Expert Roundtable, Vancouver June 15, 2006

Canada’s Biotechnology Strategy - Charting the Path Forward

Expert Roundtable, Vancouver June 15, 2006
Meeting Summary

July 3, 2006

Table of Contents

EXECUTIVE SUMMARY

1.0 INTRODUCTION

2.0 CHALLENGES FOR A FUTURE STRATEGY

3.0 IMPROVING OUR APPROACH – PROBLEMS, OPPORTUNITIES AND INITIATIVES

4.0 FUTURE STRATEGY: GOALS AND PRINCIPLES

5.0 FUTURE STRATEGY: CONSIDERATIONS AND DIRECTIONS

6.0 FUTURE STRATEGY: GOVERNANCE, FEDERAL ROLES AND LEADERSHIP

7.0 CONCLUSION

APPENDIX 1 - ROUNDTABLE AGENDA

Executive Summary

The Canadian Biotechnology Advisory Committee consulted various stakeholders interested in biotechnology to obtain input on the renewal of the Canadian Biotechnology Strategy. Given the current economic and environmental context, the strategy is an important part in the positioning of Canada as a responsible world leader in biotechnology. This roundtable, held in Vancouver, was the third of a three workshop series.

Overall, Vancouver participants supported the development of a renewed strategy if it displayed certain qualities. A new biotechnology strategy must be simplified, focused and more outcome-oriented to suggest specific actions that can be implemented (e.g. a Canadian strategy accompanied by a federal action plan). Its related governance model must be more explicit, centralized and focused so that the strategy influences government behaviour, with more involvement by stakeholders and provincial governments. Some participants recommended explicit involvement of a third-party such as a CBAC-like committee to provide advice to government. Other participants recommended moving responsibility for discussion and consideration of policy on biotechnology to a more public forum that would consider the public interest, such as Parliament (e.g. a Parliamentary committee).

At a fundamental level, we need to carefully consider how we analyze and discuss biotechnology and its stewardship. To date, views have been narrowly defined around constructs that were more economically focused. New vocabulary and new approaches to dialogue are required to assess biotechnology and its place in society. Risk assessment and impact analysis are a fundamental part of this.

The federal government should push for more advanced examination and deliberation of public policy issues related to biotechnology. For example, several participants stated strongly that “promotion” of biotechnology is not a role for the federal government. Others felt there is a fundamental federal role in advancing the biotech field through support for research and commercialization and in supporting the export of Canadian biotech products. A new strategy needs to address new ways of thinking, new ethical frameworks and possibly new vocabulary to properly equip us to deal with emerging (and still being defined) areas of biotechnology.

Some participants felt that there would be merit in "picking winners" by focusing on building excellence in specific areas of strength. They noted that different provinces and regions have different strengths that could be capitalized on successfully. Participants cautioned against developing a strategy focused on “winners” that is too prescriptive in order to avoid marginalizing activities outside the immediate scope of the strategy; the strategy should enhance, not limit, activity. Potential areas of strength on which the strategy could focus include areas where the “world needs help” (e.g. ecological restoration), agriculture and energy (e.g. renewable fuels), health and biopharmaceuticals, and industrial biotechnology. As well, concentrating on areas that cut across sectors could also provide some advantages for Canada (e.g. creating excellent graduate programs, and improving immigration and taxation policies).

The strategy also needs to strengthen public engagement with more public education and fora for dialogue that enables true, respectful and critical engagement on related public interest questions.

Several participants noted the need for balance between R&D;, and innovation and commercialization, given the current emphasis on supporting research. 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, if research is undertaken and products are developed with good market knowledge of the need, attractiveness to the consumer and potential market uptake.

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1.0 Introduction

This report summarizes the proceedings of the roundtable workshop entitled Canada’s Biotechnology Strategy: Charting the Path Forward held June 15, 2006, at the Hotel Georgia in Vancouver, British Columbia. The workshop was the third of a three workshop series convening members of the biotechnology community from academia, research centers, industry, financial support agencies, and environmental and other interested organizations.

The workshop was divided into five parts. The first part included a series of overview presentations to set the context for the discussion. In the second part, participants were given an opportunity to comment on the needs or problems and opportunities that should be addressed in a strategy for the future, and to identify initiatives to address them. In the third part, participants considered the goals and guiding principles of a renewed strategy. The fourth part enabled views on broad direction and considerations for the strategy, such as whether or not Canada should adopt a strategy that focuses on its strengths and whether it should be a Canadian or a federal strategy. The fifth part focused on governance of the strategy as well as clarification of the role and leadership of the federal government. Where appropriate, participants were asked to consider and build upon the results of the first two sessions in Montreal and Halifax (hand-out of the first session findings were provided).

