Minutes of the twenty-ninth meeting
Held at 4045 Côte-Vertu Blvd., Saint-Laurent, in the Boardroom, on Wednesday, April 4, 2001, at 2:00 PM (translation)
Mr. Claude Pichette
Mr. Raymond April
Mr. Robert Bédard
Ms. Sheila Comerford
Dr. Francine Décary
Dr. Louis R. Dufresne
Dr. André Lebrun
Dr. Jean Montreuil
Dr. Denis Cournoyer
Dr. Réjean Paradis
Dr. Yves St-Pierre
Ms. Cheryl Campbell Steer
Dr. Gilles Delage, Senior Director, Medical Affairs
Me Smaranda Ghibu, General Counsel
Mr. Guy Lafrenière, Senior Director, Administration and Finance
1. Opening of meeting
Claude Pichette chaired the meeting. He welcomed the members. Quorum being established, the meeting began at 2:10 PM
2. Adoption of agenda
The agenda was read. It was proposed, duly seconded and unanimously resolved that the agenda be adopted with the following addition:
12.1 Public forum of the National Blood Safety Council held March 30 and 31, 2001.
3. Adoption of minutes of the twenty-eighth meeting held March 7, 2001
It was proposed, duly seconded and unanimously resolved that the minutes of the twenty-eighth meeting of the Board of Directors, held on March 7, 2001, be adopted as submitted.
4. Business arising from the minutes of the twenty-eighth meeting
4.1. SD plasma: Meeting with representatives of Health Canada
The Executive Director had occasion to meet the person responsible for post-marketing monitoring of drugs at Health Canada on March 30 at the public forum of the National Blood Safety Council in Vancouver. The Health Canada representative confirmed that the SD plasma manufacturer had indeed reported serious adverse reactions resulting from the administration of SD plasma in 1999, within the 15-day period laid down in the regulations. Given that Health Canada is not obliged by the Food and Drugs Act to advise distributors such as Héma-Québec of this kind of reaction, Health Canada would expect Héma-Québec to be advised by the Canadian importer.
The Executive Director will convene a meeting with the Health Canada representative, as well as with representatives of Canadian Plasma Products, the Canadian importer, in order to agree on a communication protocol that would apply in this type of situation.
At the Board's request, the Executive Director will follow up on the progress and conclusions of the enquiry by the Food and Drug Administration (FDA) and the manufacturer of SD plasma on the cause of these reactions. Héma-Québec will also closely monitor the use of SD plasma in other countries in light of the theoretical risk of variant Creutzfeldt-Jakob disease.
4.2. Joint meeting of Héma-Québec and Canadian Blood Services Boards of Directors, May 2, 2001
The subjects for discussion proposed by Board members at the last meeting were submitted to Canadian Blood Services. (CBS). A reply has not yet been received from CBS in this regard.
The member representing donors proposed presenting the training prepared by Héma-Québec to members of the Association of Blood Donation Volunteers. The Executive Director will follow up on this proposal with the CEO of CBS.
5. 2000-2001 Budget and follow-up
The Senior Director, Administration and Finance, submitted the budget follow-up as at February 28, 2001. The operating budget is still overrun due to increased demand from hospitals, which has led to additional blood collections. The forecasts of the number of units to be delivered in 2001-2002 was also discussed, as was the budget required, which has been approved by the Québec Ministry of Health and Social Services.
6. vCJD: Results of survey on donor travel habits in Western Europe
The Bureau of Biologics and Radiopharmaceuticals (BBR) asked Héma-Québec and CBS to conduct a survey among their donors in order to learn about donor travel habits in Western Europe. The survey followed recent developments concerning bovine spongiform encephalopathy in Western European countries, as well as the opinions of the American Red Cross and the FDA on excluding donors who had visited various Western European countries.
The survey was conducted among 841 donors in February 2000. Results showed that about 1% of Héma-Québec blood donors had travelled in Western Europe for six (6) months or more since 1980. This finding did not include donors who had visited the United Kingdom.
In light of those results, the Board of Directors discussed the issues of implementing a new exclusion criterion for donors who had spent time in Western Europe. The possibility of self-exclusion by donors was discussed. On this subject, the Board requested that a study be made on self-exclusion and on other reasons why donors no longer return to give blood. The practical difficulties of applying a European exclusion were also discussed.
After discussion, members of the Board of Directors decided not to take a decision immediately on an exclusion criterion for donors who have spent time in Western Europe and to submit the results of this survey to the BBR.
7. Safety Committee recommendation of March 21,2001
The Safety Advisory Committee met on March 21. On that occasion, three (3) principal subjects were discussed.
The first subject discussed was variant Creutzfeldt-Jakob disease. Members were given a presentation on the European situation and then discussed the possibility of modifying the exclusion criteria for donors in this regard. The Committee recognized that Héma-Québec has the strictest criterion in the world for the United Kingdom and one of the strictest for France. Members discussed the risk-management premises applicable to these exclusions and agreed that, if Héma-Québec were to decide to tighten its criteria, it would be opportune to concentrate on the United Kingdom. However, no formal recommendation to this effect was made.
