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T. Catic, A. Bajramovic
1 1. 11. 2010.

PHP36 THE AVAILABILITY AND FUNDING OF ORPHAN DRUGS IN BOSNIA AND HERZEGOVINA IN COMPARISON WITH NEIGHBORING COUNTRIES

to new medicines. Our goal was to determine the time period between the registration and reimbursement date in Hungary. METHODS: We selected all newly reimbursed pharmacy drugs between January 2004 and April 2010 and looked for the date of registration and reimbursement in public websites and Bulletins of EMEA/EMA, National Institute of Pharmacy and National Health Insurance Fund. We excluded hospital only medicines and drugs with special reimbursement budget from the analysis due to the lack of transparency of reimbursement dates in publicly available data sources. RESULTS: 106 newly reimbursed innovative medicines between January 2004–April 2010 were included into the analysis. The average time period between registration and reimbursement was 677 days. CONCLUSIONS: Hungary joined the European Union in May 2004 and implemented the EU Transparency Directive. Time to reimbursement of innovative medicines in Hungary is signifi cantly longer than the recommended 90 + 90 days for pricing and reimbursement process set by Transparency Directive. The pricing and reimbursement process in Hungary takes more time than in 15 European countries included in the EFPIA Patients W.A.I.T. indicator database (from 101 to 403 days). Acceleration of patient access to innovative medicines is highly recommended in Hungary.


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