Daniel MacDonald

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

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

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.

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 Policies related to Subsequent Entry Biologics (SEBs) pertaining to Draft Guidance for Sponsors; Information and Submission requirements for SEBs, regulations and intellectual property policies, naming conventions Monitoring and engaging on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

Enhancements related to intellectual property legislation, regulations and policies applicable to rare disease medicines. Issues related to U.S. pharmaceutical importation, trade and policies, including research and development, regulatory authorizations, funding of medicines, supply sources and supply chains. Regulatory amendments and/or guidelines related to the Food and Drugs Act Regulations and Health Canada to implement an orphan drug regulatory framework. Innovation, Science and Economic Development Canada regarding the Innovation and Skills Agenda and other government policies and programs related to incentivizing research and development activities in Canada, including the Biomanufacturing and Life Sciences Strategy. Regulations, guidelines, policies and programs related to regulatory and reporting functions of the Patented Medicine Prices Review Board. Enhancement to Canada's regulatory and funding environment for new rare disease medicines, including Health Canada authorizations of medicines and framework for clinical trials, health technology assessment processes, reimbursement negotiations and funding decisions. Federally-funded public drug plans, with respect to reimbursement for medicines for federal plan beneficiaries. Implementation of the Pharmacare Act and its implications for rare disease medicines. Implementation of the National Strategy for Drugs for Rare Disease, and other policies or programs related to rare diseases.

National pharmacare, with a particular focus on access to medicines and rare disease and orphan drug policies Federal programs and budgetary initiatives related to the Federal-Provincial-Territorial funding arrangements regarding pharmaceuticals including any health technology assessment-related or other policy discussions that might involve Health Canada and its ongoing relationship with Canada's Drug Agency and/or other pan-Canadian health organizations. Regulatory amendments and/or guidelines and/or policies related to the Food and Drugs Act and Health Canada's review of medicines (particularly rare disease treatments). Innovation, Science and Economic Development Canada regarding the Innovation and Skills Agenda, the Biomanufacturing and Life Sciences Strategy and other government policies and programs related to incenting research and development activities in Canada. Guidelines, policies and programs related to regulatory and reporting functions of the Patented Medicine Prices Review Board Engagement with officials on issues related to the National Strategy for Rare Disease Drugs, and other policies or programs related to rare diseases. Federally-funded public drug plans, with respect to reimbursement for drug products for federal plan beneficiaries.

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.

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.

Increased federal investment in health-related research. Advocating for implementation of Canada's drugs for rare diseases strategy. With respect to disability, we advocate for recognition of and supports for people with episodic disabilities. In terms of science and technology, we work toward the development of precision and personalized medicines that target the basic defect of cystic fibrosis. We are exploring how the federal government may support these efforts through partnership and funding. In terms of research and development, we lobby for support of cystic fibrosis research initiatives that improve the health and wellness of Canadians living with cystic fibrosis. Improving access to precision medicines for Canadians with cystic fibrosis and other rare diseases. Advocating to stop the regulatory changes to the Patented Medicines Price Review Board (PMPRB).

Healthcare policy and potential legislation relating to employee benefit programs and the cost of pharmaceuticals, and healthcare policy related to virtual care services To ensure that the needs of the financial sector in matters related to human resources as well as its capacity to service customers are properly reflected in legislation, policies and regulations in the context of the COVID-19 public health and economic crisis. The Personal Information Protection and Electronic Documents Act with respect to privacy, customer data, and data security Taxation - discussion of taxation policy for financial institutions. Seeking to raise awareness about prescription drug coverage policy considerations and concerns in context of national universal pharmacare proposals directly and as a participant in the Together for Better Health Coalition. Other related initiatives include high cost drugs for rare disease and PMPRB regulations Review of the Proceeds of Crime (Money Laundering) and Terrorist Financing Act as it relates to insurance contracts. Pension and Retirement products and income security Guidelines of the Office of the Superintendent of Financial Institutions as they relate to insurance companies. Federal Financial Services legislation review, with respect to Financial Institutions policies, infrastructure, open banking, and financial technology Clarification of Goods and Services Tax (GST) / Harmonized Sales Tax (HST) with respect to the treatment of financial services.

