Amendments to the Decree on Pricing of Pharmaceuticals

Recent Development

On 24 October 2024, the Presidency of the Republic of Türkiye amended the Decree on Pricing of Pharmaceuticals (“Decree“). The amendments introduced by the Decree entered into force on 25 October 2024.

The Decree is available here (in Turkish).

Significance of the Decree

Türkiye applies a reference pricing system for the pricing of pharmaceuticals. In this regard, the lowest warehouse sale price determined for the relevant product in the source countries determined among members of the European Union in the Communiqué on the Pricing of Pharmaceuticals by the Ministry of Health is taken as the highest warehouse sale price for Türkiye. The reference price is converted into Turkish Lira at a fixed Euro value announced by the Price Valuation Commission every year so as not to be affected by exchange rate fluctuations. For this reason, stakeholders in the sector closely follow the EUR 1 value to be announced by the Price Valuation Commission within the first 45 days of each year or in exceptional cases at any time during the year, which is to be used in the pricing of pharmaceuticals.

What’s New?

The main amendments to the Decree are as follows:

• – When determining the real source prices of pharmaceuticals, the amount of active substance will be compared regardless of the solvent.

• – The following warehouse profit rates will apply when determining the retail price of products other than pharmaceuticals:

• ▪️ 8% for amounts up to TRY 328 (including TRY 328)
• ▪️ 6% for amounts between TRY 328-657 (including TRY 657)
• ▪️ 3% for amounts above TRY 657
• – The value of EUR 1 in TRY to be used in the pricing of pharmaceuticals was increased by 23.5% to TRY 21.6721. When applying this increase, the offsetting will not be applied to the products.

• – The thresholds have been set at TRY 74.72 for price-protected products and TRY 39.05 for other products in proportion to the change in the value of EUR.

• – The value of EUR 1 in TRY to be used in pricing the above-mentioned pharmaceuticals will also apply in 2025, and no new EUR assessment will be made for 2025.

• – When applying the increase, except for non-refundable products, the remaining increases of up to TRY 4 for products in the Detailed Drug Price List with a Sale Price to Warehouse above TRY 55.90 (including TRY 55.90) will be exempt from offsetting during the EUR value update. A periodic EUR value update will be made excluding the remaining increases. In this context, the selling prices of the products to the warehouse will be added to the selling prices of the products without any change in the TRY value.

• – During the real source price change period of 2024, the value of EUR 1 (one) in TRY to be used in the pricing of the above-mentioned pharmaceuticals will also be applied in the real source price change list without re-application from the products evaluated based on the application until 24 October 2024.

Conclusion

Amendments to the Decree introduced new regulations and thresholds in relation to the pricing of pharmaceuticals. Companies that are involved in the placement on the market, and in importation or distribution of pharmaceuticals in Türkiye, must carefully review the amendments to the pricing regulations and take the necessary actions to ensure compliance with the legislation.