Ritu Banerjee

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(SEBs) as it relates to Regulations, Policies, or Guidelines being developed by Health Canada, specifically the Draft Guidance Document on SEBs, the Notices of Changes to Health Canada's Guidance Documents on Data Protection and Patented Medicines Regulations (Notice of Compliance)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

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

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

Communications regarding funding from various Government funding programs, opportunities to improve government activity (funding, tax incentives, clinical trials infrastructure, etc) to encourage the innovation economy in Canada with a specific focus on biotech, and programs around procurement opportunities for the Government of Canada relating to biotechnology products.

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

Regulations, policies and programs related to the reimbursement recommendations decision-making process and framework done by the Canadian Agency for Drugs and Technologies in Health (CADTH)/Common Drug Review as well as the review times and processes conducted by Health Canada for the purpose of obtaining a notice of compliance. National Strategy for Drugs for Rare Disease as it relates to separate regulatory pathways for drugs for rare diseases and the government strategy. Monitoring and engaging the Government and Parliamentarians on policies and programs that would provide greater clarity and predictability in the tax outcomes and improvements to tax measures such as the Manufacturing & Processing (M&P) credit and the Scientific Research & Developmental (SR&ED). Common Drug Review Policies as it relates to reimbursement recommendation decision-making process and framework. Federal Public Drug Plans, with respect to the reimbursement of therapeutic products for Federal plan beneficiaries Policies related to the National Strategy for Drugs for Rare Disease as it relates to separate regulatory pathway for drugs for rare diseases and the government strategy. Policies related to Subsequent Entry Biologics (SEBs) pertaining to Draft Guidance for Sponsors; Information and Submission requirements for SEBs, regulations and intellectual property policies, naming conventions Monitoring and engaging on the Government’s commitment (Budget, SFT, Fall Economic Update) to create a national strategy for drugs for rare diseases; create a new Canadian Drug Agency; and the implementation of national, universal pharmacare. Pharmaceutical policy and any negotiations of a Health Accord or agreement with the Provinces/Territories, as it relates to National Pharmacare/universal or catastrophic drug coverage, Drug policies & Pricing. 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. Monitoring and engaging the Government and Parliamentarians on policies and programs related to Canada's biomanufacturing and life sciences sector strategy National Pharmacare (Bill C-64, An Act respecting pharmacare) Canadian Environmental Protection Act and Regulations in respect of modern, science-based regulations to reflect rapidly changing new technologies. 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 industry. Annual federal Budgets and Budget updates as it relates to the biopharmaceutical industry, and related updates and to Federal budgetary policy. Discussions around the World Trade Organization consideration of a TRIPS Patent Waiver - Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs) with respect to the protection of data, Access to Medicines, and TRIPs "flexibility". 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. Standing Committee on Finance (FINA) as it relates to pre-budget consultations. Pharmaceutical intellectual property protection as it relates to international trade agreements Patent Act and Patented Medicines (Notice of Compliance) Regulations, as it relates to the regulation of intellectual property, approval for therapeutic products, changes to modernize the Right of Appeal House of Commons Standing Committee of Science and Research (SRSR) as it relates to Science in Canada and/or any other pertinent legislative proposal before the committee House of Commons Standing Committee of Industry and Technology (INDU) as it

