Stefania Trombetti

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 protection of and access to intellectual property World Health Organization (WHO) issues concerning pharmaceuticals as it relates to Counterfeits, Access to Medicines, and the Intergovernmental Working Group (IGWG) The government's Science and Technology strategy as it relates to the biopharmaceutical industry Subsequent Entry Biologics (SEBs) as it relates to Regulations, Policies, or Guidelines being developed by Health Canada, specifically the Draft Guidance Document on SEBs, the Notices of Changes to Health Canada's Guidance Documents on Data Protection and Patented Medicines Regulations (Notice of Compliance) Regulations Smart Regulations as it relates to 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 Proposed pharmacare legislation related to any future national pharmacare program Pharmaceutical pricing policy issues arising from the jurisdiction of the Patended 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 New Substances Notification Regulations as it relates to the biopharmaceutical industry Income Tax Act as it relates to biopharmaceutical products Health Canada’s Interim Orders relating to COVID-19: The Interim Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19; The Interim Order Respecting Clinical Trials for Medical Devices and Drugs Relating to COVID-19; The Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19; The Interim Order Respecting the Prevention and Alleviation of Shortages of Drugs in Relation to Covid-19 Health Canada's Regulatory Roadmap for Health Products and Food as it relates to the biopharmaceutical industry Free trade treaty agreement as they relate to the North American Free Trade Agreement (NAFTA) and free trade negotiations as it relates to India, the European Union, Japan, MERCOSUR and the Trans-Pacific Partnership 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 Establish accountability with the federally financed Canadian Agency for Drugs and Technologies in Health (CADTH) Common Drug Review Policies as it relates to reimbursement recommendation decision-making process and framework Canadian Institutes of Health Research (CIHR) Clinical Research Initiative as it relates to public/private research and development partnerships Canadian Environmental Protection Act and Regulations in respect of modern, science-based regulations to reflect rapidly changing new technologies Canada-United States Regulatory Cooperation Council (RCC) initiatives related to the regulation of biopharmaceutical products Canada's Food and Consumer Safety Action Plan as it relates to the regulation and protection of biopharmaceutical products Canada's Access to Medicines Regime with respect to ensuring that the program allows for the deli

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 protection of and access to intellectual property World Health Organization (WHO) issues concerning pharmaceuticals as it relates to Counterfeits, Access to Medicines, and the Intergovernmental Working Group (IGWG) The government's Science and Technology strategy as it relates to the biopharmaceutical industry Subsequent Entry Biologics (SEBs) as it relates to Regulations, Policies, or Guidelines being developed by Health Canada, specifically the Draft Guidance Document on SEBs, the Notices of Changes to Health Canada's Guidance Documents on Data Protection and Patented Medicines Regulations (Notice of Compliance) Regulations Smart Regulations as it relates to 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 Patended 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 New Substances Notification Regulations as it relates to the biopharmaceutical industry Income Tax Act as it relates to biopharmaceutical products Health Canada’s Interim Orders relating to COVID-19: The Interim Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19; The Interim Order Respecting Clinical Trials for Medical Devices and Drugs Relating to COVID-19; The Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19; The Interim Order Respecting the Prevention and Alleviation of Shortages of Drugs in Relation to Covid-19 Health Canada's Regulatory Roadmap for Health Products and Food as it relates to the biopharmaceutical industry Free trade treaty agreement as they relate to the North American Free Trade Agreement (NAFTA) and free trade negotiations as it relates to India, the European Union, Japan, MERCOSUR and the Trans-Pacific Partnership 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 Establish accountability with the federally financed Canadian Agency for Drugs and Technologies in Health (CADTH) Common Drug Review Policies as it relates to reimbursement recommendation decision-making process and framework Canadian Institutes of Health Research (CIHR) Clinical Research Initiative as it relates to public/private research and development partnerships Canadian Environmental Protection Act and Regulations in respect of modern, science-based regulations to reflect rapidly changing new technologies Canada-United States Regulatory Cooperation Council (RCC) initiatives related to the regulation of biopharmaceutical products Canada's Food and Consumer Safety Action Plan as it relates to the regulation and protection of biopharmaceutical products Canada's Access to Medicines Regime with respect to ensuring that the program allows for the delivery of timely access to needed medicines to the developing world supported by a b

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.

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.

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.

