November

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

Held at the Québec Hilton Hotel, Salle Villeray, reception level at 1100 Blvd. René-Lévesque East in Québec City on Wednesday, November 3, 1999 at 2 p.m. (translation)

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

Absent:
Dr. O'Donnell Bédard
Dr. Louis R. Dufresne
Dr. André Lebrun

Guests:
Me Smaranda Ghibu
Legal Counsel, Héma-Québec
Mr. Guy Lafreni¾re
Senior Director, Finance and Administration, Héma-Québec
Mr. Michel Langevin
Director, Marketing and Supply, Héma-Québec
Ms. Suzanne Rémy Prince
Senior Director, Regulatory Affairs, Héma-Québec

1. Opening of meeting
Claude Pichette chaired the meeting. He welcomed the members. Quorum being present, the meeting began at 2:05 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":

15.1 Robert Bédard's nomination for the Governor General's Caring Canadian Award by the municipality of Charlesbourg
15.2 Héma-Québec Foundation
15.3 Scientific and Medical Advisory Committee It was agreed that item 10, "Negotiation mandates: renewal of collective labour agreements," be postponed to the next meeting.
(Action: F.D.)

3. Adoption of the minutes of the thirteenth meeting held on October 13, 1999
It was proposed, duly supported and unanimously resolved that the minutes of the thirteenth meeting of the Board of Directors held on October 13, 1999 be adopted with the required amendments.

4. Adoption of the minutes of the joint meeting between the boards of directors of Héma-Québec and Canadian Blood Services held on October 13, 1999
Since the minutes of the joint meeting were not available, they will be sent to the members of the Board of Directors for adoption at the next meeting.
(Action: F.D.)

5. Business arising from the minutes of the thirteenth meeting
5.1. vCJD update
5.1.1 Letters to the BBR regarding classic Creutzfeldt-Jakob disease and the product insert
On October 19, 1999, the Executive Director sent two letters to the Bureau of Biologics and Radiopharmaceuticals (BBR) regarding classic Creutzfeldt-Jakob disease, product recall, and the Bayer albumin insert.

5.2. Invitation to the Coordinator of the Québec Blood Supply System Secretariat
The Executive Director invited the Coordinator of the Québec Blood Supply System Secretariat to attend the Board of Directors' meeting in order to answer members' questions regarding the entry procedure for new fractionated products in Québec. Unfortunately, she was unable to attend the meeting today but confirmed her attendance at the next meeting of the Board of Directors, to be held on December 1, 1999.
(Action: F.D.)

5.3. Letter to the Ministry of State for Health and Social Services regarding fractionated products
The Executive Director informed members that the letter regarding the entry of new fractionated products into Québec will be sent to the Ministry of State for Health and Social Services before the next meeting.
(Action: F.D.)

5.4. Form for the members of the Board of Directors who will be remunerated
The remuneration form for the members of the Board of Directors was distributed. The members were satisfied with the form. However, it was suggested that the version date be indicated at the bottom of the form in order to track any changes.
(Action: S.G.)

5.5. Letter requesting an exemption concerning visual identification
The exemption request has not yet been completed. A request of this kind requires extensive research and Legal Counsel is currently addressing the matter. It was agreed that the request be submitted to the Board of Directors as quickly as possible.
(Action: S.G.)

5.6. Demonstration of the PROGESA software
The demonstration of the PROGESA software will take place at the next Board of Directors' meeting, to be held on December 1, 1999 at the Héma-Québec site in Ville Saint-Laurent.
(Action: F.D.)

5.7. Letter to the President of the Canadian Hemophilia Society regarding the exchange of observers between Héma-Québec and Canadian Blood Services
On October 27, 1999, following the joint meeting of the boards of directors of Héma-Québec and Canadian Blood Services, the Chairman of the Board of Directors answered the letter dated July 13, 1999 from the President of the Canadian Hemophilia Society and reaffirmed Héma-Québec's position: for the moment, there will be no exchange of observers between the two boards of directors. Two annual joint meetings of the boards of directors, in addition to regular monthly meetings between the Executive Director of Héma-Québec and the CEO of Canadian Blood Services will be held to ensure regular communication between the two companies.

5.8. Construction of laboratories (letter to the Coordinator of the Québec Blood Supply System Secretariat)
The Executive Director sent a letter dated October 19, 1999 to the Coordinator of the Québec Blood Supply System Secretariat informing her of the Board of Directors' decision regarding the relocation of the laboratories and production sites at 4045 Blvd. Cte-Vertu in Ville Saint-Laurent. A copy of this letter was distributed to the members.

