ABSTRACT

The purpose of this study is to determine conceptions and/or disagreements of local and foreign drug companies in Turkey about data exclusivity - the most controversial issue between generic and original pharmaceutical companies all over the world - during the implementation period of the new drug approval regulation. The material of this study is a questionnaire to be replied by members of Turkish Pharmaceutical Manufacturers Association. According to the shared opinion of local and foreign companies (59.4%), generic drug companies will attach importance to research and development activities in the long term. Data exclusivity will be able to encourage the generic companies to produce original drugs. Although Turkish local companies are not able to invent orjginal drugs for today, 60% of local companies that replied the questionnaire survey think that data exclusivity has an encouraging role on research and development. 66.7% of local companies that replied the questionnaire think that equivalent drug policy will not go on with data exclusivity. However, 94.1% of foreign drug companies think that equivalent drug policies will go on with data exclusivity. Although data exclusivity can cause negative effects such as decreasing in the market size of local pharmaceutical companies, in majority both of local and foreign companies perceive the data exclusivity as a necessary and beneficial change. Because replies of questionnaire state that data exclusivity has positive effects in the long term such as increasing on investments of foreign pharmaceutical companies in Turkey, encouraging the local companies for research and development activities.