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![]() ![]() ![]() ![]() ![]() Expert Roundtable Series – Summary ReportExpert Roundtable Series Summary Report Report by:
TABLE OF CONTENTS2.0 SUPPORT FOR A RENEWED STRATEGY 3.0 RECOMMENDED DIRECTIONS TO CONSIDER IN A RENEWED STRATEGY 3.1 Engaging Canadians
3.2 New Ethical Frameworks 3.3 Stewardship of Biotechnology 3.4 Advancing the Biotechnology Sector 4.0 CHALLENGES AND OPTIONAL WAYS FORWARD 5.0 NATURE AND STRUCTURE OF A RENEWED STRATEGY 6.0 FUTURE STRATEGY: GOVERNANCE APPENDIX 1 - ROUNDTABLE AGENDAS APPENDIX 2 - CBAC, CBSEC AND CONSULTATION STAFF APPENDIX 3 - BIOTECHNOLOGY STRATEGY SPECTRUM Executive SummaryThis report summarizes the proceedings of a series of expert roundtables sponsored by the Canadian Biotechnology Advisory Committee (CBAC) under the theme "Canada’s Biotechnology Strategy: Charting the Path Forward." The roundtables were held from April to June 2006 in Montreal, Halifax and Vancouver. They were attended by members of the biotechnology community including academia, research centres, industry, financial support agencies, and environmental and other interested organizations. The purpose of the roundtables was to provide input into the formulation of CBAC’s advice to the Government of Canada on the possibility of renewing and revising the 1998 Canadian Biotechnology Strategy (CBS). Overall, participants supported the development of a renewed strategy with certain conditions; the strategy should be focused and action-oriented with strong federal government leadership and an accompanying action plan. Many participants indicated that if the renewed strategy did not have strong federal leadership and exhibit these qualities, it would be preferable not to undertake or release a new strategy. Several participants expressed concern that Canada’s biotechnology strategy is, and will be, seen as biotechnology promotion alone without balanced attention to stewardship. The next strategy should provide a holistic and balanced/neutral view of biotechnology and biotechnology issues. This view should be supported by strong risk-benefit analysis as well as consideration of moral and ethical questions. The renewed strategy should take the form of a “national action plan for biotechnology” and should have a broad Canadian scope. All stakeholders, including provinces, have a role to play in biotechnology in Canada and should be involved in the strategy. Partnerships between governments and with industry and other stakeholders will be important for successful governance and implementation of a renewed strategy. On balance, participants recommended a multi-stakeholder governance model for a renewed strategy that is characterized predominantly by federal leadership with a multi-stakeholder mechanism that enables their involvement in monitoring, evaluating and advancing the strategy. The strategy should be accompanied by an action plan, the implementation of which would be the responsibility of both government and biotechnology stakeholders. Many participants noted the importance and usefulness of appointing a federal “champion” to provide leadership for biotechnology. Improving coordination across federal departments, between governments and with industry and other stakeholders (both domestic and international) was identified as another critical issue for success. Having expressed the desire for a multi-stakeholder governance model, participants also recognized the challenge associated with such a model in terms of effective decision-making leading to real results. Advancing the biotechnology sector was an important element of a renewed strategy to many participants. They felt that there would be merit in building excellence in specific areas of strength. They noted that provinces and regions have different strengths which could be capitalized on successfully. However, they cautioned against developing a strategy that is too prescriptive in order to avoid marginalizing activities outside the immediate scope of the strategy; the strategy should enhance, not limit, activity. In each session, many participants also highlighted the following challenges that must be addressed to advance the biotechnology sector, including:
Commercialization is a particular challenge in Canada. Participants noted that there is very little funding specifically allocated to help entrepreneurs take their ideas to market. There is a plethora of funding programs to support research but a lack of programs (both short- and long-term) supporting development and commercialization. Market conditions should be addressed earlier in the research and development cycle in order to evaluate the potential competitiveness of a product before too much investment is made. Public awareness activities, including the provision of information about the risks and benefits of biotechnology, and how and where biotechnology contributes and can contribute to societal needs must be balanced and unbiased to support informed decision-making by Canadians. In addition, Canadians would benefit from further dialogue around the moral, ethical, social and cultural dimensions of biotechnology. A renewed strategy needs to build new ethical frameworks to equip us properly to discuss and deal with the complex and value-laden aspects of current, emerging and still unheard of areas of biotechnology. Participants pointed out that the strategy should elicit trust and credibility. Consideration of the language used in the strategy, the way that issues are presented and an overall willingness to analyze risks and benefits fairly and accurately would help build support for a strategy. It was recommended that the federal government improve its role in strategy leadership, federal coordination, responsible stewardship, and regulatory responsiveness, coherence and harmonization. On balance, strategy leadership and federal coordination were identified as the most critical priorities for successful implementation of a renewed strategy; while regulatory responsiveness and stewardship represent the areas where the greatest gaps in federal action exist. Overall, most participants pointed out that the government has failed to provide enough leadership (strategic and applied) for biotechnology and has failed to fully implement the 1998 CBS. Federal leadership is critical to successful implementation of a renewed strategy. 