In the cancellation action filed by the Turkish Pharmacist Union against some of the provisions of the Alternative Reimbursement Regulation (“Regulation”), the 10th Chamber of the Council of State decided to annul the attacked provisions of the Regulation on the ground that the Regulation was issued by the Social Security Institute (“SSI”) without obtaining prior opinion of the Ministry of Health. Upon the service of the court decision to SSI, due to the requirement to comply with the court decisions in 30 days (even before they are final), on 6 July 2022, the SSI published an updated version of the Regulation where the annulled provisions were deleted and announced on 7 July 2022 that the practice will be carried out as per the amended Regulation, as of 8 July 2022. Please see below the summary of annulled articles of the Regulation:
- Article 3.1.a: Definition of alternative reimbursement model
- Article 3.1.d: Definition of confidentiality and ethical rules document
- Article 6.1.d: Determination of a discount out of conventional discounts in SUT and keeping thereof confidential
- Article 6.1.e: Determination of products including NPP products which will be included to the reimbursement list with purchase guarantee – delisting of therapeutic alternatives in the same group
- Article 6.1.g: Amendment of alternative reimbursement agreements due to changes in price and SmPC, termination of the agreements before the termination term and renewal of the same
- Article 6.2.b.4: As a result of negotiation, to determine the most advantageous price and company among the offers, taking into account not only the lowest price, but also efficiency, quality and superiority
- Annex 1: Confidentiality and Ethical Rules Document
It is not the first time a regulation of SSI is annulled by a court decision on the ground that the Ministry of Health’s prior opinion was not obtained. In these examples it was seen that the SSI removes this error by obtaining the opinion of the Ministry of Health and publishes the same or a revised regulation.
Although SSI announced on 7 July 2022 that the practice will be according to the updated regulation which omits the annulled provisions, there is no clear guidance with respect to the current practice. However, although not officially confirmed, it is rumored that the SSI is currently working on publishing a new regulation presumably by obtaining prior opinion of the Ministry of Health.
The SSI’s authority to determine alternative reimbursement models is based on a Law provision and the Law is still in force. Moreover, although the above provisions were annulled, the rest of the provisions of the Regulation are still in force. As there is no unlawfullness found by the State Council on the merits of the Regulation and alternative reimbursement agreements are considered as agreements also governed by private law, there is currently no indication that the agreements that are already signed will be negatively affected. On the other hand, companies may experience delays in negotiations of new agreements and alternative commission decisions until a new regulation is published by the SSI.