October

Minutes of the thirteenth meeting of the Board of Directors of Héma-Québec

Held at the Queen Elizabeth Hotel, 900 Blvd. René-Lévesque West, in Montréal on Wednesday, October 13, 1999 at 2:00 p.m. (translation)

Present:
Mr. Raymond April
Dr. O'Donnell Bédard
Mr. Robert Bédard
Ms. Sheila Comerford
Dr. Denis Cournoyer
Dr. Francine Décary
Dr. Louis R. Dufresne
Dr. André Lebrun
Dr. Réjean Paradis
Mr. Claude Pichette
Ms. Diane Roy (Observer, Chair of the Haemovigilance Committee)
Dr. Yves St-Pierre
Ms. Cheryl Campbell Steer

Guests:
Ms. Hél¾ne Akzam
Human Resources Director, Héma-Québec
Me Smaranda Ghibu
Legal Counsel, Héma-Québec
Mr. Guy Lafreni¾re
Senior Director, Finance and Administration, Héma-Québec

Mr. Julien Ponce
Partner Morneau Sobeco
Mr. André Sauvé
Partner Morneau Sobeco

1. Opening of meeting
Mr. Claude Pichette chaired the meeting. He welcomed the members. Quorum being present, the meeting began at 2:00 p.m.

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":

12.3 Minutes of the meeting between Héma-Québec representatives and groups of people with AIDS
12.4 Next meeting of the Scientific and Medical Advisory Committee
12.5 Next meeting of the Safety Advisory Committee
12.6 Five-year plan
12.7 Terms of the members of Héma-Québec's Board of Directors
12.8 Exchange of observers between Héma-Québec and Canadian Blood Services
12.9 Follow-up of the meeting between the Minister of State for Health and Social Services and the Haemovigilance Committee

3. Adoption of the minutes of the twelfth meeting held on September 1, 1999
It was proposed, duly seconded and unanimously resolved that the minutes of the twelfth meeting of the Board of Directors held on September 1, 1999 be adopted.

4. Adoption of the minutes of the public meeting held on September 1, 1999
It was proposed, duly seconded and unanimously resolved that the amended minutes of the public meeting held on September 1, 1999 be adopted.

5. Business arising from the minutes of the twelfth meeting
5.1. vCJD update
The Executive Director informed the Board of Directors that the exclusion criteria for donors who have sojourned in the United Kingdom was implemented effect as of September 30, 1999. She reminded members that Héma-Québec's policy is to exclude from giving blood any person who has sojourned for more than one (1) month, on a cumulative basis, in the United Kingdom since 1980. Also, plasma from donors who have sojourned in the United Kingdom, regardless of the length of the stay, is not sent to Bayer for fractionation.

The exclusion procedure thus far has not created any significant problems. The exclusion rate is similar to what was expected.

In response to a question raised at the last meeting, the Executive Director submitted a copy of the Blood Donation Questionnaire, indicating that the issue of sojourns in the United Kingdom is separate from issues concerning classic Creutzfeldt-Jakob disease.

With respect to Héma-Québec's role in notifying patients who received blood products prepared from previous donations by a donor who had sojourned for more than one (1) month in the United Kingdom, it was recommended that Héma-Québec consult its Safety Advisory Committee and the Haemovigilance Committee for guidance on the appropriate course of action under these circumstances.
(Action: F.D.)

Members of the Board of Directors continued to discuss classic Creutzfeldt-Jakob disease and the delay incurred by the Bureau of Biologics and Radiopharmaceuticals in amending its policy on recalling products when a donor is diagnosed with classic Creutzfeldt-Jakob disease. They expressed their concern regarding a possible product recall by Health Canada and referred to the recall that occurred in December 1998. It was recommended that the Board of Directors forward a letter to Health Canada to urge the agency to be diligent in this matter and to publish its amended policy.

As a result,

it was proposed, duly seconded and unanimously resolved that the "Request to the Bureau of Biologics and Radiopharmaceuticals (BBR) - product recall" resolution, a copy of which is attached hereto, be adopted as presented.
(Action: F.D.)

The Bayer insert must be checked to see if any changes were made regarding the possibility of transmitting the infectious agent of Creutzfeldt-Jakob. (Action:F.D.)

5.2. Retroffiting the ventilation/air conditiong/heating systems - Response from supplier in writing
The Executive Director briefly summarized the issue. On September 14, 1999, Héma-Québec received a response from the architect regarding the September 7, 1999 letter sent by the Executive Director on behalf of the Board of Directors. After reviewing the architect's response and the related circumstances, the Board of Directors recommended that the issue be closed.

