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Pashkov, V. M..
    The impact of the legal regime of intellectual property protection in the pharmaceutical market [Текст] / V. M. Pashkov, І. A. Golovanova, A. Olefir // Wiadomości Lekarskie. - 2016. - Vol. LXIX = Тom LXIX, nr 3, cz. II. - S. 582 - 586
   Перевод заглавия: Влияние правового режима охраны интеллектуальной собственности на фармацевтическом рынке

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Аннотация: INTRODUCTION: the functioning of the healthcare industry in any country is impossible without providing enough medicines for patient care. This problem can best be resolved only when the majority of drugs, especially vital, will be made at national plants (industry). In this context, competition from generic drugs is the most optimal strategy to reduce drug's prices. AIM: the paper should examine how the legal regime of intellectual property affects the availability of medicines for people and identify ways of supporting breakthrough inventions and counter ≪unreal innovations≫. MATERIALS AND METHODS: for the purpose of study were generalized information from the scientific journals of medical and legal perspective, monographs by using a set of scientific methods. Namely under systematic approach have been analyzed the problems of pharmaceutical market, ways of producing generic and original drugs. Comparative legal method was useful for learning features of flexible mechanisms of the TRIPS Agreement and market regulation of medicines in the world. RESULTS: based on the research was found that developed countries with strong pharmaceutical industry are interested in maximizing the protection of intellectual property rights, including importing countries. Flexible mechanisms of the TRIPS Agreement can be useful for developing countries. CONCLUSIONS: thus, successful development of pharmaceutical industry and health care should be accompanied by the following measures: - improvement of public health must be recognized as a main task of government policy; - substantial state support aimed at increasing the availability of drugs in the domestic market and the strengthening of export potential; - decrease patent protection of medicines and stimulate market launch of generic copies.
Вступ: функціонування галузі охорони здоров'я в будь-якій країні неможливе без забезпечення пацієнтів ліками у достатній мірі. Ця проблема може бути вирішена тільки тоді, коли більшість ліків, особливо життєво важливих, вироблятимуться у національній промисловості. У зв'язку з цим, конкуренція з боку універсальних препаратів є найбільш оптимальною стратегією зниження цін на ліки. Мета: розглянути як правовий режим інтелектуальної власності негативно позначається на доступності лікарських засобів для населення та визначити шляхи підтримки проривних винаходів та «нереальних інновацій». Матеріали і методи: для цілей дослідження були узагальнені відомості з наукових журналів, медичної та юридичної точки зору, монографій, використовуючи набір наукових методів. Саме в рамках системного підходу проаналізовано проблеми фармацевтичного ринку, способи виробництва універсальних і оригінальних препаратів. Порівняльно-правовий метод був корисний для вивчення особливостей гнучких механізмів Угоди ТРІПС та регулювання ринку лікарських засобів у світі. Результати: на підставі досліджень було встановлено, що розвинені країни з потужною фармацевтичною промисловістю, зацікавлені в максимізації захисту прав інтелектуальної власності, в тому числі країн-імпортерів. Гнучкі механізми Угоди ТРІПС можуть бути корисні для країн, що розвиваються. Висновки: таким чином, для успішного розвитку фармацевтичної галузі і охорони здоров’я повинні бути забезпечені наступні заходи: - поліпшення здоров’я населення має бути визнано в якості основних завдань державної політики; - суттєва державна підтримка, спрямована на підвищення доступності ліків на вітчизняному ринку і зміцнення експортного потенціалу; - зниження патентної охорони лікарських засобів і виведення на ринок універсальних препаратів.

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Pashkov, V. M..
    Principle of serviceability and gratuitousness in transplantation? [Текст] / V. M. Pashkov, I. A. Golovanova, P. P. Noha // Wiadomości Lekarskie. - 2016. - Vol. LXIX = Tom LXIX. nr 3. cz. II. - S. 565 - 568
   Перевод заглавия: Принцип платности и безвозмездности при трансплантации?

