The Minister of State, Department of Health (Gillian Merron): I beg to move,

The Chairman: With this it will be convenient to consider the draft Human Fertilisation and Embryology (Appeals) Regulations 2009 and the draft Human Fertilisation and Embryology (Consequential Amendments and Transitional and Saving Provisions) Order 2009. The statutory instruments are narrowly drawn and do not lend themselves to wider debate.

Gillian Merron: It is a pleasure to serve under your chairmanship, Mr. Fraser.

The three statutory instruments are necessary to implement the provisions of the Human Fertilisation and Embryology Act 2008, which was debated in great detail last year. Two of the statutory instruments are consequential to the changes introduced by the 2008 Act and the appeals regulations will supplement the 2008 Act by providing additional detail. I echo your assurance, Mr. Fraser, that the statutory instruments are mainly technical or consequential. They do not reopen the debate on matters of substance, nor undermine the principles agreed by this House when considering the 2008 Act.

I will describe briefly each of the statutory instruments, beginning with the draft Human Fertilisation and Embryology (Appeals) Regulations 2009. The Human Fertilisation and Embryology Authority licenses in vitro fertilisation and embryo research centres. The licensing regime is set out in statute by the Human Fertilisation and Embryology Act 1990 and regulation-making powers allow further detail to be added to that system. The 2008 Act updates and amends the 1990 Act, including 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 primary purpose of the appeals regulations is to ensure that the committee is as independent of the HFEA as possible and that a clear and robust appeals process is set out in legislation. The appeals regulations are in four parts. Part 1 sets out the commencement date for the regulations and the definitions of the terms used. It includes who can appeal against a licensing decision. That is a limited category, which essentially includes the person who wishes to be granted a licence and the people to whom the licence applies.

Part 2 of the regulations sets out the constitution of the committee. The regulations specify that current and former HFEA members and staff, current licence holders and current persons responsible cannot sit on the appeals committee. That is aimed at ensuring that the committee is as independent as possible.

Part 3 relates to advisers to the committee. Although the regulations will prevent licence holders and persons responsible who work in a licensed clinic from sitting on the appeals committee, they will 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.

Part 4 sets out the procedure by which an appeal will be determined. I draw the Committee’s attention to a typographical error in the regulations. Regulation 21(5) refers back to paragraph (3) of that regulation, whereas it should refer to paragraph (4). That will be amended in the final version of the regulations.

The legislation prohibits storing gametes and creating, keeping or using a human embryo without a licence from the HFEA. That was a key principle of the 1990 Act and was retained in the 2008 Act. There are two exceptions to that principle, which are set out in regulations made in 1991. Those regulations will be replaced by the draft Human Fertilisation and Embryology (Special Exemption) Regulations 2009. The two exceptions relate to circumstances in which gametes and embryos are kept for purposes other than for providing fertility treatment or for embryo research, for example, during the course of a criminal investigation into alleged breaches of the relevant Act or in relation to the storage of gametes for research into or the teaching or development of pharmaceutical or contraceptive products. The 1991 regulations were made to set out exceptions to the HFEA licensing requirements in those very specific and limited circumstances. In drafting the 1991 regulations, the Government wanted to ensure that those regulations could not be used to circumvent the stringent controls set out in the 1990 Act, and the same applies to these draft regulations.

It has been necessary to update the regulations as a consequence of the provisions of the 2008 Act, which updates the definition of gametes and embryos contained in the 1990 Act and provides for the regulation of human admixed embryos. It is also necessary to make some minor and technical amendments to the drafting of the regulations. 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 in certain limited circumstances, as is currently the case.

The 2008 Act updates the 1990 Act, and the draft Human Fertilisation and Embryology (Consequential Amendments and Transitional and Saving Provisions) Order 2009 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 Act introduced the concept of second female parents, which enables 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 those sections ensure that a woman who is a parent by virtue of the new provisions has the same rights and obligations as any other legal parent of the 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. Those ensure that the process of the transition to the new provisions, as introduced by the 2008 Act, is as clear and as straightforward as possible. I commend the regulations and the order to the Committee.

