May

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

Held at the Hilton Hotel, 12505, Côte de Liesse, Dorval on Wednesday, May 12, 1999 at 2 p.m. (translation)

Present:
Mr. Raymond April
Dr. O'Donnell Bédard
Mr. Robert Bédard (Observer, Chairman of ABDV Board of Directors)
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

Absent:
Ms. Sheila Comerford

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

1. Opening of meeting
Claude Pichette chaired the meeting. He welcomed the members. Quorum being present, the meeting began at 2:15 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 addition under Miscellaneous:

15.1 Meeting with the Minister of State for Health and Social Services

3. Adoption of the minutes of the seventh meeting, April 7, 1999
It was proposed, duly seconded and unanimously resolved that the minutes of the seventh meeting of the Board of Directors held on April 7, 1999 be adopted with the required amendments.

4. Recommendations 11 to 50 from the final Krever report
The Executive Director presented recommendations 11 to 50 from the final Krever report and explained Héma-Québec's steps in implementing them where appropriate.

5. Business arising from the minutes of the seventh meeting
5.1. Update on nvCJD following the National Blood Safety Council meeting (Vancouver, May 6-7, 1999)
The Executive Director informed the members of the Board of Directors of developments since the last Board of Directors' meeting on the subject.

On April 27, 1999, several Héma-Québec representatives met with Canadian Blood Services' representatives to inform them of Héma-Québec's position.

On May 4, 1999, Héma-Québec representatives met with Bureau of Biologics and Radiopharmaceuticals' (BBR) representatives and presented Héma-Québec's position on the exclusion of donors, adopted at the Board of Directors' meeting on April 7, 1999. During the meeting, the BBR presented the Executive Director with a letter stating that Héma-Québec and Canadian Blood Services must work together to create a coordinated proposal regarding exclusion criteria for the new variant Creutzfeldt-Jakob disease, which must then be presented to the BBR no later than June 10, 1999.

On May 5, 1999, the CEO of Canadian Blood Services informed Héma-Québec's Chairman that Canadian Blood Services has created an ad hoc advisory committee in order to establish the exclusion criteria for the new variant Creutzfeldt-Jakob disease. On the same day, both agencies issued press releases to the media with respect to the new variant Creutzfeldt-Jakob disease.

The National Blood Safety Council conducted a public forum on the new variant Creutzfeldt-Jakob disease on May 6 and 7, 1999 in Vancouver. The participants arrived at the conclusion that they must deal with the significant risk of a supply shortage while attempting to mitigate the theoretical risk of the nvCJD being a blood-borne disease. Scientific experts estimate that the risk of transmission of new variant Creutzfeldt-Jakob disease will not be known for at least two (2) years.

Following a lengthy discussion during which the risks to the blood supply and possible solutions were addressed, in addition to the BBR's request and Canadian Blood Services' position, it was proposed, duly seconded and unanimously resolved that the "New variant Creutzfeldt-Jakob disease - Exclusion of donors - Requests from the Bureau of Biologics and Radiopharmaceuticals" resolution, a copy of which is attached hereto, be adopted as presented.
(Action: FD)

5.2. Termination of contract with NGI - update
At the request of members of the Board of Directors, the Senior Director, Finance and Administration asked that NGI justify the contract termination costs. According to NGI's response, the amount requested corresponds to already incurred expenses in addition to shortfall costs (fixed costs, profit, etc.),

it was proposed, duly seconded and unanimously resolved that the "Costs related to the termination of the National Genetics Institute contract" resolution, a copy of which is attached hereto, be adopted as presented.
(Actiopn: FD)

5.3. Contract with Infectio Diagnostic Inc. - update
The Senior Director, Finance and Administration presented the prices for Infectio Diagnostic Inc.'s nucleic acid tests.

