Expert Roundtable - Montreal, April 27, 2006

Canada’s Biotechnology Strategy - Charting the Path Forward

Expert Roundtable, Montreal, April 27, 2006
Meeting Summary

Table of Contents

EXECUTIVE SUMMARY

1.0 INTRODUCTION

2.0 VISION, GOALS AND PRINCIPLES

3.0 THEMES, PILLARS AND POLICY INITIATIVES

4.0 GOVERNANCE AND FEDERAL GOVERNMENT ROLE

APPENDIX 1 - ROUNDTABLE AGENDA

Executive Summary

The Canadian Biotechnology Advisory Committee (CBAC) consulted various members of the biotechnology community to obtain input on the renewal of the Canadian Biotechnology Strategy. Given the current economic and environmental context, the Canadian Biotechnology Strategy is an important part in positioning Canada as a responsible world leader in biotechnology. This roundtable, held in Montreal, was the first of a three workshop series.

Overall, participants agreed that the strategy needed a review. There is a need and an interest to reformulate and update the current strategy; possibly considering revisions to the title to properly position it. In order to update the strategy, there needs to be a longer-term vision statement, goals and principles to provide guidance to a longer term agenda. Although the current vision, goals and principles need to be reviewed, the group felt that a more substantive, practical focus was needed and that the strategy should incorporate or be accompanied by a focused action plan and a proposed budget. The general view is that a national action plan is needed rather than a ‘grand strategy’.

The accompanying action plan should take a value-chain or life cycle approach and focus individually on each specific sector where stakeholders are engaged to discuss economic, ethical and environmental questions across the whole life cycle for their sector. There will also be a need to look at more specific plans from different industries and identify a horizontal theme, common to all the industries that could be addressed by national policy initiatives. The group also felt the strategy should focus on target industries or sectors based on Canada’s strengths, demand from the industry and potential benefits in order to better leverage existing limited resources.

The group identified potential opportunities and policy initiatives that should be included in the strategy. The proposed suggestions focused on leadership, governance and priorities; regulatory responsiveness and coherence; public engagement; social and ethical issues; risk analysis and liability; human resources and capacity building; intellectual property; and commercialization and innovation.

The strategy should become a strategy that both federal departments and external stakeholders involved in the biotechnology community should commit to. The group also felt that a central coordinating body such as CBSec is required to support implementation of the strategy and to report back to the responsible minister or department.

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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 April 27, 2006, at the Hilton Montreal Airport Hotel in Montreal, Quebec. The workshop was the first 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 current strategy and more specifically on vision, goals and guiding principles moving into the future. In the third part, participants were asked to provide their thoughts on the themes and policy initiatives that should be included in a future strategy. The fourth part enabled views on broad strategy questions such as whether Canada should adopt a strategy that focuses on its strengths. The fifth part was on governance of the strategy as well as clarifying the role and leadership of the federal government.¹

Lyne Létourneau, a member of the 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. 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 was 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.

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 the upcoming roundtables to be held in Halifax and Vancouver as well as with findings gathered from three citizen focus groups and that it would be used to inform the advice that CBAC will provide to the Government of Canada.

1.1 Setting the Context: Taking Stock

Dr. Arthur Carty, National Science Advisor for the Privy Council Office, began his presentation by recognizing the importance of this process for the biotechnology sector in Canada. He continued by describing the importance of biotechnology in the current science and technology context and more specifically its importance in research areas such as genomics, nanotechnology, information technology, and communications. Although issues related to biotechnology are not directly reflected in the five priorities of the new government, Dr. Carty believes that biotechnology issues are part of a longer term strategic agenda and will be addressed by Minister Bernier as he formulates a vision and strategy for science and technology to help position Canada in a dynamic and rapidly evolving global biotechnology environment.

Over the past 20 years, the Canadian biotechnology field has significantly evolved. For example, in 1987 there were only a few dozen biotechnology firms, and today there are close to 500 firms with sales estimated to $3.8 billion. Dr. Carty provided examples of Canada’s strengths and accomplishments to date, including examples from the infectious disease industry and life sciences sector. Dr. Carty also noted that there are many issues and challenges to be addressed, such as:

• National leadership and governance (including the issue of fragmentation);
• Regulatory responsiveness and coherence;
• Effective commercialization of Canadian innovations;
• Social, ethical and quality of life issues and public engagement; and
• Meeting the needs of developing countries.

