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1
Yarema, O., and O. M. Ilyushyk. "Legal aspects of electronic document management in telemedicine." Analytical and Comparative Jurisprudence, no. 6 (February 18, 2023): 218–24. http://dx.doi.org/10.24144/2788-6018.2022.06.39.
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In the article from the standpoint of the theory of administrative and information law, based on the current legislation and regulatory requirements of the European Union, the theoretical and practical aspects of electronic document flow in telemedicine are considered. The topicality of the topic determined by the need to improve the legislation with the aim of comprehensive theoretical justification of increasing the effectiveness of telemedicine activities in the conditions of digital transformation of Ukraine. In the course of the study, the methodology of a systematic complex analysis of legal phenomena was applied using factorial and evolutionary methods of research. It is indicated that in the countries of the European Union, three main models of health care information systems have been formed, which differ in the ways of storing medical information and management: decentralized, centralized and patient-oriented. It was noted that the main legal issues of the renewal of the medical system of Ukraine and the directions of activity in the conditions of reform include telemedicine, and its component - electronic document flow. The essence and features of electronic document management in telemedicine in the countries of the European Union have been clarified. The electronic health care systems of individual countries of the European Union considered, attention is paid to the experience of use. The state of legal provision of information security in telemedicine with regard to electronic document flow studied, taking into account the experience of the countries of the European Union. The analysis of ensuring information security in the context of personal data in the medical systems of European countries and Ukraine was carried out. The further vector and direction of the development of the national health care system in terms of the Concept of the development of electronic health care, which is important for medical care and rehabilitation of citizens who suffered during the war, was determined. Important aspects and measures to optimize activities in the field of telemedicine highlighted, which need to be paid attention to during further reform and creation of new digital resources for a more comfortable transition and use of the latest digital technologies in the field of health care.
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Туренко, Д. В. "Issues of Legal Regulation of Applying Coercive Measures of Medical Nature in International and Legal Acts and Legislation of Certain Foreign Countries." Law and Safety 80, no. 1 (March 19, 2021): 173–79. http://dx.doi.org/10.32631/pb.2021.1.24.
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The author has researched the main provisions of legal regulation in international and legal acts and national laws of some European Union countries and other foreign countries, where the possible application of coercive measures of a medical nature by courts, as well as decisions of the European Court of Human Rights on this category of criminal proceedings are regulated. The basic provisions, norms and differences of legal regulation of the application of coercive measures of medical nature in the legislation of certain foreign countries have been established. The implementation of international legal acts into national criminal, criminal procedural and other legislation has been analyzed. Based on the results of the research, the author has formulated a number of propositions and recommendations for the introduction into the legislative technique of Ukraine. Besides, the author has studied national theoretical issues of criminal law and criminal proceedings, as well as applied issues in this area of the research within law-enforcement activities of pre-trial investigation and inquiry agencies, prosecutor’s office and, in particular, procedural commissioners of pre-trial investigation. The scientific views of individual scholars and representatives of scientific schools on the researched issues have been also considered, and the relevant author’s opinions have been expressed. The author has characterized joint law-enforcement activities, problematic issues of law enforcement agencies and psychiatric medical institutions during the pre-trial investigation of criminal proceedings of this category, problematic issues and the existing system for providing psychiatric care to insane persons, as well as certain areas of cooperation in criminal and judicial proceedings. According to the results of the study, the author has suggested a number of propositions and recommendations for improving the theory of criminal law and criminal proceedings, law-enforcement activity and current criminal and criminal procedural legislation of Ukraine.
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Skrzypek, Michał, Lucyna Pachocka, Karolina Goral, and Adamina Partycka-Skrzypek. "Selected determinants of the professional identity of dietitian in the context of legal regulations on the practice of dietitian in Poland and the European Union." Polish Journal of Public Health 128, no. 2 (June 1, 2018): 63–68. http://dx.doi.org/10.2478/pjph-2018-0011.
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Abstract The subject of the article is the present status of the profession of dietitian in the Polish healthcare system, taking into account the analysis of the current legislation in force that defines the principles of employment of dietitians and the practice of the dietitian in Poland in the context of relevant provisions of the EU law, with emphasis on the position of dieticians in the health-care systems of selected European Union countries. The study advances the thesis that the current status of the profession of dietitian in Poland reflects its incomplete professionalization manifested in the lack of legal regulations on the principles of its practice that are applied in the case of other medical professions. A consequence of the present, comparatively low status of the profession of dietitian in Poland is, inter alia, the hindered availability of professional clinical dietetics counseling under public health insurance, as well as the practice of the profession as a business activity by individuals whose professional qualifications are not subject to verification by professional regulatory bodies. This produces a risk to patients, arising from the fact that interventions not verified by the EBM paradigm are nevertheless implemented as part of dietary counseling.
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Ivanenko, Dmytro, and Nataliia Hlushchenko. "LEGAL ASPECTS OF INTELLECTUAL PROPERTY IMPACT ON AVAILABILITY OF MEDICINES IN UKRAINE." Law Journal of Donbass 76, no. 3 (2021): 39–44. http://dx.doi.org/10.32366/2523-4269-2021-76-3-39-44.
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The right of a person to access medicines is derived from the right to health. At the time of the establishment of fundamental human rights, the issue of lack of access to medical supplies was not considered a violation of human rights. The spread of pandemics has led to the gradual recognition of the right of access to medicines. The TRIPS agreement fundamentally reformatted the discussion on access to medicines. Prior to the TRIPS Agreement, states had considerable independence in the formation and implementation of state policy in the field of intellectual property. TRIPS obliges countries to provide pharmaceutical patents. The growing influence of the international patent system has aroused widespread interest and concern about the impact on access to medicines. The Doha Declaration on the TRIPS Agreement defines the importance of the implementation and interpretation of the Agreement in the most favorable way for the protection of public health by making available to the public existing medicines and creating conditions for the production of new ones. Ukraine is on the way to creating its own legislation in the field of intellectual property. Art. 219 of the Association Agreement between Ukraine and the European Union contains provisions according to which the parties recognize the importance of the Declaration on the TRIPS Agreement in the field of health care. Positive changes in the field of intellectual property include the provisions of the Law of Ukraine «On Amendments to Certain Legislative Acts of Ukraine on the Reform of Patent Legislation» № 816-IX as of 21.07.2020. This law limited the range of objects to be patented. The implementation of these legislative changes is impossible without a proper methodology for the examination of novelty. Reforming the national system of intellectual property protection has created good preconditions for the formation of a civilized pharmaceutical market in Ukraine. Among the areas of legislation in Ukraine, there is an urgent need to form an institution of compulsory licensing. A separate area is the introduction of the pre-grant and post-grant procedures of the opposition. An important area of legislative work is the formation of a favorable domestic policy for innovation and invention in the field of medicine and biotechnology.
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Kozhura, Liudmila, Svitlana Zadereiko, and Andrii Omelchenko. "SYSTEM OF ECONOMIC MEANS OF STATE ADMINISTRATION OF THE RIGHTS OF PEOPLE WITH DISABILITIES TO HEALTHCARE." Baltic Journal of Economic Studies 7, no. 4 (September 27, 2021): 101–7. http://dx.doi.org/10.30525/2256-0742/2021-7-4-101-107.
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At the current stage of the development of society the problem of social protection and state support for people with disabilities is particularly relevant and requires reform and improvement. Ukraine, as a country aspiring to join the European Union, should take into account the best foreign experience of the leading countries of the world in the field of state policy to support people with disabilities and its implementation. The process of reforming the national healthcare system demonstrated the ineffective policy in this area, the high level of corruption and the inability to transform this system to the level of world standards of medical care, especially for people with disabilities. The problem of disability in Ukraine is becoming particularly acute. The goal of this article is to investigate the system of economic means of state administration of the rights of people with disabilities to healthcare, to identify the areas of budgetary management and the formation of a new mechanism of economic administration. Scientific analysis was carried out by using the method of systematic approach and analysis, which enabled us to study theoretical aspects of economic methods of state administration of the right of people with disabilities to healthcare, formation of the budget management in Ukraine for the economic security of the rights to healthcare, and features of the new mechanism of the economic administration of the right of people with disabilities to health care. It has been researched that along with administrative methods of state management of the right to health protection of people with disabilities the economic group of methods is important. These include programs of economic development of health care, rehabilitation programs for people with disabilities, implementation of pilot projects to change the mechanism of financial support for operative treatment, etc. Methods of regulating influence (indirect management) are becoming increasingly important, and economical methods of management belong to them. Implementation ensures that the financial and material interests of the management objects are satisfied through the activities of its subjects, which create favorable conditions for achieving the goals and objectives of management. For example, local self-government bodies, within the limits of their competence, can finance local programs for the development and support of community healthcare institutions. In 2019, a new mechanism of rehabilitation support for children with disabilities was introduced based on the principle of "money follows the people", which should ensure targeting, transparency and improve the quality of rehabilitation services. Resources are divided vertically among regional bodies, which divide budgetary funds among local bodies in proportion to the number of children who require rehabilitation measures, according to the place of their residence (location). The national legislation also reflects the norms that created the conditions for the implementation of the right to work of people with disabilities, as well as ratified Convention on the Rights of Persons with Disabilities and the ILO Convention on professional rehabilitation. From the point of view of the Ministry of Healthcare of Ukraine, the funds allocated by the state are extremely insufficient for the uninterrupted functioning of the medical system. In its budget memorandum for 2021 the ministry has allocated twice as much – 296 billion UAH, 225 billion UAH of which for the implementation of the medical guarantee program (which is 5% of GDP, as required by the Law of Ukraine "On State Financial Guarantees of Medical Services to Population"). But the proposals of the Ministry of Health both at the time of formation of the state budget and at the time of its approval were not taken into account. The requirement of the Law of Ukraine "On State Financial Guarantees of Medical Services to the Population" for the establishment of financing of the program of medical guarantees at the level of 5% of GDP was lengthened for one more year.
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Putkonen, Hanna, and Birgit Vollm. "Compulsory psychiatric detention and treatment in Finland." Psychiatric Bulletin 31, no. 3 (March 2007): 101–3. http://dx.doi.org/10.1192/pb.bp.106.009472.
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Despite efforts to integrate and harmonise legislation across the member states of the European Union (EU), mental health legislation, including legislation for the detention and treatment of offenders with mental disorders, differs widely across Europe. With changes to the Mental Health Act 1983 in the UK currently underway, investigating the different approaches to compulsory psychiatric care in other countries can be a stimulating and worthwhile exercise. We explored the Finnish mental health law with regard to compulsory admission and treatment and forensic care. Relevant differences between the Finnish approach and legislation in other European countries will be discussed.
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Akulin, Igor M., Ekaterina A. Chesnokova, Umberto Genovese, Roman A. Presnyakov, and Anastasia E. Pryadko. "Legal regulation of the transmission of health-related data: Balance of public interests and individual rights in the context of cross-border health care." Vestnik of Saint Petersburg University. Law 12, no. 2 (2021): 419–40. http://dx.doi.org/10.21638/spbu14.2021.211.
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The article provides a comparative analysis of the regulatory and legal regulation for the processing of a special category of personal health data in the European Union and in the Russian Federation in regard to the digitalization of national health systems. Special attention is paid to the legal framework for the transmission of health information at the cross-border level. It is established that within the framework of European and Russian legislation at this stage, in the context of the formation of digital medicine, there is a comparability in the definition of legal mechanisms for the protection of medical data. It is also noted that in the issue of the transfer of personal health data to third countries, both the Russian Federation and the European Union choose the path of strict restrictive regulation and the introduction of a closed list of grounds for overcoming the ban on cross-border transfer. The reasons for this approach to issues of supranational interaction in healthcare are analyzed, as well as the potential risks of inertia of national legislators in this issue. Based on the analysis, the authors propose a number of amendments and additions to the national legislation on personal data, aimed at simplifying the interaction between jurisdictions on the transfer of confidential medical information. The authors suggest an international agreement on the exchange of medical data in digital format, which potentially should include not only the Russian Federation and the EU states, but also other countries, including Eurasian Economic Union member states, China, and countries of the American continent. The proposed concept is intended to create an opportunity for the formation of a supranational information system in the field of healthcare, which allows for the effective exchange of medical data, taking into account the sovereign interests of the countries participating in the agreement.
