Matthew Tunis

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(SEBs) as it relates to Regulations, Policies, or Guidelines being developed by Health Canada, specifically the Draft Guidance Document on SEBs, the Notices of Changes to Health Canada's Guidance Documents on Data Protection and Patented Medicines Regulations (Notice of Compliance)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 biopharmaceutical products. Health Canada's Regulatory Roadmap for Health Products and Food as it relates to proposed policy and regulatory changes related to the review, approval, transparency and compliance activities of biopharmacuetical products. 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. Federal Government involvement in national strategies to address major chronic diseases having a significant burden on the Canadian health care system, such as Dementia, Diabetes, Hepatitis C and Cancer and major public health concerns such as Antimicrobial resistant. 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 Initiatives as it relates to public/private research and development partnerships and to the Drug Safety and Effective Network (DSEN). Canadian Environmental Protection Act and Regulations in respect of modern, science-based regulations to reflect rapidly changing new technologies. 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 business

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