Pricing of Medicinal Products for Human Use in Türkiye

Pricing of medicinal products in Türkiye is governed by a comprehensive regulatory framework that imposes specific obligations on pharmaceutical companies. Under Turkish law, prices of medicinal products are determined upon the request of license holders or applicants in accordance with the Decree No. 2017/9901 on the Pricing of Medicinal Products for Human Use. The pricing is subject to the approval of the Pricing Commission (“Commission”) within the Ministry of Health. The Commission plays a key role in determining and publishing applicable prices based on the reference pricing system regime.

The price used as the basis for calculating the manufacturer’s sale price to domestic wholesalers at the beginning of the legal supply chain is referred to as the “actual source price.” This price is determined based on the quantity of the active ingredient in the product, irrespective of the solvent in which it is dissolved. The reference pricing system sets medicinal product prices based on the lowest available prices from a specified group of reference countries -namely France, Spain, Italy, Portugal and Greece- as designated in the Communiqué on the Pricing of Medicinal Products for Human Use (“Communiqué”). If a product batch is released or imported from countries outside this reference group that offer lower prices, such lower prices become the actual source price for Türkiye. The lowest ex-factory price in these countries, excluding discounts, is taken into account when setting the prices. If the product is not licensed in any of these countries, the actual source price is determined through a hierarchical approach outlined in the Communiqué, ensuring that pricing reflects the most competitive international rates.

The Commission convenes regularly on a monthly basis during the first six months of each calendar year. Submissions to the Commission may only be made once per year, during a period explicitly announced by Turkish Medicines and Medical Devices Agency (“TMMDA”). This structured timeline ensures that all submissions are processed in an orderly and transparent manner. According to the Communiqué, the application period for initial pricing applications or renewals shall be set either between 15 August and 1 September or 22 October and 30 October, depending on factors such as whether the respective medicinal products is an original or generic product, and in the case of generics,, among others, whether there is a licensed original product in Türkiye.

Initial price applications are finalized by the Commission within approximately 90 days, and the applicants bear full responsibility for the accuracy of the submitted documents. All statements and declarations must be accurate and complete. Once approved, the prices are officially published along with their effective dates. The profit margins which are applied when determining the retail selling price of medicinal products (excluding those subject to alternative reimbursement models under Law No. 5510 on Social Insurance and General Health Insurance) are calculated as per the formula stipulated under the Communiqué.

License holders are responsible for monitoring and reporting actual source prices that are taken into reference on an ongoing basis. These companies should declare any changes in such prices on an annual basis. The procedures for price increase requests vary depending on whether there is a change in the source country. In this context, the following are taken into consideration when evaluating price increase requests:

• If the source country changes, price increase requests of up to 20% of the current ex-factory price are taken into account by TMMDA,
• If there is no change in the source country, TMMDA may consider increase requests up to 50% of the existing ex-factory price, and
• Requests exceeding these thresholds are reviewed during the Commission’s assessment period.

Any gain accrued through incomplete, misleading or false declarations can lead to financial liability. Without prejudice to the provisions of the Turkish Criminal Code, any public claims arising from such unjust gains will be recovered by the Social Security Institution or other relevant organizations and institutions. If a license holder fails to report price decreases that arise due to changes in the actual source price within the specified time frame, this may result in unjust enrichment and administrative fines.