Jocelyne Voisin

The CMA is advocating that the trade of medical goods and medications be protected to avoid disruptions to patient care. Specifically, that the government: Continue to ensure pharmaceutical products and medical devices are not included in any countermeasures on tariffs Improve safeguards for Canadian health data Improve labour mobility so physicians can work across the country Make it easier for qualified physicians to immigrate and work in Canada, including by fast-tracking immigration steps for US physicians PAN CANADIAN LICENSURE: Advocate for the ability for physicians with full licences to practise independently without restrictions or for medical resident trainees registered in any Canadian jurisdiction to practise or train in any other Canadian jurisdiction without having to acquire more than one licence or pay additional licensing fees. This includes exploring enabling legislation in the provinces and territories. INTEGRATED HEALTH HUMAN RESOURCES Advocate for an Integrated Health Human Resources Strategy, including creating retention incentives and addressing administrative burden for health care professionals, increasing the number of doctors and nurses and ensuring that every Canadian has access to a family doctor or primary health team, increasing access to virtual care, creating an action plan to get internationally trained health care professionals to work, improving workforce data collection across health systems and investing in a supply needs-based planning tool, and facilitating team-based health care. ADMINISTRATIVE BURDEN: Advocate for measures to alleviate the administrative burden on physicians and support their professional wellbeing, including investment to facilitate the development of EHRs and EMRs in Canada, improved remuneration for the completion of federal health forms, ensuring that physicians are not captured in the definition of "promoters" in the Disability Tax Credit Promoters Restrictions Regulations, and advocacy on discontinuing the requirement that employees present sick notes to their employers. INDIGENOUS HEALTH: Improvement to the health and health care services provided to Indigenous peoples in Canada, including adding inclusive lettering on health cards across Canada. Advocating for the creation of a national Chief Health Accountability Officer. THE ACQUISITION AND THE DOMESTIC SUPPLY OF PERSONAL PROTECTIVE EQUIPMENT FOR HEALTH CARE PROVIDERS: Ensuring the federal government take additional measures ensure adequate supply, proper distribution, and appropriate usage of personal protective equipment throughout health systems. TECHNOLOGY AND ARTIFICIAL INTELLIGENCE: provide CMA’s perspective on the impact of technology and artificial intelligence on the health care sector including input on Bill C-27, and the means through which advancements can be foreseen and managed. PUBLIC-PRIVATE HEALTHCARE: The CMA is conducting a series of in-person sessions across the country to engage key stakeholders, including the public, physicians, patients/PWLE, policymakers, system leaders and others, in a dialogue on public-private healthcare. What we hear will inform CMA policy moving forward, and our recommendations for action at a national level. PHYSICIAN PARLIAMENTARIAN CAUCUS: advocate for the formation of a Physician Parliamentarian Caucus as a means of examining deficiencies in the health care system and proposing solutions. PHYSICAL, PSYCHOLOGICAL AND CULTURAL SAFETY: Advocate to address the challenges and opportunities for physical, psychological and cultural safety within Canada’s health system, including the implementation of a nation-wide anti-racism plan, the creation of a Canada Mental Health transfer, improving access to mental health services to physicians and their families, gender-affirming care, creating an emergency National Mental Health Support Services hotline for all health care providers, the creation of a National Physicians Day in Canada, ensuring safe and unimpeded access to

