Expert Roundtable Series – Summary Report

Expert Roundtable Series
Montreal April 27, 2006
Halifax May 25, 2006
Vancouver June 15, 2006

Summary Report
August 2006

Report by:
InterQuest Consulting¹

Expert Roundtable Series – Summary Report, PDF Format, 280 KB

TABLE OF CONTENTS

EXECUTIVE SUMMARY

1.0 INTRODUCTION

2.0 SUPPORT FOR A RENEWED STRATEGY

3.0 RECOMMENDED DIRECTIONS TO CONSIDER IN A RENEWED STRATEGY

4.0 CHALLENGES AND OPTIONAL WAYS FORWARD

5.0 NATURE AND STRUCTURE OF A RENEWED STRATEGY

6.0 FUTURE STRATEGY: GOVERNANCE

7.0 ROLES AND LEADERSHIP

APPENDIX 1 - ROUNDTABLE AGENDAS

APPENDIX 2 - CBAC, CBSEC AND CONSULTATION STAFF

APPENDIX 3 - BIOTECHNOLOGY STRATEGY SPECTRUM

Executive Summary

This 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:

• Clear government priorities and targeted policies;
• Senior managers to build successful companies;
• Necessary human capital (especially skilled and experienced);
• Support for small- and medium-sized enterprises (SMEs);
• Venture capital investment in Canadian companies;
• Long-term investment in Canadian companies; and
• Support for the full range of activity in the biotechnology sector (e.g., from research to product development and commercialization).

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.

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1.0 Introduction

This 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:

• The extent of support that exists for a renewed strategy;
• The needs or problems and opportunities that should be addressed in a renewed strategy;
• Potential initiatives to address current and anticipated challenges related to biotechnology;
• Broad direction and considerations for the strategy (e.g., overall structure and focus);
• Specific elements of a strategy (e.g., goals, principles); and,
• Governance issues (e.g. clarifying the role and leadership of the federal government).

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 Context

Participants 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:

• 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?

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:

• Public education efforts should be increased. Efforts should be aimed at providing balanced information, not advocacy.
• Regulatory supervision/long-term research is required, including more investment, more capability, long-term focus with clear insulation from politics and industry interests.
• Larger strategic investments are needed, focusing mostly on health. Focus groups also felt that specific focus should be targeted on a) areas where we have expertise (to avoid spreading limited resources too thin); and b) addressing the human resources needs of the sector.

Focus group participants indicated that a continued strategy for biotechnology is required because of the following:

• The field is diverse and continuing to evolve which requires constant monitoring and evolution in governance.
• Other countries are developing strategies.
• The roles of government are diffuse and cannot easily be managed without a strategy.
• It is clear that careful thought must be put into investments in biotechnology especially to ensure that finite resources are invested effectively.
• Risks are high and safety and ethical issues are of significant concern.

1.2 Building a Common Framework

As a means of building a common understanding from which to work, the facilitator 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..

Participants at the session were asked to provide advice on the broad elements of a renewed CBS:

• Direction - provides statements of intent and direction;
• Priority - indicates where effort should be;
• Focus - suggests specific areas for development;
• Alignment - provides elements around which stakeholders can mobilize efforts;
• Governance - provides a model that reflects how the strategy is to be led and coordinated; and,
• Success - provide a basis for the evaluation of success and desired outcomes.

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.

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2.0 Support for a Renewed Strategy

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 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.

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3.0 Recommended Directions to Consider in a Renewed Strategy

Four 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 Canadians

The 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 Frameworks

A 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 Biotechnology

Participants 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 Sector

In each session, many participants stressed the need for a renewed strategy to support development of the biotechnology sector. They particularly highlighted the following challenges:

• There is a lack of clear government priorities and targeted government policies to support biotechnology development in Canada.
• Canada lacks the necessary human capital (especially skilled and experienced senior managers) to build successful companies. This issue is aggravated by the inability of our education system to teach and develop the entrepreneurial skills required to build successful companies and thus a successful biotechnology sector.
• Small companies are not adequately supported. Tools required for success in biotechnology (e.g. patent advice) are often inaccessible and/or unavailable to SMEs due to issues such as cost or lack of expertise/knowledge.
• There is a lack of venture capital investment in Canadian companies and investments are often short term.
• Government funding programs also need to be better targeted to support the full range of activity in the biotechnology sector (e.g., from research to product development and commercialization).

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.

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4.0 Challenges and Optional Ways Forward

Participants 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.

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5.0 Nature and Structure of a Renewed Strategy

5.1 Nature of a Renewed Strategy

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-and medium-term problems/opportunities and initiatives? Is a balance of both desirable?
   
