REGULATION

ON THE PAYMENT OF HEALTHCARE SERVICES PROVIDED IN CLINICAL RESEARCH
Social Security Institution

Official Gazette Date: March 3, 2026

Official Gazette No: 33185

CHAPTER ONE – General Provisions

Purpose

ARTICLE 1 – (1) The purpose of this Regulation is to regulate the procedures and principles regarding healthcare services to be financed within the scope of subparagraph (g) of the first paragraph of Article 63 of the Social Insurance and General Health Insurance Law No. 5510 dated 31/5/2006.

Scope

ARTICLE 2 – (1) This Regulation covers healthcare services financed by the Social Security Institution, excluding the provision of investigational products, within clinical research supported by the Turkish Health Institutes Presidency and approved by the Ministry of Health, conducted in public hospitals and state universities with the participation of general health insurance holders and their dependents.

Legal Basis

ARTICLE 3 – (1) This Regulation has been prepared pursuant to Articles 63, 64, 72, 73, and 107 of the Social Insurance and General Health Insurance Law No. 5510 dated 31/5/2006.

Definitions

ARTICLE 4 – (1) For the purposes of this Regulation:
a) Investigational product: Medical products and methods tested in a clinical research study.
b) Dependent: Persons listed in subparagraph (10) of the first paragraph of Article 3 of Law No. 5510.
c) Application: Requests submitted to the Social Security Institution by public hospitals and state universities for the payment of healthcare services provided in clinical research.
ç) General health insurance holder: Persons listed in Article 60 of Law No. 5510.
d) Law: The Social Insurance and General Health Insurance Law No. 5510 dated 31/5/2006.
e) Clinical research: A scientific study supported by the Turkish Health Institutes Presidency and approved by the Ministry of Health, conducted in public hospitals and state universities with the participation of general health insurance holders and their dependents.
f) Institution: The Social Security Institution.
g) Healthcare service: Medical products and services to be financed pursuant to Article 63 of Law No. 5510.
ğ) HIT (Health Implementation Communiqué): The Communiqué published in the Official Gazette dated 24/3/2013 and numbered 28597 determining the prices and procedures.
h) TÜSEB: The Turkish Health Institutes Presidency.

CHAPTER TWO – Procedures and Principles Regarding Payment, and Powers of the Institution

Procedures and Principles Regarding Payment

ARTICLE 5 – (1) Applications for payment shall be made according to the method determined by the Institution; in single-center research by the conducting center, and in multi-center research by each center individually.

(2) Investigational products to be used must be notified to the Institution.

(3) Approval documents, TÜSEB support documents, participant information and duration details must be submitted. Submitting institutions are responsible for accuracy.

(4) Financing of services within Article 63 shall be provided within limits determined by the Institution. Services under Article 64 shall not be financed.

(5) Services provided under this Regulation shall be evaluated outside lump-sum agreements under Article 73. Invoices shall be examined according to relevant legislation.

(6) Institutions must comply with the HIT and relevant legislation when issuing invoices.

(7) Responsibility for information and updates rests with applicant institutions.

(8) Excess or undue payments shall be recovered.

(9) Expenses covered by clinical research insurance shall not be covered by the Institution.

(10) Harm or death cases must be reported; resulting healthcare expenses shall not be paid by the Institution.

(11) Termination or suspension must be notified.

(12) Final research report shall be submitted by TÜSEB.

Powers and Supervision of the Institution

ARTICLE 6 – (1) The Institution is authorized to conduct examinations and audits and establish related rules.

(2) The Institution may request and examine all data, documents, invoices, records, and obtain copies; and consult authorized persons, employees, patients, and participants.

CHAPTER THREE – Miscellaneous and Final Provisions

ARTICLE 7 – The Institution is authorized to issue secondary regulations.

ARTICLE 8 – This Regulation enters into force on the date of publication.

ARTICLE 9 – The provisions of this Regulation shall be executed by the President of the Social Security Institution.