Meeting Minutes: June 26, 2002 - Expert Advisory Committee on Xenograft Regulation (EAC-XR)

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Contact: Director's General Office

Health Products and Food Branch (HPFB)
Biologic & Genetic Therapies Directorate (BGTD)

Teleconference - Building #6, Room 1274
Wednesday June 26^th, 2002
2:00 p.m. - 3:30 p.m.

Participants

• Dr. Michael Gross QE II Hospital, Halifax, Nova Scotia
• Dr. François Auger Hospital University Québec, Sainte-Foy, Quebec
• Dr. Lorne Babiuk University of Saskatchewan, Saskatoon, Saskatchewan
• Dr. Paul Greig The Toronto Hospital, Toronto, Ontario
• Dr. Paul Jolicoeur Institute de recherche clinique de Montréal, Montreal, Québec
• Dr. Jutta Preiksaitis University of Alberta, Edmonton, Alberta
• Dr. Bhagirath Singh University of Western Ontario, London, Ontario
• Dr. Rosalie Starzomski University of Victoria, Victoria, British Columbia

Health Canada Representatives:

Dr. Alberto Estrada Biologics and Radiopharmaceuticals Evaluation Centre, BGTD

Mr. André Bergeron Centre for Policy and Regulatory Affairs, BGTD

Ms. Amanda Collier Centre for Policy and Regulatory Affairs, BGTD

Ms. Catherine Parker Centre for Policy and Regulatory Affairs, BGTD

Dr. Eilleen Tackaberry Centre for Biologics Research (BGTD)

Ms. Karen Farrell Scientific and Regulator Officer, SOP, BGTD, HPFB

Dr. Marian Laderoute Centre for Infectious Disease Prevention and Control, Population and Public Health Branch

Ms. Marianne Tang Centre for Policy and Regulatory Affairs, BGTD

Dr. Ratna Bose In Vitro Diagnostic Device, Device Evaluation Division Medical Devices Bureau, Therapeutic Products Directorate, HPFB

Ms. Sharon Mullin BTOX Compliance Coordinator, Inspectorate, HPFB

Guest:

Dr. Janice Graham Medical Anthropology, Canada Research Chair in Bioethics, Department of Bioethics,
Dalhousie University, Halifax, Nova Scotia

Regrets:

Dr. Michele Bailey University of Western Ontario, London, Ontario

Mr. Peter Portlock Alberta Arbitration & Mediation Society, Edmonton, Alberta

Dr. Henry Dinsdale Kingston General Hospital, Kingston, Ontario

Dr. Arvind Koshal University of Alberta, Edmonton, Alberta

Dr. Francisca Agbanyo Biologics and Radiopharmaceuticals Evaluation Centre, BGTD

Roles

Chairperson: Dr. Michael Gross

Scribe: Ms. Karen Farrell

Opening Remarks

This teleconference meeting was set up at the request of the Acting Director General of the Biologics and Genetic Therapies Directorate (BGTD), Ms. Julia Hill, after discussions with Dr. Michael Gross.

Ms. Karen Farrell introduced herself as the Secretariat for the Expert Advisory Committee on Xenograft Regulation (EACXR). Ms. Catherine Parker, manager of the Policy and Promotion Division (PPD), Centre for Policy and Regulatory Affairs (CPRA), BGTD, introduced the Health Canada representatives of the internal Working Group on Xenotransplantation.

Dr. Michael Gross stated that the EAC-XR had not met for either a teleconference or for a face-to-face meeting for a long period of time. However, Dr. Gross was hopeful that members of the committee would be able to express their views on the consultation process and on the Issue Analysis Summary (IAS) presented for this meeting.

Agenda Item #1: IAS on Xenotransplantion: Round table comments

Ms. Amanda Collier introduced the IAS on Xenotransplantation to the EAC-XR members. She noted that the document had been circulated to them to 1) share the work and analyses that the internal Working Group has undertaken since the public consultation on xenotransplantation; and 2) to solicit their input on the accuracy and completeness of the content of the IAS.
Ms. Collier then handed the table over to the Chair, Dr. Michael Gross.

Concerns raised by EAC-XR members included:

1.  

   Issue

   Canadian Public Health Association (CPHA) Public Consultation on Xenotransplantation

   Description

   Is the CPHA Public Consultation on Xenotransplantation final report included in the Issue Analysis Summary?

   Response

   Health Canada representatives responded that the results of the public consultation on xenotransplantation represent a part of the IAS.

2.  

   Issue

   CPHA Public Consultation on Xenotransplantation process and final report

   Description

   Surprise was expressed by some members of the EAC-XR at not being consulted by the BGTD regarding the CPHA's public consultation process and final report. The public consultation was important and represents a milestone. The members would have liked to discuss the process used by the CPHA. It was suggested that it would be valuable to the EAC-XR members to have Dr. Ross (co-chair of the Public Advisory Group to the CPHA) present the Final Report to them in order to discuss the issues and some of their concerns regarding the public consultation process.

   Response

   Ms. Karen Farrell is to consult with the Health Canada Working Group on Xenotransplantation and the Acting Director General of the BGTD to see what possibilities there are for a face-to-face meeting before the end of the summer term and to investigate inviting Dr. Ross to give a presentation.

