Regulation of Biopharmaceuticals in Canada

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Regulation of Biopharmaceuticals in Canada

• Environmental Research
• ENVR 401
• Supervisor George McCourt
• Oct. 16, 2003

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Presentation Outline

• Client background
• Context of Research
• Research Question
• Methodology
• Expected Results
• Data Sources
• Possible Problems

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Group Members

• Ashleigh Akalehiywot
• April Aliermo
• Mara Dacso
• Lillian Harris
• Andrea Hicks
• Ted Walker
• Kate Washington

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• Regulation
• Biopharmaceuticals
• Environmental Risk

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Polaris Institute Ottawa, Canada

• "enable citizen movements to re-skill and re-tool
  themselves to fight for democratic social change"
  
• Challenges public policy making
• www.polarisinstitute.org

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Biojustice Project Lucy Sharratt

• Concerned with the power of large corporations to
  push genetically engineered products and
  industries.
• Aims to provide information and resources to
  grass-roots anti-biotech activists.

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Biojustice Project Our Role

• To fill in the gaps within research and
  regulation of plant molecular farming
  (biopharmaceuticals)
• To provide a framework on which the institute can
  use to influence regulation

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Context of Research

• 1980s advances in biotechnology
• 1990s introduction of regulations
• Regulatory Directive Dir2000-07 Guidelines for
  the Environmental Release of Plants with Novel
  Traits within Confined Field Trials in Canada

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Context of Research

• Three governing bodies
• Canadian Food Inspection Agency (CFIA)
• Health Canada (HC)
• Environment Canada (EC)
• "used existing acts to incorporate new
  regulations or amend existing ones in order to
  deal with GM foods" (CBAC, 2002)

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Context of Research

• Royal Society of Canada Report
• Elements of Precaution Recommendations for the
  Regulation of Food Biotechnology in Canada (2001)
• Commissioned by CFIA, HC, and EC
• 53 recommendations

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Context of Research

• Government Response to RSCReport
• Action Plans - November 23, 2001
• 4 updates since, most recent in June 2003

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Context of Research

• Interim Amendment to Dir2000-07 for Confined
  Research Field Trials of PNT's for Plant
  Molecular Farming
• April 22, 2003

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Original Legislation (1980s)
Directives (Pre-2001)
RSC (2001)
Action Plans (2001)
Interim Amendments (2003)
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Research Question

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

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Research Question

• Motivations for creating the amendments?
• Time-line for solidifying the amendments as
  regulation?
• Effectiveness of the amendments in addressing
  environmental risk?

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Original Legislation (1980s)
Directives (Pre-2001)
RSC (2001)
Action Plans (2001)
Interim Amendments (2003)
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MethodologyExtended Literature Review

• Extensive analysis of government regulations,
  documents, conference papers
• To determine sources of information and reasoning
  behind the amendments

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MethodologyCase Studies

• Comparison between the European Union, the United
  States and Canada
• Determine how each regulates Plant Molecular
  Farming
• Compare effectiveness

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MethodologyInterviews

• Interviews with government officials
• To determine the progress of solidifying the
  amendments and phase currently underway

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Methodology

• Comparison of the amendments with scientific data
  and the RSC report
• Determine the extent to which environmental risk
  is addressed in the amendments

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Expected Results

• Identify gaps in Canada's regulatory system
• Provide Polaris Institute with a framework for
  further work with the government and the public
  concerning regulation

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Data Sources

• Primary sources (interview)
• Published scientific research
• Published reviews of current research and
  regulation (RSC report)
• Government documents from Canada, US, and the EU

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Time Line
Weeks 1 2 establish baseline data for Canada
contact potential interviewees Week 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
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Division of Labour

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

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Division of Labour

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

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Possible Problems

• Addressing client's needs
• Focusing scope of research to a manageable area
• Accessing sufficient information
• Accessing relevant information

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In a nutshell

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