A New Era in Pharmaceutical Pricing: Communiqué on the Pricing of Medicinal Products for Human Use Published.

The Communiqué on the Pricing of Medicinal Products for Human Use (the “Communiqué”) was published in the Official Gazette No. 33355 dated 29 August 2026 and entered into force. The Communiqué has repealed the previous pricing communiqué, which had been in force since 29 September 2017.

The new Communiqué sets out the procedures and principles for the implementation of the Decision on the Pricing of Medicinal Products for Human Use No. 11031 (the “Pricing Decision”), which was published in the Official Gazette on 12 March 2026. Accordingly, it should be noted that the general framework for certain amendments commonly associated with the Communiqué had already been established by the Pricing Decision published in March, while the Communiqué sets out the principles governing the implementation of this framework.

The key aspects of the new regulatory framework are summarized below.

A Gradual Pricing Mechanism Has Been Introduced upon the Market Entry of the First Equivalent Product.

One of the most notable elements of the new system is the introduction of a gradual reduction mechanism for the price decrease triggered by the market entry of the first equivalent product.

Under the previous system, once an identical or equivalent product of a non-price-protected reference product entered the market, the source price of the reference product and the relevant equivalent products was, as a general rule, determined at 60% of the actual source price. Under the new system, for products exceeding the applicable monetary threshold, this 60% rate will be applied gradually over the first three years. Accordingly, the applicable rate will be 80% in the first year, 75% in the second year and 70% in the third year, after which the general 60% rate will apply.

The gradual mechanism will not automatically apply to all equivalent products. Under the Pricing Decision, 60% of the actual source price of the reference product, converted using the periodic Euro value, must exceed the applicable monetary threshold. As of 1 April 2026, this threshold has been set at TRY 151.25. In addition, the gradual mechanism will not apply in certain circumstances specified in the Communiqué, including where the first equivalent product is an imported equivalent product priced on the basis of its own ex-factory price.

The Communiqué also regulates when the first equivalent product will be deemed to have entered the market and the date from which the gradual pricing period will commence. Where the first authorized equivalent product is placed on the market within six months of the date of authorization, the relevant period will commence on the date of market entry. If it is not placed on the market within that period, the period will commence six months after the date of authorization. Relevant protection periods will also be taken into account for products that cannot be placed on the market due to patent protection or data exclusivity.

The Market Share of Locally Manufactured Equivalent Products Will Affect Pricing.

Under the Communiqué, the gradual pricing mechanism has also been linked to the market performance of locally manufactured equivalent products.

Where, based on Pharmaceutical Track and Trace System (İTS) data, locally manufactured equivalent products reach a 5% share of annual total consumption by the end of the first year, the 80% rate will continue to apply instead of the 75% rate otherwise applicable in the second year. Similarly, where locally manufactured equivalent products reach a 10% market share by the end of the second year, the 75% rate will apply in the third year instead of 70%.

Accordingly, the new framework is intended not only to soften the immediate price reduction resulting from the market entry of equivalent products, but also to provide a pricing incentive for locally manufactured equivalent products that achieve certain market share thresholds. In this respect, the system establishes a mechanism supporting domestic manufacturing alongside the market entry of equivalent medicines.

The Criteria for Determining Price-Protected Product Status Have Been Amended.

Another significant amendment concerns the criteria for determining price-protected product status.

Under the previous Communiqué, products for which any pharmaceutical form had first been placed on the market anywhere in the world before 1 August 1987 were regarded as price-protected products. Under the new Communiqué, this date has been changed to 1 January 2000, and the assessment has been structured on the basis of the active substance.

Accordingly, products containing an active substance for which any pharmaceutical form was first placed on the market anywhere in the world before 1 January 2000 will be regarded as price-protected products. The Communiqué also sets out specific criteria applicable to products containing more than one active substance.

The basic source price applicable to price-protected products corresponds to 80% of the benchmark source price. Therefore, moving the relevant date from 1 August 1987 to 1 January 2000 and conducting the assessment on the basis of the active substance may have significant pricing implications for the relevant product portfolios.

