Janssen

Canadian Drug Agency: the mandate and creation of a new Canadian Drug Agency and transition work to support pharmacare-related initiatives, including patient access and reimbursement framework. Communications regarding Canada’s mental health strategy, implementation and access to services for Canadians. Development of Health Emergency Readiness Canada agency, and role in promoting development life sciences sector. Subsequent Entry Biologics (SEBs): the need for regulatory amendments to facilitate their approval. Research and Development (R&D): Input on Canada's clinical trial approval and implementations processes; Investing in Canada in R&D. Proposed national pharmacare: Specifically, government’s intention to introduce a national pharmacare program. 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). 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. Incentives and programs to attract and support manufacturing activities in Canada Health Canada and the Patented Medicine Prices Review Board(PMPRB) regulatory implementation and specifically, pharmaceutical pricing policy issues arising from the Patented Medicine Regulations. 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. COVID-19: Regarding the development of a COVID-19 vaccine & policies and related to the COVID-19 pandemic. Comprehensive Economic Trade Agreement with Europe (CETA) and pharmaceutical intellectual property protection. Communications regarding the maintenance of domestic supply of essential drug products. Canada-United States-Mexico Agreement (CUSMA) and pharmaceutical intellectual property protection. 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. An amendment to the Patented Medicines (Notice of Compliance) Regulations ("PM(NOC) Regulations") regarding the right to appeal.