December

Minutes of the thirty-seventh meeting

Held at 4045 Côte-Vertu Blvd., Saint-Laurent, in the Boardroom, on Wednesday, December 5, 2001,
at 2:00 PM (translation)

Present:
Ms. Sheila Comerford
Dr. Denis Cournoyer
Dr. Francine Décary
Dr. André Lebrun
Dr. Jean Montreuil
Mr. Claude Pichette
Dr. Yves St-Pierre
Ms. Cheryl Campbell Steer

Observer:
Mr. Jean-Guy Lorrain (Hemovigilance Committee)

Absent:
Mr. Raymond April
Mr. Robert Bédard
Dr. Louis Dufresne

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

1. Opening of meeting
Claude Pichette chaired the meeting. He welcomed the members. Quorum being established, the meeting began at 2:10 PM.

2. Adoption of agenda
It was proposed, duly seconded and unanimously resolved that the agenda be adopted as submitted.

3. Adoption of minutes of the thirty-sixth meeting held on November 7, 2001
It was proposed, duly seconded and unanimously resolved that the minutes of the thirty-sixth meeting of the Board of Directors held on November 7, 2001, be adopted as submitted.

4. Business arising from the minutes of the thirty-sixth meeting
4.1. vCJD: impact of new exclusion criteria on clinics
The Executive Director presented the impact on operations of the new exclusion criteria for vCJD, implemented on October 1, 2001.

In total, 1.9% of donors were excluded during the month of October 2001 because of stays in the U.K., France or Western Europe. Furthermore, 4.9% of donors had spent less than one month in the U.K. Since the introduction of the new questions regarding vCJD, there has not been any increase in reports of non-compliance at clinics, nor complaints from donors regarding these questions.

4.2. Anti-HBc: steps taken with Bayer regarding anti-HBs rate in plasma destined for fractionation
At the last Board meeting, the Executive Director indicated that Héma-Québec had received an initial response from Bayer about the required anti-HBs rate for plasma destined for fractionation.

The parties have since communicated several times and Bayer representatives from the U.S. will meet with Héma-Québec representatives on December 11, 2001 to discuss the problem and propose solutions. This meeting will be followed up with members at the next Board meeting.
(Action: FD)

4.3. Relocation of Québec City facility: update on talks
Since the last Board meeting, Héma-Québec representatives have met with Université Laval representatives who should provide a definitive answer concerning the construction of a Héma-Québec facility on the Université Laval campus by mid-November. During this meeting, Université Laval representatives indicated that a final answer will not be available until March 2002. Due to this new delay, Héma-Québec management is actively seeking alternative solutions and plans to extend its lease for the current location.
(Action: GL)

4.4. Stable products budget: letter to assistant deputy minister of Public Health
The Executive Director and recipient representative should meet to discuss the content of the letter to the assistant deputy minister of Public Health about the stable products budget.
(Action: FD)

4.5. Héma-Québec by-law no. 2 regarding staff, the standards and scales governing the remuneration, employment benefits and conditions of employment of the personnel members.
On November 13, 2001, the Treasury Board approved the regulation that determines the standards and scales governing the remuneration, employment benefits and conditions of employment for non-unionized Héma-Québec employees. The regulation has been amended since it was presented to the Board to take into account applicable government standards.

In this decision, and pursuant to Article 37 of the Public Administration Act, the Treasury Board does not impose any additional conditions related to the determination, by Héma-Québec, of remuneration of employment benefits and conditions of employment for its non-unionized employees. Nevertheless, any subsequent modification of the regulation must be relayed to the Treasury Board within 30 days of adoption.

Approval of this regulation will permit the integration of salary class E and F, which was not done last year.

4.6. Case of bovine spongiform encephalopathy in Japan
Further to a question by a Board member at the last meeting regarding a case of bovine spongiform encephalopathy in Japan, excerpts of the October 2001 Regulatory Update from the American Association of Blood Banks and an excerpt from the ABC Newsletter from October 26, 2001 were submitted for information purposes. These publications confirm that there was one case of bovine spongiform encephalopathy in Japan, but does not recommend any exclusion measures as of this date.

5. Stable products
This item was added to the agenda by the Executive Director to allow her to provide an update to Board members regarding her meeting with the assistant deputy minister of Public Health. As this meeting was postponed, this item will be discussed at the next meeting.
(Action: FD)

Furthermore, Board members were apprised that Canadian Blood Services (CBS) and Héma-Québec launched a call for tenders for stable products on November 9, 2001.

As requested by the Board, Héma-Québec is a member of the steering committee whose mandate is to select stable product suppliers. Bids must be received by February 8, 2002 at the latest.