TECHNOLOGY AND ARTIFICIAL INTELLIGENCE: provide CMA’s perspective on the impact of technology and artificial intelligence on the health care sector and the means through which advancements can be foreseen and managed. HARMFUL ONLINE CONTENT: Advocate to address the escalation of online harassment, intimidation, and threats of violence targeting physicians, other health workers, and anyone seeking health care treatment, including measures to strengthen the Criminal Code of Canada and the Canadian Human Rights Act. BUDGET: Provide CMA’s perspective on the Government of Canada’s budget, particularly as it relates to modernizing Canada’s health care system by enhancing efficiency, driving innovation, and promoting equitable access to care. HEALTH DATA INTEROPERBILITY: Provide CMA’s perspective as it relates to health data interoperability that would ensure providers have access to the right information at the right time when providing care, and improve patient outcomes and their health care experience. The CMA is advocating that the trade of medical goods and medications be protected to avoid disruptions to patient care. Specifically, that the government: Continue to ensure pharmaceutical products and medical devices are not included in any countermeasures on tariffs Improve safeguards for Canadian health data Improve labour mobility so physicians can work across the country Make it easier for qualified physicians to immigrate and work in Canada, including by fast-tracking immigration steps for US physicians PAN CANADIAN LICENSURE: Advocate for the ability for physicians with full licences to practise independently without restrictions or for medical resident trainees registered in any Canadian jurisdiction to practise or train in any other Canadian jurisdiction without having to acquire more than one licence or pay additional licensing fees. This includes exploring enabling legislation in the provinces and territories. INTEGRATED HEALTH HUMAN RESOURCES: Advocate for an Integrated Health Human Resources Strategy, including creating retention incentives and addressing administrative burden for health care professionals, increasing the number of doctors and nurses and ensuring that every Canadian has access to a family doctor or primary health team, increasing access to virtual care, creating an action plan to get internationally trained health care professionals to work, improving workforce data collection across health systems and investing in a supply needs-based planning tool, and facilitating team-based health care. ADMINISTRATIVE BURDEN: Advocate for measures to alleviate the administrative burden on physicians and support their professional wellbeing, including investment to facilitate the development of EHRs and EMRs in Canada, improved remuneration for the completion of federal health forms, ensuring that physicians are not captured in the definition of "promoters" in the Disability Tax Credit Promoters Restrictions Regulations, and advocacy on discontinuing the requirement that employees present sick notes to their employers. MEDICAL MIS/DISINFORMATION: Provide CMA’s perspective on the impacts of medical misinformation and disinformation, including on public trust in science, medicine, and public health experts. INDIGENOUS HEALTH: Improvement to the health and health care services provided to Indigenous peoples in Canada, including adding inclusive lettering on health cards across Canada. Advocating for the creation of a national Chief Health Accountability Officer. PUBLIC-PRIVATE HEALTHCARE: The CMA is conducting a series of in-person sessions across the country to engage key stakeholders, including the public, physicians, patients/PWLE, policymakers, system leaders and others, in a dialogue on public-private healthcare. What we hear will inform CMA policy moving forward, and our recommendations for action at a national level. PHYSICIAN PARLIAMENTARIAN CAUCUS: advocate for the formation of a Physician Parliamentarian Cauc