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Busardò, Francesco Paolo, Matteo Gulino, Simona Napoletano, Simona Zaami, and Paola Frati. "The Evolution of Legislation in the Field of Medically Assisted Reproduction and Embryo Stem Cell Research in European Union Members." BioMed Research International 2014 (2014): 1–14. http://dx.doi.org/10.1155/2014/307160.
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Medically Assisted Reproduction (MAR), involving in vitro fertilisation (IVF), and research on embryos have created expectation to many people affected by infertility; at the same time it has generated a surplus of laws and ethical and social debates. Undoubtedly, MAR represents a rather new medical field and constant developments in medicine and new opportunities continue to defy the attempt to respond to those questions. In this paper, the authors reviewed the current legislation in the 28 EU member states trying to evaluate the different legislation paths adopted over the last 15 years and highlighting those EU countries with no specific legislation in place and MAR is covered by a general health Law and those countries in which there are no laws in this field but only “guidelines.” The second aim of this work has been to compare MAR legislation and embryo research in EU countries, which derive from different origins ranging from an extremely prohibitive approach versus a liberal one, going through a cautious regulatory approach.
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Martirosyan, E. G. "Legal Regulation of the EU Common Agricultural Market." Journal of Law and Administration 16, no. 2 (June 26, 2020): 89–97. http://dx.doi.org/10.24833/2073-8420-2020-2-55-89-97.
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Introduction. The article presents the analysis of legal regulation on the agricultural market of the European Union. The high growth of international economic integration, contributing to the intensification of interstate cooperation for the simplified movement of goods and services induces the harmonization of regulatory and legislative frameworks to develop uniform mechanisms of legal regulation. The diversification of agricultural exports should be considered as one of the highly promising, priority and sustainable trends of agricultural policy. EU law requirements must be taken into account by organizations engaged in foreign economic activities of food supplies. The article gives the updated analysis of the Eurasian Union regulatory framework in the sphere of agricultural products. Materials and methods. The methodological basis of the study comprises the universal dialectic method of scientific knowledge, general scientific methods (analysis, synthesis, analogy, induction, deduction, modeling, etc.), particular scientific (logical-legal method, comparative legal method of systemic analysis, etc.). Methods of content analysis of legal documentation, allowing to study key trends in the legal regulation and policies of the European Union in relation to the agricultural market were also used.The results of the study. The conducted analysis revealed that there is a confusing situation in the European Union legislation about the agricultural market. The exceptional attitude to agriculture in the European Union legislation was widely under-mined, which led to serious consequences not only for the interpretation of agricultural provisions in EU law, but also for the legal provisions about the agricultural market in other countries. The article also analyzes the changes in legislation that pave the way for a deeper understanding of agricultural law in the European Union after the reforms introduced by the Lisbon Treaty.Discussion and conclusion. Since 1974, the European Union has developed a wide range of legislative provisions related to agriculture. Pursuant to EU treaties, animals are recognized as living creatures, and therefore the EU and Member States must take due care of animal welfare requirements preparing and implementing policies in agriculture or on the domestic market. Currently, EU legislation on the welfare of farm animals contains specific provisions for the cultivation of poultry, calves and pigs, as well as to all types of agricultural machinery and livestock slaughter. Nevertheless, there are contradictions between the EU Member States stemming from the legal regulation of the common agricultural market in the European Union.The author concludes that the EU food law is comprehensive and aimed to provide consumers with safe and high-quality products, subject to timely and comprehensive information about possible risks. Taking into account the experience of the European Union in the development and correction the relevant legislative system will significantly increase the effectiveness of the measures to increase the export potential of domestic products.
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Matveevskaya, Anna S., Sergei N. Pogodin, and Juntao Wang. "Problem of human rights violations during the migrant crisis in Europe." Vestnik of Saint Petersburg University. Philosophy and Conflict Studies 37, no. 3 (2021): 508–15. http://dx.doi.org/10.21638/spbu17.2021.311.
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The aim of this study was to identify how Europe’s migrant crisis affected human rights in the European Union. It focuses on the observance of fundamental human rights in the context of migration. Violations directly related to migrants and refugees are considered. Human rights law is the most universal and general branch of law on which all other laws rely. The issue of observance of these rights becomes even more critical in regard to forced migration. While these rights are guaranteed to ‘all members of the human family’, there are conditions under which universally recognized human rights should be protected and justified with particular care. Obviously, inalienable human rights may easily be compromised when it comes to prisoners or refugees. Ensuring human rights in the European Union is based on a variety of international treaties, EU regulations and internal legislation of the member countries which have adopted high standards in the field of human rights protection. With regard to the right to asylum as an essential component of the human rights law, it can be stated that an unprecedented level of integration has enabled the EU to establish a pan-European asylum system based on the standards enshrined in the 1951 Geneva Convention and the 1967 Additional Protocol, as well as to gain considerable experience in dealing with migrants and refugees and ensuring their inalienable rights. In general, legislation in this area is constantly being improved and it reflects modern challenges and threats. The member countries of the European Union are on the way to developing a unified approach to migration policy and international protection issues. However, the asylum system is imperfect and has numerous gaps, which have been repeatedly mentioned by experts and members of the academic community even before the migrant crisis began.
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Ilona Kiel-Puślecka, Mateusz Puślecki, Marek Dąbrowski, Bartłomiej Janyga, Bartłomiej Perek, and Agnieszka Zawiejska. "Legal Aspect of Organ Donation after Death across Europe in Human Rights Context." Medicine, Law & Society 15, no. 1 (April 26, 2022): 1–24. http://dx.doi.org/10.18690/mls.15.1.1-24.2022.
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Clinical transplantation has proven to be lifesaving methods since last century. Organ transplants is still subject to ethical evaluation through the prism of basic standards of medical ethics and social phenomena that are not morally neutral. Transplant medicine has a clear social character. It is not only a relationship between a doctor and a specific patient. Authors analyzed existing postmortal donation models in European countries and the most important documents in the European legislation in securing universal rights to freedom and human dignity in transplantation area and identified 15 universal documents valid in Council of Europe and the European Union. Universal legal documents of European law protect human donor right to self-determination and integrity. Postmortal donation in transplantation performed in accordance with the applicable legislation and in the utilitarian dimension does not violate human dignity and the natural right of a person to decide about themselves.
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Demura, Marina I., Viktoriia A. Kononenko, and Nataliia A. Fedosenko. "CHALLENGES OF HEALTH CARE PROFESSIONALS' DISCIPLINARY AND CRIMINAL PROSECUTION." Wiadomości Lekarskie 73, no. 12 (2020): 2827–32. http://dx.doi.org/10.36740/wlek202012221.
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The aim of the research is to study the peculiarities of the legislative consolidation of criminal and disciplinary liability for offenses of health care professionals in Ukraine and other states. Materials and methods: Criminal legislation of Ukraine, international acts, decisions of the European Court of Human Rights (hereinafter - ECHR), data of the Integrated State Register of Judgments, as well as criminal legislation of Germany, the French Republic, the Kingdom of Denmark, the Republic of Belarus, Kazakhstan and many other countries. A set of general and special scientific methods of scientific knowledge was the methodological basis. The use of the comparative law method has become useful in the analysis of Ukrainian legislation and the legislation of other states. Conclusions: the article examined the features of the legislative consolidation of criminal and disciplinary liability for offenses of health care professionals in Ukraine and other countries. A comparative legal analysis of the legal enshrinement of the corpus delicti in the form of non-performance or misconduct of professional duties by a health care or pharmaceutical worker was carried out on the example of Ukraine and many other countries; types of penalties for medical crimes, which are established for this type of offense, were identified; sanctions for committing a disciplinary misconduct by a health care professional were determined on the example of the legislation of different countries.
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Čović, Ana. "The influence of judicial practice on the legislation in the sphere of LGBT community rights." Socioloski pregled 55, no. 3 (2021): 690–713. http://dx.doi.org/10.5937/socpreg55-32553.
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In the light of the announced adoption of the Law on Same-Sex Unions, the question arises whether the draft law is in accordance with the Constitution, especially after the announcements that the law will not be signed. Although the Constitution specifies that marriage is a union of a man and a woman, experts point out that in this case it is not a law on marriage and family, nor does it provide for the possibility of adoption of children by same-sex couples, but that it regulates property, health, pension and other legal relationships of same-sex partners living in the union. At the same time, many public figures have invited traditional religious communities to react in order to defend the "right to freedom and future of the people", emphasizing that contentious issues related to the regulation of mutual rights and obligations of same-sex couples could be resolved by amending the existing laws in those areas. In the countries where similar laws exist, case law has played a significant role, just as various medical and psychological associations. The European case law is not uniform, and cases often end before the European Court of Human Rights, while in the United States at the federal level, all anti-homosexual laws are repealed by a Supreme Court decision (Lawrence v. Texas, 539 U.S. 558 [2003]). Nevertheless, there is no single law in this area and the rights of same-sex couples vary from country to country. The paper will provide an overview of significant court decisions in this area in European countries, as well as the decisions of the US Supreme Court, which may lead us to think about the possible legal consequences of (non)adoption of the disputed Law on Same-Sex Unions, about procedures that could be initiated if partners decided to request judicial protection for the purpose of recognizing their guaranteed human rights, as well as the content and significance of such court judgments.
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Korneva, P. M. "Conflicting regulation of relations in the field of medical tourism: the experience of the European Union." Uzhhorod National University Herald. Series: Law, no. 65 (October 25, 2021): 364–69. http://dx.doi.org/10.24144/2307-3322.2021.65.66.
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The article is devoted to the study of the peculiarities of the conflict regulation of relations in the field of medical tourism in the European Union. The author analyzes the concept of «medical tourism» and other terms used to denote the phenomenon of travel of persons to foreign countries to receive medical services («cross-border healthcare», «medical tourism», «medical travel»). The article analyzes the regulation of the EU-member states and supra-national regulation of private law aspects in the field of medical tourism. In particular, the peculiarities of receiving medical care by citizens of the European Union, which are regulated with the Directive of the Euro-pean Council and the Parliament 2011/24 / EU on the application of patients’ rights in cross-border healthcare. The author concludes that the conflict regulation of medical tourism in the European Union is based on the general conflict rules on the conclusion and implementation of contracts in the field of services and insurance, as well as compensation for damage caused by improper performance of contracts or civil offenses (torts), resolving conflicts of jurisdiction, etc. Special conflict regulation of relations in the field of medical tourism in the European Union is not developed. At the same time, the author emphasizes the significant gaps in the conflict regulation of certain issues related to medical tourism, especially such debatable as cross-border surrogacy, organ transplantation, eutha-nasia and others. The author supports the view that for the countries of the European Union today in the context of medical tourism for the purpose of surrogacy in countries where such a procedure is legal, relevant today are issues of conflict regulation, such as determining the nationality of the child; recognition of paternity (origin of the child); recognition of birth certificates of a surrogate mother issued in other countries.
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Nikitchenko, Nataliia V., Andrii M. Khankevych, Dmytro V. Slynko, Tetiana I. Savchuk, and Viktor V. Lazariev. "A MEDICAL ERROR: DOES LAW HELP OR HINDER." Wiadomości Lekarskie 72, no. 4 (2019): 697–701. http://dx.doi.org/10.36740/wlek201904137.
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Introduction: Health systems and health policies across the European Union are becoming more and more interconnected and also more complex. This increased interconnection raises many health policy issues, including health care quality. Mistakes in medical care can occur anywhere in the health care system – at hospitals, doctor’s offices, nursing homes, pharmacies, or patients’ homes - and in any part of the treatment process involving wrong medication, improper treatment, or incorrect or delayed test results. The aim of the article is to develop adequate theoretical and scientific-practical proposals for the modernization of the legal regulation to protect patients’ rights aimed at observance of constitutional rights and freedoms. Materials and methods: In order to obtain the results the analysis of medical, labor and civil law norms are investigated. The article uses analysis and synthesis methods, as well as a comparative legal method. Review: A number of proposals are given for improving legislation in the area of eliminating obstacles to provision of qualitative primary care / medical-preventive care, prevention of formal attitude towards the patient, the implementation of preventive protection measures which should notify in advance about the violation of the law in the medical sphere. Conclusions: Ukraine urgently needs a legal mechanism to protect the rights of patients; it will become a systemic phenomenon and will consist of legal means, forms, ways by which the restoration of violated patients’ rights is provided, the support of protected interests by the law is maintained, legal disputes are resolved and other obstacles to realization of patients’ rights are overcome.
