News Digest 28.02.2024 — 01.03.2024
Regulators
Putin: regions need to be given more powers to use infrastructure budget loans if they are aimed at achieving the goals of national projects
As an example, President Vladimir Putin cited the renovation of a clinic - if after the work the region has funds left, then they will not need to be returned to the federal budget, but can be used to purchase equipment.
Source: https://t.me/vademecum_live/13290
The Ministry of Health named typical mistakes of clinics during public procurement
The main complaint of auditors regarding the technical execution of the expenditure of subsidies from various budget sources was either the lack of reports on the achievement of indicators of the efficiency of spending funds, or their provision with a delay of up to 50 days. In addition, frequent accounting violations were discovered, the most common ones being presented by the Ministry of Health in six points.
The list of shortcomings in public procurement under No. 44-FZ turned out to be more extensive. Most of the points, however, are typical for this area. Late payment for work, changes in contract terms without legal grounds, and conclusion of additional agreements without bank guarantees from the contractor were revealed. Often, the Ministry of Health notes, work was accepted uncompleted, and contractors were not given sanctions for late work.
The auditors noted that medical institutions accepted and paid for the supply of equipment that was not used for its intended purpose and was stored in packaging, which could be classified as an ineffective use of budget funds. Sometimes no examination of already supplied goods and services was carried out.
Other departments – Roszdravnadzor (RZN) and the Federal Compulsory Medical Insurance Fund – also compile their reviews of violations. For example, RZN, having analyzed the situation in 2023, drew up a rough plan for inspections of clinics for 2024, separately notifying that it would pay special attention to such areas as periodic medical examinations, medical and social examinations, radionuclide diagnostics of patients with cardiovascular diseases, oncological, palliative , psychiatric medical care.
The Federal Compulsory Medical Insurance Fund, for example, at the end of 2022, discovered shortcomings in the issuance and processing of invoices for medical care, in the work of regional commissions for the development of the compulsory health insurance program, and a number of violations related to the work with the Compulsory Health Insurance GIS and document flow.
Source: https://vademec.ru/news/2024/02/29/minzdrav-nazval-tipovye-oshibki-klinik-pri-goszakupkakh/
Market news
"Diacon-DS" will invest 600 million rubles in expanding the production of medical equipment
"Diacon-DS" is engaged in the production of products for in vitro diagnostics. The launch of the new production will allow us to partially replace imported products on the market used for diagnosing diabetes mellitus, cancer and diseases of the cardiovascular system.
They intend to produce products in a class 7 clean room in accordance with the requirements of ISO 13485. The company plans, along with expanding the production workshop, to increase the laboratory and research area.
To implement the project, the company took advantage of the terms of the regional program “Land for 1 ruble”, according to which for the construction of a high-tech industrial complex with an area of 3.7 thousand square meters. m allocated 4 hectares. The enterprise will create about 20 jobs.
“The current geopolitical situation and logistical difficulties with the supply of imported medical equipment have created an urgent need for rapid and high-quality replacement with domestically produced products. At the new enterprise, we plan to launch the production of semi-automatic and automatic analyzers that are used in medical laboratories,” explained the company’s general director Tatyana Korzun.
The company announced plans to increase reagent production capacity back in November 2021. At that time, investments were estimated at 350 million rubles. At that time, the Ministry of Housing Policy of the Moscow Region had already issued a construction permit.
The Diakon-DS company has been producing equipment and components for medical research for more than 25 years. At the company's existing production sites in the Moscow region, 130 reagents are produced to determine more than 50 indicators, of which 74 are kits for biochemical studies, six for immunoturbidimetric tests, eight for diagnostics of the hemostasis system, and the rest are hematological solutions.
About 20% of all biochemical research in Russia is carried out using Diakon-DS reagents. In 2023, the production of hematological reagents was launched on the basis of the production complex; the production capacity of the enterprise is up to 700 tons per year.
According to SPARK-Interfax, JSC Diakon-DS was registered in 1998 in Pushchino, Moscow region. In 2022, the company gained 813.5 million rubles, net profit amounted to 235 million rubles.
The former head of the oncology clinic in Vologda was sentenced to 3 years in prison
The Vologda City Court issued a verdict against the former head physician of the Vologda Regional Oncology Clinic, Sergei Anosenko. He was found guilty of receiving a bribe in the amount of 1 million rubles for assisting several companies in concluding government contracts for the supply of medical equipment.