BUDGET: Provide CMA’s perspective on the Government of Canada’s budget, particularly as it relates to modernizing Canada’s health care system by enhancing efficiency, driving innovation, and promoting equitable access to care. HARMFUL ONLINE CONTENT: Advocate to address the escalation of online harassment, intimidation, and threats of violence targeting physicians, other health workers, and anyone seeking health care treatment, including measures to strengthen the Criminal Code of Canada and the Canadian Human Rights Act. TECHNOLOGY AND ARTIFICIAL INTELLIGENCE: provide CMA’s perspective on the impact of technology and artificial intelligence on the health care sector and the means through which advancements can be foreseen and managed. HEALTH DATA INTEROPERBILITY: Provide CMA’s perspective as it relates to health data interoperability that would ensure providers have access to the right information at the right time when providing care, and improve patient outcomes and their health care experience. The CMA is advocating that the trade of medical goods and medications be protected to avoid disruptions to patient care. Specifically, that the government: Continue to ensure pharmaceutical products and medical devices are not included in any countermeasures on tariffs. Improve safeguards for Canadian health data. Improve labour mobility so physicians can work across the country. Make it easier for qualified physicians to immigrate and work in Canada, including by fast-tracking immigration steps for US physicians. MEDICAL MIS/DISINFORMATION: Provide CMA’s perspective on the impacts of medical misinformation and disinformation, including on public trust in science, medicine, and public health experts. PAN CANADIAN LICENSURE: Advocate for the ability for physicians with full licences to practise independently without restrictions or for medical resident trainees registered in any Canadian jurisdiction to practise or train in any other Canadian jurisdiction without having to acquire more than one licence or pay additional licensing fees. This includes exploring enabling legislation in the provinces and territories. INTEGRATED HEALTH HUMAN RESOURCES: Advocate for an Integrated Health Human Resources Strategy, including creating retention incentives and addressing administrative burden for health care professionals, increasing the number of doctors and nurses and ensuring that every Canadian has access to a family doctor or primary health team, increasing access to virtual care, creating an action plan to get internationally trained health care professionals to work, improving workforce data collection across health systems and investing in a supply needs-based planning tool, and facilitating team-based health care. ADMINISTRATIVE BURDEN: Advocate for measures to alleviate the administrative burden on physicians and support their professional wellbeing, including investment to facilitate the development of EHRs and EMRs in Canada, improved remuneration for the completion of federal health forms, ensuring that physicians are not captured in the definition of "promoters" in the Disability Tax Credit Promoters Restrictions Regulations, and advocacy on discontinuing the requirement that employees present sick notes to their employers. INDIGENOUS HEALTH: Improvement to the health and health care services provided to Indigenous peoples in Canada, including adding inclusive lettering on health cards across Canada. Advocating for the creation of a national Chief Health Accountability Officer. PUBLIC-PRIVATE HEALTHCARE: The CMA is conducting a series of in-person sessions across the country to engage key stakeholders, including the public, physicians, patients/PWLE, policymakers, system leaders and others, in a dialogue on public-private healthcare. What we hear will inform CMA policy moving forward, and our recommendations for action at a national level. PHYSICIAN PARLIAMENTARIAN CAUCUS: advocate for the formation of a Physician Parliamentarian

HEALTH DATA INTEROPERBILITY: Provide CMA’s perspective as it relates to health data interoperability that would ensure providers have access to the right information at the right time when providing care, and improve patient outcomes and their health care experience. BUDGET: Provide CMA’s perspective on the Government of Canada’s budget, particularly as it relates to modernizing Canada’s health care system by enhancing efficiency, driving innovation, and promoting equitable access to care. HARMFUL ONLINE CONTENT: Advocate to address the escalation of online harassment, intimidation, and threats of violence targeting physicians, other health workers, and anyone seeking health care treatment, including measures to strengthen the Criminal Code of Canada and the Canadian Human Rights Act. TECHNOLOGY AND ARTIFICIAL INTELLIGENCE: provide CMA’s perspective on the impact of technology and artificial intelligence on the health care sector and the means through which advancements can be foreseen and managed. HEALTH PROMOTION AND DISEASE PREVENTION: Increased investments in health and social-determinants-of-health related programs, including measures to address the opioid crisis, mental health and addictions, and the regulation of natural health products. ADMINISTRATIVE BURDEN: Advocate for measures to alleviate the administrative burden on physicians and support their professional wellbeing, including investment to facilitate the development of EHRs and EMRs in Canada, improved remuneration for the completion of federal health forms, the development of a Federal Disability Benefit, ensuring that physicians are not captured in the definition of "promoters" in the Disability Tax Credit Promoters Restrictions Regulations, providing clarity and guidance on federal forms, and advocacy on discontinuing the requirement that employees present sick notes to their employers. The CMA is advocating that the trade of medical goods and medications be protected to avoid disruptions to patient care. Specifically, that the government: Continue to ensure pharmaceutical products and medical devices are not included in any countermeasures on tariffs. Improve safeguards for Canadian health data. Improve labour mobility so physicians can work across the country. Make it easier for qualified physicians to immigrate and work in Canada, including by fast-tracking immigration steps for US physicians. PAN CANADIAN LICENSURE: Advocate for the ability for physicians with full licences to practise independently without restrictions or for medical resident trainees registered in any Canadian jurisdiction to practise or train in any other Canadian jurisdiction without having to acquire more than one licence or pay additional licensing fees. This includes exploring enabling legislation in the provinces and territories. INTEGRATED HEALTH HUMAN RESOURCES Advocate for an Integrated Health Human Resources Strategy, including creating retention incentives and addressing administrative burden for health care professionals, increasing the number of doctors and nurses and ensuring that every Canadian has access to a family doctor or primary health team, increasing access to virtual care, creating an action plan to get internationally trained health care professionals to work, improving workforce data collection across health systems and investing in a supply needs-based planning tool, and facilitating team-based health care. MEDICAL MIS/DISINFORMATION: Provide CMA’s perspective on the impacts of medical misinformation and disinformation, including on public trust in science, medicine, and public health experts. INDIGENOUS HEALTH: Improvement to the health and health care services provided to Indigenous peoples in Canada including adding inclusive lettering on health cards across Canada. Advocating for the creation of a national Chief Health Accountability Officer. PUBLIC-PRIVATE HEALTHCARE: The CMA is conducting a series of in-person sessions across the country to engage key s

