Turkish Competition Authority Publishes Pharmaceutical Sector Inquiry PreliminaryReport.
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, first of all, the Preliminary Report examines the overall outlook of the pharmaceuticals sector together with its quantitative and statistical data and summarizes the activities carried out by the TCA related to the pharmaceutical sector in the last ten years. Subsequently, based on the supply chain and the areas where regulations are concentrated in the pharmaceutical sector, the report provides assessments of the competitive structure at the production, market entry and distribution stages.
With regard to the competition at the production stage, the relationship between patent protection, intellectual property law and competition law is examined by taking into account the dynamic structure of the pharmaceutical sector. In this context, assessments are made regarding the balance between the dynamism generated by the promotion of intellectual property protection in the sector and the freedom of market entry conditions. With respect to the market entry process, the report first addresses the legislation governing health, safety and accessibility in the sector as well as the points at which this legislation contacts with the competitive structure, and examines the effect of various undertaking practices within the regulatory framework in recent years on market entry conditions. With respect to the distribution level of the pharmaceutical sector, the transformation of public pharmaceutical procurement methods and the impact of various vertical relationships at the distribution level on a healthy and competitive pharmaceutical supply are addressed.
Consequently, potential atypical competition infringements, exclusivity practices, ways to improve competitive processes in public pharmaceutical procurement, the exercise of intellectual property rights, and competition problems that may arise from the regulatory framework or the manipulation of the regulatory framework are examined. The report indicates areas open to improvement and proposes feasible and targeted solutions in these areas that do not require dismantling the existing administrative, legal, economic or institutional framework.
The key topics and assessments highlighted in the Preliminary Report are as follows:
Patent practices and generic competition
The exercise of patent rights is examined closely, with particular attention given to patent clusters, divisional patent applications and patent disputes. In this context, the Preliminary Report stresses the need for closer scrutiny of the relationship between patent rights and patenting strategies, on the one hand, and anticompetitive strategies aimed at preventing or delaying competitors’ market entry, on the other.
Marketing authorisation and reimbursement
One of the key points addressed in the Preliminary Report is that compliance with sector-specific regulations governing matters such as marketing authorisation and reimbursement does not, in itself, amount to compliance with competition law. Against this background, the Preliminary Report points to potential competition law concerns arising from practices such as the cancellation of marketing authorisations, product renewals, reference product practices or the use of the Social Security Institution (“SSI”) reimbursement system in a manner that may make it more difficult for competitors to enter or remain in the market.
Pharmaceutical wholesalers and exclusivity arrangements
The Preliminary Report emphasises that arrangements under which pharmaceutical manufacturers work with certain pharmaceutical wholesalers on an exclusive or sole-authorised basis have historically been among the issues most frequently brought before the Turkish Competition Board in the context of exemption and negative clearance applications. In this regard, general justifications such as security of supply, operational convenience or efficiency are not considered sufficient in themselves to justify exclusivity arrangements. Rather, the economic efficiencies and consumer benefits resulting from exclusivity are expected to be demonstrated in a concrete and detailed manner.
State Supply Office and Health Market
As is known, the Health Market system, which is used for the procurement of pharmaceuticals, medical consumables and medical devices by public and university hospitals, requires pharmaceutical companies to appoint pharmaceutical wholesalers as sole authorised distributors on a province-by-province basis. The Preliminary Report considers that this province-based sole-authorised distributor model may restrict competition more than necessary. As an alternative, it proposes a “shared exclusivity” model allowing more than one, and up to five, authorised distributors within the same province. Indeed, the tender analyses included in the Preliminary Report indicate that an increase in the number of bidders enhances price competition and leads to higher discounts for the benefit of public purchasers.
Private hospital channel
The Preliminary Report notes that the majority of pharmaceutical companies do not work with pharmaceutical wholesalers on an exclusive basis in private hospital tenders and, accordingly, that the use of an exclusive wholesaler is not indispensable. Similar to the approach taken in relation to other exclusivity arrangements, general justifications such as security of supply, operational convenience or efficiency are not regarded as sufficient on their own. The economic efficiencies and consumer benefits generated by exclusivity are expected to be substantiated in a concrete and detailed manner.
Public institution discount
The Preliminary Report also addresses existing uncertainties as to the stage at which, and the party by which, the public institution discount is to be applied. In this respect, it recommends the integration of MEDULA and the Pharmaceutical Track and Trace System (“İTS”), clarification that financial responsibility for the public institution discount rests with the supplier, and the establishment of a security mechanism before the SSI in respect of discounts that are either under-applied or not applied at all. If implemented, these proposals may have operational and financial implications for pharmaceutical companies’ pricing, accrual, discount and reconciliation processes.
Conclusion
Although the Preliminary Report published by the TCA has not yet been finalised, it indicates that the TCA intends to adopt a more holistic approach to the pharmaceutical sector going forward. Accordingly, sector-specific matters such as patent strategies, marketing authorisation, reimbursement and SSI processes, distribution agreements and public procurement will increasingly need to be assessed together with their competition law implications.
The Preliminary Report also reinforces the importance of Ince Legal’s work at the intersection of competition law and pharmaceutical sector regulation.
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