Enhancements related to intellectual property legislation, regulations and policies applicable to rare disease medicines. Issues related to U.S. pharmaceutical importation, trade and policies, including research and development, regulatory authorizations, funding of medicines, supply sources and supply chains. Regulatory amendments and/or guidelines related to the Food and Drugs Act Regulations and Health Canada to implement an orphan drug regulatory framework. Innovation, Science and Economic Development Canada regarding the Innovation and Skills Agenda and other government policies and programs related to incentivizing research and development activities in Canada, including the Biomanufacturing and Life Sciences Strategy. Regulations, guidelines, policies and programs related to regulatory and reporting functions of the Patented Medicine Prices Review Board. Enhancement to Canada's regulatory and funding environment for new rare disease medicines, including Health Canada authorizations of medicines and framework for clinical trials, health technology assessment processes, reimbursement negotiations and funding decisions. Federally-funded public drug plans, with respect to reimbursement for medicines for federal plan beneficiaries. Implementation of the Pharmacare Act and its implications for rare disease medicines. Implementation of the National Strategy for Drugs for Rare Disease, and other policies or programs related to rare diseases.