Create and fund a Vision Health Desk and Chief Vision Officer at Health Canada or the Public Health Agency of Canada. Develop and implement a National Strategy for Vision Health

C-64, An act respecting pharmacare - discussions around the structuring and implementation of a national pharmacare program. The government's economic, health, investment, science and technology, and trade policies as they relate to the pharmaceutical industry Pharmaceutical pricing policy arising from the jurisdiction of the Patented Medicines Prices Review Board (PMPRB) Pharmaceutical and trade policy as it relates to security of supply for Canadian medicines. Patented Medicines Pricing Review Board (PMPRB) – regulations that can impact the Canadian pharmaceutical industry. Patented Medicine Notice of Compliance (PMNOC) Regulations - enforcement of Intellectual Property with respect to the Canadian pharmaceutical industry. Patent Act - An Act respecting patents of invention with regard to Intellectual Property Protection for pharmaceutical products - federal court decisions that have changed the disclosure requirements regarding the utility of an invention. Intellectual Property - Changes to Patented Medicine (Notice of Compliance) (PMNOC) regulations - important regulations that can affect Eli Lilly Canada's business Free trade treaty agreement as it relates to the North American Free Trade Agreement (NAFTA) and free trade negotiations as it relates to Columbia, India, and the European Union Food and Drug Act - An Act respecting food, drugs, cosmetics and therapeutic devices. Discussions relating to progressive licensing and the modernization of the Food and Drug Act.

Communicating with government officials about recycling and circular economy initiatives, including as it relates to Extended Producer Responsibility ("EPR") obligations for manufacturers. Measures to facilitate internal trade in Canada, including through Bill C-5, the One Canadian Economy Act. Legislation and regulation with respect to the creation of a plastics registry, plastic labelling or recycled content for plastic products. Communications with regard to retail theft of consumer health products and e-marketplaces and concerns around product safety and product integrity resulting from e-theft. Communications with regard to retail theft of consumer health products and e-marketplaces and concerns around product safety and product integrity resulting from e-theft. Bill C-224 - An Act to amend the Food and Drugs Act (natural health products): To keep NHPs under the purview of the Food and Drugs Act (i.e. Vanessa’s Law), which gives the minister the authority to use a ministerial order for a number of reasons (product recall, delay cost-recovery NHPs, delay labelling for NHPs to a later date). Working with the government to recognize the public health benefits of a National Self-Care Strategy and urging its timely implementation. User fees for services, use of facilities, regulatory processes and approvals, product rights and privileges that are related to drugs and medical devices regulated under the Food and Drugs Act. Tax policy changes to allow certain therapeutic categories of consumer health products to be eligible under the Medical Expenses Tax Credit. Seeking harmonization of regulatory regimes and administrative processes nationally and internationally. Regulations Amending the Food and Drugs Regulations - Nutritional Labelling, Other Labelling Provisions and Food Colours – continue to engage with government to ensure clarity on compliance and enforcement of regulations. Providing input to government to restore balance and fair competition to grocery retail practices. Providing input to government on rules-based trade and e-commerce: working to ensure that international trade allows for the predictable flow of ingredients, products and people; addressing the rise of non-compliant and illicit products from entering the Canadian market; and advocating against protectionism (including new tariffs). Providing input to government on regulatory modernization initiatives, including encouraging the enforcement of an economic lens to the design and implementation of all regulations. Providing input to government on emerging COVID-19 issues and its impact on industry, and helping shape the government’s response and recovery efforts. Providing input into Health Canada's Self-Care Products Framework with respect to over-the-counter drugs (OTC), natural health products (NHPs), and cosmetics. Advocating for a framework that is based on science-based claims and regulated according to risk. Pre-Market approvals for food additives, novel foods, infant formula, health claims and functional foods in regard to consulting with Health Canada on improving the process to deal with the backlog and new applications. Plastic Charter – to monitor the development of the federal government national strategy on plastic and potential impact our industry. Participation and input into Canada's sodium reduction strategy concerning targets for certain food categories/sectors and technical aspects of the target - as well as consumer awareness, education and acceptance issues. Nutrition information with regard to how FCPC is committed to enabling consumers to make informed food choices based on Canada's Food Guide and the Nutrition Facts Table. National Food Policy – Working in consultation with Agriculture and Agri-Food Canada as the National Food Policy, designed to address issues related to production, processing, distribution and consumption of food, is developed and implemented. Modernization of food regulations and legislation - advocate to ensure

Advocate for policies which will enable upstream helium exploration and development in Canada, including for the fair and equal tax treatment provided mineral resource developers in Canada.

Understanding and informing health sector procurement with respect to radiopharmaceuticals. Engage government regarding the potential impact to patients that may be caused by disruptions to the radiopharmaceutical supply chain.

Communicating with government officials about potential collaboration, including potential funding agreements, between the company and the government related to the production of domestic medications. The goal of these communications is to alleviate medical shortages in Canada.