6. Signatory authorization grid
The Senior Director, Finance and Administration presented the proposed 1999-2000 authorization grid and commented on additions and explanations by way of a comparison with the authorization grid adopted on September 24, 1998 by the interim Board of Directors.

The main additions are as follows:

• the wording of the various expense categories, in addition to levels of approval, were clarified, making the grid easier to consult;
• the wording identifying the various categories of signatories authorized to approve contracts of undeterminable value (ex. licenses, confidentiality agreements).

Following a discussion, the members agreed that the wording for the category entitled "Approval of negotiation mandates (collective labour agreements)" should be more inclusive. It was suggested that "and other working conditions" be added.

In response to members' concerns about expense control, the Senior Director, Finance and Administration explained that on a monthly basis, all managers receive a statement of expenses incurred by their departments for all the expense categories provided for in the budget.

With respect to Legal Counsel's involvement in the approval procedure of contracts of undeterminable value, Legal Counsel indicated to the members that depending on the materiality of waived rights or required responsibilities, the contract will be submitted to one of the following for approval: the Senior Director, the Executive Director or the Board of Directors.

Questions were raised regarding the category entitled "Litigation settlements" on the proposed authorization grid. Following a discussion, it was agreed that the quarterly claims report be submitted to the Board of Directors and that the authorization grid be modified in consideration thereof.
(Action: S.G.)

Finally, members stated they would like to create an Audit Committee made up of three administrators to whom the Senior Director, Finance and Administration would report and whose mandate is more fully described in the resolution entitled "Audit Committee," a copy of which is attached hereto.

It was proposed, duly supported and unanimously resolved that the proposed 1999-2000 authorization grid be adopted as amended, in accordance with section 60 of the General By-Laws.

It was also proposed, duly supported and unanimously resolved that the "Audit Committee" resolution, a copy of which is attached hereto, be adopted as presented.

7. Five-year plan
The Senior Director, Finance and Administration commented on the five-year plan requested by the Government of Québec. The plan was distributed to the members.

The five-year plan includes budget forecasts for the next five (5) years, taking into account an annual inflation rate of 18% for fractionated products and a $12M annual increase for new security-enhancing procedures.

It is proposed, duly supported and unanimously resolved that the five-year plan, a copy of which is attached hereto, be adopted as presented.

8. Pricing: 1999-2000
The Senior Director, Finance and Administration distributed a working paper on the pricing project to the members.

The target date for officially starting to bill hospitals is still April 1, 2000. However, the implementation of the information system in the hospital sector has proven longer than expected and this date may be postponed. Where appropriate, Héma-Québec proposes to proceed with hospital billings in order to prepare for the implementation of the process.

The Senior Director, Finance and Administration commented on the main issues of the pricing project, in particular, setting up unit costs, product pricing, price smoothing and the billing process.

Explanations were given concerning the gap between some of Héma-Québec's unit costs and those of Canadian Blood Services and the effect on the proposed pricing.

It was suggested that a research project evaluating the effect of pricing on the use of blood components and fractionated products be undertaken as soon as possible.
(Action: F.D.)

Following a discussion, it was proposed, duly supported and unanimously resolved that a pricing structure be set up that more closely reflects Héma-Québec's budget reality.

With respect to the billing process, it was agreed that this part of the pricing project falls within the responsibility of Héma-Québec's Management Committee.

9. Héma-Québec's financial results as at September 30, 1999
The Senior Director, Finance and Administration presented and commented on the financial statements as at September 30, 1999 and compared them with the financial statements as at March 31, 1999 after six (6) months of operations. A copy of the financial statements as at September 30, 1999 was distributed to the members and the breakdown of expenses by activity centre for the period ended September 30, 1999 was then distributed to members.

After studying the financial statements, a question was raised regarding the surplus of revenues over expenses as at September 30, 1999. The Senior Director, Finance and Administration explained that the surplus is mainly related to income from products sent to Canadian Blood Services, interest income from investments and interest saved on the deferral of an investment project regarding the plasma retested program. The additional expenses that were taken into consideration for the implementation of the PROGESA software are consulting fees and inventory-related costs for blood collection devices. These expenses are required for the implementation of the software. The members were satisfied with the explanations and decided to approve the additional expenses.

