News Release: Health Canada Approves Proposals To Change Deferral Period For Certain Blood Donors Regulatory decision will not compromise the safety of Canada's blood system
New five-year deferral period
Under the new five-year deferral period, men who have not had sex with men in the past five years are now eligible to donate blood in Canada. Under the previous indefinite deferral period, men who had sex with men, even once, since 1977 were not eligible to donate blood in Canada.
Safety
Keeping Canada's blood supply safe is a top priority for the Government of Canada. Health Canada is confident that this change in operations will not compromise the safety of the blood supply.
As part of implementation, the blood operators will closely monitor laboratory testing results to confirm that the percentage of donors who actually test positive for an infectious disease remains low. Any change in donor infection rates will be immediately reported to Health Canada. The Public Health Agency of Canada in partnership with Health Canada will continue to monitor adverse events through the Blood Safety Contribution Program and assess emerging risks related to blood supply.
As the regulator of Canada's blood system, Health Canada assessed the risks of this change on Canada's blood system and its impact on the health and safety of Canadians.
Health Canada based its decision on the scientific data contained in the submissions and the advice of the Expert Advisory Committee on Blood Regulations. The scientific data contained in the submissions shows that infections are detected more quickly and donors are screened more efficiently today as a result of modern technology and our increased knowledge of how pathogens are transmitted in blood.
Roles and responsibilities of Health Canada and the blood operators
Health Canada is responsible for the regulatory oversight of the blood system in Canada to help ensure the safety of blood and blood components for Canadians. As the regulator, Health Canada maintains an arms-length relationship with both blood operators, Canadian Blood Services (CBS) and Héma-Quebec (HQ), and does not mandate their corporate and operational decisions. Under Canada's blood safety regulations, CBS and HQ are required to make submissions to Health Canada for any proposed operational changes. Such submissions must contain scientific data from studies that support the safety of any proposed changes. Health Canada regards the risks and benefits of any proposed changes to blood operations as the most important consideration for approval.
Submission process for changes to Canada's blood system
Under Canada's blood safety regulations, submissions for any proposed operational changes to Canada's blood system are made to Health Canada. The submission must contain scientific data from studies that support the safety of the proposed changes. To be approved by Health Canada, such submissions have to demonstrate that a proposed change will not compromise the safety of the blood system.
As the regulator of the blood system, Health Canada has the final word on whether proposed changes to the blood system are approved or not. The risks and benefits of any proposed changes are the most important consideration for Health Canada approval.
Expert Advisory Committee on Blood Regulations
The Expert Advisory Committee on Blood Regulation provides health professional and related expertise to assist Health Canada in making appropriate risk-management decisions related to blood, blood components, blood products, and associated issues.
Health Canada asked the committee for advice on considerations for relaxing the current blood donor policy for men who have sex with men (MSM) in Canada. The Committee's recommendations were taken into consideration by Health Canada.
Current risk analysis data for MSM
The Public Health Agency of Canada prepares surveillance data for HIV incidence and prevalence in Canada. The 2011 report shows that men who have sex with men account for 48.6% of all newly diagnosed cases of HIV among adults.
The MSM question in the donor screening questionnaire
The men who have sex with men question, as many other questions in the donor screening questionnaire used by Canadian Blood Services and Héma Québec, seeks to identify prospective donors who have taken part in activities that have been identified by surveillance studies and scientific evidence as placing participants at high risk of transmitting blood-borne infections.
The Ontario Superior Court of Justice found that the current "men who have sex with men" blood donor screening question used by Canadian Blood Services does not violate s.15 of the Charter of Rights and Freedoms.
Health Canada has maintained that the current "men who have sex with men" blood donor screening question used by Canadian Blood Services is not based on sexual orientation, but rather on health and safety considerations. The Ontario Superior Court of Justice agreed with this view.
Given that the highest prevalence of HIV is in this population, blood donor screening questions soliciting risk behaviour for the men who have sex with men group are a precautionary measure to protect the blood system from HIV transmission.
