Expert Advisory Committee - Cells, Tissues and Organs: Record of Meeting (Teleconference), May 30, 2008

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Contact: Director General's Office

Health Canada
Health Products and Food Branch (HPFB)
Biologic & Genetic Therapies Directorate (BGTD)
Expert Advisory Committee - Cells, Tissues and Organs

Record of Meeting Teleconference

Friday, May 30, 2008
1:00 p.m. - 2.20 p.m. EDT
Building #7, Room 0204
Tunney's Pasture, Ottawa, ON

"An ATI review of the ROM for confidential information has been conducted, in accordance with the Treasury Board Manual - Policy & Guidelines on Security. No confidential information was identified within this document."

Participants

Members:
Ms. Corinne Weernink (Chair)(London, ON), Dr. Noni MacDonald (Halifax, NS), Dr. Dana Baran (Montreal, QC), Dr. Michael McBurney (Ottawa, ON), Dr. Noel Gibney (Edmonton, AB), Mr. Christopher Snow (Winnipeg, MB), Dr. Jolanta Karpinsky (Ottawa, ON), Ms. Sandra Ann White (St. John's, NL)

Health Canada and Public Health Agency Representatives:
Ms. Lindsay Blaney (A/Associate Director General, BGTD), Ms. Marianne Tang (CPRA, BGTD), Ms. Liz Anne Gillham-Eisen (CPRA, BGTD), Ms. Cindy Hyson (PHAC), Ms. Naira Minto-Saeed (OCRM, BGTD), Dr. Farid Hindieh (CBE, BGTD), Dr. Francisca Agbanyo (CBE, BGTD), Dr. Alexandra Simniceanu (CBE, BGTD), Dr. Kelly Robinson (MHPD, HPFB), Ms. Talia De Laurentis (CPRA, BGTD), Ms. Mélanie Mercier (CPRA, BGTD), Ms. Dorothy Corbett (OCRM, BGTD), Mrs. Geeta Daté (OCRM, BGTD), Ms Gita Nayeri (HPFB-I, HPFB)

Regrets:

Members:
Ms. Linda Wright (Toronto, ON), Ms. Penny Marrett (Toronto, ON), Dr Leonard Baron (Winnipeg, MB), Dr. Bruce Light (Winnipeg, MB),

Health Canada:
Dr. Elwyn Griffiths (A/Director General, BGTD)

Agenda Item #1: Opening Remarks

Presenter: Ms. Corinne Weernink, Chair
Context: Information
Major Points:
Ms. Weernink provided updates on the appointments of new members, Dr. Jolanta Karpinski (nephrologist), Ms. Sandra Ann White (donor coordinator), Ms. Linda Wright (bioethicist), Ms. Penny Marrett (lay representative), and welcomed them to the Committee. This was also the first meeting attended by Mr. Snow, who was also welcomed as a member of the Committee.

The Chair inquired if the requested Conflict of Interest (COI) document was to provide yearly declaration of COI as required, or was specific to the meeting. Ms. Corbett clarified at this time the members should submit COI for the record as their annual declarations. Declarations of COI are a standing agenda item. If there is a declared conflict at a meeting the member should submit a COI form.

It was requested that in the future, the Teleconference call in information be provided on the final agenda for ease of reference.

Agenda Item #1: Opening Remarks

Presenter: Ms. Lindsay Blaney
Context: Information
Major Points:
Ms. Blaney conveyed regrets on behalf of Dr. Griffiths who is out of the country and informed that the selection process for a new Director General for BGTD is ongoing. It is hoped an announcement will be made during the summer.

The Federal Government tabled Bill C-51 on April 8, 2008. This bill proposes legislative changes to the Food and Drug Act. The bill maintains the rigorous assessment of health products prior to marketing authorization and proposes Health Canada have the authority to continuously monitor the safety of products following authorization. This will provide authority to mandate a recall upon becoming aware of a problem. It also includes the Ministerial Authority to establish advisory committees, and provides the flexibility to compensate advisory body members without jeopardizing their indemnification. Remuneration will be based on standard and approved amounts fixed by the Governor in Council. Health Canada hopes this would enable clinicians to give greater consideration to serving on Health Canada committees and panels. The history of the indemnification versus compensation issue was explained for the benefit of recent members.

