Decision on the Pricing of Human Medicinal Products Published

The Decision on the Pricing of Human Medicinal Products (“Decision”) was published in the Official Gazette dated 12 March 2026 and numbered 33194 by way of a Presidential Decision and entered into force on the day following its publication.

The Decision restructures the framework governing the pricing of human medicinal products in Türkiye and sets out the principles for determining the maximum prices of medicines, including the reference pricing system, pricing rules applicable to generic products, the regime for price-protected products, the profit margins applicable to pharmaceutical warehouses and pharmacies, as well as the structure and authorities of the Price Evaluation Commission.

The Decision also repeals the Decision on the Pricing of Human Medicinal Products that had been enacted by the Council of Ministers Decision dated 6 February 2017 and numbered 2017/9901.

The key amendments introduced by the Decision are summarized below:

The reference country and reference pricing system has been revised.

Pursuant to the Decision, the Ministry of Health will designate at least five and at most ten countries among the European Union Member States as reference countries and will announce these countries through a communiqué. The actual reference price to be used in the pricing of human medicinal products is defined as the lowest ex-factory price, excluding discounts, of the reference product that is licensed and available on the market within the designated countries. However, if a lower ex-factory price exists in countries where the batch of the product is released or from which the product is imported, such lower price may be taken into account as the actual reference price.

A new calculation method has been introduced for determining the Euro value used in medicine pricing.

Under the Decision, the value of 1 Euro in Turkish Lira to be used in the pricing of human medicinal products will be calculated by multiplying the annual average of the Central Bank of the Republic of Türkiye’s daily Euro selling exchange rates for the previous year by an adjustment coefficient set at 65%. The Price Evaluation Commission will convene within the first 45 days of each year and announce the Euro value applicable for that year in accordance with this method.

In addition, the Decision introduces transitional arrangements specific to 2026, whereby the Euro value used in medicine pricing will be applied as TRY 26.8767 until 1 April 2026, and TRY 29.1164 as of 1 April 2026.

The rules governing the price relationship between reference products and generic products have been maintained and restructured.

Under the Decision, the reference price of reference products may not exceed the actual reference price until a generic product enters the market. Following the launch of generic products, the reference price of the reference product will be applied at a maximum of 60% of the actual reference price recorded in the Ministry of Health’s database. In cases where the reference product is not available in Türkiye, the pricing of generic products will also be determined based on a maximum of 60% of the benchmark reference price.

A phased pricing mechanism has been introduced for high-priced generic products.

For generic products where the Turkish Lira equivalent of 60% of the actual reference price exceeds a specified threshold value, the applicable rate will be 80% in the first year, 75% in the second year, and 70% in the third year starting from the date the first generic product is launched. Furthermore, if certain market share thresholds are achieved, higher rates may be applied in the second and third years.

The regime applicable to price-protected products has been redefined.

Products that were first launched globally before 1 January 2000 are classified as price-protected products. For price-protected reference products with a company sales price above a specified threshold, the reference price may be set at a maximum of 80% of the actual reference price. In addition, decreases in the actual reference price will not be reflected in the product price until the price falls below this 80% threshold.

Special pricing mechanisms have been introduced for certain product groups.

The Decision provides that products with company sales prices below a specified threshold, over-the-counter medicines, blood products, foods for special medical purposes, radiopharmaceuticals, enteral nutrition products, allergy products, orphan products, biosimilar products, hospital products, sera, non-reimbursed medicines, vaccines and products of critical importance for public health may be subject to a separate pricing mechanism outside the general pricing rules set out in the Decision.

The structure and authorities of the Price Evaluation Commission have been redefined.

Under the Decision, the Price Evaluation Commission will consist of representatives from the Ministry of Health, the Ministry of Treasury and Finance, the Presidency of Strategy and Budget, and the Social Security Institution. The Commission is authorized to decide on the increase, decrease or maintenance of medicine prices, as well as to determine the prices of products for which prices cannot be directly established under the provisions of the Decision. The Commission is also granted the authority to take decisions ex officio in order to ensure the sustainability of healthcare services.

The margin brackets applicable to pharmaceutical warehouses and pharmacies have been revised.

The Decision revises the company sales price brackets and the profit margins to be applied in calculating the margins of pharmaceutical warehouses and pharmacies. Accordingly, the applicable margins will be calculated based on different rates corresponding to specific price ranges. These bracket values will also be updated in line with changes in the Euro value used in the pricing system.

The full text of the Decision can be reached through this link.  (only Available in Turkish)