Official Gazette dated 3 October · one publication
New regulation on pharmaceutical reimbursement and pricing processes
Regulation Amending the Social Security Institution Drug Reimbursement Regulation
Laws concerned: Social Insurance and General Health Insurance Law No. 5510 · Social Security Institution Law No. 5502
With the regulation published in the Official Gazette, amendments have been made to the Social Security Institution Pharmaceutical Reimbursement Regulation, updating and clarifying core concepts such as internal reference groups, equivalent groups, and pharmaceutical market shares. In this context, adjustments have been made to the duties and authorities of the Healthcare Pricing Commission and the Commission Working Committee, and a new member has been added to the Commission structure.
Within the framework of the regulation, Medula data has been established as the basis for market share calculations, and conditions have been redefined for the monthly tracking of market shares of certain low-cost drugs on the list, as well as their inclusion in or exclusion from payable unit price range calculations based on specific threshold values. Furthermore, the submission of a distribution certificate to the Institution has been made mandatory for pharmaceutical reimbursement applications.
Social Insurance and General Health Insurance Law No. 5510 · Article by article
Subparagraph (a) of the first paragraph of Article 3
Before The payable unit price range was determined by comparing the discounted unit prices per common smallest unit of drugs in the internal reference group/equivalent group based on public prices calculated with public institutional discounts, and adding the rate determined by the Healthcare Pricing Commission.
Now The definition has been clarified regarding the payable range determined by adding the rate set by the Healthcare Pricing Commission.
The calculation method for the payable unit price range has been updated.
Sub-clause (6) of subparagraph (a) of the first paragraph of Article 8
Before The Association of Research-Based Pharmaceutical Companies was included in the Commission's membership structure, and the number of members was set at 4.
Now In addition to the Association of Research-Based Pharmaceutical Companies, the Foundation for Pharmaceuticals, Pharmacy, Health Sciences and Technologies was also included, bringing the total number of members to 5.
A new institutional representative was included in the Commission, increasing the number of members.
Third and fourth paragraphs of Article 12
Before The market shares of newly listed drugs and the conditions for their inclusion in calculations were based on different principles.
Now Newly listed drugs with the lowest unit price are not included in calculations until they reach a 1% market share; drugs that fail to reach this 1% share within the last 5 months are excluded from the calculation.
The processes for including and excluding drugs in price calculations based on their market shares have been tied to concrete criteria.
Effective date
3 October 2026
MADDE 8- Bu Yönetmelik yayımı tarihinde yürürlüğe girer.
Who is affected
Pharmaceutical companies, pharmacies, pharmaceutical reimbursement applicants, and relevant healthcare service providers.
← Previous issue: Legislation Bulletin 2026/21 · 2 October 2026 · All issues →
This bulletin is for information purposes only and does not constitute legal advice. The official text prevails.