Agenda Item # 2: Review of Today's Agenda

Presenter: Ms. Corinne Weernink
Context: Administrative
Major Points:
Today's agenda was reviewed and accepted without changes.

Agenda Item # 3: Conflict of Interest for this Meeting

Presenter: Ms. Corinne Weernink
Context: Administrative
Major Points: Conflict of Interest was reviewed. No potential conflicts of interest were declared.

Agenda Item # 4: Approval of Records of Meeting

Presenter: Ms. Corinne Weernink
Context: Administrative
Major Points: The minutes for EAC-CTO Teleconference of September 10, 2007 were approved without any changes.

The Chair inquired if the current president of Canadian Society of Transplantation (CST), Dr. Shapiro, was contacted as requested during EAC-CTO Teleconference of September 10, 2007. Ms. Gillham-Eisen responded that Dr. Griffiths had sent a letter to Dr. Shapiro on October 22, 2007.

A member indicated that Québec Transplant will be contacted to determine if an Issue Summary will be submitted to present microbiological testing of preservation solutions used to transport organs as a potential item for discussion.

Agenda Item # 5: CTOSS Progress Report

Presenter: Ms. Cindy Hyson (PHAC)
Context: Information & Discussion
Major Points:
Work on Cells, Tissues, Organs & Assisted Reproduction Surveillance System was started in 2005, although there was not much progress until 2007. In 2007 PHAC partnered with the CCDT and the transplant community, conducting environmental scans, establishing a Steering Committee and a Data Working Group. PHAC will provide the leadership to develop a National Surveillance System through such partnerships and through the establishment of pilot sites. Proposals have been received from three pilot sites regarding data collection. The proposed system will not be an all-encompassing system or a traceability system. A phased-in approach will be taken. Initially, concentration will be on tissues. BGTD, MHPD, CORR, pilot sites, other key stakeholders will be consulted during development. Canada is in contact with AATB and the US CDC as they develop TTSN.

The intent is to capture data on moderate and severe adverse events, including the risk of transmission of infectious diseases due to transplantation; capture data on serious errors/near misses; perform data analysis to determine the risk of transplantation of cells, tissues, and organs. The system will capture and analyze data similar to the TTISS. Noting there is a difference between adverse events and errors with respect to cells, tissues and organs, it is not intended to capture errors at this time. While initially, a paper-based form is being developed to report adverse reactions and incidents, eventually a user-friendly web-based application will be developed for the end users (mainly healthcare professionals). Three types of adverse reactions will be captured by the system - graft failure, transmission of infection and malignancies.

The final goals are to:

• monitor trends in known risks;
• assess the magnitude of new or emerging risks;
• monitor the effectiveness of actions taken to reduce risks;
• explore, investigate and respond to potential problems;
• contribute to the reduction of the risk of transfusion/transplantation related blood-borne pathogens and injuries in Canada;
• provide a network for national and international groups to collaborate on new and emerging transfusion/transplantation risks; and
• harmonize with international partners like ISBT and EUSTITE to ensure Canada will capture information that can be benchmarked internationally.

There was a query with respect to PHAC's partnership with the CCDT. PHAC responded that the partnership with CCDT was only for the previous fiscal year which ended in March 2008. CBS has as yet not formulated a strategy for the surveillance of CTOs. Hema Québec is not currently participating in this project.

A question was raised with respect to how early graft failure will be defined, as early graft failure can occur due to varied reasons including faulty collection technique, faulty transportation mediums, etc. However, not all can be labeled as errors. It was recommended that graft failure as an adverse event needs to be strictly defined. PHAC responded that the data definitions are just in the developmental stages and they will take this information under advisement.

There was a query regarding Alberta's participation in the TTISS as its data was not reflected in the proportion of transfusion activity captured as of December 31, 2005. The response was that Alberta does participate but did not send data in 2005.

