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The second situation that the regulations provide for is cases where gametes are being stored for use in research. The regulations set out three purposes for which a person may store gametes without a licence from the HFEA. These are where they are stored for the purpose of research on gametes, for the development or testing of pharmaceutical or contraceptive products, or for teaching that requires the use of gametes. However, a storage licence will still be required if certain activities are intended to be carried out, including the use of gametes in treatment services, the mixing of eggs and sperm or bringing about the creation of a human or human admixed embryo. It is important to note that the regulations do not remove any licensing requirement relating to how the gametes are used; they only provide exceptions to the requirement for a storage licence.
The regulations do not reflect a change in government policy. They are being re-made in consequence of the provisions in the 2008 Act which update the provisions of the 1990 Act in light of scientific developments, and to make some minor drafting changes. We will continue to keep the regulations under review in light of further developments. As your Lordships may be aware, it was necessary for the Department of Health to withdraw an earlier version of the regulations in order to correct an oversight. We regret that this was necessary but note the Merits Committee's acknowledgement that the department acted quickly to correct the draft regulations. The 1991 regulations worked. They did what they were supposed to do and we do not see any further reasons for which exceptions
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I shall finally and briefly discuss the consequential and transitional order. The 2008 Act updates the 1990 Act. The draft Human Fertilisation and Embryology (Consequential Amendments and Transitional and Saving Provisions) Order makes provision to ensure that the changes made by the 2008 Act are reflected in other primary and secondary legislation. The order consists of four articles and four schedules. Article 2 and Schedules 1 and 2 make consequential amendments to reflect the parenthood provisions introduced by the 2008 Act. In particular, the 2008 Act introduced the concept of second female parents, which enabled the female partner of a woman to be registered as the legal parent of a child born following assisted conception treatment with donor sperm in certain circumstances. The amendments in these sections ensure that a woman who is a parent by virtue of new provisions has the same rights and obligations as any other legal parent of a child.
Article 3 and Schedule 3 contain consequential amendments to other pieces of secondary legislation. Such amendments are necessary to ensure that the secondary legislation appropriately reflects the updated definitions, terms and provisions in the 2008 Act. Article 4 and Schedule 4 contain transitional and saving provisions. These ensure that the process for the transition to new provisions, as introduced by the 2008 Act, is as clear and straightforward as possible. I commend the regulations to the House. I beg to move.
8.30 pm
Earl Howe: 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
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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
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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.
8.39 pm
Baroness Barker: My Lords, I thank the noble Lord, Lord Darzi, for the eloquent way in which he introduced the regulations. I, too, put on record my thanks to the officials who briefed me and the noble Earl, Lord Howe, last week. It was a most helpful meeting. I have a few questions and points I wish to raise.
I will deal with these regulations in the order in which the noble Lord, Lord Darzi, introduced them. The first regulations deal with the appeals committee of the HFEA. Those are important regulations. They lay down in express terms the mechanisms for appeal. Those were not included in the 1990 Act. Since then the nature of the issues which the HFEA has to consider has become increasingly complex. In recent years, a number of HFEA decisions have been challenged and it is right therefore that the appeals procedure
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I take a slightly different view from the noble Earl. One of the main reasons why this appeal committee should be structured in the way that it is and should be chaired by someone who is legally competent is that, as I envisage it working, the committee will have to deal with a number of issues in a field where scientific knowledge and ethical questions arise in a comparatively short space of time. This is cutting-edge, innovative work. The more important reason is, however, that, unlike many other areas of medicine, the issue of time can be very important to the people bringing the appeals. Women may have biological clocks running. Therefore the intent behind laying out such a detailed appeals procedure, as the noble Lord, Lord Darzi, said in his introduction, is to minimize the need for people to resort to the courts. Therefore I can see the logic of doing that.
Earl Howe: My Lords, the noble Baroness may have misunderstood me. I am supportive of the legally qualified chair concept but I do not understand why the Government have taken a different approach here from the approach they took in the Health and Social Care Act.
