No 3 (2019)

Full Issue

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Articles
Sudebnoe reshenie v patentnom spore v pol'zu proizvoditelya original'nogo preparata
Article E.
Abstract
Российский суд по интеллектуальным правам вынес решение в пользу компании «АстраЗенека» по делу о защите исключительных прав на противоопухолевый препарат гефитиниб. Решение обязывает фармпроизводителя ООО «Джодас Экспоим» (дочерняя компания индийской Jodas Expoim), ранее зарегистрировавшего в России собственный дженерик гефитиниба, отозвать как регистрационное удостоверение, так и зарегистрированную цену на свой продукт. Тем же решением производителю дженерика запрещается подавать документы для повторной его регистрации до истечения срока действия патента на оригинальный гефитиниб. По словам гендиректора «АстраЗенека Россия и Евразия» Ирины Панариной, в 2017-2019 гг. в России велось более 40 споров вокруг регистрации дженериков инновационных ЛС, находящихся под патентной защитой в России. Решение по гефитинибу стало прецедентным судебным решением по делу такого рода. Гефитиниб «Джодас Экспоим» был зарегистрирован в России в июле 2015 г., в апреле 2018-го компания зарегистрировала в РФ предельную цену на свой препарат.
REMEDIUM. 2019;(3):4-7
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Russian pharmacovigilance in a newly regulated environment: two-year results and prospects
Glagolev S.V., Gorelov K.V., Chizhova D.A.
Abstract
The article presents a review of recent changes in the pharmacovigilance legislation, an analysis of drug safety monitoring activities of the Federal Service for Healthcare Supervision, a review of the current activities on improving pharmacovigilance, and outlines its development prospects.
REMEDIUM. 2019;(3):8-14
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Rasseyannyy skleroz - «diagnoz isklyucheniya». Interv'yu s Alekseem Boyko
Article E.
Abstract
Рассеянный склероз (РС) - хроническое демиелинизирующее аутоиммунное заболевание, которое поражает людей молодого трудоспособного возраста и без адекватного лечения быстро приводит их к тяжелой инвалидизации. О распространенности, подходах к диагностике и современных методах терапии РС, позволяющих больным существенно улучшить качество жизни, мы решили поговорить с Алексеем БОЙКО, д.м.н., профессором кафедры неврологии, нейрохирургии и медицинской генетики РНИМУ им. Н.И. Пирогова, врачом высшей категории.
REMEDIUM. 2019;(3):16-19
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Supplies of medicinal products manufactured in the EAEU countries to Russia
Yutkina I.
Abstract
EAEU countries to Russia shows a rather positive picture over the past three years. The rouble volume of products imported into our country shows double-digit growth rates, while the growth rates of monetary volumes noticeably outpace physical indicators. Changes in the range of products supplied substantially contributed to this growth. On the one hand, the products range is replenished with products of the upper price segment; on the other hand, supplies of individual low-cost MPs are reduced.
REMEDIUM. 2019;(3):20-25
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Chelovek legche perenosit golod, chem poteryu sna. Interv'yu s Ol'goy Vorob'evoy
Article E.
Abstract
Среди факторов, значительно снижающих качество жизни, особое место занимает бессонница, которая негативно сказывается как на физическом, так и на психологическом состоянии человека. О том, насколько эта проблема актуальна среди россиян, почему возникают нарушения сна и какие пути решения этой проблемы наиболее оптимальны, мы решили узнать у Ольги ВОРОБЬЕВОЙ, профессора кафедры нервных болезней Института профессионального образования ФГАОУ ВО «Первый МГМУ им. И. М. Сеченова» Минздрава России, д.м.н.
REMEDIUM. 2019;(3):26-29
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How to get back healthy sleep
Prozherina J.
Abstract
In recent years, the number of people suffering from sleep disorders has been steadily increasing in many countries around the world. This problem not only causes great discomfort and has a devastating impact on human health, but also has a negative impact on the socio-economic aspect of people's lives [1]. In this regard, the phar-macotherapy of sleep disorders is one of the topical issues of modern medicine.
REMEDIUM. 2019;(3):30-32
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Review of PIC/S guidance on classification of GMP deficiencies
Orlov V.A.
Abstract
The article provides an overview of the PIC/S (PI 040-1) guidance published in January 2019, which contains recommendations on classification of identified GMP deficiencies. It provides detailed diagrams containing instructions on the recommended operating procedures in case of identification of GMP deficiencies, and decision versions of final classification of such deficiencies. In addition, the authors provide regulators with valuable recommendations on the management of possible activities in response to critical and significant GMP deficiencies.
REMEDIUM. 2019;(3):34-39
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Properties of the two one-sided tests procedure for the bioequivalence assessment of medicinal products
Dranitsyna M.A., Zakharova T.V., Niyazov R.R.
