Problems began with the import of products for the treatment of diabetes

After the US authorities included components for glucose monitoring systems in the list of dual-use products, these medical products from the Irish-American manufacturer Medtronic became unavailable in Russia. So far, products from the American Abbott remain on the market, but they are not intended for diabetic children under four years of age. Chinese systems, in turn, do not meet the requirements, experts explain.

In Russia, the availability of continuous glucose monitoring (CGM) in patients with diabetes has decreased, Natalya Mokrysheva, director of the National Medical Research Center for Endocrinology, told Kommersant. Some of the components for this system were included in the list of dual-use products published by the United States in May 2023, and now their import into the Russian Federation is difficult. The supply of Medtronic products suffered as a result.

CGM systems check the condition of diabetics every few minutes. Medtronic’s product consists of a sensor that is replaced every few days and measures glucose levels. The data is transferred to the application on the phone via a transmitter. The same sensor is used in a number of insulin pump models. There were problems with the supply of transmitters back in the winter of this year, says Yulia Pankova, federal curator of the All-Russian Organization of Parents of Disabled Children in the Healthcare area. For the supply of medical products that fall under dual-use products, a separate export license is now required.

The St. Petersburg Health Committee confirmed that some Medtronic products are not supplied due to new restrictions from the United States. There are also no sensors in the warehouse in Moscow, says Medtronic product supplier Anton Egorov. Medtronic told Kommersant that they are working to ensure stable supplies of diabetes treatment products to the Russian Federation.

In addition to Medtronic, the American Abbott supplies its CGM systems to the Russian Federation, says MDPro CEO Alexey Vanin. The products of this company, Abbott Freestyle Libre, are manufactured in the EU, while Medtronic is manufactured in the USA, as follows from their regulatory certificates. Back in the spring, patients also complained about a shortage of LMWH systems from Abbott. But now no problems arise, patient organizations and suppliers interviewed by Kommersant reported. Abbott did not respond to Kommersant’s request.

Due to difficulties with the supply of Medtronic medical products, children under 4 years of age were left without CGM systems, since Abbott products are used only after this age, explains Yulia Pankova. In a number of regions, she notes, it is possible to obtain systems from Abbott for patients under 4 years of age by decision of a medical commission, but in some regions, including Moscow and St. Petersburg, this is impossible. Therefore, parents buy these CGM systems for their children at their own expense, adds Ms. Pankova.

According to Headway Company, in 2022, government customers purchased Abbott Freestyle Libre for 4.48 billion rubles, and Medtronic sensors and systems for 611.4 million rubles. The St. Petersburg Health Committee told Kommersant that since the beginning of 2023 they have not concluded contracts for Medtronic sensors due to a lack of applications from suppliers. They are expecting sensors to be delivered in October, citing information from the manufacturer. The sensors have already been ordered with an approximate delivery date of November, says Anton Egorov.

This year, the Moscow Department of Health entered into contracts for the purchase of Medtronic products for 23.6 million rubles, but no deliveries were made, according to data from the government procurement website. They told Kommersant that children from 4 to 18 years of age are provided with the systems, and supplies of products for patients under 4 years of age are expected. According to MDPro estimates, in January-June 2023, government customers terminated 24 contracts for the supply of glucose sensors for approximately 120 million rubles. At the same time, the total amount of all contracts already concluded reaches 4.27 billion rubles.

Now the Ministry of Health and the expert center of the National Medical Research Center are analyzing alternative means, said Natalya Mokrysheva. According to her, studies have been carried out on systems from a number of manufacturers, mainly Chinese, but “not all of them meet our requirements for patients.” Nevertheless, in August, Roszdravnadzor registered the first Chinese NMG system in the Russian Federation – ST14 from Zhejiang POCTech.

Polina Gritsenko