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Tatarstan is studying the issue of a new initiative to provide drugs to orphan patients
The Constitutional Court of the Russian Federation, at the request of the State Council of the Republic of Tajikistan, confirmed the compliance of certain provisions of the federal law with the Basic Law of the country. In particular, the Tatarstan parliament instructed to study Article 16, Part 1, Clause 10 and Article 83, Clause 9 of the Federal Law "On the Basic Principles of Health Protection of Citizens of the Russian Federation".
These standards impose an obligation to provide medicines to citizens with rare (orphan) diseases in the region. However, the country's subjects often do not have sufficient funds for this, which undermines the right of the country's residents to universal access to medical care, the authors of the request note. In 2020, amendments were adopted to the Constitution of the Russian Federation, confirming the right to health protection of all Russians, regardless of place of residence and other factors.
The costs of supporting orphan patients are very high, and the capabilities of local budgets vary. This creates inequality between patients by place of residence, the republic's request says.
The only way for these patients to receive life-saving treatment is to get their medications from the state. Typically, when communities are underfunded, patients seek judicial or administrative protection. However, even if you win your case in court, you will not be able to get your medications immediately.
The existing imbalances limit patients' access to medical care, which violates a number of provisions of the Constitution of the Russian Federation. Eliminating these contradictions would allow for a more reliable priority supply of medicines at the federal level, noted the republican lawyers. • Is it acceptable to distribute powers between the Russian Federation and its subjects, where the majority of the financial burden for the supply of medicines lies with the regional budget? • Is civil equality observed to the extent that the quality of medical care for patients with rare (orphan) diseases depends on the economic capabilities of the region in which they live.
At the end of September, the Constitutional Court of the Russian Federation issued a decision on the request of the Tatarstan parliament, but not as the republic had hoped. The controversial provisions were perceived as incompatible with the basic law of Russia, since they did not provide a mechanism for providing medicines to those in need when regions do not have the financial means to do so. Therefore, the legislator took on the responsibility of providing a reserve mechanism for providing medicines to certain categories of patients.
I completely disagree with the arguments of the Tatarstan deputies from the Constitutional Court of the Russian Federation, referring to the previously adopted decision on this issue (No. 1054-O of July 2, 2013). The court limited itself to a detailed analysis of the mechanism for providing orphans with medication.
The republic's request stated that the lack of a unified approach to providing medical care to orphan patients leads to "medical migration." Families are forced to move to other cities because they have the necessary doctors and better supplies of medicines. medical equipment. At the same time, the patient's place of residence should not affect his or her ability to receive treatment, the authors of the request note.
"The Constitutional Court of the Russian Federation did not consider this issue in full, but only pointed out that when a patient moves from one subject to another, it is impossible to transfer already purchased medications or allocated funds," the republic complained. According to the decision of the Constitutional Court of the Russian Federation.
The Tatarstan Parliament pointed out the need to redistribute responsibilities between the regions and the federation, noting the advisability of transferring the purchase of expensive medicines for orphans to the federal budget level. However, the Constitutional Court's decision does not address this issue. Even if a region does not have sufficient funds to provide medicines, this does not relieve it of responsibility to citizens. At the same time, the resolution notes that determining the competence of state authorities on matters of general jurisdiction related to the performance of the functions of the social state does not mean that the Russian Federation "ceases to bear responsibility." The situation on the ground."
Often, citizens with orphan diseases, financed from the federal budget by decision of the Medical Commission, are prescribed prescription drugs that are not included in the list approved by the Government of the Russian Federation and are not registered in the state. At the same time, the provision of drugs is also the responsibility of the subjects of the Russian Federation.
— The resolution did not answer key questions. There were no answers to what to do if the region's financial capabilities do not allow it to provide adequate support to patients. Because this entails the emergence of dependence on the scale of support provided to patients. In his residence, this would violate his basic constitutional rights. At the same time, conducting the relevant agreements between centers and regions in the absence of budgetary funds for the latter takes a lot of time and jeopardizes the uninterrupted provision of necessary assistance to patients, the republic noted.
Before the preliminary mechanism was created, the Russian Constitutional Court had not decided how to proceed today. Most of the powers to provide medication to orphan patients still belong to state entities.
