Human Fertilisation and Embryology Bill [Lords]

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Mark Simmonds: My concern with new clause 2 is about the extremely broad nature of the phrase “blood relative”. Has the hon. Gentleman thought about narrowing it down to a sibling, son or daughter of the donor to exclude third cousins twice removed and so on?
Dr. Harris: That is a fair point. There are questions about whether the wording is broad. I am not wedded to the wording of the new clause, so I accept that it might need further work. I have never claimed to be a parliamentary draftsman, despite what was said earlier, and I do not seek to be one. My cup overflows already.
I wish to make a further point about surrogacy. I have not tabled an amendment on this, but any provision would be very similar to new clause 2, so the matter relates to this debate. The Human Fertilisation and Embryology (Statutory Storage Period for Embryos) Regulations 1996 specify the period for which gametes and embryos respectively can be stored in cases where the patient is, or will become, permanently infertile. In extending the normal five-year storage period, the regulations enable patients to preserve their last chance to conceive their own genetic child until the female patient in question is approximately aged 55. Although the Bill extends the normal embryo storage period from five to 10 years, which I think is a good idea, it does not amend the special regulations for extended storage. I think there is a case for the regulations to be updated to benefit patients conceiving their own children through surrogacy. Surrogacy patients are explicitly excluded and, in practice, it seems to me—and to those advising me—that it is utterly arbitrary that a woman who has had her ovaries removed due to cancer can store her eggs and embryos until she is 55, but a woman who has had a hysterectomy due to cancer can store her eggs or embryos for only 10 years. That seems to be somewhat unfair, so I was wondering if the Minister would consider there to be scope to bring the situations more into line—if not in this Bill, through regulations.
Dawn Primarolo: I ask the hon. Gentleman not to press new clause 2 to a Division because I think that he raises a number of difficult issues with regard to some aspects of the regulation. As he has pointed out, there are regulation-making powers under the 1990 Act, and the Bill allows changes to regulations, such as those relating to statutory storage periods of gametes.
The hon. Gentleman made the point that it is not always wise to make primary legislation on the basis of one case. Perhaps if I could tell him when the regulations will be available for consideration, he might rightly feel—as I do—that that would be the appropriate place to raise these considerations. New policies will be proposed in regulations and they will need to be consulted on. The timetable for those regulations is such that the drafts will likely be available toward the end of this year.
I think that the points that the hon. Gentleman raises could be appropriately dealt with in that consultation and the consideration of those regulations, rather than through new clause 2, because there will be other points to consider. For example, the hon. Gentleman touched on surrogacy, which is not addressed by the new clause. There might well be other exceptional circumstances, but it would be wise to address them all in one place in the regulations.
I hope the hon. Gentleman and the hon. Member for Hazel Grove accept that the Government see that this issue needs to be addressed and intend to ensure that that happens during the consideration of the regulations, which will take place before the end of the year. That will be the appropriate point of the consultation to add in some of the points that the hon. Gentleman is suggesting.
Dr. Harris: I thank the Minister for that response, although she did not necessarily say that she agreed that there should be a solution. I think she did accept that there was a problem in this case.
Dawn Primarolo rose—
Dr. Harris: I am sorry if I misunderstood.
Dawn Primarolo: No, no, with respect, I do not know whether there will be a solution. I agree with the hon. Gentleman that it would be desirable to find a solution and the appropriate vehicle for this is the regulations. At this time, I do not know, so that is my only point.
Dr. Harris: I apologise to the Minister. I am satisfied that she recognises that there is a problem and that she suggests that rather than trying to amend primary legislation through new clause 2, or another version of it, the appropriate time would be either during the drafting of regulations, or their redrafting following the consultation. I am delighted because she has confirmed that there will be a consultation on drafts, which we discussed earlier. That is always good when regulations are being considered because once they are laid, it is impossible to amend them unless the regulations are withdrawn.
I am grateful to the Minister for indicating that she hopes that the drafts will capture, if possible, a solution to a problem that she acknowledges. I am sure that my hon. Friend the Member for Hazel Grove, who might be listening to the debate using new or old technology, will share my gratitude—and, I suspect, that of his constituent—to the Minister for her positive response.
Question put and agreed to.
Clause 15 ordered to stand part of the Bill.

Clause 16

Grant of licence
Amendments made: No. 41, in clause 16, page 12, line 14, at end insert—
‘( ) in paragraph (c), after “application” insert “or a licence under paragraph 3 of that Schedule authorising activities in connection with the derivation from embryos of stem cells that are intended for human application”, ’.
No. 42, in clause 16, page 12, line 15, after ‘(ca)’ insert ‘— (i)’.
No. 43, in clause 16, page 12, line 16, at end insert—
‘(ii) after “that Schedule” insert “authorising activities otherwise than in connection with the derivation from embryos of stem cells that are intended for human application”, and’.—[Dawn Primarolo.]
Clause 16, as amended, ordered to stand part of the Bill.

