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 The Communiqué has repealed the previous pricing communiqué, which had been in force since 29 September 2017.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 w

İDisputes between generic and original drug companies in the pharmaceutical sector have recently assumed a new dimension with respect to lawsuits regarding the compensation of damages arising from unjust preliminary injunctions. With the decision of the 11th Civil Chamber of the Turkish Supreme Court dated 06.02.2024 and numbered E. 2022/3681, K. 2024/750, the first decision of precedent nature regarding the compensation of damages suffered by generic drug companies due to an

The Turkish Competition Authority (the “TCA”) published the Pharmaceutical Sector Inquiry Preliminary Report (the “Preliminary Report”) on 10 August 2026, following an extensive review process. The Preliminary Report is significant not only in terms of traditional competition law issues, but also because it focuses on the competitive effects of patent practices, marketing authorisation, reimbursement, distribution and public procurement processes. Within this framework, firs

Over the past several years, numerous lawsuits have been initiated seeking reimbursement for medicines used in the treatment of cancer and rare diseases that are not included within the reimbursement coverage of the Social Security Institution (“SSI”). While many of these medicines provide innovative treatment options, they are also highly expensive. As the SSI frequently refuses to cover the cost of such medicines on the grounds that they are not included within the scope of

The Law No. 7589 on Amending Certain Laws for the Efficient and Effective Operation of the Judiciary ("Law No. 7589"), publicly known as the "12th Judicial Package", was published in the Official Gazette dated 31 July 2026.Law No. 7589 introduces significant amendments across a broad spectrum, ranging from enforcement and sale procedures to administrative jurisdiction procedures, from statutory interest to claims for receivables, and from the deferral of the announcement of t

Wellness concepts at the intersection of health and tourism have become a rapidly growing commercial market in our country. This rapid growth has brought about the need to determine service standards and draw a clear legal framework. The legal infrastructure regarding the sector has officially entered into force with the Regulation on Wellness Services (‘the Regulation’), prepared by the Ministry of Health and published in the Official Gazette dated July 4, 2026. The Regulati

İnce Legal is proud to announce that Lawrence B. Landman has become of counsel to the firm. Dr. Landman’s work has focused on how authorities, particularly the Europe Commission, regulates pharmaceutical and other fast-moving, high-tech markets. Among many other contributions, Dr. Landman developed the Future Markets Model, which explains how competition authorities, in reality, protect competition to innovate. Dr. Landman brings a European perspective which supplements İn

The Turkish Constitutional Court's ("the TCC") decision on an individual application dated January 27, 2026, and numbered 2020/32193, published in the Official Gazette on June 16, 2026, contains important assessments regarding the principles of personal data protection law and administrative law. The decision sets limits on the administrative fines imposed by the Personal Data Protection Board ("Board") in recent years through guidelines and expansive interpretations. In the

With the announcement dated 08.06.2026 shared by the Turkish Medicines and Medical Devices Agency (‘‘TMMDA’’), it has been announced that amendments have been made to the Guidelines on the Procurement of Medicines from Abroad (‘‘Guidelines’’). As is known, the procurement of medicinal products for human use—which do not possess a marketing authorization in our country or possess one but face supply shortages in the market—on a prescription basis for personal use or in bulk by

The Regulation on Medical Reports (“Regulation”) entered into force upon its publication in the Official Gazette dated 19 May 2026 and numbered 33258. The Regulation comprehensively revises the rules concerning which healthcare service providers may issue medical reports, and under which procedures and formats such reports may be issued, as well as the application, examination, electronic system, objection and supervision processes. The purpose of the Regulation is stated as

As is known, within the scope of the efforts carried out for the update of the merger and acquisition legislation, certain amendments were made to the Communiqué Concerning the Mergers and Acquisitions Calling for the Authorization of the Competition Board (Communiqué No. 2010/4) in February 2026. In alignment with the updated version of the Communiqué, the Turkish Competition Board has also amended various guidelines, and the guidelines containing these amendments have been

The Procedures and Principles Regarding the Procurement of Medicinal Products for Human Use from Abroad and the Procurement of Related Services by the Social Security Institution under subparagraph (h) of Article 3 of Public Procurement Law No. 4734 (“Presidential Decree No. 11190”) entered into force upon its publication in the Official Gazette dated 24 April 2026. With Presidential Decree No. 11190, newly introduced into our legislation, the procedures and principles appli

As is known, pursuant to the Communiqué Concerning the Mergers and Acquisitions Calling for the Authorization of the Competition Board, mergers and acquisitions where the parties’ turnovers exceed certain thresholds must obtain authorization from the Turkish Competition Board (“Board”) in order to gain legal validity. Likewise, authorization from the Board is also required for transactions falling within the scope of the “technology undertaking exception” [1] . In this conte

With its decision dated 11 December 2025 and numbered 2025/185 E., 2025/258 K., published in the Official Gazette dated 9 March 2026, the Turkish Constitutional Court (“the TCC”) held that Article 43(8) of Law No. 4054 on the Protection of Competition (“Law No. 40541) is not unconstitutional. The relevant provision stipulates that “In case the process is concluded with a settlement, the parties to the settlement may not take the administrative fine and the provisions of the

The decision of the Turkish Constitutional Court (“TCC”) published in the Official Gazette dated 17 February 2026 and numbered 33171 has brought the debate on the authority of the Turkish Competition Board (“the Board”) to conduct dawn raids, one of the most significant topics of discussion in Turkish competition law practice in recent years, back to the forefront. The TCC, in its decision dated November 6, 2025 and numbered 2023/174 E., 2025/224 K., rejected the

The Regulation on Cooperation in International Health Services (‘the Regulation’), implemented by the Ministry of Health, entered into force upon its publication in the Official Gazette dated 14 February 2026.The Regulation, issued to ensure coordination in international health services between the Ministry of Health and health facilities belonging to state universities (‘Institutions’) that have been granted international health tourism authorisation certificates, regulates

The Amending on Communiqué Concerning the Mergers and Acquisitions Calling for the Authorization of the Competition Board (Communiqué No. 2010/4) (“Amending Communiqué”) entered into force upon its publication in the Official Gazette dated February 11, 2026. The Amending Communiqué implements changes in the procedures and principles regarding mergers and acquisitions that require notification to and approval from the Turkish Competition Authority in order to be legally valid,

The Regulation on Cultivation and Control of Cannabis and the Regulation on Products Derived from Cannabis were published in the Official Gazette dated January 31, 2026. As is known, Law No. 7557 on the Amendment of Certain Laws Related to Health and the Decree Law No. 663, published in the Official Gazette dated July 24, 2025, introduced certain amendments to the Law on the Control of Narcotic Substances. These amendments established a legal framework for medicinal products,

According to three separate decisions published on the Turkish Competition Authority’s (“TCA”) website on December 4, 2025, administrative fines were imposed on Modern Times Group MTG AB (“MTG”) for finalizing three different acquisitions in the video game development and publishing sector without obtaining prior clearance from the Turkish Competition Board (“Board”). The Board decided to impose administrative fines because the following transactions were closed without noti

The Decision on the Amendment of the Decision on Pricing of Medicinal Products for Human Use (“Amending Decision”) has been published in the Official Gazette dated 19 December 2025. The Amendment Decision shall enter into force one day after its publication date. The new provisions implemented by the Amending Decision are as follo ws: Warehouse and pharmacist profit rates to be applied for the determination of retail sale prices of the products and price thresholds have