Greg Loyst

Discussion with government officials on trade policy and priorities including items controlled for import and export in Canada

We plan to hold Hill Days and advocacy days where we meet with federal officials to try to influence policy in favour of the isotope industry. Federal officials will be invited to participate in CNIC meetings to raise awareness for the activities of our members and CNIC, and our policy recommendations. We met with representatives of NRCan, Health Canada, ISED, and the NRC to discuss the creation of an interdepartmental roundtable on Isotopes.

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.

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.