Industry Canada regarding export provisions of the Patent Act (pharmaceuticals).
Industry Canada with respect to the Patent Act as it pertains to pharmaceuticals.
Policies or Program
Health Canada regarding the development and implementation of an approval pathway for Subsequent Entry Biologics (SEBs).
Health Canada regarding the need for appropriate, dedicated resources for the Therapeutic Products Directorate to meet performance targets for the review of generic drug submissions.
Health Canada, Industry Canada and International Trade Canada regarding effective measures to combat counterfeit drugs in Canada and around the world.
Industry Canada's Science and Technology strategy regarding the need for a balanced Intellectual Property regime and the important role competition plays in encouraging innovation.
Regulation
As a member company, participation in the Canadian Generic Pharmaceutical Association's legal challenge of the 2006 Amendments to Health Canada's Food and Drug Regulations with respect to the extended period of data exclusivity, as well as further proposed amendments to these regulations.
Health Canada regarding the modernization of the Food and Drug Act (formerly Bill C-51) with respect to the development and implementation of a Progressive Licensing Framework for pharmaceuticals.
Industry Canada regarding the need to restore balance to the Patented Medicines (Notice of Compliance) Regulations with respect to pharmaceuticals and address operational concerns including: lack of finality to proceedings under the Regulations and lack of disincentives to discourage abuse of the Regulations.