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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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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. .
    Advertising of Medical Devices: Foreign Experience and Ukrainian Practice [Текст] / V. Pashkov, A. Harkusha, O. Bytiak // Wiadomosci lekarskie. - 2017. - Vol. 70. Issue: 3 pt 1. - P. 456-461
   Перевод заглавия: Реклама медицинских приборов: зарубежный опыт и украинская практика

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Аннотация: INTRODUCTION: Chosen European foreign policy vector for Ukraine establishes its obligation to enforce the process of adaptation of the EU law regulations in the internal legal policy. The approximation of Ukrainian law to the European Union (EU) "acquis communautaire" is not only the instrument for deepening our economic cooperation with the European Union, but also the important measure to enhance further development of Ukraine in general. National legislation, which regulate advertising and promotion of medical devices (MD), is not an exception. Some key points on legal regulation of abovementioned sphere is a base of this study. MATERIALS AND METHODS: Ukrainian legislation, European Union`s Law Acts, EU's member-states law, WHO Acts and Recommendations, European Medical Technology Industry Association (EUCOMED) Acts. Article is based on dialectical, comparative, analytic, synthetic and comprehensive research methods. DISCUSSION: In accordance with Ukrainian legislation, there is no special law that concerns advertising on MD in Ukraine, this sphere is regulated by general law that named ≪About advertisement≫, but it doesn't take into account even main characteristics of such a special object as medical devices (MD). Moreover, the law ≪About advertisement≫ contain discrepancies in terms that are used, these contradictions, in our opinion, must be eliminated by appropriate law reforms. CONCLUSION: The advertising and promotion of MD in EU is regulated by a combination of EU and national legislation of EU Member States, national advertising and promotion of MD are not harmonized with the EU MDD for now, resulting in a fragmented legal landscape that differs from one EU Member State to the other. Practice of adopting different codes and guides that regulate advertising, including advertising of MD, is widespread in EU and EU Member States and thus must be used in Ukraine with appropriate reformation of national law.

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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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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..
    Legal Aspects of Counteracting the Trafficking of Falsified Medicines in the European Union [Текст] / V. M. Pashkov, A. Soloviov, A. A. Olefir // Wiadomosci lekarskie. - 2017. - Vol. 70, Issue:4. - P. 843-849
   Перевод заглавия: Правовые аспекты противодействия торговле фальсифицированными лекарствами в Европейском союзе

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Аннотация: INTRODUCTION: The paper identifies key risks associated with the illegal production and sale of medicines. Also there were generalized features of criminal responsibility for acts related to the trafficking of drugs in some Member States of the EU and analyzed legal means of combating the falsified drugs today. The problem concerning falsification of medicines is particularly acute not only in developing countries but also in developed ones. Fake is one in ten - twenty drug. The largest share of falsified drugs comes from the so-called «Asian tigers», already from which they come to the EU market. THE AIM: In this publication authors have set following objectives: - to determine the risks associated with illegal production and sale of medicines; - organize legal means of combating the falsified medicines in the EU member states; - clarify features of criminal responsibility for acts related to the trafficking of drugs in the EU countries. MATERIALS AND METHODS: The article bases on the works of scholars and experts, statistical information and other sources. Particular attention is paid to the analysis of regulations of the EU institutions and national criminal laws. So, provisions of the criminal codes of 10 EU member states were taken into account. RESULTS: There is a system of legal measures which counter the circulation of falsified medicines in the EU and consists of general and specific regulatory requirements, mainly of economic and legal nature. The most important role among the last play package labeling requirements for drugs and license conditions. DISCUSSION: In the article were discussed factors that stimulate the production and sale of falsified drugs and the risks associated with these. Demarcated the concept of «falsified medicinal product», «counterfeit drug», «substandard drug». CONCLUSIONS: Although there are guidelines for patients to identify falsified drugs, still a major role in this process should play public authorities and enterprises. In all the countries illegal circulation of falsified drugs is prohibited under threat of criminal or administrative responsibility.

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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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61

ББК Р11

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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Gutorova, N. .
    Legal protection of public health through control over genetically modified food [Текст] / N. Gutorova, O. Batyhina, M. Trotska // Wiadomosci lekarskie. - 2018. - Vol. 71, Issue:2 pt 2. - P. 366-370
   Перевод заглавия: Правовая охрана здоровья населения посредством контроля над генетически модифицированными продуктами питания

УДК

614

ББК Р11(4УКР)

Аннотация: OBJECTIVE: Introduction: Science is constantly being developed which leads to both positive and negative changes in public health and the environment. One of the results of scientific progress is introduction of food based on genetically modified organisms whose effects on human health, to date, remain scantily studied and are ambiguous. The aim: to determine how human health can be influenced by food production based on genetically modified organisms. 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. CONCLUSION: Conclusions: Genetically modified organisms are specific human-made organisms being a result of using modern biotechnology techniques. They have both positive and negative effects on human health and the environment. The main disadvantage is not sufficient study of them in various spheres of public life.

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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.

