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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

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and examining of humangametes 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However, owing to their reclassification under the 2008 Act as "human admixed" embryos, Section 43 and Regulation 2 are no longer applicable to them as they deal only with human embryos.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,

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,

or,

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,

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.



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I also note, as acknowledged at the head of this draft statutory instrument, that it has already had to be reprinted twice,

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?



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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.

Lord Walton of Detchant: My Lords, I, too, welcome these regulations. Many of the questions that I might have asked have already been raised by other Members of your Lordships' House. I have a query on the question of storage of embryos. Bearing in mind the recent, highly publicised incident in which the wrong embryo was implanted into a woman, leading to a pregnancy that had to be aborted, the regulations relating to storage and labelling seem sufficiently tightly drawn to avoid that issue arising in future. However, can the Minister confirm that the issue is one to be met under these regulations and that that is not an incident that is likely ever to recur?

Secondly, I do not share the concerns expressed by the noble Lord, Lord Alton, about the regulations. All the important issues relating to the exceptions allowed under the regulations are handled very clearly and precisely in the Explanatory Note. The first exception to the points relating to storage of gametes and embryos deals with the,

The second exception, in Regulation 3,

and other things so clearly set out in the regulation. I understand entirely the concern expressed by the noble Lord, Lord Alton, about human admixed embryos, but it was in the Act itself that the decision to allow these admixed embryos to be created for research purposes under licence was agreed. For that reason, the issues that he has now raised should not give us any serious concern.

I would add only one other point. I know that the noble Lord and the noble Baroness will remember when I raised in some detail during our debates on the Act concern about research leading to the technique of pronuclear transfer for the prevention of mitochondrial diseases. Such diseases are very serious and could be avoided if that particular technique-now proven under licence to be feasible-were allowed and an embryo created by pronuclear transfer could be inserted into a woman. I tabled an amendment saying that a licence shall provide for such a technique, which the Government refused. The Act now states that regulations shall provide for it. I hope that once these regulations have been accepted, in the fullness of time and not before too long, the Government may consider introducing regulations to deal with that issue relating to the prevention of mitochondrial disease using that specific technique. It shows enormous promise in the prevention of those devastating diseases.

Lord Bates: My Lords, I raise the issue of fatherhood in the context of the regulations. In doing so, I am

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conscious of the great scientific expertise which has been drawn to these important regulations and the knowledge which is there. It is a great strength of this House to have that level of scientific understanding. I cannot pretend for one moment to come anywhere near to understanding that, but there are two components to any decision. One is whether you could and the other is whether you should. Whether you should implies an instinct of moral judgment about which some Members of this House are qualified to speak. Although I am probably not qualified, I would like to raise those issues as we consider them this evening.

For that reason, one of the things that I have been persuaded on by listening to the debate is the comments of the noble Lord, Lord Alton, who went through the problems that were found by the Merits Committee when looking at these regulations and its concerns about their drafting. It is a cause for concern because we are not talking about the Dangerous Dogs Act or food labelling. We are talking about the very essence of life. Therefore, to see errors occurring in these sorts of regulations raises serious concerns, which I am sure the Minister will have taken careful note of.

I am of course aware that our response to the question of whether it is proper for the state to facilitate the deliberate creation of children with the intention that they be denied the chance of ever having a father for the duration of their childhood has already been determined. However, it is important for us to note that regulations giving effect to that controversial aspect of the Act are before your Lordships' House today, and I ask the Minister for certain reassurances about their implementation.

In order to understand the need for ministerial reassurances, it is important to briefly rehearse some of the arguments and reasons for public concern. First, the point was made that since the rationale for the new Act was to have regard for key research development since 1990, one of the important points that we have to take into consideration is the explosion of research underlining the importance of fathers-demonstrating how they bring something distinctive to the parenting process. This, it was argued, should result in the Act having more and not less consideration for the role played by fathers.

Secondly, the point was made that there is all the difference in the world between the state making provision for a child in care to be adopted by a lesbian couple-a child who could otherwise be institutionalised-and its deliberately facilitating the creation of children with the intention that they should never have a father for the duration of their childhood. Thirdly, deep concern was expressed in the debate that the Government's all-important consideration seemed to be the rights of would-be parents to access IVF rather than the rights of the child created as a result of that IVF . The legislation appeared more concerned with championing the rights of the stronger party-that is, the parents-than those of the weaker party; namely, the child.

Given these concerns, particularly the fact that the research demonstrates that fathers bring something distinctive to the parenting process-which means that we have to assume that this would be missing if the father is absent-we should embark very cautiously

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indeed on a pathway of facilitating the deliberate creation of children with the intention that they be denied a father. Of course, I am aware that some research suggests that the children of same-sex parents may not be disadvantaged compared to those who have a father and a mother. I do not wish to suggest that this is not the case. My point is simply that the research is in its early stages and only pertains to relatively small sample sizes. If we are to overrule the implications of the far better-sustained findings which demonstrate that fathers bring something distinctive to parenting, we owe it to the children to tread very carefully indeed.

In light of these concerns, what new provisions is the Minister putting in place to assess child well-being in the context of the state now deliberately facilitating the creation of children with the intention that they be denied a father for the duration of their childhood? Moreover, will he give an undertaking that, if evidence comes back which suggests that child well-being is being compromised by Sections 42 and 43 and these regulations, he will act speedily to introduce appropriate changes?