Lyne Létourneau, Canadian Biotechnology Advisory Committee (CBAC), opened the workshop by welcoming participants and thanking them for attending. She explained that the input provided during the workshop would help CBAC in identifying a direction for the development of a renewed Canadian Biotechnology Strategy (CBS). A Canadian strategy appears to be imperative given the social and economic impacts of biotechnology. Dr. Létourneau explained that the original 1998 strategy was based on the three pillars of stewardship, innovation and engagement, and that it played an important part in positioning Canada as a responsible world leader in biotechnology. Given the dynamic nature of biotechnology, a renewed strategy is required and expected to be evolving, comprehensive, current and relevant. These are necessary conditions for Canada to be successful and take advantage of opportunities to deal with various issues. She suggested that participants consider two questions throughout their deliberations:

• Where do we see ourselves in the future in terms of biotechnology?
• What is required to get us there?

Dr. Létourneau noted that CBAC is well positioned to undertake a review of the Canadian Biotechnology Strategy given that it is a body that synthesizes and reconciles the streams of analysis and advice coming from a variety of other advisory groups in Canada and abroad; that it explores the various perspectives of the Canadian public and diverse stakeholders groups; and is mandated to provide advice on biotechnology and its future to the federal government.

Finally, Dr. Létourneau explained that the results from the session would be analyzed jointly with the results from all three roundtables (Montreal, Halifax and Vancouver) as well as with findings gathered from three citizen focus groups conducted in the same period, and used to inform the advice that CBAC will provide to the Government of Canada.

Next, as a means of building a common understanding from which to work, the facilitator, Lyle Makosky, provided a working definition of a strategy:

• A strategy is a description of the overall intended approach for achieving desired ends, the general plan for success...it is the summary pattern of the prescribed and aligned actions or tactics directed toward an agreed target/end state.

He also highlighted the nature of the advice on a future strategy that CBAC is seeking at this session, including a sense of direction (e.g. strategic priorities, goals, etc.) and priorities (e.g. areas of focus), identification of elements around which stakeholders can align, recommendations about how the strategy should be governed and identification of desired measurements for success.

Finally, participants listened to three presentations designed to set the context for discussion of a future strategy. The first presentation described the state of biotechnology in Canada today; the second presentation detailed some of the progress made on the 1998 Canadian Biotechnology Strategy; and the third presentation highlighted the results of the Vancouver-based focus group on biotechnology complemented with comparable results from the Montreal and Halifax focus groups. The main points of these presentations are highlighted below.

1.1 Setting the Context: Taking Stock

Trefor Munn-Venn, Associate Director, Conference Board of Canada presented an overview of the state of biotechnology in Canada. He noted that public discourse on biotechnology in Canada has been characterized by two opposing views. On the one hand, there are those who view biotechnology as inherently bad while, on the other hand, others believe that biotechnology is the answer to all our problems. In its review of the biotechnology sector, entitled Biotechnology in Canada: A Technology Platform for Growth, the Conference Board of Canada used an evidence-based approach to assess biotechnology without making judgements about whether it is good or bad. An innovation graphic was used to develop a framework for understanding biotechnology.

Mr. Munn-Venn reviewed some of the key findings from the report Biotechnology in Canada but advised caution in interpreting the findings, saying that the data available on biotechnology are generally not well developed, and differences between jurisdictions make comparisons difficult, particularly when comparing Canada to other countries.

In response to a question about the definition of biotechnology, Mr. Munn-Venn noted that there is no common definition in use around the world, making it difficult to consistently identify, measure and analyze biotechnology. However, he clarified that the Conference Board’s report uses Statistics Canada’s definition: “the application of science and technology to living organisms, as well as parts, products and models thereof, to alter living or non-living materials for the production of knowledge, goods and services.”

He identified several key questions for consideration for moving into the future:

• Can we move from commodity production to higher value-added products and services?
• Can we overcome our commercialization challenges?
• Will we be able to export our technologies?
• Do we have the scientific and business management talent we need today—and will we have it in the future—in order to compete internationally?
• Will we be able to exploit our biomass resources in an ethical and sustainable manner?
• Will Canada be able to keep up with other countries?

1.2 Illustrations of Progress of the Current Strategy

The facilitator presented a brief overview and summary impression of progress made and performance on the 1998 Canadian Biotechnology Strategy under each of the ten 1998 work plan themes, with illustrations of events, publications, capabilities and processes that had been established.

