Natalie Zakhem

Canada's Drug Agency policies as it relates to reimbursement recommendation decision-making process and framework Biomanufacturing and Life Sciences Strategy (BLSS) as it relates to the biopharmaceutical industry. Federal policies that relate to possible models of pharmacare Federal Buy Canadian Procurement Policy as it relates to government drug procurement practices and the implications for the biopharmaceutical industry 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 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 National Strategy for Drugs for Rare Diseases World Trade Organization (WTO) issues concerning the agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs) with respect to the protection of data, Access to Medicines, and TRIPs "flexibility" World Intellectual Property Organization (WIPO) issues concerning the biopharmaceutical industry World Health Organization (WHO) issues concerning 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 Pharmaceutical pricing policy issues arising from the jurisdiction of the Patented Medicines Prices Review Board (PMPRB) 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 Income Tax Act as it relates to biopharmaceutical products Health Canada's Regulatory Roadmap for Health Products and Food as it relates to the biopharmaceutical industry Free trade agreements as they relate to the biopharmaceutical industry Food and Drugs Act and Regulations and the Import and Export Permits Act with respect to cross-border trade as it relates to the export of Canadian biopharmaceuticals Food and Drug Regulations as it relates to data protection and the regulation and protection of biopharmaceutical products Canadian Institutes of Health Research (CIHR) Clinical Research Initiative as it relates to public/private research and development partnerships Annual federal Budgets and Budget updates as it relates to the biopharmaceutical industry

Advocacy for measures to reduce the federal regulatory burden and streamline administrative processes for the legal cannabis sector to improve efficiency and support economic competitiveness. Advocating for a stronger role for federal economic development ministries (e.g., Innovation, Science and Economic Development Canada or Agriculture and Agri-Food Canada) in shaping cannabis policy and programs. The goal is to ensure the sector is integrated into national agriculture and industrial strategies, enabling access to innovation funding, export development programs, and regional economic growth initiatives. This includes modernizing policies to support competitiveness, sustainability, and international trade opportunities for the cannabis industry. Advocacy related to fair competition in the legal cannabis sector, including efforts to support balanced market rules and to prevent undue concentration. Advocacy related to the need to develop a national cannabis export strategy Advocacy for enhanced consumer education and improved packaging and labeling regulations to support informed purchasing, promote safety, and strengthen the legal cannabis market. Advocacy for revising THC limits on cannabis edibles to align with consumer demand and global standards, reducing the appeal of unregulated products and strengthening the legal market. Advocacy for changes to Canada's cannabis excise tax framework to support industry competitiveness, reduce the illicit market, and enhance public policy objectives of legalization. Representations to government, Parliamentarians, and public servants regarding cannabis legalization, regulation, policy development, and program initiatives in Canada.