Eshan Naik

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 Policies related to Subsequent Entry Biologics (SEBs) pertaining to Draft Guidance for Sponsors; Information and Submission requirements for SEBs, regulations and intellectual property policies, naming conventions Monitoring and engaging on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

"In line with current government priorities, ensure greater harmonisation of policies from the Departments of Innovation, Science and Economic Development and Health Canada's regulatory efficiency and streamlining efforts with regard to drug regulation and approval, particularly under the Food and Drugs Act for pharmaceutical products offered for sale in Canada. The objective is to make quality generic and biosimilar medicines available more quickly in Canada, in the interests of patients and the provinces and territories, while generating substantial savings for private and public plans." Amend Bill C-64 to remove the risks and uncertainty that would undermine the stability and affordability of Canada's drug supply. Provide input into the Government of Canada's negotiations regarding the Canada-European Union Comprehensive Economic and Trade Agreement (CETA) and re-negotiation of NAFTA with respect to pharmaceuticals, counterfeit medicines, border measures and intellectual property. Provide input into Government of Canada's Science and Technology strategy regarding the need for a balanced Intellectual Property regime and the important role competition plays in encouraging innovation. Innovation, Science & Economic Development Canada regarding the need to restore balance to the Patented Medicines (Notice of Compliance) Regulations with respect to pharmaceuticals and address operational concerns including: lack of finality to proceedings under the Regulations and lack of disincentives to discourage abuse of the Regulations. Innovation, Science & Economic Development Canada regarding export provisions of the Patent Act (pharmaceuticals). Innovation, Science & Economic Development, with respect to the Patent Act as it pertains to pharmaceuticals. Health Canada regarding the need for appropriate, dedicated resources for the Therapeutic Products Directorate to meet performance targets for the review of generic drug submissions. Health Canada regarding the development and implementation of an approval pathway for Biosimilars as well as pricing policies. Health Canada regarding regulation about Requirement for reporting of drug shortages. Health Canada regarding Patented Medicine Prices Review Board (PMPRB) Reform and National Pharmacare Program Health Canada, Innovation, Science & Economic Development Canada and International Trade Canada regarding effective measures to combat counterfeit drugs in Canada and around the world. As part of its renewed biomanufacturing strategy, the Federal Governement has announced its intentions to reinvest in this strategic sector. Sandoz Canada is interested in initiating discussions in this contexte with the potential objective of a joint investment in the life sciences sector. As a member company, participation in the Canadian Generic Pharmaceutical Association's legal challenge of the 2006 Amendments to Health Canada's Food and Drug Regulations with respect to the extended period of data exclusivity, as well as further proposed amendments to these regulations.

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

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. Harmonizing rules for the sampling of natural health products under the proposed Canada-United States-Mexico trade agreement. 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. Engagement with government officials on disruptions to business, health & safety requirements, and opportunities to help with the COVID-19 pandemic. 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. Allow for the regulation of products containing cannabidiol (CBD) as natural health products.

ADVOCATE FOR IMPROVED AWARENESS, PREVENTION AND MANAGEMENT OF WOMEN'S HEART AND BRAIN HEALTH RISK FACTORS THROUGH BILL S-243, AN ACT TO ESTABLISH A NATIONAL FRAMEWORK FOR WOMEN'S HEALTH IN CANADA ADVOCATE FOR A MODERNIZED CHARITABLE TAXATION FRAMEWORK THAT STRENGTHENS CHARITIES AND THEIR ABILITY TO MOBILIZE RESOURCES FOR THE BENEFIT OF CANADIANS. FINALIZE REGULATIONS TO RESTRICT VAPE FLAVOURS (INCLUDING MINT/MENTHOL); INTRODUCE PLAIN AND STANDARDIZED PACKAGING FOR VAPING PRODUCTS; INCREASE TOBACCO AND VAPE TAXES; IMPLEMENT A TOBACCO COST RECOVERY FEE; PROTECT EXISTING NICOTINE POUCH REGULATIONS; BAN INTERNET/ONLINE SALES FOR TOBACCO AND E-CIGARETTES; PROHIBIT THE SALE OF TOBACCO PRODUCTS AMONGST INDIVIDUALS BORN BEFORE A DETERMINED YEAR; INCREASE THE MINIMUM LEGAL AGE OF SALE FOR TOBACCO AND VAPING PRODUCTS TO 21 YEARS OF AGE. SUPPORT POLICIES THAT ELIMINATE FINANCIAL BARRIERS TO SPORT PARTICIPATION FOR CHILDREN AND YOUTH, WHILE ENSURING SPORT PARTICIPATION FUNDING IS ROLLED OUT IN AN ACCESSIBLE, EQUITABLE, AND INCLUSIVE MANNER. ADVOCATE FOR GOVERNMENT ACTION TO REDUCE THE CONSUMPTION OF, AND HARMS ASSOCIATED WITH, ULTRA-PROCESSED FOODS. ADVOCATE FOR AND FUND EQUITABLE ACCESS TO PALLIATIVE CARE PROGRAMS FOR CANADIANS, INCLUDING EQUITY-SEEKING GROUPS. INTRODUCTION OF A NATIONAL PHARMACARE PROGRAM IMPLEMENT REGULATIONS TO RESTRICT COMMERCIAL MARKETING OF UNHEALTHY FOODS AND BEVERAGES TO CHILDREN IMPLEMENT A TAX ON SUGARY DRINKS. REVENUES FROM SUCH A TAXATION STREAM SHOULD BE USED TO SUBSIDIZE HEALTHY EATING INITIATIVES FUND PUBLIC AWARENESS FOR IMPROVED USE OF DEFIBRILLATORS AND CPR. ADVOCATE FOR A TAX-EXEMPTION ON THE SALE OF DEFIBRILLATORS. ENSURE THAT THE DEDICATED FEDERAL ACTIVE TRANSPORTATION INFRASTRUCTURE FUND BECOMES A PERMANENT ENVELOPE IN CANADA'S INFRASTRUCTURE FUNDING.

