OBJECTIVES: To examine pricing, reimbursement and market access of orphan drugs approved by EMA and FDA between January 2009 and December 2013. METHODS: Analyzed the orphan drugs approved by both EMA and FDA between Jan 2009 and Dec 2013,  by country (US & EU5) regarding; time to market, benefit evaluations, pricing and reimbursement differences, as well as any similarities or differences by size of population. RESULTS: In the time frame, 102 orphan drugs were approved in the US vs. just 31 by the EMA.  Of those, only 13 orphan drugs were approved by both agencies.  For these 13 drugs, approval took an average of 66 weeks from filing with the EMA and 45 weeks with the FDA.   Average US time to launch from approval was 9 weeks (only 2 weeks if one outlier is removed).  In the EU, all 13 drugs were available and reimbursed on the German market in an average of 16 weeks while only 5 had completed P&R in Spain in an average of 97 weeks.  Early access to reimbursement via the ATU program in France and L648 program in Italy was sometimes pursued. In the UK, SMC recommendations for orphan drugs were often negative, and NICE only reviewed oncology orphans thereby resulting in inconsistent access. Alternative funding mechanisms sometimes provide a temporary reimbursement fix in the UK. Ex- factory pricing varied by country both at launch and over time.   CONCLUSIONS: Significant differences exist between the number of orphan drug approvals and time to access in the US vs. EU.  The US is notably faster than the EU5 and Germany is notably faster than other EU5 countries.  For pricing, the US is not always the high price country.  Furthermore, there appears to be an inverse relationship between size of the indicated patient population and reimbursed price.