFEA has obtained with respect to whether or not research using human-animal chimera or hybrid embryos and specifically, embryos created through somatic cell nuclear transfer of human genetic material into enucleated animal ova, falls within HFEA remit (as referred to in Q93-98 of the session transcript).

  The Authority decided, for the usual reasons of legal privilege, not to release the independent legal opinions it had obtained. The issue of whether hybrid embryos fall within the remit of the 1990 Act is open to interpretation, and whatever decision the Authority eventually takes in this regard could in future be subject to legal challenge. Our concern was that any inadvertent disclosure of our legal advice could be damaging to the Authority if a legal challenge were mounted on our interpretation of the 1990 Act.

  For that reason, we had hoped that we could communicate the essential issues by providing the Committee with a summary of the legal position in our written statement to the Inquiry and by providing relevant Authority papers and minutes. However, it became clear during our evidence session, and in considering the issues raised in your subsequent letters, that this information was not of itself sufficient to help the Committee address some of its key questions.

  Although our legal advice on the risks of disclosure remains unchanged, we have decided to share with the Committee, on a strictly confidential basis, opinions provided to the Authority by Dinah Rose QC, on 6 July 2006 and 5 January 2007. These opinions should be read in conjunction with each other. We hope that having sight of these legal opinions will help the Committee to a better understanding of the decisions taken by the Authority on 10 January, and the points made in the Authority's subsequent statements, and help to address the Committee's outstanding questions. We are of course happy to answer any further questions that may arise from consideration of these opinions.

  Copies of the legal opinions are enclosed. As mentioned, we are providing these on terms of strict confidentiality. Members of the Committee are free to discuss the opinions amongst themselves but the contents of the opinions, or any part of them, must not be discussed outside of the Committee, or published, without the prior consent of the HFEA. I would be grateful if you could confirm that the Committee as a whole are happy to abide by these terms.

  I also enclose an unedited version of the paper considered by the Authority on 10 January (the copy submitted previously has some small sections removed that related directly to Counsel's opinion). This version of the paper should be treated on the same confidential basis as the two legal opinions.

  The Committee should be aware of one slight inaccuracy in the opinion dated 5 January 2007 which stems from a lack of clarity in our original instructions to Ms Rose. At paragraph 17, Ms Rose quotes the instructions as stating that "the Department of Health has indicated to the Authority that it considers that the 1990 Act does not empower the Authority to grant a licence authorising the creation of a hybrid embryo". This is an accurate rendition of our instructions. However, the point being made by the Department was that the Government White Paper which preceded the 1990 Act indicated an intention to prohibit the creation of hybrid embryos. This of course is not the same as the Department offering an opinion on the legal interpretation of the Act as it stands. The same point about the historical context of the Act was picked up in Ms Rose's opinion of 26 July 2006 (see paragraphs 20-27) and mentioned in the paper presented to the Authority on 10 January 2007 (see paragraph 10).

2)   Legal advice the HFEA has obtained with respect to embryo viability (Q84 of the transcript refers).

  This is contained in the two legal opinions enclosed with this letter. In particular, we would like to draw the Committee's attention to paragraphs 32-39 of the legal opinion dated 6 July 2006 and paragraphs 22-24 of the opinion of 5 January 2007.

  In discussing viability, Ms Rose refers in her first opinion to the decision of the House of Lords in Quintavalle (R (on the application of Quintavalle) v Secretary of State for Health [2003] UKHL 13). Lord Millett states at paragraph 40(c) of the judgement that a human embryo is a live human organism containing within its cells a full set of 46 chromosomes with the normal potential to develop and, if implanted in a woman, to become a fetus and eventually a human being. He then goes on to look at the words of the Act in Section 1 (1) which states that...

In this Act, except where otherwise stated- (a) embryo means a live human embryo where fertilisation is complete, and (b) references to an embryo include an egg in the process of fertilisation, and, for this purpose, fertilisation is not complete until the appearance of a two cell zygote.

