Federal Medical and Biological Agency of Russia (FMBA of Russia)

The Federal Biomedical Agency of Russia (FMBA of Russia) is a federal executive body under the jurisdiction of the Ministry of Health. It carries out the functions of control and supervision in the field of sanitary and epidemiological well-being of employees of organizations of certain industries with especially dangerous working conditions and the population of certain territories, law enforcement functions and functions for the provision of public services and state property management in the field of health care for employees of organizations of certain industries with especially dangerous working conditions and the population of certain territories.

In the early 1990s, it was called the Federal Office of Biomedical and Extreme Problems (FUMBEP).

History

2024

The leadership of the FMBA was transferred to the President of the Russian Federation instead of the government

On June 17, 2024, the president Russia Vladimir Putin signed a decree according to which the Federal Biomedical Agency (FMBA) will be subordinate to the head, not states the government. As of the specified date, this structure is headed. Veronika Skvortsova

To establish that the management of the activities of the Federal Medical and Biological Agency is carried out by the President of the Russian Federation. The words "Federal Medical and Biological Agency" are excluded from section III "Federal Services and Federal Agencies, the activities of which are managed by the Government of the Russian Federation," the document says.

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kremlin.ru

Until the beginning of 2020, the FMBA was under the jurisdiction of the Ministry of Health. In January of that year, Putin approved his reassignment to the government. In accordance with the new decree, the FMBA is excluded from the list of federal services and agencies whose activities are led by the government. At the same time, the Cabinet of Ministers is instructed to submit proposals for bringing their acts and acts of the president in line with this decree.

Deputy Prime Minister Dmitry Chernyshenko notes that the priority areas of the FMBA are science and innovation - they account for about 70% of the organization's activities. For example, in 2023, unique methods for determining harmful chemicals were proposed and new families of vaccines were developed, including against influenza and allergies. In the field of digitalization, the agency has introduced neurotechnologies to accelerate the recovery of athletes from Russian national teams after the competition. Under the auspices of FMBA, a single departmental medical information and analytical system has been created, which unites all subordinate organizations into a common digital circuit.^[1]

The Research Institute of Pulmonology of the FMBA of Russia opened in Moscow

In mid-February 2024, the official opening of the Research Institute of Pulmonology of the FMBA of Russia in Moscow took place. It is expected to become the main Russian scientific and methodological center in the field of respiratory pathology, rehabilitation of patients who have undergone coronavirus (COVID-19) infection, as well as the leading institution in Russia for the treatment of chronic nonspecific and orphan lung diseases, including cystic fibrosis. Read more here.

2023: Cooperation agreement with Rusatom Healthcare to develop radiopharmaceuticals

On January 19, 2023, Rusatom Healthcare JSC (a division that accumulates the expertise of Rosatom State Corporation in the field of health care) and the Federal Biomedical Agency of Russia (FMBA) signed an agreement on cooperation and interaction.

The document recorded several important areas, in particular, Rosatom and FMBA plan to jointly develop technologies for creating innovative radiopharmaceutical drugs, as well as unite efforts to ensure quality control of isotope production based on the Rosatom plant according to GMP standards. To this end, joint research and development will be conducted to assess the efficacy, safety and quality of innovative radiopharmaceutical drugs.

The agreement also provides for the conduct of regulated preclinical and clinical studies of innovative radiopharmaceutical drugs. The research and clinical centers of the FMBA of Russia will be used as a base for such research.

However, radioisotopes are raw materials, a kind of "oil for medicine." We want to go up to the floor above and start producing products ready for use in medical institutions, "said Alexey Likhachev, General Director of Rosatom State Corporation.

2022

The Accounts Chamber pointed to billions of dollars in budget violations in the healthcare sector

Billions of violations were identified in financial management in the Ministry of Health of Russia, Roszdravnadzor, Rospotrebnadzor and the Federal Medical and Biological Agency (FMBA). This is evidenced by the audit of the Accounts Chamber, the results of which were published on July 4, 2023. Read more here.

Assignment of bone marrow donors by the operator of the federal register

The Federal Biomedical Agency () FMBA was appointed Government of the Russian Federation by the federal operator, bone donor register brain which became known in February 2022. The agency has developed rules for maintaining this all-Russian database with protected information about citizens who are ready to become potential donors and passed tests to determine compatibility. More. here

2021

Spending half of the funds allocated for the creation of medical centers due to expensive building materials

The FMBA spent only half of the funds allocated for the creation of medical centers in 2021. Expensive building materials are to blame. This conclusion was reached in the Accounts Chamber (JV) following its audit. Its results were released on June 13, 2022.