The second subject discussed was anti-HBc tests. Once again, the Committee did not formulate a recommendation. The possibility of conducting this test on all donations or only on the first donations was discussed, as well as reintegration algorithms. Héma-Québec will meet with BBR next week to discuss implementing anti-HBc testing and, in particular, the possibility of putting in place donor reintegration algorithms.
The third subject discussed by the Safety Committee was bacterial contamination. The Committee recommended introducing systematic cultures on apheresis platelets. Héma-Québec will evaluate what tests are available and report to the Board on progress made in implementing this recommendation.
8. Quarterly report on claims
The quarterly report on claims was duly tabled. General Counsel responded to members' questions on the subject.
9. Research and Development
9.1. Sharing revenue generated by intellectual property
Five (5) general principles on intellectual property protection were submitted to the Board of Directors at its meeting on January 31, 2001. On that occasion, the Board approved the majority of the principles but requested more details on sharing revenue generated by intellectual property. The practices of several university and research institutes were analyzed. After discussion, it was proposed, duly seconded and unanimously resolved that the following principle be adopted regarding sharing revenue generated by intellectual property: Héma-Québec will recuperate the costs of developing the invention and/or the intellectual property; once those costs have been deducted, the revenue will be shared equally between Héma-Québec and the inventor.
9.2. CBS proposal regarding the Research & Development agreement
At its June 7, 2000 meeting, the Board of Directors approved a draft agreement concerning sharing intellectual property between Héma-Québec and Canadian Blood Services. Following negotiations between the two organizations, the General Counsel tabled the agreement the parties had reached.
Canadian Blood Services agreed to the principle of sharing the Canadian Red Cross Society's intellectual property. However, CBS would like to receive 25% of the revenue generated by inventions dating from before September 28, 1998, which will be assigned to Héma-Québec, the amount to be determined after recuperation of development costs and payment to the researcher. This principle would be reciprocal. Lastly, each organization agreed to award the other a non-exclusive, royalty free licence for inventions prior to September 28, 1998, on condition that they be neither commercially exploited nor assigned. It was proposed, duly seconded and unanimously resolved that the agreement with Canadian Blood Services be concluded according to the above-mentioned principles and that the Executive Director be, and she is hereby authorized to sign the above-mentioned agreement with any modifications that may be made, at her own convenience, and to sign any other document and undertake any other act she deems necessary or desirable, at her own discretion to give effect to this resolution, and to the conditions and commitments contained in the agreement. The Executive Director's signature on said agreement and on any other such document shall constitute the irrevocable consent of Héma-Québec.
10. Adjustments to agreement with Infectio Diagnostic Inc.
According to the terms of the agreement with Infectio-Diagnostic Inc. (IDI), certain adjustments can be made twelve (12) months after coming into effect. Since this agreement began in November 1999, IDI has now submitted a request for a price adjustment.
The Senior Director, Administration and Finance, tabled the proposal from IDI, as well as the financial impacts.
The Board of Directors did not accept the proposal from IDI and requested the Senior Director, Administration and Finance, to enter into negotiations in order to reduce the adjustments requested by IDI and to return to the Board of Directors with a new proposal.
11. Project follow-up
Nucleic acid amplification testing for HIV
Since NAT-HIV testing was implemented on January 17 last, there have been no positive results on this test, with negative results on the antibody test. Further, there has been no impact on the release time for labile products.
vCJD - France
Since the October 30, 2000 implementation of the exclusion criterion for donors who have spent more than six (6) months in France, the exclusion rate of 0.52% has been maintained.
Re-certification: Good Manufacturing Practices/Good Work Practices (GMP-GWP)
This week marked the launch of the third stage of GMP-GWP. This is the training phase. Posters illustrating this activity have been posted in Héma-Québec facilities.
The Executive Director and the Senior Director, Administration and Finance, will meet with members of the Procurement and Financing Management Committee on April 5, 2001 to present the method for calculating rates for labile products.
This subject will be covered under item 12.1
Negotiation of collective agreements
Union and management representatives are taking a course on interest-based negotiation in order to better use this approach in the ongoing negotiations.
Construction of laboratories
The construction project is still on schedule, and there have been no budget overruns on the project to date.
Statutory meetings with the CEO of Canadian Blood Services
Besides the meeting between the Executive Director and the CEO of Canadian Blood Services, the two Management teams met on March 16, 2001. At that meeting, presentations were prepared for the public forum of the National Blood Safety Council in March. Héma-Québec and CBS gave a joint presentation to the forum.
Also at the joint meeting of the Management teams, the objectives set at the previous year's meeting were reviewed and the level of achievement evaluated. Some objectives were achieved while others still require more work.
12.1. Public forum of the National Blood Safety Council held March 30 and 31, 2001
Board members who attended the public forum of the National Blood Safety Council on March 30 and 31 in Vancouver thought the information presented was interesting. The experience of countries who have achieved plasma self-sufficiency with voluntary donors was particularly appreciated. Forum presentations again showed that the marketing approach to recruiting donors is fundamental.
13. Next meeting
The next meeting will be held on Wednesday, May 2, 2001, at 2:00 PM, at Loews Le Concorde Hotel in Québec City.
It was unanimously resolved to adjourn the meeting at 5:40 PM.
Dr. Francine Décary