Annahat Kochhar

Communications regarding opportunities to speed patient access to live-saving medicines on publicly-funded drug formularies in Canada by reducing red tape. Innovation, Science and Economic Development (ISED)'s Health Emergency Readiness program, insofar as it pertains to growth and development of the life sciences industry in Canada. Communication regarding free trade agreements as they relate to the biopharmaceutical industry. 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. 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 Canada's 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.

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.

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. Discussion focused on sharing perspectives on priorities and resourcing. In particular, a shared observation of an increase in submission reviews exceeding established timeframes and increasing challenges with securing pre-filing meetings were discussed Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs) with respect to the protection of data, Access to Medicines, and TRIPs "flexibility". Merck is seeking to ensure Canada's continued compliance with its obligations under TRIPs relevant to the biopharmaceutical industry within all domestic legislation in addition to ongoing and future trade negotiations. Relevant domestic legislation includes the Food and Drugs Act, the Patent Act, and related regulations and guidance documents. Beyond TRIPs, Merck is seeking enhancements to increase the stability and global competitiveness of Canada’s intellectual Property legislation, regulations and policies relevant to the biopharmaceutical industry. Such enhancements may result from domestic policy in addition to bilateral and multilateral trade negotiations (e.g. Comprehensive Economic and Trade Agreement (CETA) and the Trans-Pacific Partnership (TPP). World Health Organization issues concerning pharmaceuticals as it relates to Counterfeits, Access to Medicines, and the Intergovernment Working Group (IGWG). US - Canada Regulatory Cooperation Council (RCC) as it relates to the regulation of biopharmaceutical products. 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. Policies and programs as it relates to vaccine approval, procurement and public awareness of immunization. Plan design and reimbursement policies for drug plans administered by Federal Government including NIHB and Corrections Services. Pharmaceutical pricing policy issues arising from the jurisdiction of the Patended Medicines Prices Review Board (PMPRB) and R&D reporting. 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. Partnership opportunities as it relates to Canada's policy and programs to improve health in the developing world, such as Maternal and Child Health. New Substances Notification Regulations as it relates to the biopharmaceutical industry. National Pharmaceutical Strategy as it relates to the federal government's involvement in federal/provincial access to medicines framework. Income Tax Act as it relates to biopharmaceutical products. Health Canada's Legislative and Regulatory Modernization (LRM) as it relates to the review, approval, transparency and compliance activities of biopharm

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

Detail title: Bill S-206 - National Framework for a Guaranteed Livable Basic Income Aspects that are the object of the lobbying: Supporting Bill S-206, An Act to develop a national framework for a guaranteed livable basic income, with respect to ensuring that the framework considers the economic circumstances of professional performers and other self-employed, contract and intermittent workers in Canada's cultural sector. Title: International Mobility Program and Business Visitor Provisions for Performers in Commercial and Audiovisual Production Description: ACTRA is seeking to better understand how the International Mobility Program - including the C-14 significant benefit work permit exemption (IRPR R205(a)) for film and television production workers - and the business visitor exemption (IRPR R186(a)) are applied, consulted on, and monitored as they relate to international performers working in Canada's audiovisual sector, with particular focus on commercial and advertising production. ACTRA is exploring whether existing consultation practices and regulatory thresholds appropriately balance Canada's interest in facilitating international productions and skilled talent mobility with protecting work opportunities for Canadian performers. Title: Labour protections for performers in digital and AI-mediated productions Description: Federal labour policy and labour standards as they apply to performers working in digital, online, and artificial intelligence-mediated productions, including collective bargaining protections, enforceability of performer rights, and measures addressing precarious work and non-traditional production models in the screen-based industries. Title: International trade negotiations affecting Canada's audiovisual and cultural sector Description: Government of Canada positions in international trade negotiations and reviews, including Canada-United States discussions and the CUSMA review process, as they relate to cultural policy measures, broadcasting regulation, online streaming obligations, and the economic impact on employment and production in Canada's audiovisual sector. Title: Federal procurement standards for advertising and communications production Description: Federal government procurement policies and contracting practices for advertising and communications services, including the application of performer labour standards, requirements for union-covered productions, and ethical procurement expectations for the use of performers and creative services in government-funded advertising and public communications. Title: Use of copyrighted performances in artificial intelligence training and generative AI systems Description: Amendments to Canada's Copyright Act and related policy measures regarding the use of copyrighted performances and audiovisual works in the training and operation of artificial intelligence systems, including requirements for consent, compensation, and recognition of performers' moral rights, as well as protections against unauthorized reproduction, voice cloning, and synthetic performances. Title: Federal artificial intelligence governance framework and performer rights protections Description: Development of the Government of Canada's artificial intelligence policy and regulatory framework, including the forthcoming national AI strategy, with respect to consent requirements for the use of performers' name, image and likeness, digital identity protections, reputational harm, takedown and enforcement mechanisms, and accountability obligations for AI systems that generate or replicate performances. Copyright legislation – Updating Canada's Copyright Act to implement the World Intellectual Property Organization (WIPO) Copyright and Audio Visual Treaties and deal with threats from unchecked generative artificial intelligence to performers' livelihoods. Bill C-27 with respect to artificial intelligence and future regulations to protect the rights of Canadian performers from its misuse

