Human Fertilisation and Embryology Bill [Lords]


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Dawn Primarolo: The hon. Gentleman creates a case, advances it, and then, when he does not get the answer he wants, says that a justification has not been given. He asked me a question about discrimination, and I gave him the answer with regard to advice. The hon. Gentleman knows that it is not normal for Governments to publish legal advice, and we are not about to start now. I went on to say that, notwithstanding the advice, there are ethical issues, beyond what is in the Bill, that need further consideration, and there is a difference between what we are currently providing for and what would be provided for in these circumstances. What we have is a stand-off. The hon. Gentleman simply does not agree with me. It seems to me that there is a difference between a power dealing with mitochondrial donation to avoid the transmission of serious diseases and with the repairing of existing embryos—which is where the regulation-making power is—and a different power dealing with artificial gametes and the creation of gametes and new life. There is a fine distinction.
On behalf of the Government, I am saying not that we have set our face against this, but that further discussion and further consideration of the issues is needed. I hear what the hon. Gentleman says, but not everybody agrees about how far away the science is from possible use. The appropriate way forward would be proper consultation on these issues and, if necessary, amendments to primary legislation. That is a far more significant and important place to have these sorts of discussions. I hear what the hon. Gentleman is saying and I understand that he disagrees with me, but no matter how many times he puts this proposition to me, that will be my reply on behalf of the Government.
There is a question of understanding the very fine differences between what science might be able to do in the future and how we seek to regulate it, and that goes to the very heart of what we are trying to deal with in discussing this Bill and its predecessor. Discrimination is a subset of that, but the ethical issues must come first. I am sorry if the hon. Gentleman does not agree because there is a lot about which we have agreed. However, in response to his raising such important issues in a clause stand part debate, I have laid out the reasons for the Government’s view and if the House takes a different view, that is a matter for the House. We remain wedded to our view.
Question put and agreed to.
Clause 3 ordered to stand part of the Bill.
Clause 5 ordered to stand part of the Bill.

Schedule 1

Amendments to Schedule 1 to the 1990 Act relating to membership of the Authority
Mark Simmonds (Boston and Skegness) (Con): I beg to move amendment No. 22, in schedule 1, page 54, line 4, at end insert—
‘(za) at end of sub-paragraph (2) insert—
“and no person may be appointed for more than six years in total”.’.
May I take amendment No. 23 with amendment No. 22?
The Chairman: Order. I have no strong aversion to that, but we separated the amendments deliberately because they do not cover the same issues. The hon. Gentleman will have the opportunity to debate both amendments, but preferably one at a time.
Mark Simmonds: Thank you for your guidance, Mr. Gale. The purpose of amendment No. 22 is to get across to both the Government and the Human Fertilisation and Embryology Authority that, while the HFEA is held in very high regard and is perceived globally as the lead regulator in such issues, there is concern that it has in the past and perhaps will in the future be a closed shop. The amendment would ensure that amenable clinicians who wished to serve on the HFEA and others who wanted to be reappointed could not be reappointed again and again, as can happen at the moment. The effect of that practice is keeping others out as the ratio of expert members is limited.
The majority of clinics have a good relationship with the HFEA, but that is not universal, as I have found out in my meetings with those who have had dealings with the HFEA. Some clinics have had difficulties and they put that down primarily—not solely—to the static membership of the authority. There have also been issues of competitive conflict, and it is important that clinicians do not sit on licensing committees when determining policy that might have a beneficial impact on their own clinics. I shall not give specific examples of that, but I am sure that officials are aware that that has happened.
Under the amendment, members of the HFEA could not stand for more than two consecutive terms.
Dr. Harris: Does the hon. Gentleman have similar concerns about clinicians who are rivals to other clinicians being involved in inspections, and delivering a report that might impact on the business of those other people? I do not know whether it is possible to avoid that situation, but perhaps it also needs to be considered.
Mark Simmonds: The hon. Gentleman is absolutely right. The purpose of a future amendment is not only to ensure that such a situation does not arise, but to prevent clinicians without specialist and expert knowledge in certain subjects producing reports that often have to be corrected or reworked later. I shall deal with that when we come to the subsequent amendment.