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Аннотация: INTRODUCTION: the issue of commercialization of transplantation analyses in the article. Attention is paid to the importance of transplantation as a method of treatment and saving human lives. AIM: the clarify the feasibility of the introduction of donation commercialization as an avenue to solve the shortage of donor organs and means of combating with black organ market and finding alternative avenues solving these problems, which are more morally acceptable for society is the aim of this article. MATERIALS AND METHODS: the experience of foreign countries has been analyses in the research. Additionally, we used data from international organizations, conclusions scientists and report of Global Financial Integrity in the research. RESULTS: it is impossible to solve most problems by means of paid donation. CONCLUSIONS: therapeutic organ and tissue cloning based on genetic technology is the best way out and solving ethical transplantation problems.
The impact of the legal regime of intellectual property protection in the pharmaceutical marketВступ: в статті аналізується питання про комерціалізацію трансплантації. Увагу приділено важливості трансплантації як методу лікування і порятунку людських життів. Мета: уточнити доцільність введення комерціалізації донорства як шлях для вирішення проблеми дефіциту донорських органів і способи боротьби з чорним ринком органів та знаходження альтернативних шляхів вирішення цих проблем, які є більш морально прийнятними для суспільства. Матеріали і методи: в дослідженні аналізується досвід зарубіжних країн. Крім того, в дослідженні використовувалися дані міжнародних організацій, висновки вчених і доповідь Global Financial Integrity. Результати: неможливо вирішити більшість проблем за допомогою платного донорства. Висновки: терапевтичне клонування органів і тканин на основі генної технології - це кращий вихід із ситуації і вирішення етичних проблем трансплантології.

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Pashkov, V. .
    Certain aspects on medical devices software law regulation [Текст] / V. Pashkov, A. Harkusha // Wiadomości Lekarskie. - 2016. - Vol. LXIX = Tom LXIX, nr 6. - S. 765-767

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Аннотация: INTRODUCTION: some kind of easiness of entry in creating software products on various computing platforms has led to such products being made available perhaps without due consideration of potential risks to users and patients and the most valuable reason for this have been lack of regulatory clarity. Some key points on legal regulation of abovementioned sphere is a base of this study. MATERIAL AND METHODS: Ukrainian legislation, European Union`s Guidelines on the qualification and classification of standalone software; Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices that works in United States of America. Article is based on dialectical, comparative, analytic, synthetic and comprehensive research methods. CONCLUSION: in accordance with Ukrainian legislation, software that has a medical purpose could be a medical device. Ukrainian legislation which is established on European Union Medical Devices Directives divide all medical devices on classes. But there aren't any special recommendations or advices on classifications for software medical devices in Ukraine. It is necessary to develop and adopt guidelines on the qualification and classification of medical device software in Ukraine especially considering the harmonization of Ukrainian legislation with the EU legislation, develop special rules for the application of the national mark of conformity for medical device software and defined the « responsible organization » for the medical device software approval process.

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Pashkov, V. .
    Medical device software: defining key term [Текст] / V. Pashkov, N. Gutorova, A. Harkusha // Wiadomości Lekarskie. - 2016. - Tom LXIX, nr 6. - P. 813-817
   Перевод заглавия: Медицинское программное обеспечение устройства: определение ключевых терминов.

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Аннотация: INTRODUCTION: one of the areas of significant growth in medical devices has been the role of software - as an integral component of a medical device, as a standalone device and more recently as applications on mobile devices. The risk related to a malfunction of the standalone software used within healthcare is in itself not a criterion for its qualification or not as a medical device. It is therefore, necessary to clarify some criteria for the qualification of stand-alone software as medical devices Materials and methods: Ukrainian, European Union, United States of America legislation, Guidelines developed by European Commission and Food and Drug Administration's, recommendations represented by international voluntary group and scientific works. This article is based on dialectical, comparative, analytic, synthetic and comprehensive research methods. CONCLUSION: the legal regulation of software which is used for medical purpose in Ukraine limited to one definition. In European Union and United States of America were developed and applying special guidelines that help developers, manufactures and end users to difference software on types standing on medical purpose criteria. Software becomes more and more incorporated into medical devices. Developers and manufacturers may not have initially appreciated potential risks to patients and users such situation could have dangerous results for patients or users. It is necessary to develop and adopt the legislation that will intend to define the criteria for the qualification of medical device software and the application of the classification criteria to such software, provide some illustrative examples and step by step recommendations to qualify software as medical device.