5.3. National Blood Safety Council The Executive Director delivered a positive report on Héma-Québec's performance at the National Blood Safety Council meeting on October 7 and 8, 1999. The members of the Board of Directors who attended offered their comments.
5.4. Joint meeting of the boards of directors of Héma-Québec and Canadian Blood Services
The Chairman invited members of the Board of Directors to comment on the joint meeting of the boards of directors of Héma-Québec and Canadian Blood Services held earlier in the day.

It was suggested that more time be allotted to exchanges between members of the two boards of directors at the next joint meeting.

It was also recommended that the meeting be held for one (1) entire day rather than only half a day.

It was also suggested that the coordinator for the Quebec Blood Supply System Secretariat be invited to the next meeting of the Board of Directors to answer members' questions about the entry procedure for new fractionated products into Québec. The Secretary of the Board of Directors was also asked to follow up on the issue with the Assistant Deputy Minister for Public Health.
(Action: F.D.)

6. Amendment to General By-Laws (duration of Chairman's and Vice-President's terms)
The duration of the Chairman's and Vice-President's terms are not stipulated in the Act respecting Héma-Québec and the haemovigilance committee or in Héma-Québec's General By-Laws.

Following a discussion,

it was proposed, duly seconded and unanimously resolved that the "Amendment to the General By-Laws (duration of Chairman's and Vice-President's terms)" resolution, a copy of which is attached hereto, be adopted as presented.

7. Compensation Policy for non-union personnel
The Senior Director, Finance and Administration, and the Human Resources Director presented the principles behind the compensation policy for non-union Héma-Québec personnel.

When Héma-Québec began its operations on September 28, 1998, it incorporated Québec personnel from the Canadian Red Cross Society's Blood Services, which had recently undergone restructuring. Some of the jobs were classified according to national Red Cross standards and others were classified according to provincial Red Cross standards.

In order to offer equitable compensation to its non-union personnel, and following a call for tenders, Héma-Québec hired Morneau Sobeco to review its direct compensation policy and structure with respect to market standards and wage equity.

The Human Resources Director outlined the actions taken thus far with respect to direct and indirect compensation and addressed possible choices and alternatives. The Human Resources Director also presented the total cost of implementing the wage scale. The Senior Director, Finance and Administration notified members that the 1999-2000 budget includes the funds required to implement the policy.

Board members requested further details on some policy issues, such as the compensation of doctors working for Héma-Québec. Members also inquired about the type of companies used in the market study.

Following a discussion, it was proposed, duly seconded and unanimously resolved that the "Compensation policy for non-union personnel" resolution, a copy of which is attached hereto, be adopted as presented.

8. Order 1102-99 regarding the remuneration of the members of Héma Québec's Board of Directors
Order 1102-99, regarding the remuneration of the members of Héma-Québec's Board of Directors, took effect on September 22, 1999. The Chairman invited Legal Counsel to explain the interpretation of the order to the members of the Board of Directors.

Following a discussion, it was suggested that a form be prepared that can be filled out for remuneration purposes by those members of the Board of Directors who are affected by the ruling.

The Secretary noted the Chairman's determination in dealing with this matter with the Minister of State for Health and Social Services.
(Action: G.L.)

9. Construction of laboratories
The Executive Director invited the Senior Director, Finance and Administration to present this matter to the members of the Board of Directors.

In 1995, the Bureau of Biologics and Radiopharmaceuticals determined that the building located at 3131 Sherbrooke East no longer met the operating space standards.

The relocation project for the laboratories and production sites to 4045 Blvd. Cte-Vertu had been planned as early as 1997 and 1998 by the Canadian Red Cross Society. The project included the expansion of the laboratories and setting up a site large enough for the shipping department.

At that time, many factors made the relocation essential, namely operations, the regulatory environment, municipal regulations and financial considerations.

On September 28, 1998, Héma-Québec acquired from the Canadian Red Cross Society the building located at 4045 Blvd. Cte-Vertu in Saint-Laurent. Héma-Québec thereby relaunched the laboratory relocation project and made several fundamental changes and additions after the implementation of nucleic acid amplification testing and leukoreduction procedures.

The Senior Director, Finance and Administration presented the Management Committee's proposal to the members of the Board of Directors.

