Recent Constitutional Court and Court of Cassation Decisions Regarding the Reimbursement by the SSI of the Costs of Drugs Used in the Treatment of Cancer and Rare Disease

In recent years, numerous lawsuits have been filed seeking the reimbursement of the costs of drugs used in the treatment of cancer and rare diseases that are not reimbursed by the Social Security Institution ("SSI"). Indeed, many of these drugs offer innovative treatments but are also highly expensive. As the SSI refuses to reimburse the cost of many drugs on the grounds that they are not included in the reimbursement list under the Healthcare Implementation Communiqué (“HIC”), patients are compelled to seek legal remedies.

A significant portion of these lawsuits are heard before judicial (civil) courts due to jurisdictional rules. In such cases, patients were often able to access their treatments through preliminary injunctions granted at the beginning of the proceedings. In cases where an interim injunction was not granted, patients had to wait for many months for the completion of stages of the case, such as expert examinations. Although many patients have been able to access their treatments through these lawsuits, the recent decisions of the 10th Civil Chamber of the Court of Cassation (“Court of Cassation 10th C.C.”) have made the situation more difficult for patients, both in terms of the granting of preliminary injunctions and the substantive outcomes of the cases. On the other hand, the approach adopted by the Turkish Constitutional Court (“TCC”) in a very recent individual application diverges from the stance of the Court of Cassation 10th C.C., particularly in a manner favorable to patients, with respect to the assessment of the conditions for granting preliminary injunctions.

We have addressed these recent and highly significant decisions under separate headings below.

Preliminary Injunctions: Should the Rule Prohibiting Measures That Would Essentially Resolve the Dispute Be Strictly Applied in These Cases?

The question of whether a preliminary injunction should be granted at an early stage of lawsuits filed for the reimbursement of drug costs by the SSI. has recently been the subject of decisions by both the Court of Cassation 10th C.C.and the TCC.

In its decision dated 06.12.2024 and numbered 2024/6734 E., 2024/12498 K., the Court of Cassation 10th C.C. established an important but ambiguous precedent regarding whether a preliminary injunction may be granted at an early stage of the proceedings.

Upon reviewing the case brought before it following a request to resolve the conflict between different regional courts of appeal, the Court of Cassation 10th C.C. stated that there was no medical authority report, which is generally accepted and sufficiently reliable to serve as a basis for a preliminary injunction, indicating whether the drug subject to the application is of vital importance and necessary for the treatment of the illness, whether the treatment to be administered with the drug at issue is, particularly on a continuous basis, more effective and more beneficial than known existing treatment methods, and whether its use is medically necessary, and that, in the absence of the drug, this situation would cause serious, rapid, and irreversible deterioration in the plaintiff’s health or death or a significant decrease in life expectancy or severe pain. In this context, the Court of Cassation 10th C.C. ruled that, at a stage where such a medical authority report does not exist, a preliminary injunction should not be granted that would exceed the nature of such a measure and essentially resolve the merits of the case.

On the other hand, the TCC, in reviewing an individual application filed in response to the decision of the 10th Civil Chamber of the İzmir Regional Court of Appeal, which held that a preliminary injunction that would essentially resolve the merits of the case could not be granted, that the applicant failed to meet the condition of prima facie evidence required for such a measure due to the absence of a medical authority report in the case file, and that the State is not under an obligation to provide free access to medication to citizens under all circumstances, rendered a decision that diverged from the approach of the Court of Cassation 10th C.C.. The TCC noted that, in the individual application file, there was a report indicating that the medication in question was of vital importance for the patient, and that the applicant’s failure to access the drug immediately would pose a serious threat to their life. Taking into account the critical importance and urgency of the drug in the treatment of the applicant’s illness, the TCC held that the applicant’s treatment should be initiated without delay, that the applicant faced a serious threat to their physical and mental integrity due to the lack of access to the medication, and that the necessary measures should be taken immediately to eliminate this threat, and therefore decided to accept the applicant’s request for a preliminary injunction.

