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Expert Advisory Committee - Cells, Tissues and Organs: Record of Meeting (Teleconference), February 9, 2009

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

Record of Meeting Teleconference

February 9, 2009, 2:00 p.m. - 4:00 p.m. EST
200 Tunney's Pasture Driveway, Room 0105

"These Minutes have been edited for confidential information in accordance with the Treasury Board Manual - Policy & Guidelines on Security."

Participants:

Members:
Ms. Corinne Weernink (Chair) (London, ON); Dr. Noni MacDonald (Halifax, NS); Dr. Noel Gibney (Edmonton, AB); Dr. Bruce Light (Winnipeg, MB); Dr. Len Baron (Edmonton, AB); Dr. Jolanta Karpinsky (Ottawa, ON); Ms. Penny Marrett (Toronto, ON); Ms. Linda Wright (Toronto, ON); Ms. Debbie Gaskin (London, ON); Dr. Dana Baran (Montreal, QC).

Guests:
Dr. Lindsay Nicolle (Chair, EAC-BR) (Winnipeg, MB)

Health Canada and Public Health Agency Representatives:
Dr. Elwyn Griffiths, A/Director General, BGTD; Ms. Cathy Parker, BGTD; Dr. Peter Ganz, BGTD; Dr. Farid Hindieh, BGTD; Dr. Carol Légaré, BGTD; Mr. Gilles Polnicky, BGTD; Ms. Marianne Tang, BGTD; Ms. Naira Minto-Saeed, BGTD; Ms. Dorothy Corbett, BGTD; Mrs. Geeta Daté, BGTD; Ms. Maria Carballo, TPD; Dr. Robert Gervais, PHAC; Ms. Gita Nayeri, Inspectorate; Dr. Danielle Brûlé-Brown, MHPD.

Regrets:
Ms. Sandra White, EAC-CTO (St. John's NL); Mr. Tumelo Mokoena, EAC-CTO (Edmonton, AB); Ms. Cindy Hyson, PHAC

Agenda Item #1: Opening Remarks

Opening Remarks from Dr. Elwyn Griffiths, Acting Director General, BGTD and Ms. Corinne Weernink, Chair, EAC-CTO

Presenter: Dr. Elwyn Griffiths
Context: Information

Major Points:
Dr. Griffiths welcomed Committee members, Health Canada and Public Health Agency of Canada representatives to today's meeting, and thanked Dr. Lindsay Nicolle, Chair, EAC-BR for participating in the discussion, as HIV/AIDS impacts on the blood system as well.

Dr. Griffiths gave some background on the role of the BGTD, indicating that it undertakes its responsibilities as a federal authority with colleagues in PHAC and other Directorates within the Department. He noted that while final decision-making rests with the Department, Health Canada uses Expert Advisory Committees to share and obtain advice on complex policy and regulatory issues.

In particular, BGTD welcomes the expertise, experience, perspective and professional objectiveness that its Committees bring and asks that they engage in fulsome discussions when making recommendations.

Dr. Griffiths thanked the Committee for the time they volunteered to participate and for their contributions to the health and well-being of Canadians.

Presenter: Ms. Corinne Weernink
Context: Information

Major Points:
Ms. Weernink welcomed members Linda Wright, bioethicist with Toronto General Hospital University Health Network; Penny Marrett, lay representative, Toronto; and Debbie Gaskin, Manager Tissue, Organ and Cell Banking, London Health Sciences Centre, who are participating in their first Meeting.

Agenda Item #2: Review of Today's Agenda

Presenter: Ms. Corinne Weernink, Chair, EAC-CTO
Context: Information

Major Points:
A change to the Terms of Reference was added to agenda item #5.

Agenda Item #3: Review of Conflict of Interest for this Meeting

Presenter: Ms. Corinne Weernink, Chair
Context: Information

Major Points:
P. Marrett declared her affiliation in her position as President and CEO of the Canadian Health Food Association. The Canadian Health Food Association has a Contribution Agreement with the Canadian Food Inspection Agency. This is not a perceived conflict for this Committee. No conflicts were declared for this meeting.