Finally, he pointed to a number of future opportunities for Canada in domains such as plant molecular farming, natural fibres, nutraceuticals and biofuels. In order to exploit these opportunities, Canada must be prepared to continue to enhance its research base, to build capacity, to enhance the business environment for commercialization of biotechnology innovations and to ensure that there are open and transparent policy debates on social, legal and ethical dimensions. Additional partnerships with international organizations and research institutions will be key in helping Canada attain its goals.

After Dr. Carty’s presentation, participants were given an opportunity to ask questions and to share their impressions on the gaps and challenges that the next biotechnology strategy will face. The following summarizes the key discussion points:

• There needs to be an increased focus on plant and animal adaptation. There are great benefits for rural Canada and the rural economy. Biotechnology has the potential to add value to the commodities we produce.
• Canada only represents 2% of the global biotechnology research. There needs to be ways to gather and use the knowledge and information that is being generated across the globe.
• There needs to be more focus on environmental sustainability.
• Biotechnology must be considered as more than one industry; it is a family of industries (i.e. includes sub sectors such as health, agriculture, etc).
• Currently, there are heavy investments in the front end discovery phase. There should be more investment made in the rest of the product lifecycle.
• Investment is required in human resources training. There needs to be a balance between acquiring new human resources from other countries and developing human resources within our borders by increasing the rate of university graduates and more specifically in doctoral and post-doctoral programs.
• Commercialization of biotechnology needs to be improved in Canada. Canadian companies are going internationally for investment. There needs to be an enabling environment to encourage investments, such as venture capitalists and foreign direct investments. For example, under our current regulations we cannot produce insulin in Canada.
• Need to develop a definition for biotechnology that will help focus the scope of this strategy. A suggestion would be to define biotechnology as the ability to manipulate genes.
• Need to identify “What are we trying to fulfill with biotechnology?,” “Where do we want to go,” “What do we need to get there.”
• One participant questioned whether or not a renewed Canadian biotechnology strategy was required and if more tangible actions such as funding for specific projects should be considered.
• Since there are limited resources, decisions must be made, and we must choose where we should be focusing.
• Technology should not be the ultimate driver of this strategy. It is important to define why biotechnology is needed and what benefits it could bring before engaging in a strategy.

1.2 Drivers, Capacity and Opportunities

Dr. Pierre Coulombe, President of the National Research Council, presented an overview of the drivers and opportunities for biotechnology in Canada. Dr. Coulombe raised some of the factors that need to be considered for the Canadian biotechnology strategy renewal, including internal factors such as governance and cooperation among biotechnology stakeholders, and external factors such as the pressures from rapidly developing economies, security issues and the increasing population. Furthermore, an increase in international trade, a rise of more powerful economies and a shorter production cycle, indicate that the biotechnology field will be highly competitive but also very promising for those who can follow.

Biotechnology holds promise to address international development challenges through increasing food safety, providing new medical drugs and diagnostics and supporting environmental sustainability. These factors must be considered in defining our recommendations for the future. Dr. Coulombe shared some of the key drivers and opportunities that were identified at the last BIO Conference in Chicago:

• Development of patient-targeted medicine;
• Application and integration of nanotechnology, advanced materials and computer science;
• Balancing R&D; advances with regulatory requirements (especially in areas of targeted medicine such as biomarkers and imaging);
• Development of vaccines for animal health;
• Neutraceutical and health benefits from agricultural products;
• Regenerative medicine;
• Convergence of horizontal research programs and multi-disciplinary teams;
• Development of technologies and methodologies to deal with massive data sets;
• Growing small biotechnology companies into larger ones; and
• Turning biotechnology development into products and processes that can be commercialized or used for public good.

Dr. Coulombe is optimistic that Canada has much to offer through increased R&D; in biotechnology to successfully address many of the societal issues faced in Canada and in the world. Furthermore, there are many benefits to biotechnology such as inexpensive, efficient, renewable fuel; improved food; and better managed forests.

The National Research Council (NRC) has invested in Canada’s biotechnology sector, notably through NRC’s seven core institutes involved in life sciences and other institutes across Canada. These investments are already creating benefits for Canadians. This success has been achieved in part by applying lessons learned from past experience and by moving towards a multidisciplinary approach.

Dr. Coulombe suggested further actions to move Canada’s biotechnology industry forward:

• Canada needs to concentrate its research efforts on areas of importance, such as health, environment and energy.
• Canada’s innovation system must be strengthened by encouraging small- and medium-sized enterprises (SMEs) to increase their investment in R&D.;
• Canada should improve its regulatory framework, strengthen its governance structure and allocate greater resources toward post-secondary education.

