Human Fertilisation and Embryology Bill [Lords]
Dr. Harris: I point out to my hon. Friend that there is a difference between declarable interests that one might want to make Parliament aware of and registerable interests. The registrar is quite fussy about what he or she thinks it is necessary to register.
My point concerns the issue of HFEA mission creep. If the Minister will permit me, I think that it is appropriate to raise it here, because it is relevant to proposed new section 8ZA(2), which says:
In carrying out its functions, the Authority must, so far as relevant, have regard to the principles of best regulatory practice (including the principles under which regulatory activities should be transparent, accountable, proportionate, consistent and targeted only at cases in which action is needed).
It is a minor concern, but I hope that the Minister can set my mind at rest. A couple of years ago, the HFEA sent out a mission statement to Members of Parliament. The mission statement did not stick to what Parliament had intended the HFEA to do. The HFEA decided that part of its job was to maintain public confidence in the law. If Parliament makes the law, it is Parliaments job to maintain confidence in the law. Otherwise, acceptable activity that Parliament has said should be licensed and considered appropriately should not be subject to extra regulation because of a perceived need to keep public opinion on board.
Otherwise, newspapers could raise scare stories and, if the HFEAs mission has crept to include a general issue of public confidence rather than what is set out in proposed new section 8ZA(2), it might say, Well, we might have licensed this and permitted it, but it might kick up a fuss. Theres an institutional risk. That is the other thing. The HFEAs policy documents include a little section saying what the risk is to itself of bad headlines, rating them low, medium, high or whatever. It is inappropriate for the HFEA, which was set up by Parliament to do a joba job that, generally speaking, it does wellto start having regard to interests such as what the Daily Mail might say about its decisions.
The HFEA rowed back from that position when I raised the matter, asking where it came from, as I could not find it in the HFEAs own terms of reference or the statute. It would be helpful if the Minister confirmed that the excellent paragraph that she proposes to insert in the Bill makes it clear that
activities should be...targeted only at cases in which action is needed,
and that nothing in the statute requires the HFEA to distort what it is doing in order to please what it perceives as public or media opinion. Unfortunately, it is in the firing line. I respect the HFEA for what it does, because it gets a lot of hassle from some in the media, and indeed some politicians, when it takes a decision that they do not like. However, it would be open to greater criticism if it bent towards that or away from implied criticism. I hope that she will make it clear, albeit only briefly, that the HFEAs job is to implement the law as Parliament has laid it down and develop policy where appropriate. Perceptions of public opinion, short of formal consultations where the HFEA feels them to be relevant, are not part of its remit.
Dawn Primarolo: It is always surprising what things catch a Minister in Committee. I thought that clause 7 was very straightforward. Perhaps I can explain why the Government did it and then answer the points.
Of course the Government expect all public authorities to operate effectively, efficiently and economically. That is not a reflection on the HFEAs past practice or performance. It is simply that the principles of better regulation were implemented following the Hampton report, which was quite a long way after the 1990 Act. They require regulation to be transparent. Regulators should be open and keep regulations simple and user-friendly. Regulation must be accountable. Regulators must be able to justify decisions and be subject to public scrutiny. It must be proportionate. Regulators should intervene only when necessary. Remedies should be appropriate to the risk posed and costs must be identified and minimised. The principles also require regulation to be consistent whereby rules and standards must be joined up and implemented fairly. They require regulation to be targeted so that it is focused on the problem and minimise the side effects.
The Government took the opportunity provided by the fact that we were updating the 1990 Act and included the principles in the Bill. They have been widely accepted by the House. It was no more, no less than that. Such action was not a reflection on the performance of the HFEA. We just took the opportunity offered by the Bill to put on the record something that we already expected. We did so for clarity. We did not mean to cause difficulties in Committee. In answer to the points that have been made, I must say that it is nothing to do with whether I continue to be the Minister; it is simply a tidying-up exercise.
The hon. Member for Southport raised a different issuea register of what is declared. I am not exactly sure about what detail is provided publicly at the moment, but I agree with him. I shall put to the HFEA the point that such a register should exist and be accessible. It would be good practice and I thank the hon. Gentleman for raising it with me.
The hon. Member for Oxford, West and Abingdon asked me to confirm that the measure is about complying with the Bill, not with the views of the media. I am happy to confirm that. I think that he wanted to make sure that that was on the record, and I am pleased to assist him. I hope that members of the Committee will accept that there was no other motive behind the provision,
Question put and agreed to.
Clause 7 ordered to stand part of the Bill.
Power to contract out functions etc.
Question proposed, That the clause stand part of the Bill.
Mark Simmonds: I have one or two queries about the clause. It gives the HFEA the power to contract out particular functions to other Departments or public offices. How would the contracted-out bodies be accountable? It would be helpful if the Minister could give us an idea of which bodies might be involved? Will it be the Human Tissue Authority, the Department of Health or the Medicines and Healthcare products Regulatory Agency? In what circumstances does the Minister think that the powers would be necessary?
To make sure that my understanding of the Bill is correct, I must know whether contracting out will exclude licensing and the guidance of the HFEA, and that there will be no opportunities for licensing, for example. What about inspections? We discussed that earlier. They are not specific to the granting of a licence, but are relevant to it. Such matters go to the authority for discussion and consideration. Will issues be confined to a public authority or will the HFEA contract out to the independent sector, including the private sector? What criteria will be put in place by the Department of Health or will it be left to the HFEA to make sure that the contractee will have the relevant level of appropriate skills and expertise, experience and qualifications to do the particular job?