It was proposed, duly supported and unanimously resolved that the "Contract with Infectio Diagnostic Inc." resolution, a copy of which is attached hereto, be adopted as presented.
(Action: FD)

5.4. Joint meeting of the boards of directors of Canadian Blood Services and Héma-Québec - Agenda
The members were invited to inform the Executive Director of any issues they would like to add to the agenda for the joint meeting in October. Issues pertinent to both companies could be discussed, such as the implementation of MAK-SYSTEM's PROGESA software.
(Action: Board Members)

6. Personal liability of the directors of public health establishments
The members of the Board of Directors discussed several issues with respect to the directors' personal liability. A Director's first priority must be the interests of the establishment. Generally, directors are not personally liable for actions carried out in the course of their duties. They will only be held liable in specific situations, as stipulated by law.

7. Board of Directors' Advisory Committees - The Safety Advisory Committee Report
The President of the Safety Advisory Committee requested that the terms of the committee's mandate be amended in order to take into account the fact that committee members provide the Board of Directors with reasonable advice.

It was proposed, duly supported and unanimously resolved that the "Safety Advisory Committee's mandate," a copy of which is attached hereto, be adopted as presented.

8. Board of Directors' Advisory Committees - The Scientific and Medical Advisory Committee Report
This item is postponed until the next meeting, given that the Scientific and Medical Advisory Committee report is not available.
(Action: FD)

9. Héma-Québec Foundation
Since it began operating, Héma-Québec has been contacted by many individuals, estates and agencies wishing to make donations and bequests to Héma-Québec. Furthermore, the person in charge of the unrelated bone marrow donors registry has also received numerous offers of donations from participants, their families and corporate sponsors. Therefore, with absolutely no publicity or additional effort, Héma-Québec could have benefited from many donations.

According to its incorporation act, Héma-Québec may accept gifts, bequests, subsidies and/or contributions provided that any attached condition is compatible with the exercise of its functions. However, in order to issue tax receipts for these donations, Héma-Québec must register with Revenue Québec and Canada Customs and Revenue Agency as a charitable organization.

The members of the Board of Directors would prefer to create a foundation that is separate from Héma-Québec so that its charitable goals are not part of Héma-Québec's operations. The foundation's objective will be to finance certain activities, such as blood donation promotion, information programs and donor acknowledgment, transfusional medicine scholarships and practicums, and information and recruitment campaigns for the bone marrow donor registry. The foundation will also be able to offer financing to the Association of Blood Donation Volunteers.

It was proposed, duly seconded and unanimously resolved that the "Héma-Québec Foundation" resolution, a copy of which is attached hereto, be adopted as presented.
(Action: FD)

10. Serum Bank
The Serum Bank Committee was created and is currently working on the implementation of tests for serum bank samples.

The Haemovigilance Committee will soon finalize its notice to the Minister of State for Health and Social Services on advising the serum bank's positive donors. The provincial government has yet to officially confirm the budget allotted for the tests.

As soon as the Serum Bank Committee began its work, it realized the difficulties involved in preserving the samples once the tests have been conducted. In particular, if the samples must be preserved, the handling time of the samples must be tightly controlled for the samples to be kept at the required temperatures. To do this, additional personnel and equipment are needed. In short, the procedure would be extremely cumbersome, costly and more time-consuming. It was then suggested that the samples be destroyed after testing. The legal counsel obtained legal advice regarding the possibility of destroying the samples.

Moreover, the Federal Department of Justice asked to be informed of any destruction project of preserved samples in order to be able to take protective measures if necessary.

It was proposed, duly seconded and unanimously resolved that the "Serum Bank - Destruction of samples" resolution, a copy of which is attached hereto, be adopted as presented.
(Action: SG)

11. Creation of an executive committee
It was proposed, duly seconded and unanimously resolved that the "Creation of an executive committee" resolution, a copy of which is attached hereto, be adopted as presented.

12. Annual General Meeting
The annual general meeting will be held on September 1, 1999. It was suggested that the members of the Association of Blood Donation Volunteers and the public be invited.
(Action: FD)

13. Granting of roof-repair contract (office space)
It was proposed, duly seconded and unanimously resolved that the "Roof-repair contract (office space) at 4045 Cte-Vertu, Saint-Laurent" resolution, a copy of which is attached hereto, be adopted as presented.

14. Update on current projects
The Executive Director presented a chart of current projects and discussed their progress.

