Development of the medical and pharmaceutical industry (state program)

Industrial production in Russia

Main article: Industrial production in Russia

2023

The Ministry of Industry and Trade presented an action plan for the implementation of the pharmaceutical industry development strategy

In October 2023, the Ministry of Industry and Trade presented an action plan for the implementation of the pharmaceutical industry development strategy. The document includes eight sections that contain a total of 47 events.

Ministry of Industry and Trade presented an action plan for the implementation of the pharmaceutical industry development strategy

• Improvement of the provision of medicines, including regulatory legal regulation - 19 measures, including differentiation of the amount of duties for registration of drugs; updating the list of SZLS; implementation of scientific consulting practices.
• Access to the Russian pharmaceutical market, improving pricing for drugs, establishing the priority of Russian pharmaceutical products - nine measures, including the introduction of the "second superfluous"; introduction of a system of traceability of pharmaceutical substances; improving price regulation.
• Systemic measures to support the organization of the production of medicines in Russia - five measures, including tax regimes to stimulate the transfer of technologies; grant support for drug development and CT.
• Support for the export of Russian pharmaceutical products, including harmonization of regulation with improving world best practices - six measures, including the return of part of the value of exported products; negotiations with other countries on the recognition of documents confirming the quality of production; identification of promising countries.
• The creation of a common research infrastructure and common use systems for this infrastructure - three activities, including the improvement of the system for finding and analyzing R&D results.
• Decomposition of tasks for related branches of the Russian pharmaceutical industry - two measures: formation of lists of chemicals used in synthesis and quality control; creation of an aggregator of information on actual production and needs for substance, equipment, components, etc.
• Training of scientific, technological and production personnel - two activities: provision of continuing education, as well as the creation of programs in dual specialties; setting quotas for admission to targeted training based on the needs of pharmaceutical manufacturers.
• Other measures - monitoring and implementation of measures provided for by the plan, and preparation of changes for the period 2027-2030^[1]

Mishustin approved the strategy for the development of the pharmaceutical industry until 2030

In June 2023, Prime Minister Mikhail Mishustin signed a decree approving the strategy for the development of the pharmaceutical industry in Russia until 2030. According to the Cabinet, the main goals of the document were:

• development and production of new medicinal products;
• increasing the number of enterprises implementing advanced technologies and innovations;
• increasing the competitiveness of Russian manufacturers in the foreign and domestic markets.

Prime Minister Mikhail Mishustin

Solving these problems in combination with the development of domestic production will ensure the drug independence and security of the country and meet the needs of the Russian health care system for the necessary drugs, the government believes.

The strategy will be implemented in accordance with nine main tasks. Among them are support for the organization of the production of drugs and their export, as well as the training of scientific, technological and production personnel for the industry. The strategy also provides for non-financial support measures - the elimination of administrative barriers and the accelerated introduction of new technological solutions.

The strategy also presents scenarios for the development of the pharmaceutical industry and its key indicators until 2030. According to the baseline scenario, the share of Russian-made drugs in total consumption will grow from 61.8 to 66.6%. The volume of drug exports should grow from $1.28 billion to $3.4 billion by 2030.

Another key indicator is the share of Russian drugs included in the list of strategically important medicines, the production of which is carried out in a full cycle. By mid-2023, it is 67.44%. By 2030, this value should grow to 80%.

The Ministry of Industry and Trade was instructed to submit an action plan for the implementation of the strategy within six months, the press service of the Cabinet of Ministers reported on June 19, 2023.

Government of the Russian Federation Order of June 7, 2023 No. 1495-r

The government abandoned a separate state program for the development of the pharmaceutical industry

In June 2023, Prime Minister Mikhail Mishustin signed a decree combining the state programs "Development of the pharmaceutical and medical industry" and "Development of industry and increasing its competitiveness." Thus, the Government of the Russian Federation decided to abandon a separate state program for the development of the pharmaceutical industry.

It follows from the document that the Ministry of Industry and Trade has developed a draft resolution on the resolution of the Prime Minister of February 16, 2023 No. MM-P12-2204 "on consent to the consolidation of measures" of the state program for the development of the pharmaceutical industry and the larger state program "Development of industry and increasing its competitiveness."