Baroness Barker: Quite so, my Lords. The procedures to be followed by this appeals committee follow established principles and practices in similar organisations. It is helpful that appellants, witnesses and advisers should have a clear understanding of the procedure to be followed in the event of a dispute.
I have one small technical question. Regulations 17, 18 and 27 spell out the number of days within which certain actions must be happen-notification must be given and decisions must be communicated. Are those working days or are they calendar days? I speak as one who was once caught in the vicious crossfire of a procedure where that point was not clear. It gave people who were already upset about an issue something else to have a fight about. It is a very simple matter but needs to be clarified.
I turn to the special exemption regulations that deal with storage of embryos and gametes without a licence. I understand that this is necessary for the purposes, for example, of investigating a crime. I wonder whether the Government have considered placing a limit on the length of time for which gametes and embryos could be stored in unlicensed storage. It seems to be an open-ended question.
It is not clear from the regulations whether the HFEA continues to have responsibility for safe storage for the duration of the existence of a gamete or an embryo. For example, when an investigation has been concluded, does the HFEA retain responsibility? Will embryos and gametes be returned to the HFEA or does the responsibility transfer and remain with the other authority? I point raise that point because there is considerable concern that we might just be opening a door through which unscrupulous people might chose to walk.
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I welcome the regulation that sets out the conditions for the storage of gametes for other purposes. In particular, I welcome Regulation 3(2)(c), which recognises that gametes may be stored for the purpose of teaching. That was the purpose behind an amendment that I tabled during the passage of the Bill, and I am glad that that has been recognised by the Government in the context of the safeguards that are set out in the relevant paragraph, the most important of which is that any gametes stored in that way must never be used for reproduction.
I turn briefly to the consequential amendments order. As I sat down to read these provisions, many of which essentially change other legislation to reflect the decision made by this House on second female parents, I thought that this House would do well to be reminded of what excellent legislation this Act is. Parliament and, in particular, this House should be proud because this order, in its detail, demonstrates just how difficult it has been hitherto for lesbian and gay families to give children the security that other children enjoy as of right. Anyone who reads this order can be in no doubt that the HFEA Act in its effect is serving the best interests of children and their families, and it will give those children stability in a way that was never possible before.
I have two questions to put to the Minister. First, will he explain the purposes of Paragraphs 3 and 4 on page 18 which amend the Private and Voluntary Health Care (England) Regulations and the Private and Voluntary Health Care (Wales) Regulations? It is not clear to me what those amendments are designed to do. Do they mean that private clinics providing fertility services must recognise couples where both people are women? I may be wrong and so I would welcome clarification on that.
Secondly, on the transitional and saving provisions, I understand that the intent of this order is to ensure that treatment and research programmes that were initiated under the current law can continue with minimal disruption to patients. Can the Minister confirm that nothing that was prohibited under the existing law would be permissible under the transitional arrangements? If he could give that assurance, I think that noble Lords would consider that their intentions, as expressed during the passage of the Bill, had been satisfied. I very much welcome these regulations.
8.45 pm
Lord Alton of Liverpool: My Lords, the noble Baroness, Lady Barker, has just reminded the House that she thoroughly approved of the legislation when it was before us last year. The House will recall that I was fundamentally opposed to it, and I have not changed my view. However, I am, as always, grateful to the Minister for the way in which he, with such clarity, introduced and explained the regulations that are before the House tonight. I shall follow of the remarks made by the noble Earl, particularly about the position of animal-human hybrid embryos and how they are covered by the regulations, especially the dispute that took place in the Merits Committee. Although I did not have the opportunity to meet officials, I met Dr Elizabeth Allan, who made representations to that committee, and I shall pursue some of her arguments in a few moments.
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First, I shall touch on the issue of the appeals committee to which the Minister referred. Unlike the noble Earl, I am not entirely sanguine about advisers being appointed to the appeals committee if they are currently or have previously been members of the HFEA. I would not want to misunderstand what the noble Earl said, but I felt that he thought that it was a reasonable principle for people who were or had been employees of the HFEA to be appointed among the advisers, and like the noble Baroness, he would prefer to see a lawyer as the chairman of that committee.
