Linsey Hollett

Communications regarding opportunities to speed patient access to live-saving medicines on publicly-funded drug formularies in Canada by reducing red tape. Innovation, Science and Economic Development (ISED)'s Health Emergency Readiness program, insofar as it pertains to growth and development of the life sciences industry in Canada. Communication regarding free trade agreements as they relate to the biopharmaceutical industry. The pan Canadian Pharmaceutical Alliance (pCPA) with respect to public formulary listing of new medicines, insofar as the federal government is a participating jurisdiction and holds a seat on the Board of Directors. Public Health Agency of Canada, regarding the federal response to the hepatitis C virus. Patented Medicine Prices Review Board (PMPRB) Guidelines with regard to prices charged by Rights Holders for patented medicines sold in Canada. Federal Government Non Insured Health Benefits program with respect to reimbursement of a prescription medicine and changes in type of reimbursement Engagement with Health Canada’s Regulatory Operations & Enforcement branch regarding supply chain resilience & integrity; mitigating and alleviating drug shortages. Communications with Heath Canada regarding modernization of the medical devices regulatory framework. Communications with Health Canada regarding the evolution of the regulatory framework to address advanced therapeutic products. Communications with Health Canada regarding the application of its nitrosamine guidelines. Communications with Health Canada regarding modernization of clinical trials regulations, including diversity and inclusivity of clinical trials. Communications with Health Canada regarding guidelines for pediatric action plans. Communications regarding the value assessment of new medicines by Canada's Drug Agency (CDA) and the design of proposed new work streams, insofar as the federal government is a funder and holds a seat on the Board of Directors. Communications regarding the design and implementation of the federal Drugs for Rare Diseases strategy. Communications regarding national pharmacare legislation, regulations, policies or programs. Communications regarding intellectual property protection of prescription drugs, including the Patent Act, the Patented Medicines Regulations, the Patented Medicine Notice of Compliance (PMNOC) Regulations, the Patent Term Adjustment regime and Health Canada’s Data Protection regime. Communications regarding Health Canada's Regulatory Innovation Agenda regarding proposed regulatory amendments and guidelines to enable agile licensing of drugs and medical devices. Communications regarding access to and approval of medicines addressing the growing public health threat of antimicrobial resistance.

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 Food and Drug regulations as it relates to data protection and the regulation and protection of biopharmaceutical products Canada's Drug Agency (CDA) policies as it relates to health economics assessment and recommendations made on new medicines. 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. Free Trade agreements as they relate to the biopharmaceutical industry Policy and Programs Health Canada and Public Health Agency of Canada policies and programs to prevent and treat HIV and eliminate hepatitis as a public health threat by 2030, as part of Canada's commitments under the Global Viral Hepatitis Strategy and therapeutic efforts against the fight for COVID-19. Patent Act Regulations as they relate to the regulation of intellectual property for therapeutic products, specifically the Patented Medicines (Notice of Compliance) Regulations Patented Medicine Prices Review Board (PMPRB) Regulations with regard to reporting requirements, pricing, guidelines and dispute resolution. Innovation Agenda, particularly with respect to initiatives to support and attract investments in the life sciences sector Federal Government First Nations and Inuit Health Branch program with respect to health services. Federally-funded Public Drug Plans, with respect to reimbursement for drug products for federal plan beneficiaries.

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

Pharmaceutical pricing policy issues arising from the jurisdiction of the Patented Medicines Prices Review Board (PMPRB). Free trade agreements as they relate to the biopharmaceutical industry. 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. 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. Advocacy related to the new Buy Canada policy and the implications of including goods and services related to healthcare delivery, medical treatment, in particular drugs, vaccines and biologicals. Advocacy as it relates to the Government of Canada potential responses to the US Administration Most Favored Nation drug pricing policy Monitoring and engaging on the Government’s national strategy for rare diseases; the Canadian Drug Agency; and the implementation of C64, An Act to Implement pharmacare. Patented Medicine Prices Review Board (PMPRB) amendments to the Patented Medicines Regulations and the related new guidelines. Advocacy on the 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. Advocacy related to the federal government consultation on the review of the Canada US Mexico Trade Agreement Advocacy on the role of the Health Emergency Readiness Canada (HERC) Agency Advocacy with respect to Canada's proposed Countermeasures in Response to United States Tariffs on Canadian goods 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. Monitoring and engaging the Government and Parliamentarians on policies and programs related to Canada's life sciences & biomanufacturing strategy 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.