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Khassenov, M. K. "Some issues of labor regulation of medical and pharmaceutical workers in selected OECD countries." BULLETIN of L.N. Gumilyov Eurasian National University. Law Series 137, no. 4 (2021): 98–109. http://dx.doi.org/10.32523/2616-6844-2021-137-4-98-109.
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The article presents the results of a study of the legal basis for the labor activity of medical and pharmaceutical workers in some states that are members of the Organization for Economic Cooperation and Development (hereinafter - OECD). The author provides general features and specifics of labor regulation models in the healthcare sector. The article analyzes legislation and law enforcement. Thus, the European (continental) and Anglo-American models stand out, which differ in the direction of regulation. The first model is distinguished by the social orientation of labor regulation and public law regulation of disciplinary liability issues through quasi-state bodies of control and supervision. Whereas the second model provides for more autonomy to the parties to labor relations in establishing working conditions and private law regulation of disciplinary liability issues through self-regulatory professional organizations. The second model is more flexible, allowing more freedom to build labor relations with medical and pharmaceutical personnel, contributing to the development of the market for medical services and the efficiency of the health care system. The article substantiates the need for the reception of individual institutions and norms of labor and medical law of the states in question in the legislation of the Republic of Kazakhstan. In particular, there is a need for an independent law regulating the legal status of medical and pharmaceutical workers by analogy with foreign laws on the regulation of medical professions, in order to differentiate the norms that establish the specifics of the application of disciplinary measures, compliance with professional ethics and quality standards.
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Klimek, L., A. S. Hammerbacher, P. W. Hellings, W. J. Fokkens, H. J. Hoffmann, A. Muraro, and N. Papadopoulos. "The influence of European legislation on the use of diagnostic test allergens for nasal allergen provocation in routine care of patients with allergic rhinitis." Rhinology journal 53, no. 3 (September 1, 2015): 260–69. http://dx.doi.org/10.4193/rhino14.316.
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In patients with allergic rhinitis (AR), the nasal provocation test (NPT) is the standard procedure to evaluate the clinical response of the nasal mucosa to allergens with a high specificity and sensitivity. In AR, it is the only test that really measures the response of the diseased mucosa to allergens while skin prick test and serum IgE confirm the clinical suspicion of sensitization. Moreover, it is of special relevance in the detection of patients with Local Allergic Rhinitis (LAR), where general sensitization cannot be measured. For the evaluation of therapeutic interventions, NPT has been used for the clinical monitoring of antiallergic drugs and allergen specific immunotherapy. Legislation within the European Union (EU) defines allergens used for diagnostic tests like NPT to be medicinal products according to Directive 2001/83 EC, but national law is considering these products to be medicinal devices in a number of EU countries. Thus, NPT products are governed by different legislations and therefore standards throughout the EU. In consequence, allergens used for diagnostic purposes need different registrations and Marketing Authorization by national authorities. After a transition period, regulations of EU Directives are to be implemented in national law by all member states. At the moment, most EU countries have not fully implemented these Directives, however, it can be expected that most countries will implement it and enforce their rules within the next years. This development has a tremendous impact on the availability of diagnostic allergens for NPT in Europe and will make make nasal provocation testing very difficult if not impossible. We describe the current situation of diagnostic allergens under the special legislative conditions in the EU with special focus on allergen products used for NPT and the consequences for the diagnosis of AR and LAR.
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Kobzeva, T. A., and G. Yu Mykhnovsky. "SOCIAL AND LEGAL PROTECTION OF ORPHAN CHILDREN AND CHILDREN DEPRIVED OF PARENTAL CARE." Legal horizons, no. 19 (2019): 36–41. http://dx.doi.org/10.21272/legalhorizons.2019.i19.p36.
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This article is devoted to the study of the social and legal protection of orphans and children deprived of parental care in Ukraine and other countries of the world. The authors revealed the concept, nature, regulatory framework, types of bodies, state financial support, and directions of improving the protection of orphans and children deprived of parental care. It was emphasized that the social and legal support for the protection of the rights of orphans and children deprived of parental care in Ukraine needs to be further improved due to the issues of legislative consolidation and their practical implementation. According to our study, we conducted a statistical analysis of the number of orphans and children deprived of parental care, as well as of persons receiving retirement benefits. A number of scientific studies have been analyzed by scholars in the field of social assistance, labor law, and other jurisprudence related to retirement loss. Among the main areas of improvement, it was decided to amend the current legislation of Ukraine on the delimitation of the mediation activities regarding the adoption and professional activity of teachers and patron educators. Accordingly, recommendations were made regarding the possibility of establishing orphanages or foster homes, abandoning the system of general-type orphanages, and improving the conditions for the provision of foster care to a child. It was also proposed to create a legal framework that would regulate financial assistance for families with children and by improving the funding of regions, their programs, and strategies, and improving their financial situation. These regulatory issues have been analyzed with the addition of practical research from other scholars and jurisprudence. Ways of their solution and improvement of the current legislation have been adopted and developed on the basis of a thorough analysis of the legislation of the European Union countries. Keywords: legal regulation, social and legal protection, orphan, deprived of parental care, boarding school.
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Grigorieva, Tamara A., Svetlana P. Kazakova, Alena V. Kruzhalova, Regina V. Fomicheva, and Liliya G. Scherbakova. "Pandemic-Driven E-Justice in a Civil Process: Comparative Legal Analysis." Vestnik Tomskogo gosudarstvennogo universiteta, no. 472 (2021): 235–47. http://dx.doi.org/10.17223/15617793/472/28.
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The aim of the work is to identify gaps in the regulatory framework containing the rules and procedures for the actions of persons participating in the civil law process, in the presence of external factors, namely, during a pandemic, in order to improve procedural legislation based on the relevant experience of different countries. When conducting a study of legislation, judicial acts regulating the possibility of administering justice under quarantine conditions, general scientific methods of analysis, synthesis, generalization, forecasting, as well as specific scientific methods - comparative legal, formal logical, forecasting, were used. The regulatory framework, acts of courts regulating the issues of administering justice in conditions of self-isolation were analyzed. The features of the impact of the pandemic on judicial activities in Russia, in the Republic of Kazakhstan, in the European Union, as well as in the UK were revealed. Remote means of communication with the court were investigated, as well as consideration of a court case in a civil law process using the means of online interaction. In Russia, the pandemic, along with the use of electronic justice through the systems Moy Arbitr and Pravosudie, became an incentive for the introduction of online meetings in arbitration courts, various types of web conferences. In the Republic of Kazakhstan, quarantine measures became the reason for the greater use of the TrueConf service, the mobile courtroom. The European Union increased the interaction of courts in a distance format with the help of the European eJustice portal. The UK is distinguished by its progressive approach to the legislative settlement of the circumstances associated with remote proceedings. The tasks of electronic justice are set, which must be solved by Russia in an emergency situation. In conclusion, the authors infer that the pandemic had an impact on the introduction of new information technologies in the civil process. The technical component of e-justice is important, but it is impossible to ensure its implementation without fixing the procedural rules in the relevant codified sources. Despite the fact that the legal proceedings in Russia are at a high level and an example in this issue for other countries, it is necessary to refer to the experience of the Republic of Kazakhstan, where a special mobile application TrueConf was developed, which does not require stationary equipment and is more accessible to citizens without contacting specialists. As for the UK, in the authors' opinion, it is worth paying attention to the responsiveness of the legislature regarding the issues that need to be resolved in order to normalize the work of the judicial system in emergency situations during the pandemic.
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OSADCHUK, Mikhail A., Alexey M. OSADCHUK, Ekaterina D. MIRONOVA, and Karina S. SOLODENKOVA. "Global and Russian Reproductive Care in the Context of Medical Tourism: Ethical, Social, Economic and Political Issues." Journal of Environmental Management and Tourism 12, no. 6 (September 30, 2021): 1537. http://dx.doi.org/10.14505//jemt.v12.6(54).10.
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Cross-border reproductive care is a complex issue of the modern world that also impacts the Russian Federation. The main reasons for engaging in cross-border reproductive care are various legal, social, cultural, economic and religious factors, as well as national healthcare quality. In many countries, reproduction involving third parties, i.e., their sperm, eggs and embryos, is prohibited by law. This is why gamete donation is one of the main causes of pursuing CBRC in a foreign country, with Russia holding leading positions in this industry. Current stage of healthcare development makes Russia a major surrogate tourism destination, due to its common European culture and improved public health standards. Besides, Russia, as a multiethnic state where all religions are represented, has the most liberal legislation concerning infertility treatment. Fertility tourists have the same rights as Russian citizens in terms of assisted reproduction procedures, including obtaining the birth certificate regardless of biological relation to the child.
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Hretsa, S. M. "Types of constitutional responsibilities of man and citizen in Ukraine and in the European Union." Uzhhorod National University Herald. Series: Law 66 (November 29, 2021): 46–49. http://dx.doi.org/10.24144/2307-3322.2021.66.8.
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The article is devoted to the study of the range of responsibilities of man and citizen in Ukraine and the European Union, the formation of an approach to their classification. The following range of human responsibilities in the EU have been identified: equality between women and men in terms of pay; non-discrimination; respect for human dignity; receiving compulsory education; completion of compulsory school education. The following range of responsibilities of an EU citizen has been identified: to perform military service in relation to one of the EU member states; to be registered as conscripts in one of the EU member states. Such a range of human responsibilities has been established in Ukraine (strict observance of the Constitution of Ukraine and laws of Ukraine; non-encroachment on the rights and freedoms, honor and dignity of others; responsibilities in marriage and family; parents are obliged to maintain children until they reach adulthood adult children are obliged to take care of their disabled parents; to obtain a complete general secondary education; not to harm nature, cultural heritage; to compensate for damages; to pay taxes and fees in the manner and amount prescribed by law) and the duties of a citizen of Ukraine (protection of the Fatherland, independence and territorial integrity of Ukraine; respect for the state symbols of Ukraine). According to these criteria, the responsibilities of man and citizen are classified into the following groups: criterion "subject": 1) human responsibilities; 2) responsibilities of a citizen; by the criterion of "form of implementation": 1) individual; 2) collective; by the criterion of "content": 1) economic; 2) social; 3) cultural; 4) political; 5) others; according to the criterion of "source" of consolidation: 1) enshrined in the founding treaties of the EU; 2) enshrined in international (additional) EU agreements with international organizations and other countries; 3) enshrined in regulations, directives, recommendations; conclusions; 4) contained in the decision of the Court of Justice, the conclusions of the Court of Justice; 5) contained in the national legislation of the EU member states, third countries; 6) according to the criterion of the circle of subjects in relation to which they are assigned: 1) in relation to other people; 2) in relation to the world community; 3) in relation to future generations.
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Chakaldziyan, Mikael. "THE NORMATIVE REGULATION OF MEDICAL DEVICES – A GUARANTOR FOR THE PROTECTION OF PATIENTS’ RIGHTS AS USERS OF HEALTH SERVICES IN THE REPUBLIC OF BULGARIA." Knowledge International Journal 34, no. 5 (October 4, 2019): 1567–72. http://dx.doi.org/10.35120/kij34051567c.
