Regulatory and Judicial Trends Shaping Access to NPP Products
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 Medicines from Abroad in February 2023. This regulation clarified stakeholder roles across the NPP process and introduced new compliance expectations. Foreign entities supplying medicines were formally defined as foreign drug supply sources and were required to appoint representatives in Türkiye. At the same time, the Turkish Pharmacists’ Association, the Social Security Institution, and Ministry-approved entities were designated as authorised foreign pharmaceutical product suppliers. Distribution of medicines supplied under the program was expressly aligned with good distribution practice requirements, reinforcing supply chain integrity.
In parallel, traceability and oversight were substantially strengthened. Medicines imported through the NPP channel became subject to mandatory recording in the Pharmaceutical Track and Trace System, using QR codes in the same manner as authorised products. Subsequent updates to the implementation guidelines introduced additional flexibility in how QR code procedures may be carried out, including within customs-free zones, while clarifying the allocation of financial and operational responsibilities among suppliers and their representatives. Together, these measures reflect a broader policy objective of ensuring transparency, accountability, and regulatory visibility across all stages of the import process.
More recently, the regulatory approach to NPPs has begun to extend beyond access and logistics toward outcomes and value assessment. A policy initiative announced in January 2026 signals the authority’s intention to systematically generate and analyse real-world clinical data and pharmacoeconomic evidence for medicines supplied under the NPP framework, with implementation envisaged by January 2027. This data is expected to support sustainability in healthcare financing and to inform regulatory and reimbursement decisions through evidence derived from routine clinical practice.
This development points to a strategic recalibration of the NPP model. While patient access remains central, continued reliance on the program may increasingly depend on demonstrable clinical benefit and economic justification. Real-world evidence and pharmacoeconomic analyses are, therefore, likely to become integral components of decision-making related to ongoing supply, future authorisation pathways, and reimbursement positioning.
Judicial developments in 2025 further reinforce this shift toward evidence and value-based assessment within the NPP framework, particularly in the context of reimbursement disputes. In a recent decision, the Council of State set aside lower court rulings that had favoured patient reimbursement by the Social Security Institution for a product supplied under the NPP regime, emphasising that regulatory approval alone does not automatically justify public reimbursement. The Court articulated a detailed evaluation framework requiring an individualised and data-driven assessment, including the patient’s clinical history, genetic compatibility, disease stage, prior treatment outcomes, and the availability of reimbursed alternatives, alongside robust Phase 3 and Phase 4 clinical evidence and expert opinions. Importantly, the Court highlighted the need to balance potential clinical benefit, quality-of-life impact, and cost-effectiveness within the broader context of public health policy. This reasoning signals a judicial trend toward stricter scrutiny of NPP reimbursement claims, aligning court practice with administrative efforts to link access and reimbursement more closely to demonstrable medical necessity and economic justification.