  Lord Millett states that the definition in paragraph (a) is in part circular since it contains the very term to be defined. It assumes that the reader knows what an embryo is. The purpose of the opening words of the paragraph, he states, is not to define the word "embryo" but rather to limit it to an embryo which is (i) live and (ii) human. He states that these are the essential characteristics which an embryo must possess if it is to be given statutory protection. When looking at embryos created by CNR he states that such embryos are in all respects, save the method of their creation, indistinguishable from other embryos. They are alive and human, and accordingly possess all the features which Parliament evidently considered makes it desirable to regulate their use in treatment or research.

  To the best of our knowledge, this is the only interpretation of the Act where the issue of being "live" has been discussed. The crucial concept, insofar as it was explored by Lord Millett seems to be that the human embryo must have normal potential to develop and if transferred into a woman, to become a fetus and eventually a human being. Ms Rose's assessment of how a court in future might treat this issue is at paragraph 34 of her opinion of 6 July 2006.

3)   With relevance to the work proposed by researchers at Newcastle University and King's College London, a statement on what is meant by the phrase "it probably falls within our remit". In particular, the Committee requests your reasoning for using the term "probably" (as referred to in Q80 of the session transcript)

  Again, we would draw the Committee's attention to the conclusions reached by Ms Rose in her opinions of 6 July 2006 and 5 January 2007 (paragraphs 40 & 41 and 22-24 respectively). This makes clear the level of uncertainty remaining on this issue.

  The Authority's statement that "these sorts of research would potentially fall within the remit of the HFEA to regulate and licence and would not be prohibited by the legislation" takes account of this advice as well as the conclusions reached by the Authority's Scientific and Clinical Advances Group and the Ethics & Law Committee (papers from these meetings have already been sent to the Committee).

4)   Evidence to support the claim that there is scientific opposition to work using human-animal chimera or hybrid embryos and specifically, to create embryonic stem cell lines through somatic cell nuclear transfer of human genetic material into enucleated animal ova. In particular, the Committee requests information on where this scientific opposition stems from, with the opportunity to contact such scientists directly if this is deemed necessary (as referred to in Q139 of the session transcript)

  In the press statement that we published following the Authority decision to carry out a policy review on hybrids and chimera, we said that "There is not clear agreement within the scientific community about the need for and benefits of this science." It was from this statement that the Committee inferred that there was opposition to this research. We are aware that there is a lack of agreement within the scientific community around specific issues relating to this research, for example on research priorities and also the viability of entities created following interspecies somatic cell nuclear transfer (iSCNT). However we should make clear that we have not spoken to any scientists who are in outright opposition to this research. Further differences of opinion and other issues may however emerge as we consult a wider range of scientific opinion over the coming months.

  Some members of the scientific community consulted by us felt that there was still much to learn about the process of SCNT and that it would be more appropriate for this research to be carried out in animal models without using human material. Others thought it was too early to be doing SCNT research using human eggs (but that the use of animal eggs was acceptable).

  Some scientist took the view that questions relating to iSCNT could be answered using animal models, and therefore questioned the need for this research. This of course contrasted with the views of those who think that there is great value in iSCNT work at this time.

  Much of this discussion took place at a scientific meeting linked to the Authority's consultation on Donating Eggs for Research. We reassured those researchers and scientists present that the meeting would not be minuted to enable a full and open debate. A summary of the meeting was produced but the comments were not attributed to any of the people present. A copy of this summary is enlcosed.

  The HFEA Scientific and Clinical Advances Group were also largely supportive of the use of iSCNT embryos, noting that such entities would be human and that the Group could see how creating such embryos could be necessary for research. Minutes of this meeting have already been provided to the Authority.

  In relation to the issue of viability of interspecies SCNT embryos, we contacted a group of scientists the majority of whom are on our horizon scanning panel and asked for a view on the viability of such entities. The responses we received to this were varied and there was no consensus. As this issue was relevant to the legal advice we obtained, this lack of consensus was significant. A summary of the questions and the responses received is enclosed. Individual opinions are anonymised, as we do not have the permission of the experts concerned to quote them. However, the experts consulted were as follows: Professor Peter Andrews (University of Sheffield), Dr David Edgar (University of Liverpool), Professor Henry Leese (University of York), Dr Justin St John (University of Birmingham), Professor Alan Trounson (Monash Immunology and Stem Cell Laboratories), Dr Maureen Wood (University of Aberdeen). The planned consultation will give the Authority an opportunity to broaden the range of experts consulted (see response to questions 6 & 7 below).

