I beg to move amendment No. 6, in
schedule 2, page 38, line 13, at end insert—
(3) Subject to the requirements of sub-paragraph (2) above, the Secretary of State shall exercise his power to appoint members of the Authority to secure that the Authority will also consist of members who have relevant expertise in the activities to be regulated by the Authority.'.
Having completed part 1, we move to the establishment and composition of the Human Tissue Authority. The amendment is designed to secure that, in exercising the power of appointment that is given to the Secretary of State under sub-paragraph (1)(b), he will do so in a way that ensures that the authority consists of members who have relevant expertise in the activities to be regulated by the authority. I should have said ''will also consist'', lest it be thought that we are intending that the authority should consist only of members who have relevant expertise.
I am sure that the Committee will recognise that worry has been expressed that schedule 2 has a skeleton structure. It tells us about the constitution of the authority, but little about the way in which it will conduct itself. It has pretty much of a pro forma, constitutional style. Its membership is a key aspect of the matter. In theory—I am sure not that it is so in practice—the Secretary of State can under paragraph 1 appoint to the Human Tissue Authority people who have no relevant expertise in such activity.
Members of the Committee can in various ways attest to the value of some expertise, although not all of us have expertise in the activities of the authority. It would be useful if some authority members had such expertise. The authority should comprise a mix of laypersons, those with clinical or scientific expertise and members of the public who have had unhappy or distressing experiences. It is certainly my experience of the support network in Cambridge that such people have contributed substantially and responsibly to the consultation processes that are now leading to the establishment of the Human Tissue Authority. When we consider relevant expertise, we must bear in mind that not only expertise but experience is relevant.
The purpose of the amendment is to explore the Government's intentions for the establishment of the authority. Without stretching your consent too far,
Mrs. Adams, I hope that we can explore the timetable for the establishment of the authority and what processes the Government have in mind for setting up a shadow authority, so that when the HTA begins its work, it might be able to do so with, for example, a code of practice in place. Representations that have been made to me have concerned not only the expertise available to the authority and its ability to do its job, but the fact that members of the relevant medical and scientific communities should have access to the codes of practice in as near as final a form as possible, and as soon as possible.I hope that the amendment commends itself to the Committee and that it is the Government's intention that members of the authority should include those with relevant expertise. Such expertise might, for example, include those from the medical community who are aware of the processes of taking consent and working with families and patients, people from the Royal College of Pathologists or those who have expertise in the scientific and research applications of retained organs and tissues. We shall discuss the boards of the inspectorate later, especially in relation to the Royal College of Pathologists and its special role.
I do not want the implications for the biotechnology industry to be left out of account—we will discuss that later. The Human Tissue Authority will be very concerned with the issues of licensing and of trafficking and commercial dealings. For that reason, too, there is an argument for those with relevant expertise to be included.
Lest there be any misunderstanding, I should say that the subsequent requirements relating to the absence of conflicts of interest would obviously apply to those with relevant expertise; they would not be persons who had interests that were prejudicial to their membership of the authority. That may make it more difficult to appoint people with current clinical or research interests. However, I am sure that we can devise arrangements that avoid any decisions being made that would bear on an individual's current research interests. That happens in many circumstances: for example, research ethics committees and research councils often include people who have research projects that could be directly relevant to their membership, but arrangements can be made to exclude them from any decisions where a conflict of interests might arise.
I hope that the amendment commends itself as one that the Government might adopt. In any case, it is important to understand at this stage their intentions for the composition of the authority. I hope that they will agree that the Secretary of State will take into account some of the considerations that I have mentioned. It might also be helpful at the outset of our discussion of schedule 2 for the Committee to be told what timetable the Government have in mind and what process there is for establishing the Human Tissue Authority in its shadow form before it takes up its role.
I support the hon. Member for South Cambridgeshire (Mr. Lansley). The Government are right strongly to
support the interests of relatives and patients, but I remind the Committee of comments in the General Medical Council briefing:
''The GMC is concerned about the balance that needs to be struck between the rights of patients and their families and the reasonable practice of medicine.''
There should be more in the Bill that states that people with knowledge of research practices and pathology should be on the Human Tissue Authority, particularly when it comes to discussing the codes of practice.
We have received letters from other authorities. The hon. Member for South Cambridgeshire mentioned the Royal College of Pathologists. Cancer Research UK feels that somebody from the research community must be included. The Council of Heads of Medical Schools thinks that there must be appropriate expertise in the use of human tissue for research. I support that. It is right that, as the Government say, lay members should be in the majority, but there must be a sufficient presence from the knowledgeable community of pathologists—I was going to say pathological community, which would have been a bad way of putting it—and the research community to ensure that reasonable practice of medicine is still possible.