Agenda Item #4: Approval of Records of Meeting

Presenter: Ms. Corinne Weernink, Chair
Context: Approval

Major Points:
The Record of Meeting for the May 30, 2008 Teleconference was approved with a correction that Dr. Len Baron is located in Edmonton.

Agenda Item #5: Membership Update and Change to Terms of Reference

Presenter: Ms. Dorothy Corbett, BGTD
Context: Information

Major Points: Mr. Christopher Snow, Manitoba Tissue Bank and Dr. Michael McBurney have resigned from the Committee. Dr. McBurney agreed to remain as an Ad Hoc member.

Mr. Tumelo Mokoena, the senior tissue specialist at the Comprehensive Tissue Centre, University of Alberta Hospital Tissue Transplant Service, is welcomed to the Committee. A face-to-face Meeting is proposed for June, potential dates to follow this week.

The Committee agreed to the removal of "the Assisted Human Reproduction Implementation Office" as a minor revision to paragraph 3, Section IX of the Terms of Reference for EAC-CTO to reflect the current membership of the internal Working Group.

Agenda Item #6: Update on the CTO Information Sessions

Presenter: Ms. Gita Nayeri, Inspectorate
Context: Information

Major Points:
G. Nayeri informed the Committee that seven CTO information sessions are being held across Canada to provide an opportunity for CTO establishments to gain a better understanding of Health Canada's expectations with respect to the implementation of the CTO Regulations and also to promote compliance with these Regulations. The final session will take place on February 12^th

The directorates involved in this project are the Inspectorate, MHPD and BGTD. The topics covered are a general overview of the Regulations and requirements, error and accident & adverse reaction reporting, as well as details regarding the inspection process. The sessions will also provide a forum for the CTO establishments to have their questions answered by Health Canada experts and discuss common interests with other CTO establishments.

Agenda Item #7: Committee Opinion of HIV and AIDS in Canada : Surveillance Report to December 31, 2007

Presenter: Ms. Cathy Parker, BGTD
Context: Discussion and Recommendation

Major Points:
C. Parker provided a brief background to the issue: The Safety of Human Cells, Tissues and Organs for Transplantation Regulations (CTO Regulations) came into force on December 7, 2007 and reference Annex E of the Canadian Standard Association National Standard for Cells, Tissues and Organs for Transplantation. This Annex identifies the nine behavioral risk factors which could put a prospective donor at higher risk of infection with HIV, HBV and/or HCV. In January 2008, an erroneous media report indicated that the CTO Regulations banned gay men from becoming organ donors. Men having sex with men (MSM) in the preceding 5 years is identified as a risk factor under Annex E, but the CTO Regulations do not ban gay men from becoming organ donors. The Standing Committee on Health (HESA) reviewed the MSM behavior criteria in limited hearings in March and April 2008, and recommended that the new CTO regulations on organ donor criteria be amended "since the current wording specifically excludes gay men from being organ donors" and to "replace the current regulations with scientifically based guidelines to medical practitioners".

In response, Health Canada rejected both recommendations, but committed to ongoing monitoring to insure the donor exclusion (screening) criteria remains science-based, indicating that it would request its independent external Expert Advisory Committees review any new surveillance data annually. In the fall of every year PHAC releases its surveillance report on HIV and AIDS in Canada, using the previous year's data, in this case 2007. This is the most recent and comprehensive data available to Health Canada at this time.

To follow-up on its commitment to HESA, Health Canada is requesting the opinion of the EAC-CTO on whether the newly generated data reflected in the PHAC HIV and AIDS in Canada: Surveillance Report to December 31, 2007, warrants a change to the donor screening criteria contained within Annex E.

The commitment to have the EAC-CTO respond by December was extended due to the federal election.

Based on this data, noting that it is limited to HIV and does not address Hepatitis transmission; does the Committee recommend changes to the donor screening criteria? Health Canada believes this is a valuable role for its Expert Advisory Committees and would like to make this a meaningful exercise. With a year to plan, what can it do to make this more significant and consequential interaction? What other information can be added? How can we do it better in the future?

