Recent Development
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).
What’s New?
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 pharmaceuticals:
- 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.
Conclusion
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.
