Public Bodies Bill [HL]

Lord Bishop of Oxford Excerpts

Monday 28th March 2011 Lords Chamber

[Lord Harries of Pentregarth]

My Lords, I have three brief questions for the Minister, which concern the HFEA database, research and the role of the Care Quality Commission.

First, under one of the options under consideration, the extensive and complex HFEA database will be managed by the NHS body that is at present charged with collecting and analysing all health data. There seems to be some confusion among your Lordships about the exact name of this body; it seems to be complex and changing, but I think that the Minister knows what I am referring to. As he also knows, the remit of that body covers only England, whereas the HFEA is responsible for collecting and analysing data for the whole of the United Kingdom. Furthermore, that body does not collect data from private clinics, whereas the HFEA is responsible for collecting data about IVF and its associated techniques from both NHS and private clinics, of which there are, of course, a good many. Can the Minister explain how these incompatible remits can be reconciled? One body is concerned only with England, but the HFEA is concerned with the UK as a whole; one body is concerned only with NHS data, but the HFEA is concerned with both private and NHS clinics.

My second question is on research. The Government are, I know, very interested in the recommendations in the Rawlins report and have it in mind to bring forward a Bill with a view to centralising all licensing for medical research in the proposed medical research agency, to which a number of your Lordships have referred. There is no doubt that in principle this is a welcome step in the direction of cutting out duplication and time wasting for medical research. However, the Rawlins report did not specifically recommend that research that is at present licensed by the HFEA should be passed to the proposed body; in fact, it simply left that matter to ministerial decision. If the research function of the HFEA is transferred to the new body, research involving embryos will still, because of the HFE Act, need both separate licensing procedures and separate inspection. The law will demand that. This will involve setting up a panel and inspection teams with the necessary specialised scientific expertise and specialised legal advice. What possible savings or advantage can there be in doing this? It would require the re-creation of a mini HFEA within the new parent body.

My third question is on the role of the Care Quality Commission. By October of this year, the HFEA and the Care Quality Commission will already have co-located and will be sharing back-office staff. They are working on how they can share inspections. They are already in the process of saving the kind of money that the Government have in mind. Does the Minister not agree that legally transferring some of the functions of the HFEA to the Care Quality Commission will add to the cost, entail the long drawn-out process of consultation and legislation that he mentioned in his letter to us and result in the break-up and reformation of a specialist team, with all the consequent disruption as well as the expense?

Everybody knows that the Minister commands huge respect in this House, but the questions that I and others have posed cannot be answered at the moment and it would be in the Government’s best interests simply to accept this amendment.

[The Parliamentary Under-Secretary of State, Department of Health (Earl Howe)]

My Lords, I am grateful to noble Lords for providing us with a further opportunity to debate the future of these two bodies. As is clear, these amendments would have the effect of putting the Human Tissue Authority and the Human Fertilisation and Embryology Authority outside the scope of the Public Bodies Bill. The Government recognise that a number of your Lordships remain unconvinced of the merits of our plans to reform these arm’s-length bodies. The concerns that various speakers have raised are ones that we have debated previously and are therefore familiar. I hope, nevertheless, that I can address them.

To begin, I strongly feel that we cannot continue with the parallel systems of regulation that are currently running. There must be some scope for rationalisation and relieving the overall burden on those regulated. However, in looking to achieve that, I fully recognise the need to retain regulatory rigour and expertise in the fields of embryology and human tissue. I therefore offer further reassurance on those issues that have proved of most concern: the retention of expertise, public consultation and the potential savings offered by our proposals.

First, expertise will not be lost. It is envisaged that the expertise invested in individuals will follow functions —for instance, through staff transfers and establishing expert reference groups. There will be a carefully managed transition between regulators, which will ensure that key skills and knowledge are passed on to receiving organisations.

Secondly, there will be extensive consultation later in the summer on where functions are best transferred and, subsequently, on the orders to effect the transfers. We envisage that our consultation will cover two main areas. It will set out our proposals for the transfer of the regulation of treatment and research, and set out the options and considerations for other functions where there may be several different possible destinations, such as those related to the collection and sharing of information or policy decision-making. Let me be clear that these functions, which are required under the Human Fertilisation and Embryology Act and the Human Tissue Act, will continue. A number of your Lordships have voiced the fear that, for instance, the HFEA’s registers and databases will be dissipated or lost. That will not happen. The consultation document will set out a number of different options for how these functions might be delivered in the future, and we will listen to people’s views about this. I can reassure the House that, in considering how to transfer functions, we will want to maintain the best aspects of the current regulatory system and avoid action that might undermine them.

