October

Minutes of the thirty-fifth meeting

Held at 4045 Côte-Vertu Blvd., Saint-Laurent, in the Boardroom, on Wednesday, October 3, 2001, at 2:00 PM (translation)

Present:
Mr. Raymond April
Mr. Robert Bédard
Ms. Sheila Comerford
Dr. Denis Cournoyer
Dr. Francine Décary
Dr. Louis Dufresne
Dr. Jean Montreuil
Dr. André Lebrun
Dr. Yves St-Pierre
Ms. Cheryl Campbell Steer

Absent:
Mr. Claude Pichette

Guests:
Mr. Guy Lafrenière, Senior Director, Finance and Administration
Me Smaranda Ghibu, General Counsel
Ms. Suzanne Poirier, Meeting Delegate
Héma-Québec

Observer:
Mr. Jean-Guy Lorrain

1. Opening of meeting
As the Chairperson was absent, the Vice-chairperson chaired the meeting. He welcomed the members. Quorum being established, the meeting began at 2:12 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 to Miscellaneous:

8.7 Stable product budget - recommendation from the Canadian Hemophilia Society
8.8 Liability insurance renewal

3. Adoption of minutes of the thirty-third meeting held on August 1, 2001
It was proposed, duly seconded and unanimously resolved that the minutes of the thirty-third meeting of the Board of Directors held on August 1, 2001 be adopted with the requested corrections.

4. Business arising from the minutes of the thirty-third meeting
4.1. vCJD: update on new exclusion criteria implementation
The Executive Director summarized developments since the last Board of Directors meeting on August 1, 2001. Given the events of September 11, 2001 - whose impact on Héma-Québec is described in detail in Item 5 ? the implementation date initially set for September 17, 2001, was postponed to October 1, 2001. The Canadian Blood Services (CBS) also postponed its implementation date to October 1, 2001. The American Red Cross postponed its implementation to mid-October.

On August 30, the Bureau of Biologics and Radiopharmaceuticals (BBR) held a press conference to announce its new exclusion guideline pursuant to the draft guideline described in the minutes of the August 1, 2001 Board of Directors meeting. Héma-Québec and CBS representatives attended the conference to answer questions from the media.

As implementation of these new criteria is quite recent, it is too soon to assess the repercussions. A follow-up will be made at the next meeting.
(Action: FD)

4.2. Anti-HBc: follow-up on implementation of anti-HBc screening test
The Executive Director reported on the results of the meeting with BBR representatives held in Ottawa on September 27. During this meeting, Héma-Québec presented the anti-HBc implementation option selected by the Board of Directors. The BBR referred Héma-Québec to the Medical Devices Bureau, claiming that implementation of the anti-HBc and specifically, the use of the anti-HBs test for the purposes of reintegrating false positive donors, does not fall within its jurisdiction. Héma-Québec thus must restart the process with the Medical Devices Bureau.

The members of the Board of Directors asked the Executive Director to draft a letter to the BBR relating Héma-Québec's disappointment with the BBR's attitude, and more specifically, emphasizing that the BBR should have notified Héma-Québec sooner that it had to deal with another authority.
(Action: FD)

The Board of Directors reiterated its willingness to proceed with implementation of the anti-HBc screening tests.

Consequently, it was proposed, duly seconded and resolved that the resolution entitled "Reiteration of Board of Directors' willingness to implement anti-HBc screening tests" be adopted.

4.3. Stable product management: letter to National Advisory Committee on Transfusion Medicine (NACTM)
As requested by the Board of Directors at its last meeting, the Executive Director sent a letter to the NACTM on September 10, 2001 to make them aware of the high increase in the cost of stable products. No response has been received yet.

4.4. Invoicing hospitals: letter to Minister of State for Health and Social Services
Further to the members' request, on August 14, 2001 the Executive Director sent a letter to the Minister of State for Health and Social Services to advise them that Héma-Québec is ready to begin invoicing hospitals. The acknowledgment of receipt was submitted for information purposes.

4.5. Relocation of Québec City facility
The Senior Director, Finance and Administration, summarized the talks that have been held to date with the administration of Université Laval. This matter has been presented to Université Laval's executive committee and board of directors, who have given their support to pursue the matter.