Dr. Coulombe believes Canada’s natural resources, educated workforce and expertise in biotechnology are great assets that could allow it to become highly influential in the global knowledge-based economy. It is therefore important for Canada’s innovators to understand the drivers and the trends that are shaping the world.

Following Dr. Coulombe’s presentation, participants commented on the main challenges arising for the next biotech strategy. The following points were shared:

• Need to define our comparative advantages and ensure that our strategy focuses on areas that are most beneficial to Canada and where we have leadership. Some of these areas have already been identified and it is important to take action on them.
• One participant suggested focusing on sectors that would most affect Canada such as mining and forestry. For other sectors such as health, we could rely on contributions from other countries. Other participants disagreed with the latter point and believed that health was an important sector, since future demand and investment interest in this field are significant.
• By 2020, health care is expected to account for the majority of taxes due to the aging population and the rise in chronic disease. The strategy needs to identify in which part of the health care spectrum Canada should invest (e.g. prevention and diagnostic). For example, Canada is known to perform biomedical research where the results add significant value and have an impact on current knowledge about cancer.
• Many problems that biotechnology can solve are not just problems for Canada. In other words, it is important to cooperate with other countries and to contribute to the global solution. There are many benefits to partnering with international organizations.
• Need to move up the value chain. The strategy should create correlations between the investment in specific academic research and the potential future economical outcomes. In other words, it is important to ensure that tangible products result from the research.
• Need to recognize that biotechnology is not an industry on its own, but an enabler for a family of industries. For example, biotechnology could greatly benefit current energy and transportation needs.
• From a policy perspective, it is important to differentiate between organisms that are released in contained environments and those released in non-contained environments. In a non-contained environment, altered genes from a bio-engineered organism can interact with its surrounding. The strategy should clearly identify the limits that Canada is willing to explore.
• In the health care sector, biotechnology should be focused on “prevention” more than on “treatment.”
• There are concerns that Canada’s biotechnology strategy is seen as biotechnology promotion alone without balanced attention to responsible stewardship.
• Need to encourage a proactive debate on ethical issues.
• One of the most commonly shared views was that the strategy should be driven by the country’s demands and future needs and focus on those niche sectors as opposed to concentrating on the whole sector.

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2.0 Vision, Goals and Principles

Participants were asked to focus on the vision, goals and principles as stated in the 1998 Canadian Biotechnology Strategy. The following questions were used to guide the discussion:

• Are the vision, goals and principles of Canada’s current biotechnology strategy appropriate going forward? If not, what should they be? If they are appropriate in general but in need of reformulation, what changes are suggested?
• To what extent should these goals be in support of meeting other important societal/national goals?
• How important is it to see biotechnology as an economic and social technology platform with distinct goals in its own right?

2.1 Vision

Participants agreed that the vision needs to be more focused. For example, the term “world leader” is a compelling phrase; however, it is very difficult to measure. This should be more specific and identify in which areas Canada should remain or become a leader.

Some participants questioned the need for a vision. Section 2.4 “Considerations and Directions,” below, presents some alternatives and suggestions from the group.

2.2 Guiding Principles

The following summarizes the key discussion points on the guiding principles:

• The guiding principle "Engage Canadians in open, ongoing, and transparent dialogue" should become "Engage Canadians in open, ongoing, informed and transparent dialogue." This specific guiding principle is not reflected in the nine goals. Although one of the goals refers to improving public awareness, this is different than public engagement. (See section below for suggestions on goals.)
• The group discussed the merits of engaging the general Canadian public in consultations if they were not well informed on the topic. While some participants argued that there was little value, other participants highlighted that this had been done before and that lessons could be learned from past experiences. Organizations such as the Canadian Environmental Network were created to provide a mechanism for obtaining input from public consultations.
• Public education is an important goal for this strategy and must be shared by all stakeholders. Some participants believed that it was important for the government to be cautious when publishing information in order to be perceived as neutral.
• There should be a guiding principle about ensuring that Canada is known as the best in areas where it currently has a comparative advantage.
• All guiding principles should be reflected into the goals.

