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I. The Blood System in Canada

Canada's blood system is one of the safest in the world. Canada's risk management approach to blood safety involves coordinated initiatives from many stakeholders. The result is a continual advancement of blood safety.

Canada's transfusion community is largely hospital based and includes people involved in the flow of blood from a donor to a recipient. In this community:

• Canadian blood donors donate blood for their own or others' use,
• Blood Establishments collect, process and/or distribute whole blood and blood components, and
• patient and consumer groups  receive whole blood and blood components,
• hospitals and health care professionals provide patients with blood transfusions and therapeutic interventions involving blood components,
• provincial and territorial governments are responsible for hospitals and healthcare delivery,
• Health Canada and Public Health Agency of Canada are responsible for regulatory oversight, compliance and enforcement and public health protection.

Current Regulations

The regulation of whole blood and blood components is currently governed by the provisions of the Food and Drugs Act and Food and Drug Regulations. Blood is defined as a Schedule D (biologic) drug in the Food and Drugs Act.

Whole blood and blood components are regulated primarily by Division 1A (i.e. Establishment Licences) and Division 2 (Good Manufacturing Practices) of Part C of the Food and Drug Regulations. This legislative base is complemented by regulatory guidance documents that provide detailed interpretations of the regulatory requirements described in the Food and Drug Regulations. Regulatory guidance documents may include guidelines, directives, standards and administrative policies.

Other regulations associated with whole blood or blood components include the Medical Devices Regulations, which contain requirements for blood-related devices such as test kits and blood bags.

Health Canada issues directives regarding matters such as donor deferrals in response to emerging transmissible pathogens or new processing techniques to be undertaken to improve the safety of whole blood and blood components for transfusion. Health Canada has also added conditions to the licenses of blood establishments to enforce safety requirements. Issues involving blood safety are proactively managed through cooperation and collaboration.

Roles and Responsibilities

Addressing the safety and quality of whole blood and blood components in Canada is a shared responsibility, with aspects falling under federal and provincial jurisdictions.

A. The Federal Regulator

Health Canada is the federal department responsible for helping Canadians maintain and improve their health, while respecting individual choices and circumstances. Health Canada is responsible for the safety, quality and efficacy of health products available in Canada, including whole blood and blood components. These responsibilities are achieved through the use of sound regulation, scientific data review, and regulatory compliance activities. Health Canada's regulatory responsibilities with regard to blood safety are carried out by the Biologics and Genetic Therapies Directorate and Health Products and Food Branch Inspectorate.

The Public Health Agency of Canada is the federal agency responsible for helping to protect the health and safety of all Canadians by enabling the prevention of injury and chronic disease, and by responding to public health emergencies and infectious disease outbreaks. In collaboration with provincial and territorial governments and stakeholders, it oversees blood system surveillance activities with a focus on infectious disease transmission.

Health Canada and the Public Health Agency of Canada work together to improve and protect the health of Canadians, and are members of the health portfolio that report to Canada's Minister of Health.

B. The Provinces and Territories

Healthcare legislation falls under provincial jurisdiction, and therefore varies from province to province. The practice of medicine (including transfusion) is self-regulated by colleges of physicians and surgeons in the provinces. Provincial and territorial governments are responsible for the overall direction and operation of their healthcare systems and, therefore, have overall responsibility for delivery of the blood system. They designate where blood supply and transfusion services are delivered and allocate funds for blood operation and transfusion activities.

Health regions and healthcare professionals are accountable to provincial and territorial governments and are responsible for the quality and safety of blood transfusions, the management and operation of transfusion facilities, and for ensuring that resources are available to carry out transfusion services. Health regions and hospitals are responsible for employing qualified healthcare professionals to carry out these services.

C. The Blood Operators

The Blood Operators, Canadian Blood Services and Héma-Quebec, operate the blood supply system in Canada and are federally regulated. They are responsible for ensuring the high quality of whole blood and blood components. This is achieved through donor recruitment, screening and testing, collection and processing of blood into components, frequent communication and partnerships, and product exchange when necessary.

Communication, collaboration and cooperation between all parties are essential to the safety of the blood supply and to bring Canada closer to a "vein-to-vein" approach for our national blood system.