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Maintaining and improving Canadians' health
Biotechnology, like any new technology, offers both potential benefits and risks. While Canadians readily accept innovations such as new vaccines to prevent disease, replacement heart valves that are better accepted by the body, or treatments for human infertility, they have understandable reservations about biotechnology applications that may compromise public or environmental health and safety.
In keeping with Health Canada's mandate to maintain and improve Canadians' health, Health Canada manages biotechnology's potential risks while garnering its benefits. Key to capturing the benefits is strong research and policy development, solid science-based regulation, accessible information for sound decision making, and involving Canadians directly in decisions about the technology's development.
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Research
Health Canada undertakes biotechnology-related research in health policy, regulation, population and public health, healthy environments and consumer safety, and health products and food. Research projects at Health Canada fall under the following themes:
- building biotechnology capacity (scientific, technical and human resources)
- public awareness
- efficiency, effectiveness and timeliness of the regulatory system
- generating knowledge
- genomics
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Policy development
Health Canada works with other federal departments/agencies and international organizations to develop sound, science-based policies for the regulation of biotechnology. Some areas of policy development include:
- social and ethical considerations factored into the risk management of biotechnology products, including genetic technology
- the impact of intellectual property on Canada's health system, particularly concerning higher life forms and human genetic material
- pharmacogenomics (the study of how an individual's genetic inheritance affects the body's response to drugs)
- human genetic information and privacy
- governance of health research involving humans
- assisted human reproduction and related research o assessment of technology for determining genetic health
- genetics and public health
- risk management
Health Canada is a member of the Biotechnology Assistant Deputy Minister Coordinating Committee (BACC), a government-wide committee that provides federal leadership and policy direction, which identified three "pillars" to guide the work of the Canadian Biotechnology Strategy: Stewardship; Citizen Engagement; and Innovation. Health Canada chairs the "Stewardship" pillar and was key in establishing a BACC sub-group to specifically address stewardship and regulatory issues.
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Early successes
Health Canada has many successes in its contribution to responsible regulation and use of biotechnology in Canada. Following are some of Health Canada's important milestones:
Framework for biotechnology
Health Canada has a framework for biotechnology, which clearly describes the department's responsibilities and priorities, identifies opportunities and challenges, and lists guiding principles and strategies. Priority areas include:
- Enhanced scientific and regulatory capacity to keep ahead of the technology as it evolves
- Genetic technology and its social impacts
- Evaluation of any potential long-term environmental and health impacts of genetically modified organisms
- Preparation for potential emergencies such as bioterrorism
- Public awareness of and engagement of Canadians on biotechnology
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Biotechnology stewardship
In growing recognition that appropriate governance of biotechnology is broader than a science-based regulatory system, Health Canada is leading the Government of Canada's effort to develop a federal biotechnology stewardship framework. This framework will further protect the health and safety of Canadians and their environment, while ensuring social and ethical issues are addressed and that the economic impacts of this transformative technology are considered.
As the lead department for stewardship, Health Canada hosted a workshop in June 2003 to develop a common understanding of biotechnology stewardship and government's role, and to develop a path forward to create a stewardship framework. Health Canada's Environmental Assessment Unit was established in 2001 to assess the environmental impacts of biotechnology substances in products governed by the Food and Drugs Act, as well as their potential for indirect impacts to human health.
Internationally, Health Canada receives world-wide recognition as having a first-class regulatory system. This has resulted in many requests for capacity building in lesser-developed countries and for inquiries from foreign biotechnology companies wanting to invest in Canada.
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Enhancing regulatory rigour
Canada already has one of the most rigorous regulatory systems in the world for the protection and enhancement of Canadians' health, protection of the environment and innovation in health care. In December 1999, the ministers of Health, Agriculture and Agri-Food, and Environment asked the Royal Society of Canada to establish an independent expert panel to examine future scientific developments in food biotechnology and to advise the federal government on the science capacity it needs to continue to ensure the safety of new food products developed through biotechnology.
The Royal Society released its report and recommendations in February 2001. The Government of Canada, led by Health Canada, responded with a detailed action plan to address each of the recommendations. Since then, Health Canada has provided four progress reports. Steps taken to date, in response to the Royal Society's advice, have helped ensure the effective regulation of biotechnology-derived food products.
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Developing a Canadian labelling system for genetically engineered (GE) foods
Health Canada has the mandate to ensure appropriate labelling when there are health and safety issues, such as the presence of an allergen in a food, or when the nutrition or composition of the food has been changed. Labelling for health and safety remain its priority. Under a committee established by the Canadian General Standards Board (CGSB), a draft Canadian standard was developed for voluntary labelling to indicate whether a food has - or has not - been developed through the use of biotechnology. Over 50 organizations, including a broad range of stakeholders - consumer groups, food producers and manufacturers, universities and government - were involved in this process. Consensus on the labelling standard was reached in September 2003. The purpose of the labelling standard is to provide guidance to industry on labelling of GE foods to develop meaningful criteria for labelling, understandable messages for consumers that are not false or misleading and a consistent policy to verify the truthfulness of labels and, in so doing, provide consumers with informed choice.
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Assessing the safety of foods derived from biotechnology
Health Canada is a key player in regulating biotechnology-derived food products. This includes genetically engineered (GE), genetically modified (GM) and other novel foods. The department's scientists - with individual expertise in molecular biology, toxicology, chemistry, nutritional sciences and microbiology - look at the process used to develop a food product. They assess the chemical and nutritional composition of the food and whether there is the presence of, or potential for, production of a toxin or allergenic substance in the food. Only if all of Health Canada's stringent criteria are met is a biotechnology-derived food allowed for sale in Canada.