2.3 Goals

The following summarizes the key discussion points on the goals of the Canadian biotechnology strategy:

• The nine goals as outlined in the strategy are vague. They need to be more outcome-driven, result specific and reflective of the current context. Some participants felt there were too many goals and that they could be clustered into groups such as: healthy operating environment, stewardship, capacity building and coordination.
• Need to distinguish between goals that are outcome-oriented and process-oriented. For example, one participant questioned how “engaging Canadians” could be a goal of the biotechnology strategy; it seems to be more of a goal of the process or a guiding principle.
• The goals should be global in nature and more outward looking. 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.
• The goals need to be measurable, and therefore specific metrics should be identified in order to assess how well they are achieved, i.e. the strategy needs an evaluation framework/approach.
• The following elements are missing and should be reflected in the goals:
  • Increasing Canada’s contribution to the international community. For example, many countries do not have guidelines on ethics. There is an opportunity for Canada to share its expertise with respect to ethical guidelines.
  • Engaging and informing the public. There needs to be a specific goal linked to this guiding principle.
  • Educating decision makers, i.e. particularly those in related government departments at both the political and public service level. It is important to ensure that decision makers are well informed and engaged with the strategy.

2.4 Considerations and Suggested Directions for the Strategy

Throughout the discussion, participants commented on the purpose, scope, design focus, positioning and ownership of a renewed strategy. They identified several considerations to ensure development of an effective, useful strategy:

• It is very important to clarify the scope, intent and owner of the strategy, i.e. is this a federal government strategy or a broad Canadian strategy?
  • One participant mentioned that the term “strategy” implies there is one decision maker responsible for implementing it. At the moment, the Canadian Biotechnology Strategy seems to be more of a wish list.
  • Results-based management of the strategy is useful only if someone is mandated to follow it.
• Additionally, some participants raised concerns with past usage of the advice provided by CBAC to the federal government. A report from the Office of the Auditor General noted that ministers have not acted on advice from CBAC. It will be important to ensure that the level of effort inputted into renewing this strategy will be considered by the federal government.
• There is a need to develop a focused strategy and identify Canada’s strengths (i.e. target industries and sectors). The competitive environment should also be considered in order to identify elements that would benefit Canada the most and to identify niches where Canada can be seen as a world leader.
• The strategy should not only focus on basic biotechnology research; it should also consider the full value chain from basic research to commercialization.
• The strategy should be accompanied by a business plan and a budget including an economic cost-benefit analysis (e.g. similar to the Canadian cancer strategy). One participant suggested that the report on biotechnology produced by the Conference Board of Canada would be a good starting point as it identifies some current issues as well as measurable goals.
• Some participants suggested that more specific strategies could also be developed for key sectors. These strategies would be more detailed and complement the larger strategy.
• Need to identify how to measure the success of the strategy and develop specific metrics to do so. One participant cautioned that evaluation of the strategy should not be limited by “measurable” metrics; there is still a need to evaluate the strategy even if we cannot identify measurable metrics.
• Instead of creating an incremental strategy, it may be more valuable to concentrate on identifying problems and opportunities to be solved and what actions need to be undertaken in the next decade. Although a long-term plan is required, immediate actions also need to be considered.
• The right strategy should be based on the concepts of stewardship, due diligence and ethical conduct.
• International harmonization is important but not at the expense of lowering standards. There is an opportunity to become a world leader in areas of regulation.
• To develop this strategy, we should investigate what other countries have done.
• Some participants felt it was difficult to provide input into the renewed strategy without knowing the results of the original strategy.

The facilitator pointed out that it will be challenging to properly package and communicate the strategy to enable success. To be successful, the strategy should:

1. Target industries or sectors based on Canada’s strengths, demand from the industry and potential benefits.
2. Identify areas of improvement to better support success, such as regulatory reform, investment capacity, human resources, etc.
3. Create an environment that supports stewardship, due diligence, risk analysis and ethical conduct.

Many participants agreed that targeting Canada’s strengths will help Canada become a world class leader, or a world class partner, in specific areas.

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3.0 Themes, Pillars and Policy Initiatives

The facilitator referred participants to the ten questions in their workbook on “Policy Initiatives” as a starting point to consider where new initiatives should be defined. Participants were asked to identify problems and opportunities as well as solutions and initiatives that should be addressed in Canada’s Biotechnology Strategy.