Mark Simmonds (Boston and Skegness) (Con): May I say how pleased I am to be under your guidance this afternoon, Mr. Fraser? I welcome the Minister to her post, in which she has specific responsibility for this extremely important piece of legislation and for ensuring it is put into practice as swiftly and comprehensively as possible. She will, of course, be aware of the many debates that took place both in Committee and on the Floor of the House about the very complex scientific and ethical foundations that needed to be put into place to ensure that the Bill was robust and that it will, hopefully, last at least as long as the previous Act, which was put in place in 1990.

The Minister will also be aware that Britain is—thank goodness—a world leader in reproductive and stem cell technologies. That is not just because of our scientists’ skill; it is also because of the excellent regulatory background and framework that has been put in place—both in 1990 and as updated in the 2008 Act, which was built on an ethical platform. I am happy to take the three regulations together, but I want to comment on them in the order in which they are set out in the delegated legislation information. That is a different order from that in which the Minister introduced them. I will not repeat or replicate what she said in her explanation of the regulations, but it is important to ask some key questions about the workings of the regulations.

Will the Minister explain why the draft Human Fertilisation and Embryology (Special Exemption) Regulations 2009, which I think is euphemistically referred to as regulation one, were not included in the Act? As far as I can see, they are simply restatements of the 1991 regulations and could have been included in the Act, so why are they still regulations? I was pleased that the Minister highlighted the deliberate mistake, and I take her word that it will be rectified at the appropriate time, and before the regulations are implemented. It would be helpful if the Minister will tell the Committee how frequently she expects the regulations to be used, and how frequently the previous regulations were used between 1990 and 2009, when the 2008 Act replaces the 1990 Act.

It would be helpful if the Minister will respond to a concern that was raised in the other place. The exemption under regulation one applies only to the storage of human gametes or embryos, not to admixed embryos. That was inserted into the 2008 Act. Will she clarify whether my understanding is correct, and that the HFEA would need a licence to store admixed embryos in the case of an ongoing investigation, because that is not exempt? How would it operate in practice if a licence were removed from an individual or a research establishment prior to an investigation, and what would happen to those admixed embryos, which would no longer be licensed? Will the Minister also confirm whether there is protection for the eggs and gametes to ensure that they are not damaged during the period of investigation? What will happen to the eggs and gametes after the investigation has taken place?

Another matter that is unclear concerns the export of gametes. What is the Government’s view of the export of gametes, particularly to less well-regulated environments. Certain things are not allowed under the 2008 Act, such as the insertion of artificial gametes or sperm to fertilise an embryo in this country—research is being done at Newcastle university—but that may not be the case if those artificial gametes were exported.

The Minister will be aware that under clauses 1(5) and 4(11) of the 2008 Act, the Secretary of State has the power to make further regulations, albeit restricted, that could substantially alter the definition of words such as “gametes”, “eggs” and “embryos”. It would be helpful if the Minister put it on the record that any alteration of those fundamental definitions should be considered by the whole House, and not in a regulation-making Committee such as this. That is the crux of this legislation.

The Opposition welcome the structure of the appeals committee in the draft Human Fertilisation and Embryology (Appeals) Regulations 2009, and indeed we suggested it when the Bill was in Committee because we thought that the appeal structure should be more independent and that members or former members of the HFEA should not sit on the appeals committee. We are pleased with that, but I am slightly perplexed by some of the detail. Why did the Government decide on a committee of seven people? Is a quorum of three, which is a minority of those on the committee, the right number? I would have thought that a quorum of four was the appropriate number, requiring a majority of those on the committee to attend.

Will the Minister explain today, or subsequently in a letter, what training the Minister envisages the committee undertaking prior to commencement of its work, and who she envisages being on the committee? Clearly, the balance and weighting should be appropriate. The regulations state that everyone who currently sits on the HFEA, or has done, will be excluded from the committee, so the number of people with expertise in the matter and who can make a contribution will be limited.