Following a discussion about the choice of a proposal and the assurance that the building will not be faced with further expansion requests in the next year,

it was proposed, duly seconded and unanimously resolved that the "Construction of laboratories" resolution, a copy of which is attached hereto, be adopted as presented.

10. Visual identification of the Government of Québec and its governmental logo
The Executive Director invited Legal Counsel to present this issue.

By way of a letter dated September 7, 1999, the Government of Québec informed Héma-Québec that as of June 23, 1999, the Conseil des ministres had adopted by order a new direction and new guidelines with respect to the visual identification of the Government of Québec and its governmental logo. The change was intended to enable the government to communicate in a more efficient, visible and coherent manner with citizens. The regulation applies to all government ministries, agencies and businesses. Héma-Québec is therefore subject to the order.

Given the importance of maintaining and enhancing Héma-Québec's visibility in ensuring that blood and blood product supply levels are sufficient to meet hospital needs, it was recommended that Héma-Québec not be subject to the order so that its visibility can be guaranteed through its name and logo, so that it remains independent from the government, as recommended by Justice Horace Krever, and so that it conforms with the Act, which stipules that Héma-Québec is not a government mandatary.

Following a discussion, it was proposed, duly supported and unanimously resolved that Héma-Québec apply to the Government of Québec for an exemption from Order 770-99 adopted on June 23, 1999.
(Action: S.G.)

11. Update on current projects
The Executive Director distributed a current project chart, commented on progress and answered members' questions.

It was suggested that the next meeting include a demonstration of the MAK PROGESA software for the members of the Board of Directors.
(Action: F.D.)

12. Miscellaneous
12.1. Letter from a donor dated September 17, 1999
The Executive Director gave a brief summary of the issue to members of the Board of Directors. The donor, who was excluded by the Canadian Red Cross Society in 1998, requested that Héma-Québec accept him as a donor under a name other than his own. It was suggested that this issue be submitted to the Safety Advisory Committee for comment by committee members before a policy can be established.
(Action: F.D.)

12.2. Letter from the Human Rights Commission
The Executive Director invited Legal Counsel to present this issue. Héma-Québec received a letter dated September 28, 1999 from the Human Rights Commission indicating that the complaint against Héma-Québec, filed with the Commission by Mr. Pinon, was judged to be admissible and that, as a result, an inquiry would begin in accordance with sections 74 and following of the Charter of Human Rights and Freedoms. A representative from the Commission will soon communicate with Legal Counsel on this matter. All members were aware of the importance of this matter in terms of supply safety.

12.3. Minutes of the meeting between Héma-Québec representatives and groups of people with AIDS
The Executive Director summarized the meeting between Héma-Québec representatives and groups of people with AIDS. The objective of the meeting was to discuss possible communication methods with homosexual groups with respect to criteria regarding the exclusion of men who have had sexual relations with other men since 1977. The stakeholders consulted expressed their disagreement with this policy, but they also stressed that the homosexual community is already acutely aware of the importance of the matter, given the tragic experiences of the early 1980s. However, they indicated that young people are more difficult to reach. Finally, they stated that communication regarding this criteria would be extremely sensitive and would likely have little effect.

The Executive Director informed members of the Board of Directors that the public relations department is studying the matter and will attempt to formulate the best communication strategy in this regard.

12.4. Next meeting of the Scientific and Medical Advisory Committee
The next meeting of the Scientific and Medical Advisory Committee will take place on October 26, 1999 (all day) and October 27, 1999 (half-day) in Quebec City. The proposed agenda was submitted.

12.5. Next meeting of the Safety Advisory Committee
The next meeting of the Safety Advisory Committee will take place on November 29, 2999 at Héma-Québec's offices located at 4045 Blvd. Cte-Vertu in Saint-Laurent.

The Executive Director read the proposed agenda. The Executive Director informed the members of the Board of Directors that, according to recommendation 13 of the Krever report, external audits (in addition to those of the Bureau of Biologics and Radiopharmaceuticals) must be carried out on a regular basis. The Board of Directors asked the Safety Advisory Committee to submit the names of people (auditors), preferably from other countries, who could carry out an operational audit.

Moreover, it was suggested at the National Blood Safety Council's last public debate that the same auditors be used for Canadian Blood Services and Héma-Québec. The Executive Director will bring the suggestion up with the CEO of Canadian Blood Services.
(Action: F.D.)

