Kayla Slobodnik

Communications with public office holders regarding policies, regulations and programs affecting pharmaceutical pricing and reimbursement frameworks, including the Patented Medicine Prices Review Board (PMPRB), international reference pricing approaches, most-favoured-nation pricing policies and their impacts on investment, innovation, market access and the availability of medicines and health technologies in Canada. Communicating with the Government of Canada about Bill C-22 (An act respecting lawful access) Engaging with government to better understand the Defense Investment Agency and its potential impact on defense procurement policy and processes. Engaging with Government on the Defence Industrial Strategy and its implications on defense procurement. Communications with public office holders regarding the implementation of the Digital Services Tax Act, Online News Act, Online Streaming Act, including as it relates to regulations and conditions applicable to American corporations operating in Canada. Communications with public office holders regarding policies and initiatives to encourage trade between Canada and the United States, including with regard to the United States-Mexico-Canada Agreement (USMCA). Communicating with government officials regarding Bill formerly known as C-63, the Online Harms Act. Communicating with government officials about Bill formerly known as C-27 (Digital Charter Implementation Act, 2022), more specifically the creation of the Consumer Privacy Protection Act, the Personal Information and Data Protection Tribunal Act, and the Artificial Intelligence and Data Act Lawful access requirements of Electronic Service Providers as outlined in Bill C-2, "Strong Borders Act." Engaging in policy development related to data sovereignty and the storage, use, and control of Canadian data. Encouraging Canada to honour its NATO commitment and spend 2% of its GDP on National Defence, and no less than 20% a year on new equipment. Discussions with federal officials regarding the government’s proposed Buy Canada policy, including its potential impacts on cross-border trade, investment, and supply chains. Canada's contribution to Continental Defence, including future investments in NORAD modernization.

Engage government decision-makers regarding CUSMA and Canada-U.S. trade dialogue, including on the Consumer Technology Association's submission for CUSMA consultations and to amplify areas of alignment and priorities impacting its membership.

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