Ophelia John

Seek funding and support for pilot projects making anti-infective medications available to equity seeking populations, helping to combat AMR. Engage with government to strengthen the Priority Review of Drug Submissions process. The Government of Ontario has passed legislation requiring the public disclosure of payments made to Health Care Providers and Health Care Organizations by the broader health care industry, including pharmaceutical companies, generic manufacturers, and medical device companies. GlaxoSmithKline seeks to advocate for a national approach to disclosure through either the support of similar provincial initiatives, coordinated action through the Federal / Provincial and Territorial meetings of the Ministers of Health, and / or the establishment of national requirements. Sharing information with government and Members of Parliament on different models for national pharmacare, specifically as it relates to access to medicines. Renewal of national vaccine strategy to close gaps in vaccination coverage for Canadians, especially among seniors. Reforms to the Patented Medicines Review Board (PMPRB), whose guidelines seek to ensure a balance between the prices set by manufacturers for patented medicines sold in Canada and the maintenance of an attractive environment for pharmaceutical research and development. Specifically with regard to ensuring that any actions and proposed changes by the PMPRB do not negatively impact access to patented medicines in Canada. Raise awareness regarding the potential risks to drug and vaccine supply for Canadian patients arising from new U.S. state-level reimportation legislation. Participation in consultations regarding the Digital Charter and the federal government's plans to overhaul Canada's privacy regime, to enable the use of anonymized health data for new medication research and development. Input on the work of the Advisory Committee on the Implementation of National Pharmacare, specifically as it relates to access to medicines. Ensure the National Advisory Committee on Immunization has sufficient resources to undertake timely reviews of new vaccines that are made available to the Canadian marketplace. Engaging Health Canada on the Self-Care Products Initiative as it pertains to plain language labelling and a risk-based approach to regulatory oversight for non prescription drugs. Engage the government regarding the need for clear and efficient procurement processes for COVID-19 medical countermeasures, including COVID-19 therapeutics, to ensure access for Canadians. Engage government officials regarding domestic manufacturing of seasonal and pandemic flu vaccine. Antimicrobial Resistance (AMR) - Identification of the need for a multi-sectoral stakeholder working group to pursue joint goals under a Pan-Canadian AMR strategy and to strengthen Canada's end-to-end research capacity in AMR.

Engagement with the Government regarding the Life Science Fund seeking partnership and funding to support completion of Phase I and Phase II clinical research program associated to AMR (antimicrobial resistance) Antimicrobial Resistance (AMR) - Seek funding and support for pilot projects making anti-infective medications available to equity seeking populations, helping to combat AMR. Also discuss any applicable conditions regarding this funding. Programs and policy to support Canadian biomanufacturing and access to medicines and vaccines for Canadians. National Immunization Strategy and policies and programs that impact public access to vaccines and disease prevention in Canada. Patented Medicines Review Board (PMPRB), certified under the Patent Act and whose guidelines seek to ensure a balance between the prices set by manufacturers for patented medicines sold in Canada and the maintenance of an attractive environment for pharmaceutical research and development. Engagement with federal officials regarding the Biomanufacturing & Life Sciences Strategy and policies and programming related to biomanufacturing in Canada Access to medicines - government policies, processes, legislation, and/or regulation with potential impact on access to medicines in Canada. Trade-related matters, including policies and tariffs impacting medicines and vaccines. Policies and programs related to the health of new immigrants to Canada. Policies, programs, and funding related to Canada's Sexually Transmitted and Blood-Borne Infections (STBBI) Action Plan 2024-2030. Engagement with federal officials regarding Health Emergency Readiness Canada. The National Pharmaceutical Strategy (NPS) as agreed by First Ministers in 2004. Advocacy for ways to increase access to medicines and vaccines for Canadian patients. The Common Drug Review (CDR) process for reviewing new drugs and providing listing recommendations to publicly funded drug benefit plans in Canada. Ensuring the access needs of Canadian patients are met by advocating on activities undertaken in the context of the CDR. Science and Technology (S&T) Strategy: Mobilizing Science and Technology to Canada's Advantage. Advocacy for measures which will allow for commercialization in health care to occur and for Canada to remain competitive internationally on Intellectual Property and other fronts. Public Services and Procurement Canada (PSPC) Integrity Framework - Clarifying the process for procurement of vaccines and possibly pharmaceuticals under the evolving procurement framework. Patented Medicines (Notice of Compliance) Regulations which seek to balance the protection of Intellectual Property (IP) and patents with cost containment. Advocacy to ensure that IP rights are respected and internationally competitive in order to promote Research and Development. Legislation, regulations, policies and programs concerning the federal government's response to COVID-19, including pandemic preparedness, pharmaceutical and vaccine supply-chain management, and general administration of justice. Food and Drugs Act and the bill formerly known as Bill C-51: An Act to amend the Food and Drugs Act and to make consequential amendments to other Acts. Specifically, with respect to the renewal of the drug approval process. Advocacy to ensure that Canada's review and approval process is timely, safe, effective, competitive and consistent with other jurisdictions. FedDev Ontario Advanced Manufacturing Fund - advancing manufacturing of innovative pharmaceutical products in southern Ontario Engage with government to strengthen the Priority Review for Drug Submissions process. Engage the Government regarding the need for clear and efficient procurement processes for COVID-19 medical countermeasures, including COVID-19 therapeutics, to ensure access for Canadians. Engagement with the Government regarding the Strategic Innovation Fund Drug Re-importation - Raise awareness regarding the potential risks to drug and vaccine supply fo

