Health Canada Responsibilities

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• Health Canada Responsibilities
• Brigitte Zirger, Director
• Bureau of Policy, Science and International
  ProgramsTherapeutic Products Directorate Health
  Canada
• Access to Medicines and Intellectual Property
  Workshop
• April 20, 2007

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Health Canada Role in CAMR

• Undertake product submission review to verify
  that the product meets the same requirements for
  safety, efficacy and quality as products
  available to Canadians
• Ensure that the pharmaceutical product is
  distinguishable from the patented version
  available in Canada aimed at preventing
  diversion and re-importation
• Perform a pre-export inspection to verify, among
  other things, the distinguishing features and the
  quantities to be exported.

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Health Canada Product Submission - Highlights

• Two parts to the CAMR product submission
• Domestic Submission
• Drugs and medical devices exported under the
  Regime must meet the same safety, efficacy and
  quality requirements as products available to
  Canadians
• Division 7 Distinguishing Features
• Products must be distinguishable from the
  patented versions on the Canadian market i.e.,
  specific markings, colouring and labelling
• Product submissions are reviewed immediately upon
  arrival
• Fees normally applicable to the drug review will
  be refunded once compulsory licence is granted
• Division 7 - Sale Of Drugs For The Purposes of
  Implementing The General Council Decision

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Two Application Processes
Application under the Patent Act
Application under the Food and Drugs Act
Compulsory Licence Permitting Export
Patent Hold Letter and Notification to the
Commissioner of Patents and WHO Prequalification
Supplementary to CAMR
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Status

• High quality drugs have now been reviewed by
  Health Canada but no application for a compulsory
  licence has yet been received by the Commission
  of Patents
• Apo-TriAvir (zidovudine, lamivudine, nevirapine)
  listed on the WHO PQP on August 10, 2006 pursuant
  to the alternative procedure.
• Outreach efforts to address the information needs
  of all parties continue
• Developing countries, industry, NGOs
• CAMR website WWW.CAMR.GC.CA

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Website - www.camr.gc.ca
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Contacts

• Brigitte Zirger, Director
• Bureau of Policy, Science and International
  ProgramsTherapeutic Products Directorate Health
  Canada
• [phone]
• email bpsip_info_bpspi_at_hc-sc.gc.ca
• Douglas Clark, Director
• Patent Policy Directorate
• Industry Canada
• [phone]
• email clark.douglas_at_ic.gc.ca

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Application Country Related Declarations
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Process Chart