1.3 Insights from Canadians: Focus Group Results

Jeff Walker, Senior Vice President, Decima Research, provided a summary of the results of the focus group discussions on biotechnology, organized by CBAC to further inform this consultation review, which were held recently in Vancouver, along with some results from the groups held in Montreal and Halifax. The focus group discussions were three hours in length with 12 to 15 “involved Canadians.” He highlighted some of the initial results from these discussions, noting that everyone has heard about biotechnology and can identify one or two of its applications, but most feel that they do not have a strong understanding of biotechnology including the issues involved and how it is governed in Canada. Limited public understanding is seen as a limit to public acceptance.

Canadians see biotechnology as an important technology that will affect and change their lives, and recognize that there will be benefits to them or to society in general. The range of public views in Vancouver was broader than in Halifax and Montreal. For example, in Vancouver there is greater concern for genetically modified (GM) foods but strong support for biotechnology in the health sector. Overall, public participants agreed that Canada needs to make biotechnology a priority. However, they also highlighted the importance of addressing ethical and regulatory issues in all future endeavours. They were also concerned that governance structures remain insulated from political and industry pressures.

In Vancouver, there was clear consensus that the federal government should have a stronger role in all areas of biotechnology except commercialization. Overall, focus group participants felt that a biotech strategy is needed to ensure that all biotechnology issues are addressed. The strategy must include clear direction. The biggest priority identified by the focus groups was public education (e.g. providing balanced information to Canadians so that they can make informed decisions).

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2.0 Challenges for a Future Strategy

In response to the above mentioned presentations, roundtable participants offered their insights into future challenges for biotechnology that may need to be addressed in a future strategy. The following summarizes the key discussion points (in no order of priority or importance):

• Implementation must be a key focus in the new strategy. Thus, a new biotechnology strategy must be simplified, focused and more outcome-oriented and suggest specific actions that can be implemented. Its related governance model must be more explicit, centralized and focused so that the strategy influences government behaviour.
  
  
• Government policy, as a whole, has an impact on biotechnology and an important role to play in supporting biotechnology. Therefore, there are several areas of government that could play a role in advancing biotechnology, for example, taxation and immigration policies have an affect on the success of Canada’s biotech sector.
  
  
• Success in other countries has been supported by targeted government policy. A renewed biotech strategy should address the advancement of the biotech sector. The Canadian government must identify priorities for biotechnology and develop and implement policies to strategically support them.
  
  
• At a fundamental level, we need to consider carefully how we analyze and discuss biotechnology. To date, views have been narrowly defined around constructs that were more economically focused. New vocabulary and new 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.
  
  
• We need to question the assumption that it is important and necessary to increase research and development in biotechnology and to quickly develop the Canadian biotechnology sector. We need to be clear about why we need to move quickly (competitiveness is not enough of an answer).
  
  
• More public dialogue is needed. The design of public engagement activities and the language used in both the strategy and further dialogue must be respectful of the Canadian public and its ability to engage in meaningful and considered debate. We need more mechanisms for multiple parties to discuss cross-cutting issues.
  
  
• Funding for research and development is very low outside of universities; Canada must make higher investments in private sector research to better support biotechnology in Canada. In general, a better balance needs to be found between support for R&D; and support for innovation and commercialization.
  
  
• Investment in biotechnology could be targeted to those areas where Canada is well-positioned to grow (e.g. health biotechnology).
  
  
• Balance is needed between 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.
  
  
• We need to modernize and harmonize our regulations (for example current intellectual property (IP) laws are a hindrance to all knowledge-based industries) to better support innovation and competitiveness in a global market.
  
  
• There is 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. At the level of assessing individual products, consideration must be given to both potential risks and benefits. At other levels of consideration, promotion and stewardship are inherently in conflict. We do not yet have the answers, but we have noted the problem exists.
  
  
• The next strategy should provide a more 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.
  
  
• While Canadians have an appreciation of biotechnology and its related issues, the debate in Canada has not matured enough. In addition, it is important to consider other “world views” in our analysis of biotechnology. Canadians would benefit from further dialogue around the moral, ethical, social and cultural dimensions of biotechnology.
  
  
• Biotechnology can be used both positively, to help fix and avoid ecological damage, but also negatively, by causing damage to the environment. The concepts of ecological restoration and “do no harm” should be included in a future strategy.
  