The government abandoned a separate state program for the development of the pharmaceutical industry

Such consolidation will allow you to flexibly respond to the needs for additional support mechanisms for the pharmaceutical and medical industries, quickly determine their resource support and ensure implementation, the department said.

As the chairman of the board of the Union of Pharmaceutical and Biomedical Clusters of Russia Zakhar Golant notes, this may mean that in the future the state program for the development of the pharmaceutical industry will become part of a larger state program for the development of the chemical industry as a whole.

And this would be a correct solution - the tasks that must be solved by pharmaceutical companies cannot be considered outside the context of the formation of medium and low-tonnage chemistry in the Russian Federation, the production of appropriate equipment, the creation of educational programs for personnel, he says.

At the same time, he emphasizes, the goals for the development of the industry themselves, as well as measures to support it, are unlikely to fundamentally change, since the Ministry of Industry and Trade plans to fix them in another regulatory document, the development strategy of the pharmaceutical industry of the Russian Federation for the period until 2030 - "Pharma-2030."

Government Decree No. 945 of June 8, 2023

The Ministry of Industry and Trade presented the strategy of development of the pharmaceutical industry. It should grow to 3.7 trillion rubles

The Ministry of Industry and Trade presented for discussion with the expert community a strategy for the development of the pharmaceutical industry of the Russian Federation for the period up to 2030. This became known in early April 2023.

As Kommersant writes with reference to this document, the department believes that thanks to the implementation of the Pharma-2020 program from 2009 to 2022, the volume of drug production in the country increased (nominally, in rubles) by 533.3% - from 96 billion rubles to 607.9 billion rubles. The share of drugs produced in the Russian Federation increased from 24% in 2009 to 36% in 2022 (also in monetary terms). According to the Association of International Pharmaceutical Manufacturers, referred to by the Ministry of Industry and Trade, the total volume of direct investments of foreign companies in the Russian industry during this time amounted to more than 80 billion rubles - since 2010, more than 100 foreign manufacturers have localized more than 400 international generic names of drugs in the country.

The share of drugs produced in the Russian Federation increased from 24% in 2009 to 36% in 2022

So, until 2030, the volume of the drug market in the Russian Federation should grow from 2.2 trillion rubles to 3.7 trillion rubles, the share of Russian drugs - from 35.9% to 42.6% (in monetary terms), the volume of exports - from $1.26 billion to $3.4 billion, and the share of drugs that are produced within the full cycle and are included in the list of strategically important - from 67% to 80%.

For the further development of the industry, according to the Ministry of Industry and Trade, measures are needed to improve the circulation of drugs, including its state regulation, access to the pharmaceutical market, pricing and ensuring the sale of products, as well as systemic measures to support the organization of production and export.

According to Aleksey Kedrin, Chairman of the Board of the Association of Pharmaceutical Manufacturers of the Eurasian Economic Union (AFPEAES), the current version of the document "could have been more ambitious in terms of goals," but generally meets the needs of the industry. "It can be taken, and additional measures from among the necessary to fix in the roadmap," he said in a conversation with the newspaper.^[2]

2021

The Ministry of Health listed the priorities of the state program "Health Development" for 2022

In August 2021, the Ministry of Health of the Russian Federation presented strategic priorities for the development of medicine in the country. The corresponding draft government decree "On the approval of the state program of the Russian Federation" Development of Healthcare "has been published on the federal portal of draft regulatory legal acts.

The Ministry of Health attributed to the main priorities of the state program for 2022 the maintenance of the readiness of the health care system to provide medical care to patients with infectious diseases, the development of immunobiological drugs and the provision of immunoprophylaxis, the modernization of the infectious diseases service and the restoration of the planned work of medical institutions.

