Anie Perrault

Canada's Drug Agency policies as it relates to reimbursement recommendation decision-making process and framework Biomanufacturing and Life Sciences Strategy (BLSS) as it relates to the biopharmaceutical industry. Federal policies that relate to possible models of pharmacare Federal Buy Canadian Procurement Policy as it relates to government drug procurement practices and the implications for the biopharmaceutical industry Policies and frameworks to accelerate access to innovative medicines post-Health Canada approval, including efforts to reduce time-to-reimbursement and streamline federal/provincial listing processes Policy measures to ensure security of drug supply in Canada and preserve Canada's attractiveness for biopharmaceutical launches, including in response to foreign pricing regulations National Strategy for Drugs for Rare Diseases World Trade Organization (WTO) issues concerning the agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs) with respect to the protection of data, Access to Medicines, and TRIPs "flexibility" World Intellectual Property Organization (WIPO) issues concerning the biopharmaceutical industry World Health Organization (WHO) issues concerning the biopharmaceutical industry Scientific Research and Educational Design (SR&ED) Tax Credit in respect of updating the system and increasing the expenditure limit for refundable credits Pharmaceutical pricing policy issues arising from the jurisdiction of the Patented Medicines Prices Review Board (PMPRB) Patented Medicines Regulations as it relates to the regulation and protection of biopharmaceutical products Patented Medicines (Notice of Compliance) Regulations with respect to ensuring that patent rights are respected and are internationally competitive Patented Medicines (Notice of Compliance) Regulations as it relates to the regulation of intellectual property for biopharmaceutical products Patent Act as it relates to reporting requirements and pricing guidelines, and the protection of intellectual property in biopharmaceutical products Income Tax Act as it relates to biopharmaceutical products Health Canada's Regulatory Roadmap for Health Products and Food as it relates to the biopharmaceutical industry Free trade agreements as they relate to the biopharmaceutical industry Food and Drugs Act and Regulations and the Import and Export Permits Act with respect to cross-border trade as it relates to the export of Canadian biopharmaceuticals Food and Drug Regulations as it relates to data protection and the regulation and protection of biopharmaceutical products Canadian Institutes of Health Research (CIHR) Clinical Research Initiative as it relates to public/private research and development partnerships Annual federal Budgets and Budget updates as it relates to the biopharmaceutical industry

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

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.

Monitoring and engagement on federal roles in health system planning and preparedness as they relate to blood?related products and plasma?derived medicines used in federally funded programmes and public health responses. Engagement on federal policies and programmes related to the availability, appropriate use, and continuity of supply of plasma?derived therapies, including immunoglobulins, for patients with immune?mediated and rare conditions. Health Canada regulatory modernisation initiatives, including regulatory innovation, flexibility, predictability, and alignment with international approaches. Innovation, Science and Economic Development Canada initiatives and programmes supporting life sciences research, development, and advanced therapies conducted in Canada. Federally funded public drug plans, including programmes for Indigenous Peoples, veterans, and federal plan beneficiaries, with respect to reimbursement of therapeutic products. Engagement on international trade discussions and policies that may impact access to medicines and the security of drug supply in Canada. Monitoring and engagement on legislation, regulations, and policies related to national pharmacare, including implementation of relevant federal Acts. Monitoring and engagement on the Government of Canada’s National Strategy for Rare Diseases, including related policy frameworks and implementation considerations. Health Canada policies and guidance related to the prevention, monitoring, and management of drug shortages. Regulatory frameworks related to the Patented Medicines (Notice of Compliance) Regulations as they apply to the protection of intellectual property for innovative medicines. Pharmaceutical pricing policy considerations within the mandate of the Patented Medicine Prices Review Board (PMPRB), including regulatory amendments and associated guidance. Engagement on federal policies and frameworks that support improved coordination across jurisdictions to facilitate timely patient access following Health Canada approval. Canada’s Drug Agency policy frameworks and processes related to reimbursement recommendations, including decision?making approaches and timelines. Policies and programmes related to Canada’s Biomanufacturing and Life Sciences Strategy, including support for research, innovation, and manufacturing capability in Canada. Engagement on federal budget priorities and updates affecting the biopharmaceutical sector, including implications for patient access to innovative medicines, vaccines, and therapies.