September

Minutes of the twenty-third meeting of the Board of Directors of Héma-Québec

Held at 4045 Côte-Vertu Blvd., Saint-Laurent Wednesday, September 6, 2000, at 2:00 PM (translation)

Present :
Claude Pichette
Raymond April
Dr. Louis R. Dufresne
Robert Bédard
Dr. Denis Cournoyer
Dr. Francine Décary
Dr. André Lebrun
Dr. Yves St-Pierre
Sheila Comerford
Dr. Jean Montreuil
Cheryl Campbell Steer
Diane Roy (Observer, Chair of Hemovigilance Committee)

Absent :
Dr Réjean Paradis

Guests :
Guy Lafreni¾re
Senior Director, Administration & Finance
Suzie Deschamps
Director, Financial Resources
Dr. Gilles Delage
Senior Director, Medical Affairs, Microbiology & Epidemiology
Dr. Marc Germain
Medical Director, Microbiology & Epidemiology
Gonzalo Nu¯ez
Meeting Delegate
Héma-Québec

1. Opening of meeting
Claude Pichette chaired the meeting. He welcomed the members. Quorum being established, the meeting began at 2:05 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 additions under "Miscellaneous:"
8.2. ISH - Toronto Convention
8.3. Press conference by Réal Ménard
8.4. Letter from the Office de la langue fran‚aise
8.5. Hemovigilance Committee's public forum

3. Adoption of minutes of the twenty-second meeting held on August 2, 2000
It was proposed, duly seconded and unanimously resolved that the minutes of the twenty-second meeting of the Board of Directors held on August 2, 2000 be adopted with the corrections requested.

4. Business arising from the minutes of the twenty-second meeting
4.1. Follow-up - Variant Creutzfeldt-Jakob disease in France
On August 30, 2000, Health Canada sent Héma-Québec directive D2000-01, regarding the exclusion of donors due to the theoretical risk of transmitting variant Creutzfeldt-Jakob disease (vCJD). The directive calls for the exclusion of blood donation from any persons who have travelled to France (except for French territories outside Europe) for a cumulative period of six (6) months or more between 1980 and 1996, inclusively. The directive does not apply to autologous blood donation. The Board decided on this matter during the August 2, 2000, meeting. Implementation of the directive is planned for October 30, 2000.

Moreover, at the August 2 meeting, the Board agreed to review the total exclusion criteria of plasma destined for fractionation from donors who have stayed in the U.K., for however long. By excluding a significant number of our donors from the Canadian plasma pool, do we not increase the risk, as it would require substitution with plasma from other jurisdictions such as other provinces and the U.S., where the exclusion criterion is a six-month or longer stay in the U.K.? The advantages of this decision were thus weighed against the risk of introducing plasma from the Canadian Blood Services or the U.S. According to some calculations and current data, it seems that this measure would provide an additional element of safety, though weaker than expected.Following discussion, it was proposed, duly seconded and unanimously resolved that the resolution entitled "vCJD - maintain the total exclusion criteria of plasma sent to fractionation from donors who have stayed in the U.K. since 1980," be adopted, a copy of which is appended hereto.

4.2. Public meeting
Preparations for the public meeting are in full swing. Some members gave the Executive Director their recommendations regarding the preparation of Héma-Québec's presentations on the new financing method. It was agreed that the presentation content would be validated prior to the public meeting at the next Board meeting.
(Action: FD)

4.3. 2000-2001 Budget: letter from the Minister for Health and Social Services
The Executive Director informed members that the matter of billing hospitals for blood products is still underway. The joint committee on the method of payment for determining blood product prices has already met. The document concerning fees billed to hospitals for labile products was completed and submitted to the Minister for Health and Social Services. Another meeting will be held on September 7, 2000.

4.4. Research Ethics Committee: new member
Members of the Board read the letter of resignation from the ethicist belonging to the Research Ethics Committee (REC). The Board accepted the ethicist's resignation. In order to fill the vacant position in the REC, Board members were provided with the résumé of Guy Beauregard. Following discussion, it was proposed, duly seconded and unanimously resolved that Guy Beauregard be appointed as a member of Héma-Québec's Research Ethics Committee specializing in ethics.

4.5. Letter from Fédération des infirmi¾res et infirmiers du Québec
Members read the letter dated August 9, 2000, sent by the Chairman of the Board of Directors in reply to the letter from the second vice-chairperson of the Fédération des infirmi¾res et infirmiers du Québec, received on July 24, 2000. The Executive Director informed the Board that to date, there has been no progress in this matter.

4.6. Joint meeting of the Héma-Québec and Canadian Blood Services boards of directors
A draft agenda prepared by the Canadian Blood Services was submitted.

5. Budget follow-up
The Senior Director, Administration & Finance, presented a budget follow-up for July 31, 2000. The document "Budget follow-up for July 31, 2000 (four months)" was immediately submitted. The follow-up indicates that we continue to go over budget in July, due primarily to operations.

The recovery plan was presented, it comprises two parts: (1) adjustments and (2) corrective measures in operations. The effects of these measures should be realized by September 2000.