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Pashkov, V. M..
    Legal Features of the Drug Advertising [Текст] / V. M. Pashkov, A. A. Olefir, O. Y. Bytyak // Wiadomosci lekarskie. - 2017. - Vol. 70, Issue: 1 . - p. 133-138
   Перевод заглавия: Юридические особенности рекламы лекарств

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Аннотация: Abstract INTRODUCTION:In the article discribed current trends of advertising in the pharmaceutical market and foreign experience of legal regulation of these relations. As for the advertising of medicines identified it's symptoms, types, basic rules and prohibitions. Modern pharmaceutical companies can not successfully carry out economic activities without advertising. Besides we can mention some fundamental changes in society (information overload, universal access to internet, social media, freedom of movement of goods, labor and finance), also self-medication becomes more popular. At the same time, the number of deaths after improper and uncontrolled use of drugs ranks fifth in the world among the causes of death. AIM:Investigate current trends of advertising on the pharmaceutical market, find advertising signs, basic restrictions and prohibitions on advertising of medicines, as well as foreign experience of legal regulation of these relations. MATERIAL AND METHODS:Despite the fact that pharmaceutical advertising were studied by such scholars as M. Abraham, L. Bradley, C. Dunn, J. Donoh'yu, D. Castro, M. Lipski, K. Taylor and others, number of issues related features of drug advertising, remained without proper theoretical studies. RESULTS:Based on the analysis can come to the conclusion that advertising of medicinal products are the subject of special attention from the state. Drugs, unlike other products, are a group of specialized consumer products. Risks increase when patients under the influence of «aggressive» advertising resort to self-medication. If a complete ban on advertising of medicines is inappropriate, you should set stricter requirements for the content of advertising and product placement rules. That is, in the national legislation to implement regulatory requirements of Directive 2001/83 / EC. CONCLUSIONS:Legal regulation of drug advertising can be improved by such legal means: - should provide for a mechanism of public control over the observance of ethical standards in the advertising of medicinal products; - Prohibit the advertising of medicines for children, as well as drugs for the treatment of infectious, parasitic diseases and pathogens of these diseases, chronic insomnia, cardiovascular diseases, and those costs are reimbursed by government programs or trade names may lead to mix with prescription drugs; - Adopt ethical standards (codes) promotion of drugs for pharmaceutical companies; - Advertising to the public shall not contain any reference to cost or pricing features for medicines.

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Pashkov, V. .
    European Experience of Regulating Distance Selling of Medicines for Ukraine [Текст] / V. Pashkov, Y. Hrekov, M. Hrekova // Wiadomosci lekarskie. - 2017. - Vol. 70, № 1. - pp. 96-100
   Перевод заглавия: Европейский опыт регулирования дистанционной продажи лекарств для Украины

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ББК Х623.211.84

Аннотация: INTRODUCTION: Some countries have already tried and tested mechanisms of regulating distance sales as form of distribution of medicines that have been used more or less effectively for a fairly long time. Herewith, so far, the approach of the competent authorities of some countries including Ukraine can be called prevailing in quantitative terms under which the official prohibition on distance sales of medicines is set. AIM: The aim of this study is a detailed examination of the nature of the prohibition of the medicines distance selling in Ukraine, namely the an analysis of advantages and disadvantages of this form of distribution of medicines and identification of appropriate ways for gradual repeal of the prohibition in terms of regulatory reform in Ukraine in the sphere of circulation of medicines due to the process of adaptation of statutory regulation in this area to the EU legislation. MATERIAL AND METHODS: This study is based on Ukrainian regulation acts, Council Directives 97/7/EC, 2000/31/EC, 2001/83/EC, scientific works and opinions of progressiveminded people in this sphere. Such methods as dialectical, comparative, analytic, synthetic and comprehensive have been used in the article. CONCLUSION: Reception of the described experience of regulation in EU will allow a further review of the principles of regulation in Ukraine in the sphere of medicines with a shift in the main emphasis in the direction of ensuring adequate consumer rights in this area and preventing the risks of patients' and public health.

