Experts announced the prevalence of foreign HIV tests in public procurement

A large proportion of HIV diagnostic tests purchased in RUSSIA are foreign-made, according to a study by the Treatment Preparedness Coalition.The Ministry of HEALTH called the report a "targeted discredit of the social sphere"

The number of HIV diagnostic tests purchased by the Russian authorities in 2021 does not fully cover the need for them - with a total estimated need of 2.8 million test systems, 2.3 million were purchased last year. Such data are contained in the report of the coalition on Treatment Preparedness (ITPC), dedicated to the analysis of regional public procurement of HIV diagnostics and monitoring tools in 2020–2021.

At the same time, Russia depends on foreign manufacturers of various HIV tests from countries that the Russian authorities consider unfriendly, the report says: for example, the share of imported tests for determining the immune status is 97%, for determining viral load - 31%, for determining resistance to medicines against HIV - 72%.

What tests do people with HIV need?

Test for the determination of CD4 + lymphocyte cells (test for immunological status). Shows the number of CD4 cells that are able to respond to infection. In a person not infected with HIV, this number ranges from 500 to 1.5 thousand cells, a result below 400 may indicate immunodeficiency. If the number of these cells falls below 200, this indicates a serious violation of the immune system. Taking antiretroviral therapy (ARV therapy) for HIV increases the number of CD4+ lymphocytes.

Viral load test. Shows the number of viral particles in the blood of an infected person. With an increase in viral particles, the number of CD4 + lymphocytes decreases and the risk of developing the disease increases. If a person is on HIV medication, the viral load should decrease. If the viral load is not determined by the test, that is, it is equal to zero, this means that the drugs are selected correctly and work.

Test for resistance to antiretroviral therapy. It is carried out to analyze why the virus continues to multiply in the body, despite taking ARVs. According to the report, in Russia, genotyping is most often used to study drug resistance to HIV - when mutations are detected in the genome that cause resistance to certain drugs.

HIV-related testing is free in Russia. Patients entering treatment in the first year should have five to six viral load tests and four immune status tests. If patients with HIV have been on therapy for more than a year and have not changed their drug regimen, testing for viral load and immune status is done twice a year.

The purchase of diagnostic tools is carried out as follows: the regions provide the Ministry of Health with data on the number of HIV-infected people in the region who require examination, after which the ministry sends money to purchase diagnostic tools on a co-financing basis, that is, the region must also allocate its own funds for the purchase of equipment. At the same time, “various levels of co-financing” can be established, according to the state program “Health Development”. When determining this indicator, the budgetary security of the subject is important - the center allocates less funds to donor regions for the purchase of HIV diagnostics, scarce - more, expert of the All-Russian Union of Patients Alexei Fedorov explained to RBC.

The Ministry of Health, in response to a request from RBC, explained that the purchase of HIV diagnostic tools is carried out by the regions from the funds of the regional budget, while the regions themselves form the schedule and the volume of the necessary purchase of tests.

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“A subsidy from the federal budget, having entered the regional budget, becomes the means of the regional budget,” Fedorov specified.

How many test systems were purchased

In Russia, statistics on HIV patients are maintained by the Ministry of Health and the specialized research department for the prevention and control of AIDS of the Central Research Institute of Epidemiology of Rospotrebnadzor. According to the latter, by the end of 2021, 1.1 million HIV-infected people lived in Russia, 660,821 patients received therapy.

According to the Ministry of Health, in 2021, 842,333 people with HIV were registered with dispensaries, about 74% of them, or 627,538 patients with HIV, received therapy. In 2020, 554,688 patients received therapy, bringing the number of newly diagnosed patients last year to 72,850.

Despite the increase in patients, the total number of purchased tests for determining viral load, immune status and resistance has not increased: in 2020, 2,322,268 tests were purchased, in 2021 - 2,317,408. At the same time, as the authors of the study note, only 73 1,000 new patients would require an estimated 273,195 viral load tests in 2021 (assuming five tests per year required for newly identified patients). Thus, in 2021, the total need for tests to determine the viral load and immune status for new patients and those 627.5 thousand HIV patients who have already received antiretroviral therapy is, according to the calculations of the coalition, 2,854,854 tests, with those purchased in the past year 2 310 176 (excluding resistance tests).

In total, in 2020-2021, the authorities purchased diagnostic tools for 5.4 billion rubles, acquiring 4.5 million tests. In general, in 2021, there was a decrease in funding in this area, the authors of the study summarize, however, the regions could have stocks of tests that were not used by laboratories due to their workload with tests for covid-19 during the pandemic. “Data on whether the region has reserves and their nature are not published in open sources, so it is impossible to test this hypothesis,” adds Natalia Egorova, HEAD of the ITPCru monitoring department.

As a rule, when concluding contracts, we are talking about an annual or semi-annual purchase, that is, by the end of 2022, there should be a stock of consumables, reagents and tests in case of a cessation of supplies, said Sergey Shulyak, CEO of DSM Group.

Which regions are leading in purchases

More than half (62%) of all costs for the purchase of all HIV diagnostic systems fell on nine regions, mainly with an HIV infection rate above the national average: these are the Moscow Region, Moscow, St. Petersburg, Tatarstan, Khanty-Mansiysk Autonomous Okrug , Kemerovo, Sverdlovsk regions and others. They made purchases for 1.7 billion rubles.