  
• Views on GM foods are strongly held and primarily negatively focused. The negative carry-over effects of current views on GM foods need to be considered and addressed as they may spill over into new areas of biotechnology.
  
  
• Risk assessment should be a key element of a new strategy. 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 biotechnology.
  
  
• A new strategy needs to address new ways of thinking, new ethical frameworks and possibly new vocabulary to properly equip us to discuss and deal with emerging (and still unheard of) areas of biotechnology.

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3.0 Improving Our Approach – Problems, Opportunities and Initiatives

Participants were asked to identify the needs or problems and opportunities in this field 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.

Problem – Opportunity	Solution - Initiative
Leadership, governance and priorities
Federal government leadership is lacking.	Appoint a “champion” to be responsible for strategy implementation. Governance model should include broad community: government (federal/ provincial/territorial and municipal), industry, civil society. Promote the strategy to government to encourage implementation.
There is no common or integrated approach to biotechnology among government departments.	Encourage cooperation and communication among federal departments (both in articulating and acting on priorities). Create consistent policy between departments. Create and maintain a single point of coordination for communications on biotechnology.
There is confusion/lack of understanding about roles and responsibilities, leading to lack of action and/or duplication of effort across government and between government and other sectors. It is difficult to identify all players who need to be involved in dialogue and implementation. The make-up of current forums exacerbates this issue as they are very topic specific and not relatable to biotechnology more generally.	Better communication among all parties, including stakeholders, governments (F/P/T and municipal). Stakeholders need to better coordinate efforts within their own networks. Create a formal forum to manage and encourage communication between parties.
The role of government is contradictory as it is responsible for both regulating and promoting biotechnology.	Separate responsibilities for promotion and regulation/stewardship. Support further broad-based policy discussions on the future of biotechnology in Canada; involve a wide range of stakeholders (including the “public”) in these discussions and include the dilemma of this dual role of government as a key topic.
Public Engagement
Public information on biotechnology is seen by some to be biased and promotional in nature.	Provide balanced information to avoid the perception of primarily “promoting” biotech and to provide the information necessary for informed decision-making. Appoint an independent body to give impartial advice to Parliament and Canadians (e.g. the National Science Advisor). Develop and use appropriate vocabulary to support provision of (and perception of) balanced information.
Commercialization and Innovation
Poor ability to move from research to development and commercialization; and to encourage and support innovation more generally.	Create regional specialties/strategic clusters. Adapt government infrastructure to better support commercialization by making, for example, changes to the regulatory system and Canadian policies to increase competitiveness (e.g. human resources policies to attract senior managers, removing barriers to immigration, supporting graduate programs targeted at biotechnology). Advocate for increased patent and data protection, and international harmonization of IP policy. Explore potential economic benefits that would result from reducing or eliminating restrictive formularies in place in British Columbia and Canada. This might attract more investment in Canadian biotech companies and the sector overall. Small- and medium-sized businesses require different policies and approaches than larger companies. Larger companies tend to benefit more from government processes/requirements/enablers. Facilitate access to risk capital investment. Appoint a "champion" for industry to promote biotech and communicate with government, the public and others about industry’s needs, successes, suggestions for improved biotech policy, etc. Market/promote Canada’s strengths and encourage international investment in Canada. Facilitate access to risk capital investment by continued creation of a regulatory environment that increases access to the large amounts of risk capital required for commercializing the products of industry.
Regulatory responsiveness and coherence
Canada’s regulatory environment could better support industry if it was more predictable.	Learn from others’ experiences to avoid fragmentation of regulations at F/P/T and municipal levels of government (e.g. food safety experience). Regulations should be centralized but explicitly seek cooperation at all levels of government. Address the gaps in the regulatory system.
Canada’s regulatory system is not responsive enough.	Approval of products is a lengthy process. This can reduce the marketability of products and the competitiveness of Canadian companies. Ensure that the regulatory system supports competitiveness by streamlining approval processes, etc. (while maintaining safety).
Canadian processes and regulations are not harmonized with international standards.	We operate in an international marketplace and must create an environment that supports access to and participation in this market.
Risk Analysis and Liability Framework
Lack of understanding of the risks associated with biotechnology and a lack of process/tools to assess the risk.	Add risk assessment and mitigation to the strategy. There is a need to assess long-term risk of biotech products and processes (e.g. risk assessment over decades). The need for long-term risk assessment should be addressed in the strategy. Consider liability issues and address them appropriately. Risk assessment tools must allow evaluation of the quality of biotechnology products as well as potential consequences before a product is publicly available. CFIA is already doing a good job in this regard. Explore processes and tools to avoid contamination "in the field." Industry could better demonstrate its successes in this area. Explore risk assessment models to address potential consequences to other sectors, environments, etc. (e.g. aquatic food chain). Ensure that a system of measurable thresholds is implemented to quantify and manage levels of risk. Risk assessment must be balanced with the need to remain competitive.