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Health is envisaged as a right of the citizens both in the Constitution of the Republic of Bulgaria and in the Treaty on the Functioning of the European Union. Healthcare is subject to regulation by a number of secondary European legislation acts as well as by acts of our domestic legislation. The overall state policy on health care provision and development constitutes a complex set of diverse activities. Its quality is largely the result of strict and good-faith implementation of the normative regulations, addressing both public authorities and individuals. Exercising preventive medical procedures, adequate diagnosis and conducting successful treatment are undoubtedly essential parts of healthcare. This essential part is implemented by healthcare professionals with specific qualifications and by using medicinal products that contribute to achieving positive results in each patient's health in every individual case. In turn, medical equipment such as apparatus, instruments, materials and other supplies, plays an increasingly important and crucial role in the overall process of the actual implementation of medical assistance. Today, secondary European legislation determines medical equipment as a medical device and defines it. The continued development of science in the field of medicine, as well as in other fields, is an important factor in achieving ever greater opportunities for medical care and determines the significant place of medical devices in the provision of healthcare to a particular patient. Using them is often the only way to correctly diagnose a patient, though the cases where the medicinal product itself comes into contact with the patient's body through a medical device are also not isolated. The presence of the appropriate type of medical device and its corresponding level of quality are essential prerequisites for proper diagnosis and conducting a precise treatment procedure to achieve the optimal end effect. To ensure a positive result in the patient's health, medical devices must be safe and meet a number of quality requirements. The safety and quality of medical devices are a prerequisite for the actual realization of the right to healthcare for citizens. This report examines some administrative-juridical remedies for exercising control over medical devices, as well as certain obligations that individuals should carry out when performing activities related to medical devices. Bearing in mind the actual object of protection in medical law - the patient, and that one of the principles of consumer law is to protect the life and health of the consumer as an individual, it is concluded that medical and consumer law have the same object of protection and that is every individual. The report makes a comparative analysis of the administrative-juridical measures taken by the Medicines Executive Agency and by the Consumer Protection Commission. It also compares some of the obligations that private law entities need to observe in medical law in respect to medical devices and those of private parties in consumer law regarding goods.
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Varul, Paul. "Dear reader,." Juridica International 30 (October 13, 2021): 1–2. http://dx.doi.org/10.12697/ji.2021.30.00.
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This is the thirtieth issue of Juridica International. The first was published back in 1996, and, in general, one issue has been published each year since then. While 2007, 2008, 2014, and 2017 saw the publication of two issues each, no year has failed to feature. Though serving as a journal of the University of Tartu, Juridica International is also the only peer-reviewed legal journal published in Estonia to enjoy broad international distribution. Thus, for 26 years, it has been the calling card of Estonian jurisprudence on the world stage. However, it has been more than that. The involvement of foreign authors is just as important as the aim of providing Estonian authors with an opportunity to participate in international scientific discussion. There is every reason to be proud of the fact that the journal’s 30 issues have featured authors from 25 other countries: Austria, Belgium, Bulgaria, the Czech Republic, Denmark, Finland, France, Georgia, Germany, United Kingdom, Hungary, Italy, Kazakhstan, Latvia, Lithuania, Norway, Poland, Portugal, Romania, Russia, Slovakia, Slovenia, Sweden, Ukraine, and the USA. Among the authors are many who are in the uppermost echelon of the world’s leading professors in their field. In its first years, one of the main goals for Juridica International was to introduce and analyse the legal reforms carried out in Estonia, which were of vital interest to foreign readers as well; however, this has not been the case for a long time now. Today, the primary focus is on participation in international legal discussion, wherein, alongside the development of national law, great emphasis is placed on European Union law and other cross-border regulation whose reach extends between countries. That said, the purpose of introducing the development of Estonian law and legal thinking at international level has not been discarded. After all, Estonia is still highly noteworthy as a country of successful reforms, not least legal reforms. Therefore, a matter of ongoing interest is whether this country, which has succeeded so well with groundbreaking reforms, can be as successful in a stable situation across the board. The range of topics covered in the 30 issues of Juridica International is very wide; no important area of law has been neglected, and listing all of them would take too long. What could be highlighted above all are topics related to European Union law and the Constitution of Estonia, but also crucial are the writings on many issues related to aspects of the law of obligations, property law, company law, penal law, competition law, personal data protection, media law, medical law, international law, and several other fields. Significant attention has been paid to the possibilities for harmonisation of law and mutual interactions, both between countries and between distinct branches of law. Likewise, the writings have considered key general issues of law, such as its interpretation, the effect of justice policy on legislative drafting, and the protection of the fundamental rights and freedoms of individuals. The ability to publish a journal – and a reason to do so – exists only if readers are interested in that journal. What makes me the happiest is that, over the years, readers’ interest has increased and the geographical area within which people read Juridica International has grown. Most certainly, the fact that for quite some time the journal has been available online has contributed to this. A big ‘thank you’ to all of the readers! I also want to thank every one of the authors, the members of the editorial board, and my colleagues who have made it possible to publish 30 quality issues of Juridica International. I especially wish to highlight the contribution of the foreign members of the editorial board – professors Christian von Bar, Werner Krawietz (1933–2019), Erik Nerep, and Thomas Wilhelmsson – whose participation in the board’s work has played an important role in securing the solid international reputation of the journal. I hope for continued enthusiasm on the writers’ part and interest among readers for the next 30 issues!
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Marovic, Branko, and Vasa Curcin. "Impact of the European General Data Protection Regulation (GDPR) on Health Data Management in a European Union Candidate Country: A Case Study of Serbia." JMIR Medical Informatics 8, no. 4 (April 17, 2020): e14604. http://dx.doi.org/10.2196/14604.
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As of May 2018, all relevant institutions within member countries of the European Economic Area are required to comply with the European General Data Protection Regulation (GDPR) or face significant fines. This regulation has also had a notable effect on the European Union (EU) candidate countries, which are undergoing the process of harmonizing their legislature with the EU as part of the accession process. The Republic of Serbia is an example of such a candidate country, and its 2018 Personal Data Protection Act mirrors the majority of provisions in the GDPR. This paper presents the impact of the GDPR on health data management and Serbia’s capability to conduct international health data research projects. Data protection incidents reported in Serbia are explored to identify common underlying causes using a novel taxonomy of contributing factors across aspects and health system levels. The GDPR has an extraterritorial application for the non-EU data controllers who process the data of EU citizens and residents, which mainly affects private practices used by medical tourists from the EU, public health care institutions frequented by foreigners, as well as expatriates, dual citizens, tourists, and other visitors. Serbia generally does not have well-established procedures to support international research collaborations around its health data. For smaller projects, contractual arrangements can be made with health data providers and their ethics committees. Even then, organizations that have not previously participated in similar ventures may require approval or support from health authorities. Extensive studies that involve multisite data typically require the support of central health system institutions and relevant research data aggregators or electronic health record vendors. The lack of a framework for preparation, anonymization, and assurance of privacy preservation forces researchers to rely heavily on local expertise and support. Given the current limitation and potential issues with the legislation, it remains to be seen whether the move toward the GDPR will be beneficial for the Serbian health system, medical research, protection of personal data and privacy rights, and research capacity. Although significant progress has been made so far, a strategic approach is needed at the national level to address insufficient resources in the area of data protection and develop the personal data protection environment further. This will also require a targeted educational effort among health workers and decision makers, aiming to improve awareness and develop skills and knowledge necessary for the workforce.
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Pellico-López, Amada, María Paz-Zulueta, Jimena B. Manjón-Rodríguez, Mar Sánchez Movellán, Purificación Ajo Bolado, José García-Vázquez, Joaquín Cayón-De las Cuevas, and Laura Ruiz-Azcona. "Evolution of Legislation and the Incidence of Elective Abortion in Spain: A Retrospective Observational Study (2011–2020)." International Journal of Environmental Research and Public Health 19, no. 15 (August 5, 2022): 9674. http://dx.doi.org/10.3390/ijerph19159674.
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Background: According to the WHO, “unsafe abortion occurs when a pregnancy is terminated either by people lacking the necessary skills or in an environment that does not conform to minimal medical standards, or both”. Aim: To review the legislation that ensures access to elective abortion and the main indicators of elective abortion in Spain. Methods: A retrospective observational study was conducted across all regions of Spain from 2011 to 2020. The regulations of each region on the creation of the clinical committee and the creation of the registry of conscientious objector professionals were identified. Data were collected on rates of elective abortions per 1000 women, type of health center where the intervention was performed, interval of weeks of gestation, and cause. Results: After Law 2/2010 entered into force, the Spanish regions created a clinical committee; however, very few regions have a registry of conscientious objectors. During the study period, the average annual rate in Spain was 11.10 elective abortions per 1000 women between 15 and 44 years of age, showing a decreasing trend (annual percentage change of −1.92%). Only 10.67% of abortions were performed at public centers. In 90.18% of the cases, abortions were performed at the woman’s request. Conclusion: Spain legislated late compared to most European Union countries. The current law is similar to that of other member states, allowing abortion at the woman’s request in the first fourteen weeks and thereafter for medical reasons. Most abortions are performed at private centers, although many territorial inequalities are observed.
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Lee, Hyeong-Seok. "Expanded Access Program and The European Convention on Human Rights: Hristozov and Others v. Focusing on the Bulgarian Incident." Wonkwang University Legal Research Institute 28 (December 31, 2022): 433–63. http://dx.doi.org/10.22397/bml.2022.28.433.
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In recent years, medical technology is advancing day by day. Accordingly, the importance of protecting the rights of patients is emphasized. Methods and forms of ensuring patient rights vary from country to country.
In the EU, which consists of European countries, patient protection is guaranteed through the laws of the member countries, but also at the EU level. Although the rights of patients are directly guaranteed by law, it is also supplemented by precedents of courts, so it can be seen that the interest in the protection of patients' rights is generally high. Attempts are being made to guarantee patient rights locally through Directive 2011/24 on the rights of patients and cross-border health services of 9 March 2011 in the EU. This directive is the only document that guarantees patient rights in EU legislation. The purpose of this directive is to establish a system that guarantees the right of patients to enjoy health services across EU borders. In addition, a system that can be used in other countries based on the patient's right to receive medical services equivalent to that of their own country within the EU region and prescriptions issued in their own country was established. EU member states must improve their health care system to realize the purpose of the Directive.
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Goniewicz, Krzysztof, Amir Khorram-Manesh, Attila J. Hertelendy, Mariusz Goniewicz, Katarzyna Naylor, and Frederick M. Burkle. "Current Response and Management Decisions of the European Union to the COVID-19 Outbreak: A Review." Sustainability 12, no. 9 (May 8, 2020): 3838. http://dx.doi.org/10.3390/su12093838.
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COVID-19 has proven to be a formidable challenge for many countries in the European Union to manage effectively. The European Union has implemented numerous strategies to face emerging issues. Member States have adopted measures such as the closure of borders and significant limitations on the mobility of people to mitigate the spread of the virus. An unprecedented crisis coordination effort between Member States has facilitated the ability to purchase equipment, personal protective equipment, and other medical supplies. Attention has also been focused on providing substantive money for research to find a vaccine and promote effective treatment therapies. Financial support has been made available to protect worker salaries and businesses to help facilitate a return to a functional economy. Lessons learned to date from COVID-19 in the European Union are many; the current crisis highlights the need to think about future pandemics from a population-based management approach and apply outside the box critical thinking. Due to the complexity, intensity, and frequency of complex disasters, global leaders in healthcare, government, and business will need to pivot from siloed approaches to decision-making to embrace multidisciplinary and transdisciplinary levels of cooperation. This cooperation requires courage and leadership to recognize that changes are necessary to avoid making the same mistakes we have planned countless times on avoiding. This study focuses on the European Union’s initial response to the COVID-19 pandemic, starting with how the European Union first learned and processed the global information arising out of China, followed by the incremental population-based medicine/management decisions made that currently are defining the European Union’s capacity and capability. The capacity to organize, deliver, and monitor care to a specific clinical population under a population-based management target includes strict social distancing strategies, contact testing and tracing, testing for the virus antigen and its antibodies, isolation, and treatment modalities such as new mitigating medications, and finally, a vaccine.
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Gutorova, Nataliya, Oleksandr Zhytnyi, and Oleksii Soloviov. "FALSIFICATION OF MEDICAL PRODUCTS: CRIMINAL LAW MECHANISM COMBATING THREATS TO PUBLIC HEALTH." Wiadomości Lekarskie 72, no. 5 (2019): 856–61. http://dx.doi.org/10.36740/wlek201905124.
