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Biotechnology & Biotechnological Equipment 27 (5), 4186 - 4192 (2013)



Maria Kamusheva, Assena Stoimenova, Miglena Doneva, Albena Zlatareva, Guenka Petrova

Medical University of Sofia, Faculty of Pharmacy, Sofia, Bulgaria

Correspondence to: Maria Kamusheva E-mail: maria.kamusheva@yahoo.com

Published 17 October 2013


Rare diseases are orphan diseases with low prevalence, affecting not more than 5 per 10 000 Europeans. Despite the common European Union (EU) political framework in the field of rare diseases and orphan drugs (ODs), there are differences in patient access to orphan drugs in different  EU member states.

The aim of this study was to evaluate the access to ODs and to compare it in light of the reimbursement systems in three neighboring Balkan EU Member States: Bulgaria, Greece and Romania. The policy and legislation documents related to rare diseases and ODs were reviewed and a cross-comparison between the Orphan Drug List in the EU for a six-month period (May 2012–October 2012) and the reimbursement drug lists available in each of the studied countries was made.

The available and accessible ODs with European authorization and prior orphan designation (of a total of 68 ODs) in October 2012 were 24 (35.3 %) in Bulgaria, 45 (66.18 %) in Greece, and 36 (52.94 %) in Romania. The biggest ATC group in the studied countries was that of the ‘L - Antineoplastic and immunomodulating agents’. No ‘R-Respiratory system’ medicines were found in the reimbursement lists. The dynamics in the reimbursement of available ODs with European authorization and with prior orphan designation within the six-month period showed the most remarkable increase in Romania (27.94 %). The number of ODs with European authorization and without prior orphan designation (of a total of 75 ODs) included in the Bulgarian Reimbursement List were 40 (55.33 %); in Greece, 52 (69.5 %); and in Romania, 44 (58.66 %). The ATC group ‘L - Antineoplastic and immunomodulating agents’ was again the largest. There were no ‘C - Cardiovascular system’ and ‘P - Antiparasitic products’ ODs. The most notable dynamics in the reimbursement of available ODs with European authorization without prior orphan designation were observed in Greece (a 38.08 % increase).

This is the first study comparing and analyzing the dynamics in OD access in the neighboring countries Bulgaria, Greece and Romania. It showed that although there are regulatory frameworks in the field of rare diseases in the three countries, the access to ODs is different, it being lower in Bulgaria. As it was expected, neither one of the countries reimburses all EU authorized for sale orphan drugs with and without prior orphan status designation.

rare diseases, orphan drugs, reimbursement, access, Bulgaria, Greece, Romania


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