Celia Lourenco

Scientific and analytical integrity in Health Canada's regulatory proposal Canada Gazette I & II, Volume 155, Number 26 and all other recent labeling laws including but not limited to Canada Gazette, Part II, Volume 156, Number 15. Health policy regarding the Natural Health Product Regulations, food and drug regulations, supplemented food regulations, the Prescription Drug List, the safe food for Canadians Act, Cannabis Act, Protecting Canadians from Unsafe Drugs Act, and the Food and Drug Act. Government of Canada program and policy support for the natural health product, food, health product and overall commodity manufacturing sector's.

Communicating with government officials about recycling and circular economy initiatives, including as it relates to Extended Producer Responsibility ("EPR") obligations for manufacturers. Measures to facilitate internal trade in Canada, including through Bill C-5, the One Canadian Economy Act. Legislation and regulation with respect to the creation of a plastics registry, plastic labelling or recycled content for plastic products. Communications with regard to retail theft of consumer health products and e-marketplaces and concerns around product safety and product integrity resulting from e-theft. Communications with regard to retail theft of consumer health products and e-marketplaces and concerns around product safety and product integrity resulting from e-theft. Bill C-224 - An Act to amend the Food and Drugs Act (natural health products): To keep NHPs under the purview of the Food and Drugs Act (i.e. Vanessa’s Law), which gives the minister the authority to use a ministerial order for a number of reasons (product recall, delay cost-recovery NHPs, delay labelling for NHPs to a later date). Working with the government to recognize the public health benefits of a National Self-Care Strategy and urging its timely implementation. User fees for services, use of facilities, regulatory processes and approvals, product rights and privileges that are related to drugs and medical devices regulated under the Food and Drugs Act. Tax policy changes to allow certain therapeutic categories of consumer health products to be eligible under the Medical Expenses Tax Credit. Seeking harmonization of regulatory regimes and administrative processes nationally and internationally. Regulations Amending the Food and Drugs Regulations - Nutritional Labelling, Other Labelling Provisions and Food Colours – continue to engage with government to ensure clarity on compliance and enforcement of regulations. Providing input to government to restore balance and fair competition to grocery retail practices. Providing input to government on rules-based trade and e-commerce: working to ensure that international trade allows for the predictable flow of ingredients, products and people; addressing the rise of non-compliant and illicit products from entering the Canadian market; and advocating against protectionism (including new tariffs). Providing input to government on regulatory modernization initiatives, including encouraging the enforcement of an economic lens to the design and implementation of all regulations. Providing input to government on emerging COVID-19 issues and its impact on industry, and helping shape the government’s response and recovery efforts. Providing input into Health Canada's Self-Care Products Framework with respect to over-the-counter drugs (OTC), natural health products (NHPs), and cosmetics. Advocating for a framework that is based on science-based claims and regulated according to risk. Pre-Market approvals for food additives, novel foods, infant formula, health claims and functional foods in regard to consulting with Health Canada on improving the process to deal with the backlog and new applications. Plastic Charter – to monitor the development of the federal government national strategy on plastic and potential impact our industry. Participation and input into Canada's sodium reduction strategy concerning targets for certain food categories/sectors and technical aspects of the target - as well as consumer awareness, education and acceptance issues. Nutrition information with regard to how FCPC is committed to enabling consumers to make informed food choices based on Canada's Food Guide and the Nutrition Facts Table. National Food Policy – Working in consultation with Agriculture and Agri-Food Canada as the National Food Policy, designed to address issues related to production, processing, distribution and consumption of food, is developed and implemented. Modernization of food regulations and legislation - advocate to ensure

