Human Fertilisation and Embryology Bill [Lords]

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Dawn Primarolo: The provision is a reciprocal arrangement with proposed new section 8B. New section 8E will permit the HFEA to provide services to other public bodies, such as the Human Tissue Authority or the Healthcare Commission, undertaking inspections in the same premises as the HFEA. They might arrange for the HFEA to cover their inspection in the course of the authority’s inspection regime. The HFEA, not the Healthcare Commission or the Human Tissue Authority, would then carry the cost of undertaking the inspection. The provision gives a mechanism for sharing the benefits of reducing the burden to those who are inspected and the cost to the public authorities performing the inspections.
Mike Penning: I thank the Minister for being so clear. I only wish that this part of the Bill, which is quite long and detailed, had given us a couple more sentences, as the Minister has done. The provision is very simply put: “as it thinks fit”. I do not wish the Minister to disappear soon, but other Ministers will be around to take her place. They will see the provision in the Bill, and the situation is not as clear in the Bill as the Minister has described.
Dawn Primarolo: But the clauses interact together, so if we rewind to the debate on better regulation and the obligations of the HFEA in discharging its duties as a public authority, the same duties apply to the Healthcare Commission or the Human Tissue Authority. Those public bodies would act responsibly and accountably. I think that the hon. Gentleman is concerned that the HFEA would act in a predatory fashion by charging another public authority for the purposes of income generation, following which there would be a dispute.
I do not know why parliamentary draftsmen settle for these phrases, although they are excellent people who do fantastic things and get our legislation into understandable forms, whatever the hue of the Government. I assure the hon. Gentleman that the measure does not provide for some sort of turf war or disagreement on charging, and I hope that he accepts that. It is reasonable to reduce regulation, and when there is a gain to one authority because another authority has undertaken work, there will be a sharing of benefits between the authorities, as well as a clear benefit to the establishment that was inspected, because it will end up with only one inspection, rather than two.
Question put and agreed to.
Clause 9 ordered to stand part of the Bill.

