New Pricing Communiqué Following The New Pricing Decision For Medicinal Products For Human Use: Increase Of The Euro Conversion Rate To 65% Of The Previous Year’s Average And Details Of The Pricing Incentive For The First Equivalent/Generic Product

Presidential Decision No. 11031 dated 12 March 2026 (the “New Pricing Decision”) introduced significant changes to the pricing system for medicinal products for human use established under Decision No. 2017/9901 and subsequently amended on several occasions. The New Pricing Decision provided that the provisions of the existing Communiqué on the Pricing of Medicinal Products for Human Use that did not conflict with the New Pricing Decision would continue to apply until a new communiqué was issued. The new Communiqué on the Pricing of Medicinal Products for Human Use (the “New Pricing Communiqué”), which had been closely awaited by industry stakeholders, was published in the Official Gazette on 29 August 2026 and entered into force on the same date. It repealed the previous Communiqué issued on the basis of Council of Ministers Decision No. 2017/9901, thereby largely bringing to an end the transitional period that had been in place since the publication of the New Pricing Decision.

The key changes introduced by the New Pricing Decision of 12 March 2026 included increasing the percentage used for Euro/TRY conversion from 60% to 65%, allowing higher pricing for the first equivalent/generic products in order to incentivize faster market entry, and introducing the concept of “value-based pricing” into Turkish legislation for the first time. With the entry into force of the New Pricing Communiqué, the details concerning the implementation of these significant changes have now been set out, and the pricing system for medicinal products for human use has been restructured in light of the provisions of the New Pricing Decision.

One of the key changes introduced by the New Pricing Decision concerned the coefficient used to convert the Euro value taken as the basis for determining the reference price into Turkish Lira. Under Council of Ministers Decision No. 2017/9901, this coefficient, which applies to the pricing of medicinal products for human use, was set at 60% of the average Euro exchange rate of the previous year. For the first time in many years, this percentage was increased to 65%. However, the 60% rate continued to apply temporarily until 1 April 2026, and the Euro value applicable from 1 April 2026 onwards was set at TRY 29.1164.

Although the increase in this coefficient may be regarded as a positive step, particularly given that such an adjustment had long been awaited by the industry, the measure still appears to fall short of resolving patients’ access to medicines, particularly innovative treatments. In view of the reference exchange-rate mechanism applied under Türkiye’s pharmaceutical pricing system and the limited public budget allocated to pharmaceutical expenditure, the increase alone is not expected to provide a sustainable solution. Indeed, OECD data indicate that Türkiye remains behind many OECD countries in terms of both the share of pharmaceutical expenditure in total healthcare spending and pharmaceutical expenditure per capita. Accordingly, exchange-rate adjustments alone are considered insufficient to improve patients’ access, particularly to innovative and advanced treatments; a more substantial increase in the public budget allocated to medicines is also considered necessary.

The New Pricing Decision also envisaged the introduction of a new incentive mechanism aimed at enabling the first equivalent/generic products to enter the market at higher prices, thereby encouraging faster market entry. The New Pricing Communiqué of 29 August specifically regulates the pricing of the first equivalent product, incorporating this new incentive mechanism. While equivalent/generic products may ordinarily be priced at up to 60% of the actual reference price determined in accordance with the Communiqué, under the new rules, the first equivalent/generic product placed on the market may be priced at 80% during its first year on the market, 75% during the second year, and 70% during the third year.

In addition, where an equivalent product manufactured in Türkiye reaches a market share of 5% in its second year and 10% in its third year, based on Pharmaceutical Track and Trace System (“İTS”) data, the applicable percentages may remain at 80% in the second year and 75% in the third year. Thus, whereas in jurisdictions such as the United States the first generic product to enter the market may benefit from a period of market exclusivity, Türkiye has, for the first time, introduced an incentive for first generic entry in the form of a pricing advantage. However, the New Pricing Decision provides that the new tiered pricing percentages applicable to first equivalent products will apply only to products placed on the market after the Decision entered into force.

The New Pricing Decision also provided for greater flexibility in relation to blood products, allergy products, orphan drugs, biosimilars, vaccines, products of critical importance to public health, and medicines subject to alternative reimbursement arrangements, allowing different rules to be introduced for these products without being strictly bound by the general provisions of the Decision. The New Pricing Communiqué makes use of this flexibility and sets out detailed special provisions, in addition to the general rules, for the pricing of these products under the category of products subject to special conditions.

Furthermore, the New Pricing Decision, on which the Communiqué is based, introduced the concept of “value-based pricing” into Turkish legislation for the first time. This development signalled the possibility of implementing value-based pricing and reimbursement models for medicines, the importance of which has long been emphasized, particularly by the innovative pharmaceutical industry. The New Pricing Communiqué provides that the rules applicable to products determined to be subject to value-based pricing will be set out in legislation to be issued by the Ministry of Health. Accordingly, the details of the value-based pricing mechanism have been left to separate secondary legislation to be issued in due course.

With the publication of the new Communiqué on the Pricing of Medicinal Products for Human Use, the transitional period that had been in place since the New Pricing Decision was issued on 12 March 2026—during which the provisions of the previous Communiqué issued under the former Council of Ministers Decision continued to apply to the extent that they did not conflict with the New Pricing Decision—has come to an end. Nevertheless, the full transition to the new pricing system is expected to become clearer once the temporary arrangements have been fully phased out and the rules applicable to products determined by the Commission to be subject to value-based pricing have been published.