Regulation of Biopharmaceuticals in Canada Environmental Research ENVR 401 Supervisor George McCourt Oct. 16, 2003.

Regulation of Regulation of Biopharmaceuticals in CanadaBiopharmaceuticals in Canada

Environmental ResearchEnvironmental ResearchENVR 401ENVR 401

Supervisor George McCourtSupervisor George McCourtOct. 16, 2003Oct. 16, 2003

Presentation OutlinePresentation Outline

Client backgroundClient background Context of ResearchContext of Research Research QuestionResearch Question MethodologyMethodology Expected ResultsExpected Results Data SourcesData Sources Possible ProblemsPossible Problems

Group MembersGroup Members

Ashleigh AkalehiywotAshleigh Akalehiywot April AliermoApril Aliermo Mara DacsoMara Dacso Lillian HarrisLillian Harris Andrea HicksAndrea Hicks Ted WalkerTed Walker Kate WashingtonKate Washington

RegulationRegulation

BiopharmaceuticalsBiopharmaceuticals

Environmental RiskEnvironmental Risk

Polaris Institute ~ Ottawa, Polaris Institute ~ Ottawa, CanadaCanada

"enable citizen movements to re-skill "enable citizen movements to re-skill and re-tool themselves to fight for and re-tool themselves to fight for democratic social change" democratic social change"

Challenges public policy makingChallenges public policy making

www.polarisinstitute.orgwww.polarisinstitute.org

Biojustice Project ~ Lucy SharrattBiojustice Project ~ Lucy Sharratt

Concerned with the power of large Concerned with the power of large corporations to push genetically corporations to push genetically engineered products and industries.engineered products and industries.

Aims to provide information and Aims to provide information and resources to grass-roots anti-biotech resources to grass-roots anti-biotech activists.activists.

Biojustice Project – Our RoleBiojustice Project – Our Role

To fill in the gaps within research and To fill in the gaps within research and regulation of plant molecular farming regulation of plant molecular farming (biopharmaceuticals)(biopharmaceuticals)

To provide a framework on which the To provide a framework on which the institute can use to influence regulationinstitute can use to influence regulation

Context of ResearchContext of Research

1980’s advances in biotechnology1980’s advances in biotechnology 1990’s introduction of regulations1990’s introduction of regulations Regulatory Directive Dir2000-07: Guidelines for Regulatory Directive Dir2000-07: Guidelines for

the Environmental Release of Plants with Novel the Environmental Release of Plants with Novel Traits within Confined Field Trials in CanadaTraits within Confined Field Trials in Canada

Context of ResearchContext of Research Three governing bodies:Three governing bodies:

Canadian Food Inspection Agency (CFIA) Canadian Food Inspection Agency (CFIA) Health Canada (HC)Health Canada (HC)Environment Canada (EC)Environment Canada (EC)

"used existing acts to incorporate new "used existing acts to incorporate new regulations or amend existing ones in regulations or amend existing ones in order to deal with GM foods" (CBAC, order to deal with GM foods" (CBAC, 2002)2002)

Context of ResearchContext of Research

Royal Society of Canada ReportRoyal Society of Canada ReportElements of Precaution: Recommendations for Elements of Precaution: Recommendations for the Regulation of Food Biotechnology in the Regulation of Food Biotechnology in Canada (2001)Canada (2001)

Commissioned by CFIA, HC, and ECCommissioned by CFIA, HC, and EC 53 recommendations53 recommendations

Context of ResearchContext of Research

Government Response to RSCGovernment Response to RSCReportReport

Action Plans - November 23, 2001Action Plans - November 23, 2001 4 updates since, most recent in June 4 updates since, most recent in June

20032003

Context of ResearchContext of Research

Interim Amendment to Dir2000-07 for Interim Amendment to Dir2000-07 for Confined Research Field Trials of PNT's Confined Research Field Trials of PNT's for Plant Molecular Farmingfor Plant Molecular Farming

April 22, 2003April 22, 2003

Directives(Pre-2001)

InterimAmendments

(2003)

RSC(2001)

ActionPlans(2001)

OriginalLegislation

(1980’s)

Research QuestionResearch Question

To what extent do the Interim To what extent do the Interim Amendments on field testing of Amendments on field testing of Plant Molecular Farming address Plant Molecular Farming address the environmental concerns raised the environmental concerns raised in the RSC report?in the RSC report?

