Darryl Patterson

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 Policies related to Subsequent Entry Biologics (SEBs) pertaining to Draft Guidance for Sponsors; Information and Submission requirements for SEBs, regulations and intellectual property policies, naming conventions Monitoring and engaging on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

To obtain clarity and provide input on the Government of Canada's announced transition from open-net salmon aquaculture in British Columbia as Fisheries and Oceans prepares the draft framework for that transition. To pursue understanding of what Transport Canada determines and defines as "vessels".

Funding for on-reserve housing Renewal of BC salmon farming licences in Indigenous territories

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.

Working with our Industry Associations (Innovative Medicines Canada and BIOTECanada) to provide industry recommendations on Canada's Biomanufacturing and Life Sciences Strategy, National Pharmacare, Intellectual property as well as pricing reforms (PMPRB) Science and Technology Strategy, advocating for the development of a Biopharma sector in support of more research & development in Canada. R&D requirements set forth through the Patent Medicines Pricing Review Board (PMPRB) Patent Medicines Pricing Review Board reforms, regarding both the revised regulations and draft guidelines Patented Medicines (Notice of Compliance) Regulations as it relates to regulation of intellectual property for therapeutic products. Novartis is working with our industry associations (Innovative Medicines Canada and BIOTECanada) to provide a written response to Guideline consultation process and will provide our own corporate submission. Patented Medicine Prices Review Board (PMPRB) Regulations as related to reporting requirements and pricing guidelines. Federal Public Drug Plans, with respect to the reimbursement of drug products for the Federal plan beneficiaries Federal Innovation agenda. Working with our Industry Associations (Innovative Medicines Canada and BIOTECanada) to ensure that innovative medicines, and our contribution to Research and Development in Canada are part of the consultation process in the development of this new innovation agenda. Canadian Agency for Drugs and Technologies in Health (CADTH), including Therapeutic Reviews and the Common Drug Review as it relates to reimbursement recommendations for decision-making process and framework.

Free trade agreements as they relate to biomanufacturing industry in Canada Working with our Industry Associations (Innovative Medicines Canada and BIOTECanada) to provide industry recommendations on Canada's Biomanufacturing and Life Sciences Strategy, National Pharmacare, Intellectual property as well as pricing reforms (PMPRB) Science and Technology Strategy, advocating for the development of a Biopharma sector in support of more research & development in Canada. R&D requirements set forth through the Patent Medicines Pricing Review Board (PMPRB) Patent Medicines Pricing Review Board reforms, regarding both the revised regulations and draft guidelines Patented Medicines (Notice of Compliance) Regulations as it relates to regulation of intellectual property for therapeutic products. Novartis is working with our industry associations (Innovative Medicines Canada and BIOTECanada) to provide a written response to Guideline consultation process and will provide our own corporate submission. Patented Medicine Prices Review Board (PMPRB) Regulations as related to reporting requirements and pricing guidelines. Federal Public Drug Plans, with respect to the reimbursement of drug products for the Federal plan beneficiaries Federal Innovation agenda. Working with our Industry Associations (Innovative Medicines Canada and BIOTECanada) to ensure that innovative medicines, and our contribution to Research and Development in Canada are part of the consultation process in the development of this new innovation agenda. Canadian Agency for Drugs and Technologies in Health (CADTH), including Therapeutic Reviews and the Common Drug Review as it relates to reimbursement recommendations for decision-making process and framework.

Support efforts for the adoption of the Transition Plan for Open-Net Pen Salmon Farming in British Columbia. Communicating with government officials about the establishment of marine programs, including funding programs, that will promote salmon restoration and conservation practices.

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

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.

Pharmaceutical pricing policy arising from the jurisdiction of the patented medicine prices review board (PMPRB). Arranging meetings to brief government officials on the business of Boehringer Ingelheim Canada Ltd.

Discussing the value of the subsidiary OmniaBio, as soveriegn capacity that is critical to Canada's needs in the event of future pandemics or national emergency, leading to support from federal entitities that supply capital and other financial products. Continued effort to maintain strong support for strategic value of the Strategic Response Fund support for the project re the application of automation and AI technology in our recently opened cell and gene therapy manufacutring facility operated by the subsidiary OmniaBio. The support will result in lower cost of life saving cell and gene therapy products. Pursue opportunities to benefit the Canadian cell and gene therapy ecosystem caused by global uncertainty.