In the annulment action brought by the Union of Turkish Pharmacists against certain of the provisions of the Alternative Reimbursement Regulations (“Regulations”), on 10e The Chamber of the Council of State decided to annul the contested provisions of the regulation on the grounds that the regulation was published by the Social Security Institute (“SSI”) without having obtained the prior opinion of the Ministry of Health. Upon notification of the court ruling to the SSI, due to the obligation to comply with the court rulings within 30 days (even before they are final), on July 6, 2022, the SSI issued a amended version of the rules where the canceled provisions were deleted and announced on July 7, 2022 that the practice will be conducted in accordance with the amended rules, effective July 8, 2022. Please see below the summary of the canceled sections of the rules:
- Article 3.1.a: Definition of the alternative reimbursement model
- Article 3.1.d: Document defining confidentiality and ethical rules
- Article 6.1.d: Determination of a discount based on conventional discounts in SUT and keeping it confidential
- Article 6.1.e: Determination of products including NPP products that will be included on the reimbursement list with purchase guarantee – delisting of therapeutic alternatives from the same group
- Article 6.1.g: Modification of alternative reimbursement agreements due to price and RCP changes, termination of agreements before the term of termination and renewal thereof
- Article 6.2.b.4: Following the negotiation, determine the most advantageous price and company among the offers, taking into account not only the lowest price, but also the efficiency, quality and superiority
- Annex 1: Document on confidentiality and ethical rules
This is not the first time that an SSI regulation has been canceled by a court decision on the grounds that the prior opinion of the Ministry of Health has not been obtained. In these examples, it has been seen that the SSI removes this error by obtaining the opinion of the Ministry of Health and publishes the same regulation or a revised regulation.
Although SSI announced on July 7, 2022 that the practice will be in accordance with the amended regulations which omit the rescinded provisions, there is no clear guidance regarding the current practice. However, although not officially confirmed, it is rumored that the SSI is currently working on issuing new regulations, presumably by obtaining prior notice from the Ministry of Health.
SSI’s authority to determine alternative reimbursement models is based on a provision of the statute and the statute is still in effect. In addition, although the above provisions have been revoked, the other provisions of the settlement are still in force. Given that no illegality has been found by the Council of State on the substance of the regulation and that the alternative reimbursement agreements are considered to be agreements also governed by private law, there is currently no indication that the agreements already signed will be negatively affected. On the other hand, companies may experience delays in the negotiation of new agreements and alternative decisions of the commission until a new regulation is published by the SSI.
First published by Gun + Partners, to 20.07.2022