David Lee

Working with federal partners to streamline Health Canada policies and processes related to clinical trials and drug authorization specific to children, including the passage of C-265, an Act to Amend the Food and Drugs Act. Supporting the introduction and passing of legislation that would increase protections for children and youth online, including the passage of C-34, the Safe Social Media Act. Encouraging the development and strengthening of legislation and regulations that limit children's access to nicotine. Engaging federal partners on the national and international role that SickKids plays in child health care, research and education.

Vaccine Funding - National Immunization Strategy - maintain federal leadership in providing provinces with funding for new vaccines VACCINE CONTRACTING AND SUPPLY to support the implementation of the federal biomanufacturing strategy, regulation of vaccines for Canadians, address immunization gaps, provide updated and timely information about vaccine development pipeline, support procurement of vaccines SUBMISSION REVIEW PROCESS FOR BIOLOGICS, COST RECOVERY REVIEW to ensure Canada remains competitive overall and any new costs do not put bioloigics are a comparative disadvantage RESEARCH & DEVELOPMENT (R&D) to ensure Canadian capacity in key sectors including biomanufacturing, life sciences, and biotechnology. REGULATORY APPROVAL PROCESS FOR PLANTS WITH NOVEL TRAITS as NOVEL FOODS or INDUSTRIAL BIO_PRODUCTS in respect of an efficient science-based approach and allows for greater cooperation among and between government departments PATENTED MEDECINES PRICES REVIEW BOARD (PMPRB) PRICE REVIEW to ensure new guidelines and directives do not create disincentives for the introduction of new treatments in Canada ORPHAN PRODUCTS to establish formal regulations, policies or programs to encourage the research, development and introduction of new technologies to treat "orphan" or neglected diseases NOVEL FOODS in respect of maintaining a science-based regulatory system for novel foods derived from plant and animal biotechnology INTELLECTUAL PROPERTY/PATENT POLICY AND REGULATIONS in respect of creating Canada as one of the world's most competitive jurisdictions in protecting IP (e.g., match level of European Union via CETA negotiations) IMPROVEMENTS TO THE Scientifc Research & Experimental Development TAX CREDITS FOOD LABELLING in respect of mitigating the unnecessary introduction of new labelling requirements for products already approved under current regulated process and in respect of maintaining harmonization of requirements with trading nations FOOD AND DRUGS ACT AND REGULATIONS in respect of streamlining regulatory burden and ensuring appropriate climate for the introduction of new technologies Establish accountability with the federally established Canadian Drug Agency (formerly Canadian Agency for Drugs and Technologies and Health) (CADTH) and its Common Drug Review process (Health Canada) Creation of a modern policy environment that recognizes international standards and reviews, and establishes clarity on data ownership for intellectual property Clarify the administration of SR&ED program to ensure clinical trials and international research conducted in Canada qualifies as eligible expenses CANADIAN ENVIRONMENTAL PROTECTION ACT AND REGULATIONS in respect of modern, science-based regulations to reflect rapidly changing new technologies BIOSAFETY PROTOCOL in respect of Canada's participation in global discussions to ensure an enabling environment for safe new technologies ADVENTITIOUS PRESCENCE POLICY in respect of new agricultural biotechnology products ACCESS & BENEFIT SHARING: TRIPS AGREEMENT in respect of protecting intellectual property and preventing increased uncertainty

Canadian Government investments 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. Free trade agreements as they relate to the biopharmaceutical industry. Annual federal Budgets and Budget updates as it relates to the biopharmaceutical industry. Vaccine Funding - National Immunization Strategy - maintain federal leadership in providing provinces with funding for new vaccines VACCINE CONTRACTING AND SUPPLY to support the implementation of the federal biomanufacturing strategy, regulation of vaccines for Canadians, address immunization gaps, provide updated and timely information about vaccine development pipeline, support procurement of vaccines SUBMISSION REVIEW PROCESS FOR BIOLOGICS, COST RECOVERY REVIEW to ensure Canada remains competitive overall and any new costs do not put bioloigics are a comparative disadvantage RESEARCH & DEVELOPMENT (R&D) to ensure Canadian capacity in key sectors including biomanufacturing, life sciences, and biotechnology. REGULATORY APPROVAL PROCESS FOR PLANTS WITH NOVEL TRAITS as NOVEL FOODS or INDUSTRIAL BIO_PRODUCTS in respect of an efficient science-based approach and allows for greater cooperation among and between government departments PATENTED MEDECINES PRICES REVIEW BOARD (PMPRB) PRICE REVIEW to ensure new guidelines and directives do not create disincentives for the introduction of new treatments in Canada ORPHAN PRODUCTS to establish formal regulations, policies or programs to encourage the research, development and introduction of new technologies to treat "orphan" or neglected diseases NOVEL FOODS in respect of maintaining a science-based regulatory system for novel foods derived from plant and animal biotechnology INTELLECTUAL PROPERTY/PATENT POLICY AND REGULATIONS in respect of creating Canada as one of the world's most competitive jurisdictions in protecting IP (e.g., match level of European Union via CETA negotiations) IMPROVEMENTS TO THE Scientifc Research & Experimental Development TAX CREDITS FOOD LABELLING in respect of mitigating the unnecessary introduction of new labelling requirements for products already approved under current regulated process and in respect of maintaining harmonization of requirements with trading nations FOOD AND DRUGS ACT AND REGULATIONS in respect of streamlining regulatory burden and ensuring appropriate climate for the introduction of new technologies Establish accountability with the federally established Canadian Drug Agency (formerly Canadian Agency for Drugs and Technologies and Health) (CADTH) and its Common Drug Review process (Health Canada) Creation of a modern policy environment that recognizes international standards and reviews, and establishes clarity on data ownership for intellectual property Clarify the administration of SR&ED program to ensure clinical trials and international research conducted in Canada qualifies as eligible expenses CANADIAN ENVIRONMENTAL PROTECTION ACT AND REGULATIONS in respect of modern, science-based regulations to reflect rapidly changing new technologies BIOSAFETY PROTOCOL in respect of Canada's participation in global discussions to ensure an enabling environment for safe new technologies ADVENTITIOUS PRESCENCE POLICY in respect of new agricultural biotechnology products ACCESS & BENEFIT SHARING: TRIPS AGREEMENT in respect of protecting intellectual property and preventing increased uncertainty