5)   A reference to demonstrate where and when the HFEA first indicated that it felt this was a matter best dealt with by Parliament (as referred to Q91 of the session transcript)

  The point behind Ms McNab's comment that "we thought this issue would be best dealt with in Parliament" is that, in an ideal world, we would have preferred these issues to have been debated by Parliament and set out explicitly in legislation, to give greater clarity than at present, before the Authority had to address these issues.

  The Authority has been calling for some time for the 1990 Act to be updated. In July 2002, the then Chief Executive of the HFEA Maureen Dalziel said, in response to the Science and Technology Committee report, developments in human genetics and embryology:

"New, clearer legislation is desperately needed that takes into account the massive scientific advances that have taken place since the last Act was drafted and is less open to misinterpretation."

  In May 2004, the Authority's written evidence to the Committee's inquiry into reproductive technologies and the law said:

"The regulatory framework created by the 1990 Act has in general terms responded well to new scientific and medical practice and public concerns....but other parts of the Act now seem to be in need of speedy revision, for example the definition of an embryo".

  This message was repeated to the Committee in our oral evidence sessions.

  And again, in response to the Department of Health's 2005 consultation on the review of the 1990 Act, the Authority said:

"The HFEA would recommend that hybrids and chimeras are defined in the new Act".

  This remains the Authority's position. In the meantime, however, the Authority is under a legal duty to act within the legal framework as it stands.

6)   Information detailing whom the HFEA has consulted in relation to drafting the expected public consultation on whether the creation of human-animal chimera or hybrid embryos should be allowed for research purposes. In particular, the Committee is keen to establish which scientists have been consulted in the drafting of the consultation

7)   A statement detailing how the HFEA intends to explore the issue of embryo viability with the scientific community

  There will be two strands to the HFEA's consultation exercise:

—  discussion with researchers and the scientific community on the question of whether hybrid and chimera embryos should be regarded as "live human embryos" within the meaning of the 1990 Act. This will include the question of viability (see paragraph 28 of Ms Rose's opinion of 5 January 2007).

—  a public dialogue to help us understand public attitudes and opinions on stem cell research involving the creation of a range of hybrid and chimera embryos, including embryos created through interspecies somatic cell nuclear transfer. This will include a written consultation document, focus group work and a public debate.

  Detailed plans for the consultation are still under development, but the consultation period will run from late April to late July to enable the Authority to take a policy decision at its meeting on 5 September.

  We are currently in the process of drafting the written document for the public consultation, given the long lead-in time for such documents. The focus of our current round of discussions with scientists is therefore to help inform the contents of this document, which will begin with a lay friendly explanation of the science, its purpose, likely outcomes etc. The scientists we are consulting include:

Who	When	Institution
Dr Robin Lovell-Badge	1 Feb 2007	Stem Cell Biology and Developmental Genetics National Institute of Medical Research (NIMR)
Dr Stephen Minger	5 Feb 2007	Centre for Age related disease King's College London
Dr Hui Zhen Sheng with (Dr Robin Lovell-Badge)	8 Feb 2007	Shanghai Jiao Tong University
Professor John Gurdon	23 Feb 2007	The Wellcome Trust/CR UK Gurdon Institute University of Cambridge
Professor Chris Shaw	26 Feb 2007	Clinical Neurogenetics King's College London
Dr Justin St John	27 Feb 2007	Reproductive Biology and Genetics University of Birmingham
Professor Lorraine Young	6 March 2007	School of Human Development University of Nottingham
Professor Keith Campbell	6 March 2007	Division of Animal Physiology University of Nottingham
Dr Lyle Armstrong	7 March 2007	Institute of Human Genetics University of Newcastle
Professor Roger Pederson	TBC	Institute for Stem Cell Biology University of Cambridge
Austin Smith	TBC	Wellcome Trust centre for stem cell biology University of Cambridge
Professor Henry Leese	TBC	Department of Biology University of York

  We have not yet finalised a list of the scientists and scientific and research institutions who we will consult on the first strand of the consultation exercise, including the viability question. But these will include the recognised experts in the field, scientific institutions and others.

