Human Fertilisation and Embryology (Special Exemption) Regulations 2009

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. 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 ""keeping and examining gametes and embryos in connection with crime"." 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 human gametes and embryos, since gametes and embryos are defined as human under Regulation 1. It therefore appears that these regulations do not cover the keeping or examining of human admixed embryos in relation to any offences committed in relation to them. Herein lies my concern and that expressed by the noble Earl. 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 human gametes and embryos, it seems as though there is no intention to provide for keeping and examining human admixed embryos for the purposes of investigating offences under the 1990 Act, other than for keeping and examining human gametes or embryos if they were used in the process of making human admixed embryos. However, if there has been an offence in relation to human admixed embryos, the human admixed embryos themselves would need to be examined. Furthermore, many types of human admixed embryo would not use human gametes 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 admixed embryos. 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. The case of cloned human-animal embryos is particularly helpful to consider, since they are classified as "human" under the original 1990 Act, but as "human admixed" under the 2008 Act. Therefore under the original 1990 Act, they would have fallen under Section 43, which authorises regulations to be made for the keeping and examining of human gametes and embryos in connection with the investigation of, or proceedings for, an offence. They would also have been covered under Regulation 2 of the Human Fertilisation and Embryology (Special Exemptions) Regulations 1991. It would therefore have been possible to keep and examine them without a licence, to investigate an offence under the original 1990 Act. However, owing to their reclassification under the 2008 Act as "human admixed" embryos, Section 43 and Regulation 2 are no longer applicable to them as they deal only with human embryos. Regulation 2 of the draft 2009 special exemption regulations would not apply to them—despite the purpose of these new draft regulations being to update the 1991 regulations specifically to take account of human admixed embryos and changes in definitions of "embryo" and "gametes". Regulation 3 relates to storing gametes for other purposes. According to Paragraph 7.4 of the Explanatory Memorandum, Regulation 3, ""allows the storage of gametes without a licence, provided they are only to be used for certain purposes. These purposes are … research on gametes … the development or testing of pharmaceutical or contraceptive products … teaching requiring the use of gametes"." Paragraph 7.5 states: ""However, even if the gametes are intended for one of the purposes set out above, a storage licence must still be obtained if it is intended that one of the following activities will be carried out … the mixing of live sperm with live eggs … the bringing about of any human embryo … the bringing about of any human admixed embryo … using the gametes for purposes that may not be authorised by a HFEA licence … supplying gametes to a licence holder for a purpose for which they hold a licence"." The original regulations, published on 3 June, did not include, ""the bringing about of any human embryo"," or, ""the bringing about of any human admixed embryo"." This would have meant that the gametes could have been stored without a licence, for the purpose of making cloned human embryos and human admixed embryos, with the exception of full hybrids, if the purpose was research on gametes, teaching requiring the use of gametes, or developing or testing pharmaceutical or contraceptive products. Fortunately, the Merits Committee was instrumental in bringing this to the attention of the Department of Health, and the statutory instrument was therefore redrafted to include what is now Regulation 3, paragraph 3(b) and (c). The Merits Committee is to be commended for its swift action to close up this loophole. I note that in the 21st report of 2009, the Merits Committee comments that the original wording, ""would not have met the policy intention of requiring the licensing of any process that creates embryos"." There should perhaps be some fine-tuning on that point, in that it is the unlicensed storage of gametes for the purposes of creating cloned human embryos and human admixed embryos that could have taken place under the original Regulations. Nevertheless, it was a serious drafting error, and we should be grateful to the Merits Committee for noticing it and arranging for the redrafting. I also note, as acknowledged at the head of this draft statutory instrument, that it has already had to be reprinted twice, ""in consequence of defects in two previous draft regulations"." Apparently, there was another drafting error that also had to be corrected. In view of three draft sets of regulations having been produced in June, and possibly a fourth draft set being required if there is indeed a problem relating to Regulation 2 on offences, I therefore concur with the Merits Committee’s report that it would have been better to have put these regulations out for public consultation first, to provide the opportunity for defects to have been noticed at an earlier stage. It is true that members of the public may contact the Merits Committee within a week of a statutory instrument being laid before Parliament. However, this is not the same as a public consultation process; the week might have already passed before members of the public even became aware of the regulations. There is also the issue of complexity: there needs to be time thoroughly to analyse and think through the implications. Drafts of these regulations have been raining down like confetti, with no less than three different versions having been put into the Printed Paper Office. Legislating on the hoof is demonstrably a foolish approach, a lesson painfully learnt in the notorious Dangerous Dogs Act. Government departments in general should not assume that expertise outside the department will be an obstacle rather than a help. In this case, the interventions of Dr Elizabeth Allan to the Merits Committee pointed out the flaws in the regulations, some of which remain as I have identified. Will the Minister confirm that all future draft regulations relating to the Human Fertilisation and Embryology Act will be put out for public consultation before being laid before Parliament? The Merits Committee has done the House a great service by arranging for the draft regulations to be amended to ensure that the unlicensed storage of gametes to make cloned human embryos and human admixed embryos under Regulation 3 will not be possible. The committee pointed out in its 21st report, that "the definition is complex", and recommended that the regulations were kept under review to ensure that the policy intention was retained in the light of technological developments. Many of your Lordships will remember the frequently changing definitions during the passage of the Human Fertilisation and Embryology Bill, and the long debates in this House and in the House of Commons Science and Technology Committee and the Joint Committee on the draft Bill, examining definitions of hybrids and chimeras. Since both aspects of the special exemption regulations—investigating offences and storage of gametes for certain purposes—already seem to be casualties of the complexity of definitions, with potentially serious consequences, I concur with the Merits Committee that they should be kept under review. That seems all the more necessary in view of the fact that the Secretary of State has the power to alter definitions of human gametes and human admixed embryos. Will the Minister confirm whether the Government will keep these regulations under review to ensure that the policy intention is retained in the light of technological developments and, if so, what the mechanism of review will be? When the Minister responds, I hope he will take account of the two concerns that I have expressed: loopholes and procedures. In my years in both Houses in this place, I cannot recall a stronger indictment than that expressed by the Merits Committee in the report to which I referred. Its remarks warrant serious reflection. If the Government are ever to win the public's confidence in the field of embryology, they must do far better than this in future.