Canadian Institutes of Health Research (CIHR) as it relates to federal funding & long term investment in health research. Access to treatments as it relates to the current regulatory and price negotiation processes to enhance timely access to all Health Canada approved Multiple Sclerosis (MS) disease-modifying therapies, with respect to the National Strategy for Drugs for Rare Diseases and national pharmacare. We ask the federal government to fund MS research in partnership with MS Canada, leveraging our connections and expertise to focus and further our understanding of MS, pursue leading-edge research on repair and regeneration, and explore prevention strategies, including targeting the Epstein-Barr virus (EBV). Safe Long-Term Care Act with respect to persons affected by MS. National Housing Strategy with respect for persons with MS and other chronic conditions and disabilities. Measures and funding for the charitable sector generally. Home care, with respect to creation with provincial/ territorial governments programs relating to increased home care for persons with MS and other disabilities/ diseases and the support of caregivers. Federal Budget: Allocate funding for the Canada Disability Benefit, the Employment Insurance Sickness Benefit; health research; access to treatment and care; and other budgetary policy as it relates to MS. Establishment of national strategy for neurological conditions, with respect to persons with MS and other neurological conditions. Employment Insurance sickness benefits, with respect to creation of flexible benefits for persons with MS and other episodic disabilities. Disability Tax Credit with respect to making it refundable and ensuring eligibility for Canadians with episodic disabilities. Comprehensive disability income programs, with respect to persons with MS and other chronic and episodic disabilities. Canada Pension Plan – Disability with respect to eligibility for persons with MS and other chronic and episodic disabilities Canada Health Transfer - health system funding transfer and agreements intended for provinces/territories to support the delivery of healthcare services, including MS care. Canada Health Act and regulations, as it relates to long-term and home care. Canada Disability Benefit Regulations, with respect to creating a benefit that can be accessed by Canadians with episodic disabilities and lifts Canadians with disabilities out of poverty Bill C-64, An Act Respecting Pharmacare with respect for persons with MS and other chronic conditions and disabilities

Postal service disruption and the significant hardships these disruptions cause for Canadians and on health charities We ask the federal government to fund MS research in partnership with MS Canada, leveraging our connections and expertise to focus and further our understanding of MS, pursue leading-edge research on repair and regeneration, and explore prevention strategies, including targeting the Epstein-Barr virus (EBV). Safe Long-Term Care Act with respect to persons affected by MS National Housing Strategy with respect for persons with MS and other chronic conditions and disabilities Measures and funding for the charitable sector generally Home care, with respect to creation with provincial/ territorial governments programs relating to increased home care for persons with MS and other disabilities/ diseases and the support of caregivers Federal Budget: Allocate funding for the Canada Disability Benefit, the Employment Insurance Sickness Benefit; health research; access to treatment and care; and other budgetary policy as it relates to MS. Establishment of national strategy for neurological conditions, with respect to persons with MS and other neurological conditions. Employment Insurance sickness benefits, with respect to creation of flexible benefits for persons with MS and other episodic disabilities Disability Tax Credit with respect to making it refundable and ensuring eligibility for Canadians with episodic disabilities Comprehensive disability income programs, with respect to persons with MS and other chronic and episodic disabilities CIHR as it relates to federal funding & long term investment in health research Canada Pension Plan – Disability with respect to eligibility for persons with MS and other chronic and episodic disabilities Canada Health Transfer - health system funding transfer and agreements intended for provinces/territories to support the delivery of healthcare services, including MS care Canada Health Act and regulations, as it relates to long-term and home care Bill C-64, An Act Respecting Pharmacare with respect for persons with MS and other chronic conditions and disabilities Access to treatments as it relates to the current regulatory and price negotiation processes to enhance timely access to all Health Canada approved MS disease-modifying therapies, with respect to the National Strategy for Drugs for Rare Diseases and national pharmacare.