12.6. Five-year plan
Section 29 of the Act respecting Héma-Québec and the haemovigilance committee states that Héma-Québec must prepare three-year budgetary forecasts and forward them to the Minister annually. However, according to the terms of the government reporting entity, the Conseil du Trésor requires that Héma-Québec submit five-year budgetary forecasts to the Minister of State for Health and Social Services.

Following a discussion between the members of the Board of Directors,

it was proposed, duly seconded and unanimously resolved that Héma-Québec accept the requirement by the Minister of State for Health and Social Services and prepare five-year budgetary forecasts without prejudice to Héma-Québec's actions in obtaining the status of a government enterprise in accordance with the Auditor General Act.

12.7. Terms of members of Héma-Québec's Board of Directors
The Executive Director stated that the terms of certain members of the Board of Directors will expire on March 31, 2000. She mentioned that the process has begun at the Minister's office. Those members wishing to be reappointed to the Board of Directors of Héma-Québec must take the necessary steps with the groups that recommended them to the government in this regard.

12.8. Exchange of observers between Héma-Québec and Canadian Blood Services
Board members commented on the discussion with the members of the Board of Directors of Canadian Blood Services at the joint meeting. The discussion addressed the issue of exchanging observers following the letter from the President of the Canadian Hemophilia Society, dated July 19, 1999.

Following a discussion, it was proposed, duly seconded and resolved by a majority vote, with the dissent of Ms. Sheila Comerford, to maintain the position adopted previously whereby no exchange of observers will take place at the moment between the boards of directors of Héma-Québec and Canadian Blood Services. This decision may be revised should the need arise.

It was also proposed, duly supported and unanimously resolved that the position of Héma-Québec and Canadian Blood Services with respect to the reciprocal means of communication in place between the two organizations, namely that two annual joint meetings be held, in addition to regular meetings between the Executive Director of Héma-Québec and the CEO of Canadian Blood Services, be reaffirmed.
(Action:F.D.)

12.9. Follow-up of the meeting between the Minister of State for Health and Social Services and the Haemovigilance Committee
The Observer, Chair of the Haemovigilance Committee, briefly summarized the meeting between the Haemovigilance Committee and the Minister of State for Health and Social Services, held on September 10, 1999.

The discussion included the means of communication between the Haemovigilance Committee, the Minister of State for Health and Social Services and the public. The meeting was considered to be very productive.

13. Next meeting
The next meeting will be held on November 3, 1999 in Quebec City.

14. Adjournment
It was unanimously resolved that the meeting be adjourned at 6:15 p.m.

Mr. Claude Pichette
Chairman

Dr. Francine Décary
Secretary

RESOLUTION THAT FORMS PART OF THE MINUTES OF THE HÉMA-QUÉBEC BOARD OF DIRECTORS' MEETING HELD ON OCTOBER 13, 1999
Request to the Bureau of Biologics and Radiopharmaceuticals (BBR) - Product recall

WHEREAS the Bureau of Biologics and Radiopharmaceuticals (BBR) issued a policy statement in November 1995 regarding classic Creutzfeldt-Jakob disease, stipulating that the blood and blood products supplier must recall products made from a donor's previous blood donations as soon as the supplier learns that the donor in question has developed classic Creutzfeldt-Jakob disease;

WHEREAS in December 1998, Héma-Québec was informed that a plasma donor from Utah had developed classic Creutzfeldt-Jakob disease and, in accordance with guidelines from the Bureau of Biologics and Radiopharmaceuticals, Héma-Québec quarantined all products made from donations by this donor;

WHEREAS on December 24, 1998, the Bureau of Biologics and Radiopharmaceuticals informed Héma-Québec that the quarantined products could be removed from quarantine, notwithstanding the 1995 guideline;

WHEREAS the FDA issued a guideline in August 1999 describing, among other things, the exact measures to be taken with respect to the recall of products from donors with the classic form of Creutzfeldt-Jakob disease or who present risk factors for the disease. In particular, the FDA does not recommend the recall of products from donors who have developed classic Creutzfeldt-Jakob disease;

WHEREAS the Bureau of Biologics and Radiopharmaceuticals has not yet issued guidelines specifying what measures should be taken with respect to the recall of products from donors who have developed classic Creutzfeldt-Jakob disease, and since the 1995 guideline is still in effect, we must begin recalling products from donors who have developed classic Creutzfeldt-Jakob disease;

IT IS RESOLVED:

THAT the Board of Directors of Héma-Québec formally request that the BBR explains in detail its position regarding the recall and/or quarantine of products from donors who have classic Creutzfeldt-Jakob disease or who present risk factors for the disease and to modify its guidelines issued in 1995, where appropriate, with the purpose of avoiding further situations such as that of December 1998, as described above.