   

   The renewed strategy should take the form of a ‘national action plan for biotechnology’ rather than a ‘Grand Strategy’. The strategy should be action-oriented with clear overall objectives and strong federal leadership. This could mean that the strategy itself takes the form of an action plan, or that a strategy is accompanied by a business plan; participants generally expressed a preference for a strategy/business plan combination. The strategy/action plan should also include recommendations aimed at monitoring and evaluating success. The strategy should ultimately help create a biotechnology environment that supports stewardship, due diligence, risk analysis and ethical conduct, as well as public engagement.

2. Are we creating a ‘Canadian strategy’ to guide all the stakeholders or a ‘federal strategy’ to guide mainly the federal government?

   On balance, participants recommended a ‘Canadian strategy’ and noted the advantages of reflecting a broad set of views (from industry, academia, provinces/territories and others) in implementing a strategy. However, they recognized that strong federal leadership is required for successful implementation (thus, a federal action plan may be required). 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/territories, have a role to play in biotechnology in Canada and should be involved in the strategy. Some participants pointed out the difficulties inherent in building a community-based strategy (e.g., jurisdictional issues, finding agreement among a diverse set of stakeholders) and were concerned that would delay the development and implementation of a 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 biotechnology?

   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 (see Appendix 3). He noted that the current CBS 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). 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.

4. Should the strategy reflect the 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 in determining on which biotechnology industry sub-sectors and/or value-chain stages Canada should focus?

   Many participants felt that there would be merit in building excellence in specific areas of strength. They noted that different provinces/territories/municipalities and regions have different strengths which could be capitalized on successfully. However, they again cautioned against developing a strategy that is too prescriptive.

   Potential areas of strength on which the strategy could focus include: areas where the “world needs help” (e.g. ecological restoration), Canada’s natural capital (e.g., forestry, mining), agriculture and energy (e.g. renewable fuels), health and biopharmaceuticals, and industrial biotechnology. As well, focus areas that cut across sectors or target specific elements of the biotechnology life cycle/value chain could also provide some 'winners' for Canada. For example, building expertise in regulation or commercialization, 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. These ideas would support the development of future technology as well.

   Montreal participants suggested that a renewed strategy should begin to identify niches where Canada can be seen as a “world leader” as this would help build a more competitive environment in Canada. Participants in Halifax and Vancouver generally advised against focusing the strategy on the need to become a world leader, pointing out that being a world leader is an outcome, not a goal. They also felt that articulating such a goal so early in the process could misdirect effort from other priorities; some said that if we focus on building excellence in our areas of strength, improving our ability to commercialize and ensuring we have a supportive environment for biotechnology in Canada, success and “world leadership” will follow.

5. What responsibilities do we have to meet the needs of developing countries, both from an investment and responsible development and use perspective?

   Participants were asked to comment on the responsibilities Canada has to meet the needs of developing countries, both from an investment and responsible development and use perspective. Generally, participants felt that Canada has a moral and ethical responsibility for assuming a role in this area, especially with respect to expertise related to regulation and safety (our regulatory system is seen to be a good system). Our knowledge and experience in including ethical considerations in guidelines are also areas about which the international community may be interested in learning.

   However, two important caveats were placed on this recommendation; first, we must improve our own system before we provide leadership to other countries; and second, some participants urged caution in ‘pushing’ our world view on others who may have different cultural, social and other values, priorities and sensitivities. The federal government must also recognize the importance of listening to developing countries in order to provide the guidance that the countries feel they need.

5.2 Vision, Goals and Principles

Participants commented on the need to update or alter the vision, goals and principles as stated in the 1998 CBS.

Vision
Participants in Montreal agreed that the vision needs to be more focused and explicit to better guide implementation of the strategy. Vancouver participants noted that a vision could be a useful tool for focusing a renewed strategy.

Guiding Principles

• The goals should reflect the guiding principles.
• The current guiding principle “Engage Canadians in open, ongoing, and transparent dialogue” should become “Engage Canadians in open, ongoing, informed and transparent dialogue.”
• Sustainable management of our resources (from the gene to the whole organism) should be a cornerstone of the strategy.
• Stewardship is important but must be undertaken within an overall societal context (informed by Canadian values and ethics). In addition, the health, environmental and economic dimensions of biotechnology are all equally important and should be treated in an ethical way.
• The strategy should emphasize Canada’s global responsibility. Canada’s actions have an international impact, and it is important to ensure that social problems are not simply transferred to other parts of the world, or that our world view is ‘pushed’ on others.