15. Miscellaneous
15.1. Meeting with the Minister of State for Health and Social Services
The Chairman informed the members that the two (2) vacant seats on the Board of Directors will soon be filled. The Chairman of the Association of Blood Donation Volunteers will be named representative of blood or plasma donors and of the volunteer blood drive organizers. Moreover, a private sector representative recommended by socio-economic groups will also be named shortly.

The issue of the distance between Héma-Québec and the government was also addressed and discussions will continue on the matter.

The Chairman also addressed the issue of compensating members of the Board of Directors for their loss of salary while attending meetings. The Minister of State for Health and Social Services will soon inform the Chairman of her decision on the matter.

Finally, the Minister of State for Health and Social Services informed the Chairman and the Executive Director that she is very satisfied with Héma-Québec.

16. Next meeting
The next meeting will be held on June 9, 1999 in Montréal at 2 p.m.

17. Adjournment
It was unanimously resolved that the meeting be adjourned at 8:30 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 MAY 12, 1999
"New variant Creutzfeldt-Jakob disease - Exclusion of donors - Requests from the Bureau of Biologics and Radiopharmaceuticals"

WHEREAS the final Krever report stated that:

• "The operator of the blood supply system must not only meet the standards set by the Health Protection Branch but exceed those standards whenever it believes that safety requires it to do so" (Commission of Inquiry on the Blood System in Canada, Mr. Justice Horace Krever - Final Report, p. 996);
• "It is recommended that the Bureau of Biologics and Radiopharmaceuticals accept manufacturers' or distributors' decisions to take actions that exceed the standards of safety set by the bureau" (supra, recommendation #32);

WHEREAS the Food and Drugs Act and its regulations and the Department of Health Act have created and now govern the Bureau of Biologics and Radiopharmaceuticals;

WHEREAS, at the present time, the risk of transmitting new variant Creutzfeldt-Jakob disease is restricted to persons who have travelled to the United Kingdom and not to France since virtually all cases were reported in the United Kingdom;

WHEREAS, on April 7, 1999, the Board of Directors of Héma-Québec resolved to support the following exclusions as a safety measure:

1. all plasma intended for fractionation received from donors who have sojourned in the United Kingdom for any length of time since 1980;
2. all donors of labile products who have sojourned for one (1) month or more in the United Kingdom on a cumulative or consecutive basis;

WHEREAS the above-mentioned exclusions are based on balancing the real risk to the blood supply that these exclusions might have and the management of a potential risk of transmitting new variant of Creutzfeldt-Jakob disease through blood;

WHEREAS the Bureau of Biologics and Radiopharmaceuticals requested, on May 4, 1999, that Héma-Québec and Canadian Blood Services prepare a coordinated proposal with respect to donors who have sojourned in the United Kingdom and that this proposal be submitted to the Bureau no later than June 10, 1999;

IT IS RESOLVED:

TO MANDATE Management:

a) to express again to Canadian Blood Services and the Bureau of Biologics and Radiopharmaceuticals that Héma-Québec supports, as a safety measure, the following exclusions:

1. all plasma intended for fractionation received from donors who have sojourned in the United Kingdom for any length of time since 1980;
2. all donors of labile products who have sojourned for one (1) month or more in the United Kingdom on a cumulative or consecutive basis;

b) to cooperate with Canadian Blood Services and the Bureau of Biologics and Radiopharmaceuticals in seeking a solution to the issue of excluding donors who have stayed in the United Kingdom in the context of new variant Creutzfeldt-Jakob disease;

c) to continue developing measures intended to attract more donors and improve donation frequency as well as any other measures needed to increase blood donations.

RESOLUTION THAT FORMS PART OF THE MINUTES OF THE HÉMA-QUÉBEC BOARD OF DIRECTORS' MEETING HELD ON MAY 12, 1999
"Costs related to the termination of the National Genetics Institute contract"

WHEREAS the Board of Directors decided to terminate the NGI contract on April 7, 1999 and gave Management the mandate of beginning to negotiate the costs related to the termination;

WHEREAS Management negotiated the costs related to the termination, which correspond to already incurred expenses and shortfall costs (fixed costs, profit, etc.);

WHEREAS the costs related to the termination of the NGI contract were presented to the Board of Directors for approval;

WHEREAS Héma-Québec will independently finance the cost associated with the termination of the NGI contract;

IT IS RESOLVED:

THAT the Executive Director be and is hereby authorized to terminate the service contract with NGI, sign any documents and take any other step she deems necessary or desirable, at her sole discretion, to give effect to the present resolution and to the terms and conditions included in the termination, and that the Executive Director's signature on the termination contract and any related document be irrefutable evidence that Héma-Québec has approved the signing of such documents.

