Tatarstan asks the Constitutional Court to lift the burden of providing medicines to orphan patients from the regions

The Constitutional Court (CC), at the request of the Parliament of Tatarstan, will study the norms of the federal law on health protection, which assign issues of medical care to people suffering from rare (orphan) diseases to the jurisdiction of the regions. The republic believes that such a division of powers is arbitrary (as it is not enshrined in the law on public authority), violates the constitutional principle of equality and creates a threat of regions not fulfilling their responsibilities.

The State Council (Parliament) of Tatarstan addressed the Constitutional Court in December 2023 with a request to check the constitutionality of the provisions regulating the issues of medical care for persons suffering from orphan diseases. Currently, for 11 such diseases, treatment costs are provided for from the federal budget, and for another 17 diseases the regions must pay. In particular, in the budget of Tatarstan, expenses for providing such citizens with medicines over the past few years ranged from 1.02 billion to 1.72 billion rubles. On January 1, 2023, amendments came into force according to which the federal budget pays for medications for adults, and the tasks of providing medical care for children under 18 years of age with 14 types of diseases are assigned to the Circle of Good Foundation, which is also funded by the state. However, upon reaching the age of 18, such patients find themselves without full support and can no longer receive treatment under the compulsory medical insurance system, since it is not covered by current tariffs.

The unsatisfactory state of drug provision for adults, associated with the inability of the regions to fully fulfill the powers entrusted to them, is evidenced by the increase in the number of court cases: in 2021-2022 it almost doubled, the request notes. In fact, going to court has become the only way for patients to receive treatment: in most cases, the courts accommodate patients halfway. However, many cannot get medications, even with a court decision in hand.

The authors of the request remind that, according to the Constitution, the establishment of a unified legal framework for the healthcare system is within the jurisdiction of the Russian Federation. When exercising its powers to organize medical care, the legislator cannot act arbitrarily, deputies insist, such decisions presuppose a clear, distinct and consistent delimitation of issues of national importance. Now a situation arises where the legislator has the opportunity to assign undefined powers to the regions, and the subjects can exercise them in an arbitrary manner. This leads to a violation of the principle of equality and creates a threat of regions not fulfilling their responsibilities. “The task of providing medicines to people suffering from rare diseases remains impossible for most subjects and requires the state to develop a set of coordinated measures to resolve it,” the request emphasizes.

According to Kommersant, the Ministry of Health and the Ministry of Finance have already formulated their position on Tatarstan’s request. The Ministry of Health notes that although resolving issues of organizing medical care for the population falls within the powers of the regions, part of the burden is removed from them by creating additional mechanisms, in particular through the same “Circle of Good”, which is authorized to purchase, among other things, medicines that are not registered in RF. The total volume of the program for providing drugs to patients suffering from high-cost nosologies in 2023 amounted to 87.969 billion rubles. There are no restrictive lists for the supply of medicines to patients, and regions have the opportunity to purchase the drug necessary for a particular patient based on the decision of the medical commission, the Ministry of Health emphasizes. But the procurement system at the federal level does not imply individual selection of drugs and is carried out according to average parameters. The problem of the shortage of drugs produced in unfriendly countries “is of a general nature.”

According to Roszdravnadzor, in 2024, only eight appeals were received from four regions regarding the provision of medicines to people with orphan diseases (last year there were 41 appeals from 12 regions), clarifications were sent to applicants, and warnings were issued to regional authorities about the inadmissibility of violating mandatory legal requirements.

In turn, the Ministry of Finance points out that the issue of transferring orphan diseases to the federal level contradicts the division of powers in the field of drug provision to the population and can only be considered taking into account the redistribution of budget sources.

Co-chairman of the All-Russian Patients’ Union Yan Vlasov recalls that initially the drug provision for patients with most orphan diseases lay on the shoulders of the regions, but their budgets systematically failed to cope with this burden, and the authority to purchase some of the expensive drugs was transferred to the federal level. However, inequalities between patients depending on age and place of residence remain. “We, of course, advocate federalization, that is, transferring the drug provision of all “rare” patients under the responsibility of the federal budget. But until this happens, we expect that the regions, and in particular non-subsidized Tatarstan, will continue to support orphan patients, providing their treatment,” says Mr. Vlasov.

Lawyer of the Vatamanyuk & Partners law group Alexander Zelinko notes that a dispute between the center and the regions on issues of jurisdiction is a rather rare occurrence for the Constitutional Court. The last time such a dispute was resolved more than 20 years ago during the review of the Constitution of the Altai Republic regarding the delimitation of powers in the field of environmental protection. As for the current dispute, the region’s chances of winning are quite high, the expert believes: this is due to the fact that the existing order actually leads to a violation of the rights of citizens and creates a threat that the regions will not fulfill their obligations.

Anastasia Kornya, Natalya Kostarnova