3Sixty Public Affairs

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

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

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

Discussions on the implications of Bill C-265 An Act to amend the Food and Drugs Act (List of Therapeutic Products Pre-approved for Special Access) for patients’ access to drugs for rare diseases. Regulations, guidelines, policies and programs related to regulatory and reporting functions of the Patented Medicine Prices Review Board as they relate to access for patients to rare disease medicines. Federally-funded public drug plans, with respect to reimbursement for rare disease medicines for federal plan beneficiaries. Enhancements related to intellectual property legislation, regulations and policies applicable to rare disease medicines. Regulatory amendments and/or guidelines related to the Food and Drugs Act Regulations and Health Canada to implement an orphan drug regulatory framework. Scientific Research and Experimental Development Tax Incentive Program as it pertains to research and development of treatments for rare disorders. Enhancement to Canada's regulatory and funding environment for new rare disease medicines, including Health Canada authorizations of medicines and framework for clinical trials, health technology assessment processes, reimbursement negotiations and funding decisions to improve access for rare disease patients. Innovation, Science and Economic Development Canada policies related to research and development for treatments for rare disorders. Implementation of the Pharmacare Act as it relates to rare disease medicines. Implementation of the National Strategy for Drugs for Rare Diseases, and other policies or programs for rare disease medicines.

Discussions on the implications of Bill C-265 An Act to amend the Food and Drugs Act (List of Therapeutic Products Pre-approved for Special Access) for patients’ access to drugs for rare diseases. Regulations, guidelines, policies and programs related to regulatory and reporting functions of the Patented Medicine Prices Review Board as they relate to access for patients to rare disease medicines Federally-funded public drug plans, with respect to reimbursement for rare disease medicines for federal plan beneficiaries. Enhancements related to intellectual property legislation, regulations and policies applicable to rare disease medicines. Regulatory amendments and/or guidelines related to the Food and Drugs Act Regulations and Health Canada to implement an orphan drug regulatory framework. Scientific Research and Experimental Development Tax Incentive Program as it pertains to research and development of treatments for rare disorders. Enhancement to Canada's regulatory and funding environment for new rare disease medicines, including Health Canada authorizations of medicines and framework for clinical trials, health technology assessment processes, reimbursement negotiations and funding decisions to improve access for rare disease patients Innovation, Science and Economic Development Canada policies related to research and development for treatments for rare disorders. Implementation of the Pharmacare Act as it relates to rare disease medicines. Implementation of the National Strategy for Drugs for Rare Diseases, and other policies or programs for rare disease medicines.

Raise awareness of the company HIPRA and its plans to expand in Canada to support routine and pandemic vaccination programs.

Adoption of Bill S-201, An Act respecting a national framework on sickle cell disease, to discuss measures and initiatives to improve care and treatment of Canadians affected by sickle cell disease and increase public awareness of the disease. Implementation of Canada's action plan for pain and federal initiatives related to pain management. Implementation of the the Pharmacare Act and the National Strategy for Drugs for Rare Diseases Implementation of the National Strategy for Drugs for Rare Disease, and other policies or programs related to rare diseases Regulatory amendments and/or guidelines related to the Food and Drugs Act Regulations and Health Canada to implement an orphan drug regulatory framework. Innovation, Science and Economic Development Canada 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 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. Federally-funded Public Drug Plans, with respect to reimbursement for drug products for federal plan beneficiaries.

Discussions on how the Government of Canada work collaboratively with provincial and territorial governments to commit to a long-term federal funding strategy to ensure that adult vaccines recommended for use by the National Advisory Committee on Immunizations are publicly funded and universally accessible across all jurisdictions. Discussions on the renewal of the National Immunization Strategy to bolster public vaccination programs across Canada. Discussions on strengthening Canada’s adult immunization programs, as access to adult vaccines remains inconsistent, inequitable and underfunded throughout the country.

Discussions on the renewal of the National Immunization Strategy to bolster public vaccination programs across Canada. Discussions on strengthening Canada’s adult immunization programs, as access to adult vaccines remains inconsistent, inequitable and underfunded throughout the country. Discussions on how the Government of Canada work collaboratively with provincial and territorial governments to commit to a long-term federal funding strategy to ensure that adult vaccines recommended for use by the National Advisory Committee on Immunizations are publicly funded and universally accessible across all jurisdictions.

