The Environment Canada Policy Research Seminar Series

Dr. Arnold Naimark September 8, 2000

On Friday, September 8th, 2000, the Environment Canada Policy Research Seminar Series hosted Dr. Arnold Naimark, Chair of the Canadian Biotechnology Advisory Committee.  Following is a précis of Dr. Naimark's talk, entitled "Biotechnology:  Advising Policy Makers About Opportunities and Risk".

In defining biotechnology, it is desirable to find a definition both broad and free of implicit value judgements, while avoiding the pitfall of associating the term exclusively with recently developed scientific techniques.  Defining biotechnology, then, as "a body of technical knowledge about living organisms or their constituent parts" meets these criteria.  Much of the discussion surrounding biotechnology refers to applied biotechnology, which can be defined as "the use of biotechnology to make products and drive processes that serve social, scientific or economic purposes".  The list of biotechnological applications has grown significantly in recent years and continues to grow at an ever increasing pace.  Everything from genome mapping to identifying genes responsible for predisposition to disease to using living organisms to eliminate environmental contaminants to the microorganisms used in the fermentation process of food production fall under the umbrella of biotechnology.

Biotechnology presents the opportunity to provide significant economic and social benefits to Canadians.  Its importance in raising social and ethical questions must also be considered.  Biotechnological applications often challenge current approaches to the protection of human and animal health and the environment.

Policy makers are faced with unique challenges in dealing with these issues.  These include the rapid pace of technological innovation and the shortening of the gap between discovery and application which puts pressure both on the regulatory apparatus and on the public's ability to assimilate and adapt to new developments.  Further, in some fields control of these technologies rests increasingly in the hands of large multi-national corporations, making regulation at the national level difficult.  The risks to health and to the environment may be difficult to quantify due to the newness of the technologies involved.  As a result, regulatory systems must become increasingly adaptable, providing accountability and maintaining public confidence.  International issues arise because of regional disparities, with most of the worlds genetic diversity located in the developing world while the knowledge is concentrated in the more affluent nations.  Trade and competitiveness issues also come into play here, where potential but unquantified risk may be used as the basis for raising trade barriers.  Finally, policy makers are confronted with difficulties in accessing and obtaining the enormous amount of information necessary for decision making within the time constraints involved.

The priorities for public policy makers are to protect the public health and the environment by ensuring that proper regulatory processes are in place, and to secure the maximum benefit from biotechnological advances now and in the future.  The function of the advisory mechanisms supporting these priorities are twofold:  Regulatory mechanisms provide for the (granting or withholding of approvals for specific biotechnologically-based products and processes) and are largely internal in nature.  Developmental mechanisms .(providing advice on policies and procedures for further development of biotechnology or its regulation) comprises both internal and external mechanisms.

• Biotechnology's importance is growing rapidly in terms of its social and economic benefit to Canadians, though some applications raise profound social and ethical issues.
• Unique challenges are presented to policy makers due to the rapid pace of technological innovation in the field, and the uncertainty present in assessing the risks involved.
• CBAC's role is to conduct relevant research with a view to advising Ministers of the full range of policy issues associated with biotechnology.

There are several distinct types of advisory mechanisms important to the process. Advisory mechanisms supporting the regulatory function are mainly internal.  Internal advisory mechanisms are burdened with maintaining public trust in the process and providing an interface between advisory and regulatory groups.  These internal mechanisms may be supplemented by special purpose ad hoc groups established by government and involving external advisors, such as advisory councils task forces and royal commissions, as well as by Ad Hoc reference of particular matters to other institutions (e.g. academies and societies).

Regulatory mechanisms focus on the assessment, management and communication of risk.  Risk assessment presents a particular challenge in terms of biotechnology, namely that of uncertainty, where risks are unknown and or difficult to quantify.  The management of risk involves providing as complete a range of management options as possible, distinguishing between voluntary and involuntary exposure to risk, and identifying effective management options that are not unnecessarily onerous.  Effective communication of risk includes ensuring transparency and openness at all levels, and serves the needs of audiences with diverse levels of knowledge and sophistication.

