Symbol of the Government of Canada

Common menu bar links

Canadian Generic Pharmaceutical Association

Submission — Canadian Generic Pharmaceutical Association

Important note: The content of submissions and summaries is the sole responsibility of the person and / or organization having made a submission. The posting of this content does not indicate that the Panel supports or endorses it. Submissions and summaries are posted in the language provided without modification.

Submitter(s): Keon, Jim

Summary: The Canadian Generic Pharmaceutical Association (CGPA) and its member companies welcome the opportunity to participate in the consultations conducted by the Expert R&D Review Panel. CGPA would welcome the opportunity to review the recommendations in this submission with members of the panel in greater detail. Canada's generic pharmaceutical industry is innovative and a major investor in domestic research and development and manufacturing. The following recommendations are focused on improvements to legal and regulatory frameworks and policies that would help to foster an internationally competitive environment that supports continued research, development and manufacturing by the generic pharmaceutical industry in Canada:

  1. Industry Canada should undertake a comprehensive review of the intellectual property regime for pharmaceuticals, including the Patented Medicine (Notice of Compliance) Regulations, without delay.
  2. The Government of Canada must reject the pharmaceutical intellectual property proposals of the European Union in the negotiations for a Comprehensive Economic and Trade Agreement (CETA).
  3. Health Canada must develop and implement a concrete action plan to address the significant backlog in both Notifiable Change Submissions (NCs) and Abbreviated New Drug Submissions (ANDSs), and ensure the department is properly resourced to meet its own performance targets in these areas in the future.

Full submission: PDF Version