Background

In the wake of the contaminated blood scandal that erupted in the early 90s, the Commission of Inquiry on the Blood System in Canada, chaired by Mr. Justice Horace Krever, released its preliminary report in February 1995. Although the report reassured Canadians by stating that, "The Canadian blood system is as safe as that of all other industrialized countries but it is weak," it contained no fewer than fifty recommendations for all stakeholders to improve the safety of the blood management system.

Because the final report of the Krever Commission required more time to complete than expected, the provincial health ministers created committees to plan a new blood management system in Canada. In Québec, the Gélineau Committee was made up of stakeholders representing hospitals, public health, doctors and the blood component supplier.

The Gélineau Committee held deliberations and hearings in summer 1996. From the outset, blood bank managers told Committee members that they had no concerns about the Red Cross Transfusion Services in Québec. The Gélineau Committee report, which was released in November 1996, made recommendations with respect in particular to the problems related to blood banks in hospitals. The Committee agreed that responsibilities should be given back to the appropriate authorities and it recommended three levels of accountability within the blood management system:

• A supplier that was responsible and accountable for product quality;
• Hospitals and their doctors should be responsible for transfusions;
• A hemovigilance committee should be responsible for monitoring public health with respect to blood management and supply. The Committee reported to the Minister of Health and Social Services.

Between November 1996 and summer 1997, Health Minister Jean Rochon clearly stated his hope that the Red Cross Transfusion Services would continue to ensure the blood supply in Québec. However, the Red Cross announced in August 1997 that it was relinquishing all control over Canada's blood program as of September 1998. Despite Rochon's attempts to urge the Red Cross to carry on in this area in Québec, the organization maintained its decision.

Mr. Rochon was then faced with two options: to join the new blood supplier about to be created in Canada under the name of "Canadian Blood Services," or to create an entirely new local supplier.

On the heels of the publication of the Gélineau Report and in light of the Minister's goal of bridging the gap between the blood component supplier and Québec's health system, Mr. Rochon announced the creation of a local supplier in Québec, to be known as Héma-Québec, in March 1998.

Héma-Québec was incorporated as a non-profit organization on March 26, 1998, and subsequently governed by special legislation, Bill 438, adopted by the National Assembly on June 20, 1998.

With respect to the safety of the blood supply, Héma-Québec is a national organization. Indeed, as of September 1989 and within the meaning of the law, blood is considered a drug, and as such, regulated by Health Canada through its Therapeutic Products Program and its Bureau of Biologics and Radiopharmaceuticals (now called Blood Establishment Regulation Division - BERD). As a result, the federal government stipulates the standards that must be met in order to ensure the safety of the blood supply in Canada. The government therefore issues operating licences to blood product suppliers and conducts licence audits annually, or more frequently, if necessary. Héma-Québec's operating licence number is 100862.

Moreover, Héma-Québec, through its Board of Directors, is a community-focused agency. In fact, the Board represents all stakeholders in the transfusion chain, from donor to recipient. It includes representatives of blood donation volunteers, doctors who perform transfusions in hospitals, hospital administrators, public health, academic institutions, the business community and recipients.

The Board of Directors is assisted by three advisory committees with respect to:

• Risk and safety management of the blood supply.
• Medical and scientific matters.
• Liaison with recipients.

These committees will allow the Board of Directors to solicit the opinions of completely independent groups of experts.

In addition, in autumn 2001, the Minister of Health and Social Services confirmed the necessity of applying strict quality and safety standards to the various treatments performed on human tissue. Thus, recognizing Héma-Québec’s competence in the treatment and distribution of human tissues, the Minister authorized Héma-Québec to expand its activities in this area. On December 18, 2001, the Centre de conservation de tissus humains du Québec joined Héma-Québec.