PRESENT: Lord Habgood, Dr David Cook, Mr John Dark, Dr Janet Dewdney, Mrs Jean Gaffin, Professor George Griffin, Dr Maggy Jennings, Professor Sheila McLean, Professor Herb Sewell

SECRETARIAT: Mr Martin Houghton, Ms Kate Darwin, Ms Jennie Mullins

ALSO PRESENT: Dr David Muir (St George's Hospital)

MATTERS ARISING

Xenotransplantation in Russia. Requests for further information had been submitted through the Russian Embassy and the Council of Europe. No response had yet been received.

Declarations of Interest. It was noted that the Authority's current practice was in line with advice given to Members of the Medicines Commission.

OPEN MEETING

Consideration would be given to wider advertising of the next Open Meeting.

PROGRESS IN XENOTRANSPLANTATION

Members discussed the implications of emerging evidence on porcine endogenous retrovirus (PERV). This underlined the appropriateness of the Authority's current cautious stepwise approach. Further pre-clinical research would clearly be necessary and it was agreed that this should be discussed in more detail with representatives of the Home Office Animal Procedures Committee.

Members considered the suggestion (put forward during the two consultation exercises on biosecurity and infection surveillance) that some forms of xenotransplantation might offer a lesser degree of infection risk than, for example, whole organ xenotransplantation. It was agreed that further views should be sought from the steering groups.

Whilst much of the recent media attention on human cloning / stem cell research was speculative, it was acknowledged that developments in this field had implications for the future viability of xenotransplantation.

UPDATE ON DEVELOPMENTS

Members considered recent published articles on xenotransplantation.

As of 2 March, a total of 19,526 postcards opposed to xenotransplantation had been received. A survey conducted on behalf of the British Union for the Abolition of Vivisection (BUAV) was noted.

Members' terms of office were due to be renewed shortly. Additionally, it was proposed to advertise for two additional members - one scientific and one lay post. It was agreed that this might be a suitable point to review the Authority's structure and role in regulating xenotransplantation. Prof. McLean would prepare a paper for discussion at the next meeting.

Members had been invited to participate in a proposed research project considering interactions in decision making bodies. This was considered to be a worthwhile project and it was agreed that the Authority should participate.

WORK PROGRAMME

Dr Muir reported that good progress was being made on the first of the literature reviews considering infection risks. Proposals for the physiology and the legal/ethics review were being drafted and would be submitted shortly. It was agreed that consideration of animal welfare issues should be undertaken separately from the legal/ethical review.

The steering groups considering biosecurity and infection surveillance had met to consider responses to the two draft reports that had been issued for consultation. It was hoped that final drafts of both reports would be submitted to the Authority for consideration at the next meeting. If so, publication might be expected by late summer.

Reports to the Human Genetics Commission were due shortly on proposals for media handling and furthering public understanding. It was agreed that these reports might provide useful pointers for the Authority in enhancing public knowledge in the development of xenotransplantation. Members noted that the Nuffield Council had in the past produced helpful leaflets to explain complex technical subjects to the general public. Similar literature on xenotransplantation might be useful.

XENOTRANSPLANTATION IN OTHER COUNTRIES

Health Canada had issued a document titled Proposed Canadian Standard for Xenotransplantation, the contents of which seemed to be generally in line with the Authority's own thinking.

The US Food and Drug Administration had issued draft Guidance for Industry on Precautionary Measures to Reduce the Possible Risk of Transmission of Zoonoses by Blood and Blood Products from Xenotransplantation Product Recipients and their Contacts. The recommendation that xenotransplant recipients should defer from donating blood and blood products concurred with advice in the draft Infection Surveillance document.

Reports/policy statements had also been issued recently from bodies in Sweden, Germany, and France.

DATE OF NEXT MEETING

Monday 5 June 2000.