Participate in development of, introduction of, and amendments to the Broadcasting Act through the expected re-introduction of a modernization bill, with specific respect to the use of Canadian talent, Canadian ownership in the broadcasting system, and future regulation of online undertakings. Potential impact of trade issues on audiovisual industry. Policies around the procurement of advertising services using unionized workers Legislation and policy that supports the regulation of artificial intelligence, notably in protection of performers, and including, but not limited to, moral rights for performers. Amendments to the Copyright Act relating to moral rights for performers

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.

GOVERNMENT PROCUREMENT - Reform Canada’s procurement system to support investment and ensure a competitive business environment. GOVERNMENT PROCUREMENT - Ensuring fair and open procurement practices to drive innovation and technology adoption in Canada. HOUSING - Advocate for policies and legislation that enable the creation of more housing supply, incentivize investment in residential construction and housing – enabling infrastructure, and support the development of skilled labour we need, whether domestically or through immigration, to restore housing affordability to Canadian families. TAXATION AND FINANCE – With regard to the measurement and improvement of Canada’s tax competitiveness, including: reforming the taxation, remittance, filing and audit processes of Canadian businesses and tax policy which improves the competitiveness of the Canadian business environment INTERNATIONAL TRADE – With respect to issues relating to trade controls, including tariffs, import and export controls, sanctions, and trade remedies. INDUSTRY - Improving the Scientific Research and Experimental Development (SR&ED) tax credit program to drive innovation; increase the role that the federal government plays in creating opportunities for small and medium sized businesses to digitalize and conduct more business activities online; developing a digital economy strategy for Canada. HEALTH – Ensuring we improve access to necessary medicines by building on rather than displacing the important role of private insurers and respecting provincial and territorial jurisdiction. CYBER SECURITY - Encouraging the government to prioritize cybersecurity innovation, talent development, and critical infrastructure resilience; modernize research and development; accelerate commercialization in the space; support the secure digitalization of small-and-medium-sized enterprises (SMEs); and improve the global competitiveness of Canada’s cybersecurity industry. IMMIGRATION - Reducing regulatory burdens for employers; promoting immigration to small, rural and northern communities; supporting regional and local community immigration strategies; maintaining and modernizing the Temporary Foreign Worker Program; Facilitating pathways to permanent residency for temporary residents (international students and TFWs; expediting and simplifying foreign credential recognition, calling for an international student and global talent strategy; improving language training as well as settlement and employment supports to newcomers, aligning immigration programs with labour market needs, improving the Start-Up Visa process, improving client services to potential immigrants and newcomers. EMPLOYMENT AND TRAINING – National Workforce Strategy, programs that support small and medium sized enterprises, improving collection and dissemination of Labour Market Information, establishing the Employment Insurance Council to institutionalize social dialogue between workers and employers on issues related to employment and training needs, addressing barriers to labour mobility, improving effectiveness of employment supports and skills training. EDUCATION - Aligning employer and workforce needs with education and training; expanding skilling, upskilling, reskilling and work integrated learning opportunities. INFRASTRUCTURE – Improvement of Canada’s infrastructure through the National Infrastructure Assessment, National Supply Chains Strategy, and establishment of a Canada Trade Infrastructure Plan. TRANSPORTATION - Regarding the consistent funding of trade-enabling infrastructure projects; the development of a competitive and efficient transportation network including all modes of transportation; the fluidity and stability of supply chain operations, minimizing disruptions. LABOUR - Ensuring that any changes to the Canada Labour Code are implemented in response to defined and demonstrated issues and not to increase regulatory burdens for employers; minimizing labour disruption impacts on Canadian bus

