Industry Trend Analysis - PhRMA 2017 Report Highlights Significant Market Access Barriers For Patented Medicines - MAY 2017


BMI View : Innovative pharmaceutical firms will continue to be faced by a wide array of challenges in Turkey. Significant market access barriers to new product launches are created by l ong delays for regulatory approval, poor enforcement of intellectual property and numerous regulations that are not aligned with international standards.

Pharmaceutical Research and Manufacturers of America (PhRMA) has published its annual Special 301 Submission to the United States Trade Representative (USTR), outlining the principal issues facing pharmaceutical firms in key international markets. It has once again recommended that Turkey be placed on the USTR's Priority Watch List of countries given the significant regulatory challenges faced by multinational drugmakers in the country.

The PhRMA report notes that the regulatory environment has improved in Turkey in recent years - it was recommended as a 'Priority Foreign Country' in 2015 (the worst classification: defined as a foreign country that denies adequate and effective protection of intellectual property rights or fair and equitable market access). There has been improved dialogue between the innovative pharmaceutical industry and the Turkish government, resulting in improvements to areas such as regulatory approval procedures and intellectual property protection; however, the report highlights that many of the country's regulations are incompatible with international standards, dissuading investment from foreign innovative medicine manufacturers and creating barriers to market access.

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