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Introduction: Every civilized state has the duty to its citizens to create an effective health care system, a necessary component of which is the use of safe and high-quality medical products. This duty is based both on the standards of international law and national constitutional norms and principles. The spread of falsified medical products poses a global threat to public health, can lead to death or cause significant harm to human health. Given the extreme risk of such acts, there is a need to create and operate an effective criminal law mechanism to combat such acts. The aim: The purpose of the article is to study the existing criminal law mechanism to combat the falsification of medical products at the international, regional and national levels (Poland and Ukraine as an example), as well as to develop proposals for improving of such a mechanism. Materials and methods: This study is based on the empirical and analytical data of the WHO, the United Nations Convention against Transnational Organized Crime, the Council of Europe Convention on the counterfeiting of medical products and similar crimes involving threats to public health (The Medicrime Convention), criminal legislation of Ukraine and Poland, General Prosecutor’s Office data on the criminal liability of those who committed falsification of medicines. Totally 28 laws and papers, 25 court judgments were analyzed. Dialectical, comparative, analytic, synthetic and system analyses research methods were used, also for interpretation purposes. Results: Falsification of medical products worldwide is characterized by high prevalence and is one of the highly profitable activities of transnational organized crime. Therefore, an effective counteraction to these crimes is impossible through isolated actions by one separate State and requires the establishment of a multi-level integrated mechanism to combat this phenomenon. The criminal law mechanism, as a necessary component of abovementioned mechanism, should be established at the international, regional and national levels. An analysis of the situation in Poland and Ukraine showed that the falsification of medical products is quite common in these countries, but national criminal legislation and practice of its implementation needs improvement. Conclusions: There is a need to create and implement an effective criminal law mechanism (at international, regional and national levels) to combat the spread of falsified medical products. At the international level, in order to increase the effectiveness of this mechanism, we fully support the EU initiative to amend the United Nations Convention against Transnational Organized Crime, which would establish additional liability for the falsification of medicines. Improving the criminal law mechanism to combat the falsification of medical products at the European regional level requires intensifying of The Medicrime Convention ratification process and full implementation of rules on criminal liability for falsifying medical products into national criminal legislation. At the national level, it is necessary to improve both the criminal legislation and the practice of its implementation, to intensify the activity of law enforcement agencies to combat these crimes, to ensure a fair trial and effective criminal penalties for those who have committed a crime of falsifying medical products.
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Capandová, Petra. "Selected Issues of Legislation with regard to Operating Pharmacies in the Slovak Republic / Vybrané problémy právnej úpravy prevádzkovania lekární v podmienkach Slovenskej republiky." Acta Facultatis Pharmaceuticae Universitatis Comenianae 62, no. 1 (June 1, 2015): 1–8. http://dx.doi.org/10.1515/afpuc-2015-0003.
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Abstract Among the basic rights and freedoms, stipulated in the Constitution of the Slovak Republic, are right to protection of health, free medical care based on health insurance, right to medical aids under conditions stipulated by law. These rights are guaranteed through provisions of Art. 40 of the Constitution of the Slovak Republic as part of Economic, Social and Cultural Rights and they apply to every individual. Since these rights are considered to be human rights under the international law, they are guaranteed by multilateral treaties in which Slovak Republic is a signatory, such as International Covenant on Economic, Social and Cultural Rights. Legal regulation of operating pharmacies in the Slovak Republic covers a broad scope of issues and is quite extensive. Through concerted legislative effort, the legislator had tried to set rules that would make the legal environment in this sector more transparent and easier to navigate through. In some areas, the rules were set by the legislature of the European Union (EU) and the Slovak legislature only adapted them. The most important aspect of legal regulation in this sphere that is not completely regulated by the EU legislature is providing pharmaceutical care and usage of the public health insurance system with regard to providing pharmaceutical care. The main aim of this study is to point out select issues that are associated with the position of a pharmacy operator and obligations stipulated in the Medicines Act 2011 that must be observed and incorporated into the running of a pharmacy. This area of business is fairly strictly regulated and therefore it is necessary to get acquainted with the relevant legislation. The study addresses several issues regulated by the Medicines Act 2011 or the Appropriate Pharmaceutical Practice Regulation 2012 from the legal-theoretical perspective.
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de Ávila, Renato Ivan, and Marize Campos Valadares. "Brazil Moves Toward the Replacement of Animal Experimentation." Alternatives to Laboratory Animals 47, no. 2 (May 2019): 71–81. http://dx.doi.org/10.1177/0261192919856806.
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In Brazil, efforts towards the regulatory acceptance and implementation of innovative methods to replace experimental animal use in various fields began to gather force in 2008, with the approval of Law No. 11,794/2008 (the Arouca Law). This law represented a milestone, as it created the National Council for the Control of Animal Experimentation (CONCEA) to deal with the ethical and legal issues related to the use of laboratory animals. In 2014, CONCEA put together a framework for expanding the implementation of non-animal methodologies for use in research and education. It also promoted the regulatory acceptance in Brazil of 24 test guidelines, including 15 in vitro approaches. It should be emphasised that, in Brazilian legislation, replacement is generally based on the toxicological endpoint and not on the category of product, as tends to be the case in other countries (e.g. cosmetics in the European Union). The resolution-dependent deadlines for the obligatory replacement of in vivo methods with the CONCEA-approved tests are 2019 and 2021. Brazil has advanced considerably towards the replacement of animal experimentation, and in certain aspects, this has been in a highly progressive manner. However, there is still a lot of work to be done, especially considering the current political scenario with reduced investment in research, development and innovation. The chronology of significant events following the approval of the Arouca Law, which have contributed to the promotion of the Three Rs alternatives in Brazil, will be examined.
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Arifkhodzhaieva, Tetiana, and Iryna Ponomarenko. "ECONOMIC POLICY OF THE STATE IN CONDITIONS OF INFORMATIZATION OF HEALTH CARE IN UKRAINE AS AN INTEGRAL PART OF THE SOCIAL SPHERE." Baltic Journal of Economic Studies 7, no. 5 (December 27, 2021): 228–34. http://dx.doi.org/10.30525/2256-0742/2021-7-5-228-234.
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The purpose of the article is to analyze domestic and international legal norms on the protection of medical information in order to improve the system of national legislation in the field of health care. The methodological basis of this study is a system of methods, the set of which is determined by the purpose and features of the study: dialectical, systemic, system-structural, analytical-synthetic, comparative-legal methods of analysis of domestic and international legal regulation of economic policy of the state in the conditions of informatization of health care of Ukraine. It argues that Ukraine, seeking to integrate into the European space and building its own strategy of economic development, must be clearly aware of both its capabilities and external factors of influence. The choice of possible alternatives is too complex a task, but the leading idea of socio-economic policy should remain the desire to ensure sustainable economic development of the country. In particular, the following is analyzed: recent international and domestic normative acts regulating state economic policy activities in the field of health care informatization in Ukraine: in particular, General Data Protection Regulation of the European Union (GDPR), CMS Interoperability and Patient Access Final Rule, ONC's Cure Act Final Rule, Order of functioning of the electronic health care system of Ukraine; materials of judicial practice, including materials of cases of the European Court of Human Rights, the results of sociological research. A comparative analysis of the GDPR and the Health Insurance Portability and Accountability Act (HIPAA) was conducted. The main problematic issues of state economic policy in the context of health informatization in Ukraine are highlighted. Compared to previous regulations governing medical data, the GDPR pays much more attention to the implementation of new requirements that have arisen due to the growing digitalization of healthcare, and therefore may contribute to strengthening their protection. Results. It is theoretically substantiated that quality medical reform is possible only with the introduction of modern methods of informatization and, consequently, information protection. As the analysis has shown, currently in Ukraine the legal system providing information protection in the medical sphere needs immediate improvement. This requires: systematizing and codifying national legislation in accordance with European legal norms and international law; developing a comprehensive legislative act, which would regulate the collection, protection and transition of medical information at the legislative level, following the example of GDPR (for structuring the medical information system, ensuring mandatory certification for information protection, development of cryptography/encryption technologies, delimitation of rights of access to information for medical workers, ensuring access to information with mandatory use of electronic signature, medical workers need to take short courses and register with information security specialists (defined access rights and the ability to change the level of access, provide input for identification and authentication), correcting data and entering new information is carried out with a confirmation of electronic signature, develop an algorithm for transferring information between medical institutions).
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Drastichová, Magdaléna, and Peter Filzmoser. "The Relationship Between Health Outcomes and Health Expenditure in Europe by Using Compositional Data Analysis." Problemy Ekorozwoju 15, no. 2 (July 1, 2020): 99–110. http://dx.doi.org/10.35784/pe.2020.2.11.
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The type of health system in each country and the resources devoted to it determine its outcomes. Relationships between ratios of expenditure to Gross Domestic Product (GDP) classified by provider and indicators reflecting health outcomes in 2015 are examined for 30 countries by means of a compositional data analysis and a regression analysis. The countries in the sample are the European Union (EU-28) countries plus Iceland and Norway. The outcome indicators used are life expectancy at birth (LE); healthy life years in absolute value at birth for females (HLYf) and for males (HLYm); and death rate due to chronic diseases (DR) (response variables). The results indicate that the higher the ratio of expenditure on retailers and other providers of medical goods in relation to other types of expenditure in the composition, the higher the DR indicator and the lower the LE indicator. The ratio of expenditure on residential long-term care facilities in the composition seems to have had a positive effect on both HLY indicators. The effect of expenditure ratios on providers of healthcare system administration and financing is not straightforward.
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Oelze, Ilse-Barbara, Kurt Neeser, and Elvira Müller. "PP31 Medical Device Regulation: What Is New?" International Journal of Technology Assessment in Health Care 35, S1 (2019): 42–43. http://dx.doi.org/10.1017/s0266462319001958.
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IntroductionIn 2017, the European Union (EU) commission released the final versions of the Medical Device Regulation (MDR) and In-vitro Diagnostic Device Regulation. These regulations will replace the EU directives (Medical Device Directive [MDD], In-vitro Diagnostic Device [IVDD], and Active Implantable Medical Device [AIMD]). EU regulations are effective in all EU countries at date of publication. In contrast, the EU directives must be implemented in national law first.MethodsGuidelines and respective legislation, consultation results and methods/medical device (MD) evaluations were reviewed and analyzed. Decision criteria and reasoning, assessment outcomes and potential impact on price negotiations were the main aspects for comparison.ResultsManufacturers have to be aware of the importance of clinical data for demonstrating the compliance of their products. This applies both to the approval of the products and the “post-market activities” and particularly to the “post-market clinical follow-up” for which requirements for Class I and II products need to be further developed. The MDR requires manufacturers to collect clinical data before and after approval, which could lead to excessive documentation requirements. The term “sufficient clinical data” from the MDR is unclear. A functional Eudamed specification is necessary, which enables an automated processing of relevant data. A stronger involvement in the evaluation process is needed as well as more transparency in the Joint Federal Committee (G-BA) and faster evaluation processes.ConclusionsThe MDR increases the burden especially for small businesses, and it is doubtable that the ultimate goal – improving patient safety – will be achieved. The increased demands and rising costs of the new EU MDR and bottlenecks at Notified Bodies can be a risk for the MD industry. Due to the general reduction in the remuneration for services with a high proportion of technical services, it is feared that products will be withdrawn from the market for economic reasons or that they will not be marketed.
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Drenska, Maria, Emilia Naseva, and Ilko N. Getov. "The knowledge and experience with the off-label use – results of a survey." Pharmacia 66, no. 4 (December 31, 2019): 217–21. http://dx.doi.org/10.3897/pharmacia.66.e46687.
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Introduction: The aim of this survey is to assess the current knowledge and experience of medical doctors in regard to off-label use and to determine whether it is legal, according to them, as the local current legislation on medicinal products does neither prohibit nor explicitly permit such use. Materials and methods: One hundred medical doctors from inpatient and outpatient medical care participated and answered 10 questions. The inclusion criteria were to have a degree in medicine and right to prescribe medications. Statistical analysis was performed using the SPSS v19.0 statistical program. Results: The results show that 8 out of 10 medical doctors have knowledge in regard to the meaning of the term “off-label”. More than half (62%) stated they have prescribed off-label medicine in their medical practice. Half of the respondents (49%) experienced some kind of trouble when prescribing off-label. In regard to whether the law allows this practice, opinions were divided. To a larger extent (88%), medical doctors support the introduction of clearer rules for off-label use in Bulgaria. Conclusion: Edical doctors have significant knowledge about off-label use, but feel uncertainty in their actions when they use medicines off-label. It is necessary to consider regulating this use at a national level, following the good examples of other European Union (EU) member states, until a harmonized solution within EU is found.