Clause 10

Power to delegate and establish committees
Question proposed, That the clause stand part of the Bill.
Mark Simmonds: Again, I just have a few questions for the Minister. Will she clarify the exact possible workings of clause 10, which deals with contracting out to, and the setting up of, committees? The clause gives the authority the power to delegate and establish committees, and there is concern over the accountability and transparency of the process. Will the Minister tell us her thoughts on which committees the HFEA thinks it might be appropriate to set up? To whom would it delegate and on what terms, and what would be the relationship between the committees and the HFEA?
5.30 pm
I also understand that the committees can include people who are not members of the HFEA, thereby potentially linking back to some of our discussions on earlier clauses about the appropriateness, the qualifications and the relevance of some of the people who may serve on the committees. Will the Minister explain exactly why it is necessary for the authority to be able to set up the committees? What has not worked well in the HFEA to date that makes it necessary? Why is it necessary to be able to bring in outside people who are not members of the authority?
I would also like to make sure that clause 10 will not allow the authority to move away from decisions licensed by the senior level in the authority and from responsibility for the code of practice. I understand that the purpose—again, it would be helpful if the Minister confirmed this—is to speed up the decision-making process. There is clearly concern about the time that some licensing decisions take, but it is important to maintain transparency and accountability. Some clinics have serious concerns about licensing being renewed at a purely executive level, not an authority level. A confirmation is needed that the appeal process will remain in place, despite the powers to delegate down, and that it will remain the same structure and fall to the people on the appeal panel, not the people who made the original decisions.
The Minister will also be aware of the context. There has been judicial criticism of the former chief executive. I do not want to go into detail, but it may in part drive some of the concerns. Of course I understand that a process is needed for speeding up decision-making for granting licences, but it would be helpful if she would confirm whether delegation applies to all categories set out in the Bill for which the HFEA has responsibility, which include licensing, variation, suspension and revocation.
Robert Key: The explanatory notes to clause 10 have, I regret to say, managed to confuse me. I should be grateful for clarification on two simple points. If the Minister can convince me, my mind will be at rest. I am not clear whether it is meant that staff will be able to take licensing decisions and develop the code of practice. That is what it seems to say. Can she also point us to the measure in the Bill—if she cannot, could she tell us—what functions will still be able to be exercised only by members of the HFEA?
Dawn Primarolo: At present, the 1990 Act requires HFEA members to be involved in all licensing decisions. As hon. Members have said, there has been comment about whether that is overly restrictive on the speed with which decisions are taken, particularly with regard to what might be considered routine licence applications. Clause 10 provides that the authority can set up committees to which it can delegate any of its functions. It will give the HFEA the flexibility to determine how best to manage its licensing process. That may involve divisions between more routine decisions and decisions that are slightly more challenging or contentious.
The new provisions mean that there will no longer be a specific requirement for a licence committee to be set up, nor will any such committee be required to comprise only HFEA members. Under the new provisions, for instance, the delegation to any committee could include members as well as a member of staff.
Under the 1990 Act, the authority could not delegate any function relating to licensing in that way. The Bill ensures that the HFEA can delegate licensing decisions to staff, ensuring that such decisions can be made quickly and within a framework set by the authority. There will need to be an escalation procedure to ensure that difficult or more contentious decisions are taken with the appropriate authority under these delegated powers. Therefore, we are asking the HFEA to consider how to deal speedily with licence applications.
The provisions are sensible and provide flexibility so that the authority can speed up its decision making and meet requirements of better regulatory practice. That will help the authority respond proportionately to its functions, delegating when appropriate, which should speed up decision making and cut costs. We thought that this provision was sensible to modernise regulation and would be in keeping with the Bill. It was particularly necessary following the removal of the proposal to establish the regulatory authority for tissue and embryos. As we took that part of the regulation out, we needed to have something in this clause instead. The provision should help to speed up the matter, but it does not remove the responsibility of the entire authority for the decisions that are taken. It is a question whether—I am struggling for the words to describe this—there are less complicated decisions that could then be endorsed by the full Committee, but that could be considered more quickly. The question of the appeal process and everything that needs to be in place is there. That is the main requirement. Arrangements are continuing to be reviewed and put in place to ensure that the provision is robust.
I hope that members of the Committee will be reassured that this is a proportionate response to criticism of lack of speed in agreeing licences, particularly when they are straightforward. The provision recognises the full range of expertise in the authority, but none the less makes it clear that decision making has to be speeded up.
Robert Key: I should be grateful if the Minister would be so kind as to write to me in response to one of my points and share the letter with members of the Committee. I asked her what functions could be exercised only by the members and could not be delegated.
Dawn Primarolo: I am happy to do that. The members will still be responsible for all decisions, because there will need to be an endorsement. In that sense, there is no removal of power from the members of the board. As regards providing flexibility to the HFEA, I will be happy to write to all members of the Committee, through you, Mr. Gale, to explain the sort of things that we would want to interact to ensure that there is no loss of accountability, expertise and scrutiny in this area by the regulatory authority that we have put in place.
Mark Simmonds: My hon. Friend the Member for Salisbury has, as always, hit the nail on the head. I am very grateful to the Minister for consenting to his request to circulate a clarification letter to the Committee. I think that there would be concerns if the HFEA was allowed to delegate the totality of functions, including licence suspension or revocation, without retaining control over the key ones. I am grateful to the Minister for giving way and also for agreeing to send us a letter, which we will look at closely.
Dawn Primarolo: I am more than happy to do that. This was a matter that the pre-legislative scrutiny Committee looked at when considering flexibility for the HFEA, although not necessarily in this area. I assure the hon. Members for Boston and Skegness and for Salisbury that the points that they have raised were precisely those that I and my officials, who will remain nameless, focused on. We wanted to ensure that the regulatory authority continued to discharge its statutory duties correctly. I happily undertake to get those details to members of the Committee as quickly as I can.
Question put and agreed to.
Clause 10 ordered to stand part of the Bill.
The Chairman: For clarification, and in case anyone thinks I have had a brain storm, clause 11 was taken on the Floor of the House.