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Pashkov, V. M..
    Legal Regulation of the Production and Trade of Medical Devices and Medical Equipment in the EU and US: Experience for Ukraine [Текст] / V. M. Pashkov, А. Kotvitska, A. O. Harkusha // Wiadomosci lekarskie. - 2017. - Vol. 70, Issue:3 pt 2. - P. 614-618
   Перевод заглавия: Правовое регулирование производства и торговли медицинскими приборами и медицинским оборудованием в ЕС и США: опыт для Украины

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ББК Х623.211.84

Аннотация: INTRODUCTION: The need for effective legal regulation of production and sale of medical products in Ukraine due to its social effect is obvious and requires a high level of clarity. The experience of more advanced countries in this area, given the way chosen by Ukraine to harmonize our laws with EU legislation, is certainly could be a useful source of information. The urgency of issues need further intensification of national legal reforms. Some key points on concept of legal regulation of abovementioned sphere is a base of this study. MATERIAL AND METHODS: Legislation of Ukraine, European Union, United States of America, Guidelines, developed by European Commission & Food and Drug Administration's (FDA), recommendations represented by international voluntary group and scientific works. This article is based on dialectical, comparative, analytic, synthetic and comprehensive research methods. DISCUSSION: This study provide a possibility to state that main difference of regulatory systems in EU and US is that the legal framework of the EU is more flexible. This flexibility is grounded on main principle that only basic quality requirements for medical devices is defined by legislative acts however more detailed requirements are defined in standards, technical regulations, specifications, which are discretionary in nature. Contractors are free to choose any technical solution that provides compliance with the essential requirements, they can choose among different conformity assessment procedures and between accredited conformity assessment bodies to which they want to apply. The contractors themselves is interested to pass the conformity assessment procedure and have the right to put a conformity mark on their medical device because it will give them a real competitive advantage. In contrast, US State regulatory system provides strict control over business entities and law act establishes the quality requirements of medical products. The only body that can authorize the introduction of medical products and perform post-market monitoring is Food and Drug Administration (FDA), which has almost unlimited competence in this sphere. CONCLUSION: Taking into account further deepening of the European integration process of Ukraine, establishing of the regulatory system as much similar to that of the EU as possible is a main goal of legal reforms in abovementioned sphere. On the one hand, such system allows to implement effective control of contractors in the sphere of production and sale of medical products and provide safety of medical devices that are introduced, on the other hand, it does not afflict contractors with excessive and total control, allowing them to choose behavior that is most acceptable, understandable and user-specific. However, US's experience also has some positive characteristics, which could be taken into account. Therefore, such complex symbiosis of approaches from our point of view will balance controversial interest of manufacturers, sellers and consumers of medical devices.

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Pashkov, V. M..
    The Directions of Development of Legal Regulation of Patenting the Methods of Treatment in Ukraine Considering the European and World Experience [Текст] / V. M. Pashkov, Y. A. Hrekov, M. M. Hrekova // Wiadomosci lekarskie. - 2017. - Vol. 70, Issue:3 pt 2. - P. 628-632
   Перевод заглавия: Направления развития правового регулирования патентования методов лечения в Украине с учетом европейского и мирового опыта

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Аннотация: INTRODUCTION: the current state of patenting legal regulation of medical treatment in Ukraine and in the world is analyzed, the directions for the further development are determined. The author defines "non-industrial medical" and socio-ethical theories in the field of medical treatment patent protection. The existence of exclusively formal "monopoly" of the patent owner is noted, as well as the inapplicability of the majority of the patented achievements in this field in Ukraine. AIM: the purpose of this article is to investigate the current state of patenting legal regulation of medical treatment in Ukraine and in the world, to analyze the limitation of patent protection basic conception in the medical field and to determine the tendencies and perspectives of the legal protection mechanism of further development in this field in Ukraine, considering the European and world regulation experience. MATERIAL AND METHODS: this study is based on Ukrainian regulation acts, The European Patent Convention, The Code of Laws of the United States of America, judgments, scientific works and opinions of progressive-minded people in this sphere. Such methods as dialectical, comparative, analytic, synthetic and comprehensive are used in the article. CONCLUSION: The experience analysis of the medical treatment patenting regulation in EU and in other countries of the word made it possible to substantiate the tendencies of development the patenting legal regulation of treatment methods mechanism, based on the needs of creation conditions for the availability of the recent treatment developments and technics for citizens, without increasing the cost of such treatment through license fees.

