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Standing Committee G
Tuesday 3 February 2004
(Morning)
Mrs. Irene Adams
Clause 10 ordered to stand part of the Bill.
Schedule 2
The Human Tissue Authority
9.10 am
Mr. Andrew Lansley (South Cambridgeshire): 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,
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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.
Dr. Richard Taylor (Wyre Forest) (Ind): I support the hon. Member for South Cambridgeshire (Mr. Lansley). The Government are right strongly to
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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.
The Minister of State, Department of Health (Ms Rosie Winterton): 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
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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.
Dr. Andrew Murrison (Westbury) (Con): 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.
Ms Winterton: 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.
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