Recent regulatory developments in the medical devices sector point to a shift from procedural compliance toward enforcement-driven market discipline, coupled with a gradual restructuring of technical service governance.
A major inflection point in this trajectory was the entry into force of Law No. 7557 in July 2025, which introduced Additional Article 20 to the Basic Law on Health Services. This provision significantly expanded the administrative sanctions framework…
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Interactions between life sciences companies and healthcare professionals (“HCPs”) in Türkiye continue to be governed by a well-established regulatory framework. In the pharmaceutical sector, promotional activities remain subject to the Regulation on the Promotion of Medicinal Products for Human Use, which strictly limits promotion to healthcare professionals and prohibits direct or indirect advertising to the public. Engagements such as consultancy and service arrangements…
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Counterfeit and illicitly traded health products remained a persistent concern in Türkiye throughout 2025, as reflected both in enforcement statistics and in external reporting on supply chain integrity. Despite the legal prohibition on the online sale of pharmaceutical products, there has been a noticeable increase in the circulation of counterfeit medicines through online channels, alongside growing reports of products being illicitly exported from Türkiye to foreign…
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The prices of pharmaceuticals to be launched on the market are determined in accordance with the Decision on the Pricing of Medicinal Products for Human Use (“Decision”) and the Communiqué on the Pricing of Medicinal Products for Human Use (“Communiqué”) dated 29 September 2017, published by the Ministry of Health, which has been authorised to regulate this area.
The Decision foresees a reference pricing system in which the lowest wholesaler price for the relevant product in…
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NPPs operate as special import regimes that enable access to medicines that are either not authorised in Türkiye or are temporarily unavailable on the domestic market, upon the request of a treating physician. Fundamentally designed to address urgent or exceptional patient needs, the NPP framework has gradually evolved into a more structured and regulated supply mechanism.
A significant step in this evolution was the entry into force of the Regulation on the Importation of…
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Alternative reimbursement models in Türkiye provide pathways for innovative medicines to gain coverage outside standard pricing rules, allowing the Social Security Institution (“SSI”) to negotiate terms such as discounts, budget caps, or other arrangements. These models, formalised under the 2016 Regulation on Alternative Reimbursement and updated in 2023, aim to improve patient access while managing healthcare expenditures.
The Regulation on Alternative Reimbursement…
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