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Pashkov, V. .
    Vat Rates on Medical Devices: Foreign Experience and Ukrainian Practice [Текст] / V. Pashkov, N. Hutorova, A. Harkusha // Wiadomosci lekarskie. - 2017. - Vol. 70. Issue:2 pt 2. - P. 345-347
   Перевод заглавия: Тарифы на медицинские приборы: зарубежный опыт и украинская практика

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Аннотация: Abstract INTRODUCTION: In Ukraine differentiated VAT rates is a matter of debate. Today the Cabinet approved a list of medical products that has been changed three times resulting in changed VAT rates for specific products. European Union provides another method of regulation of VAT rates on medical devices. The abovementioned demonstrates the relevance of this study. MATERIAL AND METHODS: Comparative analysis of Ukrainian and European Union legislation based on dialectical, comparative, analytic, synthetic and comprehensive research methods were used in this article. DISCUSSION: In Ukraine general rate of VAT for all business activities is 20 %. But for medical devices, Tax Code of Ukraine provides special rules. VAT rate of 7% for transactions supplies into Ukraine and imported into the customs territory of Ukraine of medical products on the list approved by the Cabinet. The list generated by the medical product name and nomenclature code that does not correspond to European experience and Council Directive 2006/112/EC. CONCLUSION: In our opinion, reduced VAT rates should to be established for all medical devices that are in a stream of commerce, have all necessary documents, that proved their quality and safety and fall under definition of medical devices.

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Pashkov, V. M..
    Ensuring right to organic food in public health system [Текст] / V. M. Pashkov, O. M. Batyhina, L. Leiba // Wiadomosci lekarskie. - 2018. - Vol. 71, Issue: 1 pt 2. - P. 226-229
   Перевод заглавия: Обеспечение права на органические продукты питания в системе общественного здравоохранения

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Аннотация: OBJECTIVE: Introduction: Human health directly depends on safety and quality of food. In turn, quality and safety of food directly depend on its production conditions and methods. There are two main food production methods: traditional and organic. Organic food production is considered safer and more beneficial for human health. Aim: to determine whether the organic food production method affects human health. PATIENTS AND METHODS: Materials and methods: international acts, data of international organizations and conclusions of scientists have been examined and used in the study. The article also summarizes information from scientific journals and monographs from a medical and legal point of view with scientific methods. This article is based on dialectical, comparative, analytic, synthetic and comprehensive research methods. The problems of effects of food production methods and conditions on human health have been analyzed within the framework of the system approach. CONCLUSION: Conclusions: Food production methods and conditions ultimately affect the state and level of human health. The organic method of production activity has a positive effect on human health.

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Pashkov, V. M..
    International medical law and its impact on the ukrainian health care legislation [Текст] / V. M. Pashkov, L. Udovyka, H. Dichko // Wiadomosci lekarskie. - 2018. - Vol. 71, Issue: 1 pt 2. - P. 201-205
   Перевод заглавия: Международное медицинское право и его влияние на законодательство Украины в области здравоохранения

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Аннотация: OBJECTIVE: Introduction: The Ukrainian state has an urgent necessity of rapid search for essentially new legal and organizational forms of the healthcare system, reform of the legal regulation of healthcare services provision. In the context of European integration, the advancement of the medical industry reform is closely related to consideration of international standards and norms of health care. The aim: To study the impact of international medical law on the Ukrainian health care legislation. PATIENTS AND METHODS: Materials and methods: International and Ukrainian regulations and documents on health care were used in the research. System and structural, functional and legal comparative methods as well as systematization, analysis and synthesis were determinative in the research process. RESULTS: Review: Systematization of international documents on health care was made. The major problems in the Ukrainian health care legislation were determined in terms of their conformity with the international legislative norms. The expediency of the Medical Code adoption was grounded and its structure was defined. CONCLUSION: Conclusions: Most health care international acts are ratified by Ukraine and their provisions are implemented in the legislation. Simultaneously, there is a row of problems, which hinder the Ukrainian health care development and place obstacles in the way of European integration. To remove these obstacles, it is expedient to create a codified act - the Medical Code, which would systematize the provisions of the current medical laws and regulations and fill in the existing gaps in the legal regulation of health care.

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Pashkov, V. .
    Screening and periodical medical examinations as important part of public health: problem of the legal implementation [Текст] / V. Pashkov, P. Noha, A. Soloviov // Wiadomosci Lekarskie. - 2018. - Vol.: 71, Issue:4 . - P. 893-896
   Перевод заглавия: Скрининг и периодические медицинские осмотры как важная часть общественного здравоохранения: проблема юридической реализации.