Goals
The following advice was offered with respect to improving the strategy’s goals:

• The current strategy has too many goals. The number of goals in a renewed strategy should be limited in number, outcome-oriented, specific and measurable (both quantitatively and qualitatively). For greater focus, the goals could be clustered into groups such as healthy operating environment, stewardship, capacity building and coordination, and/or prioritized to support the central focus of the strategy. The goals should recognize, support and avoid duplication of ongoing related efforts in other sectors (e.g. specific industry strategies).
• The strategy should include both short-term objectives and long-term goals.
• The strategy should include assessment of long-term impacts as a goal (e.g., monitoring and assessment of multi-generational effects; possible consequences of biotechnology on other environments such as the aquatic food chain).
• Goals should reflect Canadian values (recognizing that values are difficult to define and may change over time) and address development of an ethical framework/process that is informed by Canadian values.
• The goals in the CBS should support transparent, open dialogue with all stakeholders and civil society.
• Increasing public awareness should be a key goal of 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. Educating decision-makers (particularly those in related government departments at both the political and public service level) is also a key element of this goal both to build knowledge of biotechnology issues generally and to ensure that decision-makers are well informed and engaged with the strategy specifically.
• Some participants would like a goal focused on developing Canada’s capacity to rapidly commercialize products in order to support product choice and competitiveness in the Canadian economy.
• Explicit support for SMEs is needed to support growth in the biotechnology sector.

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6.0 Future Strategy: Governance

6.1 Stakeholders

There 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 Model

A 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.

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7.0 Roles and Leadership

7.1 Federal Government Roles and Leadership

The 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
To date, the government has failed to provide enough leadership (strategic and applied) for biotechnology and has failed to implement the 1998 CBS fully. Federal leadership is critical to successful implementation of a renewed strategy.

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:

• Ensuring strategy implementation and follow-up;
• Overseeing coordination and communication between federal players;
• Managing centralized funding for biotechnology;
• Encouraging involvement from other stakeholders; and
• Providing balanced information to the public.

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
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. Biotechnology is multi-disciplinary and multi-sectoral and must be approached in a coordinated manner. The federal government should implement a common, integrated approach to biotechnology across departments. Many participants suggested that federal coordination would be best undertaken by appointing a biotechnology “champion” such as a Cabinet Minister, along with a specifically designated lead department, and by creating consistent policy between departments and an accountability framework that is coordinated by the champion. Federal coordination could also be improved by implementing a program whereby government staff are exposed to different sectors and issues by moving between departments, and/or by centralizing biotechnology-related funding (maintained over time) in one agency to dispense the funds across departments and monitor and guide expenditures. The federal government also needs to approach the provinces as partners in joint planning if goals such as the development of regional clusters are to be realized and if consistent, balanced messages are going to be communicated to Canadians (e.g. a centralized location to obtain standardized information on Canadian programs and regulations).

Stewardship
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. Such activities are currently under funded. The federal government should push for more advanced examination and deliberation of public policy issues. For example, several participants stated strongly that federal “promotion” of biotechnology can place it in a conflicted position given its regulatory role.

Regulatory responsiveness, coherence and harmonization
Regulatory responsiveness, coherence and harmonization were also seen as important elements of the federal role by many participants. The government must improve the responsiveness of the regulatory system by addressing issues such as timeliness of decisions. Some participants also felt that the federal government should play an evaluation role by supporting and possibly subsidizing independent third-party monitoring and research.

7.2 Implementation Instruments

Implementation 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.

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Appendix 1 - Roundtable Agendas

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Appendix 2 - CBAC, CBSec and Consultation Staff

The following individuals attended at and assisted with at least one roundtable consultation:

Mary Alton-Mackey
Gloria Bishop
Pete Desai
Lyne Létourneau
Linda Lusby
Arnold Naimark, Chair
David Punter

Canadian Biotechnology Secretariat
Provided the advance preparation and on-site administration

Kim Elmslie, Executive Director
Glenn Kendall, Director, Biotechnology Strategy
Sonia Lebris, Senior Policy Advisor
Christine Linden, Communications Advisor
Tara Menor, Liaison Officer
Dale Synnett-Caron, Communications Manager

Facilitation Team, InterQuest Consulting
Provided the facilitation, note taking and report writing

Lyle Makosky, Lead Facilitator
Alain Rabeau, Co Facilitator
Kerrianne Carrasco, Assistant Facilitator and Report Writer
Anne-Marie Parent, note-taker
Wylie Thomas, note-taker

Appendix 3 - Biotechnology Strategy Spectrum

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¹InterQuest 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.