INDIGENOUS HEALTH: Improvement to the health and health care services provided to Indigenous peoples in Canada including adding inclusive lettering on health cards across Canada. Advocating for the creation of a national Chief Health Accountability Officer. TECHNOLOGY AND ARTIFICIAL INTELLIGENCE: provide CMA’s perspective on the impact of technology and artificial intelligence on the health care sector including input on Bill C-27, and the means through which advancements can be foreseen and managed. PUBLIC-PRIVATE HEALTHCARE: The CMA is conducting a series of in-person sessions across the country to engage key stakeholders, including the public, physicians, patients/PWLE, policymakers, system leaders and others, in a dialogue on public-private healthcare. What we hear will inform CMA policy moving forward, and our recommendations for action at a national level. PHYSICIAN PARLIAMENTARIAN CAUCUS: advocate for the formation of a Physician Parliamentarian Caucus as a means of examining deficiencies in the health care system and proposing solutions. PHYSICAL, PSYCHOLOGICAL AND CULTURAL SAFETY: Advocate to address the challenges and opportunities for physical, psychological and cultural safety within Canada’s health system, including the implementation of a nation-wide anti-racism plan, the creation of a Canada Mental Health transfer, improving access to mental health services to physicians and their families, gender-affirming care, creating an emergency National Mental Health Support Services hotline for all health care providers, the creation of a National Physicians Day in Canada, ensuring safe and unimpeded access to health care facilities for health care workers and patients. PERSONAL INFORMATION PROTECTION AND ELECTRONIC DOCUMENT ACT (PIPEDA) PRIVACY PROTECTION OF HEALTH INFORMATION AND THE REGULATORY REVIEW: Improvement to privacy legislation to protect the privacy of health information. PAN CANADIAN LICENSURE: Advocate for the ability for physicians with full licences to practise independently without restrictions or for medical resident trainees registered in any Canadian jurisdiction to practise or train in any other Canadian jurisdiction without having to acquire more than one licence or pay additional licensing fees. This includes exploring enabling legislation in the provinces and territories. NET ZERO: Advocate for sustainable health systems in Canada, including reaching net-zero emissions by 2050; advocate for the establishment of a national climate and health secretariat within the federal government to develop a pan-Canadian approach to addressing the impacts of climate change and health; and advocate for a targeted health infrastructure fund as part of the federal government’s long-term plan for public infrastructure. MEDICAL ASSISTANCE IN DYING: Advancing the medical profession’s perspectives on medical assistance in dying. INTEGRATED HEALTH HUMAN RESOURCES Advocate for an Integrated Health Human Resources Strategy, including creating retention incentives and addressing administrative burden for health care professionals, increasing the number of doctors and nurses and ensuring that every Canadian has access to a family doctor or primary health team, increasing access to virtual care, creating an action plan to get internationally trained health care professionals to work, improving workforce data collection across health systems and investing in a supply needs-based planning tool, and facilitating team-based health care. INDIGENOUS HEALTH AND RECONCILIATION WITH INDIGENOUS PEOPLES: Implementation of the Calls to Action of the Truth and Reconciliation Commission, including addressing the ongoing structural inequities that marginalize Indigenous Peoples, advancing the inclusion of Indigenous Peoples in societal systems and sectors, including health systems, and committing to collaborative and respectful relationships with Indigenous patients and communities. The CMA is also advocating to increase trust between Ind

