Nasser Haidar

The proposed amendments to the Canadian Environmental Protection Act and other Acts as put forward in Getting Major Projects Built in Canada Discussion Paper. Inform federal discussions on how to promote a sustainable domestic clean technology manufacturing industry. Inform amendments to Canada's Clean Economy Investment Tax Credits that support the further deployment of renewable energy and energy storage. Inform the further development of Canada's carbon pricing trajectory, and fix the benchmark and improve the backstop for Canada's GreenhouseGas Pollution Pricing Act. Providing advice on policy measures and improvements to increase Canada's investability in renewable energy sector Providing input on the federal government's new measures to protect and transform Canada’s steel and lumber industries Development of a fund or program to provide access to low cost capital for Canadians wishing to purchase and install residential photovoltaic solar and energy storage. Providing advice on Canada's Clean Electricity Strategy, specifically offering input that would accelerate the deployment of renewable energy and energy storage both in front of the meter and behind the meter. Advocating for policies that would encourage the development of a stronger domestic supply chain for the renewable energy and energy storage sectors. Development of financial mechanisms to increase Indigenous communities' and companies' ability to access the capital required to develop renewable energy and energy storage projects. Canada's response to the US Industry and Security Bureau's Notice of Request for Public Comments on Section 232 National Security Investigation of Imports of Wind Turbines and Their Parts and Components

Advocacy on amendments to carbon pricing to incentivize renewable energy Infrastructure - Advocating for the federal government to support the clean energy transition with payments for transmission to the provinces. Energy - Advocate for support for clean technology and green hydrogen through Investment Tax Credits and capital cost reductions in order to accelerate deployment of these technologies while striving to meet Canada's net-zero goals. Housing - Implementation of CMHC Energy Efficiency Retrofit Program Infrastructure - Expansion of Canada Infrastructure Bank Clean Power Fund Program for Deployment of Rooftop Solar Photovoltaic Systems Government Procurement - Implementation on greening government commitments to procure renewable energy Trade - Engagement with government with respect to the consultation re. surtax on critical manufacturing sectors. And more broadly, engagement respect to economic security and trade policy design.

Trade - Engagement with government with respect to the consultation re. surtax on critical manufacturing sectors. And more broadly, engagement respect to economic security and trade policy design. Infrastructure - Advocating for the federal government to support the clean energy transition with payments for transmission to the provinces. Infrastructure - Expansion of Canada Infrastructure Bank Clean Power Fund Housing - Implementation of CMHC Energy Efficiency Retrofit Program Government Procurement - Implementation on greening government commitments to procure renewable energy Program for Deployment of Rooftop Solar Photovoltaic Systems Energy - Advocate for support for clean technology and green hydrogen through Investment Tax Credits and capital cost reductions in order to accelerate deployment of these technologies while striving to meet Canada's net-zero goals.

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

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.

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.

Exploring opportunities related to interprovincial bus travel, as it relates to the federal government's motor vehicle transport act.

Exploring opportunities related to interprovincial bus travel, including the expansion of affordable low-carbon mobility options and improved connectivity for underserved communities. Highlighting the importance of modernizing the federal Motor Vehicle Transport Act to enable a more integrated and efficient national transportation framework.

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

Regulatory and program efficiencies in the approval of new products for use in the production of food (i.e. pesticides, vet drugs, feed additives). Investment in national supply chain corridors for movement of agriculture products including reliable port and rail service. Investment in road and bridges necessary to move agriculture products from the farm to the national corridors. Advocating for the alignment of Canada regulations with the US for specified risk materials for cattle processing Temporary Foreign Workers Program - National Occupation Codes for herds person. Development of new agriculture and fisheries labour program. Housing requirements for TFW. Regulatory Cooperation Council Agenda - alignment with US regulations for livestock transport, product approval and border livestock inspection requirements Anti-microbial use and resistance - classification of growth promotants Advocating government for appropriate preparedness for animal disease outbreaks including Food and Mouth Disease. Traceability Systems and regulations Trade policy and regulations as it relates to import and export of cattle to the United States and increased market access to global markets for for Canadian beef products Climate Change policy as it relates to emissions from production of cattle/beef. Canadian Agriculture Policy - business risk management programming, environmental programming, Canada Food Policy