In this context, it is observed that the recent decision of the Court of Cassation 10th C.C. is contrary to the decision of the Constitutional Court, and that the meaning of the expression “a medical authority report of sufficient reliability to serve as a basis for a preliminary injunction” remains unclear. Nonetheless, we consider that the TCC’s decision should be taken into account by first-instance courts and regional courts of appeal when reviewing applications for preliminary injunctions, and that such applications should be examined in line with the TCC’s decision. In our opinion, a strict interpretation of the principle that “a preliminary injunction that would essentially resolve the dispute may not be granted” and the imposition of more stringent requirements for preliminary injunctions would lead to patient victimization and the violation of fundamental rights guaranteed by the Constitution.

Court of Cassation 10th C.C.’s Recent Precedents on the Merits of the Cases: The Requirement to Request Official Correspondence from the Turkish Medicines and Medical Devices Agency (“TMMDA”) and the SSI

In its recent decisions [1] regarding the merits of lawsuits filed for the reimbursement of drug costs by the SSI, the Court of Cassation 10th C.C. has proposed a method for determining whether the drug in question is consistently more effective and more beneficial, and whether its use is medically mandatory. It is considered that this method, as detailed below, could increase the workload of the courts and potentially prolong the proceedings, contain technical elements that may exceed the competence of judges, and ultimately be detrimental to the patients.

According to the method adopted by the Court of Cassation 10th C.C., it is necessary to inquire with the TMMDA whether the Phase 3 studies of the drug in question have been completed, and whether the drug has been provided to patient groups and physicians. If the drug has been provided to patient groups, it is also required to obtain any available study reports and all phase study documentation related to the drug from the domestic representative of the manufacturer.

On the other hand, the Court of Cassation 10th C.C. states that it must be determined whether the medications paid for by the SSI cover the minimum treatment necessary for sustaining the patient’s life. If not, it should be assessed whether the drug in question provides a continuous or temporary benefit, and if the benefit is temporary, the duration for which this benefit is provided must be established.

Finally, in its recent precedents, the Court of Cassation 10th C.C. states that if the drug in question has benefits such as fewer side effects compared to existing treatment methods, providing short-term benefits, controlling the condition, improving the quality of life, etc., the administration, within its legal limits, may always include the drug in the HIC framework. In this context, the Court of Cassation 10th C.C. emphasizes that, when making decisions, the courts must consider that “for the drug in question to be reimbursed through judicial means, it must be medically and scientifically necessary, of vital importance, and continuously effective and beneficial beyond just short-term efficacy, and it must have completed all phase studies, be recognized by medical authorities, and there should be no acceptable objections or reservations from the defendant institution.”

Conclusion

In lawsuits filed before the judiciary for the reimbursement of drug costs, obtaining an urgent preliminary injunction is of great importance for patients. Currently, the decision of the Court of Cassation 10th C.C., dated 06.12.2024, with file number 2024/6734 E. and 2024/12498 K., diverges from the decision of the TCC dated 06.12.2024, with file number 2024/6734 E. and 2024/12498 K. Additionally, the expression "a medical authority report of sufficient reliability to serve as a basis for a preliminary injunction," as put forth by the Court of Cassation 10th C.C., and the elements that such a report must contain are considered to be ambiguous. It is believed that, at present, the Court of Cassation 10th C.C. applies the conditions for preliminary injunctions in a rigid manner.

On the other hand, it is believed that the approach adopted by the Court of Cassation 10th C.C.in its recent decisions on the merits of the cases will significantly extend the duration of the proceedings and disproportionately increase the investigatory burden on the courts.

[1] Some of these decisions are as follows: Court of Cassation 10th C.C., dated 24.02.2025, 2024/11967 E., 2025/2777 K., Court of Cassation 10th C.C., dated 03.02.2025, 2024/11663 E., 2025/1249 K Court of Cassation 10th C.C., dated 24.02.2025, 2025/290 E., 2025/2795 K.