The Turkish Competition Authority Publishes the Preliminary Report on the Pharmaceutical Sector Inquiry

The Preliminary Report on the Pharmaceutical Sector Inquiry (“Preliminary Report”), prepared by the Turkish Competition Authority (“Authority”), was published on the Authority’s official website on 10 August 2026.

Pursuant to the decision of the Competition Board dated 8 December 2021 and numbered 21-59/844-M, a sector inquiry was initiated with the aim of identifying structural competition concerns in the pharmaceutical sector and developing pro-competitive solutions.

In addition to providing an overview of the pharmaceutical sector and relevant quantitative data, the Preliminary Report addresses the Authority’s activities in the sector over the past ten years and examines in detail the competitive conditions at the production, market-entry and distribution stages.

In summary, the Preliminary Report states that:

At the production stage, the relationship between patent protection and competition law was assessed, and it was noted that certain practices relating to the acquisition or exercise of patent rights may produce anti-competitive effects. In this context, the provision of incorrect or misleading information to patent authorities, patent clusters and divisional patent practices, patent disputes that may delay competitors’ market entry, and patent settlement agreements were examined. Although approximately 350 patent cases were reviewed and certain cases were examined in detail, it was stated that no indication was identified of “pay-for-delay” agreements in Türkiye involving payments in return for delaying market entry. Nevertheless, this area was identified as one of the priority matters that should be closely monitored by the Authority.
It was stated that patent settlement agreements between originator and generic pharmaceutical manufacturers should not contain conditions delaying market entry in a manner that cannot be explained by the term of the patent or the nature of the dispute, or transfers of value that cannot be justified by ordinary litigation costs. It was also proposed that information concerning patent disputes be made more transparent across the sector and that cooperation between the Turkish Patent and Trademark Office and judicial authorities be enhanced.
At the market-entry stage, it was determined that, although sector-specific regulations serve legitimate and necessary purposes, they may be strategically used by undertakings in a manner that makes it more difficult for competitors to enter or expand in the market. In particular, it was recommended that the relevant regulations be reviewed in order to prevent the use of marketing authorisation rules as part of “product hopping” strategies aimed at hindering competitors’ market entry.
With respect to rapid inclusion in the reimbursement list and the internal reference pricing system, it was assessed that treating a medicinal product that is not actually available on the market as the lowest-priced product may prevent other medicinal products from benefiting from the expedited reimbursement process. Accordingly, it was recommended that actual market availability be taken into account when determining the lowest price and that the relevant legislation be reviewed on the basis of actual accessibility. It was further assessed that the 1% market-share criterion under the internal reference pricing system is not, in itself, sufficient to demonstrate genuine and sustainable access to a medicinal product.
At the distribution stage, a high level of concentration was identified among pharmaceutical wholesalers operating in the community pharmacy channel. According to the Preliminary Report, among the 92 pharmaceutical wholesalers operating in this channel, the two largest account for approximately two-thirds of the market, while the five largest account for approximately 90%. Pharmacists’ cooperatives and regional wholesalers were considered to constitute an important balancing factor in preserving competitive pressure and competition in service quality against large-scale wholesalers.
The single authorised distributor structure envisaged under the Health Market Application used for public pharmaceutical procurement was also assessed from a competition law perspective. Based on the examination of more than 53,000 procurement items conducted in 2022 and 2023, it was determined that discount rates increased as the number of participants in tenders increased. Accordingly, it was assessed that a “shared exclusivity” model, allowing more than one authorised distributor to participate in tenders and permitting between two and five participants, could lead to more competitive outcomes.
With respect to exclusive distribution agreements between pharmaceutical manufacturers and wholesalers, it was stated that efficiencies and consumer benefits arising from exclusivity must be demonstrated through concrete and detailed data, and that general or hypothetical efficiency justifications alone should not be considered sufficient for granting an exemption to such agreements.
At the retail distribution level, uncertainties concerning the Public Institution Discount (“KKI”) were highlighted as one of the key issues addressed in the Preliminary Report. In order to eliminate uncertainty as to which actor and at which stage of the supply chain is responsible for satisfying the KKI obligation, it was proposed that the KKI apply only to prescriptions reimbursed by the Social Security Institution (“SGK”) and approved through the MEDULA system; that the financial liability be expressly assigned to the supplier undertaking the KKI commitment; and that an integrated data-sharing infrastructure be established between MEDULA and the Pharmaceutical Track and Trace System (“İTS”) for the verification of medicinal products subject to the KKI.
In order to compensate for losses that may arise where the KKI is not applied or is applied incompletely, it was proposed that a guarantee account be established within the SGK and operated so as to compensate pharmacies for potential losses, together with the development of appropriate sanction and incentive mechanisms.

You can find the full text of the Preliminary Report (in Turkish) here.

Kind regards,

Zumbul Attorneys-at-Law

info@zumbul.av.tr

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