Through Innovation, Science & Industry discuss opportunities to enhance the Canadian life sciences sector including, biomanufacturing, partnerships, R&D investments.

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.

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.

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

Free trade agreements as they relate to the biopharmaceutical industry. Biomanufacturing and Life Sciences Strategy (BLSS) as it relates to the biopharmaceutical industry. 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. Bill C-64, the Pharmacare Act, with respect to definitional questions related to terms contained in Section 6.1, and concerns regarding the increased risk of drug shortages. Communication around existing drug shortages and shared solutions to mitigate the impact on Canadians. Advocate for the implementation of a federal diabetes and obesity strategy. Advocate for the establishment of public-private partnerships to support chronic disease prevention.

Innovation, Science and Economic Development Canada (ISED) Innovation Agenda regarding the need for a balanced intellectual property regime and the important role competition plays in encouraging innovation. Provide input into policy discussions with respect to the implementation of a national pharmacare program. Provide input into the Government of Canada's negotiations regarding trade negotiations with respect to pharmaceuticals, counterfeit medicines, and intellectual property. Provide input into the Canada-US trade relationship as it pertains to medicines, including the impact of tariffs on medicines and medicine manufacturing inputs for the Canadian healthcare system, patients and industry. Provide input into the Canada-United States-Mexico Agreement (CUSMA). To encourage the Government of Canada to continue to participate in truly international discussions with respect to effective measures to combat substandard and falsified medicines in Canada and around the world. Seeking harmonization of regulatory regimes and administrative processes nationally and internationally. Providing input with respect to the approval pathway for biosimilar medicines by Health Canada. Provide input into the Patented Medicine Prices Review Board (PMPRB) consultations regarding its Policies, Guidelines and Procedures. Provide input into the modernization of the Food and Drugs Act and related Regulations, Guidelines and Policies as they pertain to pharmaceuticals. Proposals to enhance transparency of the Health Canada Reconsiderations Policy for drug submissions. Proposals related to Health Canada's Identical Medicinal Ingredient Policy. Participation in Competition Bureau consultations with respect to pharmaceuticals. Participate in Government of Canada consultations with respect to the Regulatory Cooperation Council. Health Canada with respect to user fees for therapeutic product regulatory programs. Health Canada with respect to the process for the approval and renewal of foreign sites for Drug Establishment License (DEL) holders. Related guidance documents include the Guidance on Evidence to Demonstrate Drug GMP Compliance of Foreign Sites (GUI-0080), the Guidance on Drug Establishment Licences and Drug Establishment Licensing Fees (GUI-0002) and the Guidance on Good Manufacturing Practices for Active Pharmaceutical Ingredients (GUI-0104). Health Canada with respect to its Regulatory Systems Review for Therapeutic Products. Health Canada regarding the development of a national pharmacare strategy. Discussions with ISED towards a national strategy for the biomanufacturing and the life sciences sector.

The Cannabis Council is looking to actively engage the Department of Agriculture and Agri-Food Canada and to gain support for efforts to improve consistency and quality of the value - added agricultural crop cannabis. The Cannabis Act and Excise Act: Revising the application of excise tax on medical cannabis. The Cannabis Act: Working to develop proposed amendments to the Legislation using the Statutory Review of the Act that was initiated in the Fall of 2022. The Cannabis Act: Working to develop an appropriate marketing and branding regime that allows for producers to Differentiate their products through communication with consumers about product attributes. Seeking to eliminate the 2.3% regulatory fees charged by Health Canada. Working to improve the service standards for license changes, security clearance, export permits. Regional Economic Development. Seeking to build awareness about the sector and to encourage support from government regional and rural economic development programs. Helping to highlight the need for Diversity, Inclusion and Gender strategies within the cannabis sector. We are seeking to gain encouragement from the Government for progress in these areas. Excise Tax Framework on Cannabis products was fashioned on a premise of $ 1 in $ 10 as tax whereas in practical reality the tax is far more aggressive than planned, often coming in at or nearly 3 times higher at 30 %. This is severely compressing the financial viability of many licensed producers and processors, while keeping product prices high in comparison to competition in the legacy, illicit marketplace. CRA Excise stamp logistics and placement on adult consumer use cannabis products and co packing supply chain realities that run up against the Excise Tax Act. Cannabis Economic Development. The cannabis industry is engaging with ISED which has a new mandate to promote economic development activity stemming from the legalization of cannabis and the emergence of a robust eco system across the country. Cannabis Amnesty. The Council is actively engaged in encouraging government officials to take a proactive stance in the elimination/ expungement of Canadians with Criminal records for the posession of Cannabis for personal consumption. Calling for enhanced inclusion in Government Agency Programs at Business Development Bank (BDC) and Farm Credit Canada (FCC) as well as Export Development Canada (EDC) for the Cannabis Sector.

