Ed Morgan

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 Policies related to Subsequent Entry Biologics (SEBs) pertaining to Draft Guidance for Sponsors; Information and Submission requirements for SEBs, regulations and intellectual property policies, naming conventions Monitoring and engaging on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.

Vaccine Funding - National Immunization Strategy - maintain federal leadership in providing provinces with funding for new vaccines VACCINE CONTRACTING AND SUPPLY to support the implementation of the federal biomanufacturing strategy, regulation of vaccines for Canadians, address immunization gaps, provide updated and timely information about vaccine development pipeline, support procurement of vaccines SUBMISSION REVIEW PROCESS FOR BIOLOGICS, COST RECOVERY REVIEW to ensure Canada remains competitive overall and any new costs do not put bioloigics are a comparative disadvantage RESEARCH & DEVELOPMENT (R&D) to ensure Canadian capacity in key sectors including biomanufacturing, life sciences, and biotechnology. REGULATORY APPROVAL PROCESS FOR PLANTS WITH NOVEL TRAITS as NOVEL FOODS or INDUSTRIAL BIO_PRODUCTS in respect of an efficient science-based approach and allows for greater cooperation among and between government departments PATENTED MEDECINES PRICES REVIEW BOARD (PMPRB) PRICE REVIEW to ensure new guidelines and directives do not create disincentives for the introduction of new treatments in Canada ORPHAN PRODUCTS to establish formal regulations, policies or programs to encourage the research, development and introduction of new technologies to treat "orphan" or neglected diseases NOVEL FOODS in respect of maintaining a science-based regulatory system for novel foods derived from plant and animal biotechnology INTELLECTUAL PROPERTY/PATENT POLICY AND REGULATIONS in respect of creating Canada as one of the world's most competitive jurisdictions in protecting IP (e.g., match level of European Union via CETA negotiations) IMPROVEMENTS TO THE Scientifc Research & Experimental Development TAX CREDITS FOOD LABELLING in respect of mitigating the unnecessary introduction of new labelling requirements for products already approved under current regulated process and in respect of maintaining harmonization of requirements with trading nations FOOD AND DRUGS ACT AND REGULATIONS in respect of streamlining regulatory burden and ensuring appropriate climate for the introduction of new technologies Establish accountability with the federally established Canadian Drug Agency (formerly Canadian Agency for Drugs and Technologies and Health) (CADTH) and its Common Drug Review process (Health Canada) Creation of a modern policy environment that recognizes international standards and reviews, and establishes clarity on data ownership for intellectual property Clarify the administration of SR&ED program to ensure clinical trials and international research conducted in Canada qualifies as eligible expenses CANADIAN ENVIRONMENTAL PROTECTION ACT AND REGULATIONS in respect of modern, science-based regulations to reflect rapidly changing new technologies BIOSAFETY PROTOCOL in respect of Canada's participation in global discussions to ensure an enabling environment for safe new technologies ADVENTITIOUS PRESCENCE POLICY in respect of new agricultural biotechnology products ACCESS & BENEFIT SHARING: TRIPS AGREEMENT in respect of protecting intellectual property and preventing increased uncertainty

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.

strategic policy objectives for the MedTech sector regarding 2026 CUSMA review. export permits and export controls • Government investments in Artificial Intelligence (AI) compute infrastructure; • Government policy considerations on health data trust and privacy. Substances addressed in the third phase of the Chemicals Management Plan. Support from ISED, with respect to Strategic Innovation Fund Medical device cost recovery schemes with respect to filing fees Engage in pre-market and post-market regulatory requirements to ensure efficient and predictable processes that supports safety, effectiveness, quality, and Canada’s competitiveness in the medical device sector. Amendments to Copyright Act, regarding Technology Protection Measures (TPMs)

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 Agency for Drugs and Technologies in Health (CADTH) as it relates to health economics assessment and recommendations made on new medicines.

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

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