Thirdly, I turn to financial savings. Together, the budgets for the HFEA and the HTA total £13.6 million. Through the streamlining of regulatory functions, we envisage scope for savings in three areas. The first will be in grant-in-aid for reduced overall running costs. The second will be for the regulated bodies in licence fees. The third will be for those bodies in the preparation and demonstration of compliance with the regulatory system. A leading clinician licensed by the HFEA recently said:

“We pay over £100,000 per annum in fees to the HFEA. Since 80% of our work is NHS funded that means that over £80,000 of the money that the PCT pays for fertility treatments goes straight to the HFEA”.

That is money which in large measure could be saved and used to deliver healthcare to patients. The department will undertake more detailed analysis of current costs and potential savings to inform an impact assessment which will be developed as part of the consultation process, so the whole set of equations will be transparent.

[Lord Harries of Pentregarth]

I thank the Minister for giving way. In relation to that last point, when the impact assessment is made will it be possible not only to assess the impact of what the Government are proposing but that of simply telling the existing bodies that they have to cut costs by a certain amount, so that the one can be weighed against the other?

[Earl Howe]

My Lords, I do not think that I am chancing my arm by saying that that is my understanding of what the impact assessment ought to look like in that a typical impact assessment will have within it several alternatives so that it is possible to compare different options. I would be happy to come back to the noble and right reverend Lord with a definite answer on that but my understanding from previous impact assessments is that that kind of benchmarking ought to be possible.

The noble Baroness, Lady Thornton, has previously raised her concerns about where the ethical framework for any new arrangements will sit. Ethical safeguards, for example concerning the embryos and gametes that can be used in treatment, the need to consider the welfare of the child and the need for consent in respect of human tissue, are clearly enshrined in legislation in accordance with the wishes of Parliament. These safeguards will continue to remain firmly in place and will underpin the regulation of treatment and research as currently, by whoever is responsible for regulating. Where there are specific ethical issues surrounding new treatments, the department will consider how best to commission expert advice on an individual basis, as is currently being done for mitochondrial transfer, for example.

A number of noble Lords have shown interest in and support for the Government’s announcement last week, as part of the growth review, about streamlining research regulation and governance. The Government announced in the Plan for Growth on 23 March that they will create a health research regulatory agency to combine and streamline approvals for health research which are at present scattered across many organisations. As a first step, the Government will establish this year a special health authority with the National Research Ethics Service as its core. When established, the new agency will work closely with the Medicines and Healthcare Products Regulatory Agency to create a unified approval process and promote proportionate standards for compliance and inspection within a consistent national system of research governance.

This will reduce the regulatory burden on firms and improve the timeliness of decisions about clinical trials and hence the cost-effectiveness of their delivery in the UK, and has clear support from the Academy of Medical Sciences review of medical research regulation and governance.

In this context, it is important for me to remind the House of a key point. Here I refer particularly to the question posed by the noble and right reverend Lord, Lord Harries. The AMS report recognised at paragraph 9.5.1 that there are significant benefits in bringing all medical research regulation, including embryo research currently undertaken by the HFEA, within the remit of a single health research regulatory agency. Indeed, remarks made by Sir Michael Rawlins in the Guardian on 11 January firmly backed up that view. We agree with that proposition but again the consultation will invite views on it.

My noble friend Lord Willis expressed his fears about the Government adopting a piecemeal approach to reorganisation, as did some other noble Lords. I accept that our approach to the HFEA and the HTA may indeed seem rather complex. The powers of the Public Bodies Bill will enable us to transfer some of the functions of the HFEA and HTA to other bodies but they do not enable us to do everything that we have set out in the arm’s-length body review. In order to abolish the HFEA and HTA, or to transfer their research-related functions to any new research agency, we will require powers under future primary legislation.

It might help if I provided a rough outline of how and when we could take this forward. We intend publicly to consult on proposals to transfer all the HFEA and HTA functions to other bodies in the late summer of this year. During 2012-13, under the provisions of the Bill, we will prepare draft orders for formal consultation dealing with the transfer of functions, other than research functions. If appropriate, we would then be able to lay the orders before Parliament. This process would enable noble Lords and other interested parties to see, comment on and debate the proposals, as they progress.

Without the inclusion of these bodies in Schedule 5, we would have to provide for the transfer of their functions entirely within future primary legislation. I simply say again, particularly to the noble Lord, Lord Warner, that not including these bodies would significantly increase the risk that the underlying ethical provisions of the Human Fertilisation and Embryology Act and the Human Tissue Act were reopened for debate.