Advisory mechanisms in the developmental category are diverse, and therefore difficult to generalise.  The Canadian Biotechnology Advisory Committee (CBAC) is an example of such an advisory mechanism, and may be used as a case study.  CBAC was formed in September, 1999, and has its origins in earlier committee's and advisory groups, namely the National Biotechnology Strategy, the Biotechnology Task Force, and the National Biotechnology Advisory Committee.  Its mandate is to advise Ministers on the full range of policy issues related to the development and application of biotechnology associated with the ethical, social, regulatory, economic, environmental and health aspects of biotechnology.  It seeks to advise government on ways to optimise the benefits of biotechnology for Canadians, incorporate social and ethical considerations into policy-making, and enhance public awareness of the key issues involved.  CBAC reports to the Biotechnology Ministerial Co-ordinating Committee, and its research and reports will be available to the public.

CBAC is composed of its chair plus twenty members, taken from the public at large, the private sector, NGO's, and academia.  It is organised into three standing committees concerned with stewardship, economic and social development, and citizen engagement respectively, as well as steering committees for specific projects.  Its guiding principles include a commitment to the primacy of the public interest, independence, knowledge-based deliberation, integrity, openness, responsiveness and breadth of perspective.

CBAC's Program Plan 2000 can be broken up into two areas:  general activities and special projects.  Issues which fall under the former heading include communications and public engagement, the monitoring and reporting on developments both in Canada and abroad, and stakeholder events.  Several issues have been identified for study under special projects, including the regulation of genetically modified (GM) foods, the protection and exploitation of intellectual property, the development of an ethical framework for policy-making, the use of novel genetically-based interventions, and genetic privacy.  Looking at one of these issues more closely, the regulation of genetically modified foods can be taken as an example.  The interaction between CBAC and other external advisory groups is illustrated by the GM Food project. The issue has been broken into three main topics for consideration by CBAC:  the scientific base supporting the regulatory system, the governance and organisation of regulatory systems, and the social, ethical and legal dimensions of the introduction of GM foods.  The first of these issues has been referred to an expert scientific panel established by the Royal Society , while the CBAC itself concentrates on the latter two topics.

Though CBAC has a short history, an effective modus operandi is emerging, based on capitalising on available resources, maintaining independence, responding to urgency emergent issues and managing expectations.

Looking ahead, the pace of biotechnological innovation will continue to accelerate and the pressure to exploit the applications will intensity, leading to pressures on regulatory processes, policy making and legislative processes, and international relations involving trade and economic development.  Similarly, the need for timely and practical advice on regulatory and developmental issues informed by broad public consultation will also intensify.  The early experience of CBAC indicates that  meeting this need will require the achievement of an optimal level of co-ordination and communication among

Biography

Dr. Arnold Naimark is the current chairperson of the Canadian Biotechnology Advisory Committee, an arm's-length external committee that advises seven key Ministers on social, economic, scientific, regulatory, environmental and health aspects of biotechnology. Dr. Naimark graduated from the University of Manitoba in 1957 with a medical degree. He then received his Master of Science in 1959 followed by several international research fellowships.

Dr. Naimark, a specialist in Internal Medicine, was admitted by examination to the Fellowship in the Royal College of Physicians and Surgeons of Canada in 1964. He had a distinguished career as a Professor of Medicine at the University of Manitoba before becoming Dean of the Faculty of Medicine from 1971 to 1981, following which he served as the University's President and Vice-Chancellor from 1981 to 1996. He is currently Professor of Medicine and Physiology at the University of Manitoba, the Director of the Centre for the Advancement of Medicine and the founding Chair of the Canadian Health Services Research Foundation.

Throughout his career, Dr. Naimark has been a medical, academic, and community leader in numerous local, national and international fora. He has served and continues to serve on many committees, boards and advisory bodies in such positions as Chair, International Review Panel for the Medical Research Council of Canada; member of the Board of Trustees, Lewis Perinbaum Award for International Development; member of the Board of Directors of the Canadian Imperial Bank of Commerce; and President, Association of Universities and Colleges of Canada. He has also received several honourary degrees and awards, including the prestigious Order of Canada (1991).