Gabrielle Dolgoy

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

Législation et réglementation concernant l'utilisation de l'intelligence artificielle au Canada, y compris le projet de loi C-27, la Loi sur l'intelligence artificielle et les données. Législation et réglementation concernant le droit d'auteur dans l'industrie de l'édition du livre au Québec.

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

Having conversations about Canada’s music marketplace and the role of Canada’s major labels and artists in it Policy pursuant to International Trade, industry regulation and the Canada-United States-Mexico Agreement (CUSMA) review regarding culture, the digital environment and copyright and labour practices that protect Canadian artists and the creative industries. Discuss potential artificial intelligence regulations and governance measures that ensure that creators and their intellectual property are protected in the digital environment Having conversations about Canada's participation in the World Intellectual Property Office Standing Committee on Copyright and Related Rights Having conversations about Canada's participation at the G7 Summit and global leadership on music and cultural policy. Regulation pursuant to the implementation of the Digital Service Tax (DST). Regulations pursuant to the Copyright Board of Canada. Regulations pursuant to the Broadcasting Act - Ensuring that CRTC regulations that affect the Canadian recording industry appropriately promote Canadian artists and creative industries. Legislative proposal to ensure that individuals are able to protect the use of their voice and visual likeness from artificial intelligence applications Enforcement and Amendment of the Customs Act - Seeking amendment and adequate enforcement of provisions of the Customs Act to ensure that intellectual property rights holders are protected against counterfeiting and piracy and trade in counterfeiting or pirated goods. Amendments to the Copyright Act - To bring the Copyright Act in line with advances in technology and current international standards and provide fair and predictable rules for copyright in the digital environment. Amendments to the Broadcasting Act - to ensure that the Broadcasting Act protects and supports Canadian music creators and their works in the digital environment.

Policies aimed at reinforcing pharmaceutical supply chain. Discussion regarding the launch of new branded product in the rare disease space Improvements to the supports offered by the federal government to support R&D; in particular, generic drug research and development. Seeking support from the Strategic Innovation Fund Program for support of biomanufacturing expansion project. Policies aimed at facilitating generic drug repurposing. Discussion on the opioid crisis and the Health minister's expectations from pharmaceutical manufacturers Discussion of regulatory impediments to the launch of pediatric formulations of branded and generic products. Discussion of a possible Therapeutics Products Directorate ("TPD") workstream on complex generics regulatory pathways.