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Draft revisions to guidelines for assessing novel foods
Consistent with its commitment to continually enhance regulatory processes and protocols, Health Canada updated its Guidelines for the Safety Assessment of Novel Foods Derived from Plants and Microorganisms. These Guidelines detail the information requirements that must be considered in assessing the safety of GM and other novel foods derived from plants and microorganisms. As well, the Guidelines reflect advances in science and relevant national and international expert advice on safety assessment.
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Public/stakeholder engagement
Because public engagement and input is essential to understanding biotechnology's potential benefits and risks, Health Canada has informed and sought feedback from individual Canadians and other stakeholders on biotechnology-related issues through numerous initiatives since 1999, including:
- Stakeholder consultations on genetic information and privacy, as well as governance of health research involving humans
- Public consultation on xenotransplantation1
- Public opinion research on biotechnology issues conducted twice yearly over four years
- Citizen conference on food biotechnology
- Public consultations on the regulation of genetically modified and other novel foods
- Public consultation on revised guidelines for the safety assessment of genetically modified and other novel foods
- Public consultation on revised guidelines for the environmental assessment of genetically modified plants
- Health Canada's Public Advisory Committee (PAC) consultation on Health Canada's Communications Plan for biotechnology
Health Canada is currently drafting guidelines for the Safety Assessment of Livestock Animals and Fish Derived from Biotechnology. They will also be the focus of ongoing consultations with Canadians.
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Keeping pace with new technologies
Federal departments, including HC, are working cooperatively to establish clear authorities, regulations and guidelines for animal biotechnology in Canada. Health Canada also continues to collaborate with international experts to establish a sound approach to the regulation and assessment of animal biotechnology related to global trade.
Other new technologies include "molecular pharming," which involves growing and harvesting genetically modified crops for the production of biological pharmaceuticals or industrial materials, rather than for food production. The department works closely with its partners to determine the issues to consider regarding this technology.
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Improving transparency
Health Canada and the Canadian Food Inspection Agency (CFIA), in cooperation with CropLife Canada - the trade association representing developers of biotechnology-derived plant products for use in agriculture - are conducting a pilot project to post information on the Internet about the safety assessments of biotechnology-derived crops, livestock feeds, and foods.
This is the first time in Canada that the public will be notified of new biotechnology product submissions under review by government and have access to a list of the scientific studies conducted on the products regarding safety. The project gives Canadians an opportunity to provide input, via the CFIA Web site, on scientific matters relevant to the safety assessment of new products.
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Responding to emergencies
Health Canada plays an essential primary role in national emergencies, whether caused by humans or a natural disaster, in order to protect the health of Canadians. The department's Centre for Emergency Preparedness and Response serves as the country's single coordinating point for health security in Canada and for dealing with public health emergencies. The Centre, which is active 24 hours a day, seven days a week, works closely with departmental experts in areas such as infectious disease, food, blood, nuclear emergencies and chemicals.
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Scientific expertise
Health Canada's National Microbiology Laboratory is Canada's first biosafety Level 4 laboratory, which allows scientists and researchers to work safely with the most serious human and animal pathogens (e.g., hantavirus, hepatitis and influenza viruses), and to carry out research and diagnostic programs with some of the most virulent strains of viruses (e.g., SARS, West Nile virus, the Ebola virus, Marburg virus and Lassa fever). It was scientists at the National Microbiology Lab who isolated the SARS virus and, in collaboration with the British Columbia Genome Centre at the B.C. Cancer Agency, identified the genetic sequence of the virus.
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Health Canada at work with global partners
Biosafety Protocol
Canada is a signatory to the Cartagena Protocol on Biosafety, which was negotiated under the United Nations Convention on Biological Diversity. The Protocol addresses transboundary movement of living modified organisms that are products of modern biotechnology. This allows countries to determine whether such movement could have adverse effects on their biodiversity. Health Canada, along with other federal departments, is developing tools of ratification (e.g., new regulations) that would put Canada in a position to ratify the Protocol.
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Organisation for Economic Co-operation and Development (OECD)
Health Canada actively participates in the OECD Working Group on Harmonization of Regulatory Oversight in Biotechnology, and the Task Force for the Safety of Novel Food and Feeds. The department also plays a significant role in shaping international policies that impact all OECD member countries, including Canada. The OECD guidance document on the use of taxonomy in risk assessment of microorganisms (which Health Canada co-wrote with the U.S. Environmental Protection Agency), was published in 2003. Health Canada also sits on the Working Group on Human Health-Related Biotechnologies and the Working Party for Biotechnology, and contributes to activities related to issues such as: xenotransplantation;2 genetic testing and privacy; infection and immunity; and drinking water. The department also coordinated Canada's involvement in OECD's International Survey of Quality Assurance in Genetic Testing Labs, and will co-chair the spring 2004 OECD Workshop on Human Genetic Information in Research Databases - Issues of Privacy and Security.
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Codex Committee on Food Labelling (CCFL)
The CCFL, part of the international Food and Agriculture Organization based in Rome, is responsible for preparing international standards and guidelines for labelling food products. The Committee also studies specific problems, such as the labelling of genetically modified (GM) foods. In Canada, Health Canada leads this international work in conjunction with the Canadian Food Inspection Agency (CFIA).
1 Xenotransplantation is the transfer of living cells, tissues and/or organs from one species to another, including animal to human.
2 Xenotransplantation is not currently a recognized medical practice in Canada. When put in place, a new regulatory framework would facilitate the review of clinical trial applications for xenotransplantation, and help ensure the safety of patients, their families and all those involved.