Cost Recovery Programs with respect to the Pest Management Regulatory Agency for registered pest control products, the Health Products & Food Branch for hard surface disinfectants, sanitizers and food contact sanitizers and CEPA's New Substances Regulations. Food and Drug Regulations with respect to the pre-market authority for the sale of disinfectant products, sanitizers, food contact sanitizers and post-market reporting. Canadian Environmental Protection Act (CEPA) with respect to amendments (S5). Competition Act with respect to Environmental Claims Guidance, Made in Canada/Product of Canada Guidance. Canadian Environment Protection Act and its regulations for Volatile Organic Compounds in certain products and HFCs. Pest Control Products Act and regulations of domestic and institutional pest control products. Hazardous Products Act and Regulations regarding interpretation and technical amendments/guidance to the Workplace Hazardous Materials Information System. Chemicals Management Plan regarding the review of existing, and new substances, which may be used in consumer and commercial products. Cabinet Directive on Regulation regarding the expectations and requirements in the development, management and review of federal regulations. Controlled Drugs & Substances Regulation with regard to precursors Canada Consumer Product Safety Act, in respect of regulations for labelling, incident reporting and compliance of consumer products.

Trade and Export Promotion Programs, including the AgriMarketing Program and Global Affairs Canada’s Trade Commissioner Service, with respect to increasing export opportunities for Canadian natural health and wellness products Safe Food for Canadians Regulations –Impact on Organic Product Regulations. Impact on GMO labelling for foods. Impact on small businesses. Regulations affiliated with the Cannabis Act regarding the legalization of cannabis; regulatory amendments related to phytocannabinoids Natural Health Products Regulations – fair and consistent interpretation by the regulator. Plain Language Labeling under the self-care products framework. Personal importation of natural health products. Food Directorate and Canadian Food Inspection Agency – draft guidance on foods/supplemented foods/nutrition facts/food labelling and label modernization. GMO mandated labelling for food. Food & Drug Regulation - ensure appropriate interpretation of regulations. Impact on GMO labelling for food. Amendments to the Food and Drugs Act – Ensure sensible rules for natural health products. Address prohibition on sampling of natural health products directly to the consumer. Implication of Health Canada’s proposed Consumer Health Products Framework. Consideration of the 53 recommendations made in 1998 by the Standing Committee on Health.

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 Food and Drug regulations as it relates to data protection and the regulation and protection of biopharmaceutical products Canada's Drug Agency (CDA) policies as it relates to health economics assessment and recommendations made on new medicines. 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 Policy and Programs Health Canada and Public Health Agency of Canada policies and programs to prevent and treat HIV and eliminate hepatitis as a public health threat by 2030, as part of Canada's commitments under the Global Viral Hepatitis Strategy and therapeutic efforts against the fight for COVID-19. Patent Act Regulations as they relate to the regulation of intellectual property for therapeutic products, specifically the Patented Medicines (Notice of Compliance) Regulations Patented Medicine Prices Review Board (PMPRB) Regulations with regard to reporting requirements, pricing, guidelines and dispute resolution. Innovation Agenda, particularly with respect to initiatives to support and attract investments in the life sciences sector Federal Government First Nations and Inuit Health Branch program with respect to health services. Federally-funded Public Drug Plans, with respect to reimbursement for drug products for federal plan beneficiaries.

Invitations to a roundtable event to discuss HIV in Canada will be going to several MPs and Senators.

Provide support to inform and enable Canada to meet it's international committments on Fast-Track strategy to end the AIDS epidemic by 2030