Bill C-64 (Pharmacare Act - 2024) Patented Medicine Prices Review Board (PMPRB) Reform Most Favored Nation National Pharmacare Drugs for Rare Diseases

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 importation legislation in the United States. Pharmaceutical intellectual property protection as it relates to international trade agreements Patent Act as it relates to reporting requirements and pricing guidelines, and the protection of intellectual property in biopharmaceutical products. Monitoring and engaging the Government and Parliamentarians on policies and programs related to Canada's biomanufacturing and life sciences sector strategy Food and Drugs Act updates, as it relate to the reform of clinical trial applications, and drug/device submission review and approval process. Scope includes new drug submissions/indications and post market submissions, reliance & recognition pathways, service standards, fees, biosimilars, clinical trial modernization. Federal Public Drug Plans, with respect to the reimbursement of therapeutic products for Federal plan beneficiaries Standing Committee on Finance (FINA) as it relates to pre-budget consultations. 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, and as it relates to Canada’s Biomanufacturing and Life Sciences Strategy. Canadian Environmental Protection Act and Regulations in respect of modern, science-based regulations to reflect rapidly changing new technologies. Income Tax Act as it relates to biopharmaceutical industry. Annual federal Budgets and Budget updates as it relates to the biopharmaceutical industry, and related updates and to Federal budgetary policy. House of Commons Standing Committee of Industry and Technology (INDU) as it relates to Artificial Intelligence and/or any other pertinent legislative proposal before the committee Patented Medicines Prices Review Board (PMPRB), as it relates to reporting requirements, pricing guidelines, and dispute resolution Economic Growth Initiatives as it relates to pharmaceutical, clinical trials investment, life sciences industry Clinical Trials environment in Canada: operational issues, investment, enrollment

Public health and prevention programs including the Public Health Agency of Canada and efforts to support the development and procurement of innovative vaccines and therapies to address major public health issues such as pandemic preparedness and RSV Federally-funded public drug plans, including the Non-Insured Health Benefits program, Canadian Armed Forces Drug Benefit List and veteran programs, with respect to reimbursement for drug products for beneficiaries Canada's Drug Agency policies and processes as it relates to reimbursement recommendation decision-making process and framework Engage with Canadian government officials to discuss and provide input on Canada’s countermeasures and policies in response to foreign tariffs affecting the pharmaceutical industry, as well as free trade agreements as they relate to the biopharmaceutical industry Establish accountability with Health Canada, Canada’s Drug Agency and the pan-Canadian Pharmaceutical Alliance, as well as Regulations, policies and programs related to the review and reimbursement processes 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 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 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 Biomanufacturing and Life Sciences Strategy (BLSS) as it relates to the biopharmaceutical industry Pharmaceutical pricing policy issues arising from the jurisdiction of the Patented Medicines Prices Review Board (PMPRB) Engagement with the Government regarding the Strategic Response Fund (SRF) (previously known as SIF) and investment in Canada Annual federal Budgets and Budget updates relating to the biopharmaceutical industry. Scientific Research and Experimental Development (SR&ED) Tax Incentive Program regarding eligible expenditures. Discussions on policies such as "patent box" and Investment Tax Credits.