Research QuestionResearch Question

Motivations for creating the amendments?Motivations for creating the amendments? Time-line for solidifying the amendments as Time-line for solidifying the amendments as

regulation?regulation? Effectiveness of the amendments in Effectiveness of the amendments in

addressing environmental risk?addressing environmental risk?

Directives(Pre-2001)

InterimAmendments

(2003)

RSC(2001)

ActionPlans(2001)

OriginalLegislation

(1980’s)

MethodologyMethodologyExtended Literature ReviewExtended Literature Review

Extensive analysis of government Extensive analysis of government regulations, documents, conference regulations, documents, conference paperspapers

To determine sources of information and To determine sources of information and reasoning behind the amendmentsreasoning behind the amendments

MethodologyMethodologyCase StudiesCase Studies

Comparison between the European Union, the Comparison between the European Union, the United States and CanadaUnited States and Canada

Determine how each regulates Plant Molecular Determine how each regulates Plant Molecular FarmingFarming

Compare effectivenessCompare effectiveness

MethodologyMethodologyInterviewsInterviews

Interviews with government officialsInterviews with government officials

To determine the progress of solidifying To determine the progress of solidifying the amendments and phase currently the amendments and phase currently underwayunderway

MethodologyMethodology

Comparison of the amendments with Comparison of the amendments with scientific data and the RSC report scientific data and the RSC report

Determine the extent to which Determine the extent to which environmental risk is addressed in the environmental risk is addressed in the amendmentsamendments

Expected ResultsExpected Results

Identify gaps in Canada's regulatory Identify gaps in Canada's regulatory systemsystem

Provide Polaris Institute with a Provide Polaris Institute with a framework for further work with the framework for further work with the government and the public concerning government and the public concerning regulationregulation

Data SourcesData Sources

Primary sources (interview)Primary sources (interview) Published scientific researchPublished scientific research Published reviews of current research Published reviews of current research

and regulation (RSC report)and regulation (RSC report) Government documents from Canada, Government documents from Canada,

US, and the EUUS, and the EU

Time LineTime LineWeeks 1 & 2 establish baseline data for Canada & contact potential intervieweesWeek 3 begin case study research (EU &US)

Week 4 compile/analyze/compare findings

Week 5 design framework for final report

Week 6 prepare for presentation

Week 7 presentation & finish report

Division of LabourDivision of Labour

Administrative TasksAdministrative Tasks Liaison with Lucy (Mara)Liaison with Lucy (Mara) Liaison with Field Study Group (Lillian)Liaison with Field Study Group (Lillian) Research Paper editors (April, Kate)Research Paper editors (April, Kate) PowerPoint presentation (Ted, Ashleigh)PowerPoint presentation (Ted, Ashleigh) Final Oral (Andrea, Kate)Final Oral (Andrea, Kate) Website (Ted, April)Website (Ted, April)

Division of LabourDivision of Labour

Research Tasks Research Tasks EU Case Study (Lillian, Kate)EU Case Study (Lillian, Kate) US Case Study (Mara, Ashleigh)US Case Study (Mara, Ashleigh) Government contact interview (April)Government contact interview (April) RSC expert (Andrea)RSC expert (Andrea) Action Plan expert (Ted)Action Plan expert (Ted) Canadian Regulation experts (everyone)Canadian Regulation experts (everyone)

Possible ProblemsPossible Problems

Addressing client's needsAddressing client's needs Focusing scope of research to a Focusing scope of research to a

manageable areamanageable area Accessing sufficient informationAccessing sufficient information Accessing relevant informationAccessing relevant information

In a nutshell…In a nutshell…

Determine effectiveness of Canada's Determine effectiveness of Canada's regulatory system for the field testing of regulatory system for the field testing of biopharmaceuticals.biopharmaceuticals.