Amendments on Decree on the Pricing of Pharmaceuticals

Recent Development

On 16 December 2023, the Presidency of Republic of Türkiye amended the Decree on the Pricing of Pharmaceuticals (“Decree“). The amendments introduced by the Decree entered into force as of 25 December 2023. The Decree is available online 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 the 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, which is to be used in the pricing of pharmaceuticals.

What’s New?

The main amendments to the Decree are as follows:

• The following warehouse profit rates will apply when determining the retail price of products other than pharmaceuticals:
  • 8% for amounts up to TRY 100 (including TRY 100),
  • 6% for the amounts between TRY 100-200 (including TRY 200),
  • 3% for the amounts above TRY 200.
• The value of EUR 1 in TRY to be used in the pricing of pharmaceuticals was increased by 25% to TRY 17.5483.
• The thresholds have been set at TRY 60.51 for the price-protected products and TRY 31.62 for other products in proportion to the change in the value of EUR.
• 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.
• To ensure sustainable health service delivery, the Price Valuation Commission will be able to take ex officio decisions upon the invitation of the TİTCK in case of supply problems that affect or are foreseen to affect the normal life activities of the whole or certain segments of society.

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, 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.