1.0 IntroductionThis report summarizes the proceedings of a series of expert roundtables on the theme “Canada’s Biotechnology Strategy: Charting the Path Forward” held from April to June 2006 in Montreal, Halifax and Vancouver. These roundtables assembled members of the biotechnology community from academia, research centres, industry, financial support agencies, and environmental and other interested organizations. The purpose of the roundtables was to provide input into the formulation of CBAC’s advice to the Government of Canada on the possibility of renewing and revising the 1998 Canadian Biotechnolgy Strategy (CBS). Where appropriate, the results from each session were used to inform the discussion in the next sessions. The workshops were designed to provide opportunities for participants to comment on several aspects of strategy renewal, including the following:
This document synthesizes the results from all of the roundtables and attempts to draw some broad conclusions on the challenges identified by participants, possible actions for moving forward, and recommendations about the structure, nature and governance of a renewed strategy. Detailed summaries of discussions from the Montreal, Vancouver and Halifax roundtables were also produced and can be accessed at http://cbac-cccb.ca. 1.1 Setting the ContextParticipants at each session listened to presentations designed to set the context for discussion of a renewed strategy. In Montreal, Arthur Carty, National Science Advisor for the Privy Council Office, provided an overview of biotechnology in Canada. This was followed by a presentation from Pierre Coulombe, President of the National Research Council, who provided an overview of the drivers and opportunities for biotechnology in Canada. The presentations in Vancouver and Halifax were also designed to set the context for discussions. The first presentation described the state of biotechnology in Canada today; the second presentation detailed some of the progress made on the 1998 CBS; and the third presentation highlighted the results of the focus groups on biotechnology that were held in conjunction with the expert roundtables. Trefor Munn-Venn, Associate Director, The Conference Board of Canada, presented an overview of the state of biotechnology in Canada. He identified several key questions for consideration moving into the future:
A brief overview and summary impression of progress made and performance on the 1998 strategy2 was provided under each of the ten 1998 work plan themes, with illustrations of events, publications, capabilities and processes that had been established. Jeff Walker, Senior Vice-President, Decima Research provided a summary of the results of the focus group discussions on biotechnology which were held recently in Vancouver, Montreal and Halifax. The focus groups were commissioned by CBAC to further inform the committee members’ considerations around modifications required to the CBS. Each session involved 12-15 Canadians in a discussion about biotechnology issues. The focus groups’ concerns and priorities were reflected in the discussions of the expert roundtables. Mr. Walker highlighted the following top priorities for Canada with respect to biotechnology as identified in the focus groups:
Focus group participants indicated that a continued strategy for biotechnology is required because of the following:
1.2 Building a Common FrameworkAs a means of building a common understanding from which to work, the facilitator provided a working definition of a strategy:
Participants at the session were asked to provide advice on the broad elements of a renewed CBS:
The characteristics of the current CBS, launched in 1998, were outlined both to provide a better understanding of its purpose and clarify what qualities it had and did not have. The current strategy provides overall guidance for biotechnology in Canada; it is a statement of the Government of Canada’s commitment to biotechnology. It provides guidance to the federal government although its goals and principles also suggest action for biotechnology stakeholders more broadly. It identifies areas of development but is not prescriptive. The strategy is not specifically or centrally funded as a federal program. Each department with biotechnology-related activities is responsible for defining its role under the strategy, undertaking actions related to the department’s mandate, and defining and measuring successful implementation using their own performance measures. Mechanisms for interdepartmental coordination are in place through a governance structure that includes a ministerial coordinating committee along with deputy ministerial and assistant deputy ministerial coordinating functions. These are supported by a secretariat, which also provides support to the government’s independent external advisory committee, CBAC. These broad parameters were laid out as a foundation on which roundtable participants were asked to consider whether the strategy should be renewed and, if so, the particular form and content of a renewed strategy. 