June 6Minutes of the thirty-first meeting heldat 4045 Côte-Vertu Boulevard, Saint-Laurent, Boardroom, Wednesday, June 6, 2001, at 2:00 PM Absent : Guests : 1. Opening of meeting 2. Adoption of the agenda It was proposed, duly seconded and unanimously resolved that the agenda be adopted with the following modifications: 6. Working group on qualification technologies To miscellaneous: 3. Adoption of minutes of the thirtieth meeting held on May 2, 2001 4. vCJD: Update on Canadian and U.S. situation - Decision to be made by Héma-Québec After having commented on the results, members noted that inappropriate self-exclusion further to the introduction of vCJD exclusion criteria is a rare occurrence, the impact of which can be deemed negligible. The Medical Director, Microbiology and Epidemiology, also presented a document on "Stratégies pour réduire davantage le risque d'exposition des donneurs – l'ESB" (Strategies to further reduce the risk of exposing donors to BSE). The document provided the latest information gathered on the subject and the various possible solutions. From a scientific standpoint, to this day, studies have not shown that vCJD can be transmitted to humans through blood transfusion. Three solutions were submitted and analyzed in detail. They take into consideration the potential decrease of the "theoretical" risk of transmitting vCJD through blood and the consequences of tighter exclusion criteria on supply.
We discussed the various positions taken by organizations such as the American Red Cross (U.K., 3 months since 1980 and Western Europe including France, 6 months since 1980), the Canadian Blood Services (CBS), (U.K. and France 3 months, since 1980) and the US Food and Drug Administration (US FDA) (currently being discussed, no position taken to this day). We also discussed the necessity of including Western Europe in the exclusion criteria. This involves a change in the risk theory, i.e., the inherent risk was considered to reside where cases of vCJD were observed to the inherent risk residing where bovine spongiform encephalopathy (BSE) was observed. However, it was also noted that the calculation of the risk reduction presented is based on the potential risk, arbitrarily set at 2%, that a person who has travelled to a Western European country has ingested U.K.-beef. In light of these observations, the importance of Héma-Québec reaching a level of safety which is at least equal to that of other organizations, such as the American Red Cross, was also considered. Finally, members inquired how many times Héma-Québec could compensate for the loss of donors due to the constant addition of new exclusion criteria. Consequently, it was proposed, duly seconded and resolved in majority that the resolution entitled "vCJD - Implementation of a new exclusion criterion for France and Western Europe," of which a copy is appended hereto, be adopted. Héma-Québec shall present the solution retained to the CBS and the Bureau of Biologics and Radiopharmaceuticals (BBR). 5. Anti-HBc: options to consider for implementation
Considering the pros and cons described in the table above, Option 1 was selected. Consequently, it was proposed, duly seconded and resolved that the resolution entitled "Hepatitis B [Anti-HBc] screening test: Implementation option," be adopted. Héma-Québec shall present this option to the CBS and the BBR. 6. Working group on qualification technologies 7. 2001-2002 budget and follow-up 7.2. Letter from the Minister for Health and Social Services - May 11, 2001 8. Recommendation of the Liaison Committee following its May 26, 2001 meeting 9. Public meeting 10. Centre de conservation des tissus humains du Québec (CCTHQ; Québec Human Tissue Conservation Centre) - decision document The Executive Director mentioned the Department of Health and Social Services' reservations about incorporating the CCTHQ and its preference that Héma-Québec take charge of these activities. On May 17, Héma-Québec's Management issued a recommendation to integrate the CCTHQ so that it becomes a division of Héma-Québec and asked Héma-Québec's Board of Directors to approve this recommendation. Following discussion, it was duly proposed, seconded and unanimously resolved that the resolution entitled "Integration of the Centre de conservation des tissus humains du Québec (CCTHQ) with Héma-Québec," of which a copy is appended hereto, be adopted. 11. Project follow-up 12. Miscellaneous The CBS, Bayer, Héma-Québec as well as the Canadian Hemophilia Society are following the progress of this matter at weekly meetings. The recipient representative said that a meeting is planned at the Children's Hospital on June 14, at 7:00 PM. Various parties involved will attend the meeting to answer questions from hemophiliacs facing this problem. The Executive Director mentioned that she will delegate a Héma-Québec representative at this meeting. 12.2. National Advisory Committee on Transfusion Medicine (NACTM) - summary of meetings 12.3. 