However, the Communiqué also contains an important transitional provision in relation to this amendment. Prices calculated on the basis of the new 1 January 2000 criterion will become applicable on the effective date to be announced at the end of the 2026 actual source price revision period. Until that date, prices calculated under the previous 1 August 1987 criterion will continue to apply. The transitional timetable should therefore be taken into account when assessing the impact of the new criteria on individual product portfolios.

Prices of Certain Products Will Be Updated Every Two Weeks Based on the Current Euro Exchange Rate.

The Communiqué introduces specific pricing mechanisms for certain product groups with a view to supporting their availability on the market.

For products containing Alpha-1 Antitrypsin, human albumin and certain immunoglobulins specified in the Communiqué, the source price will be determined at 100% of the benchmark source price. The company selling prices of these products will be updated every two weeks based on the Euro selling rate announced by the Central Bank of the Republic of Türkiye on the last business day of the relevant week.

Specific pricing provisions have also been introduced for various other product groups, including blood products, foods for special medical purposes, enteral nutrition products, radiopharmaceuticals, allergen products, biosimilars, hospital products, serums, non-reimbursed products, orphan products and products considered critical from a public health perspective.

In particular, for biosimilar products, the source price may be determined at up to 100% of the benchmark source price, and the market entry of a biosimilar product will not affect the source price of the relevant biotechnology reference product.

A Regulatory Framework for Value-Based Pricing Has Been Established.

Under the Communiqué, medicinal products subject to value-based pricing have expressly been included among products subject to special pricing conditions. The medicinal products falling within this category will be determined by the Price Evaluation Commission, while their prices will be determined in accordance with secondary legislation to be issued by the Ministry.

Although the general framework for value-based pricing had already been established by the Pricing Decision, the express inclusion of these products among those subject to special pricing conditions under the Communiqué is significant. In particular, the regulation strengthens the regulatory basis for applying pricing methodologies other than the conventional reference pricing mechanism to innovative medicinal products.

Nevertheless, the specific products to which the value-based pricing system will apply, as well as the criteria governing its implementation, are expected to be further defined through secondary legislation to be issued by the Ministry. Regulatory developments in this area should therefore be closely monitored, particularly by pharmaceutical companies with innovative product portfolios.

Nevertheless, the specific products to which the value-based pricing system will apply, as well as the criteria governing its implementation, are expected to be further defined through secondary legislation to be issued by the Ministry. Regulatory developments in this area should therefore be closely monitored, particularly by pharmaceutical companies with innovative product portfolios.

New Rules Have Been Introduced for the Pricing of Non-Reimbursed Products.

The Communiqué also introduces significant amendments to the principles applicable to the pricing of non-reimbursed products.

Identical and equivalent products of a non-price-protected reference product that is included in the Social Security Institution’s List of Reimbursed Medicines, is available on the market and has no equivalent product included in that list may not, as a general rule, be priced as non-reimbursed products. However, identical and equivalent products may be priced as non-reimbursed products where at least one equivalent of the reference product is included in the List of Reimbursed Medicines or where the reference product is subject to cost-card pricing or special pricing conditions.

A transitional arrangement has also been introduced for products that, as of the effective date of the Communiqué, are priced as non-reimbursed products in a manner inconsistent with the new rule. For these products, an application for pricing as a reimbursed product must be submitted within three months at the latest. Where no application is submitted, the product may be priced ex officio in accordance with the Communiqué.

The Communiqué also establishes a direct link between product availability and non-reimbursed pricing. Where a product included in the List of Reimbursed Medicines is not available on the market at a level sufficient to meet demand, a product containing the same quantity of active substance and having the same pharmaceutical form but a different pack size may not be priced as a non-reimbursed product. In such circumstances, following notification by the Ministry, the company must, within three months at the latest, either apply for reimbursed pricing for the relevant product or make the product available on the market in quantities sufficient to meet demand. Otherwise, the product may be priced ex officio as a reimbursed product by reference to its reimbursed form.

The Source Pricing, Application and Price-List Procedures Have Been Revised.

Under the Communiqué, in line with the previous regulatory framework, France, Spain, Italy, Portugal and Greece have been designated as reference countries. Subject to the conditions set out in the Communiqué, countries in which the relevant product is batch-released or from which it is imported may also be taken into account for source price research. The Communiqué also expressly permits the use of national or international databases in determining source prices.

