§ Mr. BakerTo ask the Secretary of State for Health (1) what advice he has received from the Advisory Group on the Ethics of Xenotransplantation regarding the possibility of cross-species viral transfer as a result of xenotransplantation; [22612]
(2) what advice he has received from the Advisory Group on the Ethics of Xenotransplantation regarding clinical trials involving genetic material from pigs. [22611]
§ Mr. BoatengThe Advisory Group on the Ethics of Xenotransplantation completed its work in August 1986. Its advice is contained in its Report "Animal Tissue into Humans" which was published in January 1997. Copies are available in the Library.
§ Mr. BakerTo ask the Secretary of State for Health what assessment he has made of the impact of the proposals in the white paper on Freedom of Information on the modus operandi of(a) the United Kingdom Xenotransplantation Interim Regulatory Authority and (b) the Advisory Group on the Ethics of Xenotransplantation. [22633]
§ Mr. BoatengThe Government have recently published a White Paper "Your Right to Know: Freedom of Information" setting out our proposals for a Freedom of Information Act. These proposals will be discussed by the United Kingdom Xenotransplantation Interim Regulatory Authority and appropriate action taken. The Advisory Group on the Ethics of Xenotransplantation completed its work in August 1996 and no longer exists.
§ Mr. BakerTo ask the Secretary of State for Health if he will list the Members of the Advisory Committee on Dangerous Pathogens, indicating(a) the date on which each membership commenced, (b) those members who are employed or have been employed by companies with interests in biotechnology and (c) those members who, either individually or on behalf of groups, are known to be opposed to xenotransplantation on ethical grounds. [22629]
145W
§ Mr. BoatengThe joint Department of Health/Health and Safety Executive Advisory Committee on Dangerous Pathogens (ACDP) was reconstituted in January 1995 for a three-year term (subsequently extended for a further 10 months). All current members, except for the two indicated, have served on the ACDP for the full term since January 1995. The members are:
- Chairman
- Dr. M. J. Crumpton: Served as Chairman since 1991
- Export members
- Dr. B. Bannister: Member since 1993
- Professor G. E. Griffin: Appointed December 1994
- Professor D. J. Jeffries: Member since 1993
- Dr. E. A. Gould: Member since 1991
- Dr. P. W. Jones: Appointed December 1994
- Dr. H. S. Tranter: Appointed December 1994
- Dr. R. W. A. Girdwood: Appointed December 1994
- Dr. T. D. Wyatt: Member since 1987
- Employer/employee representatives
- Mr. A. R. Clare: Member since 1984
- Miss A. M. Harris: Member since January 1984
- Ms V. Bevan: Member since May 1994
- Dr. R. C. Slade: Appointed December 1994
- Dr. R. Owen: Member since 1981
- Mr. P. Taylor: Re-joined ACDP November 1996, served previously 1986–1990
- Ms P. Smith: Appointed November 1996
- Mrs. T. McGuire: Appointed December 1994
Of the expert members Dr. Bannister, Professor Griffin, Professor Jeffries, Dr. Girdwood and Dr. Wyatt are employed within the health service. Dr. Gould is an Assistant Director at the National Environment Research Council Institute of Virology and Environmental Microbiology. Dr. Jones is the head of the Division of Environmental Microbiology at the Institute for Animal Health. Dr. Tranter is a microbiologist at the Centre for Applied Microbiology and Research.
In line with the tripartite principle of all Health and Safety Commission Advisory Committees, employer and employee representatives were nominated by the Confederation of British Industry, The Public Health Laboratory Service (PHLS) Board, the Committee of Vice Chancellors and Principals, the Trades Union Congress and the Royal College of Nursing. Mr. Clare is under contract to his former employer, SmithKline Beecham and Miss Harris is the Medical Affairs Manager at Glaxo Research and Development Ltd. Ms Bevan is head of PHLS Technical Services. Dr. Slade is Safety Advisor at King's College London. Dr. Owen is now retired; he was the former Deputy Director of Medical Services at the Health and Safety Executive. Mr. Taylor, Ms Smith and Mrs McGuire all work within the health service.
We shall write to the hon. Member with further details of the commercial and non-commercial interests of the Chairman and members.
The ACDP is concerned with formulating advice on the infection risks of xenotransplantation. They have not been required to provide advice on ethical issues, and their personal views are not known.
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§ Mr. BakerTo ask the Secretary of State for Health, pursuant to his answer of 27 November 1997,Official Report, column 652, when the invitation to visit Imutran's animal facilities was received by his Department; and on which date the visit occurred. [22636]
§ Mr. BoatengMy noble Friend, The Baroness Jay, Minister of State, who has responsibility for this area, at Imutran's invitation, visited their facilities on 17 October 1997. During her visit she was advised of the developments in their work. The invitation was oral and the proposed itinerary was faxed to the Department on 10 September 1997.
§ Mr. BakerTo ask the Secretary of State for Health if he will list those companies and other organisations from whom his Department has formally sought views in respect of the development of a regulatory structure for xenotransplantation, indicating in each case the date on which views were formally sought. [22609]
§ Mr. BoatengAn open consultation was held in January 1997 to which industry and others responded. The responses have been considered in depth by the United Kingdom Xenotransplantation Interim Regulatory Authority and advice submitted to Ministers. Copies of all those responses, other than those made in confidence, will be placed in the Library in due course.
§ Mr. BakerTo ask the Secretary of State for Health (1) which animals he plans to exclude, on ethical grounds, from use as source animals for xenotransplantation; and if he will make a sttaement; [22628]
(2) if he will list those studies which he has evaluated regarding the transfer of pig viruses into human cells through the process of xenotransplantation; and if he will make a statement; [22610]
(3) if the government will make it their policy to prohibit clinical trials of xenotransplantation involving genetic material from pigs until further data have been collected on cross-species viral transfer; and if he will make a statement. [22607]
§ Mr. BoatengProposals for the use of any animal in xenotransplantation will be carefully considered by the United Kingdom Xenotransplantation Interim Regulatory Authority (UKXIRA).
The Government are advised by the UKXIRA on the acceptability of any application to undertake trials in xenotransplantation involving humans. The UKXIRA's advice will include consideration of issues such as the microbiological risk of any proposed procedure, the use of the animal proposed as the source, and the likely effect on the patient and their relatives. Within the UK we will allow clinical trials involving humans to take place only if and when we are satisfied that the risks associated with such procedures are acceptable. The UKXIRA will take the latest published information and other evidence offered into account in its advice.
The Home Office has responsibility for the use of animals in scientific procedures and their view on the acceptability of the use of any animal as a source will depend on a consideration of the harm of the procedure against the benefit it may bring. My right hon. Friend the Secretary of State for the Home Office, however, has indicated that he is not prepared to sanction the use of Great Apes for use in scientific procedures.
147WResearch continues into the science underlying xenotransplant developments, including cross-species viral transfer. The Advisory Committee on Dangerous Pathogens (ACDP) is also working with the UKXIRA on microbiological issues involved in xenotransplantation.