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).

Regulations, policies and programs related to the reimbursement recommendations decision-making process and framework done by the Canadian Agency for Drugs and Technologies in Health (CADTH)/Common Drug Review as well as the review times and processes conducted by Health Canada for the purpose of obtaining a notice of compliance. National Strategy for Drugs for Rare Disease as it relates to separate regulatory pathways for drugs for rare diseases and the government strategy. Monitoring and engaging the Government and Parliamentarians on policies and programs that would provide greater clarity and predictability in the tax outcomes and improvements to tax measures such as the Manufacturing & Processing (M&P) credit and the Scientific Research & Developmental (SR&ED). Common Drug Review Policies as it relates to reimbursement recommendation decision-making process and framework. Federal Public Drug Plans, with respect to the reimbursement of therapeutic products for Federal plan beneficiaries Policies related to the National Strategy for Drugs for Rare Disease as it relates to separate regulatory pathway for drugs for rare diseases and the government strategy. Policies related to Subsequent Entry Biologics (SEBs) pertaining to Draft Guidance for Sponsors; Information and Submission requirements for SEBs, regulations and intellectual property policies, naming conventions Monitoring and engaging on the Government’s commitment (Budget, SFT, Fall Economic Update) to create a national strategy for drugs for rare diseases; create a new Canadian Drug Agency; and the implementation of national, universal pharmacare. Pharmaceutical policy and any negotiations of a Health Accord or agreement with the Provinces/Territories, as it relates to National Pharmacare/universal or catastrophic drug coverage, Drug policies & Pricing. 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, and as it relates to Canada’s Biomanufacturing and Life Sciences Strategy. Monitoring and engaging the Government and Parliamentarians on policies and programs related to Canada's biomanufacturing and life sciences sector strategy National Pharmacare (Bill C-64, An Act respecting pharmacare) Canadian Environmental Protection Act and Regulations in respect of modern, science-based regulations to reflect rapidly changing new technologies. 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 industry. Annual federal Budgets and Budget updates as it relates to the biopharmaceutical industry, and related updates and to Federal budgetary policy. Discussions around the World Trade Organization consideration of a TRIPS Patent Waiver - Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs) with respect to the protection of data, Access to Medicines, and TRIPs "flexibility". 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 importation legislation in the United States. Standing Committee on Finance (FINA) as it relates to pre-budget consultations. Pharmaceutical intellectual property protection as it relates to international trade agreements Patent Act and Patented Medicines (Notice of Compliance) Regulations, as it relates to the regulation of intellectual property, approval for therapeutic products, changes to modernize the Right of Appeal House of Commons Standing Committee of Science and Research (SRSR) as it relates to Science in Canada and/or any other pertinent legislative proposal before the committee House of Commons Standing Committee of Industry and Technology (INDU) as it

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.

Support input regarding Canada’s pharmaceutical sovereignty. Support input into the consultation on draft guidance on decentralized clinical trials. Support input into the consultation on Canada Gazette, Part I, Volume 159, Number 51: Order Providing for Reliance on Decisions of, or Documents Produced by, Foreign Regulatory Authorities in Respect of Certain Drugs. Share patient groups perspectives on drug pricing and access to medications/vaccines/clinical trials, specifically regulations and guidelines related to the Patented Medicine Prices Review Board, along with feedback on their policies and practices, and processes related to PMPRB. Recommend the creation of a Patient Ombudsman. Recommend the creation of a Chief Patient Officer. Recommend that the government and regulators adopt proactive approaches to communicating drug supply and shortages issues and measures to address them. Provide input on the government's response to tariffs and other trade measures as they relate to pharmaceuticals and related treatments, including their ingredients, as well as other health products and devices. Also recommend providing financial relief to patients impacted by price increases. Provide input on pharmacare. Provide input on a national strategy for drugs for rare diseases. Learn more about and provide feedback on plans around COVID-19 vaccines, including protein based ones. Ensure timely access to a comprehensive range of medicines, vaccines and related treatments and protect access to clinical trials, while helping to rebuild domestic capacities to develop and make drugs and vaccines. Ensure patient organizations are consulted and provide feedback on policies, processes, patient representation and other initiatives from Canada's Drug Agency. Discuss Canada's response to the proposed bulk importation of medications from Canada to the United States.

