On 14 March 2023, the Presidency of Republic of Türkiye amended the Decree on the Pricing of Pharmaceuticals (“Decree“). The amendments regarding the calculation of real source price will enter into force as of 9 November 2022, whereas the other amendments to the Decree will enter into force as of the date of publication. The Decree is available online here (in Turkish).
The main amendments to the Decree are as follows:
- In cases where the source product the following imported
products cannot be determined, the warehouse sale price of the
product that does not have retail sales in any country and is only
offered for sale through hospital channels will be taken into
account in the real source price calculation:
- Products that already have retail sales in Türkiye, or
- Products for which a retail sales price will be requested.
- A source country search will not be conducted for the following
manufactured generic products:
- Products without a reference product
- Products whose reference product cannot be considered as a source product
For manufactured generic products that are already priced with the cost card and for which there is no reference product in Türkiye, the Turkish Pharmaceuticals and Medical Devices Authority (“TİTCK”) will not conduct a reference product search again, or if a reference price is determined in the source countries, this price will not be taken into account in the calculations.
- The following pharmacist profit rates will apply when
determining the retail price of products other than
- 28% for amounts up to TRY 328 (including TRY 328),
- 18% for amounts between TRY 328-657 (including TRY 657),
- 13% for amounts over TRY 657.
- Except for non-reimbursable products, for products included in
the Detailed Pharmaceutical Price List with a Warehouse Sale Price
below TRY 55.90 (not including TRY 55.90), the Warehouse Sale Price
will be increased up to TRY 4 for:
- products with a current Warehouse Sale Price of TRY 37.10 and below, and
- products with a current Warehouse Sale Price between TRY 37.11 (included) and TRY 55.89.
- The foregoing increase applied to price-protected products that are priced at or below TRY 37.10 and other products priced below TRY 19.39 is exempt from offsetting. The increase applied to price-protected products between TRY 37.11 and TRY 55.89 and other products priced between TRY 19.39 and TRY 55.89 is not exempt from offsetting during the real source price change period.
Amendments to the Decree introduced new regulations and thresholds in relation to the pricing of pharmaceuticals and set out an alternative pricing regime for cases where the source product or reference product cannot be identified. Companies that are involved in the placement on the market, importation or distribution of pharmaceuticals in Türkiye must review the amendments to the pricing regulations carefully and take the necessary actions to ensure compliance with the legislation.
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.