Through Innovation, Science & Industry discuss opportunities to enhance the Canadian life sciences sector including, biomanufacturing, partnerships, R&D investments. The Canada-European Union Comprehensive Economic and Trade Agreement (CETA) negotiations with respect to biopharmaceuticals and intellectual property right protection. Scientific Research and Experimental Development (SR&ED) Tax Incentive Program with regard to expansion of eligible expenditures to recognize the impact on innovation and the research and development (R&D) investment by the pharmaceutical industry in Canada. Science and Technology (S&T) Strategy with regard to ensuring that the implementation of that strategy encourages a public policy environment that attracts business investment in innovation and enhances the ability of Canadian industry to compete internationally. Representation with Ministry of Health and Public Service Procurement Canada to achieve emergency approval, procurement and utilization of the AZD1222 vaccine (Covishield) and long-acting antibody (LAAB) combination AZD7442 to fight the Covid-19 pandemic. Public policy issues related to Health Canada's review of NCE Patented Medicines Price Review Board (PMPRB) with regard to ensuring that PMPRB Guidelines, Policies and Procedures reflect PMPRB mandate to ensure that prices charged for patented medicines in Canada are not excessive and that potential changes consider impact to the pharmaceutical industry. Patented Medicines (Notice Of Compliance) Regulations with regard to ensuring that Canada's intellectual property (IP) laws and regulations are internationally competitive and continue to provide a stable and predictable business environment to encourage continued pharmaceutical investment in Canada. Patented Medicine Prices Review Board (PMPRB) with regard to ensuring guidelines also provide incentives for innovation through research and development in addition to PMPRB mandate of protection from excessive prices. National Pharmaceutical Strategy (NPS) with regard to ensuring development or implementation of any policies or programs include consultations with all affected stakeholders and focus on bettering access to medicines for Canadians. Cost Recovery Initiative, ensuring a framework where user fees adequately fund a safe and efficient review process. Canada's Food and Consumer Safety Action Plan with regard to ensuring that patient safety is a priority in a modern, efficient and internationally harmonized regulatory system that must be evidence-based, efficient and continuous while supporting timely access to innovative medicines and vaccines for Canadians, protecting intellectual property rights and preserving competitive research advantage. Canada's Access to Medicines Regime (CAMR) with regard to ensuring that the program allows for the delivery of timely access to needed medicines to the developing world supported by a business climate in Canada that continues to encourage research into further treatment and prevention of disease. Blueprint for Renewal with regard to ensuring a modern, efficient and internationally harmonized regulatory system that must be evidence-based, efficient and continuous while supporting timely access to innovative medicines and vaccines for Canadians, protecting intellectual property rights and preserving competitive research advantage.

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.

Meetings with elected and non-elected officials to obtain federal funding for the development of innovative medical technology solutions to be integrated into the federal health care system.

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. Discussion focused on sharing perspectives on priorities and resourcing. In particular, a shared observation of an increase in submission reviews exceeding established timeframes and increasing challenges with securing pre-filing meetings were discussed Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs) with respect to the protection of data, Access to Medicines, and TRIPs "flexibility". Merck is seeking to ensure Canada's continued compliance with its obligations under TRIPs relevant to the biopharmaceutical industry within all domestic legislation in addition to ongoing and future trade negotiations. Relevant domestic legislation includes the Food and Drugs Act, the Patent Act, and related regulations and guidance documents. Beyond TRIPs, Merck is seeking enhancements to increase the stability and global competitiveness of Canada’s intellectual Property legislation, regulations and policies relevant to the biopharmaceutical industry. Such enhancements may result from domestic policy in addition to bilateral and multilateral trade negotiations (e.g. Comprehensive Economic and Trade Agreement (CETA) and the Trans-Pacific Partnership (TPP). World Health Organization issues concerning pharmaceuticals as it relates to Counterfeits, Access to Medicines, and the Intergovernment Working Group (IGWG). US - Canada Regulatory Cooperation Council (RCC) as it relates to the regulation of biopharmaceutical products. 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. Policies and programs as it relates to vaccine approval, procurement and public awareness of immunization. Plan design and reimbursement policies for drug plans administered by Federal Government including NIHB and Corrections Services. Pharmaceutical pricing policy issues arising from the jurisdiction of the Patended Medicines Prices Review Board (PMPRB) and R&D reporting. 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. Partnership opportunities as it relates to Canada's policy and programs to improve health in the developing world, such as Maternal and Child Health. New Substances Notification Regulations as it relates to the biopharmaceutical industry. National Pharmaceutical Strategy as it relates to the federal government's involvement in federal/provincial access to medicines framework. Income Tax Act as it relates to biopharmaceutical products. Health Canada's Legislative and Regulatory Modernization (LRM) as it relates to the review, approval, transparency and compliance activities of biopharm

