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Drug Data Exclusivity In Turkey
Ecz. Oğuzhan GÜRSON,a Dr. Gülbin ÖZÇELİKAY,a Dr. Eriş ASİLa
aEczacılık İşletmeciliği AD, Ankara Üniversitesi Eczacılık Fakültesi, ANKARA
In many countries, health authorities do not approve the usage of originator’s data as a reference for abridged applications by generic companies for a period (usually 6 or 10 years) after the original product gets drug licence. This application is known as data exclusivity.
Turkey implemented the patent protection to its regulatory system in 1995 and subscribed to apply the data exclusivity with TRIPS and Customs Union agreements. Data exclusivity caused arguments between local and foreign drug companies until the publication of “Human Medicinal Products Licensing Regulation”. This regulation is published on the Official Newspaper on 19th of January, 2005.
Relationships between data exclusivity and patent protection, data exclusivity applications in international legislation and other countries will be mentioned in this study.
Because of the limitation with patent period, it can be thought that data exclusivity does not have important negative effects on generic drug companies. But in the medium and long term, human health and probable legislation changes must be considered and research and development activities must be attached importance.Keywords: Data exclusivity, patent, Turkish pharmaceutical industryTurkiye Klinikleri J Med Ethics 2006, 14:107-110
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