Life Sciences Newsletter, October 2017

New communiqué on medicines pricing

Dicle Doğan, Bentley James Yaffe and Fatma Sevde Tan, Gün + Partners

On 29 September 2017, the Ministry of Health published the new “Communiqué on the Pricing of Medical Products for Human Use” in the Official Gazette numbered 30195. The communiqué contains significant amendments to the pricing of products subject to special conditions and the timetable of the pricing procedure.

Definitions have been added for the terms “exactly equal product”, “closely equal product”, “price declaration” and “price protected product”, with the term “reference price” being changed to “source price”. Additionally, for the products for which no source price tracking is made, the value ranges have been increased:

  • For price protected products, to a sale price of up to TRY 8.09 (approx. £1.65) per dose or package size.
  • For products that are not price protected, to a sale price of up to TRY 4.24 (approx. £0.87) per dose or package size.

Amendments were made to the procedure for determining real source price, with different methods of determination of the price for imported and manufactured products. The timetable for the application request, determination and evaluation regarding the changes in the real source price have also been changed, with a move to a more detailed timetable.

The communiqué became effective as of its date of publication, with the exception of some amendments to provisions regarding the period of implementation for the real source price change.

Source: Official Gazette: Notification number 30195, Communiqué on the pricing of human medical products, 29 September 2017 (Turkish language).

 First published by Practical Law, in 01.11.2017