Problem - Opportunity	Solution - Initiative
Leadership, governance and priorities
Lack of cooperation and coordination on biotechnology across all levels of government.	Increase dialogue between federal and provincial governments to ensure more alignment.
Lack of focused priorities.	Need to identify clear priorities to focus on demand outcomes. This will require expertise from the sectors in order to identify sector specific priorities. Need to consider the value chain approach, i.e. identify pressure points and areas of advantage at each stage of the value chain.
Canada’s natural capital is in agriculture, forestry, mining and energy.	Identify areas of strengths that we can capitalize on and that would be of most benefit to Canada. Ensure that patents created will generate royalties for Canada.
Regulatory responsiveness and coherence
Existing regulations are problematic. With the huge growth of new products, many resources and efficient processes will be required to deal with these. Regulations need to be amenable to business and transparent to the public.	Implement Smart Regulation Initiatives. This will require greater cooperation beyond Canada’s borders and possible harmonization with international standards (while being careful to not lower Canadian standards).
Public Engagement, Social and Ethical Issues
Need adequate capacity to conduct public engagements and ethical analysis. Canada does not current have an organized capacity to do the ethical analysis of the technology.	Strengthen capacity for engagement and ethical analysis. There are two approaches to examining ethical questions: (1) consult with the public, (2) much like law, use a thought process to get answers. Implement mechanisms to engage the public.
Citizen and public engagement.	Develop a broad consultation and engagement strategy to reach decision makers and engage Canadians (i.e. develop broader set of consultation mechanisms and approaches).
Risk Analysis and Liability Framework
Long term risk analysis is lacking. Biotechnology is about modifying the genetic code; the consequences are not fully known.	Identify and recognize the potential risks that could be faced in the future (even the extreme catastrophes). Improve our ability to do risk analysis. Need to establish long-term safeguards and determine who is legally liable if catastrophes or damages occur. The Civil Law framework is not sufficient. Need to ensure that all Canadian companies are subject to the same standards and regulation whether they are working inside or outside of Canada. Need to ensure that imported products are subject to Canadian standards. (Some participants raised their concerns with making the regulations so stringent that they are limiting researchers).
Human Resources, Capacity Building, Intellectual Property
Potential shortage of human resources, especially in research and business management related to biotechnology development.	Establish a Human Resources Plan. This may include activities such as recruiting from other countries. Invest in strategies to increase graduation rate of researchers. Ensure linkages to a Canadian economic strategy. Increase training and linkages to larger schools. Improve coordination between federal and provincial efforts in identifying priorities and areas ripe for investment.
Intellectual property issues.	Identify common standards (see report from Conference Board that was recently released).
Commercialization and Innovation
The level of innovation in Canada is not effectively measured. Need to measure effectiveness of our investments and consider the economic value of our inventions.	Identify better ways to measure “innovation” and “wealth creation” (e.g. number of patents, peer reviews, etc.) Improve our ability to conduct economic analysis in this field. Include economic analysis in proposals to request funds. R&D; funds can then be prioritised based on their expected economic value. (Some participants mentioned that even if there was a strategy, it could be difficult to control the R&D; agenda which the government does not directly control.)
Need for better commercialization of our research.	Reallocate developmental funds to support commercialization. Identify ways to translate an invention into economic value for the country. This could help us determine our R&D; priorities.
Need better allocation of funds. Only 6% of biotechnology funds are allocated to regulatory activities and 3% to commercialization.	Reallocate funds to commercialization and regulatory activities.
Lack of investments in biotechnology from Canadian investors; most investment currently from outside of Canada.	Need to engage more Canadian investors in early development stages.

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4.0 Governance and Federal Government Role

4.1 Governance

The group was presented with a diagram identifying a range of governance models that could be applied to manage the biotechnology strategy. The following six models were defined along a possible governance spectrum for consideration:

1. Laissez-faire: No explicit governance.
2. Self-managed, multiple points of coordination: Biotechnology community manages collective interests/direction using existing sectoral association mechanism to provide guidance.
3. Self-managed, managed central coordination: Biotechnology community manages collective interests/direction using a central national mechanism to provide guidance.
4. Joint leadership: Biotechnology community and federal government jointly define and guide strategy, with distinct roles in relevant areas.
5. Joint leadership, central mechanism: Biotechnology community and federal government form multi-partner mechanism to jointly define and guide strategy and provide coordinating leadership with distinct roles in relevant areas.
6. Federal leadership: Federal government provides leadership to national strategy, uses coordinating mechanism with internal and external integrating roles.

The group was then asked to define which model of governance should be used to provide ongoing guidance, direction and coordination to the promotion and advancement of the biotechnology strategy. On the whole, participants seemed to lean between joint leadership, and joint leadership and central mechanism.