Clause 17

The person responsible
3 pm
Mark Simmonds: I beg to move amendment No. 142, in clause 17, page 12, line 23, at end insert—
‘(1A) In subsection (1)(b) for “equipment is” substitute “equipment and premises are”’.
Although the premises would have been inspected before the licence was granted or renewed, it is also important for the person responsible to ensure that the right equipment and parts of the premises are used for each procedure, and that there is no risk of cross-contamination between admixed embryos and IVF embryos, for example. On my visit to the Centre for Life in Newcastle I saw that it undertakes different types of medical research or treatment in separate parts of the same building. It is obviously the responsibility of the licence holder to ensure that there is no transfer or confusion between the two.
There is an inconsistency. There is no mention of equipment and premises in clause 17, yet in clause 18(d) and (e) they are mentioned as specific reasons for the potential revocation of the licence. Will the Minister explain that inconsistency?
Dawn Primarolo: The amendment would add a requirement to section 17 of the 1990 Act to ensure that it would be a duty of the person responsible to secure appropriate premises as well as equipment in which to carry out activities as they are licensed under the Act. Furthermore, the requirements of the Human Fertilisation and Embryology (Quality and Safety) Regulations 2007, which incorporate the European Union tissue and cells directive into the 1990 Act, would apply to any embryos that are intended for human application. The directive made various extensions to licence conditions, which are set out in schedule 3A to the Act and incorporated by section 14A. The provisions ensure that appropriate equipment and materials are used as well as suitable facilities and premises. It means that any licence that relates to gametes and embryos intended for human application must satisfy those conditions. If they do not, they will be in breach of the licence.
I hope that I have put the hon. Gentleman’s mind at rest. The HFEA always ensures that the person responsible will secure the appropriate premises as part of the licence application. The suitability of the premises is already part of the HFEA inspection process so the twin arrangements are catered for and, if that were not the case, it would be a breach of the licence,
Mark Simmonds: I am grateful to the Minister for clarifying the fact that there is not an inconsistency between the two clauses. I beg to ask leave to withdraw the amendment.
Amendment, by leave, withdrawn.
Clause 17 ordered to stand part of the Bill.

Clause 18

Revocation and variation of licence
Mark Simmonds: I beg to move amendment No. 143, in clause 18, page 13, line 29, after ‘person’, insert
‘and is so qualified by training and experience’.
The amendment relates to the variation of a licence. Under section 16 of the 1990 Act, the initial applicant had to satisfy the licensing committee that the character, qualifications and experience of the applicant were suitable. My understanding is that, under this Bill, the person to whom the licence is transferred will not need to satisfy the authority that they are anything more than suitable. There is a difference between those two definitions. One could have a suitable character without the required qualifications and necessary experience. Is the Minister happy with that difference? Would she not prefer a more robust system, with a new inspection under the person responsible or the licence holder?
Will the Minister also clarify whether there is a prohibition on the sale of a licence? Can a licence effectively be bought and sold within the context of the criteria I have just mentioned?
I have one further issue with regard to this amendment. In proposed new section 18A(3), a very clear distinction is made between
“the person responsible”
“the holder of the licence (if different).”
Will the Minister say how many licences have been granted where the person responsible and the licence holder are not the same person? In the revocation categories, again, it refers only to “the person responsible”, not the licence holder, which implies that one, “the holder of the licence”, is a subset of the other, “the person responsible”. If they are different, why are they not different in the revocation categories, and if they are the same, why is there a distinction in the first part of clause 18?
The Chairman: The hon. Gentleman has indicated a rather broad range of questions, which effectively constitute a stand part debate. I am perfectly content with that.
Dawn Primarolo: The Bill simplifies provisions in order to allow the HFEA to determine applications by a licence holder in a more flexible manner. However, this does not change the strict criteria for determining whether people are suitable to be the person responsible. That remains the same.
In 2005, the HFEA, in consultation with stakeholders, took a decision to revise its assessment process for the person responsible, and there are now formal assessments to ensure that the designated person is proficient in their role and up to date with the latest developments in their field. This process consists of various assessments that the person must satisfy. For a research licence, for example, the assessment consists of three workbooks that must be completed by the designated responsible person. One is on the regulatory framework, one is on quality management and risk, and the third covers research regulations. The workbooks also include details outlining certain person specifications, including qualifications. They state all relevant medical, biological, scientific or professional healthcare qualifications, and require the applicant to demonstrate experience, including experience and extensive knowledge of fertility-related management, clinical and scientific developments and treatments, including ethical viewpoints.
The hon. Member for Boston and Skegness went on, as he did before, to ask about the process and refusals in varying or revoking a licence. All the decisions relating to granting, revoking, suspending or varying a centre’s licence are taken by the licence committee of the authority, based on inspection. Inspections need to assess quality, effectiveness of the clinical management, and a whole list of things that I will not read into the record. I will write to him about them.
He asked specifically whether a licence could be sold, passed on or transferred to another responsible person. It could be, but the HFEA must approve any transfer of licence, and it would need to be satisfied that the transfer would go to a responsible person and under all the conditions that I have outlined, as agreed after the 2005 consultation process.
I do not know the answer to the hon. Gentleman’s last question about whether there is a difference between a responsible person and a licence holder. I have a feeling that there is not, but I do not want to commit myself unnecessarily to that and I will come back to him. I hope that he is satisfied that measures are still there to ensure that the responsible person is properly qualified and experienced in the relevant fields, and that the HFEA will scrutinise the licence and the responsible person very closely.
Mark Simmonds: I am grateful to the Minister for that reply. The only outstanding issue is the one to which she referred at the end. It would be helpful if after the Committee I could explain to her in more detail what I feel is not consistent. Perhaps I was not clear enough in my explanation—I will not go through it again now, but it is something that should be looked at. I am happy to receive a response from the Minister after she has had a chance to discuss it with her officials and I beg to ask leave to withdraw the amendment.
Amendment, by leave, withdrawn.
Clause 18 ordered to stand part of the Bill.

Clause 19

Procedure for refusal, variation or revocation of licence
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