On 25 August 2022, the Social Security Institution Reimbursement Regulation (Turkish language) was published in the Official Gazette numbered 31934. The regulation has replaced the previous Social Security Institution Reimbursement Regulation from 2016. The most important amendments are made on the Pharmaceutical Reimbursement Commission's (PRC) working procedures.
The regulation includes new definitions for therapeutic reference (TR) group, biosimilar medicinal product, equivalent medicinal product and reference medicinal product. They are defined in accordance with other legislation which already introduced those terms.
In addition, the Chairman of the PRC has been given prioritisation authority on the reimbursement claims of:
- Pharmaceuticals that are difficult to supply and of vital importance.
- First biosimilar medicinal products that do not have an equivalent or TR group and are determined to have a unit price of at least 30% below the unit price of the reference pharmaceutical product in the reimbursement list.
The PRC has also been granted the authority to evaluate requests of companies to keep public institution discount rates confidential.
The regulation is in force as of date of publication.
First published by Practical Law Life Sciences Monthly Newsletter in Oct 04, 2022.