Abstract

COMPARATIVE ANALYSIS OF THE REIMBURSED MEDICAL DEVICES IN SERBIA AND BULGARIA

Krklješ Dragana, Nikolay Gerassimov, *Guenka Petrova

ABSTRACT

The aim of the current study is to analyze the legislation and reimbursed market of medical devices in Serbia and Bulgaria. Comparative legislation analysis was performed focusing on the European Directives, National legislative acts and regulations endorsing the rules for medical devices authorization, classification, quality control, and reimbursement of medical devices. First was analyzed the development and major requirements of European legislation on medical devices since 1990 when the first EU Directive was issued. Next was analyzed the national laws on medicines in both countries and related regulations and institutions for medical devices authorization and quality control. Then was reviewed the legislative requirements for medical devices reimbursement and payment in both countries under consideration. Market analysis was performed towards the officially published data by the health insurance authorizes in both countries for the reimbursed cost by type of medical devices and by dispensing retail pharmaceutical companies. In Serbia are authorized for sale on total 23 156 medical devices. According to the information published by the Serbian health insurance fund in 2009 the reimbursed sum for medical devices accounts for 155 536 millions of Euro. In Bulgaria are authorized 137 000 devices and the total cost paid by the national health insurance fund for medical devices in 2011 accounts for 29.95 million of Euro, in 2012 it increases to 35.9 million of Euro, and in 2013 is near 37 million of Euro. The National health insurance fund defines the ceiling retail price that it will reimburse for a particular medical device ranging between 75 and 25000 Euro.In both countries the medical devices performs significant and important part of the pharmaceutical sales and reimbursement. The market and reimbursement is expected to grow up in future but there is a need for more precise registration of authorized devices.

Keywords: Medical devices, regulation, retail dispensing, reimbursement.