Towards A Canadian Codes for Biotechnology

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TowardsA Canadian Code(s) for Biotechnology

• Marc Saner
• APEC RDEAB Group Meeting
• Seoul, 9 November 2004

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Overview

• What is a code?
• Reasons for a code (in general)
• Research towards a Canadian code
• Results of stakeholder interviews
• Does the Queensland model work?
• An open question

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What is A Code?

• A voluntary approach to regulation
• Values-based codes (e.g., principles)
• Compliance-based codes (soft law)
• Normally A mixture of the two
• There are written and unwritten codes
• Professional codes
• Culture
• There are codes with or without clear
  implementation plans

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Examples of Written Codes

• Human Rights
• Responsible Care industry self-regulation
• Code of Ethical Practice for Biotechnology in
  Queensland
• Ancient, yet modern
• New Public Management
• Shared duties, governance

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Reasons for a Code

• To restore trust solve a problem
• Human rights Holocaust
• Responsible Care Bhopal
• To build trust create an opportunity
• Queensland Create a biotech industry
• To set a standard and educate
• Professional codes (e.g., for engineers)
• To exert competitive pressure
• Especially when combined with product labels
• To pre-empt mandatory measures
• Can be more effective than mandatory measures

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The Canadian Project

• The federal government has a mandate for
  biotechnology stewardship
• Stewardship Framework (all of biotechnology)
• Champion located in the Health Department
• Code idea has been investigated since 2003

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Methodology

• Interviews with stakeholders
• Should we have a Canadian code?
• Should the Queensland Code be our model?
• Collecting information of on the effectiveness of
  the Queensland model
• Interviews
• Reports

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Note on the Queensland Code

• Detailed and comprehensive, examples
• Integrity of research
• Access to biological resources
• Biodiversity and sustainable agriculture
• Import and quarantine controls
• Risk assessment and approval
• Long term ecological monitoring
• Medical research and health care
• Biological weapons
• Facilitation of discussion about ethical issues

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Level of Support for a Code
Industry
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Views of Government Officials

• For a code
• A code will achieve transparency and promote
  confidence
• A code will fill in the gaps
• A code will show our commitment
• The Queensland Code is a good model for Canada
• Against a code
• Weve already got codes
• Cost implications
• Queensland is too different from Canada

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Views of Industry and Academe

• For a code
• It will standardize ethical practice
• Improve application and comprehension of
  regulatory framework
• International harmonization
• Against a code
• Current regulatory system adequate
• Onerous elements will limit opportunity
• (Academics are less supportive than industry)

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Views of Non-Government Orgs.

• For a code
• A code would increase confidence, fill gaps and
  make a commitment
• The Queensland model covers many areas and has
  high detail
• Against a code
• Regulation of agricultural biotech needs to be
  strengthened first
• The Queensland model is not mandatory

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Queensland Lesson EY Report

• Queensland Biotechnology Report 2003 compiled by
  Ernst Young
• Majority (69) believe the Code significantly
  provides regulatory certainty for Queenslands
  biotechnology industry
• Majority (71) believe it has not placed a
  compliance burden on biotech organizations

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Queensland Lesson Interviews

• The Queensland Code came into being because it
  was supported from the very top
• There was not enough consultation in the
  development of the Code
• The Code needs more teeth
• It has caused national and international interest
• Overall, the Code was worthwhile

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Preliminary Conclusion

• There seems merit in pursuing the idea of a
  national code of practice for biotech

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However Departmental Efforts

• Agriculture Department
• RIONAP Responsible Introduction of New
  Agricultural Products
• Environment Department
• EPR Extended Producer Responsibility for the
  bio-based economy
• Forestry Department
• Canada Forest Accord (not biotech specific)

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And Industry Efforts

• BioteCanada Code
• CropLife Canada Code
• Monsantos stewardship efforts

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Open Questions

• How far should the nation-wide integration of
  voluntary measures go?
• Departments, provinces, industry, academe,
• Push the limits or simply collate the existing?
• Is it better to have a system of diverse
  approaches (an ecosystem)
• or is is better to unify and have clear national
  standards
• or can we have both?
• Who is first and who pre-empts who?