Clause 8
Human Fertilisation and Embryology Bill [Lords]
5:00 pm

Mark Simmonds (Shadow Minister, Health; Boston and Skegness, Conservative)

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.

Evan Harris (Shadow Minister, Innovation, Universities and Skills; Oxford West and Abingdon, Liberal Democrat)

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  reading that I have done of some of the complexities around the European directive on cells and tissues for human application, it seems that that sort of thing will be necessary. I hope that the Minister will confirm that.

I understand and hope—again I might be wrong—that 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 (Shadow Minister, Health; Boston and Skegness, Conservative)

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.

Roger Gale (North Thanet, Conservative)

Order. The hon. Gentleman is right—we shall come on to clause 10 in due course.

Evan Harris (Shadow Minister, Innovation, Universities and Skills; Oxford West and Abingdon, Liberal Democrat)

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 (Minister of State (Public Health), Department of Health; Bristol South, Labour)

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 9—we are coming on to that—that 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 authority’s 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  decisions, the right to enter, the search or seizure of property, or other functions prescribed in an order made by the Secretary of State.

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 (Shadow Minister, Health; Boston and Skegness, Conservative)

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 (Minister of State (Public Health), Department of Health; Bristol South, Labour)

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 (Shadow Minister, Health; Boston and Skegness, Conservative)

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.