УДК

61

ББК Р11(4УКР)

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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Pashkov, V. .
    Assisted reproductive technologies: the problems of legal enforcement [Текст] / V. Pashkov, A. Lyfar // Wiadomosci lekarskie. - 2018. - Vol. 71, Issue: 5. - P. 1066-1070
   Перевод заглавия: Вспомогательные репродуктивные технологии: проблемы правоприменения

УДК

618

ББК Р11

Аннотация: OBJECTIVE: Introduction: Today, the use of assisted reproductive technologies (including surrogacy) is an effective method of guaranteeing realization of person's right on maternity or paternity. Through therapeutic efficiency reproductive means have become incredibly popular among population. However, the lack of certain legal relations in the sphere of surrogacy (both at the international level and the national one) leads to the confusion in the theory and practice. The aim: In this article, the author has set himself the following aims: a) to determine the state of legal regulation of surrogate maternity at national and international levels; b) to focus on problematic moments in legal regulation of surrogacy, which cause such phenomena as medical tourism and human trafficking; c) to investigate the regimes of legal regulation of surrogacy in the countries of the world. PATIENTS AND METHODS: Materials and methods: The methodological framework of the research consists of general scientific and special methods. The dialectical method is used to identify the term surrogacy and its meaning; the method of summarization is applied to the case laws (judgements of European Court of Human Rights and other high legislative bodies of foreign countries). The statistical method is applied to statistical data; the formal method is used for analysing the experience of such foreign countries as the USA (state Illinois, Nevada, California), Sweden, the Netherlands, India, Great Britain. Lastly, the method of comparison is applied to determine the similarities or differences between domestic and foreign legislation. RESULTS: Review: There are three regimes of surrogacy in the world which contradict one another (altruistic, permitting and prohibiting). The difference between legal regulations of surrogacy contributes expansion of such a phenomenon as medical tourism. CONCLUSION: Conclusions: Owing to absence of unified principles and standards on international level in the sphere of surrogacy, subjects of such legal relations are absolutely unprotected. Such phenomena as medical tourism, human trafficking and commercial exploitation of surrogate mothers are extending.

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Kraіnуk, H. S..
    Problems of transplantation of human organs and other anatomical materials and directions of their solution in Ukraine [Текст] / H. S. Kraіnуk, S. M. Pороva, E. V. Vakulovych // Wiadomosci lekarskie. - 2019. - Vol. 3, Issue: 3. - P. 457-461
   Перевод заглавия: Проблемы трансплантации органов человека и других анатомических материалов и направления их решения в Украине

УДК

614

ББК Р + Х811.4 + Ю665 + Х623.211.84

Аннотация: OBJECTIVE: Introduction: The focus of the work is the importance of transplantation of human organs and other anatomical materials as the method of treating and a way of saving people's lives and it also attaches particular importance to solving issues of transplantations in Ukraine. The aim: To find out the problems of human organ transplantation and other anatomical materials and determine the directions of their solutions in Ukraine. PATIENTS AND METHODS: Materials and methods: The assessment and analysis of domestic and foreign experience has been developed. In addition, data collected from Ukrainian and international organizations and the results of scientific research by scientists are used in the work. RESULTS: Review and conclusions: Investigating the legislation of Ukraine in the part of transplantation of human organs and other anatomical materials, conclusions were made on the necessity of its improvement, in particular, Article 16 of the Law of Ukraine On the application of transplantation of anatomical materials to a person dated by May 17, 2018, is proposed to be worded as follows: Any adult may give written consent or disagreement to become a donor of anatomical materials in case of his death. In the absence of such a statement of disagreement with the transplantation of his organs or other anatomical materials, consent of relatives or others is not required. In this case, the deceased person is deemed to have given consent to the transplantation of his organs or other anatomical materials. It is proposed to make changes and significant additions to Art. 17 of the Law of Ukraine On the application of transplantation of anatomical materials to a person of May 17, 2018 regarding the creation of the Unified State Register of persons in need of transplantation, as well as to consolidate the procedure for its administration. In the context of urgent transformations, the necessity to significantly increase state funding for the provision of medical services, raise the awareness and informality of citizens about transplantation, as well as to change their misconceptions about this issue are sometimes put forward.

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Shulzhenko, N. V..
    Legal bases for improving legislation on the transplantation of human anatomical materials [Текст] / N. V. Shulzhenko [Авторство не підтверджено 07.06.2021 р.] // Wiadomosci lekarskie. - 2019. - Vol. 72, Issue: 4. - P. 707-710
   Перевод заглавия: Правовые основы совершенствования законодательства о трансплантации человеческих анатомических материалов