6. Update on the plasma self-sufficiency assessment project
Following a call for tender, Héma-Québec awarded Canadian Plasma Products with the job to undertake an analysis on plasma self-sufficiency. It was agreed that Canadian Plasma Products be invited to give a presentation to the Board of Directors in November 2000.
(Action: FD)

7. Project follow-up
The Executive Director gave a follow-up on the implementation of various projects and answered questions from members. For informational purposes, she presented the Board with some architectural plans of the new laboratories.

8. Miscellaneous
8.1. Election of David Page to the Board of Directors of the World Federation of Hemophilia
Board members read a letter from the Canadian Hemophilia Society which mentions the election of David Page to the Board of Directors of the World Federation of Hemophilia (WFH). David Page is a member of Héma-Québec's Liaison Committee and Safety Committee.It was proposed, duly seconded and unanimously resolved that David Page be congratulated for his election into the Board of Director's of the World Federation of Hemophilia.
(Action: FD)

8.2. International Society of Hematology - Toronto convention
A transfusing physicians representative mentioned that during the International Society of Hematology (ISH), Hemosol will be giving a presentation on Hemolink, a product that can be used as a blood substitute for some surgeries.

Hemosol representatives met with Héma-Québec management to present their new product. During the meeting, the Executive Director referred Hemosol to the National Advisory Committee on Transfusion Medecine (NACTM). The Board asked the Executive Director to write a letter to the NACTM to make them aware of the possible approval of this product and of Héma-Québec's willingness to distribute this product.
(Action: FD)

8.3. Press conference by Réal Ménard
On September 6, 2000, Hochelaga-Maisonneuve MP, Réal Ménard, called in the media to express his disagreement with the federal government's allocation of funds solely to the Canadian Blood Services for blood research. The MP asked the federal government to grant Québec $6.5 million for blood research.

The Executive Director brought up Héma-Québec's budget commitments for research and development. She mentioned that the matter of financing, as addressed by MP Ménard, falls under federal-provincial relations. Members agreed that Héma-Québec should not get publicly involved in this matter.

8.4. Letter from the Office de la langue fran‚aise
The Office de la langue fran‚aise granted Héma-Québec its francization certificate.

8.5. Hemovigilance Committee's public forum
The Chairperson of the Hemovigilance Committee invited Board members to attend the public forum on transfusion consent. This event will be held on October 13, 2000, in Montréal.

9. Next meeting
The next meeting will be held on October 4, 2000, at 2:00 PM, at Radisson Htel Gouverneur, 690 boulevard René-Lévesque Est, in Québec City.

10. Adjournment
It was unanimously resolved that the meeting be adjourned at 5:35 PM.

Claude Pichette
Chairman

Dr. Francine Décary
Secretary

RESOLUTION TO BE INTEGRATED INTO THE MINUTES OF THE HÉMA-QUÉBEC BOARD OF DIRECTORS MEETING OF SEPTEMBER 6, 2000
"Variant Creutzfeldt-Jakob disease - Maintain the total exclusion criteria of plasma sent to fractionation from donors who have stayed in the U.K. since 1980."

WHEREAS the risk of infection by variant Creutzfeldt-Jakob disease (vCJD) would be linked to the consumption of U.K. beef products contaminated with mad cow disease, with the maximum risk period between 1980 and 1996;

WHEREAS at the April 7, 1999 meeting, the Board of Directors resolved to adopt the following exclusion criteria, which apply to donors who have stayed in the U.K.:

IT IS RESOLVED:

THAT as a precautionary measure, Héma-Québec favours the following exclusions:

1. All plasma from donors who have stayed in the U.K., for however long, since 1980, and to be sent to fractionation;
2. All donors of labile products who have stayed in the U.K. for one (1) month or more since 1980, consecutively or cumulatively;

WHEREAS during the August 2, 2000 meeting, the Board of Directors resolved to adopt the following exclusion criterion, which applies to donors who have stayed in France:

IT IS RESOLVED:

• To exclude blood donations from any person who has stayed in France for a cumulative six-month or longer period, between 1980 and 1996, inclusively;

WHEREAS in light of the adoption of the exclusion criterion linked to vCJD-France, the Board of Directors agreed to reassess the exclusion criterion of plasma to be sent to fractionation from donors who have stayed in the U.K. since 1980;

WHEREAS during the September 6, 2000 meeting, the Board of Directors undertook a quantitative assessment of the effect of a total exclusion of plasma to be sent to fractionation from Héma-Québec donors who have stayed in the U.K., based on various hypotheses and several scenarios;

WHEREAS the consequence of this measure would result in an increased supply of plasma from Canadian Blood Services (CBS) and/or U.S. donors who are susceptible to have stayed in the U.K. for up to six months. However, according to the calculations presented and considering the current data, the effect of such a measure would provide an additional, yet weak, safety element;

WHEREAS the currently available scientific data does not indicate any major changes to the decrease in the "theoretical" risk of vCJD infection through blood supply;

IT IS RESOLVED:

TO MAINTAIN the total exclusion criterion regarding plasma to be sent to fractionation from donors who have stayed in the U.K., for however long, since 1980.