ENVR 401December 1, 2003

Supervisor: George McCourtAshleigh Akalehiywot Andrea HicksMara Dacso Ted WalkerLillian Harris Kate Washington

Regulation of Biopharmaceuticals in Canada

Presentation Outline

Client Context of Research Research Question Methodology

RSC Recommendations Government Response Analysis Comparative Studies

Conclusion Suggestions to Client

Polaris Institute - Ottawa

Biojustice Project, Lucy Sharratt Canadian regulatory system Plants with Novel Traits - Biopharmaceuticals Environmental risks of biopharming

Context of Research

Regulatory Bodies Canadian Food Inspection Agency Environment Canada Health Canada

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

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?

InterimAmendments

Directive2000-07

Action Plan&

Progress ReportsRSC

(2001)

Government Legislation

Non-government Risk assessment

Government Mandate

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

InterimAmendments

Directive2000-07

Action Plan&

Progress ReportsRSC

(2001)

Government Mandate

Government Legislation

Non-government Risk assessment

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

RSC Recommendations

RSC Recommendations

Recommendation 6.6 (Reproductive Biology)

environmental assessments should pay particular attention to reproductive biology obtained from specific experiments

Concerns: Gene flow

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

InterimAmendments

Directive2000-07

Action Plan&

Progress ReportsRSC

(2001)

Government Mandate

Non-government Risk assessment

Government Legislation

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.

Action Plan and Progress ReportRec 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

InterimAmendments

Directive2000-07

Action Plan&

Progress ReportsRSC

(2001)

Government Mandate

Non-government Risk assessment

Government Legislation

Interim AmendmentsBiopharmaceutical field testing

Environmental safety measures: Increased isolation distances and

mandatory buffer zone Strict disposal requirements Increased monitoring Contingency Plan

InterimAmendments

Directive2000-07

Action Plan&

Progress ReportsRSC

(2001)

Gaps

Gaps

Identified Gaps

Regulation for approval of biopharmaceuticals does not include

• Measures preventing risk to wild ecosystems

• Insufficient precaution• Incentives/funds for further scientific

research

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

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?

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

Employs "Best Science" Framework

Regulatory Bodies U.S. Department of Agriculture - Animal and

Plant Health Inspection Service

Environmental Protection Agency Food and Drug Administration

Comparative Study ~ United States

Biopharming in the United States

Exclusivity of farm equipment Isolation distance vs closed-pollination Temporal isolation

Based on "Precautionary Principle"

Moratorium No field testing of biopharmaceuticals

Comparative Study European Union

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

Suggestions to Client

Empirical knowledge Effects on non-agricultural ecosystem Restrictions on confined field testing Explicit rather than suggestive

language

Everybody is welcome to join us for a GMO-free beer at

Hurley’s Irish Pub.

First round’s on George!