RESOLUTION THAT FORMS PART OF THE MINUTES OF THE HÉMA-QUÉBEC BOARD OF DIRECTORS' MEETING HELD ON MAY 12, 1999
"Contract with Infectio Diagnostic Inc."

WHEREAS the Board of Directors decided to outsource nucleic acid tests ("NAT") to Infectio Diagnostic ("IDI") on April 7, 1999 and gave Management the mandate of signing an agreement in principle with Infectio Diagnostic Inc. and beginning to negotiate the terms and conditions of a service contract for NAT;

WHEREAS following the signature of the agreement in principle, Héma-Québec's management negotiated the cost of NAT and the members of the Board of Directors were thereof informed;

IT IS RESOLVED:

THAT the Executive Director be and is hereby authorized to sign a service contract with IDI for a duration of three (3) years for nucleic acid testing, including any amendments that might be made thereto, as she deems appropriate, and to sign any other document and take any step which, at her sole discretion, she might deem necessary or desirable to give effect to the present resolution and to the terms and conditions included in the said contract and documents, and that the Executive Director's signature on the contract and any related documents be irrefutable evidence that Héma-Québec has approved the signing of such documents.

RESOLUTION THAT FORMS PART OF THE MINUTES OF THE HÉMA-QUÉBEC BOARD OF DIRECTORS' MEETING HELD ON MAY 12, 1999
"Safety Advisory Committee's mandate"

WHEREAS the Safety Advisory Committee's mandate was adopted during the Board of Directors' meeting held on December 2, 1998;

WHEREAS the Safety Advisory Committee's first meeting took place on March 9, 1999;

WHEREAS the members of the Safety Advisory Committee requested at their meeting on March 9, 1999 that the description of the committee's mandate, in the first paragraph, be modified;

IT IS RESOLVED:

TO MODIFY the first paragraph of the Safety Advisory Committee's mandate so that it reads as follows:

"Provide reasonable advice to the Board of Directors regarding blood supply safety, particularly with respect to existing or emerging pathogens, and assist the Board of Directors in the process of risk assessment, particularly É"

RESOLUTION THAT FORMS PART OF THE MINUTES OF THE HÉMA-QUÉBEC BOARD OF DIRECTORS' MEETING HELD ON MAY 12, 1999
"Héma-Québec Foundation"

WHEREAS Héma-Québec may, under its incorporating act, accept gifts, bequests, subsidies or other contributions provided that any attached condition is compatible with the exercise of its functions (sections 4 and 25 of An Act respecting Héma-Québec and the haemovigilance committee);

WHEREAS Héma-Québec has been contacted on numerous occasions by individuals, estates and agencies that wish to make gifts or bequests to Héma-Québec;

WHEREAS it is desirable for Héma-Québec to benefit from gifts, bequests and other contributions;

WHEREAS it is preferable to create a distinct foundation whose charitable goals are clearly defined and separate from Héma-Québec operations;

IT IS RESOLVED:

TO CREATE a foundation;

THAT the Executive Director be and is hereby authorized to sign the incorporating documents for the said foundation, including any amendments that might be made thereto, as she deems appropriate, and to sign any other document and take any other step which, at her sole discretion, she might deem necessary or desirable to give effect to the present resolution, and that the Executive Director's signature on the incorporating documents and any other related document be irrefutable evidence that Héma-Québec has approved the signing of such documents.