2.0 Support for a Renewed StrategyOverall, participants supported the development of a renewed strategy with certain conditions. The strategy should be focused and action-oriented with strong federal government leadership as well as stewardship and an accompanying action plan. Participants noted, however, that it might be a “tough sell” to get industry and other stakeholders interested and involved in the development and implementation of a renewed strategy in any active way unless there was evidence that this strategy would be different, address current issues, be pragmatic, and show strong federal commitment and leadership. In fact, on balance, many participants indicated that if the renewed strategy did not exhibit these characteristics including strong federal leadership, then it would be preferable not to undertake or release a new strategy (i.e. it would be more damaging to offer a less acceptable strategy). Several participants expressed concern that Canada’s biotechnology strategy is, and will be, seen as biotechnology promotion alone without balanced attention to stewardship. Some noted a built-in contradiction in creating a government strategy on biotechnology. This contradiction is rooted in the tension between the government’s responsibility to both regulate and promote biotechnology. We do not yet have the answers to this dilemma, but we have noted the problem exists. The next strategy should provide a holistic and balanced/neutral view of biotechnology and biotechnology issues. This view should be supported by strong risk-benefit analysis as well as further consideration of moral and ethical questions. The strategy should push for further examination and deliberation of public policy issues, with consideration for a wide range of views and needs from the public to civil society to industry, clearly articulating the risks and benefits of biotechnology in a balanced, fair way. 3.0 Recommended Directions to Consider in a Renewed StrategyFour main challenges emerged as priority directions for further consideration and action in a renewed strategy. These interrelated directions are: engaging Canadians in informed dialogue; ensuring ethical frameworks are developed and used to consider all the implications of biotechnology applications in our society; stewardship of biotechnology; and advancing the biotechnology sector. 3.1 Engaging CanadiansThe public would benefit from information that contributes to a better understanding of how and where biotechnology contributes and can contribute to societal needs, and from further dialogue around the moral, ethical, social and cultural dimensions of biotechnology. The design of public engagement activities, and the language used in both the strategy and further dialogue, must enable the Canadian public to engage in meaningful and considered debate. Some participants felt that the biotechnology sector and the government could do a better job of communicating to the public the nature of discoveries and their potential applications. Improved public understanding of biotechnology could reduce consumer fear. In addition, the negative carry-over effects of current views on genetically modified foods need to be considered and addressed as they may spill over into new areas of biotechnology. Public awareness activities, including the provision of information about biotechnology, must be balanced and unbiased to support informed decision-making by Canadians. Information to inform the public should provide an accurate assessment of risks and benefits in such a way as to support informed decision-making and not to unduly promote or negate biotechnology. Evaluation and discussion of the biotechnology sector must be based not only on statistics and science-based evidence but also on needs, ethics and social values. 3.2 New Ethical FrameworksA renewed strategy needs to provide new ethical frameworks and possibly new vocabulary to equip us properly to discuss and deal with the complex and value laden aspects of current, emerging and still unheard of areas of biotechnology. At a fundamental level, we need to consider carefully how we analyze and discuss biotechnology. Some participants felt that, to date, views have been narrowly defined around constructs that were too economically focused. New vocabulary and approaches to dialogue are required to assess biotechnology and its place in society. Risk assessment is a fundamental part of this; we may even need to change the way we talk about risks and benefits. Participants pointed out that the strategy should elicit trust and credibility. Consideration of the language used (i.e., neither excessively pro nor con applications, issues etc.) in the strategy, the way that issues are presented and an overall willingness to analyze risks and benefits fairly and accurately would help build support for a strategy. 3.3 Stewardship of BiotechnologyParticipants agreed that the federal government, with stakeholders and civil society among others, must conscientiously steward biotech by enabling dialogue and informing Canadians, identifying and brokering related social and ethical issues, and advocating responsible development and use. Some participants cautioned against immediate action to advance the biotechnology sector in order to take the time to engage Canadians in further dialogue about biotechnology issues. Participants noted a need to challenge the assumption that it is important and necessary to increase research and development in biotechnology and to develop the Canadian biotechnology sector quickly. We need to be clear why biotechnology is needed, as well as if, and why we need to move quickly. Technology and competitiveness should not be the ultimate drivers of this strategy. As well, participants in each session pointed out a need to better understand and communicate