I completely understand Opposition Members' points about the need for appropriate expertise on the authority, but the amendment is unnecessary. However, I want to use this opportunity to emphasise that we support people with appropriate expertise being on the authority.
The Bill provides for the authority to have not less than half lay membership. It is intended that, as in all arm's length bodies in specialist areas, the non-lay membership will comprise people who have relevant expertise. It is clear that the Human Tissue Authority would not be able to function properly if its members did not have suitable expertise. We have provided for the authority to have a majority of lay members, because it is important that all concerned are able to improve public confidence. There will be representation from professionals with an interest in using tissue, but we need to ensure that they do not dominate the regulatory body.
It is important that there is a range of expertise among the other members, because the authority's remit is relevant to such areas as transplantation, anatomy, pathology, surgery, tissue banking, and so on. I do not want that list to sound exhaustive, because it would be unfortunate to leave out any group that felt that it should be represented. A very wide group of people could be included. One difficulty with the amendment is that it might allow for every sub-speciality to lay a claim to having a member on the authority by virtue of their expertise in one of the matters regulated. People with a variety of expertise will be needed, but they will be appointed to the authority on merit in accordance with the Nolan principles. The numbers of people who are needed and
how the relevant expertise is covered will be a matter of judgment. Members of the authority will, perhaps, be appointed through the NHS Appointments Commission, or there may be a recruitment exercise.
I am glad that the Minister has dealt with the subject of numbers, if only peripherally. I hope that she agrees that it is important for her to give us some idea of the size of the Human Tissue Authority. At the moment we have only an inkling of the possible numbers from a reference in clause 17(3) to an appeals committee of five.
Many of the structures of the Human Tissue Authority are based on the Human Fertilisation and Embryology Authority, which is made up of approximately 20 people. It will be necessary to make a judgment about exact numbers after consultation—but that is a possibility. We will consider other bodies with similar responsibilities. We may consider whether there should be a similar number of people to the HFEA, but I would not like completely to tie that down, because it is important that we ensure that we have the relevant numbers of people with expertise. I assure hon. Members that organisations and others with an interest in the work of the authority will be made aware of all vacancies, so individuals with relevant expertise will have the opportunity to apply.
The hon. Members for South Cambridgeshire and for Wyre Forest (Dr. Taylor) raised the issue of when the authority and the shadow Human Tissue Authority will start work. If we were to anticipate Royal Assent before next summer, we would need a period before fully implementing the legislation to prepare any necessary regulations and orders, and to allow the practical aspects, such as the licensing procedures, to be developed. Full implementation is likely to occur in 2005, but we anticipate a shadow authority getting to work quite quickly. We in the Department can start preparing the shadow Human Tissue Authority very soon. We would hope to see drafts of the codes, to which the hon. Member for South Cambridgeshire referred, beginning to emerge over the coming year. The shadow authority will start to prepare the licensing and inspection procedures and the codes of practice. We will want that shadow authority to consult family groups, professional groups and so on, and to start to set up the infrastructure for the new authority.
The Retained Organs Commission, as the hon. Gentleman says, is due to close on 31 March. However, the Department of Health is in close contact with the commission about the process for handing over its work in the first instance to strategic
health authorities. There will certainly be continuity with the central telephone advice line. At the moment, the commission is working with strategic health authorities so that they follow its guidance on inquiries from families and so on. The hon. Gentleman will know that a lot of expertise has been gained during the past three years on how to deal with such sensitive issues.
I share the concern of the hon. Member for Oxford, West and Abingdon (Dr. Harris). The proposition is that the responsibilities and expertise acquired by the Retained Organs Commission should be let go, and that much of it should be recreated in the Human Tissue Authority after an intervening period in which strategic health authorities try to deal with the same issues in the same way. On the face of it, that is not the best way of proceeding. It seems that we are dispersing responsibilities around the country and gathering them back together at the Human Tissue Authority. Is there not a case for continuing the work of the Retained Organs Commission until the shadow Human Tissue Authority can pick up its responsibilities and some of the staffing at the centre?
I understand the hon. Gentleman's point. However, we have to be clear about what the Retained Organs Commission will be able to do and what one would expect it to be doing at this stage, given the work that has already been done. We are talking about the retention of organs and tissue that has taken place over a number of years. The job of the Retained Organs Commission is to ensure that, wherever possible, retained organs and tissue are returned as quickly as possible—if that is appropriate and what families wish—or that such organs and tissue are retained for medical research and so on. We want that to continue.
