To ensure objectivity and impartiality, the advisory committee is composed of external experts, not advocates, as well as representatives of the general public. CBAC members bring expertise in such diverse fields as science, business, nutrition, law, environment, philosophy, ethics and public advocacy. The 12 to 20 members serve on a volunteer basis.

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One of the Committee's key functions is to provide the Government of Canada with comprehensive advice on current policy issues associated with the ethical, social, regulatory, economic, scientific and environmental aspects of biotechnology.

Specifically, it is mandated to advise government on ways to:

• optimize the economic, health, safety and environmental benefits of biotechnology in a sustainable way in Canada through the CBS;
• ensure the science base which supports the government's regulatory role is maintained and internationally competitive;
• incorporate social and ethical considerations into policy making; and
• enhance public awareness and facilitate an open, transparent national conversation on key issues around the development and application of biotechnology in Canada.

CBAC's activities and deliberations are communicated to Canadians via numerous publications and its interactive Web site - www.cbac-cccb.ca - which encourages the exchange of ideas, information and perspectives. CBAC posts relevant research it receives or produces, as well as minutes of the Committee's meetings and advice delivered to ministers, on its Web site. A much-improved Web site, with greater interactivity and easier navigation, was launched on March 28, 2003.

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CBAC reports to the Biotechnology Ministerial Coordinating Committee, which is comprised of the federal ministers of Industry, Agriculture and Agri-Food, Health, Environment, Fisheries and Oceans, Natural Resources and International Trade.

The work of CBAC is supported by the Canadian Biotechnology Secretariat, which coordinates the management and operations of the Canadian Biotechnology Strategy. The Secretariat performs two main functions:

• to coordinate "horizontal" decision making across the Canadian Biotechnology Strategy departments and agencies, and
• to provide secretariat services for CBAC.

The federal government has approved $9.52 million annual funding for the Canadian Biotechnology Strategy. CBAC's allocation is $2.25 million for operational and secretariat support, research, publications, communications, and public outreach activities.

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CBAC's activities are divided into two categories: general activities and special projects. When CBAC concludes that an issue requires early attention by government, it produces an advisory memorandum on the subject for the Biotechnology Ministerial Coordinating Committee.

General activities are those of a broad, continuing nature. These include monitoring biotechnology developments nationally and internationally, facilitating public awareness of biotechnology issues, maintaining a forum for citizen engagement, issuing news releases, posting items on the Web site, participating in regional, national and international forums and major conferences, and expanding the exhibit program. In addition, CBAC members are active in their own right as commentators on major issues of public interest related to biotechnology.

More information about CBAC's general activities can be found in its annual reports, including a summary of developments during the year in genomics and proteomics, stem cells and cloning, agricultural biotechnology, patenting, genetic information and privacy, transgenic technologies and xenotransplantation.

The Government of Canada looks to the Canadian Biotechnology Advisory Committee for advice based on the in-depth study of specific subjects that is informed by consultation with experts, stakeholder groups and the public at large. CBAC originally identified five special projects for study: regulation of genetically modified food; intellectual property issues in biotechnology; issues related to novel uses of biotechnology (such as stem cells); incorporating social and ethical considerations into policy making around biotechnology; and privacy issues related to genetic information. Major research and consultation programs were undertaken with respect to the first two areas.

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Biotechnology is not without controversy. Among the most contentious issues in Canada, and even more so in many other countries, are those related to genetically modified (GM) foods.

At its inaugural meeting in October 1999, the Canadian Biotechnology Advisory Committee highlighted the need to study and evaluate the effectiveness of Canada's systems to assess and regulate the application of biotechnology innovations. CBAC identified three sub-topics for special consideration: the science base underpinning the regulatory system; the governance and organization of regulatory processes; and the social, ethical, legal, economic and environmental aspects of food biotechnology.

In December 1999, following consultations with CBAC, the ministers of Health, Agriculture and Agri-Food, and Environment jointly announced their intention to request the Royal Society of Canada to establish an Expert Panel on the Future of Food Biotechnology. Its mandate was to provide Health Canada, the Canadian Food Inspection Agency and Environment Canada with advice on Canada's regulatory system as well as the scientific capability the federal government requires in the 21st century to ensure the safety of new food products developed through biotechnology.