Regulatory and program efficiencies in the approval of new products for use in the production of food (i.e. pesticides, vet drugs, feed additives). Investment in national supply chain corridors for the movement of agriculture products including reliable port and rail service. Investment in roads and bridges necessary to move agriculture products from the farm gate to the national corridors. Temporary Foreign Workers Program - National Occupation Codes for herd persons, development of new agriculture and fisheries labour program, housing requirements for TFW. Advocating for the alignment of Canadian regulations with the US for specified risk materials for cattle processing Antimicrobial use and resistance - classification of growth promotants Regulatory Cooperation Council Agenda - alignment of Canada/ US regulations for livestock transport, product approval and border livestock inspection requirement Trade policy and regulations as it relates to import and export of cattle to the United States and increased market access to global markets for Canadian beef products. Traceability systems and regulations Canadian Agriculture Policy - business risk management programming, environmental programming, Canada Food Policy Advocating government to appropriately prepare for animal disease outbreaks including Foot and Mouth Disease. Climate policy as it relates to emissions from producing cattle/beef.

Opportunities for the Canadian Light Utility Vehicle (LUV) procurement using Canadian made steel to support domestic jobs and manufacturing. New opportunities for Canadian defence procurements and other buy Canadian opportunities such as infrastructure and transportation. Potential new policies, regulations, or international agreements impacting Canada’s international trade framework, with implications for the steel industry. Federal government priorities and policies related to the international trade of steel and improve the competitiveness of the domestic steel industry. Support measures for steel industry and workers based on domestic economic conditions, increased tariffs, and ongoing global trade issues.

Opportunities for the Canadian Light Utility Vehicle (LUV) procurement using Canadian made steel to support domestic jobs and manufacturing. New opportunities for Canadian defence procurements and other buy Canadian opportunities such as infrastructure and transportation. Potential new policies, regulations, or international agreements impacting Canada’s international trade framework, with implications for the steel industry. Support measures for steel industry and workers based on domestic economic conditions, increased tariffs, and ongoing global trade issues. Federal government priorities and policies related to the international trade of steel and improve the competitiveness of the domestic steel industry.

Communicating with government officials about improved health outcomes, including, but not limited to (i) expanding equitable access to innovative therapies, diagnostics and vaccines, (ii) promoting pricing reform, (iii) enhancing health security, including via the Health Emergency Readiness Canada ("HERC") Agency and (iv) promoting regulatory efficiency and modernization, including through the Order Providing for Reliance on Decisions of, or Documents Produced by, Foreign Regulatory Authorities in Respect of Certain Drugs. Communicating with government officials about the implementation and expansion of the national pharmacare program, including as it relates to the Pharmacare Act, S.C. 2024, c. 24. Communicating with government officials about the implementation, renewal and expansion of the "National Strategy for Drugs for Rare Diseases" (2023). Communicating, in general, with government officials about research, development and innovation in Canada's life sciences and biopharmaceutical sectors, including the impact these sectors have on the Canadian economy. Communicating with government officials about international trade agreements, including the Canada-United States-Mexico Agreement (CUSMA), formerly known as the North American Free Trade Agreement (NAFTA), more specifically as it relates to trade in the life sciences and biopharmaceutical sectors. Communicating with government officials about international trade, more specifically tariffs and non-tariff trade barriers affecting the life sciences and biopharmaceutical sectors. Communicating with government officials about regulations, guidelines, reviews, references and reporting requirements issued by and/or related to the Patented Medicine Prices Review Board ("PMPRB"). Communicating with government officials about regulations related to patented medicines, including the "Patented Medicines (Notice of Compliance) Regulations" (SOR/93-133) under the Patent Act. Communicating with government officials about a national pharmaceutical strategy, more specifically as it relates to (i) enhanced access to orphan drugs and (i) incentives for the development of rare disorder treatments. Communicating with government officials about the Food and Drugs Act, including about (i) the approval framework for drug products, such as subsequent entry biologics (also known as biosimilars), (ii) export and cross-border trade restrictions for drug products, (iii) data exclusivity for drug products, (iv) approvals (and subsequent reviews) for new drug submissions, and (v) post-market surveillance of drug products. Communicating with government officials about federal healthcare plans and benefits. Communicating with government officials about the Government of Canada's "Biomanufacturing and Life Sciences Strategy" (2021). Communicating with government officials about programs, reports, reviews and policies issued by or related to Canada's Drug Agency (formerly known as the Canadian Agency for Drugs and Technologies in Health). Communicating with government officials about the pan-Canadian Health Data Strategy, more specifically about health data foundations.

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