Scientific Publications by FDA Staff

Clin Pharmacol Ther 2016 Dec;100(6):626-32

Pharmaceuticals licensing and reimbursement in the European Union, United States and Japan.

Oye KA, Eichler HG, Hoos A, Mori Y, Mullin TM, Pearson M

This paper describes recent developments in licensing and reimbursement policies in the EU, US and Japan, examines causes of changes, compares differences and projects trends. With respect to licensing, the EMA, FDA and PMDA are committed to rigorous evaluation of pharmaceuticals in advance of market access with feedback from post-market experience. The EMA is exploring integrated adaptive pathways for licensing, with formal pilot tests to provide a practical proof of concept. The FDA is augmenting traditional licensing procedures through reforms including Breakthrough Product Designation. The PMDA is implementing reforms to foster innovation and earlier patient access through its Sakigaki strategy and licensing reforms on regenerative medicines. With respect to reimbursement, several generalizations emerge. Relative to US counterparts, EU payers typically set higher standards for evidence of effectiveness as a condition of reimbursement, impose tougher limits on reimbursement by indication, and drive harder deals in negotiations over prices.