6. Modification of Héma-Québec's mission statement
Héma-Québec's mission statement was drafted on January 1998. After having presented the mission for more than three years, Héma-Québec management believes that a few changes could be made to improve the current version.

In the proposed version, references to scientific terms have been dropped, while references to efficiency specialized services and research and development have been added.

Board members discussed these new elements and also suggested some changes.

The Executive Director will resubmit the corrected version of Héma-Québec's mission statement at a next Board meeting.
(Action: FD)

7. Safety Advisory Committee
7.1. Recommendations from the meeting held on October 4, 2001
The Executive Director presented the recommendations of the Safety Advisory Committee (SAC) made during its October 4, 2001 meeting.

• Anti-HBc
  The SAC analyzed the difficulties in getting answers from Bayer about the anti-HBs rate required in plasma destined for fractionation. In view of the lack of a clear answer from Bayer, the SAC recommended a formal letter should be sent to Bayer notifying them that the absence of a response is delaying the implementation of a blood safety measure. Board members agreed with this recommendation.
  
  It was proposed, duly seconded and unanimously resolved that the SAC's recommendation be adopted, i.e., in view of the lack of a clear answer from Bayer regarding the anti-HBs rate required for plasma destined for fractionation, a formal letter will be sent to Bayer stating that the absence of a response is delaying the implementation of a blood safety measure. In addition, if no satisfactory answer is received from Bayer by the December 11, 2001 meeting, Board members ask that said letter be sent before the next Board of Directors' meeting on February 6, 2002.
  (Action: FD)
• Rh-negative plasma
  The labels on plasma bags that Héma-Québec delivers to hospitals do not indicate whether the plasma is Rh-positive or Rh-negative. A hospital in the Québec City area has asked that the plasma bags be labelled with an Rh factor. Members of the SAC consider there to be minimal risk of reaction when Rh-negative patients receive Rh-positive plasma and that there are other alternatives to Rh-negative plasma. They thus recommended that the Rh factor not be indicated on plasma bags. Members of the Board of Directors agree with this recommendation.
  
  It was proposed, duly seconded and unanimously resolved that the recommendation of the SAC not to indicate the Rh factor on plasma bags be adopted.
  (Action: FD)
• Simian foamy virus
  This matter was first presented to the Board of Directors on August 1, 2001. In order to make a decision, the Board decided, on that date, to submit the matter to the Héma-Québec advisory committees. The matter was discussed on October 4, 2001 at the SAC meeting and on October 20, 2001 during the Liaison Committee meeting.
  The Executive Director presented some of the foamy virus' characteristics, notably their low rate of replication in the host. Furthermore, she said that there is no evidence of illness in infected species. There have been no reports of infection via blood transfusion and a review of an infected person's previous blood donations show that none of the four recipients were infected. Finally, this virus resides in white blood cells, which are greatly reduced by the filtration of all labile products.
  In view of the preceding, the SAC and the Liaison Committee have deemed that the scientific data does not justify, at this time, the exclusion of persons exposed to non-human primates at work.
  
  It was proposed, duly seconded and unanimously resolved that the recommendations of the SAC and the Liaison Committee be adopted. Accordingly, donors who are exposed to non-human primates at work will not be excluded, considering the current scientific data.
• Blood clinics on the Island of Montréal
  In 1995, Justice Krever, who presided over the Commission of Inquiry on the Blood System in Canada, issued a recommendation in his interim report that the location of blood clinics must take into account the high risk of blood-borne diseases.
  Further to this recommendation, the Montréal Red Cross Centre conducted a study on the provenance of certain donations that were HIV positive and suggested not holding blood clinics in certain Montréal neighbourhoods where positive donors resided.
  Héma-Québec never questioned this position until now. However, by not holding clinics in these Montréal neighbourhoods, Héma-Québec is depriving itself of a large pool of healthy donors. Consequently, Héma-Québec management asked for a more exhaustive inquiry on the geography of blood donations from donors confirmed to be positive for HIV and hepatitis B and C.
  During the October 4, 2001 SAC meeting, the Medical Director, Microbiology and Epidemiology, presented a thorough study on the geography of blood donations and donors confirmed to be positive on the Island of Montréal.
  According to the results of this inquiry, there is no significant indication that geographical targeting of clinics on the Island of Montréal would have a major impact on the prevalence of virus markers.
  The results of this study as well as the methodology used were discussed on October 4, 2001 at the SAC meeting and on October 20, 2001 at the Liaison Committee meeting. In addition, the SAC considers the conclusions of the study to be applicable throughout Québec as the prevalence of positive donations outside Montréal is very low. However, the SAC asked for increased monitoring on the prevalence of positive donations in this territory. These committees have thus approved the conclusions of the inquiry and have recommended not taking geographical territory into account when planning clinics in Québec.
  