International trade regarding tobacco control, alcohol, products containing carcinogens and products associated with cancer. Internal trade regarding tobacco control, alcohol, products containing carcinogens and products associated with cancer. Funding for programs to be operated by the Canadian Cancer Society to advance cancer control. Canadian Partnership Against Cancer, as it relates to continued federal funding for the cancer control strategy Canada Health Transfer and health system bilateral funding agreements intended for provinces/territories to support the delivery of healthcare services Framework Convention on Tobacco Control, including protocols, guidelines and implementation Tobacco and Vaping Products Act, as it relates to regulations, implementation and enforcement Non-Smokers' Health Act including implementation and enforcement Food and Drugs Act and regulations, as it relates to nciotine replacement products Federal Tobacco Control Strategy, including all matters related to tobacco control Taxation, revenue measures, controlled products regulations, including implementation, for alcohol, tobacco control, products containing carcinogens and products associated with cancer. Communication regarding alcohol consumption guidance. Food and Drugs Act and regulations, as it relates to alcohol warning labels Food and Drugs Act and regulations, as it relates to restricting the advertising to children of foods high in sodium, sugars and saturated fat. Healthy Living - Supporting initiatives, legislation, regulation, policies, and programs that prevent cancer or improve the social determinants of health Adoption of HPV testing and increasing HPV vaccination rates Sustainable funding of the National Advisory Committee on Preventive Health Services to ensure timely, up?to?date cancer screening guidelines Equitable and timely access to cancer screening. Measures and funding related to the charitable sector generally Equitable access to care along the full cancer continuum for First Nations, Inuit and Métis communities Employment Insurance special benefit programs, including the sickness benefit and compassionate care benefit Canada Labour Code and Employment Insurance Act, as it relates to job-protected leave, employment insurance special benefits, return to work policies, and human rights protections for people affected by cancer Access to information and support to make decisions regarding end-of-life care, including Medical Assistance In Dying Supports for mental health during people's cancer journeys Implementation and funding of the National Grief Action Plan as part of the government's work on palliative care and mental health Canada Health Act as it relates to access to care, including long-term, home, and palliative care National Caregiving Strategy Financial supports for caregivers, including the Canada Caregiver Credit Implementation of the Framework on Palliative Care in Canada and integration of a palliative approach to care in our health system, including national standards and data, care provider training, research, and implementation of the National Grief Action Plan and distinctions?based frameworks for First Nations, Inuit and Métis people Setting and measuring pan-Canadian wait time benchmarks and targets and measures to address them, including addressing healthcare shortages, increased and sustainable funding for care, infrastructure and equipment, targeted strategic funding to PTs for workforce shortages, particularly in rural and remote communities. Sustained core funding for federal research agencies, improved coverage of indirect research costs, Canadian research sovereignty, strengthening capacity and the economic benefits of domestic research, research commercialization. Increasing access to care including models of care, removing barriers to care, particularly for underserved communities, using innovative approaches to improve access to care including AI to improve timely diagnosis and treatment. Issu

Discussion on the use of AI/digital health and how that can help improve the profession and more efficient access to care for patients. Discussion on the health human resource issues facing dermatologists such as shortages, wait times and access to care for patients.

Advocate for supportive economic and tax policy for Canada's pharmaceutical manufacturing sector. Work with government to promote and support Canada’s pharmaceutical manufacturing sector and advocating for supportive public policy Raise awareness of role of Canadian drug producers in exports to the U.S. and other parts of the world. Advocate for including Canada's drug exports as part of CUSMA negotiations Advocate for regulatory policy to support review of generic drug submissions from Canadian drug producers

Lobbying for the preservation of affordable rental housing Lobbying for the development of new affordable housing, including co-operative housing. Lobbying to ensure that low-income households can continue to live affordably in federally-administered housing co-operatives after their operating agreements end with Canada Mortgage and Housing Corporation (CMHC). Lobbying for renewed low-income subsidies for federal indigenous co-operatives. Lobbying for new low-income subsidies for federal co-ops (including Section 95 program co-op housing). Lobbying for government to examine the consequences of the steady erosion of rent-geared-to-income (RGI) capacity for low-income households in existing federally administered housing providers, including co-operatives. Lobbying for energy retrofit programs for co-op housing. Lobbying around the elimination of homelessness in Canada.