Clarification of Goods and Services Tax (GST) / Harmonized Sales Tax (HST) with respect to the treatment of financial services. AI, with respect to the regulation of AI in financial institutions and insurance, and use and protection of data and information. Infrastructure investment, with respect to institutional investment and government partnerships. Healthcare policy and potential legislation relating to employee benefit programs and the cost of pharmaceuticals, and healthcare policy related to virtual care services The Personal Information Protection and Electronic Documents Act with respect to privacy, customer data, and data security Taxation - discussion of taxation policy for financial institutions. Review of the Proceeds of Crime (Money Laundering) and Terrorist Financing Act as it relates to insurance contracts. Pension and Retirement products and income security Guidelines of the Office of the Superintendent of Financial Institutions as they relate to insurance companies. Federal Financial Services legislation review, with respect to Financial Institutions policies, infrastructure, open banking, and financial technology

Working with the government on an open and inclusive regulatory regime for generic pharmaceuticals that continues to allow the industry to grow in Canada, and discuss with the government how Apotex can work with them to ensure the security and increase the self-sufficiency of Canada’s drug supply, how the government can help ensure access to international markets, and how the government can utilize generic and biosimilar medications to make pharmacare and other drug programs more sustainable.

International trade regarding tobacco control, alcohol, products containing carcinogens and products associated with cancer. Internal trade regarding tobacco control, alcohol, products containing carcinogens and products associated with cancer. Funding for programs to be operated by the Canadian Cancer Society to advance cancer control. Canadian Partnership Against Cancer, as it relates to continued federal funding for the cancer control strategy Canada Health Transfer and health system bilateral funding agreements intended for provinces/territories to support the delivery of healthcare services Framework Convention on Tobacco Control, including protocols, guidelines and implementation Tobacco and Vaping Products Act, as it relates to regulations, implementation and enforcement Non-Smokers' Health Act including implementation and enforcement Food and Drugs Act and regulations, as it relates to nciotine replacement products Federal Tobacco Control Strategy, including all matters related to tobacco control Taxation, revenue measures, controlled products regulations, including implementation, for alcohol, tobacco control, products containing carcinogens and products associated with cancer. Communication regarding alcohol consumption guidance. Food and Drugs Act and regulations, as it relates to alcohol warning labels Food and Drugs Act and regulations, as it relates to restricting the advertising to children of foods high in sodium, sugars and saturated fat. Healthy Living - Supporting initiatives, legislation, regulation, policies, and programs that prevent cancer or improve the social determinants of health Adoption of HPV testing and increasing HPV vaccination rates Sustainable funding of the National Advisory Committee on Preventive Health Services to ensure timely, up?to?date cancer screening guidelines Equitable and timely access to cancer screening. Measures and funding related to the charitable sector generally Equitable access to care along the full cancer continuum for First Nations, Inuit and Métis communities Employment Insurance special benefit programs, including the sickness benefit and compassionate care benefit Canada Labour Code and Employment Insurance Act, as it relates to job-protected leave, employment insurance special benefits, return to work policies, and human rights protections for people affected by cancer Access to information and support to make decisions regarding end-of-life care, including Medical Assistance In Dying Supports for mental health during people's cancer journeys Implementation and funding of the National Grief Action Plan as part of the government's work on palliative care and mental health Canada Health Act as it relates to access to care, including long-term, home, and palliative care National Caregiving Strategy Financial supports for caregivers, including the Canada Caregiver Credit Implementation of the Framework on Palliative Care in Canada and integration of a palliative approach to care in our health system, including national standards and data, care provider training, research, and implementation of the National Grief Action Plan and distinctions?based frameworks for First Nations, Inuit and Métis people Setting and measuring pan-Canadian wait time benchmarks and targets and measures to address them, including addressing healthcare shortages, increased and sustainable funding for care, infrastructure and equipment, targeted strategic funding to PTs for workforce shortages, particularly in rural and remote communities. Sustained core funding for federal research agencies, improved coverage of indirect research costs, Canadian research sovereignty, strengthening capacity and the economic benefits of domestic research, research commercialization. Increasing access to care including models of care, removing barriers to care, particularly for underserved communities, using innovative approaches to improve access to care including AI to improve timely diagnosis and treatment. Issu

