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Dr. Murrison: Although we can agree that the Lords amendments appear to increase the transparency of the way in which transplantable material will be defined, will the Minister confirm that that is the purpose of Lords amendment No. 18? Lords amendments Nos. 40, 43 and 47 appear to say that the Secretary of State may define transplantable material, but that that could not be annulled by a resolution of the House. I am somewhat confused about that, so I would be grateful for her clarification.
Dr. Evan Harris: I welcome the amendments because it is always important to ensure that the House has the opportunity to comment on such regulations.
Does the Minister think that altruistic donation will fall within the procedures on which she expects the Secretary of State to make regulations? In Committee in the House of Lords, there was a debate on altruistic donation and on whether current arrangements allow for stranger donation or indeed domino donation. I have tabled parliamentary questions about the matter because it is unclear whether regulations that the Secretary of State has already promulgated under equivalent provisions in existing Acts allow such donations to take place. If the Minister does not think that that is the case, will she give me an undertaking that under the power that the amendments will rightly give the Secretary of State through clause 33(7), rapid progress will be made to provide a structure under which the relevant authority may determine whether such donations may go ahead? I have received many representations from people who believe that it should be possible to make such donations.
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If the Secretary of State is to make regulations instead of the authority—it will have rather less on its plate than him, albeit still a lot—it would be helpful if the Minister could assure me that she and her colleagues are considering the issue urgently. People have been telling me for several years that the existing regulations do not allow the relevant authority to permit such donations. The Minister might think that this is a small point, but people's lives depend on ensuring that the pool of donors is as wide as possible, so I hope that she will be able to address my point.
Ms Rosie Winterton: The hon. Member for Westbury (Dr. Murrison) is right that the purpose of Lords amendment No. 18 is to give the power to the Secretary of State. The other amendments are consequential and relate to the procedure for making regulations.
To respond to the point made by the hon. Member for Oxford, West and Abingdon (Dr. Harris), altruistic donations are not prohibited at present, but the Unrelated Live Transplant Regulatory Authority does not currently allow them. The Human Tissue Authority will be in a position to consider altruistic donation further, and I know from our debates on Report and in Committee that the hon. Gentleman is concerned about the supply of transplantable material. However, although such donation is not prevented at the moment, ULTRA has the power to decide whether a procedure can go ahead. The matter is being considered, but as I am sure that he knows, many issues must be resolved before we can proceed. The HTA will be able to consider altruistic donation and will do so.
Dr. Harris: Is the Minister saying that if such donations are to be considered and carried out, new regulations under clause 33(7) need not be promulgated and the Secretary of State need not give approval?
Ms Winterton: Nothing prevents the donations at the moment except for the fact that ULTRA makes decisions about which donations can happen. If ULTRA said that altruistic donations could go ahead, I am not sure whether the Secretary of State would have to approve that. I suspect that ULTRA currently has the power to make the decision without referring back to the Secretary of State, but if that is not the case, I shall certainly write to the hon. Gentleman.
Ms Winterton: I beg to move, That this House agrees with the Lords in the said amendment.
Mr. Deputy Speaker: With this is it will be convenient to consider Lords amendments Nos. 20 to 28, 31 to 33, 41, 42, 45, 46, 48, 58, 59, 70 and 71.
Ms Winterton:
The structure of the Human Tissue Authority originally envisaged under the Bill was a single authority incorporating two inspectorates that would license and inspect regulated activities. The
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inspectorate for anatomy and pathology would have dealt principally with consent and ethical issues in relation to such matters as teaching anatomy and tissue banking for research. The inspectorate of organs and tissue for human use would have regulated banks holding tissue for transplantation and implemented the safety and quality protocols of the EU directive on tissues and cells.
As a result of the review of the arm's-length body, the Government announced in July that the Human Tissue Authority will merge its activities with those of the Human Fertilisation and Embryology Authority when the current review of the Human Fertilisation and Embryology Act 1990 is complete, which is likely to be in about 2008. At that time, both the HTA and the HFEA will be subsumed into a new organisation called the regulatory authority for fertility and tissue, or RAFT.