It would also be helpful if the HFEA made public the dates of appointments so that people could see how long someone had been a member of the authority. The public should also be given assurances about the HFEA’s fresh expertise and vigour. It is clear from my discussions that if the Bill passes—as most of us on this Committee hope it will, as a result of the substantial discussions in pre-legislative scrutiny and both Houses of Parliament—the HFEA will have an even busier time, as we gradually extend the type of activities that it can license. It is therefore important that it does not atrophy—although I am not suggesting that it has—but continues to move forward with vigour, bringing in new blood as often as possible. That is the purpose of amendment No. 22.
Dawn Primarolo: Members of the HFEA are appointed by the Appointments Commission on behalf of the Secretary of State for Health following advertisements in the national press. Anyone is free to apply and can be considered for membership. The Human Fertilisation and Embryology Act 1990 provides that:
“A person shall not be appointed as a member of the Authority for more than three years at a time”.
However, that can be extended for another three years with the agreement of the Appointments Commission. After six years, if members wish to continue to sit on the authority, it is not prohibited, but they must reapply through an open competition. They may be reappointed, but only if they are the best candidate for the job.
The hon. Gentleman’s amendment would set a six-year limit on the full period that any member can serve. Although it does not necessarily sound unreasonable, it would mean a lack of flexibility to reappoint people with valuable expertise and experience in their field. It is essential that the HFEA comprises the best calibre of candidates available. The amendment could restrict that.
While the hon. Gentleman was speaking, I was looking at some of my notes in relation to his point about the dates when people were appointed and how long their term ran for. I do not have that information. I think that some members of the HFEA have served for more than six years, but they started before the process was run by the Appointments Commission. I understand that three members have served for six years. They would have to apply for reappointment under the current recruitment exercise.
Mike Penning (Hemel Hempstead) (Con): Will the Minister clarify whether that is retrospective? If they have already served six years when the legislation comes into force, will they then have another three plus three before they have to apply, or will the previous years be taken into account, meaning that they will have to apply straight away?
Dawn Primarolo: I think that I am correct in saying that, once the Appointments Commission became responsible, the period considered included whatever period they might already have served. If the hon. Gentleman will forgive me, I will need to double-check that, but the point is that it is common on many public bodies to have a period in which people can be reappointed before going through a complete re-application. As I said to the hon. Member for Boston and Skegness, an open competition is advertised and run by the Appointments Commission, which is specifically charged with ensuring that the public body—in this case HFEA—is staffed by people with appropriate skills. It will also look to ensure that anybody who applies meets the specification. Although this is published nationally, that would still happen. I am not aware whether appointment periods are in the public domain or whether they were on the HFEA website. I do not have that information to hand, but I am happy to check.
4.30 pm
What the hon. Gentleman is trying to achieve in terms of the make up of the HFEA is already in place with respect to the break at six years and the need to reapply. I am sure that he would agree that the converse is true, and that even if someone has served six years, if they clearly have the expertise and are the best person despite advertising, national recruitment and consideration, we would not want to refuse them access to being appointed by the Appointments Commission. I hope that he is reassured that he can track how long members have served—I will check that that is the case—and that there is, in effect, a six-year break, with the caveat that people can reapply. I am sure that he would agree with that, and I hope that he is satisfied.
Mark Simmonds: I am grateful to the Minister for that response. Of course, I understand and agree with the flexibility argument that she put forward. Obviously, we must have people of the best calibre on the authority. However, she will also be aware that there are a limited number of clinician places on the authority. I am not going to press the amendment to a Division, but I wanted to ensure that the Minister, the Committee and those responsible for the HFEA understood the concern that a position on the authority should not be a permanent fixture that is renewable every three years. Certainly, publicly detailing appointment dates and the length of time that those on the authority have served would go some way towards satisfying people, and it would show that there was change and turnover. I beg to ask leave to withdraw the amendment.
Amendment, by leave, withdrawn.
Mark Simmonds: I beg to move amendment No. 23, in schedule 1, page 54, line 17, at end add—
‘4 In sub-paragraph 8(2), after “experience”, insert “in at least one of the activities that may be licensed under this Act”.
The amendment would add a provision to schedule 1, which amends the 1990 Act. To return to the point made by the hon. Member for Oxford, West and Abingdon, it would ensure that HFEA inspectors were doctors, embryologists or researchers who were qualified to conduct inspection at IVF research units. That is not necessarily what happens at the moment, and there have been conflicts between clinics and the HFEA, some of which have been successfully challenged through negotiations and, ultimately, the threat of legal action.