I have reservations about specifying who should be made the chairman of such a committee, and whether it needs to be a lawyer. There are many lay people, as the noble Earl hinted, who could easily fulfil those duties. Certainly they should have rigour and the ability to chair the committee, but sometimes we hand over our own rights to particular disciplines without thinking through the consequences. By specifying that it would never be anyone other than a lawyer would be an error. I am also bothered about the conflict of interest that could arise if someone is currently or has previously been an employee of the HFEA and is then placed in an advisory position on the appeals committee. If they were involved in one of the disputes or making the policy earlier on, the watchdog could be too easily identified with the burglar in this case. We need to ensure that there is never any conflict of interest. I know that that was the purpose underlying the Minister's remarks earlier, but I want him to say a little more about who the advisers will be. Is he really content that they might have some kind of conflict by virtue of their membership or employment?
My real concerns about the regulations are twofold. First, I have grave anxieties about what seem to be loopholes and, secondly, there is serious concern about the way in which the regulations have come before your Lordships' House. It appears that the Government's main intention is to update the 1991 special exemption regulations to take into account the new definitions of gametes and embryos, and to include human admixed embryos, following the updating of the 1990 Human Fertilisation and Embryology Act in the 2008 legislation.
The regulations provide for exceptions to the general rule that a licence is required to keep human embryos and gametes and human admixed embryos. There are two special exemptions: first, Regulation 2 on keeping and examining embryos in connection with offences under the amended 1990 Act; and, secondly, Regulation 3 on storing gametes for the purposes of research or teaching, or for developing or testing pharmaceutical or contraceptive products. I particularly draw attention to Regulation 2, which relates to offences under the Act.
However, Regulation 1 clarifies that embryo and gametes refer to human embryos and gametes. This sets the context for Regulation 2, which relates to
This permits the unlicensed keeping and examining of human gametes and embryos in connection with an offence under the 1990 Act. The regulation appears to refer solely to humangametes and embryos, since
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Paragraph 7 of the Explanatory Memorandum also states that a licence exemption applies to,
- "cases where an offence under the 1990 Act is being investigated or proceedings are taking place in relation to such an offence. Embryos may be kept and examined and gametes may be stored without a licence from the HFEA in these specific circumstances. Any such embryos or gametes will have been seized by the Authority or transferred to a place where they are now on the instructions of the Authority".
Again, since this applies only to humangametes and embryos, it seems as though there is no intentionto provide for keeping and examining human admixedembryos for the purposes of investigating offences under the 1990 Act, other than for keeping and examining humangametes or embryos if they were used in the process of making human admixedembryos. However, if there has been an offence in relation to human admixed embryos, the human admixed embryosthemselves would need to be examined. Furthermore, many types of human admixedembryo would not use humangametes or embryos in their creation. For example, cloned human-animal embryos created by cell nuclear replacement using enucleated animal eggs and an adult human skin cell would not use either human gametes or embryos in their creation.
Many of the new offences introduced by the 2008 Act into Section 41 of the 1990 Act, are offences relating to human admixedembryos. These offences are serious and include not only creating, keeping or using human admixed embryos without a licence, but also placing a human admixed embryo in a woman, a point to which the noble Baroness, Lady Barker, referred. That appears in Section 41 and new Sections 4A(1) and (2) of the 1990 Act. Noble Lords will recall grave misgivings expressed in your Lordships' House and felt by vast numbers of the general public about the line we crossed with the HFE Bill. Omissions such as this will heighten, not stem, those anxieties. We cannot expect the public to trust us if the regulator does not enforce the standards that it sets out in the parent legislation. I am sure that all noble Lords would agree that there needs to be a way of investigating a crime effectively and rapidly, such as placing human admixed embryos in a woman. I agree with the noble Baroness about the importance of examining these matters expeditiously.
A mechanism needs to be in place that allows rapid investigation of the offence involving human admixed embryos. I would be grateful if the Minister would clarify whether there is provision in the special exemption regulations for human admixed embryos to be both kept and examined for the purposes of investigating an offence under the Act.
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