Government Regulation of Pricing and Reimbursement of Prescription Medicines: Results of a Recent Multi-country Review

Access to prescription medicines is an essential component of publicly funded or publicly assisted healthcare programs. Thus, important policy questions are presented when government agencies that administer those programs establish procedures for making decisions about the appropriate use of medicines, including determinations as to which medicines will be reimbursed, at what prices, and for which patients. The authors reviewed systems for making determinations on pricing and reimbursement of prescription medicines under public healthcare systems in 10 countries, including four member states of the European Union (EU) (France, Germany, Italy and the United Kingdom), plus Australia, Brazil, China, India, Japan and Korea. In addition to national regulatory requirements, the authors considered international agreements that may impose obligations with respect to procedures for pricing and reimbursement of prescription medicines, including the EU's Transparency Directive, agreements administered by the World Trade Organization (WTO), and bilateral free trade agreements negotiated by the United States in recent years. Drawing on this experience, the authors sought to identify common themes, pitfalls and best practices in national systems for regulating pricing and reimbursement of prescription medicines. The authors have focused primarily on procedures, rather than the underlying political assumptions or substantive economic objectives. They have assumed that all countries have--or should have--a common interest in assuring that decision-making procedures afford interested persons who have relevant information a meaningful opportunity to participate