The inspection reports take place during the licensed period—either three or five years—or at the end of those licensed periods for renewal for IVF clinics. They are undertaken to inform the authority about whether a licence should be renewed or whether there are issues as the licensed period progresses. Those are, of course, made public and are accessible to those who use the clinics. There have been some issues when the interim report that the inspectors put together has been completely disagreed with by the clinic. There is a great nervousness among those who run some—although not all—of the clinics that part of the reason for that is that those doing the inspections do not necessarily have the expertise that they require and there is a lack of understanding. There are numerous examples of having to rework the reports.
I understand the positive move that clinics now have the ability to make official responses to those inspectorate reports, which are also made public. However, the starting point must be that those doing the inspections in the first place have a detailed understanding and knowledge of what they are inspecting. Picking up the point made by the hon. Member for Oxford, West and Abingdon, we must also ensure that we do not get into a situation in which someone who is doing an inspection has a conflict of interest, or an interest in producing a relatively negative report on a particular clinic that might may have an advantageous effect on the clinic that they work for.
Dr. Harris: I am grateful to the hon. Member for Boston and Skegness for raising this matter. Although I encouraged him to make his point, there is a difficulty for the HFEA in finding someone with clinical expertise who is not in competition with someone else, unless it has a cadre of professional inspectors, which might be possible, or one has a way of identifying people who clearly are not in competition. For example, we would have to consider the situation for people working in London.
Mark Simmonds: The hon. Gentleman is absolutely right to make that point. I am not going to raise specific examples, but I am sure that he will be aware of one particular example in the HFEA when this very situation arose because of the very close proximity in geographical terms of the two clinics. That is the sort of issue that needs to be avoided.
Dr. Harris: Absolutely. The hon. Gentleman’s analysis is spot on. I would say that more creative thinking needs to be done by the HFEA to ensure not only that conflicts of interest do not arise, but that suspicions of conflicts of interest do not arise. This is unfortunately—or, some would say, fortunately—a very competitive field in which large amounts of income are at stake. I know that the HFEA and indeed the Government are aware of the situation, which is why they strive to ensure that there are basic standards so that people are not misinformed about what success rates are, for example.
Dawn Primarolo: The hon. Members for Boston and Skegness and for Oxford, West and Abingdon have raised an important point, and the hon. Member for Oxford, West and Abingdon went on to elaborate why the balance is difficult to strike. Perhaps it would be helpful if I gave the hon. Gentlemen some indication of how the HFEA is proceeding.
At present, the HFEA has nine inspectors. Three are embryologists, three are nurses, one is a doctor, one is a scientist and one is a generalist with an audit background. The HFEA has in-house inspectors and no longer uses inspectors from outside the HFEA.
The amendment would require inspectors to have experience in at least one of the activities that may be licensed under the Act. That would mean that the HFEA would be able to recruit only people who were, for example, doctors or nurses with experience in infertility, embryologists, scientists with experience of using human embryos in research, and people who perhaps run internet sperm delivery services—I think that the hon. Member for Oxford, West and Abingdon was touching on that point.
The qualities that make a good inspector are not necessarily limited to experience in licensable activities, although that may be helpful. The ability to gather evidence to ensure that centres are conducting licensable activities in adherence with the Act, the licence conditions, and the code of practice are vital. Therefore, people with experience of auditing or investigating, or scientists, nurses, and doctors with other specialist knowledge, could make equally good inspectors as those who work in the field.
I do recognise, and of course it is obvious, that an understanding of the licensable activities is essential for an HFEA inspector. The authority has thus introduced a competency-based training programme for all new inspectors to achieve that. Part of the programme includes spending time in a licensed centre to observe practice and to gain an understanding of how a centre works from day to day. The HFEA also has a number of external advisors who have experience in activities that may be licensed under the Act, such as nurses, doctors and embryologists who act as inspectors on a number of inspections every year.
I think that the concerns of the hon. Member for Boston and Skegness are being addressed by ensuring that the inspectors are suitably qualified and able to report with regard to the code and the licence conditions. He and the hon. Member for Oxford, West and Abingdon flag up a live issue to the HFEA concerning a reasonably small community of practitioners, the importance of having such expertise, and the need not to undermine the commercial or business concerns that often underpin these clinics.
I hope that the hon. Member for Boston and Skegness will accept that the amendment is not necessary, that it would be over-restrictive, and that there might be problems with recruiting the qualified people he feels might be necessary. Nonetheless, the HFEA is addressing this matter, and what is important is that the inspectors can consider the issues before them. I hope, on that basis, that he will be prepared to withdraw his amendment.
 
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