The Ministry of Health is asked to amend the law at the cellular level
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The All-Russian Union of Patients (VSP) asks the Ministry of Health to adjust the requirements that are proposed for CAR-T drugs. Doctors note that the technology based on the modification of cells of the patient’s immune system has made a real revolution in oncohematology, the appearance of such drugs on the Russian market is expected next year. However, the VSP is confident that the amendments to the law “On the Circulation of Medicines” submitted for public discussion may make such drugs inaccessible to domestic patients, and ask to exempt manufacturers from quality control of batches imported into the country. In the Ministry of Health, Kommersant promised to consider the proposals of the public.
Yan Vlasov and Yuri Zhulev, co-chairs of the All-Russian Union of Patients, sent an appeal to the Ministry of Health with a request to review the requirements of the law “On the Circulation of Medicines” in relation to cell preparations. We are talking about CAR-T technology (Chimeric Antigen Receptor of T-Cells): the drug is created for a specific patient based on his cells. The technology is based on the extraction of cells of the immune system (T-lymphocytes) from the body, their genetic modification, followed by reinfusion to the patient. Such drugs registered in the world are used to treat severe oncohematological diseases – acute leukemia, lymphomas, multiple myeloma – both in children and adults. One of the foreign pharmaceutical companies, VSP told Kommersant, is at the final stage of the process of registering a CAR-T drug in the Russian Federation. According to market participants, cell preparations should appear in Russia next year.
The current legislation requires pharmaceutical companies or organizations, when importing into the country, to submit to Roszdravnadzor a quality test report for a medicinal product that entered civil circulation during the year. “In simple terms, several packages of the drug imported during the year are selected, they are sent for testing to the appropriate laboratories, and a protocol is issued based on the results,” explains VSP expert Alexei Fedorov.
The Ministry of Health intends to amend the law “in terms of bringing it into line with the law of the Eurasian Economic Union governing the circulation of medicines for medical use.” As amended by the draft amendments developed by the Ministry of Health in May (dated May 30), Art. 52.1 provided for the possibility of exempting manufacturers and distributors from the annual submission of such a protocol to Roszdravnadzor. However, this indulgence was removed from the new edition, published in October.
In an appeal to Minister of Health Mikhail Murashko, VSP experts warn that in the case of certain high-tech medicines, the need to conduct quality tests every year can lead to patients losing life-saving therapy. The current legal requirements, explains Alexey Fedorov, work for large batches of medicines. “In the case of high-tech drugs, the situation is different. They are produced in limited series, and their cost is usually very high. For example, if autologous CAR-T drugs are manufactured outside the Russian Federation, one package for a specific patient will be imported. It is not possible to give this single package for testing,” says Mr. Fedorov. These drugs, the authors of the appeal to the Ministry of Health specify, are used by patients who have undergone several lines of therapy, often in the terminal stage: the amount of donor material is limited, which does not allow producing additional volumes only for testing them. In addition, they emphasize in the patient organization, even in those rare cases when there is enough donor material, this will lead to a significant increase in the cost of therapy and, accordingly, the cost of the state for the treatment of the patient. According to open sources, the cost of a course dose of such drugs can be from €300,000. According to Alexei Fedorov, for CAR-T, quality assurance can be outgoing production control and a conclusion on compliance with the requirements of the rules of good manufacturing practice of the EAEU, issued by the authorized body of the state – a member of the Union.
Hematologist, medical expert of the Tinkov Family Foundation (supports blood cancer patients) Andrey Abrosimov explains that CAR-T technology allows you to take leukocytes from the blood of a sick person, equip them with special receptors and teach them to recognize and destroy a tumor. “Smart”, modified and trained T-lymphocytes return to the patient’s blood and begin to perform their task. Mr. Abrosimov emphasizes that CAR-T technology has made a real revolution in oncohematology and is the most effective therapeutic option. “However, its legal definition at the moment in Russia, unfortunately, is vague and varies in legal acts,” says Mr. Abrosimov. In his opinion, patients’ concerns are “understandable and justified”, as the regulation of cell preparations may become more complicated, and with it the availability of treatment. “Due to the uniqueness, it is impossible to administer a drug for patient A to patient B, there is no serial production, which means that quality assessment measures that apply to conventional drugs cannot be used for cell and gene drugs,” the expert continues. “In our opinion, an urgent and active discussion of these amendments is needed”
The Ministry of Health of the Russian Federation did not explain to Kommersant why the draft amendments in the May edition, providing for an exception for high-tech drugs, were changed. However, the department said that the document will be finalized based on the results of public and expert discussion. “The VSP proposals will also be considered,” the Ministry of Health assured.
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