Our Role

Health Canada's purpose is to help Canadians maintain and improve their health. In terms of biotechnology our roles and responsibilities are as follows:

• To provide leadership in the development and enforcement of policy and regulations;
• To inform and engage the public;
• To ensure an international position for Canada; and
• To apply the benefits of biotechnology to Health Canada's mandate.

On this page:

• Roles and Responsibilities
• Health Canada's Biotechnology-related Work
• Governance of Biotechnology at Health Canada

Roles and Responsibilities

Providing leadership in the development and enforcement of policy and regulations

The number and complexity of the issues underlying biotechnology and health require that Health Canada provides national leadership to develop health policy and regulations and to enforce these regulations. Health Canada is mandated to regulate health products, food, and pest control products including those that rely on biotechnology in any way under the Food and Drugs Act (FDA), and the Pest Control Products Act. The department is also responsible for administering the health-related aspects of the Canadian Environment Protection Act 1999 (CEPA).

Informing and engaging the public

In order to fulfill its role as regulator and policy maker, Health Canada needs to ensure that the public has access to objective information about biotechnology and that Canadians are engaged in the discussions on biotechnology leading to decision making. The Promoting Public Awareness section provides more in-depth information on these activities.

Ensuring an international position for Canada

To be a responsible world leader in biotechnology, Health Canada needs to: participate in the development of international policies & standards; seek opportunities to collaborate in areas of research, information exchange and product assessment; and where appropriate, harmonize Canadian regulations and standards with those of other countries. More information on Canada's international role can be found under the Partnerships section of the Biotechnology Theme.

Applying the benefits of biotechnology to Health Canada's mandate

Health Canada is a user of biotechnology where or when it provides tools for fulfilling its roles in surveillance for and detection of infectious diseases, detection of food contaminants and food-borne pathogens, detection of environmental toxicants, and service to First Nations and Inuit communities.

In support of its role regulating biotechnology, we fund research in a variety of areas, such as health policy, regulation, population and public health, healthy environments and consumer safety, and health products and food.

Health Canada's Biotechnology-related Work

In order to respect Health Canada's mandate to maintain and improve Canadian's health, the Department wants to provide access to new products of biotechnology while at the same time, manage potential and actual risks.

The Department has drafted a Departmental Framework for Biotechnology in order to effectively assess and manage biotechnology on behalf of Canadians. This is a working document reviewed periodically to ensure relevancy to current issues. The Framework is based on the federal government's biotechnology policy, as outlined in the Canadian Biotechnology Strategy, and it underlines the need for close collaboration among all levels of government with health responsibilities as well as coordination of their respective policies and programs.

The Framework also outlines the Department's biotechnology-related roles and responsibilities, including:

• Providing leadership in policy and regulation development;
• Informing and engaging the public;
• Ensuring an international position for Canada; and
• Applying the benefits of biotechnology to Health Canada's mandate.

Governance of Biotechnology at Health Canada:

• Health Policy Branch (HPB) plays a lead role in health policy, communications and consultations. It is leading Health Canada work on human cloning and genetic testing, and privacy issues.
• Public Health Agency of Canada (PHAC) promotes health and prevention and control of injury and diseases. It is leading activities in public health issues (for example, food-borne and infectious diseases) and in the development of surveillance and knowledge management systems.
• Health Products and Food Branch (HPFB) takes an integrated approach to the management of the risks and benefits to health of health products and food. It regulates biotechnology products such as drugs and genetically modified foods and is involved in post-market surveillance.
• Within HPFB, the Office of Biotechnology and Science (OBS) provides a focal point for work on health-related biotechnology within Health Canada, as well as within the federal government and externally.
• Healthy Environments and Consumer Safety Branch (HECSB) promotes healthy behaviours, develops and applies harm reduction and applies prevention methods. It is leading Health Canada responsibilities regarding the health component of CEPA 1999.
• Pest Management Regulatory Agency (PMRA) protects human health and the environment by minimizing the risks associated with pest control products. The Agency carries out its responsibility by evaluating pesticides to ensure they meet the latest human health and environmental safety standards before being registered for use in Canada, by re-evaluating older pest control products to ensure they remain acceptable for use based on the latest standards and by setting the safe residue levels for pesticides in food.
• Office of the Chief Scientist (OCS) brings leadership, coherence and expertise to the overall strategic direction of Health Canada's scientific trends and opportunities. The Chief Scientist is responsible for articulating a broad science vision and ensuring that the science performed and supported by Health Canada is meeting national and international standards.