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

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.

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.

Government Bill (Senate)- Bill S-5 - Connected Care-An Act respecting the interoperability of health information technology and to prohibit data blocking by health information technology vendors Federal guidelines with respect to procurement of medical technologies and adoption of innovation in the healthcare industry, and economic development and promotion for the life sciences sector Public Bill (Senate) S-243- National Framework for Women's Health Federal life sciences strategy with respect to patient safety, managing high-risk drugs, medication errors, healthcare worker safety, infection and disease prevention, health system planning and resilience. Canadian-United States-Mexico Agreement (CUSMA) with respect to provisions relating to medical devices and technologies Federal life sciences strategy with respect to global value chain and supply chain management and investment towards medical technology manufacturing and export. Federal budget with respect to medical technology and device innovation and adoption, support and delivery of new models of care, equitable healthcare access, innovation, women’s health, and investments in long-term care and home care Discuss policies around healthcare system resiliency, health system planning, infection prevention, medication errors, women's health, and health equity including access Regulations under the Food and Drugs Act, including the Medical Devices Regulation, with respect to the approval of medical technologies Federal life sciences strategy, focusing on promoting collaboration with respect to clinical and scientific research in the healthcare industry and accelerating innovation to improve health and economic outcomes.

Regulations under the Food and Drugs Act, including the Medical Devices Regulation, with respect to the approval of medical technologies North American Free Trade Agreement (NAFTA), with respect to provisions relating to medical devices and technologies Federal science & technology strategy, focusing on promoting collaboration with respect to clinical and scientific research in the healthcare industry Federal life sciences strategy with respect to patient safety, managing high-risk drugs, medication errors, healthcare worker safety, infection and disease prevention, antimicrobial resistance, and diagnostic testing. Federal life sciences strategy, focusing on promoting collaboration with respect to clinical and scientific research in the healthcare industry and accelerating innovation to improve health and economic outcomes. Federal initiatives with respect to the Canadian Life Sciences strategy and intergovernmental policy, funding, legislative, and guideline changes. Federal guidelines with respect to procurement of medical technologies and adoption of innovation in the healthcare industry, and economic development and promotion for the life sciences sector Federal budget with respect to science and technology in the healthcare sector, specifically with respect to medical technology and device innovation and adoption, support and delivery new models of care, equitable healthcare access, and women’s health. Federal budget with respect to public sector investments in long-term care and home care. Discuss policies around anti-microbial resistance, infection prevention and medication errors

Engaging government regarding the implementation of software and software-related services, information management, and information technology for payroll and human resource solutions.

Engage with the Government of Canada on programs and policies related to innovation, the digital economy, and the adoption of information and communication technologies. Engage with the Government of Canada on Procurement Policy as it related to technology adoption. Engage with the Government of Canada on Policy as it relates to cybersecurity and national security. Engage with the Government of Canada on Policy as it relates to artificial intelligence and data privacy and protection. Engage with the Government of Canada on Accessibility policy as it relates to the enactment of the Accessible Canada Act.

Engage with the Government of Canada on Procurement Policy as it related to technology adoption. Engage with the Government of Canada on Policy as it relates to cybersecurity and national security. Engage with the Government of Canada on Policy as it relates to artificial intelligence and data privacy and protection. Engage with the Government of Canada on Accessibility policy as it relates to the enactment of the Accessible Canada Act. Engage with the Government of Canada on programs and policies related to innovation, the digital economy, and the adoption of information and communication technologies.

Engage with the Government of Canada on programs and policies related to innovation, the digital economy, and the adoption of information and communication technologies. Engage with the Government of Canada on Procurement Policy as it related to technology adoption. Engage with the Government of Canada on Policy as it relates to cybersecurity and national security. Engage with the Government of Canada on Accessibility policy as it relates to the enactment of the Accessible Canada Act.

The submission of an application for a ministerial exemption under s. 56 of the Controlled Drugs and Substances Act.

Policy to promote innovation in antimicrobial stewardship, surveillance and infection prevention and control. Address the growing public health threat of antimicrobial resistance through policy to encourage research, innovation and adoption of novel therapeutics, diagnostics, vaccines and other alternative technologies

Seeking funding support for genomics and related sciences research in Canada through the financing of Genome Canada's activities.