Midkhat Kurmanov, former Minister of Justice of the Republic of Tatarstan, expert on constitutional law, confirmed that the republic has been working for several years to solve the problem of drug provision for citizens with orphan diseases. As an example, he cited examples of his work when he headed the Ministry of Justice of Tatarstan. A woman who did not receive expensive and important drugs appealed to the Vakhitovsky Court of Kazan, and it appealed to the Constitutional Court for approval. Whose power is this: the regional or the federal center?
"The Vakhitovsky court acted very wisely and wrote that, despite the appeal to the Constitutional Court of the Republic of Tatarstan, the medicines should still be provided. "The Constitutional Court responded that this is reserved for the subject by law, so it should be provided for," he explained. As for the current situation, I believe that the Tatarstan parliament should not appeal to the highest judicial body of constitutional control in Russia. "It has already expressed its point of view."
"Not only in Tatarstan, but also in the Mari Republic or the Ulyanovsk Region - where will you get 50 or 20 million rubles per patient?! This is nonsense! Therefore, I believe that according to the Constitution, healthcare is the responsibility of the state, our country is the Russian Federation, and we are obliged to provide our citizens with expensive medicines," he assures.
Realnoe Vremya inquired whether Tatarstan legislators are considering the possibility of preparing a legislative plan to transfer the regulation on the purchase of expensive medicines for orphans to the federal budget level. So what period of time and what work is planned in this area?
“The case is at the investigation stage,” the State Council of Tatarstan responded to Realnoe Vremya.
However, earlier the Tatarstan parliament submitted a similar initiative to the State Duma. Since there was no further progress, a request was sent to the Constitutional Court of the Russian Federation, since, according to the author, the existing procedure for providing medications to orphan patients violates their constitutional rights.
The medical community of the republic also shares this opinion. It is impossible to fully trust the purchase of such expensive drugs to local budgets. The patient himself suffers from this.
According to him, only a federal program can solve the problem. Currently, Moscow pays tribute to the Circle of Goodness foundation, which was founded in 2021 to support children with rare (orphan) diseases. However, it is not possible to cope with the treatment of all patients, and now there are problems with providing medicines to "graduates", that is, adult patients (over 19 years old). Therefore, the problem has to be solved locally, which is not always possible, Vavilov noted:
— Do you always have to take a pencil and a calculator with you to calculate the financial capacity of your district? If not, what about the region? They will do nothing, and relatives will write complaints. This will not run the ship aground. A huge increase in prices for orphan drugs. Several years ago, it asked for 31.5 million rubles to supply the drug "Orphadin" to Russia. This is a year's treatment for a boy, and I brought it from Germany for 6 million dollars. Markup included! Companies that purchase orphan drugs benefit from this. Prices are several times higher, so neither the federal nor local authorities have enough money.
"Today everyone is talking about centralization, and in fact, a lot is centralized, so the money should go accordingly," says a veteran of the medical community of Tatarstan. He added that the regions will not be able to purchase such drugs on their own. "It would also be wrong if the entire budget of the republic was spent only on drugs and treatment of orphan diseases. There are many other problems that require funding. This problem cannot be solved by one region. And when it is related to purchases, where large purchases are made centrally, then discounts increase, and violations decrease," the host said.
"A person's life cannot depend on financial capabilities"
The Office of the Department of Human Rights of Tatarstan also regularly receives appeals from citizens suffering from rare (orphan) diseases. As Sariya Saburskaya told Realnoe Vremya, the Ombudsman's office is only engaged in resolving these issues, primarily by consulting citizens on how to resolve them and raising the issue with the Tatarstan Ministry of Health.
According to her, the organization appealed to the Ministry of Health and the government of the republic with a request to increase funding for this category of citizens suffering from orphan diseases. In 2018-2019, more than 130 people needed expensive medical services, including special therapeutic nutrition. Minors received support from the budget, but at the request of the ombudsman, it was decided to extend this support to adult patients.
Another problem is related to providing patients diagnosed with SMA with the drug "Spinraza" costing 7 million rubles per bottle. At the same time, the earlier the drug was administered to a sick child, the more pronounced the positive response. Therefore, there were many requests for this.
"In this regard, we have asked the Human Rights Commissioner of the Russian Federation to allow the use of the drug in hospital settings. Unfortunately, this drug is not included in the following clinical and statistical groups for the treatment of patients: She described Sariya Saburskaya as follows: "We also received a positive response to this, and today this topic has been removed. Of course, we must move on. A person's life certainly cannot depend on financial capabilities.