Skip to main content

Human Fertilisation and Embryology (Special Exemption) Regulations 2009

Volume 712: debated on Tuesday 7 July 2009

Motion to Approve

Moved by

That the draft Regulations laid before the House on 17 June be approved. Relevant Documents: 18th Report from the Joint Committee on Statutory Instruments.

My Lords, I shall speak to the draft Human Fertilisation and Embryology (Appeals) Regulations, the draft Human Fertilisation and Embryology (Special Exemption) Regulations and the draft Human Fertilisation and Embryology (Consequential Amendments and Transitional and Saving Provisions) Order. I will describe briefly each set of statutory instruments, starting with the appeals regulations.

The Human Fertilisation and Embryology Authority licenses IVF and embryo research centres. The HFEA licensing regime is set out in statute by the Human Fertilisation and Embryology Act 1990, with regulation-making powers to add detail to the licensing system. In 2004, the Government announced a review of the 1990 Act, which resulted, after interesting and valuable debate, in the Human Fertilisation and Embryology Act 2008. The 2008 Act updates and amends the 1990 Act and, as part of this, updates the licensing and appeals regime.

The 2008 Act requires regulations to be made to set out the details of the constitution of an appeals committee and the process by which an appeal will be heard. The appeals regulations will replace existing regulations that deal with the current appeals processes. The draft appeals regulations aim to ensure that the committee is as independent from the authority as it can be, and that a clear, robust appeals process is set out. There are requirements under common law and the European Convention on Human Rights for appeals procedures to be impartial and fair, and I believe that these draft regulations set out such a procedure.

The draft appeals regulations are in four parts. Part 1 sets out the commencement date for the regulations, and definitions of the terms used. Most provisions in the draft appeals regulations will be commenced on 1 October 2009. However, regulations 4 and 6, and the relevant definitions under regulation 2, will be commenced the day after the draft regulations are made. These provisions relate to the constitution of the committee and the appointment of members, and enable the HFEA to appoint and train members of the appeals committee so that the committee is in place on 1 October.

Part 2 of the draft appeals regulations sets out the constitution of the committee. As the appeals process is a legal procedure, the regulations provide that both the chair and deputy chair must be legally qualified. The appeals committee will have seven members and must have a lay majority. A non-lay member—a person with a professional interest—is defined as either a registered medical practitioner, a person concerned with keeping or using gametes or embryos outside the body, or a person who is directly concerned with commissioning or funding any research involving such keeping or use of gametes or embryos. This is the same definition as in the 2008 Act. The quorum of the committee will be three, which includes the chair or deputy chair and at least one person with a professional interest.

The committee is prevented from sitting with an even number of members, and voting is by a simple majority. Members are prevented from abstaining to ensure that a tied vote does not arise. This provision was introduced following the consultation process. The draft regulations specify who cannot sit on the committee, including current and former HFEA members and staff, current licence holders and current persons responsible under a licence. This aims to ensure that the committee is as independent as possible. The draft regulations prevent licence holders and “persons responsible” working in a licensed clinic from sitting on the appeals committee, but do not restrict who may be appointed as an adviser to the committee. Therefore, should the committee require advice from persons who are excluded from being members, they may be appointed as advisers. Provision for the committee to appoint advisers is made in Part 3 of the regulations. I am confident that, in enabling the committee to appoint expert advisers, we have the correct balance between the maximum independence and objectivity of the committee and its access to expert advice.

Part 4 sets out the procedure by which an appeal is determined. I will draw attention to a typographical error in the regulations. Regulation 21(5) refers back to paragraph (3) of that regulation. It should refer to paragraph (4). This will be amended in the final version of the regulations. Part 4 sets out the detail of what documentation the committee will require and when it must be provided. A determination may either be by reference to the papers or at an actual hearing. The draft regulations introduce case management meetings, which may be at the request of either party, to allow the chair to make preliminary rulings on the admissibility of evidence and points of law. This will streamline the appeals process by enabling early agreements on such matters to be reached.

Part 4 goes on to provide for witness evidence and sets out the powers held by the committee to summon witness evidence. This part includes the requirements to ensure that the determination is recorded and made available to both parties. The record will include any advice that the committee receives from an adviser, whether given during the deliberations or the hearing.

I now turn to the special exemption regulations. The Human Fertilisation and Embryology Act 1990 prohibits storing gametes and creating, keeping or using a human embryo without a licence from the HFEA. This is a key principle of the 1990 Act and has been retained following the update of the legislation by the Human Fertilisation and Embryology Act 2008. However, there are two exceptions to this principle, which were set out in regulations made in 1991. These regulations will be replaced by the draft Human Fertilisation and Embryology (Special Exemption) Regulations.

These draft regulations do not represent a change in government policy. It has been necessary to re-make these regulations in consequence of the provisions of the 2008 Act, which update the definitions of “gametes” and “embryos” in the 1990 Act and which provide for the regulation of human admixed embryos. It was also necessary to make some minor and technical amendments to the drafting of the regulations.

The draft Human Fertilisation and Embryology (Special Exemption) Regulations set out the cases in which embryos may be examined or kept, and gametes may be stored, without a licence from the HFEA. There are some circumstances where gametes and embryos may be kept for purposes other than for providing fertility treatment or embryo research; for example, during the course of a criminal investigation into alleged breaches of the Human Fertilisation and Embryology Act or the storage of sperm for teaching purposes. The 1991 regulations were made to set out exceptions to the HFEA licensing requirements in these very specific and limited situations. In drafting the 1991 regulations, the Government wanted to ensure that these regulations could not be used to circumvent the stringent controls set out in the 1990 Act. The same applies to these draft regulations.

The first exception relates to the examination and keeping of embryos, and the storing of gametes in the course of the investigation of an offence under the 1990 Act, or in relation to proceedings for such an offence. This exemption applies to gametes or embryos that have been seized by the HFEA or which have been transferred to premises where they are held on the instructions of the authority.

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 should be made. For these important reasons we have not updated the policy in these regulations but simply re-made the regulations with the same exceptions.

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.

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.

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 should be placed on a similar basis to that of other organisations such as the GMC and the Royal Pharmaceutical Society.

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.

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.

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.

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.

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”,


“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.

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,

“examination of embryos, or the storing of gametes, in connection with the investigation of, or proceedings for, an offence under the Human Fertilisation and Embryology Act 1990”.

The second exception, in Regulation 3,

“applies to the storing of gametes for the purpose of research”,

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.

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

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?

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.

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 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.

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.