James Fitz-Morris

Advocacy on the creation of the Health Emergency Readiness Canada (HERC) Agency Contribution to the Government Public consultations on Canada-United States-Mexico Agreement to inform Canada’s priorities in preparation for the first joint review of CUSMA by Canada, the United States and Mexico in 2026 and ahead of Canada’s chairing of the 5th meeting of the CUSMA Free Trade Commission, in 2025. Advocacy on the proposed Regulations Amending the Patent Rules and Certain Regulations Made Under the Patent Act which were published for consultation in Canada Gazette Part I (CGI) on May 18, 2024.1 Share concerns with Canada’s implementation of a patent term adjustment (PTA) system that is not compliant with its trade obligations, as it does not provide a meaningful remedy to patentees who are impacted by unreasonable patent office delays. The Department of Innovation, Science and Economic Development and the Innovation Agenda for the life sciences sector: policy or program initiatives to support life science research and development conducted in Canada and manufacturing capability. Regulations, policies and programs related to the reimbursement recommendations decision-making process and framework done by the Canadian Drug Agency as well as the review times and processes conducted by Health Canada for the purpose of obtaining a notice of compliance. Patented Medicine Prices Review Board (PMPRB) amendments to the Patented Medicines Regulations and the related proposed guidelines. Monitoring and engaging the Government and Parliamentarians on the House of Commons Standing Committee on Public Accounts (PACP) motion related to the discloser on vaccine contracts Monitoring and engaging the Government and Parliamentarians on policies and programs related to Canada's life sciences & biomanufacturing strategy Monitoring and engaging on the Government’s commitment to create a national strategy for rare diseases; the Canadian Drug Agency; and C64, An Act to Implement pharmacare. Health Canada’s policies, program and guidelines related to the management, prevention, mitigation and notification of drug shortages Federal Public Drug Plans, with respect to the reimbursement of therapeutic products for Federal plan beneficiaries Engage the Federal Government on Health Canada’s Regulatory Innovation Agenda (Agile Licensing Modernization) to discuss opportunities for further harmonization; flexibility and predictability in the new regulatory framework being develop and its linkage to pillar 5 of the Biomanufacturing and Life Sciences Strategy. Discussions on the procurement of a COVID19 vaccine and therapy Discussions around the World Trade Organization consideration of a TRIPS Patent Waiver and the World Health Organization pandemic treaty proposal Consider amendments to the Food and Drugs Act, or the Export and Imports Permits Act (Export Control List) or any other legislative and regulatory means in order to protect the Canadian supply of drugs in light of potential importation legislation in the United States. Advocacy to maintain and increase funding for the National Immunization Strategy and discussions on vaccine procurement.

The Official Development Assistance Accountability Act and its cross-partisan support. Canadian International Development Program: we want the Government to maintain a strong commitment towards poverty reduction in developing countries, through a good and clear policy framework and through funds and programs that allow Canadian Civil Society Organizations to participate actively in international development, with their local partners. (including humanitarian assistance) A project to enhance contributions of Canadian civil society organizations (CSOs) to the effectiveness of Canada’s international cooperation efforts.

Changes to the Competition Act and their implementation. Trade and/or shipment of crude oil, petroleum products, and natural gas between/within Canada and/or the United States. Development of regulations under the Canadian Environmental Protection Act, 1999 (CEPA): Volatile Organic Compounds (VOC) Clean Electricity Oil and Gas Emissions Methane Base-level Industrial Emission Requirements Development of air pollutant, greenhouse gas and other energy transition policies and programs. Clean Fuel Regulations (SOR/2022-140) and their implementation, in particular plans related to the implementation of these regulations in Canada's Atlantic Provinces