International trade regarding tobacco control, alcohol, products containing carcinogens and products associated with cancer. Internal trade regarding tobacco control, alcohol, products containing carcinogens and products associated with cancer. Funding for programs to be operated by the Canadian Cancer Society to advance cancer control. Canadian Partnership Against Cancer, as it relates to continued federal funding for the cancer control strategy Canada Health Transfer and health system bilateral funding agreements intended for provinces/territories to support the delivery of healthcare services Framework Convention on Tobacco Control, including protocols, guidelines and implementation Tobacco and Vaping Products Act, as it relates to regulations, implementation and enforcement Non-Smokers' Health Act including implementation and enforcement Food and Drugs Act and regulations, as it relates to nciotine replacement products Federal Tobacco Control Strategy, including all matters related to tobacco control Taxation, revenue measures, controlled products regulations, including implementation, for alcohol, tobacco control, products containing carcinogens and products associated with cancer. Communication regarding alcohol consumption guidance. Food and Drugs Act and regulations, as it relates to alcohol warning labels Food and Drugs Act and regulations, as it relates to restricting the advertising to children of foods high in sodium, sugars and saturated fat. Healthy Living - Supporting initiatives, legislation, regulation, policies, and programs that prevent cancer or improve the social determinants of health Adoption of HPV testing and increasing HPV vaccination rates Sustainable funding of the National Advisory Committee on Preventive Health Services to ensure timely, up?to?date cancer screening guidelines Equitable and timely access to cancer screening. Measures and funding related to the charitable sector generally Equitable access to care along the full cancer continuum for First Nations, Inuit and Métis communities Employment Insurance special benefit programs, including the sickness benefit and compassionate care benefit Canada Labour Code and Employment Insurance Act, as it relates to job-protected leave, employment insurance special benefits, return to work policies, and human rights protections for people affected by cancer Access to information and support to make decisions regarding end-of-life care, including Medical Assistance In Dying Supports for mental health during people's cancer journeys Implementation and funding of the National Grief Action Plan as part of the government's work on palliative care and mental health Canada Health Act as it relates to access to care, including long-term, home, and palliative care National Caregiving Strategy Financial supports for caregivers, including the Canada Caregiver Credit Implementation of the Framework on Palliative Care in Canada and integration of a palliative approach to care in our health system, including national standards and data, care provider training, research, and implementation of the National Grief Action Plan and distinctions?based frameworks for First Nations, Inuit and Métis people Setting and measuring pan-Canadian wait time benchmarks and targets and measures to address them, including addressing healthcare shortages, increased and sustainable funding for care, infrastructure and equipment, targeted strategic funding to PTs for workforce shortages, particularly in rural and remote communities. Sustained core funding for federal research agencies, improved coverage of indirect research costs, Canadian research sovereignty, strengthening capacity and the economic benefits of domestic research, research commercialization. Increasing access to care including models of care, removing barriers to care, particularly for underserved communities, using innovative approaches to improve access to care including AI to improve timely diagnosis and treatment. Issu

Cost Recovery Programs with respect to the Pest Management Regulatory Agency for registered pest control products, the Health Products & Food Branch for hard surface disinfectants, sanitizers and food contact sanitizers and CEPA's New Substances Regulations. Food and Drug Regulations with respect to the pre-market authority for the sale of disinfectant products, sanitizers, food contact sanitizers and post-market reporting. Canadian Environmental Protection Act (CEPA) with respect to amendments (S5). Competition Act with respect to Environmental Claims Guidance, Made in Canada/Product of Canada Guidance. Canadian Environment Protection Act and its regulations for Volatile Organic Compounds in certain products and HFCs. Pest Control Products Act and regulations of domestic and institutional pest control products. Hazardous Products Act and Regulations regarding interpretation and technical amendments/guidance to the Workplace Hazardous Materials Information System. Chemicals Management Plan regarding the review of existing, and new substances, which may be used in consumer and commercial products. Cabinet Directive on Regulation regarding the expectations and requirements in the development, management and review of federal regulations. Controlled Drugs & Substances Regulation with regard to precursors Canada Consumer Product Safety Act, in respect of regulations for labelling, incident reporting and compliance of consumer products.

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.