Clause 12

General conditions of licences
Dawn Primarolo: I beg to move amendment No. 39, in clause 12, page 8, leave out line 31 and insert—
‘(1) Section 12 of the 1990 Act (general conditions of licences under that Act) is amended as follows.
(2) In’.
The Chairman: With this it will be convenient to discuss Government amendments Nos. 40 to 43, 106, 108 and 115 to 117.
Dawn Primarolo: I was looking for clause 11, Mr. Gale—it has been rather a long afternoon already.
During the passage of the Bill through another place, a debate took place on the use of embryonic stem cells derived under research licences in therapeutic applications. The Government subsequently wrote to all peers involved in that debate setting out how, in the Government’s view, embryonic stem cells derived under an HFEA research licence could be used in therapeutic applications. The amendments are consequential to the Government’s taking that view in another place. They will ensure that research centres deriving embryonic stem cells that are intended for therapeutic use are required to abide by the quality and safety standards set out in the European tissues and cells directive, in relation to stem cells and the embryos from which they are derived.
The directive lays down standards of quality and safety for human tissues and cells intended for human application, including gametes and embryos. The relevant requirements already apply to embryos used in reproductive treatment under the Human Fertilisation and Embryology (Quality and Safety) Regulations 2007. Stem cells derived from embryos are also regulated under the Human Tissue (Quality and Safety for Human Application) Regulations 2007. It is important that those standards are applied also to the embryos used to derive stem cells in human applications in order to ensure the necessary levels of quality and safety of tissues to be used in treatment.
I commend the amendments to the Committee.
Mark Simmonds: I am grateful to the Minister for introducing this batch of amendments. I have one or two queries. I understand the logic of what she said, but there is no mention anywhere else in the Bill of therapeutic applications for humans. Indeed, on the Floor of the House I and the hon. Member for Oxford, West and Abingdon tabled separate amendments and new clauses to allow licence for therapies to take place, but they were rejected by the Minister.
It would be helpful if the Minister were to explain the wording used in the letter that she kindly sent Committee members. How does the phrase
“intended for non-reproductive therapeutic application for humans”
fit in with her view that she will not allow licences for therapies in the Bill? That letter then refers to
“Directives on safety and quality of cells and tissues for human applications”
and “the relevant requirements”. What are the relevant requirements to which the Minister refers? The letter refers euphemistically to “these safeguards”. Will the Minister explain what they are?
After the debates in the other place, I initially thought that the application of the EU directive did not apply to non-medical fertility services. However, the Minister has confirmed today that it does apply to them. Will she clarify that matter? Does it also cover the provision of gametes for such purposes for both non-medical fertility services and non-reproductive therapeutic applications?
5.45 pm
Dr. Harris: I seek your advice, Mr. Gale. I think that the last two important questions raised by the hon. Member for Boston and Skegness, were clause stand part-type questions, because the deletion of the exception for non-medical fertility services is already in clause 12. We are debating, initially, additional amendments to that. Will you let me know shortly whether you wish me to deal with my questions around non-medical fertility services?
The hon. Member for Boston and Skegness has raised an important issue. I am aware that we cannot really reopen the question of licences for therapy at this stage, but, as he said, the issue involves stem cells intended for non-reproductive therapeutic applications to humans. My question for the Minister is simple. Would that cover non-research applications to humans, or would that always cover research applications for the lifetime of the Bill? If it includes non-research applications, then further questions are raised about whether the Government are right to be confident that any applications of stem cells derived from embryos created under a licence could be created under a licence for research, because there will always be research involved in the process? We cannot reopen that discussion here, and I am not proposing to, but it would be helpful for the Minister to clarify her view. Would those non-reproductive therapeutic applications to humans apply to non-research applications? Does her definition of research apply to clinical trials? That is one understanding—research carried out under a research ethics committee approval, with a clear protocol. Or is research to be read more widely—some would say much more widely?
I will make two more points. It is important, looking at the 1990 Act as amended, that the safeguards apply here. The safeguards referred to include the transfer of money and information and maintaining proper records. The clause is important, therefore, because those are the general conditions of licences.
My second question I cannot remember. I might seek to intervene on the Minister, if it occurs to me.
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