3.  

   Issue

   CPHA Public Consultation on Xenotransplantation final report and public opinion.

   Description

   Some EAC-XR members noted that caution should be taken when discerning the presentation of public opinion. Some felt that the results of each of the regional citizen forums may have been influenced by the presentations of experts at those forums. Some members questioned whether the results from the consultation process were a true representation of the public's opinion. It should be noted that one EACXR member attended each of the regional citizen forums as an observer. In contrast to the above, however, the EAC-XR observer concluded that by the end of the process, the public themselves were able to move away from the focus of the expert panellists and to arrive at their own opinions. The EAC-XR observer gave the example of one region where the majority of the expert panellists were in favour of proceeding with xenotransplantation, however, the public ended up with a very cautious viewpoint.

   Each of the public groups were dynamic and very different. This observer felt that in the majority of cases the panel experts made an attempt to present the issues without bias.

   Response

   Not Required

4.  

   Issue

   The weighting of the criteria used to assess the options found on page 35 - 36 of the IAS.

   Description

   The criteria and their respective weighting is described on pages 34 - 36 in section 6.2 Options Analysis, Criteria Used to Assess Options of the IAS. An EAC-XR committee member asked what weight was given to the Calgary Citizen's Jury with respect to the CPHA Final Report, and in fact why it was considered at all. An EAC-XR committee member advised that the government should weigh the opinion of the EAC-XR members greater than that of the results of the CPHA public consultation. One EAC-XR committee members was concerned with the weighting value given to Animal Welfare issues?

   Response

   It was noted that Health Canada fully supports the commitment made by Health Minister Allan Rock in 2000 to consider the views of Canadians in the development of government policy on xenotransplantation. All input received from the public was considered, including the Calgary Citizen's Jury Report. Interestingly, the conclusions of the Citizen's Jury were similar to those of the CPHA's public consultation. As described on page 35 of the IAS, the Working Group considered public input (reflecting societal tolerance for risk) to be as reported to Health Canada in the CPHA's final report and the Calgary Citizen's Jury Report. These represent the only available gauges of public opinion on the subject, although the Working Group recognized that they may have limitations. Public input was one of 15 criteria used to assess the options, as described on page 35 and 36 of the IAS. The Health Canada Working Group arrived at the weighting described in the IAS after considerable deliberation and discussion. The weighting of criteria related to animal welfare was discussed and explained.

5.  

   Issue

   Human versus animal clinical trials

   Description

   Do Options 6 and 7 refer to animal or human clinical trials?

   Response

   As stated in the IAS on page 5, section 3.1 Background, Definitions; Xenotransplantation is defined to include any procedure that involves transplantation, implantation or infusion into a human recipient or either (a) live cells, tissues or organs from a non-human animal source, or (b) involves human body fluids, cell , tissues or organs having ex vivo contact with live non-human animal cells, tissues or organs.

6.  

   Issue

   Scientific references

   Description

   It was asked if all of the scientific references used to write the IAS could be provided to the EAC-XR committee members.

   Response

   All scientific references were footnoted throughout the IAS.

7.  

   Issue

   Request for a face-to-face meeting and more time to review the IAS presented at this teleconference meeting

   Description

   The IAS was not received by the EAC-XR with enough time for them to carefully review it. Therefore it is recommended that a face-to-face meeting of the committee be set up in order that members might review the documentation, discuss and debate the parameters of the issue. It was also recommended that Dr. Ross be invited to the meeting to present CPHA process and final report.

   Response

   The recommendation to the Minister would be based on the IAS and on any input related to the accuracy and completeness of the issue analyses from EAC-XR during this teleconference meeting. The deadline had already been extended in order to include the EAC-XR members input. If a face-to-face meeting were organised it would have to take place so that the IAS and it's recommendations could be presented to the Minister before the end of the summer term (stated as September 21st).

Agenda Item #2: Conclusions and Recommendations

The EAC-XR recommended that the next meeting be a face-to-face as soon as possible in order that the members have a chance to review the IAS and then provide further scientific advice. The EAC-XR also requested that Dr. Ross give a presentation of the CPHA's Final Report to discuss the results of the public consultation.

Action Item

Ms. Karen Farrell is to consult with the Health Canada Working Group on Xenotransplantation and the Acting Director General of the BGTD regarding the appropriateness of and need for a face-to-face meeting before the end of the summer term and to investigate the invitation of Dr. Ross to give a presentation.

Completed

A letter from the Acting Director General of the BGTD, Ms. Julia Hill, to the EAC-XR members has been sent outlining Health Canada's response to the recommendation for a face-to-face meeting.

Next Meeting: To be scheduled when appropriate.

Acronyms

BGTD

Biologics and Genetic Therapies Directorate

CPHA

Canadian Public Health Association

CPRA

Centre for Policy and Regulatory Affairs

EAC-XR

Expert Advisory Committee on Xenograft Regulation

HPFB

Health Products and Food Branch

IAS

Issue Analysis Summary

PPD

Policy and Promotion Division

SOP

Office of Strategic and Operational Planning