Carbon Removal Canada seeks to ensure that demonstration funding programs are open to permanent carbon removal technologies, helping more projects bridge the gap between pilot and commercial scale, while securing new funding streams for demonstration projects. Carbon Removal Canada advocates for policies and programs that ensure the Canadian carbon removal compliance markets maintain their scientific integrity. This may include measurement, reporting, and verification requirements, or industry best practices. Carbon Removal Canada advocates to develop a permanent carbon removal procurement program that enables the Government of Canada to catalyze the growth of Canadian carbon removal technologies, while meaningfully dealing with its own emissions, such as the Canadian military, without impacting necessary operational flexibility. Carbon Removal Canada seeks to provide advice to the Government of Canada on achieving a balance on ocean carbon removal technologies; ensuring that the integrity of the ocean is maintained, while also creating business certainty. Carbon Removal Canada advocates for the recognition of permanent carbon removal as critical to Canada's economic and environmental future. Carbon Removal Canada advocates for programs and policies that make Canada more competitive in attracting investment for carbon removal technologies and companies. This includes tax credits and regulatory structures that ensure Canada has a high-level of business certainty and active business environment.

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

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. Pharmaceutical intellectual property protection as it relates to international trade agreements Patent Act as it relates to reporting requirements and pricing guidelines, and the protection of intellectual property in biopharmaceutical products. Monitoring and engaging the Government and Parliamentarians on policies and programs related to Canada's biomanufacturing and life sciences sector strategy Food and Drugs Act updates, as it relate to the reform of clinical trial applications, and drug/device submission review and approval process. Scope includes new drug submissions/indications and post market submissions, reliance & recognition pathways, service standards, fees, biosimilars, clinical trial modernization. Federal Public Drug Plans, with respect to the reimbursement of therapeutic products for Federal plan beneficiaries Standing Committee on Finance (FINA) as it relates to pre-budget consultations. 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. Canadian Environmental Protection Act and Regulations in respect of modern, science-based regulations to reflect rapidly changing new technologies. 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. House of Commons Standing Committee of Industry and Technology (INDU) as it relates to Artificial Intelligence and/or any other pertinent legislative proposal before the committee Patented Medicines Prices Review Board (PMPRB), as it relates to reporting requirements, pricing guidelines, and dispute resolution Economic Growth Initiatives as it relates to pharmaceutical, clinical trials investment, life sciences industry Clinical Trials environment in Canada: operational issues, investment, enrollment

Resuming issuance of Canadian real return bonds. Discussing climate, environmental, and sustainable finance policies, including the incorporation of climate-related and transition-related risks into government policy and frameworks, and factors influencing institutional investor capital allocation decisions. Linking mining practices in Canada to climate-aligned initiatives, and supporting the Mining 2030 initiative, which seeks to responsibly develop critical mineral mines while attracting investor capital. Discuss improvements to Canada's carbon markets and the industrial price on carbon. Request for amendments to the Income Tax Regulations to allow a jointly sponsored pension plans to accept pension funds for an incoming single employer pension plan member who already has overlapping service in the jointly sponsored pension plan for the same period. General discussions on investments, including possible investments in Canadian infrastructure projects and linking investments with federal priorities and announcements (e.g., the latest Fall Economic Statement includes pension-related investment programs and the Stephen Poloz led working group targeted how to increase domestic investments by Canadian pensions). Implementing the Sustainable Finance Action Council's recommendations, including the development and implementation of a Canadian Green and Transition Taxonomy. Taxonomies help in addressing the climate change funding issue by making clear opportunities for climate-related investment. Implementing climate-related financial disclosure frameworks, policies, and other measures for public and private companies. Working with various government representatives and entities to understand and implement measures to overcome barriers to increasing the level of climate-related financial disclosures. This includes defining what constitutes a small company and other work to identify appropriate levels of disclosure.