Baroness Barker: My Lords, when the noble Lord referred throughout his speech to evidence relating to the importance of fathers, what evidence exactly was he citing? Was he, for example, citing the document produced by Christian Action, Research and Education, which was referred to throughout the passage of the Act?

Lord Bates: My Lords, I am grateful to the noble Baroness for her question. Of course, that was the information that I directly referred to. There is also some excellent work that has been done by the Centre for Social Justice. Most fundamentally, I was drawing on my own personal experience of having been blessed by having a father, and of being a father to two children.

Lord Darzi of Denham: My Lords, yet again I am grateful for a very constructive debate on these regulations. I will attempt to address the large number of questions. If I do not complete in time, I will be more than happy to write to noble Lords with more detailed answers.

I start with the exemption powers, which the noble Earl, Lord Howe, raised in relation to Regulation 2. The power under which these regulations are made is set out in Section 43 of the 1990 Act. This limits the scope of the regulation to make provision in relation to the keeping and examination of gametes and embryos, and not human admixed embryos. It is a criminal offence to keep human admixed embryos without a licence. If it was necessary for the Human Fertilisation and Embryology Authority to keep a human admixed embryo in connection with a crime, it would need to be stored in licensed premises. I hope that also addresses the question of the noble Lord, Lord Alton.

Turning to the question about the review of the special exemption regulations, which was raised by the noble Earl, Lord Howe, the answer is yes: I have no doubt that we need to keep up with scientific advances in relation to the exemption regulations and the demand for different purposes, other than the creation of embryos. The noble Baroness, Lady Barker, raised the issue of who will be responsible for the ongoing storage. The

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regulation provides for the HFEA to store embryos without a licence in connection with the exemptions listed. The HFEA would arrange for another clinic with appropriate storage facilities to have the embryos for as long as necessary. The noble Baroness also asked about the time limit for unlicensed storage. No time limit is set out in the legislation. Embryos are kept only in very specific circumstances but there is no time limit relating to that.

The noble Lord, Lord Alton, referred to the consultation process and made a very strong point in relation to that. I reassure the House that the Department of Health consulted for 12 weeks on the other aspects of the regulations in front of us. I recognise the value of consultation and will consider very carefully on each occasion whether a consultation on all future regulations should take place.

As regards the appeals regulations, I am grateful for the noble Earl's acknowledgement that a legal chair would be appropriate. The Health and Social Care Bill passed through the House a long time ago but I am more than happy to go back to it to look at the reasons why a legal chair was not considered appropriate. However, in relation to these regulations it is considered appropriate in the case of the HFEA appeals committee to have a legally qualified chair. These cases will nearly always be legally complex and the HFEA supported this provision. The noble Earl asked whether a member of the committee could vote. It is important-we recognise this and it was supported during the consultation-that the appeals committee reaches a decision and does not have a tied result. For that reason the regulations provide that the membership must be an odd number. Preventing a member abstaining maintains that position.

The noble Baroness, Lady Barker, asked what we meant by "day". We mean a calendar day. The noble Lord, Lord Alton, said that the appeals committee should not be advised by a member or former member of the HFEA. I have no doubt there are two views on this. It is important that the correct expertise is available. The relevant people will need to declare any conflicts. We believe that we have the correct balance of expertise and independence. I further reassure the noble Lord that the chair of the appeals committee has the right to choose his or her advisers. If the legally qualified chair of that committee feels there is a conflict, that issue could be dealt with there and then.

The noble Lord, Lord Walton, referred to the issue of the wrong embryo being put in a woman and asked whether that was addressed by these regulations. The answer is no. However, the HFEA has processes in place to address the very unfortunate situation that arose in Wales. I would be more than happy to send more details in relation to the current investigations which have been carried out.

I wish to deal with two other points raised by the noble Baroness, Lady Barker. I confirm that nothing which is prohibited under current law is allowed under the transitional provisions. She asked whether private clinics must provide fertility services to same-sex couples under the private and voluntary care regulations. The answer is no but they can do so. We are not putting that in regulations.



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The noble Lord, Lord Walton, raised a very important issue and asked whether the Government would bring forward regulations to address mitochondrial disease. We shall certainly monitor that. Given his very persuasive arguments and support for that, we will look into it. The noble Lord, Lord Bates, asked whether the Government have denied fathers. We debated this in great depth through the passage of the Bill. I remember many of the interesting debates that we had. I refer the noble Lord to Hansard. Research by academics indicates that it is the quality of parenting, certainly not the sex of the parents per se, that is important. The Government have considered a child's need for supportive parenting. As I have said, this was comprehensively debated during the passage of the Bill. I hope that I have covered most of the questions. I am very grateful for the very constructive feedback.

Motion agreed.

Human Fertilisation and Embryology (Consequential Amendments and Transitional and Saving Provisions) Order 2009

Motion to Approve

9.20 pm

Moved By Lord Darzi of Denham

Motion agreed.

Human Fertilisation and Embryology (Appeals) Regulations 2009

Motion to Approve

9.20 pm

Moved By Lord Darzi of Denham

Motion agreed

Coroners and Justice Bill

Committee (5th Day) (Continued)

9.21 pm

Amendment 175

Moved by Baroness D'Souza


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