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Drugs and Health Products

Fact sheet: Canada's Blood Regulations

What are the New Blood Regulations?

Health Canada is proposing to introduce, under the Food and Drugs Act, specific regulations for human blood and blood components intended for transfusion or for further manufacturing into drugs for human use. The proposed regulations will formalize Canada's existing internationally recognized best practices for blood safety.

The Krever Commission delivered its final report in November 1997 to Health Canada. What steps has Health Canada taken since then regarding the safety of the blood system in Canada?

Canadians' access to safe blood for themselves and their families has been the cornerstone of Health Canada's response to the Krever Commission of Inquiry on the Blood System in Canada. As such, Health Canada took immediate and interim steps to address Justice Krever's recommendations.

In 1997, the development of national "vein to vein" standards for blood was initiated by the Canadian Standards Association (CSA). This followed an extensive collaborative process by the CSA which involved the participation of experts in the fields of haematology, the blood establishments and federal and provincial and territorial governments.

Starting in 1998, Health Canada proceeded with a new licensing framework for blood establishments. Under this framework blood establishments obtain an Establishment License and are subject to annual inspections to assess their compliance with the Good Manufacturing Practices (GMP) requirements under the Food and Drug Regulations (FDR).

Health Canada meets regularly with the Expert Advisory Committee on Blood Regulation to provide the medical, scientific, and ethical advice required to assist the regulatory decision-making process for blood. Throughout the regulatory development process, Health Canada has consulted with industry stakeholders, Provincial and Territorial governments, Public Health Agency of Canada (PHAC), and the blood establishments.

Since 1997, Health Canada has published a number of directives and guidance documents to provide assistance to industry on how to comply with the Regulations and to address new and emerging safety issues. In 2006, the Food and Drug Regulations were further amended to include provisions for human plasma collected by plasmapheresis.

The proposed blood regulations will formalize Canada's existing internationally recognized best practices for blood safety.

Did Health Canada consult with stakeholders on the new Blood Regulations?

Stakeholders are supportive of Canada's Proposed Blood Regulations.

Health Canada, Canadian Blood Services, Héma-Québec and the Provincial/Territorial governments have worked collaboratively to enhance the safety of the blood supply for Canadians. As a result of this collaboration, the World Health Organization regards Canada as having developed the highest standards of blood safety.

Over the last 15 years, stakeholders have been engaged on the development of the blood standards, as well as the proposed regulations, through a series of public consultations and communication activities across Canada.

In addition, based on comments received by Health Canada during the pre-publication period of Canada Gazette, Part I, the proposed Blood Regulations will be revised through the drafting process with an expectation for final publication in Canada Gazette, Part II in 2013 and a coming into force date one year later.

Some European countries have relaxed the Men who have sex with men (MSM) donor deferral from indefinite to one year. Will Health Canada consider relaxing the deferral period to one year?

Under Canada's blood safety regulations, the blood operators, Canadian Blood Services and/or Héma-Québec are required to make submissions for any proposed changes to Health Canada.

Such submissions must contain scientific data from studies that support the safety of any proposed changes.

As the regulator of Canada's blood system, Health Canada will regard the risks and benefits of any proposed changes to blood operations as the paramount consideration to granting approval.

How do the Blood Regulations compare to international standards?

The World Health Organization for a number of years has regarded Canada as having developed the highest standards of blood safety.

While there are some minor differences in our regulations due to the legislative frameworks under which we operate, Canada's Blood Regulations align well with the blood regulatory requirements, guidelines and policies of the U.S., EU, UK and Australia, including the overall approach of protecting the health of blood donors and recipients.

Will the new Blood Regulations have a mandate regarding Canadian Blood Services and/or Héma-Québec blood processing facilities?

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 such, we maintain an "arms-length" relationship with Canadian Blood Services and Héma-Québec and do not mandate their corporate and operational decisions. However, Canadian Blood Services and Héma-Québec are required to make a submission on this proposed operational change to the regulator in order to demonstrate that it would not compromise the safety of the blood system.