World Health Organization issues concerning pharmaceuticals as it relates to Counterfeits, Access to Medicines, and the Intergovernment Working Group (IGWG). US - Canada Regulatory Cooperation Council (RCC) as it relates to the regulation of biopharmaceutical products. 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. Policies and programs as it relates to vaccine approval, procurement and public awareness of immunization. Plan design and reimbursement policies for drug plans administered by Federal Government including NIHB and Corrections Services. Pharmaceutical pricing policy issues arising from the jurisdiction of the Patended Medicines Prices Review Board (PMPRB) and R&D reporting. 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. Partnership opportunities as it relates to Canada's policy and programs to improve health in the developing world, such as Maternal and Child Health. New Substances Notification Regulations as it relates to the biopharmaceutical industry. National Pharmaceutical Strategy as it relates to the federal government's involvement in federal/provincial access to medicines framework. Income Tax Act as it relates to biopharmaceutical products. Health Canada's Legislative and Regulatory Modernization (LRM) as it relates to the review, approval, transparency and compliance activities of biopharmaceutical products. Health Canada's Regulatory Roadmap for Health Products and Food as it relates to proposed policy and regulatory changes related to the review, approval, transparency and compliance activities of biopharmacuetical products. 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. Federal Government involvement in national strategies to address major chronic diseases having a significant burden on the Canadian health care system, such as Dementia, Diabetes, Hepatitis C and Cancer and major public health concerns such as Antimicrobial resistant. 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 Initiatives as it relates to public/private research and development partnerships and to the Drug Safety and Effective Network (DSEN). Canadian Environmental Protection Act and Regulations in respect of modern, science-based regulations to reflect rapidly changing new technologies. 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 business

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.

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. Innovation, Science and Economic Development (ISED)'s Biomanufacturing and Life Sciences Strategy, pertaining to growth and development of the life sciences industry 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 the Canadian 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.

Discuss Canada’s talent attraction strategy as part of the expansion of the nation’s industrial and research capacity. Engagement on government’s Innovation Agenda Biomanufacturing and Life Sciences Strategy as it relates to Health and Bio Sciences sector. Johnson & Johnson (Canada) Inc. supports the development of a strong life science strategy and emerging policies that may impact the life sciences ecosystem in Canada, including the use and development of medical devices, digital health and robotics. Development of Health Emergency Readiness Canada agency, and its role in promoting development of life sciences sector in Canada Zero plastic waste by 2030 – Regarding potential legislative proposal regulating harmful single-use plastic items and implementing implementation of plastic waste management programs and impact on medical technologies. Treasury Board initiative to address international regulatory cooperation as well as their work on the Canada US, and Canada EU Regulatory Cooperation Councils Proposed national pharmacare. Specifically, government’s intention to introduce a national pharmacare program. Modernizations of the Food and Drugs Act, with respect to inspection, reporting and confidential business information. Local manufacturing of healthcare products – Regarding the development of policies and programs (including funding programs) to support the expansion of existing manufacturing facilities or the establishment of additional manufacturing capacity in Canada. Health Canada’s multi-year Regulatory Modernization initiative to modernize the Food and Drugs Act and Regulations, specifically with respect to approval, regulation and life cycle management of therapeutic products, including Agile Regulations. Health Canada and the Patented Medicine Prices Review Board (PMPRB) regulatory implementation and specifically, pharmaceutical pricing policy issues arising from the Patented Medicine Regulations. Food and Drugs Act: Delays in product approvals and changes to existing products. COVID-19: Regarding the development of policies and programs to address the COVID-19 pandemic and support the recovery of the Canadian economy, including as it relates to tackling health equity across marginalized communities in Canada and surgical backlogs. Communication to officials on labelling and product monographs. Chemical Management Plan as related to the regulation of chemical substances, particularly as affecting ingredients used in therapeutic products. Canadian Drug Agency: Specifically, the creation of a new Canadian Drug Agency and transition work to support pharmacare-related initiatives. Canada’s partnerships on global health and global community impact with Johnson & Johnson relating to maternal and child health, First Nations, mental health and other areas. Canada’s engagement in international trade agreements in particular Comprehensive and Economic Trade Agreement (CETA) and North American Free Trade Canada-United States-Mexico Agreement (NAFTACUSMA) and any other agreements as it relates to intellectual property considerations and other aspects which affect the local business environment for J&J companies.

