James Keon

Innovation, Science and Economic Development Canada (ISED) Innovation Agenda regarding the need for a balanced intellectual property regime and the important role competition plays in encouraging innovation. Provide input into policy discussions with respect to the implementation of a national pharmacare program. Provide input into the Government of Canada's negotiations regarding trade negotiations with respect to pharmaceuticals, counterfeit medicines, and intellectual property. Provide input into the Canada-US trade relationship as it pertains to medicines, including the impact of tariffs on medicines and medicine manufacturing inputs for the Canadian healthcare system, patients and industry. Provide input into the Canada-United States-Mexico Agreement (CUSMA). To encourage the Government of Canada to continue to participate in truly international discussions with respect to effective measures to combat substandard and falsified medicines in Canada and around the world. Seeking harmonization of regulatory regimes and administrative processes nationally and internationally. Providing input with respect to the approval pathway for biosimilar medicines by Health Canada. Provide input into the Patented Medicine Prices Review Board (PMPRB) consultations regarding its Policies, Guidelines and Procedures. Provide input into the modernization of the Food and Drugs Act and related Regulations, Guidelines and Policies as they pertain to pharmaceuticals. Proposals to enhance transparency of the Health Canada Reconsiderations Policy for drug submissions. Proposals related to Health Canada's Identical Medicinal Ingredient Policy. Participation in Competition Bureau consultations with respect to pharmaceuticals. Participate in Government of Canada consultations with respect to the Regulatory Cooperation Council. Health Canada with respect to user fees for therapeutic product regulatory programs. Health Canada with respect to the process for the approval and renewal of foreign sites for Drug Establishment License (DEL) holders. Related guidance documents include the Guidance on Evidence to Demonstrate Drug GMP Compliance of Foreign Sites (GUI-0080), the Guidance on Drug Establishment Licences and Drug Establishment Licensing Fees (GUI-0002) and the Guidance on Good Manufacturing Practices for Active Pharmaceutical Ingredients (GUI-0104). Health Canada with respect to its Regulatory Systems Review for Therapeutic Products. Health Canada regarding the development of a national pharmacare strategy. Discussions with ISED towards a national strategy for the biomanufacturing and the life sciences sector.