Susan Fitzpatrick

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(SEBs) as it relates to Regulations, Policies, or Guidelines being developed by Health Canada, specifically the Draft Guidance Document on SEBs, the Notices of Changes to Health Canada's Guidance Documents on Data Protection and Patented Medicines Regulations (Notice of Compliance)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

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.

Increased federal investment in health-related research. Advocating for implementation of Canada's drugs for rare diseases strategy. With respect to disability, we advocate for recognition of and supports for people with episodic disabilities. In terms of science and technology, we work toward the development of precision and personalized medicines that target the basic defect of cystic fibrosis. We are exploring how the federal government may support these efforts through partnership and funding. In terms of research and development, we lobby for support of cystic fibrosis research initiatives that improve the health and wellness of Canadians living with cystic fibrosis. Improving access to precision medicines for Canadians with cystic fibrosis and other rare diseases. Advocating to stop the regulatory changes to the Patented Medicines Price Review Board (PMPRB).