Raise awareness of challenges that cancer clinicians face on behalf of their patients in receiving equitable access to cancer care, specifically: - expanding access to diagnostics, including molecular genetics testing - ensuring faster, more equitable access to new cancer therapies - improving efficiencies in patient care, and addressing human resource contraints

Raising awareness of OBI’s federated Intelligence Network for Brain Health Data and expanding its capabilities beyond Ontario. The objective of the federal engagement is to raise awareness of OBI and its impact on brain health, artificial intelligence, and the growth and scale?up of brain health SMEs in Ontario. Over time, this engagement aims to expand OBI’s federated learning model beyond Ontario and position Canada as a global leader in AI, data sovereignty, and brain health.

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

Discuss the Vaccine Voucher Demonstration Project, a time-limited, federally funded initiative focused on improving equitable access to shingles vaccination for Canadians aged 50+

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.

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

Bill C-64: An Act respecting pharmacare, with a particular focus on access to medicines and rare disease and orphan drug policies. Engagement with officials on issues related to the National Strategy for Rare Disease Drugs, and other policies or programs related to rare diseases. Regulatory amendments and/or guidelines and/or policies related to the Food and Drugs Act and Health Canada review of drugs for rare diseases. Guidelines, policies and programs related to regulatory and reporting functions of the Patented Medicine Prices Review Board. Innovation, Science and Economic Development Canada regarding the Innovation and Skills Agenda and other government policies and programs related to incentivizing research and development activities in Canada, including the Biomanufacturing and Life Sciences Strategy. Federal programs and budgetary initiatives related to the Federal-Provincial-Territorial funding arrangements regarding pharmaceuticals including addressing any health technology assessment-related or other policy discussions that might involve Health Canada and its ongoing relationship with Canada's Drug Agency and/or other pan-Canadian health organizations. Federally-funded public drug plans, with respect to reimbursement for drug products for federal plan beneficiaries.

Scientific Research and Experimental Development (SR&ED) Tax Incentive Program regarding eligible expenditures. Discussions on policies such as "patent box" and Investment Tax Credits. 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 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 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 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 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 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 Engagement with the government regarding the Strategic Response Fund (SRF) (previously known as SIF) and investment in Canada Canada’s Drug Agency policies and processes as it relates to reimbursement recommendation decision-making process and framework Biomanufacturing and Life Sciences Strategy (BLSS) as it relates to the biopharmaceutical industry Annual federal Budgets and Budget updates relating to the biopharmaceutical industry

Programs and policies of the federal government to reduce the incidence of HIV in Canada, including access to testing, treatment, and ongoing care and support and reducing stigma and discrimination, including implementation of the Pan-Canadian STBBI Framework for Action.

Innovation, Science and Economic Development Canada regarding the Innovation and Skills Agenda, the Biomanufacturing and Life Sciences Strategy and other government policies and programs related to incentivizing research and development activities in Canada. Regulations regarding the exportation of medicines packaged and labelled for the Canadian market to countries other than Canada. Patent Act and Patented Medicines (Notice of Compliance) Regulations as it relates to the regulation of intellectual property and approval for therapeutic products. National Strategy for Rare Disease Drugs, and other policies or programs related to rare diseases and incentives for development of the treatments for rare diseases. 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 in Canada. Food and Drugs Act Modernization initiative, including the Regulatory Review of Drugs and Devices. Food and Drugs Act and Regulations, as they relate to the review and approval of new drug submissions and post market surveillance of drug products. Food and Drugs Act and Regulations, as they relate to the provision of data exclusivity for innovative drug products. Food and Drugs Act and Regulations, as they relate to drug export and cross-border trade. Federally-funded Public Drug Plans, with respect to reimbursement for drug products for federal plan beneficiaries. Common Drug Review and the pan-Canadian Oncology Drug Review, as they relate to health technology assessments and drug product reimbursement recommendations.

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.

Health, innovation, rare disease policy, free trade agreements & tariffs as they relate to the biopharmaceutical industry.