  After discussion, it was proposed, duly seconded and unanimously resolved that the recommendations by the SAC and the Liaison Committee not to take into account geographical territory when planning clinics in Québec be approved.

7.2. Modification of Safety Advisory Committee's mandate
Modifications to the SAC mandate in effect since its creation on December 2, 1998, are necessary. A modified version of the SAC mandate has been submitted for approval.

It was proposed, duly seconded and unanimously resolved that the modified version of the SAC mandate be adopted as submitted, a copy of which is appended hereto.

The Executive Director suggested transferring Dr. Paul Holland from the Scientific and Medical Advisory Committee (SMAC) to the SAC as Dr. Holland's fields of expertise match those sought for SAC members.

It was proposed, duly seconded and unanimously resolved that Dr. Paul Holland be transferred from the SMAC to the SAC, in order to appoint him a member of the SAC.

8. Liaison Committee
The Executive Director presented the recommendations the Liaison Committee made during its October 20, 2001 meeting.

• Informed consent - follow up on the Hemovigilance Committee Forum
  
  The Liaison Committee suggested sending a letter to hospitals recommending to them to distribute the brochure by the Minister of Health and Social Services (MHSS) entitled: Blood Transfusion - Answers to your questions. The Board members support this suggestion.
• Blood clinics on the Island of Montreal
  The recommendation of the Liaison Committee and the SAC was addressed in Item 7.1.
• Simian foamy virus
  The recommendation of the Liaison Committee and the SAC was addressed in Item 7.1.

9. Scientific and Medical Advisory Committee
9.1. Recommendations from the meeting held on October 31, 2001
The Executive Director presented the recommendations made by the SMAC during its October 31, 2001 meeting.

• Screening tests for vCJD
  The Executive Director announced that a vCJD screening test will be on the market within three years.
  Considering the ethical questions surrounding the implementation of this test, the SMAC recommended that the questions be considered by all interested parties at a consensus conference. The members of the Board of Administrators approved the SMAC's recommendation.
  
  It was proposed, duly seconded and unanimously resolved that the SMAC's recommendation to set up a consensus conference on the implementation of a vCJD test be approved.

9.2. Modification of Scientific and Medical Advisory Committee's mandate
Modifications to the SMAC mandate, which has been in effect since its creation on December 2, 1998, are needed. A modified version of the SMAC mandate has been submitted for approval.

It was proposed, duly seconded and unanimously resolved that the modified SMAC mandate be adopted as submitted, a copy of which is appended hereto.

10. Audit Committee
10.1. Appointment of new Audit Committee members
Further to the request made by the Chairperson of the Audit Committee, the Board of Directors appointed a new member to the Audit Committee.

It was proposed, duly seconded and unanimously resolved that Dr. André Lebrun be appointed a member of the Audit Committee. The terms of Robert Bédard, Raymond April and Cheryl Campbell Steer have been renewed for one year. The Audit Committee now has four members.

11. Follow up on Auditor General's comments
The Senior Director, Finance and Administration, commented on the document entitled "Rapport à la direction sur la vérification des livres et comptes pour l'exercice terminé le 31 mars 2001" (Report to management on the audit of books and accounts for the fiscal year ended March 31, 2001) and Héma-Québec's response to the Auditor General's comments.

The Board members declared themselves satisfied with this report and the actions taken by Héma-Québec in response to the Auditor General's comments.

12. National Blood Safety Council - Report of meeting held on November 1 and 2, 2001, in Winnipeg
The Executive Director summarized the meeting and the main items that were discussed.

13. Follow up on projects
The Executive Director gave an update on pending projects. Details are appended hereto. However, Board members discussed the following projects at greater length:

Construction 4045 Côte-Vertu
Schedule:

14. Miscellaneous
14.1. Recommendations from the National Advisory Committee on Transfusion Medicine (NACTM)
Board members read an October 31, 2001 letter from the chairperson of the NACTM regarding the NACTM's recommendations for Hemolink. The NACTM did not find any clinical indications for this product. However, once it has been approved, a discussion on special use can be started anew.

14.2. Submission of the minutes of the September 7, 2001 meeting of the National Advisory Committee on Transfusion Medicine
Further to the request of the Board members, the minutes of the September 7, 2001 NACTM meeting were submitted for information purposes.

14.3. Submission of the minutes of the February 2, 2001, April 6, 2001 and June 14, 2001 meetings of the Research Ethics Committee
Further to a request by Board members, the minutes of the Research Ethics Committee meetings held on February 2, April 6 and June 4, 2001, were submitted for information purposes.