the risks associated with biotechnology. Liability issues must also be considered and addressed. New risk assessment models may need to be developed to ensure that issues such as assessing risk over time (e.g. risk over decades) and potential consequences on other sectors/environments (e.g. aquatic environment) are explicitly addressed. Proper stewardship of biotechnology also means making certain that we have a strong regulatory environment to ensure the health and safety of Canadians and their environment. Overall, participants recognized that a supportive, responsive regulatory system is part of the foundation of a strong biotechnology sector. They acknowledged that Canada has a strong regulatory system; in fact, many participants pointed to our regulatory system as a Canadian success that could be marketed and shared with other countries. However, they also called attention to several deficiencies that should be addressed in a renewed strategy. Participants noted, for example, that government staff often have few resources and little knowledge of current and emerging biotechnologies. In addition, the nature of the Canadian process makes it difficult for it to remain flexible enough to keep up with the fast pace of the biotechnology sector. Participants also suggested that Canada needs to harmonize its regulatory process in order to support innovation and competitiveness in a global market. They pointed out that our process is significantly longer than most other countries and that delays in decision-making (and in some cases, an absence of key decisions) can reduce the marketability of products and the competitiveness of Canadian companies. As well, Canadian companies should be subject to the same standards and regulation whether they are working inside or outside of Canada. Efforts to harmonize Canadian and international regulations and standards should not negatively affect the overall high quality of our regulatory system. 3.4 Advancing the Biotechnology SectorIn each session, many participants stressed the need for a renewed strategy to support development of the biotechnology sector. They particularly highlighted the following challenges:
Some participants also noted that Canada has a great environment for developing “ideas” but a poor business-oriented environment. Building a better environment for business would aid in the development of Canadian biotechnology, attract talent and companies to Canada and create revenues that could be reinvested in other programs such as education and intellectual property production. One way to address this challenge would be to focus on creating world-class processes and structures to support biotechnology thus creating a biotechnology-friendly environment in Canada. Commercialization is a particular challenge in Canada. Participants noted that there is very little funding specifically allocated to help entrepreneurs take their ideas to market. There is a plethora of funding programs to support research but a lack of programs (both short- and long-term) supporting development and commercialization. It was pointed out that success in other countries has been supported by targeted government policy. Thus, many participants suggested that the Canadian government identify priorities for biotechnology, and develop and implement strategic policies to support them. Investment in biotechnology could be targeted to those areas where Canada is well-positioned for success (e.g. health biotechnology). Many participants pointed out that ‘picking the winners’ in this way can create the conditions needed for innovation in other areas both within and outside biotechnology (e.g. investment in defence led to the development of the Internet). Participants generally supported this approach but noted that the idea of strategic clusters should not be embraced at the expense of continued investment in other biotechnology areas. Balance is needed between research and development (R&D;), and innovation and commercialization. We need to consider the context in which research is undertaken and new products are developed (e.g. balance drug development with public health. We also need to consider potential gaps between “product push” and “consumer pull”; that is, whether research is undertaken and products are developed with good market knowledge of the need, attractiveness to the consumer and potential market uptake. Market considerations should be addressed earlier in the research and development cycle in order to evaluate the potential competitiveness of a product before too much investment is made. It was noted that innovative companies are skilled at connecting technologies to markets early. A well-functioning regulatory system is also needed to advance and support the biotechnology sector. Some participants in all three sessions stated that Canada’s regulatory system is not responsive enough. Many felt that our regulatory environment is too slow and does not respond easily to changing technology thus creating an unpredictable environment that is not conducive to helping biotechnology products reach the market. It was also pointed out that the regulatory system is complicated and involves many players (e.g., Canadian Food Inspection Agency, Health Canada, Environment Canada, etc.). Consequently, the specific requirements, timelines, processes and players are often not well understood by the Canadian public and in some cases by government and industry. 4.0 Challenges and Optional Ways ForwardParticipants were asked to identify the needs or problems and opportunities in biotechnology that should be addressed as part of any plan or strategy going forward. Participants also suggested initiatives that could be undertaken to respond to these challenges and problems.
