Canada-United States-Mexico Agreement (CUSMA) and pharmaceutical intellectual property protection.
Comprehensive Economic Trade Agreement with Europe (CETA) and pharmaceutical intellectual property protection.
Health Canada's enforcement of Canada's Food and Drugs Act and Regulations as they relate to the cross border sale of drugs to the United States.
Legislative Proposal, Bill or Resolution, Policies or Program, Regulation
Research and Development (R&D): Input on Canada's clinical trial approval and implementations processes; Investing in Canada in R&D
Policies or Program
Canada's Innovation Agenda: ensuring that the life sciences industry is included and promoting awareness of and support for the full ecosystem from early stage research to commercialization and reimbursement.
Input into the Patented Medicines Price Review Board evaluation of annual R&D investments by companies in Canada based on Scientific Research and Experimental Development (SR&ED) tax rules. Working with PMPRB and legislators to ensure appropriate measures of R&D investment are in place.
National Pharmacare. Specifically the proposed delivery of a universal pharmacare program. This universal format would eliminate the private insurance benefit industry and thereby reducing the amount of medications available to Canadians
Policies or Program, Regulation
Health Canada Patented Medicine Prices Review Board (PMPRB) proposed regulation changes are the regulations
Health Canada consulted on Proposed Amendments to the Patented Medicines Regulations. Discussions on changing the basket of comparative countries and its unintended economic consequences in Canada. In particular its impact on the Life Sciences Sector and wait times for medicines for Canadians
Title: “Protecting Canadians from Excessive Drug Prices: Consulting on Proposed Amendments to the Patented Medicines Regulations”
Regulation
An amendment to the Patented Medicines (Notice of Compliance) Regulations ("PM(NOC) Regulations") regarding the right to appeal.
Modernization of Food & Drug Act: support for proposed regulatory changes, modernization and international harmonizations with other regulatory bodies (European Medicines Agency/U.S. Food and Drug Administration).
Subsequent Entry Biologics (SEBs): the need for regulatory amendments to facilitate their approval.