Changes have also been made to the procedures applicable to pricing applications. Pricing applications other than those submitted during the actual source price revision period or to the Price Evaluation Commission must be concluded within 45 days from the date of application at the latest. Considering that the previous Communiqué provided for a 90-day period in relation to initial pricing applications, the timeframe for concluding such applications has been significantly shortened.

Applicants are responsible for the accuracy of the documents submitted and for providing the originals upon request by the Authority. The originals of such documents must also be physically retained for a period of 10 years so that they can be produced if requested by the Authority.

As a general rule, the price list will be published every Friday and enter into force on the following Tuesday. Products that have not been available on the Turkish market for three consecutive years will be announced each January and may be removed from the price list in February if the marketing authorization holder does not provide an explanation or submit an objection.

The Duties and Powers of the Price Evaluation Commission Have Been Revised.

The Price Evaluation Commission will operate under the coordination of the Ministry of Health and will comprise representatives of the Ministry of Health, the Ministry of Treasury and Finance, the Presidency of Strategy and Budget and the Social Security Institution. The Commission is expected to convene ordinarily once a year. Extraordinary meetings may also be held, where necessary, upon the invitation of any of the institutions represented on the Commission.

The Commission has been granted powers to approve product-specific price increases, reassess previously granted increases, and differentiate source prices, selling prices and profit margins, or apply alternative pricing models, in relation to medicinal products covered by alternative reimbursement models and non-reimbursed medicinal products. The framework also allows decisions to be adopted where necessary to ensure the sustainable provision of healthcare services.

The periodic Euro value will be announced by the Commission within the first 45 days of each year. Increases in the Euro value will enter into force 5 days after the announcement of the Commission’s decision, while decreases will enter into force 45 days after the announcement.

Transitional Provisions Have Been Introduced for 2026.

The new system will not apply to existing product portfolios all at once. Various transitional provisions for 2026 have been introduced under the Communiqué and the Pricing Decision.

In particular, the gradual rates of 80%, 75% and 70% will, as a general rule, apply to first equivalent products placed on the market after the Pricing Decision entered into force and to their other identical and equivalent products. Products already priced at the 60% rate will not be brought within the new gradual mechanism.

However, certain equivalent products that are included in the price list, have not yet been placed on the market and have been priced at the 60% rate may be reassessed subject to the conditions set out in the Communiqué.

During the 2026 actual source price revision period, applications must be submitted for all products other than locally manufactured non-reimbursed products and non-reimbursed traditional herbal medicinal products. The Communiqué also sets out specific documentation and application requirements applicable to this period.

In addition, the three-month application period following the entry into force of the Communiqué must be carefully monitored for existing products that do not comply with the new rules applicable to non-reimbursed pricing, as described above.

Our Assessment

The new Communiqué introduces not only technical and terminological amendments to Türkiye’s pharmaceutical pricing framework, but also significant changes that may affect the system’s underlying economic parameters and the pricing strategies of pharmaceutical companies.

In particular, the gradual reduction of prices following the market entry of equivalent products, the linkage between the market share of locally manufactured equivalent products and pricing, the amendment of the date and assessment criteria used to determine price-protected product status, the establishment of a regulatory framework for value-based pricing, and the new rules applicable to non-reimbursed pricing constitute some of the most notable elements of the new system.

The overall approach of the new framework appears to maintain expenditure control and the reference pricing mechanism while, at the same time, introducing greater flexibility with respect to product availability, the market entry of equivalent products, the assessment of innovative products under alternative pricing models and the sustainability of domestic manufacturing. The introduction of biweekly price updates based on the current Euro exchange rate for certain products and the direct consideration of product availability in the context of non-reimbursed pricing may also be regarded as concrete reflections of this approach.

Against this background, pharmaceutical companies should reassess their existing product portfolios, particularly with regard to price-protected product status, the market entry date of the first equivalent product, the market share of locally manufactured equivalents, reimbursed or non-reimbursed pricing status, potential eligibility for special or value-based pricing, and the transitional timetable applicable in 2026.

AUTHORS

Nuri Melih İnce

Lara Bayrakdar