Advocate for changes to facilitate adoption of auto features for retirement savings. Advocate for legislative or regulatory changes to allow for automatic features in workplace pension plans. Discussions related to the implementation of CRA Notice 344 Consultation on the National Strategy on mental health of men and boys Discussions related to Bill S-5 Connected Care for Canadians Act. FCAC direction to update complaint-handling information for insurers Discussions related to drug pricing, including decisions, policies and processes of the Patented Medicine Prices Review Board (PMPRB) Discussions related to supply and shortages of drugs in Canada, including the Multi-Stakeholder Steering Committee. Discussions related to regulatory burden, including “cutting red tape”. Impacts on Canadian insurers of proposed U.S. tax measures. Discussions relating to the efficiency and effectiveness of the financial sector regulatory system as it pertains to insurance companies. Discussing plans on the Data Collection Modernization initiative Promotion of a broader range of investments by insurance companies (e.g., farmland, timberland, fintechs) Statutory review of the Insurance Companies Act as it relates to insurance products and investments. Discussions related to the implementation of national pharmacare including bilateral agreements with provinces and territories; the committee of experts on the implementation of pharmacare and the advisory panel on bulk purchasing. Promotion of pension products, including decumulation solutions. Discussions related to the implementation of the Interpretation letter on the Canada health act related to physician equivalent services. Inter-provincial harmonization and trade barriers as it relates to insurance products. Discussions related to the financial sector policy review. Office of the Superintendent of Financial Institutions (OSFI). Guidelines related to risk management, capital and accounting for insurance companies. This includes capital charges for infrastructure investments under the LICAT. International Trade with respect to opening trade relations, regulations, foreign ownership and national treatment in foreign markets, with regards to India, Europe, China, Japan, Trans-Pacific partnership (TPP), Canada-United States-Mexico Agreement (CUSMA), Plurilateral Trade In Services Agreement (TISA) and the World Trade Organization (WTO). Work to ensure that the income tax act does not put insurance companies at a competitive disadvantage. Promotion of risk-based and principles-based regulation for financial institutions regulations. Personal Information Protection and Electronic Documents Act: seeking workable approaches to privacy rules affecting life and health insurers when the Act is updated. Income Tax Regulations (section 6(1)(f) as it relates to income tax withholding on wage loss replacement plans (disability income benefits). Income Tax Regulations, Part XIV. Income Tax Regulations, Part III: Updating income tax rules for life insurance policies. Income Tax Act, Section 146: Retirement income recommendations regarding the treatment of life insurance companies; Section 146.2 (TFSAs); Section 146.3 (RRIFs). Income Tax Act, Part VI as it relates to capital tax on financial institutions. Financing infrastructure projects, as it relates to investments by insurers Financial Transactions and Reports Analysis Centre of Canada (FINTRAC) risk-based guidance as it relates to life insurance Employment Insurance (EI) reform as it relates to disability benefits; and EI Premium Reduction Program issues. Amendments to Proceeds of Crime (Money Laundering) and Terrorist Financing rules as they affect insurance companies

C-64, An act respecting pharmacare - discussions around the structuring and implementation of a national pharmacare program. The government's economic, health, investment, science and technology, and trade policies as they relate to the pharmaceutical industry Pharmaceutical pricing policy arising from the jurisdiction of the Patented Medicines Prices Review Board (PMPRB) Pharmaceutical and trade policy as it relates to security of supply for Canadian medicines. Patented Medicines Pricing Review Board (PMPRB) – regulations that can impact the Canadian pharmaceutical industry. Patented Medicine Notice of Compliance (PMNOC) Regulations - enforcement of Intellectual Property with respect to the Canadian pharmaceutical industry. Patent Act - An Act respecting patents of invention with regard to Intellectual Property Protection for pharmaceutical products - federal court decisions that have changed the disclosure requirements regarding the utility of an invention. Intellectual Property - Changes to Patented Medicine (Notice of Compliance) (PMNOC) regulations - important regulations that can affect Eli Lilly Canada's business Free trade treaty agreement as it relates to the North American Free Trade Agreement (NAFTA) and free trade negotiations as it relates to Columbia, India, and the European Union Food and Drug Act - An Act respecting food, drugs, cosmetics and therapeutic devices. Discussions relating to progressive licensing and the modernization of the Food and Drug Act.