14.4. Letter of resignation from Dr. Keith Stewart, Scientific and Medical Advisory Committee member
Board members noted the resignation of Dr. Keith Stewart from the SMAC, effective as of November 15, 2001.

15. Next meeting
The next meeting will be held on Wednesday, February 6, 2002, at 2:00 PM, at 4045 Côte-Vertu, Saint-Laurent.

16. Adjournment
It was unanimously resolved to adjourn the meeting at 5:45 PM.

Claude Pichette
Chairperson

Dr. Francine Décary
Secretary

Héma-Québec
Safety Advisory Committee

"It is recommended that, in addition to the customary committees of a corporate board of directors, the following standing committees be created to facilitate the work of the national blood service:

A safety committee, consisting of persons from the fields of infectious diseases, epidemiology, public health, medicine, and blood banking, as well as consumers. The purpose of the committee is to advise the board about the safety of the blood supply, including existing and emerging pathogens. It should also assist the board in the process of risk assessment."
___________________________
Justice Horace Krever, Commission of Inquiry on the Blood System in Canada, Final report, Volume 3, p. 1055.

Mandate

Advise the Board of Directors in a reasonable manner on matters concerning the safety of the blood supply, especially with regard to existing or emerging pathogens, and assist the Board in assessing risks:

• Monitor and report to the Board on international developments to ensure the quality and safety of blood products (new tests, viral inactivation, donor selection, other methods)
• Monitor, study and report to the Board on any emerging risk that could affect the quality and safety of blood products and the measures to be taken to eliminate or attenuate it, as the case may be
• Advise the Board on any other matter pertaining to reducing the risks associated with blood products
• Advise the Board on the scientific relevance of epidemiology research as well as its costs.

Composition

• The committee is composed of 10 voting members.
• The chair will be held by an external member and voted by members.
• Members shall sit for a renewable term of three (3) or five (5) years.
• At least two (2) members of the Héma-Québec Board of Directors shall sit as observers, but all members of the Héma-Québec Board shall be invited to attend meetings as observers, should they so wish.
• Some Héma-Québec employees are invited to attend meetings and to perform clerical duties for the committee.
• A donor representative will be appointed by the Association of Blood Donation Volunteers.
• A recipient representative will be appointed by the Liaison Committee.

The member selection process must take into account the following fields:

Fields
Infectious diseases
Public health
Transfusion medicine and practice
Recipient
Donor
Epidemiology
Ethical and legal advisor

Héma-Québec
Scientific and Medical Advisory Committee

"It is recommended that, in addition to the customary committees of a corporate board of directors, the following standing committees be created to facilitate the work of the national blood service:

A technical and scientific committee, to keep abreast of the frequent and rapid technical and scientific developments that affect the blood supply system. This committee should ensure that the board of directors always has current information about scientific developments. It should also advise the board about the expenditure of the research funds for the blood supply system and should monitor technical developments affecting the blood supply system, including alternatives to blood components and blood products, and methods of improving the safety and efficacy of blood components and blood products."
_____________________________
Justice Horace Krever, Commission of Inquiry on the Blood System in Canada, Final report, Volume 3, p. 1055.

Mandate

• Advise the Board of Directors on scientific and medical developments that might have an impact on the supply of blood components, derivatives and substitutes, particularly technological developments, therapeutic effectiveness and replacement products.
• Advise the Board of Directors on Héma-Québec's research and development programs and medical services.
• At regular intervals, assess the state of progress of Héma-Québec's research and development programs and medical services and advise the Board of Directors thereon.
• Advise the Board of Directors on Héma-Québec's policies and procedures for managing scientific and medical matters.

Composition

• The committee consists of 12 external voting members.
• The chair will be held by an external member and voted by members.
• Conflicts of interest (organization and intellectual property) must be avoided when choosing external members. In addition, external members must sign a confidentiality agreement.
• Members serve for a renewable term of three (3) or five (5) years.
• At least two (2) members of the Héma-Québec Board of Directors will serve as observers, however all members of the Héma-Québec Board of Directors are invited to attend meetings as observers if they so wish
• Some Héma-Québec employees are invited to attend meetings and to perform clerical duties for the committee.
• A representative from the recipient group will be appointed by the Liaison Committee.
• At the request of Héma-Québec, a representative from Canadian Blood Services will be appointed by the CBS.

The member selection process must take into account the following fields:

Fields
Transfusion medicine
Hematopoiesis
Plasma derivatives
Blood component manufacturing
Diagnostic technologies
Molecular biology
Immunology
Biotechnology
Industrial research

PROJECTS PENDING