5.0 Nature and Structure of a Renewed Strategy5.1 Nature of a Renewed StrategyThroughout the discussion, participants commented on the purpose, scope and characteristics of a renewed strategy as well as on some of Canada’s responsibilities in biotechnology. Participants provided advice in five specific areas:
5.2 Vision, Goals and PrinciplesParticipants commented on the need to update or alter the vision, goals and principles as stated in the 1998 CBS. Vision Guiding Principles
Goals
6.0 Future Strategy: Governance6.1 StakeholdersThere are numerous stakeholders involved in and impacted by biotechnology. They are illustrated in the diagram below which was used during the Vancouver and Halifax roundtable sessions for the purpose of discussion on roles and governance. 6.2 Governance ModelA range of governance options is available to administer a strategy. A spectrum was presented to initiate discussion on options ranging from no explicit governance of a strategy (e.g. laissez faire) to a jointly led strategy (e.g. biotech community and government work together) to exclusive federal leadership of a strategy. Overall, participants recommended a governance model for a renewed strategy that is characterized predominantly by federal leadership with responsibility for implementing an action plan (also called a ‘business plan’ by some participants) shared by biotechnology stakeholders. However, some participants recommended moving responsibility for discussion and consideration of biotechnology as a critical public interest issue to a more public forum such as Parliament (e.g. via a Parliamentary committee). Partnerships between governments and with industry and other stakeholders will be important for successful governance and implementation of a renewed strategy. Participants in Montreal noted that successful implementation of a renewed strategy relies not only on who ‘owns’ the strategy but also on who invests in it. Thus, they recommended that resources for implementation of the strategy should be provided by industry (and others, as appropriate), as well as the federal government. It should be noted that many participants cautioned against choosing a governance model too soon. They felt that the purpose of the governance model is to ensure better government and stakeholder coordination and action, and good implementation of the strategy. Thus, formulation of the strategy would ultimately guide the type of governance that is required. 7.0 Roles and Leadership7.1 Federal Government Roles and LeadershipThe federal government plays a variety of roles related to strategy implementation including: providing financial support; regulatory responsiveness, coherence and harmonization; strategy leadership; coordination; international leadership; and stewardship. These are illustrated in the graphic below which was used to initiate discussion on areas for improvement. Participants recommended that the federal government improve its role primarily in four of the six core areas: strategy leadership, coordination, stewardship, and regulatory responsiveness, coherence and harmonization. On balance, strategy leadership and federal coordination were identified as the most critical priorities for successful implementation of a renewed strategy; while regulatory responsiveness and responsible stewardship represent the areas where the greatest gaps in federal action exist. Strategy Leadership Overall, participants noted the importance and usefulness of appointing a federal “champion” to provide leadership for biotechnology. In Halifax, participants indicated that this champion should be appointed at a senior government level to have enough authority to influence government action on biotechnology positively. Some felt this could be achieved through a Minister of Science. Other sessions did not provide specific guidance of this nature but noted that the responsibilities of the “champion” could include:
Participants also acknowledged that support and leadership are required from outside government to help build government priorities around biotechnology, to leverage available resources better and to take advantage of successes in other areas (e.g., provinces, industry, and civil society). One way to build political momentum around biotechnology is to promote recent “success stories” that illustrate the importance of biotechnology by pointing out the relevance of biotechnology to Canada and its potential positive influence on different aspects of Canadian society (e.g., the lives of Canadians, the Canadian economy, etc.) Some participants also noted that the biotechnology sector has a role to play in better coordinating its own efforts to support and promote biotechnology. For example, industry associations could work together to provide consistent messages about their needs to the government, offer solutions, promote successes and link industry and government priorities effectively. Federal Coordination Stewardship Regulatory responsiveness, coherence and harmonization 7.2 Implementation InstrumentsImplementation of the current biotechnology strategy is supported by Canadian Biotechnology Secretariat and CBAC. There was some indication in all three sessions that CBAC is not well-known even within the biotechnology sector. Participants in Halifax articulated this viewpoint clearly and urged CBAC to develop a more active relationship with industry associations and others across Canada. Overall, many participants indicated that it is too soon to make a recommendation about the potential role of an external, arm’s-length committee such as CBAC. The ultimate formulation of the strategy will dictate the need for an external committee, as well as its form and function. With this in mind however, participants in Halifax and Montreal generally supported the concept of an external advisory committee while the views in Vancouver were more mixed. Some participants felt that such a committee is extremely useful for creating additional authority and prominence for the strategy and for biotechnology, in general. They noted that advice based on consensus originating from a CBAC-like committee would be difficult for the government to ignore. On the other hand, some participants felt that CBAC is inherently biased toward the industry and cannot fairly represent all views. Appendix 1 - Roundtable Agendas
Appendix 2 - CBAC, CBSec and Consultation StaffThe following individuals attended at and assisted with at least one roundtable consultation: CBAC MembersAttended as observers Mary Alton-Mackey Canadian Biotechnology Secretariat Kim Elmslie, Executive Director Facilitation Team, InterQuest Consulting Lyle Makosky, Lead Facilitator Appendix 3 - Biotechnology Strategy Spectrum1InterQuest Consulting is a leading private firm that specializes in public policy consultation, citizen engagement and dialogue processes involving public interest issues including those dealing with Biotechnology. InterQuest designed and facilitated the Roundtable process and prepared this report. 2See Annex 2 of the roundtable background paper, Canada’s Biotechnology Strategy: Charting the Path Forward, circulated to participants prior to the sessions. It can be accessed at http://cbac-cccb.ca.
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Created: 2006-07-25 Updated: 2006-10-04 ![]() |
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