Michelle Boudreau

Innovation, Science and Economic Development Canada (ISED) Innovation Agenda regarding the need for a balanced intellectual property regime and the important role competition plays in encouraging innovation. Provide input into policy discussions with respect to the implementation of a national pharmacare program. Provide input into the Government of Canada's negotiations regarding trade negotiations with respect to pharmaceuticals, counterfeit medicines, and intellectual property. Provide input into the Canada-US trade relationship as it pertains to medicines, including the impact of tariffs on medicines and medicine manufacturing inputs for the Canadian healthcare system, patients and industry. Provide input into the Canada-United States-Mexico Agreement (CUSMA). To encourage the Government of Canada to continue to participate in truly international discussions with respect to effective measures to combat substandard and falsified medicines in Canada and around the world. Seeking harmonization of regulatory regimes and administrative processes nationally and internationally. Providing input with respect to the approval pathway for biosimilar medicines by Health Canada. Provide input into the Patented Medicine Prices Review Board (PMPRB) consultations regarding its Policies, Guidelines and Procedures. Provide input into the modernization of the Food and Drugs Act and related Regulations, Guidelines and Policies as they pertain to pharmaceuticals. Proposals to enhance transparency of the Health Canada Reconsiderations Policy for drug submissions. Proposals related to Health Canada's Identical Medicinal Ingredient Policy. Participation in Competition Bureau consultations with respect to pharmaceuticals. Participate in Government of Canada consultations with respect to the Regulatory Cooperation Council. Health Canada with respect to user fees for therapeutic product regulatory programs. Health Canada with respect to the process for the approval and renewal of foreign sites for Drug Establishment License (DEL) holders. Related guidance documents include the Guidance on Evidence to Demonstrate Drug GMP Compliance of Foreign Sites (GUI-0080), the Guidance on Drug Establishment Licences and Drug Establishment Licensing Fees (GUI-0002) and the Guidance on Good Manufacturing Practices for Active Pharmaceutical Ingredients (GUI-0104). Health Canada with respect to its Regulatory Systems Review for Therapeutic Products. Health Canada regarding the development of a national pharmacare strategy. Discussions with ISED towards a national strategy for the biomanufacturing and the life sciences sector.

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

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 protection of and access to intellectual property World Health Organization (WHO) issues concerning pharmaceuticals as it relates to Counterfeits, Access to Medicines, and the Intergovernmental Working Group (IGWG) 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 Proposed pharmacare legislation related to any future national pharmacare program Pharmaceutical pricing policy issues arising from the jurisdiction of the Patended 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 New Substances Notification Regulations as it relates to the biopharmaceutical industry Income Tax Act as it relates to biopharmaceutical products Health Canada’s Interim Orders relating to COVID-19: The Interim Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19; The Interim Order Respecting Clinical Trials for Medical Devices and Drugs Relating to COVID-19; The Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19; The Interim Order Respecting the Prevention and Alleviation of Shortages of Drugs in Relation to Covid-19 Health Canada's Regulatory Roadmap for Health Products and Food as it relates to the biopharmaceutical industry Free trade treaty agreement as they relate to the North American Free Trade Agreement (NAFTA) and free trade negotiations as it relates to India, the European Union, Japan, MERCOSUR and the Trans-Pacific Partnership 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 Establish accountability with the federally financed Canadian Agency for Drugs and Technologies in Health (CADTH) Common Drug Review Policies as it relates to reimbursement recommendation decision-making process and framework Canadian Institutes of Health Research (CIHR) Clinical Research Initiative as it relates to public/private research and development partnerships Canadian Environmental Protection Act and Regulations in respect of modern, science-based regulations to reflect rapidly changing new technologies Canada-United States Regulatory Cooperation Council (RCC) initiatives related to the regulation of biopharmaceutical products Canada's Food and Consumer Safety Action Plan as it relates to the regulation and protection of biopharmaceutical products Canada's Access to Medicines Regime with respect to ensuring that the program allows for the deli

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

Canadian Drug Agency: the mandate and creation of a new Canadian Drug Agency and transition work to support pharmacare-related initiatives, including patient access and reimbursement framework. Communications regarding Canada’s mental health strategy, implementation and access to services for Canadians. Development of Health Emergency Readiness Canada agency, and role in promoting development life sciences sector. Subsequent Entry Biologics (SEBs): the need for regulatory amendments to facilitate their approval. Research and Development (R&D): Input on Canada's clinical trial approval and implementations processes; Investing in Canada in R&D. Proposed national pharmacare: Specifically, government’s intention to introduce a national pharmacare program. Modernization of Food & Drug Act: support for proposed regulatory changes, modernization and international harmonizations with other regulatory bodies (European Medicines Agency/U.S. Food and Drug Administration). Input into the Patented Medicines Price Review Board evaluation of annual R&D investments by companies in Canada based on Scientific Research and Experimental Development (SR&ED) tax rules. Working with PMPRB and legislators to ensure appropriate measures of R&D investment are in place. Incentives and programs to attract and support manufacturing activities in Canada Health Canada and the Patented Medicine Prices Review Board(PMPRB) regulatory implementation and specifically, pharmaceutical pricing policy issues arising from the Patented Medicine Regulations. Health Canada's enforcement of Canada's Food and Drugs Act and Regulations as they relate to the cross border sale of drugs to the United States. COVID-19: Regarding the development of a COVID-19 vaccine & policies and related to the COVID-19 pandemic. Comprehensive Economic Trade Agreement with Europe (CETA) and pharmaceutical intellectual property protection. Communications regarding the maintenance of domestic supply of essential drug products. Canada-United States-Mexico Agreement (CUSMA) and pharmaceutical intellectual property protection. Canada's Innovation Agenda: ensuring that the life sciences industry is included and promoting awareness of and support for the full ecosystem from early stage research to commercialization and reimbursement. An amendment to the Patented Medicines (Notice of Compliance) Regulations ("PM(NOC) Regulations") regarding the right to appeal.