In addition, the facilitator circulated a summary of the Montreal and Halifax Expert Roundtable’s results: Problems/Opportunities and Initiatives and asked for feedback from Vancouver participants:

• Biotechnology provides an opportunity for federal and provincial/territorial governments to work together more effectively. Unlike most other fields, provincial legislation does not yet exist providing an opportunity for governments to work together to create centralized and collaborative policies/strategies and to avoid creating a fragmented and duplicative regulatory system.
  
  
• Some participants disagreed with the statement in the Leadership and Governance summary that “Cabinet needs to adopt biotechnology as a government priority," noting that government’s role is not to promote but to assess biotechnology.
  
  
• One participant supported the statement “Implement the Smart Regulation Initiative” (under Regulatory Responsiveness) and pointed out that the Privy Council Office has a new directive on regulation that emphasizes risk assessment and meeting our responsibilities under international agreements.

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4.0 Future Strategy: Goals and Principles

Participants were asked to comment on the need to update or alter the goals and principles as stated in the 1998 Canadian Biotechnology Strategy (considering their own experience as well as the array of proposed initiatives suggested in Section 3.0 above and the summary of the Montreal and Halifax Expert Roundtables’ discussions on goals and principles, distributed at the session).

The following advice was offered with respect to improving strategy goals:

• 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.
• The goals should be limited in number (the current strategy has too many goals) and prioritized to support the central focus of the strategy.
• The goals should be outcome-oriented, specific and measurable. The strategy should also include both short-term targets and long-term goals.
• The strategy should include assessment of long-term impacts as a goal (e.g. multi-generational effects; possible consequences on other environments such as the aquatic food chain).
• The goals should reflect Canadian values and should support openness and open dialogue with all stakeholders and civil society.
• The goals should recognize, support and avoid duplication of ongoing related efforts in other sectors (e.g. specific industry strategies).
• Raising public awareness is an important goal and should be emphasized strongly in a renewed strategy. This goal should focus on providing the public with balanced and accurate information about the risks and benefits of biotechnology in order to support informed decision making. Participants recognized that science-based information is not the only valid information needed to provide a balanced view of the issues.
• The strategy should support choice and competitiveness in the Canadian economy. It should also support Canadian access to Canadian biotechnology (e.g. if a product has been innovated in Canada, Canadians should have access to it).
• A vision could be developed to help focus the strategy.

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5.0 Future Strategy: Considerations and Directions

Throughout 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:

1. Should the new "Strategy" take on the form of a "Grand Strategy" with long-term vision, goals and principles, etc. or more of a "National Action Plan for Biotech" with more short/medium term problems/opportunities and initiatives? Is a balance of both desirable?
   The strategy should be action-oriented with strong federal leadership. One participant noted that the name of the strategy should be changed from “National Action Plan for Biotech” to “National Action Plan about Biotechnology” so that the purpose of the strategy is not to promote biotechnology.
   
   
2. Are we creating a "Canadian strategy" to guide all the stakeholders or a "federal strategy" to guide mainly the federal government?
   Participants agreed that a Canadian strategy is more desirable than a federal strategy, but it should be accompanied by a federal action plan. Focusing the strategy on the federal government would give it too narrow a focus and place the entire burden for implementation on the federal government. All stakeholders, including provinces, have a role to play in biotechnology in Canada and should be involved in the strategy.
   
   
3. Is there a case to be made for developing an innovation strategy that is focused specifically on biotechnology and which could call for a legislative umbrella, a regulatory regime and financial inducements that are specific to biotech?
   The facilitator presented a spectrum of strategy options ranging from an informal strategy (e.g. characterized by independent stakeholder action) to a strongly influenced and directed strategy with a very narrow approach. He noted that the current Canadian Biotechnology Strategy would fall between lightly influenced/coordinated and moderately influenced/coordinated.

   Using the spectrum as a basis for discussion, participants reiterated the need for a focused, action-oriented strategy with specific goals (e.g. toward the right hand side of the spectrum). One participant noted the value of using a range of policy tools, such as tax incentives, to promote innovation and investment in Canada. Some participants suggested that efforts to build success in biotechnology could be used as a testing ground for other sectors.