RESOLUTION THAT FORMS PART OF THE MINUTES OF THE HÉMA-QUÉBEC BOARD OF DIRECTORS' MEETING HELD ON MAY 12, 1999
"Serum Bank - Destruction of samples"

WHEREAS the Serum Bank Committee was created to oversee the implementation of tests of Serum Bank samples;

WHEREAS there are practical difficulties in preserving samples after completing the tests, related to such issues as completion time, additional personnel and equipment and further handling of the samples;

WHEREAS Héma-Québec received legal advice regarding their obligation to preserve samples;

WHEREAS the Federal Department of Justice requests that it be informed of the destruction of any samples;

IT IS RESOLVED:

TO NOT PRESERVE samples after testing for hepatitis C. This is subject to possible protective measures the Federal Department of Justice may deem appropriate.

RESOLUTION THAT FORMS PART OF THE MINUTES OF THE HÉMA-QUÉBEC BOARD OF DIRECTORS' MEETING HELD ON MAY 12, 1999
"Creation of an executive committee"

WHEREAS An Act respecting Héma-Québec and the haemovigilance committee stipulates in section 17 that the Board of Directors may establish an executive committee composed of not fewer than five members of the Board of Directors, including the Chairman and the Executive Director, determine its functions and powers and fix the term of office of its members;

WHEREAS Héma-Québec's General By-Laws state, in sections 67 and thereafter, that the Board of Directors may create an executive committee of not fewer than five managers;

WHEREAS Héma-Québec's General By-Laws state, in section 70, that the rules that apply to the meetings of the Board of Directors will also apply to the committee, following any necessary changes;

WHEREAS the executive committee will exercise the authority conferred to it by the Board of Directors;

WHEREAS the executive committee will report on its activities to the directors, who may in turn reverse or modify the decisions made by the executive committee, subject to third-party rights;

IT IS RESOLVED:

TO APPOINT the following directors to the executive committee:

• Mr. Claude Pichette, Chairman
• Dr. Francine Décary, Secretary
• Dr. André Lebrun, Vice-President
• Dr. Louis R. Dufresne, Hospital Representative
• Dr. Réjean Paradis, Public Health Representative

THAT executive committee members are appointed for a term equal in duration to their mandate as members of Héma-Québec's Board of Directors;

THAT the executive committee holds the same powers as the Board of Directors with respect to Héma-Québec's normal activities;

THAT the executive committee exercises any other authority conferred to it by the Board of Directors;

THAT the notice for the executive committee's meetings must be issued to members at least one (1) working day before the day and time set for the meeting.

RESOLUTION THAT FORMS PART OF THE MINUTES OF THE HÉMA-QUÉBEC BOARD OF DIRECTORS' MEETING HELD ON MAY 12, 1999

"Roof-repair contract (office space) at 4045 Cte-Vertu, Saint-Laurent"

WHEREAS the roof of the building located at 4045 Cte-Vertu in Saint-Laurent shows several deficiencies:

• Watertightness of membrane;
• Leakage from several areas in the ceiling space on the third floor;
• Lack of thermal insulation on the roof and non-conformance of soakers;
• Accumulation of water on the roof caused by a lack of slopes leading to the roof's drain-holes;

WHEREAS repairing the roof above the office space for the building located at 4045 Cte-Vertu in Saint-Laurent is necessary;

WHEREAS Héma-Québec conducted a call for tenders without quotes in accordance with the guidelines established by the Treasury Board;

WHEREAS the selection committee, following a review of the tenders received, recommended that the roof-repair contract be awarded to Lemay & Associés;

WHEREAS the work will cost an estimated $455,000 ($395,600 excluding GST/QST) according to the payment-of-fee methods provided for under the Treasury Board guidelines;

WHEREAS the amount of $455,000 was approved by the Board of Directors as part of Héma-Québec's start-up/capitalization budget, which was in turn approved by the Treasury Board;

IT IS RESOLVED:

THAT Héma-Québec award the office space roof-repair contract to Lemay & Associés in consideration for an amount not exceeding $455,000 ($395,600 excluding GST/QST);

THAT the Executive Director be and is hereby authorized to sign the repair contract mentioned above, including any amendments that might be made thereto, as she deems appropriate, and to sign any other document and take any other step which, at her sole discretion, she might deem necessary or desirable to give effect to the present resolution and to the terms and conditions in the said contract and documents, and that the Executive Director's signature on the office space roof-repair contract and any other related documents be irrefutable evidence that Héma-Québec has approved the signing of such documents.