The Ministry of Health presented the priorities of the state program "Health Development" for 2022

It is planned to achieve the goals of state policy in the field of supporting demography and human development by solving the following tasks:

• increasing life expectancy, reducing the mortality rate of disability of the population, preventing occupational diseases;
• improving the quality and availability of medical care, including vaccination, and drug supply;
• ensuring the sustainability of the health care system, its adaptation to new challenges and threats, including those related to the spread of infectious diseases, the creation of reserves of medicines and medical devices;
• increasing the motivation of citizens to lead a healthy lifestyle, engage in physical education and sports;
• development of biological risk monitoring system for threat prevention and response;
• ensuring the sanitary and epidemiological well-being of citizens, the development of social and hygienic monitoring.

Earlier it was reported that the costs of implementing the state program "Health Development" in 2021-2023 will amount to about 2.5 trillion rubles.^[3]"

Tatyana Golikova - curator of programs for the development of health care and the medical industry

Russian Prime Minister Mikhail Mishustin approved the list of curators of state programs at the level of deputy prime ministers. The list was published on the website of the Government of the Russian Federation on July 8, 2021.

The programs "Healthcare Development," "Development of the Pharmaceutical and Medical Industry" and "Ensuring Chemical and Biological Safety of the Russian Federation" will be supervised by Deputy Prime Minister Tatyana Golikova. In total, nine state programs were transferred under her supervision.

Mishustin approved the curator of programs for the development of health care and the medical industry - Tatyana Golikova

The government expects that the introduction of the institute of supervision will make the management of state programs more flexible. In addition, management councils will start working under the guidance of curators. They will have to promptly make changes to the passports of state programs, thereby keeping them up to date.

It is assumed that supervision will be one of the stages of the transition to a new system of government program management, which provides for the formation of a list of socially significant indicators, simplification of the procedure for adjusting programs and approval of their unified structure. In addition, the project part with the fulfillment of specific tasks for a limited period of time will become mandatory in them.

During a direct line at the end of June 2021, Russian President Vladimir Putin reported that it was also planned to consolidate the supervision of specific territories of the country for the deputy prime ministers.

The budget of the state program "Development of the pharmaceutical and medical industry" (2013-2024), according to the passport, is 147 billion rubles. 32 trillion rubles are allocated for the program "Development of Healthcare" (2018-2024). Information on the financing and indicators of the program "Ensuring chemical and biological safety of the Russian Federation" (2019-2025) refers to limited access information.^[4]

The Accounts Chamber recognized the state program for the development of the medical industry as the worst

The Accounts Chamber (JV) recognized the state program for the development of the medical industry as the worst in the first quarter of 2021. During this period, the implementation of expenses under the state program "Development of the medical and pharmaceutical industry" amounted to only 1.2%. The joint venture reported this in June 2021 as part of an operational report on the execution of the federal budget.

As of January 1, 2021, the responsible executor of the state program "Development of the pharmaceutical and medical industry" Ministry of Industry and Trade fulfilled the costs by 83.5%.

The Accounts Chamber of the Russian Federation recognized the state program for the development of the copper industry as the worst in the first quarter of 2021

In addition, the auditors noted inconsistencies in the state program "Development" and the Health health care Development Strategy until 2025. In their opinion, the state program lacks the goals, objectives and indicators contained in the strategic document.

According to the joint venture, the federal budget expenditures on health care for the first quarter of 2021 were fulfilled only by 19.4% against 33.8% a year earlier. To combat the COVID-19coronavirus pandemic, the Ministry of Health of the Russian Federation allocated 39.4 billion rubles, including 29 billion rubles for additional financial support of medical institutions within the framework of territorial programs. 4.6 billion rubles were received by the Moscow Campus Management Fund, 2.7 billion were allocated to subjects for the purchase of drugs for the treatment of patients at home.

Earlier, the deputy head of the Accounts Chamber of the Russian Federation Galina Izotova said that the coronavirus pandemic should motivate the authorities to form a new model of health care and basic social and economic institutions. According to her, according to the results of its inspections, the joint venture has repeatedly focused on the need to increase funding and improve the quality of professional training of medical personnel - about 41% of patients do not trust the doctor's diagnosis.

In addition, the Accounts Chamber reported that the department is preparing an expert and analytical event to develop recommendations for the modernization of the health care system.^[5]

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