Manuela Tomic

Policies aimed at reinforcing pharmaceutical supply chain. Discussion regarding the launch of new branded product in the rare disease space Improvements to the supports offered by the federal government to support R&D; in particular, generic drug research and development. Seeking support from the Strategic Innovation Fund Program for support of biomanufacturing expansion project. Policies aimed at facilitating generic drug repurposing. Discussion on the opioid crisis and the Health minister's expectations from pharmaceutical manufacturers Discussion of regulatory impediments to the launch of pediatric formulations of branded and generic products. Discussion of a possible Therapeutics Products Directorate ("TPD") workstream on complex generics regulatory pathways.

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

The client is seeking the renewal of funding from the Government of Canada. The client wishes to engage with decision makers regarding the funding of spinal cord research and policies which affect those living with spinal cord injury.

Communicating with ISED, regarding the receipt, allocation, and outcomes of funding received. Familiarizing Health Canada, ISED, and Members of Parliament about the work of the Praxis Spinal Cord Institute.

The client wishes to engage with decision makers regarding the funding of spinal cord research and policies which affect those living with spinal cord injury. The client is seeking the renewal of funding from the Government of Canada.

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.

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

Advocacy regarding the Government of Canada’s defence and research agenda, including policies, programs and regulations developed by the Department of National Defence, Defence Research and Development Canada and other relevant departments and agencies that directly or indirectly impact the post-secondary education sector. Advocacy regarding the Government of Canada’s innovation and economic development agenda, including policies, programs and regulations developed by Innovation, Science and Economic Development Canada and other relevant departments and agencies that directly or indirectly impact the post-secondary education sector. Advocacy regarding the Government of Canada’s health research and life sciences agenda, including policies, programs and regulations developed by Health Canada and other relevant departments and agencies that directly or indirectly impact the post-secondary education sector. Advocacy regarding immigration policies, programs and regulations related to international students, faculty, and highly qualified research personnel developed by Immigration, Refugees and Citizenship Canada and other relevant departments and agencies that directly or indirectly impact the post-secondary education sector. Advocacy regarding housing strategy issues, policies and programs that directly or indirectly impact the post-secondary education sector. Advocacy regarding Government of Canada training, employment and skills policies or programs, developed by Employment and Social Development Canada and other relevant departments and agencies, that directly or indirectly impact the post-secondary education sector with respect to their research and education activities. Advocacy regarding Canada’s research and development agenda, including research funding administered through the granting agencies and other federal departments and agencies, program design, and regulatory concerns related to research, including research security. Advocacy to ensure that proposals to develop or amend federal legislation, regulations, policies or programs that directly or indirectly impact the post-secondary system reflect the needs of universities and support research and education activities, including communication with public office holders in the House of Commons of Canada, the Senate of Canada and relevant departments and agencies. Activities related to the operation of U15 digital initiatives including Cognit.ca and SecureScholar.

Requesting amendments to the Copyright Act to make the private copying regime technologically neutral.

Timeliness of decisions regarding Temporary Residence Visas in the recruiting of international faculty. Student assistance and financial support for higher education, sources of funding to be determined Science and Technology Policy - Operating funding for major scientific installations and equipment from the Canada Foundation for Innovation. Regulations related to the provision of immigration advice (under section 91 of the Immigration and Refugee Protection Act) Military and Veteran's Health - seeking support for the national research program of the Canadian Institute for Military and Veteran Health through Veterans Affairs Canada and the Department of National Defence. Maintenance and growth in funding for investigator-driven grants from tricouncils. International Assistance to Democracy Promotion that directly addresses objectives for Canadian Policy outlined in Government of Canada response to the 2007 Standing Committee on Foreign Affairs and International Development on democracy policy through funding to Queen’s Centre for the Study of Democracy and Diversity. Indirect Costs of Research Program - increase in support to levels of international peers, source of funding to be determined. Funding under the New Building Canada Plan for infrastructure to support advanced research and teaching Funding for health sciences initiatives - Obtain federal funding to extend the value chain of cancer clinical trails in Canada. Sources of funding to be determined. FedDev Ontario Applied Research and Commercialization (ARC) initiative to support applied research and commercialization for SME-University partnerships

Advocacy for investment in the Canadian energy sector. Advocacy to advance international collaboration to support sustainable development. Advocacy to support funding for higher education programs and research initiatives in the health sciences. Advocacy to advance Canadian leadership in key areas through long-term support for major research facilities and initiatives. Advocacy related to policies that impact international students. Advocacy to represent university interests in the allocation of land. International collaboration to support the reputation of Canadian universities abroad. Advocacy to advance Canadian leadership in priority areas, including artificial intelligence and defence, to support world-class research and the attraction and retention of top talent, including, but not limited to, specific calls for proposals. Regulations related to visitor visas to support international engagement. Support in principle for high-speed rail along the Québec–Toronto corridor and advocacy for the inclusion of a stop in Kingston. Advocacy to secure support in the budget for post-secondary education, research, innovation, and science. Advocacy to increase support for university research, including research funding and granting programs administered by the tri-agencies (SSHRC, NSERC, CIHR) and other departments and agencies. Advocacy to enhance support for university research mobilization and commercialization. Timeliness of decisions regarding Temporary Residence Visas in the recruiting of international faculty. Student assistance and financial support for higher education, sources of funding to be determined. Science and Technology Policy - Operating funding for major scientific installations and equipment from the Canada Foundation for Innovation. Regulations related to the provision of immigration advice (under section 91 of the Immigration and Refugee Protection Act) Military and Veteran's Health - seeking support for the national research program of the Canadian Institute for Military and Veteran Health through Veterans Affairs Canada and the Department of National Defence. Maintenance and growth in funding for investigator-driven grants from tricouncils. Indirect Costs of Research Program - increase in support to levels of international peers, source of funding to be determined. Funding for infrastructure to support advanced research and teaching Funding for health sciences initiatives - Obtain federal funding to extend the value chain of cancer clinical trails in Canada. Sources of funding to be determined. FedDev Ontario Applied Research and Commercialization (ARC) initiative to support applied research and commercialization for SME-University partnerships

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.

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.