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Baulin, Yuriy, Borys Rohozhyn, and Inna Vyshnevska. "LEGAL REGULATION OF PROFESSIONAL OBLIGATIONS OF PHYSICIANS IN UKRAINE." Wiadomości Lekarskie 72, no. 9 (2019): 1839–43. http://dx.doi.org/10.36740/wlek201909224.
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Introduction: It was identified that one of the priorities of medical reform in Ukraine is the establishment of an effective system of legal regulation of professional physician’s obligations that meets European standards. However, the legal regulation of relations between actors in the field of health care lags behind the practice of their development. The aim to find out the status of legal regulation of the professional obligations of health workers, to identify the gaps in this regulation, to formulate proposals for improving the legal framework for the issue under investigation. Materials and methods: Legislation of Ukraine and certain European countries, international declarations and conventions, scientific works, 28 judgments of the European Court of Human Rights, 96 sentences of the practice of the national courts of Ukraine. Conclusions: During the study, the stages of determining the professional physician’s obligations were singled out, which would optimize the legislative process of regulation of obligations. One of the problems is the incorrect translation of protocols, which is assigned to a medical care institution. It was proposed to solve this problem by introducing a unified system of protocols and standards, the duty of translation and adaptation of which is entrusted to the central body of executive power in the field of health care. It is relevant to consolidate the duty of medical records management at the level of law, which will serve as a guarantee of ensuring the proper performance by the physician of a professional obligation to treat and diagnose a particular patient. In order to avoid cases of judgments, based on the results of the сommission’s assessment of the actions of a physician and to eliminate the number of cases of unjustified attraction of physicians to liability, it is necessary to consolidate a clear list of general professional physician’s obligations in a single regulatory act.
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Marushchak, Anatoly. "International-Legal Approaches and National-Legal Regulation of Counteraction to Misinformation." Information Security of the Person, Society and State, no. 31-33 (December 20, 2021): 64–71. http://dx.doi.org/10.51369/2707-7276-2021-(1-3)-7.
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The article analyzes some aspects pertaining to the issues of counteraction to misinformation. The subject of the study encompasses the relations arising in the field of international-legal and national-legal regulation of this activity. In March 2021, the Center for Counteracting Disinformation was established in Ukraine. Its development under the influence of threats to the state’s information security requires a detailed analysis of theoretical and legal foundations of countering disinformation, taking into account the fundamental principles of freedom of thought and speech. The aim of the article is to reveal international legal approaches and national legal regulation of countering disinformation. Theoretical methods of analysis, synthesis and comparison were used in the process of research. In particular, the work provided an analysis of international law, as well as the European Union initiatives aimed at combating misinformation. The comparative-legal method was used in conducting a comparative study of international and Ukrainian legislation. The article presents the outcomes of the analysis of the empirical basis of the study, namely: international law and domestic regulations of Ukraine, research works, etc. The methodological approach to the study of international legal issues and national legal regulation of countering disinformation is based on the fundamental principles of freedom of thought and speech and their mandatory consideration in the development of a new legislation. The research reveals the presence of several groups of government experts within the UN system who focused on studying the issues related to cyber operations, the use of ICT that contradicts the norms of a responsible behavior of states. They proved that the issue of countering misinformation had not yet been resolved. On the basis of the Tallinn Handbook 2.0 analysis, the author concluded that the interference in the spheres of elections, health care system and other areas pertaining to state sovereignty through disinformation operations could be interpreted as contrary to the international law provisions.
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Salihu, Ekrem. "Fiduciary Transfer of Ownership in Order to Secure the Satisfaction of Claim to Contemporary Right - Proposal De Le Lege Ferenda." European Journal of Multidisciplinary Studies 4, no. 1 (March 30, 2019): 6. http://dx.doi.org/10.26417/ejms-2019.v4i1-524.
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Fiduciary transfer of ownership in order to secure the claim satisfaction represents the form of non-possessory securing of claim satisfaction, which is experiencing the Renaissance in the transition countries and in the contemporary right. This form of non-possessory pledge right is not regulated by law in our own right, nor does it enjoy legal protection. Fiduciary transfer of property on the contemporary right and legal circulation is experiencing affirmation because of the essential advantages in relation to the real means of securing the claim satisfaction. The most important advantage of fiduciary agreements in relation to the pledge (mortgage) is the efficiency of the fulfilment of the claims, because there are no extensively long court proceedings in this institution. In addition to the fiduciary agreement, unlike the pledge right, the object that is subject to the fiduciary agreement, the debtor may keep such property under possession and may use it for the fulfilment of the obligations towards the creditor, thus offering practical benefits to the debtor itself. In the Republic of Kosovo, fiduciary agreements and fiduciary transfer of ownership are not regulated at positive rates. The author of this paper is committed to regulate this legal institute with positive provisions, i.e. the issuance of a special law for this institute, or the same to be included in the new Civil Code of Kosovo, as it is about an institute which has been applied for a long time by countries of the continental system and is experiencing renaissance also in the countries of the region (Slovenia, Macedonia, Montenegro, Croatia). The regulation of this institute with positive provisions would have a positive effect on legal circulation and faster economic development in Kosovo. At the same time, regulation of this institute with positive provisions would enable alignment and approximation of the Kosovo legislation with the European Union legislation. In this paper we will present the reasons why this institute should be regulated by special law or incorporated in the new Civil Code of Kosovo. However, despite the fact that local positive provisions do not particularly regulate the fiduciary transfer of ownership institution in order to secure the satisfaction of claim, nevertheless, this institute is not entirely excluded. Thus, the Law on Obligational Relationship of the Republic of Kosovo, in Article 429 provides for the ceding in order to secure "Where ceding is made in order to secure the claim satisfaction of the concessionaire against the cedant, the concessionary is obliged to behave with the care of a good economist, namely of a good housekeeper on the collection of ceded application and after the collection is completed, after keeping as much as it is needed to meet its demands against the cedant, shall hand him over the surplus.
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Hotsuliak, Svitlana. "Legal regulation of sanitary affairs in Europe in the 19th century." Law and innovations, no. 1 (29) (March 31, 2020): 65–70. http://dx.doi.org/10.37772/2518-1718-2020-1(29)-10.
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Problem setting. Since ancient times, guardianship of the health of the population has become an obligatory part of the foundation of a powerful state. Later on, special bodies began to be created, whose powers at first were limited only to the monitoring of food supplies, but with the spread of epidemics their role increased and spread around the world. In the 19th century, cities began to grow rapidly and the number of inhabitants increased. States were faced with the challenge of ensuring healthy living conditions. Analysis of recent researches and publications. The scientific research on this issue is reflected in the works: Derjuzhinsky V.F., Busse R, Riesberg A., Lochowa L. V., Hamlin C., Shambara K., Norman G. Scientists have analysed the regulatory framework of individual countries in the medical context. Target of research. Identification of the essence and features of sanitary legislation (including international sanitary conventions, interstate agreements on sanitation and epidemiology) operating in the territory of European countries in the XIX century. Article’s main body. The legal and regulatory framework for sanitation includes a set of legal, technical and legal standards, the observance of which involves ensuring that an adequate level of public health is maintained. European countries in the nineteenth century devoted considerable attention to sanitation not only in domestic law, but also in the international arena. Health protection, sanitation and preventive measures are reflected in many legislative acts, for example, the “Medical Regulations” (Prussia, 1725), the “Law on Health Insurance during Diseases” (Germany, 1883) and, in Austria, the “Health Statute” (1770), the “Public Health Act” (Great Britain, 1848 and 1875) and the “Medical Act” (Great Britain, 1858) and the “Public Health Protection Act” (France, 1892). The legislative acts formulated the powers of sanitary authorities, and in the same period, works on the impact of ecology on human health and on the importance of a healthy lifestyle appeared. The State has a duty to protect citizens who have the sole property, their labour, but health is essential to work. Separately, it should be noted that in the middle of the XIX century elements of the international health system began to emerge in Europe. In particular, starting from 1851. At the initiative of France, a number of international conferences on sanitation were organized in Paris. Subsequently, such conferences were held in Constantinople (1866), Vienna (1874), USA (1881), Rome (1885), Dresden (1893). These conferences addressed various issues of sanitation and the fight against epidemic diseases. At the same time, the application of land and river quarantine in Europe was considered impossible by most delegates. Instead, the use of “sanitary inspection” and “observation posts” with medical personnel and the necessary means for timely isolation of patients and disinfection of ships was recommended Conclusions and prospects for the development. Thus, the forms of organization of national health systems in Europe in the 19th century were diverse. Each country created and developed its own unique systems, different ways of attracting financial resources for medical care and health preservation. Thanks to the development of the legislative framework, water supply, sewerage, working and living conditions, sanitation and hygiene have improved. International cooperation to combat epidemics has made a significant contribution to the development of effective and progressive legislation in the international arena, and has greatly influenced the creation of appropriate domestic legislation in Member States, developing more effective models to combat epidemic diseases.
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Dierks, Christian. "Legal Aspects of Telepathology." Analytical Cellular Pathology 21, no. 3-4 (2000): 97–99. http://dx.doi.org/10.1155/2000/563904.
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In some legal surroundings telepathology is considered a breach of registrational barriers. The recommendation of the G 8 states in Europe for required legislation in telemedicine suggests to recognise that the localization of the remote health care professional defines the site not only of licensure but also of liability. This approach must be considered helpful, since it can solve many problems brought about by the doubtful results of private international law and conventions like the European Union (EU) and Lugano Convention. Under today's conditions in private international law it must be considered essential to agree upon a choice of law and stipulate a court of jurisdiction when doing telepathology. However, the opposing aims of insuring the patients claims and avoiding jurisdictions that exceed the local expectations of the medical professional must be reconciled. Data protection and data security are other crucial topics that require attention. Generally speaking, the principles of minimum data exchange, anonymity, pseudonymity and cryptography must be established as a basis for all telepathology procedures. Only when personal data is needed, its use can be legitimated. Written consent of the patient is advised. To guarantee a cross‐border security level the regulations of the EU‐Data Protection Directive need to be transformed into national law. In practise, cross‐border dataflow shall only take place where the security level can be maintained even within the other country. Finally, reimbursement questions must be answered to establish a sound economical basis for telepathology. The spatial distance between the participants may yield the question, whether the service has been rendered to an extent necessary and sufficient for reimbursement. If reimbursement takes place on a cross‐border or cross‐regional level, severe disturbances of the health systems can occur. Regulation schemes or treaties need therefore to be developed to avoid such disturbances and encompass mutual standards of care as well as methods to balance reimbursement.
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Kudeikina, Inga, and Karina Palkova. "The right to health in context of ensuring the best interests of the child." SHS Web of Conferences 51 (2018): 01015. http://dx.doi.org/10.1051/shsconf/20185101015.
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The right to health is one of the human fundamental rights. In present socio-legal area in health security issues, the human as an unconditional obedient patient, transforms into medical practitioner's associate, actively participating in all discussions of issues, which affect his health and executable medical manipulations. The human from medical object has turned into the medical subject. As exceptions can be mentioned persons who, for objective reasons, are not able to exercise their rights in full. One of such person group is children. Children have no capability to exercise their rights themselves. Therefore it is important to understand whether the volume of child's right is equal to the volume of adult's rights. Conditionally, we can say that in the stage of exercising the right, children depend on their representatives. The article will provide information on the issues, which affect child's right to health in context of ensuring the best interests of the child in Latvia according to the local and the European Union legal documents. In addition, the article will show the mechanism for dispute resolving, which may occur between a medical institution (doctor) and a person, who represents the child in Latvia. Both international and national legal acts stipulate that a child requires a special care, which includes ensuring the best interests of the child. It is essential that the concept “best interests of the child” is not defined in legislation and in all cases it is subject to interpretation of the adopter of the law (the user). On the fact, how fully the child's natural or legal guardians will defend the interests of the child, depends observation of the child's fundamental right – right to health. To find the answers to the current research questions descriptive, analytical, deduction-induction methods, etc. are used.