I do not understand why there is a ban on Committee members abstaining. Surely, that option could be beneficial in some cases. I understand why the Minister may not want to have a draw on the decision of the appeals committee, but the chairman, who will have a quasi-judicial role, should and could have a casting vote.

It would be helpful if the Minister said something about the advisers, who will play a significant role in the context of those who have been on the HFEA, in the past and currently, not being able to sit on the appeals committee. Is she concerned that, if the advisers cannot be drawn from the HFEA process, they may not be sufficiently independent? They may not be sufficiently independent if they are drawn from the HFEA structure. How does the Minister intend to balance those conflicting positions? I understand that the adviser can give advice and ask questions. Has the Minister considered whether that gives the authority too much power in the appeals process? Is the Minister concerned that the chair will be predisposed to accept the advice of the professional advisers and, if so, in what way has she considered potential conflicts of interests?

Inevitably, the independent body will incur additional costs allied to the appeals procedure. Perhaps the Minister could explain how those costs will be incurred and how the changes to the licensing system, which is set out in the additional documentation that comes with the regulations, will pay for them. Will the additional appeals procedure be self-financing? Again, we discussed that during the Bill’s Committee stage.

There is not a great deal of clarity about the time scale in which the appeal must be heard. There seems to be clarity about the time scale in which the result comes out—that is, seven days after the appeal—but not about the time within which the appeal procedure must take place. How many times can an appeal take place? The Minister may feel that that is a non sequitur, and that may be so, but I am thinking of times when a licence has been revoked, rather than when a research licence has been given.

In mentioning the consequential amendments and transitional and saving provisions, I will not reopen the debate about clauses 42 and 43 of the Act, which were debated at great length in the main Chamber and in the Committee Room. I am sure that you would rule me out of order if I did so, Mr. Fraser. Why were the amendments not contained in schedule 6 of the original Bill? There is no reason why they should be introduced in an order rather than in the Bill.

On the question of timing and when the Act will come into force, having read the order it appears that some parts of the Act came into force on 6 April 2009 and that the remainder will be brought into force on 1 October 2009. Why is there such a disparity and why are there two dates for the commencement of the Act? That matter throws up some potential anomalies. Perhaps the Minister will assure us that there will be no breaches of patient consent, because research projects that begin prior to 30 September 2009 will, on my understanding of the order, not have to meet the more stringent consent requirements of the 2008 Act and will still meet the requirements of the 1990 Act. How does that fit in with the implementation of this Act?

Will those who are undergoing treatment, but whose child is born after the commencement of the order, have their birth registered under the provisions of the 1990 Act or the 2008 Act? Under which Act will the changes in respect of same-sex partners that the Minister mentioned be made? The 2008 Act does not come into force until 1 October, so we are in limbo. Some of the transitional arrangements in the order address some of the points at issue, but they do not address the ones that I am raising.

I should like the Minister to say for the record how many of the ongoing cases that the authority is currently considering for revocation or for a variation of a licence are still likely to be ongoing by 30 September 2009. Will the appeals be dealt with under the 1990 Act or the 2008 Act, or will the appellant have the choice, as seems to be the case in the details of these regulations?

Dr. John Pugh (Southport) (LD): Although I promise not to reopen the debate, I should like to mention in passing that one of the issues of the debate was the beneficial effect of adult stem cell research compared with embryonic stem cell research, about which we argued long and hard. Recent evidence and research breakthroughs bear out the point that adult stem cell research is enormously more promising, but that is by the by.

I have no objection to the structure of the appeals committee. It seems sensible, and provision has been made for people to make decisions in areas in which they have no obvious personal interest. My concerns—like those of the hon. Member for Boston and Skegness—largely revolve around the very powerful role of the adviser of the appeals committee.