Issues related to U.S. pharmaceutical importation, trade and policies, including research and development, regulatory authorizations, funding of medicines, supply sources and supply chains. Innovation, Science and Economic Development Canada and Innovation Agenda, Science and Technology Strategy, or other Government policy or program initiatives to support research and development activities and attract investments 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 Federally-funded Public Drug Plans, with respect to reimbursement for medicines for federal plan beneficiaries. Enhancement to Canada's regulatory and funding environment for new medicines, including Health Canada authorizations of medicines and framework for clinical trials, health technology assessment processes, reimbursement negotiations and funding decisions. Enhancements related to intellectual property legislation, regulations and policies applicable to pharmaceuticals. Implementation of the National Strategy for Drugs for Rare Diseases and the Pharmacare Act.

Canada’s Innovation and Skills Plan, led by Innovation, Science and Economic Development Canada, with respect to ensuring that the life sciences sector is a priority of the government. Health Canada Regulations Amending the Patented Medicines Regulations (Additional Factors and Information Reporting Requirements) (SOR/2019-298) published in the Canada Gazette Part 2 on August 21, 2019 Guidelines, policies and programs related to regulatory and reporting functions of the Patented Medicine Prices Review Board Engagement with officials regarding Health Canada’s proposed development of a strategy for drugs for rare disorders and other aspects of national pharmacare, including proposals for a Canada Drug Agency and a national formulary Engagement with federal officials regarding Innovation, Science and Economic Development Canada’s plans for the creation of new biomanufacturing capacity for Canada

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.

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.

GOVERNMENT PROCUREMENT - Reform Canada’s procurement system to support investment and ensure a competitive business environment. GOVERNMENT PROCUREMENT - Ensuring fair and open procurement practices to drive innovation and technology adoption in Canada. HOUSING - Advocate for policies and legislation that enable the creation of more housing supply, incentivize investment in residential construction and housing – enabling infrastructure, and support the development of skilled labour we need, whether domestically or through immigration, to restore housing affordability to Canadian families. TAXATION AND FINANCE – With regard to the measurement and improvement of Canada’s tax competitiveness, including: reforming the taxation, remittance, filing and audit processes of Canadian businesses and tax policy which improves the competitiveness of the Canadian business environment INTERNATIONAL TRADE – With respect to issues relating to trade controls, including tariffs, import and export controls, sanctions, and trade remedies. INDUSTRY - Improving the Scientific Research and Experimental Development (SR&ED) tax credit program to drive innovation; increase the role that the federal government plays in creating opportunities for small and medium sized businesses to digitalize and conduct more business activities online; developing a digital economy strategy for Canada. HEALTH – Ensuring we improve access to necessary medicines by building on rather than displacing the important role of private insurers and respecting provincial and territorial jurisdiction. CYBER SECURITY - Encouraging the government to prioritize cybersecurity innovation, talent development, and critical infrastructure resilience; modernize research and development; accelerate commercialization in the space; support the secure digitalization of small-and-medium-sized enterprises (SMEs); and improve the global competitiveness of Canada’s cybersecurity industry. IMMIGRATION - Reducing regulatory burdens for employers; promoting immigration to small, rural and northern communities; supporting regional and local community immigration strategies; maintaining and modernizing the Temporary Foreign Worker Program; Facilitating pathways to permanent residency for temporary residents (international students and TFWs; expediting and simplifying foreign credential recognition, calling for an international student and global talent strategy; improving language training as well as settlement and employment supports to newcomers, aligning immigration programs with labour market needs, improving the Start-Up Visa process, improving client services to potential immigrants and newcomers. EMPLOYMENT AND TRAINING – National Workforce Strategy, programs that support small and medium sized enterprises, improving collection and dissemination of Labour Market Information, establishing the Employment Insurance Council to institutionalize social dialogue between workers and employers on issues related to employment and training needs, addressing barriers to labour mobility, improving effectiveness of employment supports and skills training. EDUCATION - Aligning employer and workforce needs with education and training; expanding skilling, upskilling, reskilling and work integrated learning opportunities. INFRASTRUCTURE – Improvement of Canada’s infrastructure through the National Infrastructure Assessment, National Supply Chains Strategy, and establishment of a Canada Trade Infrastructure Plan. TRANSPORTATION - Regarding the consistent funding of trade-enabling infrastructure projects; the development of a competitive and efficient transportation network including all modes of transportation; the fluidity and stability of supply chain operations, minimizing disruptions. LABOUR - Ensuring that any changes to the Canada Labour Code are implemented in response to defined and demonstrated issues and not to increase regulatory burdens for employers; minimizing labour disruption impacts on Canadian bus