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.

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.

Engagement with the Government regarding the Life Science Fund seeking partnership and funding to support completion of Phase I and Phase II clinical research program associated to AMR (antimicrobial resistance) Antimicrobial Resistance (AMR) - Seek funding and support for pilot projects making anti-infective medications available to equity seeking populations, helping to combat AMR. Also discuss any applicable conditions regarding this funding. Programs and policy to support Canadian biomanufacturing and access to medicines and vaccines for Canadians. National Immunization Strategy and policies and programs that impact public access to vaccines and disease prevention in Canada. Patented Medicines Review Board (PMPRB), certified under the Patent Act and whose guidelines seek to ensure a balance between the prices set by manufacturers for patented medicines sold in Canada and the maintenance of an attractive environment for pharmaceutical research and development. Engagement with federal officials regarding the Biomanufacturing & Life Sciences Strategy and policies and programming related to biomanufacturing in Canada Access to medicines - government policies, processes, legislation, and/or regulation with potential impact on access to medicines in Canada. Trade-related matters, including policies and tariffs impacting medicines and vaccines. Policies and programs related to the health of new immigrants to Canada. Policies, programs, and funding related to Canada's Sexually Transmitted and Blood-Borne Infections (STBBI) Action Plan 2024-2030. Engagement with federal officials regarding Health Emergency Readiness Canada. The National Pharmaceutical Strategy (NPS) as agreed by First Ministers in 2004. Advocacy for ways to increase access to medicines and vaccines for Canadian patients. The Common Drug Review (CDR) process for reviewing new drugs and providing listing recommendations to publicly funded drug benefit plans in Canada. Ensuring the access needs of Canadian patients are met by advocating on activities undertaken in the context of the CDR. Science and Technology (S&T) Strategy: Mobilizing Science and Technology to Canada's Advantage. Advocacy for measures which will allow for commercialization in health care to occur and for Canada to remain competitive internationally on Intellectual Property and other fronts. Public Services and Procurement Canada (PSPC) Integrity Framework - Clarifying the process for procurement of vaccines and possibly pharmaceuticals under the evolving procurement framework. Patented Medicines (Notice of Compliance) Regulations which seek to balance the protection of Intellectual Property (IP) and patents with cost containment. Advocacy to ensure that IP rights are respected and internationally competitive in order to promote Research and Development. Legislation, regulations, policies and programs concerning the federal government's response to COVID-19, including pandemic preparedness, pharmaceutical and vaccine supply-chain management, and general administration of justice. Food and Drugs Act and the bill formerly known as Bill C-51: An Act to amend the Food and Drugs Act and to make consequential amendments to other Acts. Specifically, with respect to the renewal of the drug approval process. Advocacy to ensure that Canada's review and approval process is timely, safe, effective, competitive and consistent with other jurisdictions. FedDev Ontario Advanced Manufacturing Fund - advancing manufacturing of innovative pharmaceutical products in southern Ontario Engage with government to strengthen the Priority Review for Drug Submissions process. Engage the Government regarding the need for clear and efficient procurement processes for COVID-19 medical countermeasures, including COVID-19 therapeutics, to ensure access for Canadians. Engagement with the Government regarding the Strategic Innovation Fund Drug Re-importation - Raise awareness regarding the potential risks to drug and vaccine supply fo