Guillaume Couillard

Enhancements related to intellectual property legislation, regulations and policies applicable to rare disease medicines. Issues related to U.S. pharmaceutical importation, trade and policies, including research and development, regulatory authorizations, funding of medicines, supply sources and supply chains. Regulatory amendments and/or guidelines related to the Food and Drugs Act Regulations and Health Canada to implement an orphan drug regulatory framework. Innovation, Science and Economic Development Canada regarding the Innovation and Skills Agenda and other government policies and programs related to incentivizing research and development activities in Canada, including the Biomanufacturing and Life Sciences Strategy. Regulations, guidelines, policies and programs related to regulatory and reporting functions of the Patented Medicine Prices Review Board. Enhancement to Canada's regulatory and funding environment for new rare disease medicines, including Health Canada authorizations of medicines and framework for clinical trials, health technology assessment processes, reimbursement negotiations and funding decisions. Federally-funded public drug plans, with respect to reimbursement for medicines for federal plan beneficiaries. Implementation of the Pharmacare Act and its implications for rare disease medicines. Implementation of the National Strategy for Drugs for Rare Disease, and other policies or programs related to rare diseases.

National pharmacare, with a particular focus on access to medicines and rare disease and orphan drug policies Federal programs and budgetary initiatives related to the Federal-Provincial-Territorial funding arrangements regarding pharmaceuticals including any health technology assessment-related or other policy discussions that might involve Health Canada and its ongoing relationship with Canada's Drug Agency and/or other pan-Canadian health organizations. Regulatory amendments and/or guidelines and/or policies related to the Food and Drugs Act and Health Canada's review of medicines (particularly rare disease treatments). Innovation, Science and Economic Development Canada regarding the Innovation and Skills Agenda, the Biomanufacturing and Life Sciences Strategy and other government policies and programs related to incenting research and development activities in Canada. Guidelines, policies and programs related to regulatory and reporting functions of the Patented Medicine Prices Review Board Engagement with officials on issues related to the National Strategy for Rare Disease Drugs, and other policies or programs related to rare diseases. Federally-funded public drug plans, with respect to reimbursement for drug products for federal plan beneficiaries.

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.

Pharmaceutical research & development -support for R&D in Canada. Domestic pharmaceutical manufacturing: trade, tariffs, and sustainability of domestic manufacturing. Pharmaceutical policy: Ongoing interactions related to increased and sustainable utilization of cost-saving generic and biosimilar medicines, and a predictable and viable business environment for generic medicines.

Advocate for supportive economic and tax policy for Canada's pharmaceutical manufacturing sector. Work with government to promote and support Canada’s pharmaceutical manufacturing sector and advocating for supportive public policy Raise awareness of role of Canadian drug producers in exports to the U.S. and other parts of the world. Advocate for including Canada's drug exports as part of CUSMA negotiations Advocate for regulatory policy to support review of generic drug submissions from Canadian drug producers

Offer recommendations on the Patented Medicines Pricing Review Board excessive pricing policy guidelines and implementation approaches to support drug supply stability and system sustainability Discuss policy measures to protect Canada's drug supply, distribution, and pharmacy systems against the impact of US tariffs Medical cannabis policy impacts on pharmacy and the wholesale industry Health Canada, with respect to the role of wholesalers in the management of drug shortages Health Canada, with respect to the regulation and funding of wholesale distribution of pharmaceuticals and regulation of pharmacy activities Health Canada, with respect to pandemic planning, particularly federal/provincial/territorial storage and distribution of pharmaceuticals Development of screening programs in First Nations communities Approaches towards National Pharmacare policy Approaches to mitigating the impact of COVID-19 on the pharmaceutical distribution, pharmacy, primary care, and other healthcare sectors

Policies aimed at reinforcing pharmaceutical supply chain. Discussion regarding the launch of new branded product in the rare disease space Improvements to the supports offered by the federal government to support R&D; in particular, generic drug research and development. Seeking support from the Strategic Innovation Fund Program for support of biomanufacturing expansion project. Policies aimed at facilitating generic drug repurposing. Discussion on the opioid crisis and the Health minister's expectations from pharmaceutical manufacturers Discussion of regulatory impediments to the launch of pediatric formulations of branded and generic products. Discussion of a possible Therapeutics Products Directorate ("TPD") workstream on complex generics regulatory pathways.

Seeking amendments to the Patented Medicines Regulations with the objective to introduce mechanisms to protect non-patentees, including pharmacy wholesalers and pharmacies, from unduly incurring financial losses as a result of changes to price guidelines.