The Decree by the Council of Ministers on Pricing of Medicinal Products for Human Use ("Decree") entered into effect on 10 July 2015, when it was published in Official Gazette numbered 29412. It introduces detailed procedures and principles for establishing, publicizing and changing the prices of medicinal products for human use in Turkey. The Decree supersedes the Decree on Pricing of Medicinal Products for Human Use, which was published in Official Gazette numbered 26568 on 30 June 2007.

A new Communiqué is expected to be issued in accordance with the new Decree. Until this occurs, provisions of the Communiqué on Pricing of Medicinal Products for Human Use issued under the now superseded Decree will continue to apply, provided they do not contradict the new Decree.

Procedures and principles introduced by the Decree include:

  • Annual Determination of the Euro Value: The Price Evaluation Commission will determine the value of 1 Euro, which will be basis for pricing medicinal products for human use. The determination must be made within the first five days of January each year (Article 2(2)). The value of 1 Euro will be 70% of the annual average Euro value, calculated based on the Central Bank of the Turkish Republic's daily indicative exchange rate, announced in the previous year's Official Gazette.
  • Monitoring Reference Prices: Companies are responsible for monitoring and following-up the relevant reference price and for their declarations to the Ministry of Health (Article 2(1)). The Ministry of Health will not automatically follow-up the reference price, but it has the discretion to check declared reference prices.
  • Declaring Changes to Reference Prices: Companies must declare changes of reference price every six months (Article 5). Companies' obligation to declare reductions in reference prices continue under the Decree.
  • Profit Rates: Profit rates of storekeepers and pharmacists indicated under Article 6 of the Decree will not be applied to medical prices to be purchased within the scope of alternative reimbursement models in accordance with Article 73 of the Law of Social Security numbered 5510. The Price Evaluation Commission can determine medical prices and/or profit rates without being restricted to the Decree's provisions.
  • Announcing Price Changes: Changes to price lists must be announced each Friday (or the previous workday, if Friday is public holiday). The new prices will enter into force the following Tuesday. Voluntary reductions to the price list will become valid sixty days after the announcement date.
  • Transition Period: The Price Evaluation Commission was required to publish the Euro value to be used until 31 December 2015 within five working days of the Decree being published in the Gazette (Transitional Article 1). Accordingly, the Price Evaluation Commission announced the value of 1 Euro to be applied for this period will be TRY 2.0787.

Please see this link for the full text of the new Decree (only available in Turkish).

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.