It was proposed, duly supported and unanimously resolved that the resolution entitled "Héma-Québec's financial results as at September 30, 1999 - Additional expenses," a copy of which is attached hereto, be adopted.

10. Negotiation mandates: renewal of collective labour agreements
10.1. SPIIQ (Nurses - Québec)
This issue will be presented at the meeting in January 2000.

10.2. CNTU group (Montréal)
This issue will be presented at the meeting in January 2000.

11. Implementation of the guidelines regarding the exclusion of donors who have sojourned in the United Kingdom for more than one (1) month
The Senior Director, Regulatory Affairs presented the various steps involved in requesting a licence amendment regarding the implementation of the guideline for the exclusion of donors who have sojourned in the United Kingdom for more than thirty (30) days. The Senior Director also presented a chronology of the written communication between Héma-Québec and the Bureau of Biologics and Radiopharmaceuticals on the subject. The Senior Director reviewed the various amendments made to the standard manufacturing procedures in implementing this security measure (Blood Donation Questionnaire, donor coding, plasma disposal).

12. Liaison Committee meeting held on October 23, 1999
The Executive Director informed members that the Liaison Committee met on October 23, 1999 and, during the meeting, a recommendation was made to the Board of Directors concerning the communication between recipients of blood products and physicians.

One of the points on the agenda was the definition of "transparency." Well-known ethicist Me Pierre Deschamps was invited to meet the committee in order to offer his assistance. The Liaison Committee is generally satisfied with Héma-Québec's transparency in its acts and decisions.

It was proposed, duly supported and unanimously resolved that the "Liaison Committee - Communication between recipients of blood products and physicians" resolution, a copy of which is attached hereto, be adopted as presented.

13. Advertising campaign
The Director, Marketing and Supply, presented a video of the new fall advertising campaign. The theme of the campaign is similar to that of the previous campaign, but Québec's cultural diversity is more visible in the new campaign. The ads will be broadcast on television and radio and posters will be placed within the public transit system.

The new ads will show children resuming their normal activities after receiving blood, which has a direct impact on the public. In addition, televised and radio announcements will end with the question, " will you be giving blood this week?"

The members were satisfied with the new ad campaign. They thanked the Director, Marketing and Supply for the presentation and offered their congratulations.

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

15. Miscellaneous
15.1. Nomination of Mr. Robert Bédard for the Governor General's Caring Canadian Award by the municipality of Charlesbourg
The Board of Directors would like to support Robert Bédard's nomination for the Governor General's Caring Canadian Award by the municipality of Charlesbourg.

It was proposed, duly supported and unanimously resolved that the "Nomination of Mr. Robert Bédard for the Governor General's Caring Canadian Award by the municipality of Charlesbourg" resolution, a copy of which is attached hereto, be adopted as presented.

15.2. Héma-Québec Foundation
The Héma-Québec Foundation's letters of patents were distributed. The measures needed to be issued a charity number will soon be taken. A member noted that it is important for the Foundation to be registered before January 1, 2000.
(Action: S.G.)

15.3. Scientific and Medical Advisory Committee
The Scientific and Medical Advisory Committee held a meeting on October 26 and 27, 1999. The Executive Director invited the members of the Board of Directors that sit on the committee to offer their comments.

Those members were impressed with the quality of Héma-Québec's research scientists.

It was noted that the current projects are in line with the research and development direction taken by the Board of Directors on June 9, 1999. Moreover, the committee asked the Senior Director, Research and Development to prepare a business plan for some of the projects.

It was also recommended that Héma-Québec create an ethics committee to approve research protocol concerning research and development projects. The committee will report to the Board of Directors.
(Action: F.D./S.G.)

15.4. Royal Canadian Mounted Police (RCMP)
The Executive Director informed members that representatives of the Royal Canadian Mounted Police will come to the offices of Héma-Québec on November 15, 1999 for the Canadian Red Cross Society documents that Héma-Québec has in its possession and that are relevant to the inquiry into contaminated blood.