My third and final specific question about clause 8 concerns proposed new section 8C(2)(c) that states:
it is a function of making subordinate legislation (within the meaning of the Interpretation Act 1978).
Perhaps the Minister could clarify what is meant by subordinate legislation, and whether it is the same, or different, from regulation.
Dr. Harris: I thought that the hon. Member for Boston and Skegness asked interesting questions. I am particularly interested in the answer to the last one, as I, too, had that written down. Inspections would not be excluded from being contracted out under proposed new section 8C(2), and that leads to the question about whether it is necessary to identify other people who can provide inspections, albeit apparently public bodies.
My purpose in supporting clause 8 is to recognise that in this increasingly complex area of regulation, particularly with the advent of potential stem cell therapies, it is important that the HFEA is able to hand over this aspect of its work and contract it out, under negotiation and with consultation, to the HTA or the MHRA, so that there is a smooth working arrangement. The MHRA, for example, could take the lead and would obviously have to refer back on occasion to the HFEA. From the
I understand and hopeagain I might be wrongthat one of the other points of this is to ensure that the authority can delegate certain powers to a sub-committee, which might speed up processes. There is concern in the clinical world that it can take a very long time for the authority to make a decision. I think that without that provision, the authority has to meet as a full authority to sign off a number of things, and that potentially refers to the creation of sub-committees or committees of the authority. Again, I would be grateful if the Minister could clarify that.
Mark Simmonds: The hon. Gentleman is absolutely right. Perhaps I may refer him to clause 10, which relates to the power to delegate and establish committees. The purpose of that clause is to speed up the licence process. He is right to highlight the concern of many clinics about the time it takes for the HFEA to make its decisions.
Dr. Harris: I agree with you, Mr. Gale. The hon. Member for Boston and Skegness is right, and perhaps that answers the point. Clause 10 deals with that concern, not clause 8.
Dawn Primarolo: At present, the 1990 Act does not allow the HFEA to enter into an arrangement with either a public or private body to undertake any of its functions. That means that there is limited flexibility when carrying out some of its functions, which could lead to the duplication of inspections or other aspects of its regulatory work. The new provision in clause 8 introduces more flexibility to the way in which the authority operates. The provisions work together with those in clause 9we are coming on to thatthat enable the HFEA to assist other public bodies. It will help the authority to carry out its functions more effectively and avoid duplication, thus reducing the burden on clinics and others subject to licensing. The provision was thought to be sensible to modernise the regulation and keep certain issues within the Bill, following the removal of proposals to establish the regulatory authority for tissue and embryos.
Proposed new section 8B gives the authority power to make agency arrangements with Government bodies, other public authorities or holders of public office, and provides for that body to exercise the authoritys functions, or for it to provide services to the authority. Such arrangements may include, for example, those with the Human Tissue Authority or the Healthcare Commission to carry out inspections on its behalf. Both those authorities are regulated, transparent and responsible. However, the responsibility for the functions themselves would remain with the HFEA, so that body would still be accountable.
Proposed new section 8C gives the power to make a contract with any person to carry out functions of the authority. However, under the provision, the authority cannot contract out functions related to licensing
For example, the provision allows a private company to undertake inspections of laboratories on behalf of the authority, and the clause provides that the authority remains in control of its functions and responsible for all acts or omissions under such arrangements. We are seeking to remove duplication with other public authorities when that is sensible, thus reducing the number of inspections and the regulatory burden. Any powers in the area would have to be subordinate to the legislation, and that includes the regulating-making powers. It could also include powers such as making orders. The approach is quite straightforward, and because of the exclusions on specific issues, I hope that hon. Members will accept that this is about using similar inspections and expertise in the public sector and reducing duplication, not the HFEA losing control of its responsibilities or transparency. I hope they will also accept my points about what cannot be contracted out and what will remain absolutely central to the work of the HFEA.
Mark Simmonds: I might have misunderstood what the Minister said. Did she clarify the point about this relating only to other public sector bodies so that no independent or private sector charitable or voluntary organisations will get involved, particularly with regard to inspections? Inspections are not specifically excluded as are, quite rightly, licensing and the other issue with regard to the code of practice. What about the specific point regarding the interim inspections?
Dawn Primarolo: May I help the hon. Gentleman by making an intervention? Proposed new section 8C gives authority to contract with another person to carry out functions and sets out exclusions. In the example I gave, such a function might be undertaking an inspection of a laboratory on its appropriateness, but would not include the other functions: licensing, right of entry, and search or seizure. That would occur in limited circumstances, and that possibly could go beyond a public authority. However, others provisions relate to public authorities.
Mark Simmonds: I am grateful for that clarification, as I understood what the Minister just confirmed: the HFEA is going to be allowed to contract out not just to the public sector, but, in very specifically defined circumstances, to the independent sector, as the Minister explained.
Question put and agreed to.
Clause 8 ordered to stand part of the Bill.
Power to assist other public authorities
Question proposed, That the clause stand part of the Bill.
Mike Penning: I will not detain the Committee for long. I find the clause quite interesting because of the ambiguous language in the Bill. It allows the authority to assist other public authorities and then, quite naturally, to charge them should it do so. I am conscious that
Assistance provided by the Authority under this section may be provided on such terms, including terms as to payment, as it thinks fit.
Could we be in a situation in which one departmentthe authorityis charging another part of Government, but they do not agree and therefore the work cannot be done? The measure is very ambiguous. This is the second time this afternoon that we have seen such terminologyas it thinks fitin the Bill, so will the Minister clarify it?
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