The Committee asked how and when the denominator data will be collected, and were informed that CORR has agreed to share its data on organs and that the Working Group is currently determining what information will be used for tissues denominator.

Agenda Item # 6: U.S. Transplantation Transmission Sentinel System (TTSS)

Presenter: Ms. Marianne Tang(CPRA, BGTD)
Context: Information & Discussion
Major Points:
Ms. Tang attended the Transplantation Transmission Sentinel Network (TTSN) Workshop in Atlanta. The TTSN is a new, secure, internet-based registry and communications network that tracks disease transmission data regarding allografts and will link organizations providing organs and tissues, clinical centers, and appropriate regulatory and public health authorities. The US Food and Drugs Administration's Center for Biologics Evaluation and Research collaborates with the US Centers for Disease Control and Prevention (CDC) on the TTSN to identify and prevent infectious disease transmission through tissue transplantation.

The TTSN was created by the United Network for Organ Sharing (UNOS) through a contract with the US Centers for Disease Control and Prevention (CDC). The TTSN Advisory Group includes the American Association of Tissue Banks, American Society of Transplantation, Eye Bank Association of America, American Society of Transplant Surgeons and many other groups.

This workshop was held to demonstrate the system now that the TTSN programming has been completed, and to launch the three month pilot from May 12-August 12. As the Canadian regulator, BGTD is participating in this project to assure that the TTSN aligns with Canada's existing CTO regulatory framework and that the requirements for the reporting of adverse events involving organs and tissues are shared between the two countries. For the pilot, the FDA's regulatory requirements for notification/reporting will be followed and only when the investigation is concluded and the information confirmed will an entry be inputted into the system.

Several US Tissue and Organ procurement organizations were selected for the pilot. This "user" group will test the system and provide insight into potential challenges of a national implementation of the TTSN. It is hoped that this system will not be a significant burden on the end users. All data provided by participants during the pilot will be considered confidential and will be accessible to institutional users only, in read-only format. Canadian establishments will not be participating in the pilot. However, Canada will continue to monitor the progress of this initiative to benefit from the US experience. An evaluation and follow up will be conducted at the end of the three month pilot.

Agenda Item # 7: MSM update

Presenter: Ms. Liz Anne Gillham-Eisen
Context: Discussion
Major Points:
The Safety of Human Cells, Tissues and Organs for Transplantation Regulations which came into force on December 7, 2007, references National Standards published by the Canadian Standards Association (CSA). The Regulations include nine behaviours that would classify a donor as higher risk for transmission of infectious diseases such as HIV and hepatitis. In January 2008 an erroneous media report indicated that the new Regulations banned gay men from being organ donors. It generated further media interest and calls by some gay rights groups for Health Canada to revoke the Regulations. Health Canada attempted to clarify this issue with further media communication and the issuance of a Fact Sheet indicating that anyone can be an organ donor regardless of age, gender and sexual orientation as the Regulations do not ban anyone from donating. However, due to increased incidence of transmissible disease associated with certain behaviours, some individuals are considered "higher risk donors". Men who have had sex with another man in the preceding five years are considered higher risk donors, as are IV drug users, sex trade workers and recent inmates. As organs are in short supply, the Regulations stipulate that organs from high risk donors can be used with patient consent and on physician's authorization. (Section 40. Exceptional Distribution).

Following the media attention, the parliamentary Standing Committee on Health (HESA) decided to review this issue in two hearings held on March 4th and April 3rd, 2008. After 4 hours of deliberation and testimony by eight witnesses, the committee gave two recommendations:

1. That the Minister of Health take action, at the earliest possible opportunity, to amend the new health regulations on organ donor criteria since the current wording specifically excludes gay men from being organ donors; and
2. That the Minister also replace the current regulations with scientifically based guidelines to medical practitioners that protect the supply of organs, promote participation of donors and preserve the integrity of the organ supply.

A response to the HESA recommendations is being prepared by Health Canada with a due date of mid-August.