With the creation of the Expert Panel, CBAC concentrated its own efforts on the governance and organization of regulatory processes as well as the social, ethical, legal, economic and environmental aspects of food biotechnology.

In early 2000, CBAC initiated a research program on the regulation of GM foods. Following discussions with a reference group of stakeholder representatives, the committee began a series of public consultations based on a widely distributed consultation document. Roundtable discussions were held in five cities across Canada, attended by more than 90 members of various stakeholder groups. Some environmental groups chose not to participate in the consultations, but their views on various issues were accessible by other means.

After deliberating on the input it received, the Committee released an interim report in August 2001 containing draft recommendations. To further strengthen its report, it solicited comments from all interested parties. The comment period closed January 31, 2002.

Improving the Regulation of Genetically Modified Foods and Other Novel Foods in Canada was released on August 26, 2002. This report represents the views of CBAC on the regulatory system for genetically modified foods after having taken into account the results of commissioned policy research studies, sector roundtables, a review of public opinion research, multistakeholder consultations, the work of the Expert Panel of the Royal Society, and public responses to the Interim Report of August 2001.

CBAC concluded that GM foods approved under the current regulatory system do not pose any greater health or environmental risk than their conventional counterparts. The report identified opportunities to improve the management of the regulatory system and to strengthen its capacity to deal with more complex GM food products, as well as to incorporate scientific and technical advances as they emerge. The report also expressed support for the initiative to establish a standard for voluntary labelling and addressed issues related to environmental stewardship, international cooperation and informed dialogue.

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In a related endeavour, CBAC initiated work on the "Acceptability Spectrum" - a tool to facilitate discussion on the acceptability of GM foods or other biotechnology-based products.

At the outset of its GM food project, CBAC identified its desire to have stakeholders engage in a dialogue on the social and ethical considerations that are not part of the normal risk-based health and environmental regulatory assessments. These included matters such as environmental stewardship (e.g., sustainability), ethical acceptability, traditional knowledge and resources, power imbalance and vulnerability, and environmental ethics and economics. During the 2001 consultations, participants suggested criteria for assessing a GM food or feed (GMFF) product. These criteria were ultimately grouped into five themes: health considerations, environmental considerations, social considerations, ethical considerations, and broader societal considerations.

From this, a new conceptual framework emerged - designing a dialogue process around the concept of "acceptability." This concept, notionally called an Acceptability Spectrum, was first discussed at the initial consultation session in Vancouver, in April 2001, and enlarged at each subsequent consultation event. The early discussions generated considerable interest in the potential to facilitate a discussion of the acceptability of GMFFs, and the conditions that might affect this.

The framework was based on the premise that different kinds of GMFFs could be classified along a spectrum of "acceptability" - that is, as being more or less acceptable, according to a variety of criteria.

The Acceptability Spectrum consisted of four categories: acceptable; acceptable with certain conditions; unacceptable at the present time and until more is known or a given standard is met; or not acceptable under any circumstances.

A real-world parallel to the category "not acceptable under any circumstances" might be an unconditional prohibition (i.e., ban). "Not acceptable until more is known" might be likened to a moratorium. Under this framework, it might be feasible to consider either groups or classes of food or individual products as belonging to a position on the Acceptability Spectrum. These initial views could change, that is, move along the Acceptability Spectrum as knowledge improves, as society's views change, or as certain standards are either met or not met.

In 2002, CBAC initiated a three-phase pilot project to examine the "Acceptability Spectrum" and to assess its viability and usefulness as a mechanism to facilitate discussion among people with divergent views on the acceptability of GMFF. The first phase of the project involved the creation of a steering group, called the Exploratory Committee, to develop the tool through an extensive consultation process. Phase 2 involved six stakeholder sessions, held in March and April 2002 in Montréal, Ottawa, Hamilton, Toronto and Vancouver, to review and improve the dialogue tool. The results of the sessions were compiled in a summary report, available on CBAC's Web site.