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Аннотация: OBJECTIVE: Introduction: Public health is an important concept, which is continually being globalized and integrated into today's society. It helps to improve and prolong the quality of life of people and prevent the spread of epidemics and serious incurable diseases. The components of public health include protection, prevention, and promotion. Prevention, the measures taken to prevent disease as opposed to treatment consist of screening and periodical medical examinations. There are two types of screening- universal screening and case finding (individual screening). Universal screening and periodical medical examination are identical concepts; the terms dispensary and individual screening (case finding) have similar meanings and can be used interchangeably. These concepts and their importance are analyzed in this research. The aim: A research on the legal regulation of periodic health examinations and screening as a two systems, which provides the implementation of prevention within the public health. Analysis of foreign experience such countries as: Great Britain, USA, Austria, Germany, Australia, France, Italy and others. PATIENTS AND METHODS: Materials and methods: The research based on: Ukrainian legislation, European Union's Law Acts, decisions of the ECHR, EU's member-states law, WHO Acts and Recommendations, scientific articles. The research is also based on general scientific and special research methods (such as dialectical, comparative, analytic, synthetic). RESULTS: Review: In Europe (except Germany and Austria) is happening the transition from the system of mandatory periodical medical examination to new screening system. However, despite this, periodical medical examinations of Europeans held in connection with exist system health insurance (both voluntary and mandatory). CONCLUSION: Conclusions: Screening and periodical medical examinations are two of the most important aspects of public health as they help to diagnose diseases at an early stage, even before showing any symptoms. Screening and periodical medical examinations ensures the safety and health of the entire population as opposed to certain individuals and therefore be mandatory procedure in today's society.

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Baulin, Y. V..
    Risk in the performance of medical activities: medico-legal overview [Text] / Yu. V. Baulin, K. O. Pavshuk, I. A. Vyshnevska // Wiadomosci lekarskie. - 2019. - Vol. 72, Iss. 12, cz. 2. - p. 2410-2415
   Перевод заглавия: Риск при выполнении медицинской деятельности: медико-правовой обзор

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ББК Х623.211.84
РУБ DOI: 10.36740/WLek201912203

Аннотация: OBJECTIVE: Introduction: The article analyzes the medical and legal analysis of the professional right to justified medical risk and the grounds for exclusion of their responsibility for the occurrence of negative consequences as a result. The aim:of the article is to review the legal regulation of medical risk at the international level and, based on that analysis, to define the concept of justified medical risk and to analyze its main features. PATIENTS AND METHODS: Materials and methods: International acts, legislation of European states, scientific developments, jurisprudence were analyzed, building on dialectical, comparative, analytical, formally logical, statistical, complex methods of scientific research and sociological method (questionnaire). RESULTS: Results: The survey found that most physicians understand some of the actions that a doctor takes to improve a patient's health, and believe that the risk begins with the identification of circumstances that may endanger the patient's life and health. The results made it possible to confirm that the medical risk is present in the practical activity of each of the doctors, and the main purpose is to save the life and health of the patient. The analysis of court convictions shows that due to insufficient regulation of risk, its onset and basic features, most of the concepts are evaluative, which leads to a lack of uniformity of jurisprudence on medical risk issues and the unlawful prosecution of doctors. CONCLUSION: Conclusions: Based on the analysis of key signs of medical risk, it has been formulated that justified medical risk is the risky action of a doctor within the framework of normative acts on treatment, which are performed in order to protect the life and health of the patient, if the stated goal cannot be achieved by risk-free actions. The study also revealed trends in the use of justifiable risk by physicians in practice.

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Pashkov, V. M..
    Enforceability of non-compete agreements in medical practice: between law and ethics [Текст] / V. M. Pashkov, A. O. Harkusha // Wiadomosci lekarskie. - 2019. - Vol. 72, Issue: 12 cz 2. - P. 2421-2426
   Перевод заглавия: Возможность применения неконкурентных соглашений в медицинской практике: между законом и этикой.

