Loris Mirella

C-64, An act respecting pharmacare - discussions around the structuring and implementation of a national pharmacare program. The government's economic, health, investment, science and technology, and trade policies as they relate to the pharmaceutical industry Pharmaceutical pricing policy arising from the jurisdiction of the Patented Medicines Prices Review Board (PMPRB) Pharmaceutical and trade policy as it relates to security of supply for Canadian medicines. Patented Medicines Pricing Review Board (PMPRB) – regulations that can impact the Canadian pharmaceutical industry. Patented Medicine Notice of Compliance (PMNOC) Regulations - enforcement of Intellectual Property with respect to the Canadian pharmaceutical industry. Patent Act - An Act respecting patents of invention with regard to Intellectual Property Protection for pharmaceutical products - federal court decisions that have changed the disclosure requirements regarding the utility of an invention. Intellectual Property - Changes to Patented Medicine (Notice of Compliance) (PMNOC) regulations - important regulations that can affect Eli Lilly Canada's business Free trade treaty agreement as it relates to the North American Free Trade Agreement (NAFTA) and free trade negotiations as it relates to Columbia, India, and the European Union Food and Drug Act - An Act respecting food, drugs, cosmetics and therapeutic devices. Discussions relating to progressive licensing and the modernization of the Food and Drug Act.

Seeking amendments to the Copyright Act to create new rights for copyright owners to protect their works in the internet environment, and to clarify responsibilities of internet service providers.

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.

Communicating with the Government of Canada about Bill C-8 (An Act respecting cyber security, amending the Telecommunications Act and making consequential amendments to other Acts). Communicating with the Government of Canada about Bill C-22 (An Act respecting lawful access) Communicating with the Government of Canada about Bill formerly known as C-27 (Digital Charter Implementation Act, 2022), more specifically the creation of the Artificial Intelligence and Data Act. Communicating with the Government of Canada about Bill C-2 (An Act respecting certain measures relating to the security of the border between Canada and the United States and respecting other related security measures). Work with government to promote and support Canada’s digital economy, including ensuring the availability of a high-skilled tech workforce. Seeking to influence policy direction related to cloud based services. Seeking government contract with multiple government departments and institutions with regards to Amazon Cloud based solutions and related support services.

Pharmaceutical research & development -support for R&D in Canada. Domestic pharmaceutical manufacturing: trade, tariffs, and sustainability of domestic manufacturing. Pharmaceutical policy: Ongoing interactions related to increased and sustainable utilization of cost-saving generic and biosimilar medicines, and a predictable and viable business environment for generic medicines.

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.

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

Suivi des négociations commerciales actives afin de défendre l'exemption culturelle Loi sur la radiodiffusion: favoriser des changements pour que la loi s'applique à l'environnement numérique Loi sur le droit d'auteur: assurer la protection effective des droits Convention de l'UNESCO sur la protection et la promotion de la diversité des expressions culturelles : échange avec les représentants gouvernementaux sur l'évolution des débats et les programmes nationaux qui en découlent

Arranging meetings to introduce the Consumer Technology Association and to learn about the government's perspective on artificial intelligence, international trade and electric vehicles.

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.