REMEDIUM

The article presents the results of a comparison of the Orphan Drugs Register approved for use in the United States and the 2020 Vital andEssential Drugs List approved on October 12, 2019 by Order of the Government of the Russian Federation No. 2406-r. The comparison identified305 international non-proprietary names relating to the main and/or auxiliary therapy for rare diseases. The analysis of the market of drugs included in the Vital and Essential Drugs List, which can be used to treat rare (orphan) diseases in Russia was conducted.The analysis results allowed to draw the following conclusions:• the nomenclature of drugs used to treat rare diseases is much wider than the list of drugs purchased as part of personalized purchases at the federal and regional levels, which determines the task to formalize the therapy regimens and obligations in relation to patients with rare diseases under the state guarantee program;• comparison of the existing drug registers in the world practice and rare diseases themselves should form indicators for government programs to determining the need for financing the drug therapy, which will directly affect the marketing authorisation of new drugs, as well as the use of alternative mechanisms, in particular compulsory licensing;• the high cost of original drugs to treat rare diseases affords additional grounds for the introduction of procedures and mechanisms to assess healthcare technologies at the marketing authorization stage or in case of implementation of mechanisms to localize production and technology transfer in order to reduce the costs of this therapy;• the Strategy for the Pharmaceutical Provision of the Population of the Russian Federation for the Period until 2025 requires the development and formation of the National Formulary, which should include matching rare (orphan) diseases with a specific type of drug therapy. This will allow the regulatory bodies to optimize the load on budgets of all levels and exercise the personalized control over provision of drugs to the patients;• import dependence and extremely high cost of the original therapy in this sector leads to a decrease in the target indicators of national programs. This problem can be partially solved through technology transfer and production localization within the framework of the relevant industry programs to support the pharmaceutical industry.The implementation of these measures will increase the number of original and reproduced orphan drugs from the nomenclature of the Rare (Orphan) Diseases List published by the Ministry of Health that passed market authorization and circulate on the domestic market, and will improve the supply of drugs to patients, who need them.

Today, the epidemiological situation and the socio-economic crisis are bringing their own adjustments to our plans. Due to the introduction of a high alert regime related to the coronavirus pandemic, the authorities have introduced the temporary new rules for public procurement. The spread of COVID-19 was recognized as a circumstance of insuperable force (force majeure), inspections were cancelled, and the complaints were handled in the remote mode. In this regard, one more Government Decree No. 647 of May 08, 2020 entered into force on May 10, which defined new cases and the procedure for purchasing from a single supplier until the end of 2020. The Cabinet of Ministers adjusted the rules for calculating the time limits for purchases on non-working days under the same document. However, due to the coronavirus, single supplier tenders were not allowed for all goods, but only for those used to prevent or eliminate the consequences of the spread of coronavirus infection.

Заболевания суставов занимают одно из ведущих мест в структуре забо- леваемости населения России. О важности проблемы остеоартрита и современных подходах к его лечению мы попросили рассказать Людмилу АЛЕКСЕЕВУ, заведующую отделом метаболических заболеваний суставов с центром профилактики остеопороза ФГБНУ НИИР им. В.А. Насоновой, д.м.н., профессора.

Biliary diseases are the most important medical and social problem associated with a high prevalence among working age population and a significant decrease in patients’ quality of life.Modern therapy methods, including the latest advances in medical science, have sustained significant progress in the treatment of biliary pathology. The design and introduction into clinical practice of the original drug Phosphogliv URSO has become an important step in making progress in this direction.

Chronic lymphocytic leukemia (CLL) is the most common type of leukemia in adults. Its prevalence is expected to increase alongside rising overall survival rates in patients with CLL achieved due to advances in therapy [1]. B-cell receptor signalling through Bruton’s tyrosine kinase (BTK) is one of the main pathways for the development of CLL. Acalabrutinib, the second-generation VTK inhibitor, has been made available recently to Russian patients, which presence in the market can improve the prognosis for such patients.

The new guidelines of the Global Initiative for Asthma (GINA) has inspired a heated discussion among experts. The next version was published in 2018, but its revision appeared as early as in 2019. This is primarily due to the revision of the attitude towards short-acting beta-2-agonists, however, the approaches have changed significantly at other stages of bronchial asthma treatment as well, especially at the early stages. The emphasis has been placed on low-dose inhaled corticosteroids, as they have accumulated an evidence base at an adequate quality level. In fact, the 2019 GINA proposals are reduced to discontinuation of the common clinical practice and switching to fundamentally different approaches to the management of bronchial asthma, especially its mild form.

Currently, the increase in the efficiency of pharmacy organizations is due to the efficiency of team management. Each pharmacy organization strives to strengthen the workforce and monitors staff turnover rates, because this can affect the economic results of the organization. The most effective tool for preventing the layoff of staff turnover. This article presents the results of a sociological study of the factors that lead pharmaceutical workers to change jobs. The objects of the study were pharmaceutical workers of pharmaceutical organizations of various organizational and legal forms in Moscow. The methodological basis of the research was formed by general theoretical methods of information

The investment activities of pharmaceutical enterprises were analysed using the data from the state statistical reporting form No. P-2 “Information on investments to non-financial assets” (quarterly).

По данным Росстата, индекс физического объема за первое полугодие 2020 г. по крупным, средним и малым организациям по отношению к соответствующему периоду предыдущего года по кодам ОКВЭД2 составил: 21.1 «Производство фармацевтических субстанций» - 161,2%. 21.2 «Производство лекарственных препаратов и материалов, применяемых в медицинских целях» - 115,8%. 32.5 «Производство медицинских инструментов и оборудования» - 122,0%. 26.6 «Производство облучающего и электротерапевтического оборудования, применяемого в медицинских целях» - 173,3%.