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 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 delivery of timely access to needed medicines to the developing world supported by a b

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

Advocacy on the creation of the Health Emergency Readiness Canada (HERC) Agency Contribution to the Government Public consultations on Canada-United States-Mexico Agreement to inform Canada’s priorities in preparation for the first joint review of CUSMA by Canada, the United States and Mexico in 2026 and ahead of Canada’s chairing of the 5th meeting of the CUSMA Free Trade Commission, in 2025. Advocacy on the proposed Regulations Amending the Patent Rules and Certain Regulations Made Under the Patent Act which were published for consultation in Canada Gazette Part I (CGI) on May 18, 2024.1 Share concerns with Canada’s implementation of a patent term adjustment (PTA) system that is not compliant with its trade obligations, as it does not provide a meaningful remedy to patentees who are impacted by unreasonable patent office delays. 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. Regulations, policies and programs related to the reimbursement recommendations decision-making process and framework done by the Canadian Drug Agency as well as the review times and processes conducted by Health Canada for the purpose of obtaining a notice of compliance. Patented Medicine Prices Review Board (PMPRB) amendments to the Patented Medicines Regulations and the related proposed guidelines. Monitoring and engaging the Government and Parliamentarians on the House of Commons Standing Committee on Public Accounts (PACP) motion related to the discloser on vaccine contracts Monitoring and engaging the Government and Parliamentarians on policies and programs related to Canada's life sciences & biomanufacturing strategy Monitoring and engaging on the Government’s commitment to create a national strategy for rare diseases; the Canadian Drug Agency; and C64, An Act to Implement pharmacare. Health Canada’s policies, program and guidelines related to the management, prevention, mitigation and notification of drug shortages Federal Public Drug Plans, with respect to the reimbursement of therapeutic products for Federal plan beneficiaries Engage the Federal Government on Health Canada’s Regulatory Innovation Agenda (Agile Licensing Modernization) to discuss opportunities for further harmonization; flexibility and predictability in the new regulatory framework being develop and its linkage to pillar 5 of the Biomanufacturing and Life Sciences Strategy. Discussions on the procurement of a COVID19 vaccine and therapy Discussions around the World Trade Organization consideration of a TRIPS Patent Waiver and the World Health Organization pandemic treaty proposal Consider amendments to 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 potential importation legislation in the United States. Advocacy to maintain and increase funding for the National Immunization Strategy and discussions on vaccine procurement.

