Canada's Biotechnology Strategy
The Canadian Biotechnology Strategy (CBS) is Canada's plan for the emerging field of biotechnology that supports and compliments the regulatory and research activities of various federal departments and agencies. The CBS is rooted in the late 70's when a task force, composed of industry and academia was set up to determine how to facilitate the potential of new recombinant DNA techniques that were coming out at the time. In 1983 the National Biotechnology Strategy (NBS) was created to develop biotechnology to enhance economic, health and environmental benefits to Canada.
As an on-going commitment to move Canada forward in its biotechnology efforts, the NBS was renewed in 1998 after extensive consultation with numerous stakeholders including the provinces, industry, non-government organizations, scientific and academic institutes and other partners. Components of the newly named CBS include:
- Its management structure and governance;
- An arms-length advisory committee;
- The framework underpinning the strategy; and
- Mechanisms to facilitate the evolution of biotechnology towards refining a science-based regulatory system, commercialization and social acceptance, (for example, funding and working groups).
The CBS is managed through an infrastructure of federal committees and supported by the Canadian Biotechnology Secretariat. Primary oversight of the CBS is governed by: the Biotechnology Ministerial Coordinating Committee (BMCC), which consists of seven ministers representative of the key biotechnology sectors:
- Industry Canada;
- Agriculture and Agri-Food;
- Health Canada;
- Environment Canada;
- Fisheries and Oceans;
- Natural Resources Canada; and
- International Trade.
A key element of the CBS was the establishment of the Canadian Biotechnology Advisory Committee (CBAC), an arms-length committee consisting of multidisciplinary experts and members of the general public. Charged with the task of raising public awareness and engaging Canadians in a dialogue on biotechnology issues, CBAC provides independent advice to the BMCC on biotechnology topics that cut across the mandates of various federal departments and agencies. These include ethical, social, regulatory, economic and environmental and health issues. However, while some of CBAC's projects and advice touch on regulatory matters and may impact policy decisions, neither CBAC nor the BMCC is involved in directing specific regulatory decisions. These decisions are left to the individual departments and agencies to determine.
The CBS operates within a policy framework which has defined the following objectives and principles:
- Ensure that Canadians have access to, confidence in and benefit from safe and effective biotechnology-based products and services;
- Ensure an effective scientific base and invest strategically in research and development;
- Position Canada as a responsible world leader in the development, commercialization, sale and use of biotechnology;
- Be sensitive to the needs of developing countries to build local capacity in managing the potential risks of biotechnology.
- Improve public awareness and understanding of biotechnology;
- Ask for broadly based advice;
- Promote awareness of and maintain excellence in Canada's regulatory system;
- Ensure Canada's continued high standards for protecting health, safety and the environment;
- Support the development of human resources in the sector; and
- Work with the provinces, territories, businesses, academia and consumer and other groups to develop and carry out action plans.
Smart Regulations and Biotechnology
The Canadian government established the External Advisory Committee on Smart Regulation (EACSR) in May 2003. The Committee was asked to provide the government with an external perspective and expert advice on the best way to redesign the government's regulatory approach to create and maintain a Canadian advantage.
What is a "Smart Regulation"?
Smart Regulation is about finding better, more effective ways to protect the health and safety of Canadians and Canada's natural environment within a regulatory system that supports innovation and economic growth. It is based on four guiding principles:
- Protecting the public interest;
- Extending the basic values of democracy;
- Leveraging the best available knowledge; and
- Promoting effective and efficient processes.
The industrial revolution changed the world. Developments in the life sciences sector will likely have the same impact. Recent scientific discoveries have significantly increased our ability to develop new knowledge and innovative products and processes such as pest-resistant crops with higher yields, better disease diagnostic tools, and treatments that complement one's genetic make-up. The life sciences sector is research-based and capital-intensive and could yield positive benefits in such fields as health care, the environment, safety, agriculture, aquaculture, economic development, food safety and sustainable development.
Canada is internationally well positioned in this field, as it now accounts for almost 10% of the world's biotechnology-related revenues and ranks second behind the US in number of biotechnology firms. The federal government has made significant efforts and investments to support the development of biotechnology. In 1998, it released the Canadian Biotechnology Strategy, which has so far formed the basis of federal government action. Various committees such as BMCC were also established to oversee the development and implementation of the broad policy issues associated with biotechnology. The Canadian Biotechnology Advisory Committee (CBAC) was also created to provide external advice to government.
As it applies to issues related to biotechnology, the EACSR is of the opinion that the analysis is relevant to other emerging multidisciplinary areas such as nanotechnology.
Recognizing the complexities of biotechnology, the EACSR recommended:
- Implementing a government-wide biotechnology regulatory strategy;
- Addressing legislative gaps impacting biotechnology;
- Improving international regulatory cooperation activities; and
- Enhancing communications and citizen engagement on public policy issues.
For more information you can visit the Government of Canada's new Regulation Web site.
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