Overview Of Innovative Medicine Sector In Turkey

Abstract

Investments in innovative medicines are prioritized and prompted by Turkish government. Turkish Biotechnology Strategy Document and Action Plan for 2015-2018 have been published. Main challenges and weakness are lack of infrastructure in terms of know how, facilities and human resource, not compatiblity of regulations on intellectual property rights with the investment and manufacturing goals in long term and transferability of know how to Turkey. he aim of this study is to compare Turkey with EU countries in terms of access to innovative medicines. A computer based search has been conducted for understanding Turkey`s innovative or bitotechnology medicines policies. Web pages of Turkish Medicines and Medical Device Agency (TITCK) and European Medicine Agency (EMA) were used to check the marketing authorization of products. A policy enviroment report for biotechnology sector in Turkey has been conducted. Marketing authorization of innovative products were compared between TITCK and EMA from 2011 to 2016. Regulations on licensing are compatible with the EU regulations. No specific regulations regarding biotechnology (including biosimilars) and innovative medicines in terms of pricing and market access is available for Turkey. General problems faced by originator drugs are also valid for biotechnological and innovative medicines as fixed exchange rate, cost containment measures and investment pressure. 59 innovative medicines have been granted marketing authorization by EMA between 2011 to 2016, while TITCK granted only 17. Depending on analysis, Turkey has not written rules or hurdles for biotechnology or innovative medicines. However, access to innovative medicines may take longer than EU countries. Detailed analysis is needed to understand the possible cause of the delayed process.