Pharmaceutical pricing policy issues arising from the jurisdiction of the Patented Medicines Prices Review Board (PMPRB). Free trade agreements as they relate to the biopharmaceutical industry. 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. Advocacy related to the new Buy Canada policy and the implications of including goods and services related to healthcare delivery, medical treatment, in particular drugs, vaccines and biologicals. Advocacy as it relates to the Government of Canada potential responses to the US Administration Most Favored Nation drug pricing policy Monitoring and engaging on the Government’s national strategy for rare diseases; the Canadian Drug Agency; and the implementation of C64, An Act to Implement pharmacare. Patented Medicine Prices Review Board (PMPRB) amendments to the Patented Medicines Regulations and the related new guidelines. Advocacy on the Regulations Amending the Patent Rules and Certain Regulations Made Under the Patent Act which were published for consultation in Canada Gazette Part I (CGI) on May 18, 2024.1 Share concerns with Canada’s implementation of a patent term adjustment (PTA) system that is not compliant with its trade obligations, as it does not provide a meaningful remedy to patentees who are impacted by unreasonable patent office delays. Advocacy related to the federal government consultation on the review of the Canada US Mexico Trade Agreement Advocacy on the role of the Health Emergency Readiness Canada (HERC) Agency Advocacy with respect to Canada's proposed Countermeasures in Response to United States Tariffs on Canadian goods 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. Regulations, policies and programs related to the reimbursement recommendations decision-making process and framework done by the Canadian Drug Agency as well as the review times and processes conducted by Health Canada for the purpose of obtaining a notice of compliance. Monitoring and engaging the Government and Parliamentarians on policies and programs related to Canada's life sciences & biomanufacturing strategy Health Canada’s policies, program and guidelines related to the management, prevention, mitigation and notification of drug shortages Federal Public Drug Plans, with respect to the reimbursement of therapeutic products for Federal plan beneficiaries Engage the Federal Government on Health Canada’s Regulatory Innovation Agenda (Agile Licensing Modernization) to discuss opportunities for further harmonization; flexibility and predictability in the new regulatory framework being develop and its linkage to pillar 5 of the Biomanufacturing and Life Sciences Strategy. Discussions on the procurement of a COVID19 vaccine and therapy Discussions around the World Trade Organization consideration of a TRIPS Patent Waiver and the World Health Organization pandemic treaty proposal Consider amendments to 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 potential importation legislation in the United States. Advocacy to maintain and increase funding for the National Immunization Strategy and discussions on vaccine procurement.

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.

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. Innovation, Science and Economic Development (ISED)'s Biomanufacturing and Life Sciences Strategy, pertaining to growth and development of the life sciences industry 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 the Canadian 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.

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 Food and Drug regulations as it relates to data protection and the regulation and protection of biopharmaceutical products Canada's Drug Agency (CDA) policies as it relates to health economics assessment and recommendations made on new medicines. 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. Free Trade agreements as they relate to the biopharmaceutical industry 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.

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.

Enhancing cybersecurity resiliency and standards in the health sector. Improving Canada’s physical and digital infrastructure for both health research and healthcare delivery. Strengthening Canada’s health workforce including through the development of a pan-Canadian health workforce plan. Federal role in the health system as it relates to funding, the use of federal spending power, and pan-Canadian priorities, including in the areas of aging, older adult care, child and youth health, mental health and substance use, palliative care, Indigenous health, public health, and data. Advancing Canada’s health research and innovation agenda as it relates to funding, policy and program design, and regulatory matters, including in the areas of clinical trials and development of innovative medical treatments.

Strengthening Canada’s health workforce including promoting health workforce safety. Advancing adoption of AI in the healthcare and health research sectors. Improving Canada’s physical and digital infrastructure for both health research and healthcare delivery. Federal role in the health system as it relates to funding, the use of federal spending power, and pan-Canadian priorities, including in the areas of aging, older adult care, child and youth health, mental health and substance use, palliative care, Indigenous health, public health, and data. Advancing Canada’s health research and innovation agenda as it relates to funding, policy and program design, and regulatory matters, including in the areas of clinical trials and development of innovative medical treatments.

Federal role in the health system as it relates to funding, the use of federal spending power, and pan-Canadian priorities, including in the areas of physical and digital infrastructure, health workforce, immigration, aging, older adult care, child and youth health, mental health and substance use, palliative care, cybersecurity, Indigenous health, environment, and data. Advancing Canada’s health research and innovation agenda as it relates to funding, policy and program design, and regulatory matters, including in the areas of clinical trials and development of innovative medical treatments.