УДК

61

ББК Х623.211.84
РУБ DOI: 10.36740/WLek201912205

Аннотация: OBJECTIVE: Introduction: The core of physician's non-compete agreements problematics lies in complex system of controversial interests, rights and goals of subjects involved. On the one hand non-compete restrictions and their enforceability is an obvious part of employer's legitimate business interest based on the freedom of contract, on the other - free unrestricted market, preventing of monopolization, availability of medical assistance and healthcare, right to choose a doctor are social standards and thus - a part of public interest, in addition to this - non-compete restrictions impact physician's right to work. Balance between these components is pretty sensitive and hard to achieve. We can find enforceability of physician's non-compete provisions in different types of relations: employment contracts, partnership agreements, sale of medical practice. But complexity of mixing law, ethical, social issues along with different approaches of legal regulations rises the relevance of research. PATIENTS AND METHODS: Material and methods: This study is based on German, British, Spain, Swiss, USA regulation acts, scientific researches and opinions of progressive-minded people in this sphere. The article is based on dialectical, comparative, analytic, synthetic and comprehensive methods. RESULTS: Results: Non-compete agreements may have social benefits in some situations: serve as an instrument to protect trade secrets thus stimulate innovation; reducing of worker's exit probability could increase quality of medical services due to training of employees etc. But also, there are some serious risks to employee, to employer and to society as a whole. Analyzing the sense of non-compete clause in general we can assume that it includes seven main points: the subject; the form; the time; the territory; the scope and type of restrictions; "buy out" of the clause and the compensation. These characteristics are the core of non-compete clause, and, taking into account the principle of freedom in terms of agreement conclusion, it is up to law enforcement practice to determine minimal and maximal limits of such restrictions. US legal concept is clearly based on implementing of legally prescribed restrictions for non-compete with physicians (along with other categories). European practice being pretty similar in view on what non-compete agreement is and what principles it is based on however is obviously different in approach chosen because of absence of special legal provisions for physicians' non-compete regulation. CONCLUSION: Conclusion: Lack of legal regulation and law enforcement practice in this sphere worldwide is obvious, so the starting point in resolving of physician's non-compete enforceability issue will be choosing of suitable concept. Analyzing of proposed concepts, we came to the conclusion that the most perspective will be an approach of specification and clarification of "reasonability" meaning in terms of evaluation physicians' non-compete agreement validity and their impact on public interest.

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Kaplina, O. V..
    Medical errors: patients' opinion, lawyers' standpoint, medical doctrine and practice of the european court of human rights [Текст] / O. V, Kaplina, S. L. Sharenko, N. Y. Shumylo // Wiadomosci lekarskie. - 2019. - Vol. 72, Issue:12 cz 2. - P. 2416-2420
   Перевод заглавия: Медицинские ошибки: мнение пациентов, точка зрения адвоката, медицинская доктрина и практика Европейского суда по правам человека.

УДК

61

ББК Х623.211.84
РУБ DOI: 10.36740/WLek201912204

Аннотация: OBJECTIVE: Introduction: The problem of medical errors is always relevant in medical literature and law. Meanwhile, it is understood diametrically opposite by doctors, patients, and lawyers. This has a negative impact on patients' trust in medical professionals, and sometimes leads to criminal prosecution for a so-called "medical error", which in fact is conscientious deception, not a crime, and should exclude criminal liability. The aim: The aim of this work is the illustration of diametrically opposed approaches to understanding the essence of the concept of "medical error" from patients', doctors', and lawyers' views that are often generated by subjective approaches and results in distrust between doctors and patients, medical professionals and lawyers. The aim of the article is also to realize the ECHR's approach to understanding the essence of a medical error and distinguishing it from the negligence that should lead to liability of the medical professionals. PATIENTS AND METHODS: Materials and methods: In this research a legal doctrine, scientific works, provisions of international legal acts, in particular, the Convention for the Protection of Human Rights and Fundamental Freedoms were used, as well as the practice of the ECHR (12 relevant ECHR decisions), where the Court considered cases related to "medical errors" and formulated positive obligations of the state in the field of health care were analyzed. A complex set of general and special methods of cognition was used to achieve the aim, they are comparative legal method, systemic and structural method, methods of generalization, analysis and synthesis, sociological method, hermeneutical method, etc. RESULTS: Results: A survey of patients, medical professionals and lawyers conducted by the authors (300 persons), analysis of doctrinal approaches are illustrated the gap between the doctrinal approaches existing in the understanding of the essence of the "medical error" phenomenon and the perceptions of the medical services recipients, which indicates the need of understanding the essence of the phenomenon of medical error in order to increase the confidence in the medical profession, the inadmissibility of doctors liability for a medical error. CONCLUSION: Conclusions: The research gave the authors a reason to conclude that both medical and legal sciences are still far from the unity of views on the concept of "medical error". Medical errors significantly affect the authority of a medical institution, a particular doctor, or the state as a whole, and have severe consequences for patients. An analysis of the medical literature and ECHR practices has led to the conclusion that a medical error occurs when it is possible to completely exclude the guilt of medical professionals in the form of intent or negligence. In case of a medical error the criminal liability of the doctor is excluded.

