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
Canadian Drug Agency: Specifically, the mandate and creation of a new Canadian Drug Agency and transition work to support pharmacare-related initiatives.
Proposed national pharmacare: Specifically, government’s intention to introduce a national pharmacare program.
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
COVID-19: Regarding the development of a COVID-19 vaccine & policies and related to the COVID-19 pandemic.
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.
Incentives and programs to attract and support manufacturing activities in Canada
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.
Policies or Program, Regulation
Health Canada and the Patented Medicine Prices Review Board(PMPRB) regulatory implementation and specifically, pharmaceutical pricing policy issues arising from the Patented Medicine 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.