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

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

Connected Care for Canadians Act (BILL S-5) : Urging federal policy makers to adopt this legislation quickly and to ensure that it is supported by a robust set of regulations. Provide CFPC's perspective on Federal Budget 2025's initiative to “Improving Access to Health Care in the Arctic and the North”. Funds should be directed to supporting family practices, as part of the Federal government's Health Infrastructure Fund announced in Budget 2025. Fulfill key investments to support family doctors, promised by the Liberal Party during the 2025 Federal elections. This includes initiatives to provide admin burden relief, set up a new FP practice fund, and create new residency seats. Indigenous Health: support for health care initiatives and education that improve health outcomes for Indigenous people of Canada and address the adverse effects of systemic racism, in line with the Truth and Reconciliation Commission of Canada’s calls for action. Support family doctors with teams, as that is a key enabler to providing high quality primary care Fund CFPC efforts to streamline foreign credential recognition of internationally educated family physicians to bolster the health workforce. Invest in family medicine by adding new family doctors and directing funding to expand training, have fair compensation, and other recruitment/retention measures. Addressing administrative burden: Administrative burden consistently ranks as a top concern for family physicians. This time comes in the way of providing patient care. One of the significant sources of administrative burden for family physicians is filling out federal health forms. Universal Pharmacare - We advocate for universal national single payer program for prescription medication that would improve coverage across Canada and result in logistical efficiencies for the system.

Connected Care for Canadians Act (BILL S-5) : Urging federal policy makers to adopt this legislation quickly and to ensure that it is supported by a robust set of regulations. Provide CFPC's perspective on Federal Budget 2025's initiative to “Improving Access to Health Care in the Arctic and the North”. Funds should be directed to supporting family practices, as part of the Federal government's Health Infrastructure Fund announced in Budget 2025. Fulfill key investments to support family doctors, promised by the Liberal Party during the 2025 Federal elections. This includes initiatives to provide admin burden relief, set up a new FP practice fund, and create new residency seats. Support family doctors with teams, as that is a key enabler to providing high quality primary care Invest in family medicine by adding new family doctors and directing funding to expand training, have fair compensation, and other recruitment/retention measures. Fund CFPC efforts to streamline foreign credential recognition of internationally educated family physicians to bolster the health workforce. Addressing administrative burden: Administrative burden consistently ranks as a top concern for family physicians. This time comes in the way of providing patient care. One of the significant sources of administrative burden for family physicians is filling out federal health forms.

Universal Pharmacare - We advocate for universal national single payer program for prescription medication that would improve coverage across Canada and result in logistical efficiencies for the system. The importance of family medicine research and the impact it has on family medicine, primary care and the health care system. Want to ensure that family medicine research is acknowledged by federal officials as requiring sufficient supports. Scopes of Practice and collaborative care: support for enhanced intra- and inter-professional collaboration Public Health: support for family physician involvement in not only playing a pivotal role in the delivery of public health but also in planning for public health emergencies. Family physicians and their practices are essential in contributing pandemic response and are fundamental partners in supporting large-scale vaccination rollout in all provinces and territories - both as a source of accurate information and delivery points for vaccines. Patient's Medical Home (PMH): identified by its patients as the place that serves as the home base or central hub for the timely provision and/or coordination of all their health and medical care needs. Implementation of PMH is desired across Canada, including appropriate integration of virtual care and its application as a part of longitudinal relationship-based care in alignment with the PMH vision. Looking for support for and understanding of the role of social determinants of health (SDoH) and how these determinants, such as poverty, impact Canadians. The CFPC continues to call attention to SDoH, the role family physicians play and the expectations we have of federal decision-makers to acknowledge SDoH when crafting policies and programs. Indigenous Health: support for health care initiatives and education that improve health outcomes for Indigenous people of Canada and address the adverse effects of systemic racism, in line with the Truth and Reconciliation Commission of Canada’s calls for action. The CFPC maintains strong support of the proposed National Consortium for Indigenous Medical Education involving medical learners, educators, and physicians to ensure that training and continued professional development in caring for Indigenous patients are delivered through a lens of cultural humility and cultural safety. Health Human Resources: encourage support for the College of Family Physician's goal of every Canadian having their own family physician. The College of Family Physicians of Canada is also recommending increased federal support for a pan-Canadian health human resources plan to strengthen primary care. Investment into Primary Health Care Transition Fund would help improve Canada-wide access to family practices and allied primary care.