RESOLUTION THAT FORMS PART OF THE MINUTES OF THE HÉMA-QUÉBEC BOARD OF DIRECTORS' MEETING HELD ON OCTOBER 13, 1999
"Amendment to General By-Laws" (Duration of Chairman's and Vice-President's terms)

WHEREAS the Act respecting Héma-Québec and the haemovigilance committee states in section 10 that the members of the Board of Directors designate a Chairman and Vice-President from among their number;

WHEREAS on October 7, 1998, the members of the Board of Directors elected Mr. Claude Pichette as Chairman of the Board of Directors;

WHEREAS on November 4, 1998, the members of the Board of Directors elected Dr. André Lebrun as Vice-President of the Board of Directors;

WHEREAS the duration of the Chairman's and Vice-President's terms is not stipulated in the Act respecting Héma-Québec and the haemovigilance committee or in Héma-Québec's General By-Laws;

WHEREAS the members of the Board of Directors wish to amend the General By-Laws in order to specify the duration of the Chairman's and the Vice-President's terms;

WHEREAS in accordance with section 30 of the General By-Laws, the directors may, by way of a resolution, modify any by-law regarding the business practices of Héma-Québec;

IT IS RESOLVED:

THAT the General By-Laws be amended in order to include a new section 15, which will read as follows:

"15. Duration of the Chairman's and Vice-President's terms. The members of the Board of Directors designate a Chairman and Vice-President from among their number; the Vice-President shall chair the Board of Directors when the Chairman is absent or unable to act.

The Chairman and the Vice-President are elected by a quorum of members by a simple majority vote.

The Chairman and the Vice-President are elected for a term of not more than two (2) years. Upon the expiry of their term, they shall remain in office until replaced or reappointed."

RESOLUTION THAT FORMS PART OF THE MINUTES OF THE HÉMA-QUÉBEC BOARD OF DIRECTORS' MEETING HELD ON OCTOBER 13, 1999
"Compensation policy for non-union personnel"

WHEREAS Héma-Québec must determine the standards and scales governing the compensation of non-union personnel in order to adopt a by-law on this matter as stipulated in section 19 of the Act respecting Héma-Québec and the haemovigilance committee;

WHEREAS at its creation, Héma-Québec integrated the Québec personnel of the Canadian Red Cross Society's Blood Services;

WHEREAS in order to ensure an equitable compensation for its non-union personnel, Héma-Québec hired Morneau Sobeco, following a call for tenders, to revise its direct compensation policy and structure;

WHEREAS the job ranking factors used (qualifications, responsibilities, effort and work environment) correspond to those of the pay equity legislation in effect;

WHEREAS Héma-Québec has revised the working conditions of non-union personnel in order to standardize the laws in effect and ensure they are enforced;

IT IS RESOLVED:

THAT Héma-Québec adopt the compensation policy for its non-union personnel, as presented to the Board of Directors.

RESOLUTION THAT FORMS PART OF THE MINUTES OF THE HÉMA-QUÉBEC BOARD OF DIRECTORS' MEETING HELD ON OCTOBER 13, 1999
"Construction of laboratories"

WHEREAS Héma-Québec must proceed with the construction of laboratories and production sites at 4045 Blvd. Cte-Vertu in Saint-Laurent;

WHEREAS in 1995, the Bureau of Biologics and Radiopharmaceuticals (BBR) considered that the building at 3131 Sherbrooke Street East in Montréal did not meet operating space requirements and stated as much in an audit;

WHEREAS Héma-Québec made several changes and basic additions to the program and the concept of the project that had been planned in 1997 and 1998 by the Canadian Red Cross Society, in particular with respect to the preparation of blood drives, the unloading platform, receiving and centrifugation, production, quarantine, call rooms (verification), products ready for hospital delivery, shipping, blood bank and virology laboratories, the immunobiology laboratory, storage, air-conditioned storage, the central corridor, the office building, mechanical and electrical rooms, the building enclosure and the exterior of the building;

WHEREAS Héma-Québec wishes to integrate new technologies into the production and analysis of blood products;

IT IS RESOLVED:

THAT Héma-Québec proceed with the construction of the laboratories according to the following criteria:

The above is described in further detail in the conceptual design report prepared by NFOE architects, Pellemon Inc. and Calculatec Inc. dated July 21, 1999 (scenario Y).