The Government listened to the debate on the structure of the inspectorates of the Human Tissue Authority in the other place and reconsidered their position. We believe that it will be helpful for the HTA to have maximum flexibility as it organises its activities alongside those of the HFEA and prepares for the eventual merger. We thus tabled the large group of amendments to remove the inspectorates of anatomy and pathology and of organs and tissue for human use from the structure of the HTA. The amendments will also allow the HTA to delegate its inspection and licensing functions to any members and staff of the HTA, or a committee composed of members and staff, or both.
The amendments will not in practice affect the way in which the authority will inspect and regulate licensed activities. It will still be able to call on the advice of experts in the various fields that it regulates, but it will operate in as streamlined a way as possible. It will still be possible for the HTA to hear appeals against decisions taken by those to whom it delegates certain functions, for example committees that deal with licensing decisions.
Opposition Members asked us in Committee to ensure that the system was not overly bureaucratic. I hope that the amendments address some of the points raised.
Mr. Lansley: Clauses come and clauses go, and quite a number are going in this respect.
The amendments address some of the questions raised about excessive bureaucracy, but we need further assurances. It was generally understood that one of the originating reasons for the design of the legislation, with the two parallel inspectorates under the authority, was not least because of the existing body of expertise and the confidence that was placed in the inspectorate of anatomy in particular. We were only too aware that the tragic events that gave rise to the mischief that the Bill is intended to remedy did not arise in respect of functions inspected by the inspectorate of anatomy. The measures partly originated to assure people that things done well, not least by the inspectorate of anatomy, would not be messed about. So the first assurance that we need is that the existing body of relevant expertise built up in the inspectorate of anatomy will be properly protected in the HTA.
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That said, we are happy that what might have become a bureaucratic structure of parallel boards all within one authority is being dispensed with and that the HTA is being given the flexibility to structure its functions. Although the Minister did not refer to this, I am sure that she would recognise that clause 40 extends to the authority the ability to manage itself by giving agency functions to other public bodies and authorities. Given the intention to combine the HTA and HFEA into the regulatory authority for fertility and tissues from 2008, there are immediate questions for the HTA to consider about the extent to which it establishes parallel functions or agrees with the HFEA that they carry out functions on a jointly administered basis from the outset. I hope that the Minister can confirm that clause 40 does not bar any of that happening.
The amendments would probably have been desirable regardless of the arrangements proposed between the HFEA and HTA. They are not contingent on those two bodies being pushed together. However, the Minister has put them in that context, which raises one or two important issues.
The Minister will not be surprised if I remind her that on Third Reading on 28 June at column 118, I asked whether it was the intention of the Government, who had initiated the review of arm's-length bodies at that stage, to combine the work of the HFEA and HTA. Those of us who served on the Standing Committee were only too well aware that the two authorities were designed to function in a similar manner, and we raised that issue in February. Happily, our advice was that if that was the Government's intention, they should at least tell the other place before the Bill completed its passage. That was overtaken in September by further announcements on the review.
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It does, however, mean that we are proposing to introduce the HTA for it to disappear at a future point into a new and different authority. That will only reinforce the public's occasional cynicism about the nature of the legislative process and how we conduct things. I say "we" advisedly. Governments of perhaps all descriptions tend to set things up with greater frequency than they get rid of them. At least on this occasion two turn into one rather than the other way around.
Many people who were surprised at the Retained Organs Commission disappearing before the HTA arrived will also be surprised to find that the HTA will be around for just three years. That raises a serious question, which the Minister should answer. The Government are looking for members of the HTA, comprising a chair and up to 14 members, with the understanding that they will be in office for three years. That is a normal term, but there is also the expectation that the authority will disappear after three years because it will be wrapped up in early 2008 and replaced by the new authority. There will be competing interests from members of the HFEA and HTA. Does that make sense? Is there a case for joint appointments to the two authorities and for anticipating some of the changes?