The Retained Organs Commission is talking with trusts and strategic health authorities at a local level—the level at which we feel that decisions and guidance can be most adequately dealt with. It is not a question of handing responsibility over. It is appropriate that such expertise is passed on to individual trusts and to strategic health authorities so that the casework and the support for families also transfers to the local level. Much of the work has been completed, but there will be advice and draft guidance, which the shadow Human Tissue Authority can pass on if necessary. Initially, it is most appropriate for trusts and strategic health authorities to deal with and build on the valuable expertise that the Retained Organs Commission has established.
I am a little concerned because the Retained Organs Commission will be a repository for the experience of the civil servants working for it. Does the Minister envisage that expertise going elsewhere and individuals being reappointed? The natural corollary of what she is saying is that those people will be subsumed within the shadow authority and ultimately the HTA. However, under the scheme that
she outlined, those civil servants will presumably be reappointed to areas completely outside the sphere, and that would represent a huge loss of experience.
As I have said, the Department will continue to work closely with trusts and strategic health authorities to ensure that they are able to follow the guidance that the commission will pass on. The scheme is an appropriate way to continue the commission's work, and some civil servants involved with it may join the shadow authority. We have been working closely with the commission to ensure that we are fully aware of the guidance and the expertise that it has accumulated and will disperse to trusts and strategic health authorities.
I hope that that provides reassurance, both on the timetable for the establishment of the shadow authority, and on the fact that we understand the need for the authority to have proper expertise. The proposals outlined in the Bill are the best way to secure that, and I hope that the hon. Member for South Cambridgeshire will withdraw the amendment.
I am grateful to the Minister for responding to the range of subjects that were raised. I shall deal first with the timetable. Given that the shadow authority may be established in the summer if the Bill receives Royal Assent before the summer recess, I am not entirely persuaded that it is sensible for all the commission's functions to be dispersed, although I realise that some might be held by the Department of Health rather than the strategic health authorities. The authority should not necessarily work with families individually in the longer term; trusts should take on that responsibility.
If the shadow authority will be functioning later this year, with a view to becoming a legal body in 2005, there will be an intervening period during which codes of practice and the like will be established. As we have already discovered, and will discuss further, the codes of practice are instrumental to the authority's functioning. It is obviously in the interests of the medical and research communities that the codes of practice are available as early as possible, and in a form that is unlikely to change repeatedly subject to consultation, otherwise that would create confusion.
I want to ensure that substantive appointments are made to the authority which are likely to subsist, so that those making decisions are likely to have to live with them and follow them up once the body is formally established. That means getting on with the job fairly quickly.
The Minister directed us to look at the structure of the Human Fertilisation and Embryology Authority. I have seen several links between this Bill and the legislation governing that authority which suggest that they operate in similar ways. On matters such as transparency, which we will discuss, the HFEA is a good example for the Human Tissue Authority to follow.
On membership and numbers, it is interesting that last year we discussed the structure of the independent regulator for foundation hospitals. I was in an adjacent Committee Room, in which the Department
of Health sternly insisted that the regulator could not be more than one person, although it finally bent to the idea of two or three. It said that the only way to deliver executive authority properly was through one person. That number has now increased to 20, which is going from the ridiculous to the sublime, depending on which part of the Department of Health one is dealing with. [Interruption.] Perhaps it depends on which Minister one is dealing with.
Twenty people seems to be a large authority, but if—as the Minister says—several members of the Human Tissue Authority will have relevant expertise, many people in the areas that I mentioned should be satisfied. If the authority were reduced to a smaller number of people, with only a few having relevant expertise, it would have difficulties in representing the areas of interest to which the hon. Member for Wyre Forest and I referred. We want to ensure that those areas of expertise will be represented.
As long as we have the Minister's assurance that that is the intention and that it will be delivered in due course, there is no value in pressing the matter. On that basis, I beg to ask leave to withdraw the amendment.
Amendment, by leave, withdrawn.
Question proposed, That this schedule be the Second schedule to the Bill.
I have one question for the Minister about holding meetings in public. The HFEA, to which she previously referred, is pleased to be holding in public those parts of its meetings that can be held in public. I welcome that development, but that authority has been in existence for many years. There is no reason why the Human Tissue Authority should take several years to ensure that it has a default policy of holding in public all of its meetings that do not involve confidential business. Information should be available on its website so that members of the public and interested parties may attend to see the workings of the authority.
I hope that I can reassure the hon. Gentleman. If no confidential business needed to be discussed in private, I would hope that meetings would, as far as possible, be held in public.
Question put and agreed to.
Schedule 2 agreed to.