I accept that the adviser’s role is entirely transparent; there is a record of what he says and to whom. None the less, it is a powerful role. His advice is recorded, and if it is not taken, the matter is referred to the appellant. His role in this process is even more powerful than that of a planning officer advising a planning committee at a council. He is also an interrogator of witnesses. I accept that the appeals committee will require a level of expertise that it may not have. However, what we would not welcome is a level of bias that should not be there. Unlike members of the committee who are obliged to declare a professional interest, the adviser is under no such obligation. Obviously, if the adviser has a professional interest and shows a clear bias, it will be detected, because there is an audit trail, a record and transparency.

However, anxiety was voiced in Committee that the HFEA can be an easy touch when it comes to research projects because its record of turning things down is very poor. Even the things it turns down are generally won on appeal. We must show that there is not some backdoor method by which research projects almost effortlessly get through without proper scrutiny and examination, so the adviser’s role is critical. Will the Minister confirm whether it is true that the adviser does not need to declare a professional interest, unlike other members involved in the process?

On the draft Human Fertilisation and Embryology (Special Exemption) Regulations 2009, given the fast pace of change in the field, I accept that this is a difficult area to get right. The Merits Committee of the House of Lords has recorded the difficulties of the Department of Health. It says that

Clearly, that was not the policy intention of the Department of Health. So, the Department is by no means infallible here, and we must be cautious that it has done all that it should have done, and that it has got things right on this particular occasion.

The hon. Member for Boston and Skegness mentioned admixed embryos, which were not considered when the exemption regulations were brought forward. Will the Minister confirm three things for which there are fairly obvious answers. Clearly, the statutory instrument does not allow as an exemption the storing and examination of admixed embryos where there is considered to be a breach of the legislation, where a criminal activity has occurred. It does not mention it, so we cannot read an inference into it that does not appear to be there. My second question follows from the first, but perhaps I should ask my third question next. Will the Minister confirm that there can be a breach of licence conditions, which is a criminal offence, which involves admixed embryos? It seems self-evident that there can be such breaches: there can be offences involving gametes and embryos, so surely there can be offences involving admixed embryos.

The only other question to ask is whether there is any other way of dealing with an offence that involves admixed embryos. We might be more concerned about such offences than about those involving simply gametes. The primary legislation says that storing and examining admixed embryos for the purpose of a criminal investigation is not a licensable purpose under the Act, so there seems to be a loophole that is not being addressed by the Government in this statutory instrument. Let me reiterate a point that I have made before, because I do not think that it was well understood in the Lords. Lord Darzi’s response was to say, “If this is all going to be done, it is going to be done in a licensable premise,” but that is almost completely irrelevant when it comes to answering certain fundamental questions. Is there an offence? If so, does the statutory instrument allow it to be investigated? If not, does the legislation allow it to be investigated? We should bear in mind that investigation consists of two processes—the storing and retention of admixed embryos that may be the subject of contention, and the examination of them. I cannot see how both can be allowed, and I should like the Minister to confirm that they are not both allowed.

Ms Dari Taylor (Stockton, South) (Lab): It is important to put on record that both the 1990 and 2008 Acts were excellent and extraordinarily complex, dealing with ethical questions that most of us battled with again and again on the Floor of the House and in Committee.

I would greatly appreciate it if the Minister would reassure the House that the timing of appeals will be carefully monitored and controlled. The HFEA has a reputation for being slow and cautious in its deliberations, invariably taking 18 months to establish, through investigation, a decision on a licence. That process is extremely slow because the majority of those who are deliberating are non-specialists, and it puts an enormous strain on them to understand these issues and to reach conclusions. As Members have said, this is an extremely fast-moving area of research, and we need to be much more aware of that so that we have people who are competent enough to instigate and work the appeals system very quickly. The HFEA is a non-specialist organisation, but is it not time, as we move into some of the most complex issues, in terms of appeals, to use the Health Care Commission? It is there for us, it has a good reputation and it would be very valuable to see the involvement and deliberation of specialists at this stage.