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Regulation of Biopharmaceuticals in Canada

Regulation of Biopharmaceuticals in Canada. ENVR 401 December 1, 2003 Supervisor: George McCourt Ashleigh Akalehiywot Andrea Hicks Mara Dacso Ted Walker Lillian Harris Kate Washington. Presentation Outline. Client Context of Research

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Regulation of Biopharmaceuticals in Canada

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  1. Regulation of Biopharmaceuticals in Canada ENVR 401 December 1, 2003 Supervisor: George McCourt Ashleigh Akalehiywot Andrea Hicks Mara Dacso Ted Walker Lillian Harris Kate Washington

  2. Presentation Outline • Client • Context of Research • Research Question • Methodology • RSC Recommendations • Government Response • Analysis • Comparative Studies • Conclusion • Suggestions to Client

  3. Polaris Institute - Ottawa Biojustice Project, Lucy Sharratt • Canadian regulatory system • Plants with Novel Traits - Biopharmaceuticals • Environmental risks of biopharming

  4. Context of Research Regulatory Bodies • Canadian Food Inspection Agency • Environment Canada • Health Canada

  5. Context of Research • Dir94-08 and Dir2000-07 biotechnology directives • Royal Society of Canada report • Action Plan and Progress Reports • Interim Amendments to Dir2000-07

  6. Research Question Do the most recent Federal Government regulations on Plants with Novel Traits take into consideration the Royal Society of Canada Report’s recommendations concerning environmental risks of field testing?

  7. Interim Amendments Government Legislation Non-government Risk assessment Government Mandate RSC (2001) Action Plan & Progress Reports Directive 2000-07

  8. Methodology • Selected recommendations for analysis • Assessed government's response: Action Plan and Progress Reports • Analyzed Interim Amendments • Identified gaps in Canadian regulation • Comparative studies: United States and European Union

  9. Interim Amendments Government Legislation Non-government Risk assessment Government Mandate RSC (2001) Action Plan & Progress Reports Directive 2000-07

  10. RSC Recommendations • Recommendation 6.3 (Effects of Selection) • potential effects of selection: on an introduced organism or on genes transferred to natural recipients • Concerns: Perpetuation of transgenes within wild populations

  11. RSC Recommendations Recommendation 6.6 (Reproductive Biology) • environmental assessments should pay particular attention to reproductive biology obtained from specific experiments Concerns: Gene flow

  12. RSC Recommendation Recommendation 6.7 (Greater Ecosystem Knowledge) • environmental assessments should include potential impacts on natural and disturbed ecosystems Concerns:Biodiversity; genetic diversity within populations

  13. Interim Amendments Government Legislation Non-government Risk assessment Government Mandate RSC (2001) Action Plan & Progress Reports Directive 2000-07

  14. Action Plan and Progress Report • Focus of Action Plan: • Transparency • Inspection and monitoring • Harmonization of CFIA and EC regulation • Although the Action Plan makes reference to specific RSC recommendations, the proposed actions and their implementation deal with the environmental concerns on a general level.

  15. Action Plan and Progress Report • Rec 6.3 (effects of selection) • Effects of Selection now required under New Substances Program of the CEPA • Rec 6.6 (reproductive biology) • Not addressed • Rec 6.7 (greater ecosystem knowledge) • Canadian Biotechnology Strategy Fund: supports relevant research projects

  16. Interim Amendments Government Legislation Non-government Risk assessment Government Mandate RSC (2001) Action Plan & Progress Reports Directive 2000-07

  17. Interim AmendmentsBiopharmaceutical field testing Environmental safety measures: • Increased isolation distances and mandatory buffer zone • Strict disposal requirements • Increased monitoring • Contingency Plan

  18. Interim Amendments RSC (2001) Action Plan & Progress Reports Directive 2000-07 Gaps Gaps

  19. Identified Gaps Regulation for approval of biopharmaceuticals does not include • Measures preventing risk to wild ecosystems • Insufficient precaution • Incentives/funds for further scientific research

  20. The Reasons These gaps exist because one of the following reasons: a) Concerns not mentioned in regulation OR b) Concerns mentioned but regulation not adequate OR c) Concerns addressed through suggestions not requirements

  21. Research Question Do the most recent Federal Government regulations on Plants with Novel Traits take into consideration the Royal Society of Canada Report’s recommendations concerning environmental risks of field testing?

  22. Answering the Research Question The newest Canadian regulation (interim amendments) does address some additional environmental concerns as recommended by the RSC report, but key elements still missing • Further research to gain empirical knowledge • Greater precaution until more knowledge acquired • More comprehensive regulation to prevent danger to ecosystems

  23. Comparative Study ~ United States • Employs "Best Science" Framework • Regulatory Bodies • U.S. Department of Agriculture - Animal and Plant Health Inspection Service • Environmental Protection Agency • Food and Drug Administration

  24. Biopharming in the United States • Exclusivity of farm equipment • Isolation distance vs closed-pollination • Temporal isolation

  25. Comparative Study ~ European Union • Based on "Precautionary Principle" • Moratorium • No field testing of biopharmaceuticals

  26. Conclusions • RSC raises specific environmental concerns • Interim amendments partially reflect RSC concerns • U.S. imposes additional precautions in field testing • E.U. restricts testing of biopharmaceuticals

  27. Suggestions to Client • Empirical knowledge • Effects on non-agricultural ecosystem • Restrictions on confined field testing • Explicit rather than suggestivelanguage

  28. Everybody is welcome to join us for a GMO-free beer at Hurley’s Irish Pub. First round’s on George!

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