 Drug Pricing and the Impact on Treatment Access - International Wim Vandevelde - European AIDS Treatment Group (EATG) 2010 HIV Research Catalyst Forum April Baltimore

Warning: European health care “socialist”!

Europe’s Internal Market  27 countries in the European Union, aka the “Internal Market” – 500 Mio customers  distinct national regulatory approaches in health care legislation  Central approval of new drugs by EMA  National Marketing authorisations

European reference price vs national price-setting  National marketing authorisations  National price negotiations and discounts  ARVs reimbursed by the National HC Systems  European reference price bracket

UK - France - Germany distinct regulatory approaches  UK: profit control for patented drugs, maximum reimbursement price with pharmacy clawback for generics  Germany: until 2010 no price control for patented drugs, reference price system for generics (now also includes patented drugs)  France: price negotiation for patented drugs, less of an emphasis (historically) on the generic market; moved to generic drug reference pricing in 2003

Developing world  Generic competition  WHO-prequalication  New WHO treatment guidelines criteria  Continued patent/IPR issues

Martin Delaney 