4. Should the strategy reflect intent for Canada to be a "world leader" in this field? In what aspects/areas should we strive for world leadership? Would a life cycle/value chain analysis be helpful to determining which biotech industry sub-sectors and/or value chain stages we should focus on?
   Many participants felt that there would be merit in ‘picking winners’ by focusing on building excellence in specific areas of strength. They noted that different provinces and regions have different strengths that could be capitalized on successfully. Participants 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.

   Participants recognized the difficulties inherent in doing so: picking one or two priorities is a lengthy process, especially given the number of potential regions/sectors in Canada; it can be difficult to maintain government focus long enough to generate agreement; there is potential for conflict and competition between sectors/regions/priorities; and, it can be difficult to maintain focus on a particular priority over time.

   Potential areas of strength on which the strategy could focus include: areas where the “world needs help” (e.g. ecological restoration), agriculture and energy (e.g. renewable fuels), health and biopharmaceuticals, and industrial biotechnology. As well, focus areas that cut across sectors could also provide some "winners" for Canada. For example, creating excellent graduate programs and improving immigration and taxation policies to support biotechnology would help support biotech in Canada. Focus on these types of issues could help create an enabling environment in Canada that attracts capital, funding and talent, from both domestic and international sources. This would support the development of future technology as well.

5. What responsibilities do we have to meet the needs of developing countries, both from an investment and responsible development and use perspective?
   Some participants felt that Canada has a moral and ethical responsibility to share its expertise related to our regulatory system (which is seen to be a good system) with other countries that may be in the process of developing their own systems. However, it is important that we improve our own system before we provide leadership to other countries. Other participants urged caution in "pushing" our world view on others who may have different cultural, social and other considerations and sensitivities.

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6.0 Future Strategy: Governance, Federal Roles and Leadership

6.1 Governance Model

A range of governance options is available to administer a strategy. Options range 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. With respect to a future biotechnology strategy, some participants recommended a governance model characterized predominantly by federal leadership with joint responsibility (with stakeholders) for implementing an action plan, with explicit involvement of a third-party such as a CBAC-like committee to provide advice to government. Provincial involvement in the strategy is important for successful implementation. Other 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).

6.2 Federal Government Roles and Leadership

The federal government plays a variety of roles related to strategy implementation including the following: providing financial support; regulatory responsiveness, coherence and harmonization; strategy leadership; federal coordination; international leadership; and responsible stewardship.

Participants identified areas where there are gaps in the federal government’s role as well as areas where the federal role can be strengthened.

• To date, the government has failed to provide enough strategic leadership for biotechnology.
• Federal leadership is critical to successful implementation of the strategy.
• With respect to leadership, some participants noted the importance and usefulness of appointing a “champion” for biotech; this could be a role for the federal government to play. Within this role, the federal government should encourage partnerships with other stakeholders in order to better leverage its resources and take advantage of successes in other areas (e.g. provinces, industry, and civil society).
• Better coordination among federal departments, between governments and with industry and other stakeholders is also important to successful implementation.
• 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.
• Important roles for the federal government include the following: a) regulatory responsiveness, coherence and harmonization; b) strategy leadership; and c) federal coordination.
• Responsible stewardship was also highlighted as an important role for the federal government, including activities such as identifying/brokering social and ethical issues, and enabling national dialogue and citizen engagement.
• The federal government should push for more advanced examination and deliberation of public policy issues. For example, several participants stated strongly that “promotion” of biotechnology is not a role that the federal government should undertake.
• The federal government should also provide financial support (maintained over time) for building biotech in Canada. This will help create an enabling environment, leading to improvements in financial support from other stakeholders (e.g. industry).

6.3 Implementation Instruments

Federal coordination of the current biotechnology strategy is supported by the Canadian Biotechnology Secretariat (CBSec) and external, independent advice is provided by the Canadian Biotechnology Advisory Committee (CBAC).

There were mixed views as to whether continuation of an arm’s length committee such as CBAC is useful or desired. Some participants felt that such a committee is extremely useful for creating additional authority and prominence for the strategy and for biotech generally. 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 and cannot fairly represent all views. As well, CBAC’s credibility was questioned because it does not currently include representation from all industries and viewpoints (e.g. organic farmers).

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7.0 Conclusion

In conclusion, most participants supported the development of a renewed strategy, with an accompanying action plan, with certain conditions. Overall, the strategy should be relevant to Canada, targeted and action-oriented with strong federal government leadership as well as stewardship. The strategy should also 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.

Appendix 1 - Roundtable Agenda