Abstract
In this paper, an overview of the decision-making rules and two one-sided tests procedure when assessing bioequivalence is provided. This includes a discussion of how the type I error is controlled, i.e. the way how the patient risks arising from the inherent uncertainty of statistical inferences are handled. Additionally, certain weaknesses of the current approach for the bioequivalence assessment are discussed.
REMEDIUM. 2019;(3):40-47
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Inflationary processes in the pharmaceutical market: development forecasting
Livansky S.M., Utyomova A.S., Denisova M.N.
Abstract
The article presents a review of the Russian pharmaceutical market development over the past few years from the perspective of the inflationary processes. Key drivers and the degree of their influence on the dynamics of the main market segments are identified. The authors present the drivers that will determine the development of the pharmaceutical market in the future and generate forecasts for the domestic pharmaceutical market development in the midterm based on the scenario approach.
REMEDIUM. 2019;(3):48-52
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Review of Federal medicine assistance schemes
Kovaleva K.A., Narkevich I.A., Nemyatykh .D., Vasyagina Y.A.
Abstract
Today in Russia, a new paradigm in building a healthcare system is being created - a value-oriented approach to treating each patient - with the aim of achieving high quality medical care in conditions of limited funding of healthcare system. An effective system of drug provision of patients forms the basis for the quality of medical services. The article presents a review of the medicine assistance schemes at the federal level. The data have been acquired from marketing agencies, as well as reports from the executive authorities of the Russian Federation for 2014-2017. Against the background of the positive dynamics of GDP in 2017 (+ 1.5% compared 2016), the amount of funding for the «Healthcare» expenditure section decreased by 13%. In recent years, the centralized expensive drug procurement system has been noted to be formed in the field of medicine assistance schemes. In the period from 2014 to 2017, the budget allocation for the provision of essential drugs (ED) saw a 12.5% increase. At the same time, the share of people who receive free drugs is only 21.6%, the rest of the patients prefer a cash payment. The high-priced nosologies program (about 50%) holds the leading place in terms of financial investments. In Russia, the drug supply system is built on the basis of optimization of resources, so it seems promising to find successful models of interaction between the state and the population at different levels in the segment of medicine assistance schemes.
REMEDIUM. 2019;(3):54-58
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Current state and prospects of the russian market for nonwovens and kits: surgical kits, medical ware, linen
Vanin A.
Abstract
The market analysis has been conducted on the basis of the data on state purchases of surgical kits, medical ware, linen, and the export-import transaction database of the official customs statistics. In the article, the notion of non-wovens and kits is used to refer to this type of medical devices, which purchases is most important for the needs of the public health system.
REMEDIUM. 2019;(3):60-63
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Monthly review: production, investment, finance
Romanova S.
Abstract
Performance analysis of industry enterprises is conducted using the national statistics reports: Form No. P-1, term (monthly), Form No. P-2 Information on Investments in Non-Financial Assets (quarterly), Form No. P-3 Information on Company Financial Status (monthly).
REMEDIUM. 2019;(3):64-69
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Monthly review: business activity of industry enterprises
Romanova S.
Abstract
The rating was carried out using the national accounting statements of top 150 industry enterprises.
REMEDIUM. 2019;(3):70-77
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Quarterly judicial review pertaining to the production and circulation of medical products for November 2018 - February 2019
Borzova M.
Abstract
The monthly review provides an analysis of court practice pertaining to the production and circulation of medical products to help industry specialists avoid mistakes in solving similar problems.
REMEDIUM. 2019;(3):78-81
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Na styke biologii i farmakologii
Shirokova I.
Abstract
В середине февраля в Москве состоялась шестая по счету ежегодная конференция ОСТ «Клинические исследования. Панельные дискуссии» при поддержке Минздрава и Минпромторга РФ. Мероприятие включало несколько панельных дискуссий, одна из которых была посвящена перспективам развития клеточных технологий в России.
REMEDIUM. 2019;(3):84-86
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Telemeditsinskie resheniya - okno vozmozhnostey
Shirokova I.
Abstract
В начале прошлого года в России вступил в силу закон о телемедицине, предусматривающий оказание медицинской помощи дистанционно и открывающий новые возможности в сфере здравоохранения. Произошедшие за это время изменения и наметившиеся тренды обсудили эксперты, собравшиеся в марте на конференции «Телемедицина-2019. Вызовы и перспективы», организованной издательским домом «Коммерсантъ».
REMEDIUM. 2019;(3):87-88
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TOP-pozitsii. Pokazateli vedushchikh mirovykh i otechestvennykh proizvoditeley i distrib'yuterov
Article E.
Abstract
Производство медицинской продукции Импорт ГЛС в Россию по итогам октября 2018 года Экспорт ГЛС из России по итогам октября 2018 года Фармацевтическая реклама ЛП и БАД в российских СМИ в январе 2018 года
REMEDIUM. 2019;(3):90-95
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