Thank you.
Good morning, everyone.
Thank you for having invited me to speak to the committee today. I am pleased to be here to speak to the role Health Canada, as a regulatory body, plays in optimizing the safety of Canada's blood supply. The issue, more specifically, is the role we play with regard to donor program exclusion criteria that apply to men who have had sex with men.
The federal government, through Health Canada, is responsible for regulating the safety of Canada's blood supply. Ensuring that Canadians have access to safe blood has been the cornerstone of Health Canada's response to the Krever Commission of Inquiry on the Blood System in Canada. Canada now has one of the safest blood systems in the world, thanks to the strict standards for the collection and processing of blood that are now in place in Canada. This has been highly effective, with no cases of HIV transmission by blood transfusion in over 25 years in Canada.
The lessons of the tainted blood crisis must never be forgotten, and the current regulatory system for blood safety has been designed to ensure that such a tragedy never happens again in Canada. It has also been designed to be sufficiently flexible to allow changes to be made to these standards when new information or technological developments warrant such a change. The safety of the system is paramount, and safety must be based on science.
In our commitment to maintain this high level of safety, Health Canada works in partnership with national and international stakeholders to actively look for any potential blood safety issues and to put into place any precautions, as needed, to stop the spread of infectious diseases through the blood supply. The cornerstone of those partnerships is our relationship with Canada's two blood operators: Canadian Blood Services and Héma-Québec, with whom we collaborate in an open and transparent way while still maintaining our arm's-length regulatory role.
As Dr. Sher has just stated, in Canada, blood is legally defined as a drug and is subject to the requirement of the Food and Drugs Act. A stand-alone set of regulations, known as the blood regulations under the Food and Drugs Act, describes all the stringent requirements that blood operators must meet for the collection, processing, testing, labelling, storage, and distribution of blood in Canada. These regulations are supplemented by comprehensive guidance, which interprets each clause of the regulation in non-legal terms. Blood collection sites across the country must be licensed by Health Canada and are subject to regular inspections by Health Canada inspectors.
The blood regulations mandate a series of steps that the operators must take when collecting blood, resulting in an overlayering of safety steps to maximize safety. The two most critical steps are advance donor screening and the use of state-of-the-art blood testing technology in order to eliminate the possibility of an infectious disease being transmitted to a recipient.
Blood recipients are among some of the most vulnerable of patients in the Canadian health care system, as many would not be able to fight potential infections that could be transmitted via blood. Donor deferrals, which attempt to identify prospective donors at higher risk of transmitting an infection and not allowing them to donate, are used extensively in blood donor screening. Donor testing is not sufficient alone, because, as Dr. Sher has described, despite advances in testing, there remains a period of time known as the window period between infection and the possible detection of a pathogen, during which there is a risk that infected units of blood may not be identified by testing.
Donors are therefore deferred for various periods of time if they are identified as being at higher risk for HIV, hepatitis, malaria, and other infectious diseases. However, specific deferrals are not part of regulatory requirements themselves. The blood regulations require that establishments collecting blood obtain from the donors information about their identity and their medical and social history that is relevant to determining their risk of infectious disease.
The blood operators themselves, meaning the CBS and Héma-Québec, can determine what types of questions are necessary. This is known as “performance-based regulation”, in which a standard is set in regulation but the regulated parties have the flexibility in determining how to meet this standard. Performance-based regulation allows for changes due to advances in technology and science to be implemented without the need for a complicated process to amend regulations and bring them up to date.
Under the blood regulations, the blood operators must have their processes, as well as any changes to these processes, approved by Health Canada. This is accomplished by the filing of a submission containing complete information pertaining to the process or change, which is reviewed by a team of Health Canada scientists.
In Canada, there are no regulations prohibiting MSM and other groups from donating blood. These donor deferrals are part of the processes that CBS and Héma-Québec have developed to meet the standard of safety by deferring a group that is statistically at a higher risk of transmission of certain diseases.
As we have seen recently, this is no longer a permanent deferral. Both CBS and Héma-Québec have worked diligently over the past few years to modify the MSM deferral, work which has resulted in two amendments: from a lifetime to a five-year deferral in 2013, and subsequently to a one-year deferral in 2016. Health Canada approved both of these changes following review of a comprehensive package of information filed by both CBS and Héma-Québec containing scientific information showing that these changes would not diminish the safety of the blood supply.
We acknowledge and support the efforts under way by CBS in researching possible alternatives to the MSM deferral as well as other deferrals. We are open to future submissions for further changes. However, our review of any request for a change to a deferral will be based on the principle that it is supported by current science and would not introduce unacceptable risk to the blood supply. This is a high bar to reach, but both CBS and Héma-Québec have reached it twice already with respect to MSM deferral.
Health Canada's decisions as the regulator must be based on scientific evidence. Therefore, should Health Canada be presented with sound evidence to support that the MSM-specific donor deferral policy can be eliminated without compromising the safety of Canada's blood system, this information will be assessed in accordance with Health Canada's standards.
Merci beaucoup.