The Exploratory Committee used the knowledge gleaned from these sessions to undertake further improvements to the Spectrum tool, to prepare it for the more-challenging multistakeholder review and to design the approach for such a multistakeholder session. These included the idea of testing the Spectrum tool with a substantial policy issue to explore the full range of considerations and impacts available in the model. During the development of the policy case studies, it became clear that the purpose of the tool needed to be clarified. As a result, there has been a change of name to "Genetically Modified Food and Feed Dialogue Tool."

At the end of the reporting period, the Exploratory Committee was working on a comprehensive progress report to CBAC, recommending continuation of the Pilot Project. The report was posted on the Web site.

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Biotechnology has sparked a society-wide debate about the ability to manipulate life forms and, potentially, even create life. It is challenging the values and beliefs that underpin society, forcing Canadians to confront complex ethical questions never before faced. As a result, Canadians' views about the life-altering applications of biotechnology play a central role in Canada's approach to the responsible development and regulation of this emerging industry.

In early 2000, CBAC initiated a research and consultation program on the patenting of higher life forms and related issues. It chose this topic for study because the application for a patent on the Harvard "onco-mouse" - regarding a mouse genetically modified for cancer research - was before the courts in Canada.

As well, both government officials and CBAC members had identified intellectual property issues related to biotechnology generally, and to the patenting of higher life forms in particular, as areas of growing concern.

Canada currently does not permit plants and animals to be patented, while most member countries of the Organisation for Economic Co-operation and Development (OECD), including the United States and members of the European Union, do. Many developing countries have concerns about the impact of patenting biological inventions derived from plants and animals in the absence of recognition of traditional knowledge. There is also a segment of the population that believes that patents on plants, animals or any biological material whatsoever (DNA sequences, genes, cells) should not be permitted on moral grounds. Even among countries that do consider higher life forms patentable, there is no consensus on how associated social and ethical considerations should be addressed.

Article 27.3(b) of the World Trade Organization (WTO) Agreement on the Trade-Related Aspects of Intellectual Property (TRIPs) allows member countries to exclude plants and animals from patentability. When the mandated review of this section takes place, some countries (mostly developing nations) can be expected to support maintaining or expanding this section, while other countries (most notably the United States) will likely want to either narrow or eliminate this exception. Canada will be better able to contribute to this debate by developing a domestic position on this matter prior to the commencement of these negotiations.

The report Patenting of Higher Life Forms was released on June 6, 2002. It represents the views and advice of the Committee on patent and intellectual property issues after having taken into account the results of commissioned policy research studies, sector roundtables, review of public opinion research, multistakeholder consultations, and public responses to the Interim Report of November 2001.

In its report, CBAC recommended that patents not be granted on the human body at any stage of development, and that higher life forms meeting the criteria of the Patent Act be patentable subject to certain limits. The report discussed pertinent social and ethical considerations, made recommendations on improving the patent system, and addressed issues related to the equitable sharing of the benefits of biotechnological inventions and the recognition of traditional knowledge.

The CBAC report figured prominently in the Supreme Court of Canada's deliberations on the Harvard Mouse case. There was substantial congruence between the Court's findings and CBAC's report. The Court, in a decision released in December 2002, concluded that the Harvard Mouse did not meet the definition of an invention and therefore is not patentable. However, it did not take a position on whether higher life forms ought to be patentable, leaving this matter for legislators to decide.

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Following completion of its two special projects in 2002, CBAC developed a new articulation of the general theme of its ongoing work, namely, Biotechnology in Canadian Society. A statement on this matter was presented at the Government of Canada's National Summit on Innovation and Learning held November 18-19 in Toronto.

CBAC will examine how Canadian institutions, both within and outside government, might be transformed to enable them to best capture the benefits of biotechnology while managing risks and facing social and ethical challenges. These transformations may involve changes in how institutions are organized and perform their functions, the development of new organizations, and/or the cultivation of new partnerships, alliances and networks. The institutional transformations fall into two categories: those that focus on social and economic development (e.g., education, research, knowledge transfer, risk capital) and those that focus on regulatory matters (e.g., risk assessment, management and communication, health, environment and respect for core social values). The exploration of this topic will involve research to determine its parameters, examination of the short-term issues and opportunities associated with biotechnological innovations, and assessment of the pathways for longer-term institutional transformation.