How many foreign tests are purchased

The group of viral load tests is the only one where Russian drugs are leading in purchases. The share of tests of the Central Research Institute of Epidemiology of Rospotrebnadzor, Vector-Best and DNA-Technology companies accounts for almost 70% of all purchased tests of this type. 30% is shared between Abbott and Roche Molecular Systems. At the same time, more budget funds were spent specifically on foreign test systems - a total of 1.2 billion rubles. out of 1.7 billion

Significant purchases of foreign tests can be explained by the fact that closed-type analyzers of the same foreign manufacturing companies are used in the regions. “Tests from other manufacturers are not technically suitable for them, so customers are forced to spend money on compatible ones and cannot save on the purchase of other test systems,” explains Natalia Egorova.

What is the Ministry of Health responsible for?

The Ministry of Health, in response to a request from RBC, said that, according to government decree No. 552, which establishes the specifics of the circulation of medical devices, in the event of a shortage or a similar risk under sanctions, it is possible to use non-original consumables in closed systems without the consent of the copyright holder. You can also use a medical device for which the manufacturer has limited the list of consumables with other registered consumables, if the manufacturer itself has confirmed the possibility of such a combination.

The purchase of HIV diagnostic tools is in the zone of priority monitoring and control of the Ministry of Health, including when it comes to episodes of a shortage of diagnostic tools due to objective factors of logistics violations, Aleksey Mazus, chief freelance specialist of the Ministry of Health on HIV infection, told RBC. According to him, the purchase of test systems in the area of ​​responsibility, primarily the regions of Russia.

At the same time, Mazus did not agree with the conclusions of the report of the treatment readiness coalition, calling them untrue and deliberately discrediting the social sphere. “Additionally, we note that the data given in the “analysis” are not true and are aimed at deliberately discrediting the social sphere of our country, and in no way at ensuring the interests of the patient community,” Mazus said in a response to RBC.

In the category of tests for immune status (CD4+ lymphocytes), imported drugs dominate: 97% are foreign tests and only 3% are domestic. Most of the tests were purchased from two companies - Beckman Coulter and BD Biosciences, in third place - tests for the immune status of the pharmaceutical company Abbott. In total, a little more than 946 million rubles were spent on them from the total budget for this type of diagnostics in the amount of 964.3 million rubles.

Despite the fact that tests for resistance to HIV therapy are purchased by a limited number of regions, this category is also occupied by foreign systems: 72.3% are tests from Abbott, 27.7% are tests from the Central Research Institute of Epidemiology of Rospotrebnadzor. The authors of the study also found that some regions hold auctions to purchase resistance testing services from third parties. This may be due to a lack of either equipment or funding, the report says. Tests for resistance to therapy are the most expensive: the regions spent almost 97 million rubles on 5.2 thousand Abbott tests, and almost 16 million rubles on 2 thousand tests produced by the Central Research Institute of Rospotrebnadzor.

At the same time, there is no list of regions in which the level of resistance is high and where such diagnostics are recommended for patients taking antiretroviral therapy, the report states.

Is there a risk of not being tested for HIV?

At the request of the Patient Control public movement, which represents the interests of patients with HIV, the Central Research Institute of Epidemiology of Rospotrebnadzor explained that there are no difficulties in the production of reagent kits for determining resistance and viral load, it can be increased. However, they also added that resistance tests are performed on analyzers from the American company Applied Biosystems, which “mandatoryly” require the use of special reagents and consumables from the same company. “If the company stops supplying consumables and reagents to Russia, drug resistance testing will be impossible,” says Vadim Pokrovsky, head of the Specialized Research Department for Epidemiology and Prevention of AIDS, in a response (available to RBC).

It is absolutely impossible to replace foreign HIV tests in the near future, says Natalya Egorova, since this industry has not been the subject of attention of Russian manufacturers. “Everything could always be imported and bought, there was no realization that we were dependent on imports. The equipment in the regions is also foreign, it requires maintenance by manufacturing companies and their consumables,” she says. If foreign pharmaceutical companies refuse to supply, a significant number of patients will suffer, including pregnant women who are also being tested for HIV.

The issue of import substitution of diagnostic tools is now more relevant than ever, at present it is possible to replace only about 5% of such systems, says Sergey Shulyak, CEO of DSM Group. “There are not enough reagents and instruments of Russian-made test systems. The second problem is that the instruments supplied are calibrated for reagents from a specific manufacturer. In theory, it is possible to replace the reagents, but the sensitivity of the tests is important, and in this case, the final reliable result may not be guaranteed,” Shulyak warns.

RBC sent inquiries to Abbott, Beckman Coulter, BD Biosciences, but they did not respond at the time of publication of the material.

The pharmaceutical company Roche agreed with the calculations of the treatment readiness coalition, explaining to RBC that in 2021 about 218,000 viral load tests were put on the market. The company representative also confirmed that the test systems are designed for analyzers of a closed type (that is, from the same manufacturer), which ensures the sensitivity of the tests themselves and "confidence in the result." “Roche continues its activities in Russia and makes every effort to ensure the continuous supply of reagents and consumables within the limits of existing possibilities,” the company added.

What the Treatment Preparedness Coalition Experts Recommend

In order to achieve the goals of the Russian HIV 2030 strategy, which assumes 95% detection of HIV infections, coverage of antiretroviral therapy for people with the virus, suppression of viral load below the detection threshold in those receiving therapy, the authors of the study propose the following set of measures:

consider the issue of centralizing the purchase of test systems, which will reduce prices through large purchases; increase funding from the federal and regional budgets against the backdrop of an increase in the number of HIV-infected people and a recurring shortage of diagnostic tools; introduce expanded monitoring of drug resistance to minimize its spread; lower prices for test systems to increase testing coverage; accelerate the development and implementation of Russian-made tests and overcome import dependence.