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Obolentsev, V. F..
    Information technology of verification of algorithmic of medical regulations [Текст] / V. F. Obolentsev, O. M. Hutsa, O. B. Demchenko // Wiadomosci lekarskie. - 2019. - Vol. 72, Issue:12 cz 2. - P. 2427-2433
   Перевод заглавия: Информационные технологии верификации алгоритмов медицинского регулирования

УДК

61

ББК Х623.211.84 + Р
РУБ DOI: 10.36740/WLek201912206

Аннотация: OBJECTIVE: Introduction: In the medical field, using of information-analytical technologies and expert systems is becoming increasingly common. Therefore, the problem of quality of normative acts (documents), which unify the standards of the newest methods of medical activity, becomes urgent. But, unfortunately, legal experts state that there is a problem of errors in regulations of different branches of rulemaking. A rulemaking error can be recognized as inconsistency of a text or a rule of law's content regarding its purpose. There are two types of legal errors: purely textual and substantive (algorithmic). The aim: The aim of the article is to demonstrate the possibilities of using information technology based on BPMN to display algorithms and identify algorithmic errors in regulations that adjust activities of health care professionals. PATIENTS AND METHODS: Materials and methods: It is used BPMN (Business Process Model And Notation) technology in the research. With its help, a logical-analytical check of algorithm scheme for treatment of abnormal uterine bleeding, provided in the normative document of the Ministry of Health of Ukraine "Unified Clinical Protocol of Primary, Secondary (specialized) and Tertiary (highly specialized) Medical Care. Abnormal Uterine Bleeding", approved by the order of the Ministry of Health of Ukraine on 13.04.2016, No. 353. Algorithmic errors in the scheme were checked using Microsoft Visio software. According to the results of the logical-analytical examination of the mentioned normative act's text, a scheme of algorithm for treatment of abnormal uterine bleeding in BPMN was constructed. RESULTS: Results: The use of the proposed BPMN-based information technology and Microsoft Visio software allows you to control the algorithmic nature of regulated medical practice processes and to detect errors, to create visual models of schematically regulated medical practice algorithms. CONCLUSION: Conclusions: The proposed information technology, based on BPMN can be used to display algorithms and detect errors in regulatory acts that adjust activity of medical professionals.

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Razmetaeva, Y.
    Euthanasia in the digital age: medical and legal issues and challenges [Текст] = Эвтаназия в цифровую эпоху: медицинские и правовые проблемы и вызовы / Y. Razmetaeva, O. Sydorenko // Georgian medical news. - 2020. - Iss. 1 (298). - P. 175-180

УДК

61

ББК Р

Аннотация: The purpose of this article is to analyze the main medical, legal, and ethical issues and challenges of euthanasia in the digital age. The methods that were used in this study are historical, logical, empirical, as well as comparative legal method for comparison of laws and practices of the EU and post-Soviet countries, including Ukraine. This choice determined by the fact that both groups of countries have common features and relations, while the features of their development affect approaches to regulating such sensitive and potentially open to abuse problems as euthanasia. There is no final legal answer as to whether to legalize, decriminalize or prohibit euthanasia in any of its forms. The features and legal terms of active and passive, voluntary and non-voluntary euthanasia and assisted suicide, especially for psychiatric and minor patients were researched, as well as conflicting arguments, which include individual autonomy, right to choose, the opportunity to get rid of suffering, as well as undermining the practice of palliative care, abuse in cases of vulnerable and dependent patients, moral burden on the doctors. The issue of control of the practice of euthanasia is complicated, given the extent to which it is possible to obtain informed consent, establish criteria for suffering and hopelessness, check the persistence, conviction and validity of requests for euthanasia, especially in the digital era. The potential legislation and judicial practice should provide for strict and effective guarantees, respect for the beliefs of each person and the right not to participate in any contentious practices, the balance of human rights and social values.

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