The following summarizes the key points that resulted from the discussion:

• Governance is dependant on who owns the strategy and who will be investing in it. A key element in determining a workable governance mechanism lies in identifying who is willing to invest. Some participants mentioned that we should not assume that all funds to support this strategy will come from the federal government; some funds could also be provided by industry.
• One participant mentioned that another possible scenario was for the federal government to be a facilitator/coordinator but not the leader or the ultimate decision-maker.
• Governance is not just about identifying leadership. Further clarification on the roles and contribution of various parties involved in the Canadian strategy (e.g. federal government, provincial governments, CBSec, biotech community, public, etc.) is needed.
• There was general agreement that governance of the biotechnology strategy should be about joint leadership. A proposed model was to establish an arms-length council of partners (including the federal government) to provide leadership and coordination to the strategy.
• Alternatively, the federal government or a centralized body could play a coordinating role for all parties involved in the strategy.
• One participant suggested that the strategy should follow a framework similar to the one used to develop the Canadian Cancer Strategy. In other words, the strategy should be developed by the community including experts, interest groups, representatives from different federal departments, industry and others. The strategy should be accompanied by an action plan to which the federal government can allocate funds. Funds could be managed by CBSec, who would continue to report back to Industry Canada.
• Other participants proposed alternate models including governance models used in the Canadian Forestry Strategy, the Canadian Council of Municipalities, and the National Round Table on the Environment and the Economy (NRTEE).
• A new biotechnology strategy should incorporate a significant partnering dimension, since Canada does not have the scale or capacity to go alone either within a subsector or across a field. This will require establishing partnerships among Canadian firms as well as with firms (and whole sectors) in other countries.
• Some participants questioned the roles and the purpose of CBAC and CBSec and their impact. It was clarified that CBSec is a horizontal coordinating body that has two main functions: (1) to support CBAC; and (2) to promote interdepartmental coordination.

4.2 Federal Government Role

A graphic outline of suggested roles for the federal government was presented to the participants and included the following roles:

Fundamental Roles

• Regulatory responsiveness, coherence and harmonization
  • Patents
  • Intellectual property and privacy legislation and regulations
  • Health and food environment regulations
• Federal coordination
  • Coordinate federal policies and departments
  • Provide independent advisory capacity
  • Federal-provincial coordination
• Financial support
  • Provide R&D; grants
  • Provide research tax incentives, investment and trade incentives
  • Provide value capture and commercialization incentives

Other more subjective roles

• Strategic leadership
  • Assist/lead definition of national innovation and biotech strategies
  • Provide guidance to strategy and monitor progress
  • Align federal policies to the strategy
• International leadership
  • Advocate common standards
  • Harmonize internal policies to international standards
  • Negotiate international agreements
  • Inform/assist developing countries
• Responsible stewardship
  • Inform and educate Canadians
  • Identify / broker social and ethical issues
  • Enable national dialogue and citizen engagement
  • Advocate responsible development and use

In general, participants agreed with the proposed roles for the federal government. The following summarizes key points that resulted from the discussion:

• In a knowledge-based economy, the federal government needs to play a coordinating role and to develop a partnership agenda including:
  • coordination across federal departments
  • partnerships with provincial government to leverage from their expertise (It is important for the federal government to gain buy-in from provincial governments)
  • partnerships with international governments and organizations
• There needs to be more streamlined and harmonized programs between federal and provincial governments. The government can benefit from economies of scale. One participant mentioned how it was confusing for small businesses to obtain standardized information. There should be a centralized place for Canadians to obtain information on Canadian support programs and regulations.
• Responsible stewardship is an important role that the federal government should play and that is currently under funded. One participant clarified that this was not only about liability, but about having a plan in place if some decisions result in a loss.
• The federal government (being a more neutral body) should convene and bring together stakeholders on issues of common concern and to facilitate the development and advancement of the strategy.
• There was some debate on liabilities and accountability of the government. Can the federal government assume responsibility for strategies that were broadly based on input from stakeholders?
• Considering the regulatory role, the federal government should support and possibly subsidize independent third party monitoring and research. In other words, the federal government could play more of a post evaluation role.

The facilitator reviewed the role of CBSec and CBAC as instruments of the strategy. He asked participants to consider whether they were appropriate instruments going forward, or if there were other suggestions to strengthen them. Some participants felt that it was too early to suggest anything and that a revised strategy would be needed to identify the requirements for such instruments first. On the other hand, it is clear that a central coordinating body such as CBSec is required to support implementation of the strategy and to report back to the responsible minister or department.

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Appendix 1 - Roundtable Agenda

Canada’s Biotechnology Strategy: Charting the Path Forward

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¹A copy of the workshop agenda is available in Appendices 1.