Calling on the Government to develop a comprehensive strategy to eradicate the illicit market. This involves coordination with the PTs to tackle illegal production, illegal sale (both bricks and mortar and online), interdict the shipment of illegal product through legal means and to launch a public awareness and education campaign on the dangers of buying illegal product. The Cannabis Council of Canada seeks to assist its members with International Trade issues, specifically, to help navigate unclear issues around exporting cannabis to various locations around the world. Israel recently issued a determination in an anti dumping case which lacked transparency, fairness and due process among other concerns. The Cannabis Council will work with government partners to defend the cannabis industry and it's world class reputation - as well as pursue all possible avenues to remedy the situation. The Cannabis Council is looking to actively engage the Department of Agriculture and Agri-Food Canada and to gain support for efforts to improve consistency and quality of the value - added agricultural crop cannabis. The Cannabis Act and Excise Act: Revising the application of excise tax on medical cannabis. The Cannabis Act: Working to develop an appropriate marketing and branding regime that allows for producers to Differentiate their products through communication with consumers about product attributes. Seeking to eliminate the 2.3% regulatory fees charged by Health Canada. Working to improve the service standards for license changes, security clearance, export permits. Regional Economic Development. Seeking to build awareness about the sector and to encourage support from government regional and rural economic development programs. Helping to highlight the need for Diversity, Inclusion and Gender strategies within the cannabis sector. We are seeking to gain encouragement from the Government for progress in these areas. Excise Tax Framework on Cannabis products was fashioned on a premise of $ 1 in $ 10 as tax whereas in practical reality the tax is far more aggressive than planned, often coming in at or nearly 3 times higher at 30 %. This is severely compressing the financial viability of many licensed producers and processors, while keeping product prices high in comparison to competition in the legacy, illicit marketplace. CRA Excise stamp logistics and placement on adult consumer use cannabis products and co packing supply chain realities that run up against the Excise Tax Act. Cannabis Economic Development. The cannabis industry is engaging with ISED which has a new mandate to promote economic development activity stemming from the legalization of cannabis and the emergence of a robust eco system across the country. Cannabis Amnesty. The Council is actively engaged in encouraging government officials to take a proactive stance in the elimination/ expungement of Canadians with Criminal records for the posession of Cannabis for personal consumption. Calling for enhanced inclusion in Government Agency Programs at Business Development Bank (BDC) and Farm Credit Canada (FCC) as well as Export Development Canada (EDC) for the Cannabis Sector.

Work with the Government of Canada to bolster and create pan-Canadian standardized health data and digital tools to better track and have an up-to-date picture of diabetes and it's evolving impacts. Increase funds for diabetes in the Federal Budget specifically to increase funds directed to the Canadian Diabetes Strategy to reflect growth in diabetes prevalence and cost. Increase Federal funding for Diabetes Research - work directed towards increasing funding to federal granting councils, in particular the Canadian Institutes of Health Research (CIHR) through the Federal Budget. Funding for Implementation of the Framework for Diabetes tabled by the Minister of Health on October 5, 2022.

Issues with respect to the implementation of Bill C-64, An Act respecting pharmacare Work with the Government of Canada to bolster and create pan-Canadian standardized health data and digital tools to better track and have an up-to-date picture of diabetes and it's evolving impacts. Increase funds for diabetes in the Federal Budget specifically to increase funds directed to the Canadian Diabetes Strategy to reflect growth in diabetes prevalence and cost. Increase Federal funding for Diabetes Research - work directed towards increasing funding to federal granting councils, in particular the Canadian Institutes of Health Research (CIHR) through the Federal Budget. Funding for Implementation of the Framework for Diabetes tabled by the Minister of Health on October 5, 2022.

Increase funds for diabetes in the Federal Budget specifically to increase funds directed to the Framework for Diabetes in Canada its components and a strategy to reflect growth in diabetes prevalence and cost. Bill C-64 - An Act Respecting Pharmacare Increase Federal funding for Diabetes Research - work directed towards increasing funding to federal granting councils, in particular CIHR through the Federal Budget. Aboriginal Diabetes Initiative - work towards making funding for this Initiative permanent. (Previous work directed towards continuation of funding beyond 2010).