On February 24, 2017, a new Decree Regarding Pricing of Pharmaceuticals (“New Pricing Decree”) was published which introduced several changes in details without effecting the overall rules applicable to the pricing of pharmaceuticals in Turkey. Since publication of the New Pricing Decree, the Communique Regarding Pricing of Pharmaceuticals dated December 11, 2015 (“Former Pricing Communique”) has been expected to be replaced by a new communique in line with the New Pricing Decree.
Accordingly, a new Communique Regarding Pricing of Pharmaceuticals was published on September 29, 2017. The new Communique Regarding Pricing of Pharmaceuticals generally follows the structure and rationale of the Former Pricing Communique. Yet, several revisions to the wording and terminology in addition to certain detailed pricing rules have been introduced by the new Communique Regarding Pricing of Pharmaceuticals with the ultimate purpose of reflecting the changes brought by the New Pricing Decree in February 2017 and ensuring harmony between the communique and decree.
Turkey applies a reference pricing system in which France, Spain, Italy, Portugal and Greece are taken into consideration as the reference countries. The New Pricing Decree and the new Communique Regarding Pricing of Pharmaceuticals regulate the rules applicable to pricing of pharmaceuticals including general principles of pricing, definition of different kinds of product categories (such as orphan drugs, biosimilar, radiopharmaceutical products, medical infant formula, allergy products) and the specific pricing rules applicable for such categories, working principles of the Pricing Evaluation Committee, procedural rules for pricing declarations and required actions in the event of a change in the declared prices.
Following the latest changes made in the aforesaid legislation in 2017, minor discrepancies between the Former Pricing Communique and the New Pricing Decree have now been eliminated and the new rules are expected meet the needs of the industry.