Human Fertilisation and Embryology (Special Exemption) Regulations 2009

My Lords, I thank the Minister for introducing these three sets of regulations and for the opportunity given to me last week to be briefed on them by his officials. That briefing served to resolve a number of questions that I would otherwise have posed in this debate, so he will be pleased to hear that my remarks this evening will be quite short. I begin with the special exemption regulations which, as the Minister said, provide for two exceptions to the rule that anyone who keeps or uses human embryos, or who stores human gametes, may only do so if he first obtains a licence from the HFEA. Regulation 2 creates an exemption in the case where an embryo is kept or a gamete is stored in connection with the investigation of an offence under the 1990 Act, or in connection with proceedings for such an offence. Regulation 3 creates an exemption where gametes are stored for the purposes of research on gametes, developing or testing pharmaceuticals or contraceptives, or teaching—as long as the gametes are not being stored for various other specified purposes. I am, in general, content with these regulations, but have a specific question relating to Regulation 2. The Act as amended is constructed in such a way as to require a licence to be issued by the HFEA whenever a human embryo or a human admixed embryo is stored or kept, unless regulations provide otherwise. It would appear from the wording of Regulation 1 that the exemption created under Regulation 2 extends only to the keeping or examination of human embryos and the storing of human gametes. There is therefore a puzzle in my mind in relation to human admixed embryos; the storage of human admixed embryos appears to be expressly excluded from the exemption. I should like to know whether this understanding is correct. If it is, it follows that there are no circumstances in which a human admixed embryo may legally be stored without a licence—even where such an embryo was being seized by the HFEA in connection with the investigation of an offence. I do not understand why this should be. It seems odd: one would naturally assume that, under the circumstances envisaged in Regulation 2, where a crime was being investigated, there would be just as much reason for the HFEA to seize, store and examine a human admixed embryo as to seize, store and examine a human embryo. Any operation of this nature would need to be done with speed. How practical would it therefore be for the authority to issue a licence to someone for the storage of a human admixed embryo before transferring the embryo to that person? When these regulations were first published in draft, certain errors in them were pointed out by the Merits Committee, as the Minister said, and the drafts were withdrawn. In 21st report, the Committee made the following comment: ""The revised draft appears to broadly meet the concerns expressed. However, the definition is complex, and we suggest it should be kept under review to ensure it maintains the policy intention in the light of technological developments"." I should like to endorse that suggestion, not only because of the need to keep alert to technological developments, but also because, under the 1990 Act as amended, the Secretary of State has the power to make further regulations altering the definitions of human gametes and embryos, and human admixed embryos. So I hope the Minister agrees with the recommendation of the Committee. I turn now to the appeals regulations. First, in general, I welcome the provisions relating to the composition and procedure of the appeals committee. In particular, it is positive that the rules will now prevent members or former members of the HFEA from sitting as members of the committee. It is important that those who determine appeals should be, and be seen to be, independent of the HFEA itself. That visible separation of membership is very much in keeping with the letter and spirit of recent legislation in other areas, such as that relating to the Office of the Health Professions Adjudicator. The comment was made by certain respondents to the consultation that to exclude former members of the HFEA from membership of the committee might be too restrictive, as it is clearly necessary to have a sufficient pool of expertise on which to draw. However, I am satisfied that the Government have answered that point by highlighting Regulation 10, which provides for advisers to be appointed to the committee. There is nothing to prevent such advisers from being members or former members of the HFEA. That flexibility ought to be enough to allay any fears about the committee's lack of access to relevant expertise. I support the idea of the committee having a legally qualified chair and deputy chair. Respondents to the consultation were also supportive of that because the committee is quasi-judicial in nature, and the arrangement would reduce the likelihood of court action. I agree with that. However, it is interesting to hark back to the debates that we had last year on the Health and Social Care Bill, when we argued about whether the Office of the Health Professions Adjudicator should or should not be required to have a legally qualified chair. The Government resisted the idea, which I and other noble Lords proposed, that that should be a requirement, and instead felt it right to allow the OPHA to appoint a legally qualified chair to a particular panel if it wished. The noble Baroness, Lady Thornton, reminded us at the time that, with the exception of the disciplinary committee of the Royal Pharmaceutical Society of Great Britain, all the professional regulatory bodies currently carrying out adjudication use lay and professionally qualified chairs, supported by a legal assessor. She said: ""While we agree that there may be merit in having legally qualified chairs for complex cases, all the evidence shows that lay and professionally qualified chairs are perfectly capable of doing a good job in these and any other case. Within the system of professional regulation there is strong reliance on lay and registrant involvement as chairs and panel members. Lay involvement is not unique to this jurisdiction. We need to look only at the contribution of the 30,000 lay magistrates in England and Wales, who deal with 95 per cent of all criminal cases, to understand the value of lay involvement". —[Official Report, 14/5/08; col. GC 373.]" I would be interested to know from the Minister why the appeals committee of the HFEA is thought to be so very different from the Office of the Health Professions Adjudicator in that sense. I have one more question for the Minister. The response to the consultation promised that the draft regulations would be amended to prevent members of the appeals committee abstaining from voting. The regulations indeed reflect that undertaking. However, what precedent is there for tying the hands of committee members in that way? I of course understand why it should be thought desirable to avoid a tied vote, but it strikes me as odd that the discretion of panel members to vote or not to vote should be fettered by legislation. That has the appearance of bowing unnecessarily to the forces of expediency. I would be grateful for the Minister's comments on that, and I look forward to his reply.