  The Authority has also ensured that the lead researchers who have submitted licence applications to the Authority have been kept appraised of developments throughout. After they submitted their applications to the Authority in November, Professor Minger and Dr Armstrong were informed in writing of the decision to defer consideration of their applications until the Authority had taken a policy decision at its meeting on 10 January. They also received personal phone calls on 11 January to inform them of the outcome of the Authority's meeting, including the decision to consult (Ms Harrison spoke to Dr Minger and Ms McNab to Dr Armstrong).

8)   A list of all public consultations held by the HFEA. In particular, the Committee would be grateful for a list of any public consultations, held by the HFEA, directly related to research and applications for research relevant to HFEA remit

9)   Criteria used by the HFEA in deciding on the appropriateness/ necessity for holding public consultation in areas in which it has done so

  A list of public consultation held by the HFEA is enclosed showing those which have been directly related to research.

  The HFEA follows the Cabinet Office Code of Practice on Consultation which promotes "effective consultation as a key part of the policy making process". There is an expectation that ggovernment departments, and independent regulators such as the HFEA, should carry out a full public consultation whenever options are being considered for a new policy or if new regulation is planned. This is the general approach taken by the Authority.

  The scope of HFEA consultations, and the range of people consulted, varies depending on the subject matter:

—  narrow consultations on practice in licensed clinics (egg on laboratory witnessing procedures or Dewar safety) will normally be limited to the clinics directly affected and the relevant professional and patient bodies and other experts;

—  consultations on issues which have a more direct impact on patients or donors (such as the SEED Review on donation practice and the review of guidance to clinics on conducting Welfare of the Child assessments) will be broader and involve a written consultation document, public meetings etc; and

—  consultations on issues of broader public concern where is the issue is of interest to society as a whole (egg the consultations on social sex selection; the use of pre-implantation genetic diagnosis to detect late onset diseases such as inherited breast cancer (the Choices and Boundaries review) and the present consultation on the creation of hybrids and chimera embryos). These consultations inform and educate the public, give people an opportunity to engage with the relevant experts and provide an opportunity for the public to express their opinions to the HFEA. These types of consultations may also involve the Authority engaging with groups outside of its normal sphere of interest, egg disease specific patient or lobby groups.

  In addition to these ad hoc consultation exercises, the Authority consults on an ongoing basis with its on-line Patients Panel, "Fertility Views" and its Licensed Centres Panel. These consultations enable the Authority to understand patient needs and expectations, improve service delivery, check how things perform at a local level, check that measures work etc.

10)   Other Issues: "Fairness"

  There is a further point that we would like to make that may help the Committee. In advising the Authority on the appropriate procedures to adopt in taking a policy decision on the creation of hybrid embryos, Dinah Rose addresses the issue of procedural fairness (see paragraphs 25-29 of her opinion of 6 January 2007). The issue of "fairness" was also discussed during the evidence session on 31 January (see Qs105-07).

  The concept of fairness addressed by Dinah Rose relates to an expectation which arises on the part of individuals that procedural fairness will be adopted in the case of decisions affecting their interests which are made by public bodies. For example, in this case it could be argued that the law recognises the creation of hybrids for research purposes on the part of both scientists and the general public as "an interest". This interest cannot be properly be withdrawn or denied without those interested in it being given an opportunity to comment and without the Authority communicating rational grounds for any adverse decision made.

  The concept of fairness raised in the evidence given to the Committee needs to be seen in the context of Ms Rose's opinion regarding the Authority's obligations to have regard to the interests of the scientists and the public in this particular research. It would be wrong for example to refuse to allow the research without the scientists being given an opportunity to comment and wrong to go ahead with it without other interested parties, including those opposed to the research, also being given an opportunity to comment.

  I hope this information is of help to the Committee in furthering its Inquiry. Please let me know if you have further questions.

February 2007