New tariffs for license fees collected under the Medicinal Products for Human Use Act threaten the stability of the drug policy in Bulgaria. This is the opinion of the leaders united in Bulgarian Generic Pharmaceutical Association, whose members include companies such as Sopharma, Actavis, Pharmachim Holding, Antibiotic- Razgrad, Balkanpharma and Teva Pharmaceuticals. According to a board member of the generic association, Dr. Valentin Dimitrov, higher rates that pharmaceutical manufacturers will pay to the Bulgarian Drug Agency for each of its preparations may lead to a shortage of medicines on the Bulgarian market. His colleague Vladimir Afenliev added that the state is providing dramatic increases in most of the fees, in some cases going up to 400-percent increases. According to him, this will affect companies with a large portfolio of products and increase their costs by about 1 million levs a year. To offset this amount, they will either have to increase the prices of some of the drugs or to withdraw them from the market. Mr. Afenliev argues that the increase is contrary to the promises of the government to ease the administrative burden on companies, as well as go in line with the European trends to reduce this type of charges. He said that it will have a direct effect on the healthcare system, as higher income is not going to improve the performance of the drug agency nor help increase the number of its inspectors.
If the tariff is adopted, the most common and most frequently used medicines sold, will probably jump in prices dramatically. These are soothing medications, influenza and anti-inflammatory pills and products that hold now the lowest prices. Fees for registration of new drugs are expected to soar between 500 and 4000 levs, and the annual maintenance of the license will cost 1,000 levs instead of the previous 250 levs. Increased will be the rates to assess the documentation and the fee for authorization of clinical trials will be raised two-fold. Manufacturers will pay more for inspections.
Generic association disagreed with upcoming amendments to the Health Insurance Act.
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