Abstract

ANALYSIS OF ACCESS TO ORPHAN DRUGS IN FIVE NEIGHBORING EUROPEAN COUNTRIES - BULGARIA, GREECE, MACEDONIA, ROMANIA, AND SERBIA

*Albena Zlatareva, Dragana Lakic, Maria Kamusheva, Danijela Spaskov, GeorgiMomekov, Guenka Petrova

A

ABSTRACT

The purpose of this study is to evaluate the access to drugs for rare diseases and make a comparison in terms of the reimbursement systems in five neighbors Bulgaria, Greece, Macedonia, Romania and Serbia. A survey on the legislation and policies in the field of rare diseases in the 5 countries under consideration, and on the access and reimbursement of the drugs to treat these diseases was launched. The discovered documents were analyzed in terms of regulatory policies, non-government sector, models of access and reimbursement of drugs, as well as statistical indicators, geo-political and economic development of the 5 countries and their historical time to enter the EU. The information on the authorized orphan drugs in Europe, included in the List of Orphan Drugs in the EU for a six-month period (May 2012-October 2012), including orphan drugs with and without preliminary orphan designation, was used to investigate any differences in the access to orphan drugs in the investigated countries. The information from the officially published drug reimbursement lists in the five countries, systematized under INN and ATC code from the databases of official national authorities, was analyzed with medicines reimbursement lists comparing the official EU lists with the lists of the five countries, and the lists of the countries themselves. The national health policies for diagnosis, treatment and rehabilitation of patients with rare diseases differ in the five analyzed countries in terms of the availability and quality of services. All five countries adapt national plans for rare diseases, whose purpose is to create an institutional framework and services for diagnosis and treatment of such diseases, improve the access to information, stimulate research and emphasize the position of the patient organization. However, these countries have difficulties in the implementation of the national plans and ensuring the adequate access to orphan drugs. Countries also could not provide equal access to medicines for patients with rare diseases.

Keywords: Rare diseases, orphan drugs, access to orphan drugs, regulatory analysis.