Héma-Québec must now present a detailed plan of its needs to the persons in charge at Université Laval so that they can prepare an official proposal. Héma-Québec has thus set up the Québec construction steering committee.

Lastly, the Executive Director indicated that Héma-Québec would develop an alternate plan for relocating the Quebec City facility.
(Action: FD)

4.6. Public Board of Directors meeting
The public meeting initially planned for September 12, 2001 was cancelled due to the WTC attack on September 11, 2001.

Following discussion, the members of the Board of Directors agreed to reconsider the format for the public meeting. The members of the Board will discuss a formula again. Several suggestions were made: discuss this matter again with the Liaison Committee; replace the meeting with an annual press briefing and enhance Héma-Québec's publications and web site.
(Action: FD)

The public meeting has been postponed to April 3, 2002.

It was proposed, duly seconded and unanimously resolved that the next public meeting be postponed to April 3, 2002.

5. Report on the week of September 11, 2001
The Executive Director listed the main actions Héma-Québec has taken in the wake of the September 11, 2001, terrorist attacks in the US.

Immediately following the events of September 11, 2001, Héma-Québec set up an emergency committee that has met twice a day until September 14, 2001. This emergency committee - made up of members of the Executive Committee, the Director, Québec City Facility Operations, and the Director, Industrial Safety - was mandated to assess the situation and keep abreast of the latest developments in order to respond quickly in an emergency.

More than 9,565 donors went to Héma-Québec clinics that week ? compared with about 5,000 donors in a normal week. Donor centres and mobile clinics extended their opening hours.

Nevertheless, the US did not require any blood components from Canada.

The Executive Director indicated that a study has been requested to assess the impact of this extraordinary week on donation habits, particularly the numerous first-time donors who went to give blood during that time.
(Action: FD)

6. Submission of five-year plan
The Senior Director, Finance and Administration, submitted and commented on the 2002/2003-2006/2007 five-year plan which had already been distributed to members of the Board.

He explained that the plan must be approved by the Board of Directors, but in view of the cancellation of the September 12, 2001 meeting, it was sent to the Minister of Health and Social Services after it was approved by the Chairperson of the Board of Directors.

He said that an increase of 5,000 units of red blood cells per year is expected until 2006-2007. Members suggested an annual increase in terms of percentage rather than an absolute number for red blood cells.
(Action: GL)

It was proposed, duly seconded and unanimously resolved that the five-year plan be adopted as submitted (a copy of which is appended hereto).

7. Project follow-up

• Relocation
  Laboratories at 4045 Côte-Vertu Blvd.
  The relocation schedule is still being respected and the move is planned for May 2002.
  
  Place Versailles
  The donor centre will be relocated to Place Versailles. A new marketing concept has been adopted to promote this location. The opening date is planned for October 29, 2001.
• Invoicing
  The volumes for labile products were sent to the Minister of Health and Social Services.
• Thrombapheresis platelet bacteria culture
  Nothing new to report.
• Collective agreement negotiations
  Negotiations for collective agreements have been pushed back to March 2002.
• Application for Food and Drug Administration (FDA) licence
  Héma-Québec's application, which was filed earlier this year, was deemed valid by the FDA. Steps to obtain the licence are underway.
• Plasma self-sufficiency
  Héma-Québec has set up a working group to start this project.

8. Miscellaneous
8.1. November 2001 Ottawa conference on HIV and hepatitis transmitted through blood: Optimization of donor selection process
This conference has been organized jointly by Héma-Québec and the Canadian Blood Services, and will be held in Ottawa on November 7, 8 and 9, 2001. Three Héma-Québec Medical Affairs executives will speak at the conference. The conference invitation has been distributed to members of the Board.

8.2. Appointment of Dr. Jerry Teitel as Chairperson of the National Blood Safety Council
A letter from the federal Minister of Health, dated August 7, 2001, announcing the appointment of Dr. Jerry Teitel as chairperson of the National Blood Safety Council, was submitted for information purposes.

8.3. Adoption of Board of Directors' 2002 meeting schedule
A draft 2002 meeting schedule for Héma-Québec's Board of Directors was submitted and discussed by members of the Board.