In response to a question, the Committee was informed that there had not been any wording changes since the CTO Regulations came into force.

The Committee agreed a wording change would be helpful in clarifying the intent of the Regulations, and suggested replacing the words "exclusionary criteria" with 'cautionary factors to consider in risk mitigation'. It also recommended that a footnote be added to guide individuals to the Exceptional Release clause and its requirement.

A member noted that while it is the behaviour which is the risk factor it is difficult to avoid the perception that it is not the individual.

The Committee reiterated that the risk factors are valid. However, as the risk factors stated Annex E are not in order of risk, the Committee recommended that the exclusion criteria be re-visited by the CSA Technical Committee to consider ranking the exclusion criteria from the greatest to the least degree of risk. However it was further discussed that the determination of a ranking order of risk is virtually impossible and it was suggested that the factors could simply be re-ordered so as to not have the MSM factor at the top of list and hence not give the impression that this particular group is being targeted.

It was thought that individual cases could take into consideration factors such as a current long-term monogamous relationship of the donor, recent test results, reviewing of donor's medical history, etc., if such information is readily available through co-joined laboratory network; likewise safe practices with regard to tattooing could be considered on an individual basis. However, the Committee noted that these factors do not belong in the CTO Regulations, but would be considered under Exceptional Release.

Human-derived clotting factor concentrates were discussed as persons with haemophilia or related clotting disorders are excluded under Annex E. In response to a question regarding their use, HC responded that clotting factors licensed in Canada are free of concentrates. Human-derived clotting factor concentrates are still available to those who were started on this regime due to difficulty in switching, but this represents a very small number of individuals. It is available in other counties such as the United States. The Committee recommended that the exclusion for haemophiliacs and others with clotting factor disorders should be re-examined to determine the actual risk.

The Committee discussed the data collected for the PHAC HIV and AIDS in Canada: Surveillance Report to December 31, 2007, and queried if this was the most complete information which could be made available to the Committee, noting a lack of denominator data which would make it more meaningful. Health Canada responded that this is not easy. PHAC taps into ongoing studies but is highly dependant on the provinces and territories to report and not all do so. It is felt that the Agency produces a very good report within its limitations to collect.

PHAC also produces Prevalence and Incidence Studies every 3 years with one due in 2009. As only the most current information was considered relevant for the Committee to review, the past Prevalence and Incident Studies were not provided. This information will be available for the next review.

The PHAC data is completely harmonized with data available in the United States, and with some exceptions, most of Europe. There is no intent in the US for (regulatory) changes at this time.
Any changes in the US or other countries would have to be evaluated from a Canadian perspective. Health Canada recognizes that exclusionary criteria is current, and can only continue to be supported by critical scientific data. While NAT testing is not currently in use for the most part, a move towards it in the future could have an impact.

When the EAC-CTO was asked to consider whether future reviews of HIV data should be done jointly with EAC-BR, the Committee responded positively in favour of a joint review.

The Committee was asked to provide feedback on question # 2, i.e., what additional data/information is required to make the annual review a useful exercise for the Committees and Health Canada?
[Action item: Committee members to provide input to EAC Secretariat]

Any recommendations from the Committee for changes to the CTO Regulations will be forwarded by Health Canada with a rationale to the CSA Technical Committee on Cells, Tissues and Organs for consideration. The CSA Technical Committee will meet in April 2009.
[Action item: EAC-CTO will provide recommendations in the form of a report].

Agenda Item #8: Review of this Meeting

Presenter: Ms. Corinne Weernink
Context: Information

Major Points:
In summary:

New members were welcomed to the Committee.
Change to the TOR was approved.
Committee informed of face-to-face Meeting in June.
The Inspectorate updated on six cross-country CTO Information sessions; Report expected 6-8 weeks after the last session.
Discussion of PHAC Surveillance Report and exclusion criteria in Annex E of CTO Regulations.
CTO Regulations Guidance document nearly finalized, following major revisions. Anticipated to be available in March.