CYBER SECURITY - Encourage the government to invest in cybersecurity innovation, talent, and infrastructure; modernize research and development; accelerate commercialization in the space; support the secure digitalization of small-and-medium-sized enterprises (SMEs); and improve the global competitiveness of Canada’s cybersecurity industry. ARTIFICIAL INTELLIGENCE - Advocate for future-proofed, globally competitive, and interoperable policies that position artificial intelligence as a positive economic driver, and support the responsible development, deployment, and use of AI in business. PRIVACY AND ACCESS TO INFORMATION - Ensure that the modernization of Canada’s privacy legislation strikes the right balance between protecting consumers and promoting the ability of firms to innovate and compete by responsibly and securely using data. HOUSING - Support policies that enable the creation of more housing supply, incentivize investment in residential construction, and restore housing affordability for Canadian families. NATIONAL SECURITY/ECONOMIC SECURITY - Advancing policies related to enhancing Canada’s economic and national security. Key priorities include strengthening economic resilience, prudently navigating geopolitical challenges to trade and international relations, safeguarding business operations against new and emerging threats, and fostering conditions for economic growth. TRANSPORTATION - Regarding the consistent funding of trade-enabling infrastructure projects; the development of a competitive and efficient transportation network including all modes of transportation. TELECOMMUNICATIONS - Creating the right investment incentives to foster vibrant competition in the sector as a whole; responding to decisions regarding third-party access that will impact the deployment of internet services in rural and remote communities; and responding to regulatory proposals re: cell phone pricing. TAXATION AND FINANCE – With regard to undertaking a comprehensive and independent tax system review. TAXATION AND FINANCE – With regard to the measurement and improvement of Canada’s tax competitiveness, including: reforming the taxation, remittance, filing and audit processes of Canadian businesses; removing tax barriers for childcare expenses; addressing the taxation of family business transfers; and mobilizing private capital for recovery and growth. TAXATION AND FINANCE - With regard to modernizing our financial systems through open banking and digital currencies TAXATION AND FINANCE - Responding to proposals addressing taxation of digital services. TAXATION AND FINANCE - Maintaining and expanding real-time data made freely available to Canadian businesses, municipalities, academic researchers, and community groups. SMALL BUSINESS – Legislation, regulations and support programs that give Canadian small and medium-sized enterprises (SMEs) the tools to grow in Canada and internationally, including reducing their red tape and compliance burden. PRIVACY AND ACCESS TO INFORMATION - Improving digital privacy legislation to meet the needs of industry. PENSIONS - Treatment of corporate pensions in the event of bankruptcy. NATURAL RESOURCES - Support for the adoption of policy recommendations to strengthen Canada’s world-leading position in the mining industry, oil and gas, and forestry products. OPEN DATA - Maintaining and expanding real-time data made freely available to Canadian businesses, municipalities, academic researchers, and community groups. LABOUR: Ensuring that any changes to the Canada Labour Code are implemented in response to defined and demonstrated issues and not to increase regulatory burdens for employers. INTERNATIONAL TRADE – With respect to issues relating to import and export controls INTERNATIONAL TRADE - Negotiating bilateral, regional, and multilateral trade agreements and promoting them to Canadian businesses. INTERNATIONAL TRADE - Improving federal laws and regulations pertaining to responsible business conduct r

That the federal government reinstate Canadian Certified Counsellors (CCCs) as eligible providers in unregulated provinces under the Non-Insured Health Benefits (NIHB) and Jordan’s Principle programs, and commit to reforming these programs to ensure culturally safe, equitable, and inclusive access to mental health services for First Nations and Inuit peoples. That the federal government enact the Mental Health and Substance Use Health Care for All Parity Act and commit to sustainable funding. That the federal government strengthen mental health services in rural, remote, and northern communities by expanding the Canada Student Loan forgiveness program to include counsellors, psychotherapists, and counselling therapists, supporting both access to care and workforce recruitment.

CCPA recommends that the federal government re-instate Canadian Certified Counsellors (CCCs) to the list of approved service providers for NIHB Program for First Nations and Inuit in provinces currently working toward regulating the counselling/psychotherapy profession. CCPA recommends that the federal government pass a companion piece of legislation to the Canada Health Act called the Mental Health and Substance Use Health Care for All Parity Act – which equally values mental health, substance use health and physical health. CCPA recommends that the federal government exempts the profession of counselling therapy and psychotherapy from paying GST/HST on business operations, thus providing Canadians with improved access to one of the most cost-effective mental health care options available.

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.