Is the pharmaceutical market in Bulgaria innovative?

Abstract

After the turn to market oriented economy a lot of drugs were authorized for sale in the East European countries. Because of the limited resources of these countries, mainly generic or brand generic products were licensed. The number of the patented drugs on the market could be used as measure of the market attractiveness to the R&D producers. The study shows the analysis of the innovativeness of the Bulgarian drug market comparing the registration and the patient activity of the producers. The number of the authorized products for five years period (1990-2000) and share of the patented products were investigated. During the observed period the number of newly authorized pharmaceuticals increased almost seven times from 800 (650 INN) to 6000 (2000 INN) dosage forms. The prevailing part of the newly registered drugs was found to be brand generics and possess only trade name protection. The share of drugs that are patented is less than five percent of all newly registered medicines, and among the fifty most commonly prescribed and sold medicines between 1996-2000, only 0.5 percent of drugs were patented. Obviously the Bulgarian pharmaceutical market is very competitive but not that attractive for most of the R&D producers. In general the registration of the patent protected products is increasing during the years and especially after harmonization of the related legislation with the EU requirements. The patent activity of the pharmaceutical companies regarding newly authorized drugs is influenced by the structure of morbidity and population. During the last two years the patent activity is increasing and is oriented mainly towards the protection of newly authorized drugs or pharmaceutical forms and obligatory registration of trademarks for the privatized Bulgarian pharmaceutical manufacturers.