WTO (World Trade Organization) Negotiations on Agriculture as it relates to supply management. Use of Veterinary Natural Health Products in dairy livestock production - Veterinary Drugs Directorate of Health Canada. Trans fats, Saturated fats, Sodium and Sugar as it relates to dairy products, Food Guide recommendations and nutritional labelling. Traceability Under "Agricultural Partnership", the establishment of regulations for traceability. Collaborating with provincial and federal governments in the determination of private and public interests and in discussions with Ministers re government/industry share of costs. Research Under "Canadian Agricultural Partnership", the federal Minister of Agriculture and Agri-food announced a research cluster, in cooperation with Dairy Farmers of Canada, worth $12M. Quality Milk Program - Implementation and administration of the Quality Milk Program under the Canadian On-Farm Food Safety Program of AAFC. Product of Canada consultations Dairy Farmers of Canada participated in federal government consultations on regulations pertaining to "Product of Canada". proAction - implementation and administration of the proAction program. Mitigation measures for Trade Agreements. Ingredients Industry stakeholders discussion on domestic ingredient strategy, pricing of components, marketing of ingredients. Involves discussions with the Canadian Dairy Commission. Implementation of Special Agricultural Safeguard for supply-managed products, dairy products in particular. Implementation of new tariff rate quotas for milk protein isolates as per GATT Article XXVIII, Amendment to Customs Tariff (tariff line 3504). Work with Finance Canada, AAFC and DFAIT on implementation and allocation of said TRQ. Implementation of a Grocers Code of Conduct. Guide for Food labelling and Advertising in respect of all dairy products and use of dairy terminology (modifiers, highlighted ingredients). Growing Forward. This is a federal-provincial agreement with oversight for many of our issues (Business Risk Management, Research, etc.) Food and Drug Act and its accompanying regulations as they apply to all dairy product compositional standards, in particular those on cheese and yogourt. Food and Drug Act and its accompanying regulations as it applies to the labelling and advertising of dairy products Federal framework and action plan on antimicrobial us and antimicrobial resistance. Explicit and implied Health Claims related to dairy and non-dairy products Ensure the appropriate allocation of the Tariff Rate Quotas under the Comprehensive Review of the Allocation and Administration of Tariff Rate Quotas for Dairy, Poultry and Egg Products. Discretionary Food Fortification policy of Health Canada. DFC has particular interest in the discretionary food fortification of non-nutritious foods and vitamin fortification of dairy products. Discretionary Food Fortification Governed by Food and Drug Act and the Agricultural Products Marketing Act. Development of the Code of Practice for the Care and handling of Dairy Cattle in cooperation with CFIA's activities in OIE (Organisation mondiale de la Santé Animale). Contribute to a Vision Exercise on the future of dairy with AAFC. Consultations on supplemented foods. Consultation on Vitamin D fortification. Climate Change / Environment Farm practices for greenhouse gas mitigation; documenting programs that exist provincially and federally that are available to dairy producers; promoting best management practices. Canadian Agricultural Products Act with respect to standards for ice cream and yogurt. Canada-EU Trade Agreement, CUSMA, CPTTP and Canada-UK. The components within these agreements that we are interested in are agriculture and protection/exemption of supply management. Canada's position on agriculture at the UN Food System Summit. Animal Health - development of the Animal Health Canada with CFIA and AAFC. Agriculture, Canadian Dairy Farming, and Supply Management issues in Bill C-282