УДК

614

342.746

ББК Р + Х811.4 + Ю665 + Х623.211.84

Аннотация: OBJECTIVE: Introduction: From January 1, 2019, the Law of Ukraine "On application of the transplantation of anatomical materials to a human being" dated May 17, 2018, № 2427-VIII (hereinafter referred to as Law № 2427), which defined a new system of legal relationship in the field of transplantation and related activities. Simultaneously the validity of the Law of Ukraine "On transplantation of organs and other anatomical materials to a human being" adopted in July 16, 1999. № 1007-XIV was canceled. The development of medical science overlooks the prospect of humanity's salvation from many incurable diseases. One of the directions of medical advancing is the development of transplantation, which is special method of treatment that involves the transplantation of anatomical human material from a donor to a recipient and a focuses on the restoration of human health. Admitting the fact that life or health can be saved for hundreds of thousands of people with its' usage today and the need for it is growing relentlessly. Therefore, research and improvement of legislation on the transplantation of human anatomical materials is well-grounded and timely. The aim: To establish and specify the problematic issues of legal regulation that arise in the transplantation of human anatomical materials sphere. PATIENTS AND METHODS: Materials and methods: During the study, international acts, national legislation and Conclusions of scientists were used. The article is based on dialectical, legal comparative, systemic, historical and complex methods of research. RESULTS: Review: In this paper the main problems of legal regulation of transplantation of human anatomical materials according to the Ukrainian legislation are analyzed and specific suggestions for their solution are proposed. CONCLUSION: Conclusions: The solution to this problem is to create a legislative framework and provide an effective and effective mechanism for regulating and implementing transplantation of human anatomical materials.

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Gornostay, A. .
    Medical error and liability for it in some post-soviet countries (Belarus, Kazakhstan, Moldova, Ukraine) [Текст] / A. Gornostay, A. Ivantsova, T. Mykhailichenko // Wiadomosci lekarskie. - 2019. - Vol. 72, Issue:5 cz 1. - P. 877-882
   Перевод заглавия: Медицинская ошибка и ответственность за нее в некоторых постсоветских странах (Беларусь, Казахстан, Молдова, Украина)

УДК

614

342.746

ББК Х623.211.84

Аннотация: OBJECTIVE: Introduction: Infliction of harm to life and health due to medical errors is common for the whole world and post-Soviet countries, in particular. The problem of these errors is one of the most important in medical law, although there is no unified concept of it. A small number of sentences in cases of criminal negligence of medical professionals indicates a high latency and often unprovability of this crime in a number of post-Soviet countries. The aim: To disclose the objective and subjective prerequisites of a medical error, reasons for its occurrence, to establish the grounds for criminal liability of medical professionals in case they commit an error and to examine the judicial practice in this regard. Also, to define the concept and types of circumstances exempting criminal liability and their impact on criminal liability issues concerning medical professionals. PATIENTS AND METHODS: Materials and methods: The study is based on the Belarusian, Kazakh, Moldavian and Ukrainian statutory acts as well as international acts, the European Convention for the Protection of Human Rights and Fundamental Freedoms, case law of the European Court of Human Rights (ECHR), national court judgments. Such methods as dialectical, comparative, analytic, synthetic and comprehensive have been used in the paper. RESULTS: Review: On the basis of the study, it has been established that there is no unified concept of a medical error, medical personnel are fairly brought to criminal liability only if they commit an unjustifiable error in the presence of all the mandatory elements of a crime provided for in the relevant article of the Criminal Code. At the same time, it is extremely difficult to prove existence of such an error. Besides, at the state levels, causes and mechanisms of occurring errors have not been revealed, they are not even discussed, which makes it impossible to outline measures to prevent them or reduce their frequency and degree of danger. CONCLUSION: Conclusions: The struggle against medical errors should encompass a number of such activities as standardization of clinical treatment protocols, further education of medical professionals and lawyers in regard to patient safety, thorough investigation of each incident in order to exclude a justifiable error or circumstances exempting criminal liability. Equitable, severe and uncompromising punishments for perpetrators should be an effective means preventing commission of crimes in medicine.

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Shevchuk, O.
    Realization of the human right to palliative care in Ukraine: problems and legal issues (review) [Текст] / O. Shevchuk, V. Trofymenko, V. Martynovskyi, G. Goncharenko, D. Zatenatskyi // Georgian medical news. - 2019. - Issue: 289. - P. 168-173
   Перевод заглавия: Реализация права человека на паллиативный уход в Украине: проблемы и правовые вопросы (обзор)

УДК

614

ББК Р + Х621.154 + Х811.4 + Х916.7 + Ю665

Аннотация: The aim of the study is to analyze individual legal problems of the implementation of the human right to palliative care. To achieve this goal, statistical data on the number of palliative patients, their access to medical services were analyzed. The absence of reasons for limiting the patient's right to receive palliative care, as such a right is a fundamental human right, is substantiated. An analysis of the understanding of the legal construction of "palliative care" in the scientific literature, national and international legal documents was carried out. It was revealed that the terms "hospice care", "end-of-life-care", "respite care" are components of a precise definition - "palliative care". Two groups of subjects that ensure the human right to this type of medical care are identified, their powers are indicated. In the course of the research it was established that palliative patients, more often than other patients, need medical care, including children. This category of patients faces the following problems: incomplete providing of high-quality free medical palliative care; insufficient number of palliative and hospice departments for such patients; palliative care does not meet international standards (logistical support for palliative departments, there are no specialists of a multidisciplinary team); there is no special training for medical personnel working with incurable patients; painkillers (non-narcotic and narcotic) drugs for relieving pain syndrome of such patients are not provided in full volume; there is no cooperation of state authorities in the field of palliative care with public and charitable organizations; palliative patients do not have access to free legal services (pensions, inheritance).

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