It was proposed, duly seconded and unanimously resolved that the 2002 meeting schedule for Héma-Québec's Board of Directors be adopted (a copy of which is appended hereto).

8.4. Appointment of Safety Advisory Committee (SAC) observer
Further to the resignation of Dr. Réjean Paradis, administrator, on August 1, 2001, the position of observer in the Safety Advisory Committee needs to be filled.

It was proposed, duly seconded and unanimously resolved that Robert Bédard be appointed acting observer of the Safety Advisory Committee. He may be replaced by a member from the public health sector when he is appointed to the Board of Directors by the Québec government to replace Dr. Paradis.

8.5. National Safety Council, in Winnipeg on November 1 and 2, 2001
The Executive Director told Board members that the National Safety Council which should have been held in September 2001, has been rescheduled for November 1 and 2, 2001.

8.6. Submission of NACTM letter: Hemolink
The members of the Board of Directors read the August 23, 2001 acknowledgment of receipt from the chairperson of the NACTM regarding Hemolink.

8.7. Stable product budget - recommendation from the Canadian Hemophilia Society
A meeting of the Canadian Hemophilia Society's safety committee was held last week. Members of the committee shared their concerns about the significant cost increase for fractionation products, which - according to them - could have repercussions on procurement when Héma-Québec starts invoicing for blood products. The Canadian Hemophilia Society asked that the budget for stable products destined for hemophiliacs be separated from the total stable product budget.

The Executive Director indicated that the main problem currently lies in the fact that no organization knows the invoicing process that will be implemented by the Minister of Health and Social Services. In this context, Héma-Québec considers the Procurement and Financing Management Committee to be the best authority for the Canadian Hemophilia Society to address.

The Executive Director will draft a letter to the assistant deputy minister of Public Health on behalf of the Board of Directors advising him of the concerns that were raised, specifically those by the Canadian Hemophilia Society, and that Héma-Québec would like to obtain details on the implementation of blood product invoicing.
(Action: FD)

8.8. Liability insurance renewal
The General Counsel summarized the procedure for renewing Héma-Québec's liability insurance, which expired on September 28, 2001, including the government's decree to provide temporary coverage in the event that there is no coverage. She concluded by saying that Héma-Québec has renewed its coverage within the set deadline, but there was a very high increase in premiums.

Consequently, Héma-Québec will review its insurance structure this year and assess the possibility of implementing mechanisms to protect its insurance rates from market fluctuations.

9. Next meeting
The next meeting will be held on Wednesday, November 7, 2001, at 2:00 PM, at Auberge Saint-Antoine, 10 Saint-Antoine Street, Québec City.

10. Adjournment
It was unanimously resolved to adjourn the meeting at 5:25 PM.

Dr. André Lebrun
Vice-chairperson

Dr. Francine Décary
Secretary

RESOLUTION TO BE INTEGRATED INTO THE MINUTES OF THE HÉMA-QUÉBEC BOARD OF DIRECTORS MEETING OF OCTOBER 3, 2001
"Reiteration of the Board of Directors' willingness to implement anti-HBc screening tests"

WHEREAS on January 31, 2001, the Board of Directors accepted the Safety Advisory Committee's recommendation to implement anti-HBc screening tests after a review of the impact of these tests on procurement, and mandated management to proceed to analyze the various implementation scenarios;

WHEREAS on June 6, 2001, the Board of Directors had analyzed the anti-HBc implementation options which were presented to them and selected the option to conduct these tests on new donors and reintegrate them on the basis of one positive anti-HBs test;

WHEREAS on September 27, 2001, Héma-Québec management presented the selected option to the Bureau of Biologics and Radiopharmaceuticals (BBR);

WHEREAS during this meeting, Héma-Québec management was notified by the BBR that this was a matter for the Medical Devices Bureau;

WHEREAS the Board of Directors is of the opinion that Héma-Québec must proceed with implementation of the anti-HBc screening tests;

IT IS RESOLVED:

• To reiterate the Board of Directors' willingness to implement anti-HBc screening tests as soon as possible;
• To mandate management to take the necessary measures to follow up on the Board of Directors' resolution to implement anti-HBc screening tests, according to the formula adopted by the Board of Directors on June 6, 2001.