Previously, in April 1999 the Standing Committee on Health had published the report entitled: "Organ and Tissue Donation: A Canadian Approach". At the time the committee had invited approximately100 witnesses to give testimony. At that time the Standing Committee on Health recommended that the CSA Standards be approved and made mandatory through incorporation by reference into Regulations, to be developed under the Food and Drugs Act. PHAC data analysis and other scientific published information support the current Regulations.

The EAC-CTO requested a transcript of the recent HESA Meetings and its recommendations. Health Canada will provide the web link to the proceedings.

[Action: Secretariat to forward the Web link to EAC-CTO - Done]

The Committee commented that the MSM behaviour criteria do not ban gay men from donating CTOs as exceptional distribution can always be used to distribute organs that do not fulfill all requirements of the Regulations. Furthermore, the MSM behaviour criteria do not mention gay men but applies to men having sex with men, which is a behaviour and not a social group. The members of EAC-CTO inquired if Health Canada presented information to HESA and the response was affirmative.

The Committee wondered if the negative feedback and the negative media item could be result of misunderstanding the wording of the behaviour criteria as exclusionary and recommended changes/edits to clarify the intent. The EAC-CTO advised a better communication strategy be developed by Health Canada to explain the CTO Regulations.

The Committee commented that the media item was a case of lack of proper research by the media. They further inquired if a letter stating this opinion and a complaint should be sent to the media.

The Committee discussed and unanimously agreed to send a letter of support of the CTO Regulations to HESA. The letter would detail the opinions of the EAC-CTO members and be signed by the chair on behalf of all members.

[Action: Chair to prepare letter to HESA for circulation amongst Committee]

Furthermore Health Canada commented that the community itself had asked in 1999 that regulations be developed to maximize the safety of CTO for transplantation in Canada. The Committee commented that letters from programs / institutions detailing their objections to the recommendation by the Standing Committee would be most helpful.

The Committee stated that guidelines are discretionary in nature, whereas the regulations afford the department a regulatory authority to enforce the regulations, and as such, the Regulations should remain. It was also noted that the Regulations are normally accompanied by a guidance document which interprets the Regulations.

The Committee commented that replacing the Regulations by guidelines would expressly go against the recommendations made by the Krever Commission. The point was made by the Committee that Regulations provide safety for the donor, the recipient, and the healthcare provider.

The Committee requested follow up information related to four documented cases in US of transmission of HIV infection through transplantation of organs & tissues from a single donor. Health Canada responded they would provide all the information available electronically.

[Action: Secretariat to email referenced documents to Committee - Done]

Agenda Item # 8: Review of this Meeting

Presenter: Ms. Corinne Weernink
Context: Information
Major Points:
The Chair summarized as follows

• A competition for the new Director General for BGTD is ongoing. Decision expected by the end of summer.
• Bill C-51 proposes legislative changes to the Food and Drugs Act providing Health Canada authority to mandate a recall of a problematic health product.
• This bill also gives Health Canada explicit authority to establish advisory committees allowing Health Canada to indemnify members of such committees and provide compensation.
• Four new members were welcomed.
• Update on Chagas Workshop will be sent by Health Canada
• Work on CTOSS is ongoing with partnerships with CCDT and pilot sites; initial emphasis will be on tissues.
• TTSS workshop hosted by the UNOS. TTSN is a new, secure, internet-based registry and communications network that tracks disease transmission data in the U.S.
• Ms. Gillham-Eisen led discussions on CTO regulations and the issue involving deferral criteria for CTOs.
• In response EAC-CTO will write a letter to HESA supporting the CTO Regulations as they stand.

Acronyms

AATB

American Association of Tissue Banks

BGTD

Biologics and Genetic Therapies Directorate

CCDT

Canadian Council for Donation & Transplantation

CORR

Canadian Organ Replacement Register

CSA

Canadian Standards Association

CTOSS

Cell, Tissue, Organ & Assisted Reproduction Surveillance System

EAC

Expert Advisory Committee

EAC-CTO

Expert Advisory Committee - Cells, Tissues and Organs

FDA

Food and Drug Administration

HPFB

Health Products and Food Branch

PHAC

Public Health Agency Canada

UNOS

United Network for Organ Sharing

US CDC

US Centers for Disease Control & Prevention