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It is not for any of us to anticipate what Parliament may dispose of in relation to statutory bodies in future legislation, but we made it clear in Committee and on Third Reading that the two authorities could be run together and operate as one. There are compelling reasons to look critically at the range of inspectorates, going beyond the two authorities. I talked to hospitals about the number of inspectorates to which they were subjected in the course of their daily business. One drew up a list with 42 inspectorates.
I raised the problem at a meeting and discussed it with the chief executive of the Healthcare Commission. She did not think that 42 was correct. I thought that she would say that there are far fewer, but on the contrary I was astonished to find that she reckons there are 102 inspectorates. I have not seen that list, but these two inspectorates are part of the burgeoning inspection process overall.
It is essential to find ways to rationalise inspection. The Healthcare Commission wants to do that, and I hope that the Government support it to the utmost extent. Although authorities have responsibilities, which clearly have to be discharged, those institutions that are inspected find that if inspectors talk to one another, the duplication is removed and the processes of providing data and information are rationalised, including the processes of providing access and giving people the opportunity to visit premises and to put specific activities in context. The role of inspectors could be rationalised in a way that minimises the burden of inspection. Happily, clause 43, which requires the authority to
and to have regard to best regulatory practice, should help us to ensure that it has no choice but to participate. However, it depends on the Healthcare Commission exercising its function, and doing so aggressively.
My next point relates to the authority's membership. Before these clauses were removed, there were different mechanisms by which different areas of expertise would be included in the authority's decision-making processes, either through membership of the HTA itself or through the two boards or the two inspectorates. In the absence of those boards, it is even more important that the authority and its members can bring the relevant expertise and perspectives—I am distinguishing between the two—to their work.
The advertisement for the authority's chair and membership posts—which I note, for anybody listening to our debate, requires completed applications by tomorrow—gives examples of the areas of knowledge and experience from which people may be drawn, dividing them between lay and professional members. Examples of those who may want to apply to be professional members include pathologists, coroners, anatomists, surgeons, researchers and pharmacologists, which seems to imply that professional and academic expertise is being sought.
A range of examples are given for lay members, including the areas of media and finance, but no specific reference is made to industrial experience. I am thinking of the pharmaceutical industry, biotech industry or bio-industry experience. I do not understand how we are to try to ensure that some of the issues concerned, such as tissue banking and the conduct of research in a
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commercial context, which we have discussed in our proceedings on the Bill, will be covered by the relevant expertise.
Dividing the advertisement into lay and professional members and not including any reference to private sector and industrial expertise begs the question whether such expertise is likely to be included. It may depend on whether biochemists and pharmacologists who have worked in pharmaceutical or bio-industries are appointed. Let us face it: 13 categories of members are instanced in the advertisement, and only 12 appointments—up to 12—other than the chairman, will be made through the NHS Appointments Commission. It may therefore be difficult to ensure that members have the relevant expertise.
In Committee, my hon. Friend the Member for Westbury (Dr. Murrison) referred to the experience of pathologists. Although we know that there is no place for a representative, as it were, of the Royal College of Pathologists, it is difficult to see how the authority could conduct its business without being sure that it could draw on the expertise of a pathologist and, perhaps, an anatomist and someone with not only a pharmacological background but an understanding of the use of tissues in research. There are specific areas of expertise that clearly have to be represented.
I hope that we can have some assurance from the Minister that although the appointments are being conducted on Nolan principles, excluding conflicts of interest and ensuring that any appointment is entirely on merit, the NHS Appointments Commission will make it absolutely clear that specific areas of expertise and knowledge need to be represented on the authority if it is to be able to perform its functions effectively.
Subject to all those points, we, like the Government, are happy to remove the clauses from the Bill by way of these amendments.
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