2001-2002 advertising campaign Board members were apprised of the various advertising formats and congratulated the Assistant Director of Direct Marketing as well as the advertising agency for their excellent work. 12.4. Association of Blood Donation Volunteers (ABDV) - New board of directors 12.5. Hemolink follow-up 12.6. Appointment of a new Safety Advisory Committee (SAC) member 12.7. Follow-up on Hemovigilance Committee's public forum - Free and informed consent for transfusions 13. Next meeting 14. Adjournment Claude Pichette Dr. Francine Décary RESOLUTION TO BE INTEGRATED INTO THE MINUTES OF THE HÉMA-QUÉBEC BOARD OF DIRECTORS MEETING OF JUNE 6, 2001 WHEREAS Héma-Québec has decided, as a precaution and in compliance with the recommendations of the Honourable Justice Horace Krever, to implement certain donor selection criteria related to the theoretical risk of vCJD; WHEREAS since September 30, 1999, donors who have stayed in the U.K. for more than one month, cumulatively or consecutively since 1980, are excluded from giving blood; WHEREAS since October 30, 2000, donors who have stayed in France for more than six months, between 1980 and 1996, are excluded from giving blood; WHEREAS the above-mentioned exclusions are based on the balance between the real risk to the supply such an exclusion may have and the management of a theoretical risk, which is the transmission of the new variant Creutzfeldt-Jakob disease through blood; WHEREAS according to the "risk" exposure scale model developed for vCJD, we expect the risk of exposure to lie in the ingestion of infected U.K.-beef, and thus estimate exposure in the U.K. to be 100%, 10% in France, and 2% in Western Europe; WHEREAS an exclusion of donors who have stayed in France for more than three months, and in Western Europe for six months represents, according to the above-described scale model, a decrease of 42.8% of the residual risk and 87% of the total risk; WHEREAS the Canadian Blood Services has decided to exclude donors who have stayed in France for more than three months; WHEREAS in September 2001, the American Red Cross will implement tighter donor exclusion criteria for vCJD and more specifically the exclusion of donors who have stayed in Western Europe for more than six months, cumulatively or consecutively, since 1980; WHEREAS according to a donor survey conducted by Héma-Québec, the exclusion of donors who have stayed in France for more than three months, and in Western Europe for more than six months since 1980, represents a loss of 2.7% donors; WHEREAS the Board of Directors may review its decision in relation to new developments as certain organizations, especially the Food and Drug Administration, have not yet taken a position on new exclusionary criteria for vCJD in France and Western Europe, IT IS RESOLVED:
RESOLUTION TO BE INTEGRATED INTO THE MINUTES OF THE HÉMA-QUÉBEC BOARD OF DIRECTORS MEETING OF JUNE 6, 2001 WHEREAS the Safety Advisory Committee considers there to be scientific proof that there exists a residual risk of transmitting hepatitis B through blood that has tested positive for anti-HBc; WHEREAS during its November 21, 2000 meeting, the Safety Advisory Committee recommended the implementation of anti-HBc and has recommended that the cost and implementation feasibility of these tests be assessed; WHEREAS on January 31, 2001, the Board of Directors accepted the Safety Advisory Committee's recommendation, but has requested a study on the impact of implementing anti-HBc on supply and has assigned management to undertake an analysis of various scenarios in place which take the pros and cons into account; WHEREAS the Board of Directors has analyzed the anti-HBc implementation options presented to it; IT IS RESOLVED: To implement the anti-HBc screening test according to a combination of options 1 and 4, to be defined:
To assign management to:
RESOLUTION TO BE INTEGRATED INTO THE MINUTES OF THE HÉMA-QUÉBEC BOARD OF DIRECTORS MEETINGOF JUNE 6, 2001 WHEREAS on May 8, 2000, the Héma-Québec Scientific and Medical Advisory Committee recommended proceeding with the pilot project with CCTHQ; WHEREAS on June 7, 2000, the Board of Directors approved this recommendation and accepted the joint-venture concept as a time-limited pilot project; WHEREAS on March 7, 2001, the Board of Directors approved a draft agreement for a joint-venture between Héma-Québec and the CCTHQ, which presumed the incorporation of the CCTHQ as a non-profit company; WHEREAS the Québec Department of Health and Social Services prefers that Héma-Québec assume the responsibilities of the CCTHQ; WHEREAS following a review of the pros, such as optimization of tissue distribution to patients in Québec, and cons related to the integration of CCTHQ activities with those of Héma-Québec, it appears to be in the interest of Héma-Québec and the CCTHQ that the latter be integrated as a division; IT IS RESOLVED:
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