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Goniewicz, Krzysztof, Eric Carlström, Attila J. Hertelendy, Frederick M. Burkle, Mariusz Goniewicz, Dorota Lasota, John G. Richmond, and Amir Khorram-Manesh. "Integrated Healthcare and the Dilemma of Public Health Emergencies." Sustainability 13, no. 8 (April 19, 2021): 4517. http://dx.doi.org/10.3390/su13084517.
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Traditional healthcare services have demonstrated structural shortcomings in the delivery of patient care and enforced numerous elements of integration in the delivery of healthcare services. Integrated healthcare aims at providing all healthcare that makes humans healthy. However, with mainly chronically ill people and seniors, typically suffering from numerous comorbidities and diseases, being recruited for care, there is a need for a change in the healthcare service structure beyond direct-patient care to be compatible in peacetime and during public health emergencies. This article’s objective is to discuss the opportunities and obstacles for increasing the effectiveness of healthcare through improved integration. A rapid evidence review approach was used by performing a systematic followed by a non-systematic literature review and content analysis. The results confirmed that integrated healthcare systems play an increasingly important role in healthcare system reforms undertaken in European Union countries. The essence of these changes is the transition from the episodic treatment of acute diseases to the provision of coordinated medical services, focused on chronic cases, prevention, and ensuring patient continuity. However, integrated healthcare, at a level not yet fully defined, will be necessary if we are to both define and attain the integrated practice of both global health and global public health emergencies. This paper attains the necessary global challenges to integrate healthcare effectively at every level of society. There is a need for more knowledge to effectively develop, support, and disseminate initiatives related to coordinated healthcare in the individual healthcare systems.
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Perkhov, V. I., S. I. Kolesnikov, and E. V. Pesennikova. "Formation of public-private model in Russia health care organization." Acta Biomedica Scientifica 6, no. 3 (August 17, 2021): 216–26. http://dx.doi.org/10.29413/abs.2021-6.3.22.
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The pandemic of COVID-19, the threat of technogenic and anthropogenic character, brought to the foreground non-market aspects of the general, corporate branch culture and strategy in medicine and health care. Therefore, in many countries, despite differences in state and private property ratios in health infrastructure, the state priority is ensuring cooperation within the national health care system which capable quickly and well-coordinated work in the extremely dangerous epidemics conditions and other emergency situations. The purpose of this article is discussing a problem of public and private models of medical care organization in Russian health care system.Materials and methods. Content analysis methods, economical and statistical analysis, information and analytical materials of the Russian and foreign news agencies, a summary across Russia of Rosstat form No. 62 of the state statistical observation «Data on resource providing and on delivery of health care to the population» (legal entities - the medical organizations which are carrying out activity in the sphere of compulsory health insurance), analytical materials and statistical data of World Health Organization (The European portal of information of health care of WHO: https://gateway.euro.who.int/en/hfa-explorer/), statistical data and metadata on the countries of the Organization for Economic Cooperation and Development (OECD, https://stats.oecd.org/), the materials of monographic researches and periodicals including placed on the Internet were used in this article.Results: the system of compulsory health insurance is an ancestor of the program of the state guarantees of free medical care of in Russian citizens. The length of the text of this Program so far was increased in 130 times in comparison with initial edition of 1998. At the same time, there is still no clear delineation for the bases, volumes and conditions differentiation of free and paid medical care rendering. As a result, the major human right to free medical care remains not completely realized. The numbers of the non-state medical organizations to provide free of charge medical care to the population according to the policy of obligatory medical insurance (i.e. financed from the state sources) in the period of 2011 to 2019 – from 648 to 2423 organizations respectively were increased in Russia four times. This demonstrates the creation of the new, «integrated» model of health care in Russia in the mode of public and private partnership for deciding of social tasks. Although, free medical care for citizens in the private medical organizations is not mentioned in the Constitution of Russian Federation (Main Law). In emergency situations such integration allows private medical structures to involve capacities and also be coordinated with one of the tasks of the Ministry of health target program «Development of the Fundamental, Transmitting and Personalized Medicine».Conclusions. There is a formation of the integrated, public and private (hybrid) model of health care in modern Russia that needs developing of a new partnership and principles of management in the sphere of medical care organization. State policy in the health care financing sphere should be directed not only to the state guarantees of medical care specification, but also to a gap in social and economic inequality reduction. The social protection systems should be focused, first of all, on people who are most in great need of medical care. For the protecting population from catastrophic payments for medical care, it is necessary to bring the concept of the social standards - a number of the general rules, norms and standards which must guarantee the state ensuring constitutional rights of citizens to free medical care in the health care legislation.
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Kyrsanova, Maryna. "The right to euthanasia in the context of the right to life guaranteed by the European Convention of human rights." Law and innovations, no. 2 (30) (June 2, 2020): 105–10. http://dx.doi.org/10.37772/2518-1718-2020-2(30)-16.
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Problem setting. Increasingly, European countries are legalizing euthanasia nationally. At the same time, this issue is a circle for scientific debate, as some experts believe that it is a natural human right that can be disposed of at its discretion. Others emphasize that no one can interrupt a person’s life, even herself. In order to summarize all positions and to determine unanimity on certain aspects of euthanasia, it is necessary to refer to the provisions of the European Convention of Human Rights, which in art. 2 proclaims the right to life and the case law of the European Court of Human Rights, which has argued for the possibility of a “right to die” as part of the right to life. The purpose. Analysis of the legal position of the European Court of Human Rights regarding the possibility of applying the euthanasia procedure, exploring the prospects of introducing this procedure into the national law. Analysis of recent research and publications. The problem of euthanasia is a matter of debate in the scientific community. This topic was researched by А.В. Malko, AS Nikiforova, O.V Khomchenko, I.O Koval, O.M Mironets, O.A Miroshnichenko, Yu.S. Romashova, K. Basovskaya, Yu.M. Rybakova, O.M Shchokin, S.V Chernichenko. Article’s main body. In science will distinguish 2 types of euthanasia - active and passive. Active euthanasia involves actions aimed at ending the life of a sick person, for example, by administering a lethal injection. Passive euthanasia involves discontinuation of medical care for a patient at his will, which in the future leads to death. Considering the issue of passive euthanasia, the European Commission concluded that it could not be interpreted art. 2 of the Convention as such, which gives the right to death, but everyone has the right to dispose of his life by giving appropriate instructions in the event of an incurable disease.. The issue of the “right to die”, the right to active euthanasia has been resolved in the case of Pritty v. The United Kingdom. The European Court of Human Rights in this case was not convinced that the “right to life” guaranteed by Article 2 of the Convention could be interpreted negatively. As for Ukraine, euthanasia in our country is being prosecuted and considered a crime. In particular, according to the Fundamentals of Healthcare Legislation, medical professionals are prohibited from taking deliberate actions aimed at ending the life of a patient who is terminally ill to end his or her suffering. The Civil Code of Ukraine contains a similar warning about the prohibition to deprive a person of his life at his request. Conclusions.The European Court of Human Rights does not consider that the content of art. 2 of the Convention it is possible to derive the “right to die”. This right does not come from the right not life, is not an independent right, can not be a fundamental right, to which all the guarantees of art. 2 of the Convention. With regard to passive euthanasia, the ECtHR does not, in fact, prohibit it; it proceeds from the human right to dispose of one’s life. Speaking about the introduction of the euthanasia procedure in the national legal order, the ECtHR did not give a clear assessment on this issue. In fact, the ECtHR has taken the position that it is not entitled to assess national legislation in terms of introducing effective mechanisms to protect their citizens’ right to life.
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Briko, Nikolay I., P. I. Melnichenko, V. R. Kuchma, N. I. Prokhorov, and Yu V. Pavlova. "DEONTOLOGY IN PREVENTIVE MEDICINE: SCIENTIFIC AND HISTORICAL BASES, CHALLENGES OF THE PRESENT AND SOLUTIONS." Hygiene and sanitation 97, no. 5 (May 15, 2018): 389–95. http://dx.doi.org/10.18821/0016-9900-2018-97-5-389-395.
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The article presents the peculiarities of medical deontology in preventive medicine. The differences between deontological problems in the activity of a Clinician and a Physician in the specialty of medical and preventive medicine are considered. The historical stages of the formation and development of ideas of deontology and medical ethics in Russia are shown. The comparative plan presents an analysis of the main legislative acts in the field of bioethics and deontology of medical and preventive medicine. The world community was noted to show a great interest in topical problems of bioethics: several World Congresses and European Conferences were held, in most countries of Europe and America national bioethics committees were established (in the USA and France they were organized under the Presidents of these States). The main goal of the doctor’s professional activity is to preserve human life, prevent diseases and restore health, as well as reduce suffering from incurable diseases. Much attention is paid to this problem in the Federal law of November 21, 2011. (N 323-FZ) about bases of the protection of the health of citizens in the Russian Federation “which is fundamental in the field of healthcare”. It establishes the obligation of medical and pharmaceutical workers to carry out their activities in accordance with the legislation of the Russian Federation, guided by the principles. The aim of this study was to develop and substantiate the main differences between deontological problems in the activities of clinicians and physicians in the specialty medical and preventive care in the historical aspect. An invaluable role in the development of the principles of deontology was played by outstanding doctors of the past: Hippocrates, Abu-l-Faraj, as well as Russian and Soviet scientists and doctors M.Ya. Mudrov, 8N.I. Pirogov, V.A. Manassein, V.I. Davydovsky, N.Kh. Petrov, B.V. Petrovsky. Separately, it is noted that the role of medicine can be radically changed, if not exclude the importance of the preventive direction, but, on the contrary, through it to strengthen the ideological and controlling.
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Korzeniowski, L. F., Ye Lytvynovskyi, and L. Vinnikova. "STATE CONTROL OF SECURITY EDUCATION IN THE REPUBLIC OF POLAND." Collected Scientific Papers of the Institute of Public Administration in the Sphere of Civil Protection 7 (December 22, 2019): 87–105. http://dx.doi.org/10.35577/iducz.2019.07.08.
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Civil security is a newly formed field of education in Ukraine that was preceded by civil defense and civil protection fields. Nowadays, the sphere of population protection from emergencies in Ukraine is one of the most non-identified spheres in its categorical apparatus.
The mentioned above and the necessity to examine civil protection’s condition in order to develop a new strategy in the shortest period of time, including training specialists in this field, initiated the necessity to find the best practices.
The process of rapprochement with the European Union countries demands research on the state control experience of the neighboring countries. The last research has stopped on the Polish experience.
Studying the Republic of Poland’s state control experience in training specialists for the security sector was not the subject of the previous research.
The aim of the article is to represent the current condition of the state control of education in the security sector of the Republic of Poland through the professional qualifications occurrence and educational standards development.
It is initial to be acquainted with the peculiarities of the system, regulatory enactments that control its work in order to analyze the state of training specialists for a certain system. In Poland such specificity is recognized by the two management in emergency situations state systems such as Population Protection and Crisis Management.
All legislation and regulations mentioned in the article are the bases of the state regulatory policy in the sphere of training specialists for the security sector. Moreover, the state regulation occurs through the process of professional qualifications recognition. As for organization of specialists training for the security sector, it should be mentioned that the basic regulatory act is the higher education standard.
It is worth noting that in Poland, at the University level, the specialization ‘Security Management’ at the Faculty of Management and Marketing, ‘Security Administration’ at the Faculty of Administration and ‘European Security’ at the Faculty of European Studies has occasionally appeared since 2003.
And only in 2006 the Minister of Science and Higher Education introduced the new directions of education development and later, the new standards which allowed State Higher Educational Establishments to train specialists at the faculties of the first and second education levels in such specialties as National Security, Internal Security, Safety (Security) Engineering and Emergency Medical Service (Care).
In addition, since 2011 the new Higher Education National Qualification Framework has been introduced with the demand to the academic results (knowledge, skills, social competence) for general academic specialization and for practical specialization in the fields of education, and in regard to security, in the field of humane sciences. The context of these educational standards is analyzed in the article.
