Arancibia Rodrigo

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 Policies related to Subsequent Entry Biologics (SEBs) pertaining to Draft Guidance for Sponsors; Information and Submission requirements for SEBs, regulations and intellectual property policies, naming conventions Monitoring and engaging on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

"In line with current government priorities, ensure greater harmonisation of policies from the Departments of Innovation, Science and Economic Development and Health Canada's regulatory efficiency and streamlining efforts with regard to drug regulation and approval, particularly under the Food and Drugs Act for pharmaceutical products offered for sale in Canada. The objective is to make quality generic and biosimilar medicines available more quickly in Canada, in the interests of patients and the provinces and territories, while generating substantial savings for private and public plans." Amend Bill C-64 to remove the risks and uncertainty that would undermine the stability and affordability of Canada's drug supply. Provide input into the Government of Canada's negotiations regarding the Canada-European Union Comprehensive Economic and Trade Agreement (CETA) and re-negotiation of NAFTA with respect to pharmaceuticals, counterfeit medicines, border measures and intellectual property. Provide input into Government of Canada's Science and Technology strategy regarding the need for a balanced Intellectual Property regime and the important role competition plays in encouraging innovation. Innovation, Science & Economic Development Canada regarding the need to restore balance to the Patented Medicines (Notice of Compliance) Regulations with respect to pharmaceuticals and address operational concerns including: lack of finality to proceedings under the Regulations and lack of disincentives to discourage abuse of the Regulations. Innovation, Science & Economic Development Canada regarding export provisions of the Patent Act (pharmaceuticals). Innovation, Science & Economic Development, with respect to the Patent Act as it pertains to pharmaceuticals. Health Canada regarding the need for appropriate, dedicated resources for the Therapeutic Products Directorate to meet performance targets for the review of generic drug submissions. Health Canada regarding the development and implementation of an approval pathway for Biosimilars as well as pricing policies. Health Canada regarding regulation about Requirement for reporting of drug shortages. Health Canada regarding Patented Medicine Prices Review Board (PMPRB) Reform and National Pharmacare Program Health Canada, Innovation, Science & Economic Development Canada and International Trade Canada regarding effective measures to combat counterfeit drugs in Canada and around the world. As part of its renewed biomanufacturing strategy, the Federal Governement has announced its intentions to reinvest in this strategic sector. Sandoz Canada is interested in initiating discussions in this contexte with the potential objective of a joint investment in the life sciences sector. As a member company, participation in the Canadian Generic Pharmaceutical Association's legal challenge of the 2006 Amendments to Health Canada's Food and Drug Regulations with respect to the extended period of data exclusivity, as well as further proposed amendments to these regulations.