Regulation of biopharmaceuticals in canada
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Regulation of Biopharmaceuticals in Canada. Environmental Research ENVR 401 Supervisor George McCourt Oct. 16, 2003. Presentation Outline. Client background Context of Research Research Question Methodology Expected Results Data Sources Possible Problems. Group Members.

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Regulation of biopharmaceuticals in canada

Regulation of Biopharmaceuticals in Canada

Environmental Research

ENVR 401

Supervisor George McCourt

Oct. 16, 2003


Presentation outline

Presentation Outline

  • Client background

  • Context of Research

  • Research Question

  • Methodology

  • Expected Results

  • Data Sources

  • Possible Problems


Group members

Group Members

  • Ashleigh Akalehiywot

  • April Aliermo

  • Mara Dacso

  • Lillian Harris

  • Andrea Hicks

  • Ted Walker

  • Kate Washington


Regulation of biopharmaceuticals in canada

  • Regulation

  • Biopharmaceuticals

  • Environmental Risk


Polaris institute ottawa canada

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


Biojustice project lucy sharratt

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.


Biojustice project our role

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


Context of research

Context of Research

  • 1980’s advances in biotechnology

  • 1990’s introduction of regulations

  • Regulatory Directive Dir2000-07: Guidelines for the Environmental Release of Plants with Novel Traits within Confined Field Trials in Canada


Context of research1

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)


Context of research2

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


Context of research3

Context of Research

  • Government Response to RSCReport

    • Action Plans - November 23, 2001

    • 4 updates since, most recent in June 2003


Context of research4

Context of Research

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

    April 22, 2003


Regulation of biopharmaceuticals in canada

Original

Legislation

(1980’s)

Directives

(Pre-2001)

RSC

(2001)

Action

Plans

(2001)

Interim

Amendments

(2003)


Research question

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?


Research question1

Research Question

  • Motivations for creating the amendments?

  • Time-line for solidifying the amendments as regulation?

  • Effectiveness of the amendments in addressing environmental risk?


Regulation of biopharmaceuticals in canada

Original

Legislation

(1980’s)

Directives

(Pre-2001)

RSC

(2001)

Action

Plans

(2001)

Interim

Amendments

(2003)


Methodology extended literature review

MethodologyExtended Literature Review

  • Extensive analysis of government regulations, documents, conference papers

    • To determine sources of information and reasoning behind the amendments


Methodology case studies

MethodologyCase Studies

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

    • Determine how each regulates Plant Molecular Farming

    • Compare effectiveness


Methodology interviews

MethodologyInterviews

  • Interviews with government officials

    • To determine the progress of solidifying the amendments and phase currently underway


Methodology

Methodology

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

  • Determine the extent to which environmental risk is addressed in the amendments


Expected results

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


Data sources

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


Time line

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


Division of labour

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)


Division of labour1

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)


Possible problems

Possible Problems

  • Addressing client's needs

  • Focusing scope of research to a manageable area

  • Accessing sufficient information

  • Accessing relevant information


In a nutshell

In a nutshell…

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


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