According to the materials of the joint venture, out of 4.4 billion rubles provided for in 2021 for capital investments, the agency spent less than half (2.1 billion rubles). Separately, 626 million rubles were not spent under the Federal Targeted Investment Program (out of 1.5 billion rubles provided).

FMBA spent only half of the funds allocated for the creation of medical centers due to expensive building materials

Due to the rise in prices for building materials, a particularly low percentage of funds (16.7%) was recorded during the construction of the second stage of the medical and sanitary part of the Vostochny cosmodrome (171.4 million out of 855.5 million rubles). In addition, the implementation of this project with a total cost of 6 billion rubles, as indicated in the conclusion of the joint venture, is lagging behind due to the epidemiological situation and "the complexity of organizing the access of contractor employees to the territory of the ZATO."

The joint venture reported that the new building of the Research Institute of Pulmonology in Moscow could not be completed on time due to problems with mutual settlements with contractors. FMBA receivables in 2021 increased 1.09 times to 9.1 billion rubles, payables - 5.6 times to 98.2 million rubles. All debts are of a current nature. The reason for the significant increase in accounts payable was the debt on payment of contracts for the procurement of donated blood and its components.

Among the violations, the Accounts Chamber noted non-compliance with the terms of payment under state contracts, failure to declare claims for the payment of penalties under certain contracts, as well as the transfer of another interbudgetary transfer in the absence of relevant applications from the regions.^[2]

Opening of the Technology and Microfabrication Center

On September 29, 2021, the official opening of the first technology and microfabrication in the Russian Center took place. It was created on the basis of the Federal Scientific and Clinical Center for Physicochemical Medicine of the Federal Medical and Biological Agency (FMBA). Read more here.

FMBA has created a center for strategic initiatives, which will deal with medical tech projects

In July 2021, the Federal Biomedical Agency (FMBA of Russia) announced the creation of a center for strategic initiatives, which, among other things, will be engaged in the implementation of medical tech projects. Read more here.

2020

FMBA will receive 3.7 billion rubles to modernize its primary medical institutions

In early October 2020, the Federal Biomedical Agency (FMBA) presented a rule for the distribution of subsidies to subordinate medical institutions under the regional program for the modernization of primary care under the national project "Healthcare." According to the document posted on the federal portal of draft regulatory legal acts, the department should receive subsidies in the amount of 3.7 billion rubles from 2021 to 2023. It is assumed that annually during this period the department will receive 1.242 billion rubles from the federal budget.

FMBA will receive 3.7 billion rubles from 2021 to 2023. to modernize its primary care medical institutions

These funds are planned to be spent on the overhaul of medical institutions, the re-equipment of clinics in accordance with the standards provided for by the provisions on the organization of medical care approved by the Ministry of Health of the Russian Federation, the purchase of cars for transporting patients, the delivery of biological materials of laboratory research and medicines for residents of remote areas.

To receive a subsidy, regional medical organizations will need to conclude an agreement with the FMBA. The assessment of the effectiveness of the development of subsidies will be carried out on the basis of the number of medical institutions in which the overhaul was completed, the volume of purchased equipment and medical transport.

At the same time, the FMBA established additional restrictions: in particular, the use of subsidies for the overhaul of medical institutions is possible only if the wear of buildings is from 40 to 80%, and equipping with medical equipment - only if there are medical workers qualified to work on purchased medical devices.

FMBA itself will monitor compliance with the conditions for the provision of subsidies by comparison the plan values established by the agreement and the actual values of the following results of the use of the subsidy.^[3]

Withdrawal from the subordination of the Ministry of Health of the Russian federation

In January 2020, the president Russia Vladimir Putin signed a decree "On the structure of federal executive bodies," which removed Roszdravnadzor Federal Medical and Biological Agency (FMBA) from subordination. Ministry of Health of the Russian Federation More. here

2016: Skin Bank Plan

At the end of November 2016, it became known about the creation in Russia of a bank of human skin, which the immune system of patients will perceive as their own. Izvestia writes about this.

The division of the Federal Medical and Biological Agency - FNCC of Physical and Chemical Medicine (FNCC FCM) - has developed a technology for growing artificial skin with reduced immunogenicity necessary for the treatment of burn patients. Read more here.

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