Anosenko was sentenced to 3 years in a maximum security correctional colony and a fine of 4 million rubles. He was also banned from holding positions in the civil service and local government for seven years.
The general director of Medservice-Region was given a 3-year suspended sentence
On February 29, the Central District Court of Chelyabinsk found the general director of the Medservice-Region company, Elena Selishcheva, guilty of fraud in the supply of computed tomographs to the Ministry of Health of the Chelyabinsk Region at inflated prices (the damage was estimated at 82 million rubles) and sentenced her to three years of suspended imprisonment with probation for a period of 3 years. In addition, Selishcheva was banned from engaging in procurement activities for two years.
Source: https://vademec.ru/news/2024/02/29/gendirektoru-medservis-region-naznachili-tri-goda-uslovno/
The Moscow Department of Health defended offset for medical furniture worth 5.1 billion rubles
The Ninth Arbitration Court of Appeal declared the decision and order of the Federal Antimonopoly Service illegal: it had previously decided to cancel the offset results for medical furniture for 5.1 billion rubles.
FAS found signs of competition violations in the conditions of the tender of the Moscow Health Department. The auction was held in August 2023. The commission rejected the applications of competitors, with the exception of the Labromed company of Mikhail Shilenkov.
Two more applicants (Medstalkonstruktsiya LLC and Reabilitik LLC) appealed the actions of the DZM to the FAS, as a result of which the signing of the contract with the winner was blocked during the proceedings and then the litigation. Now nothing interferes with Labromed’s work under the contract.
Source: https://t.me/delotom/380
Investments in the construction of a medical center in Perm are planned to increase to 320 million rubles
The investor of the treatment and diagnostic center in Perm, EXO Property LLC, proposed at a meeting of the city council for entrepreneurship and improving the investment climate to increase investments in the construction of the facility from the previously announced 80 million rubles to 320 million rubles, excluding costs for finishing and medical equipment. It is also planned to increase the area of the clinic from 1.5 thousand to 4 thousand square meters. m. The number of floors of the building will increase from two to five.
Приморское УФАС оштрафовало участников карты по поставке лекарств и МИ
Управление Федеральной антимонопольной службы (УФАС) России по Приморскому краю оштрафовало пять местных компаний на 650 тысяч рублей за организацию карты при поставке лекарств, медицинских оборов удования и расходников для нужд Владивостокской клинической больницы №4.
The FDA, after authorizing human testing of Neuralink brain implants, revealed violations at the company's California center
The results of a June 2023 inspection by the US Food and Drug Administration (FDA) of Elon Musk's company have now been published by Reuters, citing an organization involved in data analysis.
Among the violations found by the FDA: lack of records of calibration of instruments used in experiments involving animals, lack of signatures of quality assurance staff on research reports. Also, workers did not document deviations in the progress of such experiments from approved protocols and standards.
However, a similar check in the Texas office of Neuralink did not reveal any problems. As Reuters points out, last year's inspections are the only recorded case of an FDA inspection of an American company's facilities. A month before them, in May 2023, the FDA approved CI of the Neuralink brain implant.
Previously, in December 2022, following complaints from company employees about animal rights violations, the United States Department of Agriculture (USDA) conducted an investigation. The department reported that no violations were identified.
Other
The FDA, after authorizing human testing of Neuralink brain implants, revealed violations at the company's California center
The results of a June 2023 inspection by the US Food and Drug Administration (FDA) of Elon Musk's company have now been published by Reuters, citing an organization involved in data analysis.
Among the violations found by the FDA: lack of records of calibration of instruments used in experiments involving animals, lack of signatures of quality assurance staff on research reports. Also, workers did not document deviations in the progress of such experiments from approved protocols and standards.
However, a similar check in the Texas office of Neuralink did not reveal any problems. As Reuters points out, last year's inspections are the only recorded case of an FDA inspection of an American company's facilities. A month before them, in May 2023, the FDA approved CI of the Neuralink brain implant.
Previously, in December 2022, following complaints from company employees about animal rights violations, the United States Department of Agriculture (USDA) conducted an investigation. The department reported that no violations were identified.
New registered medical devices
We publish a list of new medical devices registered from 02/22/2024 to 03/01/2024
Link to the list: [see. table in attachment]
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