16. Next meeting
The next meeting will be held on December 1, 1999 in Ville Saint-Laurent, at 4045 Blvd. Cte-Vertu.

17. Adjournment
It was unanimously resolved that the meeting be adjourned at 7:15 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 NOVEMBER 3, 1999
"Audit Committee"

WHEREAS Héma-Québec's budget is approved by the Board of Directors on an annual basis and is then brought before the Conseil du Trésor (and whereas this will be the procedure until Héma-Québec can finance its operations out of the revenues deriving from the supply of its products to hospitals, as stipulated in sections 21 and following in the Act respecting Héma-Québec and the haemovigilance committee);

WHEREAS the authorization grid included in Héma-Québec's By-Laws stipulates that expenses can be authorized up to a certain amount by different levels of signatories without exceeding the annual budget;

WHEREAS the members of the Board of Directors of Héma-Québec request that an Audit Committee be created to ensure that expenses are in line with the approved budget and that the expense authorizations and commitment signatures are in accordance with the By-Laws;

IT IS RESOLVED:

THAT an Audit Committee be created;

THAT the Audit Committee be made up of the following members:

- Ms. Cheryl Campbell Steer, President
- Mr. Raymond April
- Mr. Robert Bédard

THAT the members' terms be for a duration of one year and subject to renewal;

THAT the committee hold quarterly meetings;

THAT the committee report to the Board of Directors after each meeting;

THAT the committee hold all the powers necessary in carrying out its mandate.

RESOLUTION THAT FORMS PART OF THE MINUTES OF THE HÉMA-QUÉBEC BOARD OF DIRECTORS' MEETING HELD ON NOVEMBER 3, 1999
"Héma-Québec's financial results as at September 30, 1999 - Additional expenses"

WHEREAS the implementation of the PROGESA software is essential to blood supply;

WHEREAS the initial cost forecasts for the PROGESA software implementation project are inadequate due to certain unexpected incidents;

WHEREAS the implementation of the PROGESA software requires consulting fees in excess of those forecast on September 30, 1999 in the amount of approximately $300,000;

WHEREAS some blood collection devices currently in stock will become obsolete as a result mainly of the implementation of the PROGESA software and Héma-Québec may consequently incur a loss of $640,000 that has been provisioned;

IT IS RESOLVED:

TO authorize the expenses for consulting fees and for the inventory of obsolete blood collection devices as at September 30, 1999.

RESOLUTION THAT FORMS PART OF THE MINUTES OF THE HÉMA-QUÉBEC BOARD OF DIRECTORS' MEETING HELD ON NOVEMBER 3, 1999
"Liaison Committee - Communication between recipients of blood products and physicians"

WHEREAS the Liaison Committee met on October 23, 1999 and adopted the following resolution at that time:

"WHEREAS it is in the interest of the individual (the recipient);

WHEREAS the information must be complete;

WHEREAS the information must be understandable;

WHEREAS the information must reflect reality;

WHEREAS the information must admit doubt when it exists;

WHEREAS the information must enable the individual (recipient) to evaluate the situation and make an informed decision;

IT IS RESOLVED:

THAT the Liaison Committee recommend to the Board of Directors of Héma-Québec that it bring the committee's concerns to the attention of the Haemovigilance Committee regarding information about the risks involved in physicians administering blood products to their patients.

THAT the Liaison Committee also recommend that training be given to physicians on this matter."

WHEREAS the Board of Directors of Héma-Québec wishes to approve the above-mentioned recommendation by the Liaison Committee;

IT IS RESOLVED:

THAT on behalf of the Board of Directors, the Executive Director bring to the attention of the Haemovigilance Committee the Liaison Committee's concerns regarding information about the risks involved in physicians administering blood products to their patients and regarding the fact that no standard describing the circumstances in which patients should be informed currently exists in Québec.

RESOLUTION THAT FORMS PART OF THE MINUTES OF THE HÉMA-QUÉBEC BOARD OF DIRECTORS' MEETING HELD ON NOVEMBER 3, 1999
"Nomination of Mr. Robert Bédard for the Governor General's Caring Canadian Award by the municipality of Charlesbourg"

WHEREAS Robert Bédard is a volunteer plasma donor who has made over 375 donations since 1982;

WHEREAS Robert Bédard was the first volunteer to sit on the Board of Directors of Héma-Québec;

WHEREAS Robert Bédard was a founding member of the Association of Blood Donation Volunteers, a first in North America;

WHEREAS Robert Bédard's advice was of significant importance regarding the issues of blood donors and sojourns in the United Kingdom;

WHEREAS Robert Bédard wishes to be nominated for the Governor General's Caring Canadian Award by the municipality of Charlesbourg;

IT IS RESOLVED:

THAT Héma-Québec support Robert Bédard's nomination for the Governor General's Caring Canadian Award by the municipality of Charlesbourg.