Teleconference Minutes: February 22, 2001 - Expert Advisory Committee on Xenograft Regulation (EAC-XR)

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Contact: Director's General Office

Committee Members Present:

Dr. Michael Gross, chairperson; Dr. Lorne Babiuk, Dr. Michele Bailey, Dr. Henry Dinsdale, Dr. Paul Greig, Dr. Lyne Letourneau, Dr. Stephen McColl, Mr, Peter Portlock, Dr. Rosalie Starzomski.

Absent:

Dr. Francois Auger, Dr. Paul Jolicoeur, Dr. A. Koshal, Dr. Jutta Preiksaitis, Dr. Bhagirath Singh, Professor Tim Caulfield.

Health Canada Representatives:

Dr. Ping Lu, Medical Devices Bureau, Therapeutic Products Directorate (MDB) (TPD); Ms. Mandy Mills, Policy Division, Biologics and Genetic Therapies Directorate (B&GT D); Ms. Sue-ann Blakely, Bureau of Policy and Coordination, TPD (BPC).

Observer:

Ms. Sylvia Fanjoy, Canadian Public Health Association (CPHA)

Opening

Committee members were asked to comment on the draft Key Issues document developed by the CPHA with guidance from the Public Advisory Group (PAG) on Xenotransplantation, particularly Issue # 2 and #4.

Issue # 2 was entitled "Is Xenotransplantation viable?" and Issue #4 was "Is the risk to the public acceptable?"

Dr. Lorne Babiuk requested clarification regarding an invitation he had received to be a guest speaker/presenter at one of the upcoming Citizens Forums, organized by the CPHA. It was stressed that EAC members could certainly provide their expertise to groups outside of Health Canada, however they must do so as an individual expert and not as an Expert Advisory Committee member.

Dr. Michael Gross updated the EAC with respect to his conversation with Dr. Peterson, of the Therapeutic Products Directorate. The various roles and responsibilities of the different advisory groups dealing with Xenotransplantation issues was discussed and he agreed to forward a letter of clarification to the committee. Dr. Gross also discussed the possibility of drafting a scientific paper which would provide Canadian Scientific and Medical experts with current information on Xenotransplantation research.

Ms. Sylvia Fanjoy from Canadian Public Health Association (CPHA) who is the Director the Public Consultation Project on Xenotransplantation introduced the Key Issues document explained that it is intended to be distributed to approximately 4000 organizations and individuals. In addition to the Key Issues document, the CPHA, together with the PAG, has also developed questionnaire on Xenotransplantation, both of which will be posted on their website. The intent the document is to provide unbiased, accurate and current background information on Xenotransplantation to participants of the public involvement activities and other interested members of the public.

The EAC provided comments on the content of the entire Key Issues document. The comments provided by the EAC were updated in the document and forwarded by Mandy Mills of the Policy Division, Biologics and Genetic Therapies Directorate to the CPHA. CPHA, through direction and advice of the PAG, will consider all the suggested revisions from various sources in the finalization of the document.

The EAC requested the final version of the Key Issues document and the accompanying questionnaire to be forwarded to them as soon as possible. The EAC extended their congratulations to the CPHA and PAG on the Key Issues document.

Teleconference adjourned: 17:30