Key Amendments to the Social Security Institution Pharmaceutical Reimbursement Regulation
The Regulation Amending the Social Security Institution Pharmaceutical Reimbursement Regulation (the “Amendment Regulation”) was published in the Official Gazette dated 3 October 2026 and entered into force. The Amendment Regulation introduced amendments in various areas, notably the definition of the “pharmaceutical market ratio” for reimbursement purposes and the re-regulation of the 1% threshold by reference to this concept, as well as the formation of internal reference groups/equivalent groups within the framework of rational use of medicines. In particular, significant amendments were made with respect to the calculation of the reimbursable unit price range, the formation of internal reference groups and the consideration of the use of pharmaceuticals in the market.
The amendments also appear to be broadly aligned with certain assessments set out in the Turkish Competition Authority’s Preliminary Report on the Pharmaceutical Sector Inquiry, published in August 2026, concerning the reimbursement framework. In particular, the actual availability and accessibility of pharmaceuticals in the context of reimbursement mechanisms were among the issues addressed in the Preliminary Report.
The principal amendments introduced by the Amendment Regulation are set out below.
The 1% Pharmaceutical Market Ratio Criterion Has Been Updated.
One of the significant changes introduced by the Amendment Regulation is the addition of the definition of the “pharmaceutical market ratio” to the Regulation. The pharmaceutical market ratio is defined as the ratio of the number of packs of each pharmaceutical reimbursed by the Social Security Institution (“SSI”) to the total number of packs of pharmaceuticals within the relevant internal reference group or equivalent group. Under the new rules, this criterion will be applied with a view to improving the accessibility of pharmaceuticals for patients and pharmacies.
In this context, a newly listed pharmaceutical with the lowest unit price in its internal reference group or equivalent group will not be included in the calculation of the reimbursable unit price range until it reaches a pharmaceutical market ratio of 1%. The market ratio of the relevant pharmaceutical will be monitored on a monthly basis and the pharmaceutical will be included in the calculation once it reaches the 1% threshold. The market ratios of the lowest-priced pharmaceuticals already included in internal reference groups or equivalent groups will likewise be monitored. Pharmaceuticals that have failed to reach the 1% pharmaceutical market ratio in any of the data periods covering the preceding five months will be excluded from the calculation of the reimbursable unit price range. If such pharmaceuticals subsequently reach the 1% pharmaceutical market ratio, they will be included in the calculation again.
Accordingly, the system under which the actual use and accessibility of the lowest-priced pharmaceutical are taken into account in the calculation of the reimbursable unit price range has been re-regulated by reference to the concept of the “pharmaceutical market ratio”.
The Definition of “Reimbursable Unit Price Range” Has Replaced the Definition of “Band Range”.
The Amendment Regulation has replaced the definition of “band range” under the previous Regulation with the definition of “reimbursable unit price range”.
Under the new rules, the “discounted unit prices” per common smallest unit of the pharmaceuticals within the relevant internal reference group or equivalent group will be compared on the basis of public prices calculated by applying public institution discounts. The reimbursable unit price range will be determined by adding the percentage set by the Health Services Pricing Commission to the lowest discounted unit price. Accordingly, the prices resulting after the application of public institution discounts will be taken as the basis for determining the reimbursable unit price range.
The Definition of “Internal Reference Group” and the Rational Use of Medicines Criterion Have Been Introduced.
The definition of “group” under the previous Regulation has been replaced by the definition of “internal reference group”. Accordingly, an internal reference group will be determined, within the framework of rational use of medicines, by the Pharmaceutical Reimbursement Commission and the Medical and Economic Evaluation Commission, in which the Ministry of Health is also represented, and will also encompass equivalent groups.
MEDULA Data Will Be Used as a Basis for Assessments.
The references to “market shares” in various provisions governing the assessments of the Pharmaceutical Reimbursement Commission and the Medical and Economic Evaluation Commission have been replaced with references to “MEDULA data”. Accordingly, MEDULA data will be used in assessing the budgetary impact and market position of pharmaceuticals.
The Composition of the Medical and Economic Evaluation Commission Has Been Amended.
A representative of the Foundation for Pharmaceuticals, Pharmacy, Health Sciences and Technologies has been added to the observer members of the Medical and Economic Evaluation Commission, increasing the number of observer members from four to five.
Conclusion and Assessment
The new rules will have implications that should be closely monitored, particularly in respect of the lowest-priced products within internal reference groups or equivalent groups. Although the existing system already included a 1% market share threshold, the Amendment Regulation has separately defined the concept of the “pharmaceutical market ratio” and re-regulated the principles governing its calculation and its effect on the reimbursable unit price range. In this context, for newly listed low-priced products, reaching the 1% pharmaceutical market ratio will be significant for the inclusion of the relevant product in the calculation of the reimbursable unit price range.
The amendments may also be considered to be broadly aligned with the assessments made in the Turkish Competition Authority’s August 2026 Preliminary Report on the Pharmaceutical Sector Inquiry concerning the reimbursement framework. The Preliminary Report emphasised that, in internal reference pricing and reimbursement-list entry procedures, consideration should be given not only to price but also to whether pharmaceuticals are actually available on the market and constitute a genuine alternative for patients. The definition of the pharmaceutical market ratio by reference to actual utilisation data and the consideration of that ratio in calculating the reimbursable unit price range may be regarded as moving in the same direction. Nevertheless, although the Preliminary Report stated that the 1% threshold was not a sufficient measure of actual accessibility, the new rules have retained that threshold.
Against this background, the rules introduced by the Amendment Regulation will need to be assessed together with the timing of market entry, distribution capacity, accessibility, sales volume and reimbursement strategy of the relevant products. In particular, marketing authorisation holders should closely monitor the monthly pharmaceutical market ratios of their products and their position within the relevant internal reference group/equivalent group.
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