Taking everything into consideration, we can arrive at the conclusion that similar to Ukraine there is an open status issue on discrepancy between the requirements of the job market and the number of specialists trained for the security sector. The arrangement of the number of educational establishments that train specialists in the sphere of civil protection and the estimation of the job market needs in their services would be rewarding for Ukraine to gain from Poland’s experience.
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Jianjiang, Wang. "Where is Bie-Modern Going? Responding to Professors who study Bie-modern Theories." Asian Journal of International Affairs 1, no. 1 (December 31, 2021): 55–65. http://dx.doi.org/10.3126/ajia.v1i1.44752.
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“Bie-modern” is a theory about social form. It refers to “doubtful modernity” or pseudo modernity, manifested in the hybridity of the modern, pre-modern and post-modern. At present, Bie-modern theory is applied in philosophy, aesthetics, literature, linguistics, art, design, psychology, tourism, law, economics, and Human-Computer Interaction. Bie-modernism is to seek the direction of future development in the mixed society and to reduce human misjudgments and errors on the way forward. Therefore, it is the priority of Bie-modernism to distinguish between truth and falsehood. Where is Bie-modern going? Firstly, we shall leave the ambiguity of the word “Bie”, to distinguish the difference between Bie-modernism and “plural modernity”, to distinguish true and false modernity, to distinguish the difference between Bie-modernism and modernism and post-modernism. Secondly, towards authenticity, to seek the truth and reality and implement the real modernity. Thirdly, we will be implementing life equity/life stocks, an inherent right to life of every individual, and the share that the right to life holds in the total wealth of society that cannot be deprived, transferred for the whole of their life, that means the right to enjoy free medical care, free education, free old-age pension, and the right to food, clothing, housing, and transportation. To realize human life equity/life stocks, the historical mission of society lies in eliminating the proletariat rather than the bourgeoisie. Life equity/life stocks is a primitive and real right, which is not influenced by acquired ideas and has the most irreplaceable dignity and value of life. Life equity/life stocks are closely related to human well-being and aesthetic feeling, and it has become the source of both. Lastly, we will be upholding “Bie”, the distinguishing, to the end through entering the ideological market and keeping authenticity, implementing life equity/life stocks, and the Great-leap-forward Pause of Bie-modernism. At present, Bie-modernism has rippled in the United States and the European Union. In the future, we will bring it to more countries and regions. The future development of Bie-modernism will focus on returning to the origins and implementing life equity/life stocks.
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Šarotar Žižek, Simona, Matjaž Mulej, and Živa Veingerl Čič. "Results of socially responsible transformational leadership: increased holism and success." Kybernetes 46, no. 3 (March 6, 2017): 400–418. http://dx.doi.org/10.1108/k-06-2016-0129.
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Purpose The aim of this paper is to present a research on how – the extremely necessary – systemic rather than one-sided and short-term behavior can enjoy support from (corporate and individual) social responsibility (SR) enhanced by transformational leadership as a source of success. Design/methodology/approach Based on the previously published empirical research, the authors use qualitative research methodology including desk and informal field research, the Dialectical Systems Theory and its law of requisite holism. Findings The entire humankind is in big trouble and facing the danger of the Third World War resulting from the “war against terrorism” proclaimed in USA in 2002 and making close to 100 million persons need relief aid; this situation is because of monopolies in the global economy, both business and government monopolies. Application of knowledge that might be able to solve the problem depends on values, culture, ethics and norms that prevail in all/any entities from families via corporations and other organizations, countries, international entities (such as European Union) to the entire world and humankind (and its United Nations Organization). The most influential of all of them are the corporations, hence, their corporate governance and strategic management. Hence, they should urgently implement SR principles and methods supporting its realization instead of the prevailing short-term and one-sided criteria of right and wrong, for clear and proven economic reasons; satisfied and healthy people are causing much less cost and trouble than strikes, medical care, renewal of safe natural environment, wars, unhappy/abused partners, etc. Research limitations/implications The hypothesis is researched to the greatest extent possible, with qualitative analysis in desk and field research. Quantitative methodological approach took place in the cited previous publications. Practical implications For humankind and managers, the use of the transformational leadership is very important because of its positive impact on health and well-being of employees and, hence, on humankind’s survival in the current global socio-economic crisis. Social implications Good health and well-being of employees reduce many societal troubles and related cost resulting otherwise from the too short-term and narrow-minded behavior of managers and employees, potentially their families as well, all way to tens of millions of homeless migrants, killed and injured people, children with no chance for education, etc. Originality/value No similar concept is offered in the available literature.
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周伯翰, 周伯翰. "生技產物或方法相關專利法制之研究." 中正財經法學 18, no. 18 (January 2019): 93–214. http://dx.doi.org/10.53106/207873752019010018003.
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近年來，各種生技產物或方法無論於技術研發或實際應用上均快速成長，因此關於何種生技產物或方法得授予專利，以及生技產物或方法之專利權人行使該等專利的權利範圍是否應加以限制與如何限制所衍生之爭議也愈來愈多，而專利法制先進之國家或地區無不企圖藉由司法裁判或增修法規以解決此等問題。美國法制上與專利之申請及應用有關之規範涵蓋範圍甚廣，包括35 U. S. C. §101、§102及§103所訂有關得成為申請專利之標的之條件及其他申請專利之要件、35 U. S. C.§112所訂有關專利說明書之記載方式與內容、35 U. S. C. §287（c）所訂醫療從業人員及健康照護相關機構利用有關醫療的生技產物或方法之專利從事醫療活動得適用責任限制之條件及其範圍；美國專利商標局公布的「實用性審查基準」中有關基因之成分可授予專利的條件；美國專利商標局在2018年修正公布的「專利審查程序手冊」有關如何判斷「專利標的之適格性」與如何適用「標的適格性之兩部標準」所進行的說明；以及由美國聯邦最高法院與美國聯邦巡迴上訴法院之判決所建立的關於生技產物或方法是否能取得專利之判斷標準，此部分之內容將於本文第二部份詳加分析說明。歐洲相關公約與法制中為有效解決生技產物或方法是否能取得專利之問題，主要由歐洲專利公約與歐洲專利公約執行規則的相關規定；歐洲議會與理事會公布的相關指令；以及歐洲專利局與歐洲法院的相關案例建立其判斷標準，此部分之內容將於本文第三部分詳細說明。在台灣，有關生技產物或方法是否能作為申請專利之標的，以及生技產物或方法是否符合發明專利審查之要件，其主要規範為專利法第24條第2款及第3款、第22條第1項及第2項、第26條第1項；專利審查基準第2篇第2章及第14章；以及智慧財產法院的相關案例對於生技產物或方法是否符合專利要件之見解，此部分之內容將於本文第四部份詳細分析說明。本文之內容係綜合研究生技產物或方法之專利對於生技產業之研發誘因、改良發明之技術障礙、醫療倫理與醫療資源之妥適性等層面之影響，並檢討有關醫療的生技產物或方法是否應授予專利及其專利權人行使該等專利之權限應如何限制較為合理。最後，對於與生技產物或方法之專利有關的重要議題進行比較分析與彙整討論，並提出相關建議，作為台灣的專利相關規範適用與修訂之參考，以促進台灣有關生技產物與生技方法之專利法制能夠健全發展，期能有助於台灣的生技產業之成長與人民福祉之提升。 In recent years, various biotechnological products and processes all rapidly grow regardless of the technology research and development or the practical application, so are the issues which biotechnological products and processes can be granted patents, whether the fields of the patents should be limited and how it will be done; therefore, a number of the advanced countries or regions of the various patent legal system all attempt to resolve the issues by the judicial judgments or upgrading regulations. The scope covered by the provisions related to the application and use of patents in the U.S. legal system is very wide, including the conditions for being a patentable subject set by the United States Patent Law Article 101, Article 102 and Article 103, the manner and content recorded in the patent specification set by the United States Patent Law Article 112, the conditions and its scope of the limitation of liability for the medical practitioners and the products and processes in relation to medical therapy to practice medical activities set by the United States Patent Law Article 287 (c); the conditions for being patentable genetic components set by the “Utility Examination Guidelines” published by the United States Patent and Trademark Office; the interpretations with regard to how to determine “Patent Subject Matter Eligibility” and how to apply “Two Criteria for Subject Matter Eligibility” set by the “Manual of Patent Examining Procedure” amended and published by the United States Patent and Trademark Office in 2018; the criteria for the patentable biotechnological products and processes established by the decision of the Supreme Court and the Court of Appeals for the Federal Circuit in U.S. The previous provisions will be particularly analyzed and explained in the Part 2 of this Article. On the relevant European conventions and the legal system to effectively solve the problem of the patentable biotechnological products and processes, respectively, it relies on the provisions of the directive published by European Parliament and the Council of the European Union, the European Patent Convention, and the Implementing Regulations to the Convention on the Grant of European Patents; the criteria established by the related case of the European Patent Office and the Eurpean Court. The previous provisions will be particularly explain in the Part 3 of this Article. In Taiwan, the provisions related to whether the biotechnological products and processes are patentable and match the requirement of the examination of the inventions are mainly regulated in Taiwan's Patent Law Article 24, Item 2 and Item 3, Article 22, Item 1 and Item 2, Article 26, Item 1; the Patent Examination Guidelines in Chapter 2 and Chapter 14; the criteria for the patentable biotechnological products and processes established by the decision of the Court of the Intellectual Property. The previous provisions will be particularly analyzed and explained in the Part 4 of this Article. biotechnological products and processes for the effects on the R & D incentives of biotechnology industry, the technical barriers to the improvement of the inventions, the appropriation of medical ethics and health care resources, the review on whether the biotechnological products and processes in relation to medical therapy are patentable and how it is more reasonable to limit the exercise of such patent of patent holders. Finally, by comparing, analyzing and collectively discuss the important issues regarding the patents of the biotechnological products and processes and providing suggestions as the references for the application and the modification of Taiwan's patent-related legal provisions, in order to promote the sound development and the patent-related legal systems of the biotechnological products and processes, so as to look forward to assisting the growth of the Taiwan's biotechnology industry and the promotion of the public welfare.
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"The Process of Health Legislation Reform in the Republic of Slovenia." European Journal of Health Law 7, no. 1 (2000): 73–84. http://dx.doi.org/10.1163/15718090020523061.
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AbstractSlovenia was among the first European countries to introduce laws and regulations in the social security field, including public health. The current health legislation is the culmination of a century-long development of the health care system through different periods and diverse political and economic conditions affecting the region. The present organization of the health care system reflects the pattern of partnership which already existed in the former Yugoslavia. The ultimate goal of all countries is to implement health care activities within a system ensuring active participation and partnership of citizens who are universally covered by a public health insurance scheme, health legislators and providers of health services. Slovenia has therefore not been confronted with any major difficulties in implementing health care system reforms. By amending and modifying its health legislation Slovenia will build upon its good points, improve clarity and integrate certain approaches important for the functioning of its health care system in the European Union when Slovenia becomes a full member. Changes are directed towards:strengthening inter-sectoral cooperation and health and safety at work;creating environments supporting a healthy life style and emphasizing personal responsibility for one's own health;— maintaining a unified public health insurance scheme and sufficient financing through employer and employee contributions;— introducing voluntary health insurance;— developing in a controlled way an efficient and effective private medical practice;— strengthening of management in public health institutions and increasing staff's responsibility for business success.— implementing quality improvement systems.
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"Elderly Patients as a Vulnerable Category of the Population Requiring Special Legal Protection With Respect to the Provision of Medical Care." European Journal of Health Law 14, no. 4 (2007): 349–54. http://dx.doi.org/10.1163/092902707x261285.
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AbstractRussia like other European countries is seeing a growing trend to increased life span of its population. This situation results in an urgent need to address problems not only those related to provision of qualified medical care but a special treatment to protection of rights and legal interests of elderly people. In accordance with effective legislation of the Russian Federation aging and elderly patients enjoy all rights and freedoms of capable citizens, but due to their physical and mental condition they are not always able to exercise their rights. Federal law "Legal basis of health care in the Russian Federation" does not provide for representatives of such group of patients to take part in medical care provision. It is necessary to ensure additional legitimate right protection mechanisms in the legislation for capable elderly patients in the sphere of medical care. The government should act as a guarantor of rights protection for such socially vulnerable group of population.