Health Canada's consultation and next steps around regulation of foods derived from somatic cell nuclear transfer clones. Agriculture and dairy farming (Farm Management and Technology and Social/Policy Challenges) International trade negotiations and ensuring mitigation measures for existing/future trade agreements. WTO (World Trade Organization) Negotiations on Agriculture as it relates to supply management. Use of Veterinary Natural Health Products in dairy livestock production - Veterinary Drugs Directorate of Health Canada. Trans fats, Saturated fats, Sodium and Sugar as it relates to dairy products, Food Guide recommendations and nutritional labelling. Traceability Under "Agricultural Partnership", the establishment of regulations for traceability. Collaborating with provincial and federal governments in the determination of private and public interests and in discussions with Ministers re government/industry share of costs. Research Under "Canadian Agricultural Partnership", the federal Minister of Agriculture and Agri-food announced a research cluster, in cooperation with Dairy Farmers of Canada, worth $12M. Quality Milk Program - Implementation and administration of the Quality Milk Program under the Canadian On-Farm Food Safety Program of AAFC. Product of Canada consultations Dairy Farmers of Canada participated in federal government consultations on regulations pertaining to "Product of Canada". proAction - implementation and administration of the proAction program. Ingredients Industry stakeholders discussion on domestic ingredient strategy, pricing of components, marketing of ingredients. Involves discussions with the Canadian Dairy Commission. Implementation of Special Agricultural Safeguard for supply-managed products, dairy products in particular. Implementation of new tariff rate quotas for milk protein isolates as per GATT Article XXVIII, Amendment to Customs Tariff (tariff line 3504). Work with Finance Canada, AAFC and DFAIT on implementation and allocation of said TRQ. Implementation of a Grocers Code of Conduct. Guide for Food labelling and Advertising in respect of all dairy products and use of dairy terminology (modifiers, highlighted ingredients). Growing Forward. This is a federal-provincial agreement with oversight for many of our issues (Business Risk Management, Research, etc.) Food and Drug Act and its accompanying regulations as they apply to all dairy product compositional standards, in particular those on cheese and yogourt. Food and Drug Act and its accompanying regulations as it applies to the labelling and advertising of dairy products Federal framework and action plan on antimicrobial us and antimicrobial resistance. Explicit and implied Health Claims related to dairy and non-dairy products Ensure the appropriate allocation of the Tariff Rate Quotas under the Comprehensive Review of the Allocation and Administration of Tariff Rate Quotas for Dairy, Poultry and Egg Products. Discretionary Food Fortification policy of Health Canada. DFC has particular interest in the discretionary food fortification of non-nutritious foods and vitamin fortification of dairy products. Discretionary Food Fortification Governed by Food and Drug Act and the Agricultural Products Marketing Act. Development of the Code of Practice for the Care and handling of Dairy Cattle in cooperation with CFIA's activities in OIE (Organisation mondiale de la Santé Animale). Contribute to a Vision Exercise on the future of dairy with AAFC. Consultations on supplemented foods. Consultation on Vitamin D fortification. Climate Change / Environment Farm practices for greenhouse gas mitigation; documenting programs that exist provincially and federally that are available to dairy producers; promoting best management practices. Canadian Agricultural Products Act with respect to standards for ice cream and yogurt. Canada-EU Trade Agreement, CUSMA, CPTTP and Canada-UK. The components within these agreements that we are interested in are ag

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.

Canada's Drug Agency policies as it relates to reimbursement recommendation decision-making process and framework Biomanufacturing and Life Sciences Strategy (BLSS) as it relates to the biopharmaceutical industry. Federal policies that relate to possible models of pharmacare Federal Buy Canadian Procurement Policy as it relates to government drug procurement practices and the implications for 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 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 National Strategy for Drugs for Rare Diseases 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 biopharmaceutical industry World Health Organization (WHO) issues concerning 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 Patented 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 Income Tax Act as it relates to biopharmaceutical products Health Canada's Regulatory Roadmap for Health Products and Food as it relates to the biopharmaceutical industry Free trade agreements as they relate to the biopharmaceutical industry 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 Canadian Institutes of Health Research (CIHR) Clinical Research Initiative as it relates to public/private research and development partnerships Annual federal Budgets and Budget updates as it relates to the biopharmaceutical industry

Communications regarding funding from various Government funding programs, opportunities to improve government activity (funding, tax incentives, clinical trials infrastructure, etc) to encourage the innovation economy in Canada with a specific focus on biotech, and programs around procurement opportunities for the Government of Canada relating to biotechnology products.

Legislative proposals and policy changes affecting local economies, the investment climate and general competitiveness of the beverage sector in Canada, including tax, tariff advertising, CUSMA, labelling and pre-budget consultations. Matters regarding the regulation of environmental labelling, recycled content and single-use plastics; discussion about the collection and recycling of beverage containers. Improving regulatory interpretation (guidance) development to enhance regulatory transparency and outcomes Food and Drug Regulations as it pertains to food ingredients, food additives, food labelling, food advertising and food safety. Beverage container recycling programs, recycling targets for beverage containers, a federal plastics registry, national standards for extended producer responsibility reporting, environmental labelling, recycled content requirements, microplastics, single-use plastics, and international plastics policy and agreements.