HIV CRIMINALIZATION'S ORIGINS, ENFORCEMENT, AND SOCIAL IMPACTS.

This article aims to raise awareness and stimulate serious discussion about the ineffectiveness of HIV criminalization and its impact on human rights and public health and to propose improvements in criminal law regulation. The study is based on the empirical and analytical data of the Joint United Nations Programme on HIV/AIDS, the World Health Organization, legal acts, drafts legal acts, legal practice, and statistics of Ukraine, legal acts of the USA, Germany, Estonia, Latvia, Lithuania, and Poland. In total, 21 laws, drafts of laws, other documents, and 26 court decisions were analyzed. Dialectical, comparative, analytical, synthetic, systemic, sociological, induction, and deduction research methods were applied. The criminalization of HIV stems from a lack of awareness among policymakers and society about advances in medical science and ways to control the epidemic. Such regulation is ineffective, leads to stigmatization of people living with HIV, and has a negative impact on the epidemic. Causing harm to a person's health by intentionally infecting a person with a severe infectious disease could be criminalized under the general norm on bodily harm, excluding the stigmatization of patients with certain nosologies.

LEGAL AND SOCIAL CHALLENGES OF COVID-19 VACCINATION BEFORE AND AFTER THE 2022 RUSSIAN INVASION OF UKRAINE.

OBJECTIVE: The study aims to develop ways of solving the social and legal problems of vaccination against COVID-19, showing them the example of Ukraine before and after the beginning of the active phase of Russian aggression. PATIENTS AND METHODS: The study is based on international documents and legal acts adopted to combat the COVID-19 epidemic, the survey results of 165 ordinary Ukrainians on vaccination, interviewing health care organizers; statistical information, and content analysis of the media on vaccination, as well as ways of avoiding it. Dialectical, analytical-synthetic, system-structural methods, as well as methods of content analysis, questionnaires, interviews, and included observation, were used. RESULTS: Legal restrictions on the realization of persons' rights who have not been vaccinated against COVID-19 are an acceptable remedy, as they aim to protect human rights to life and health. Restrictions on the realization of labor and other rights of unvaccinated persons introduced in Ukraine have caused the following related social-legal problems: a) negative attitude of some persons to human rights' restrictions due to mandatory vaccination for workers, related fears of the population; c) stratification of the population according to the availability of vaccine of a particular manufacturer; d) background phenomenon in the form of imitation of vaccination with subsequent forgery of certificates. These restrictions have been lifted during the martial law, and anti-epidemic measures are recommendatory. Despite the availability of vaccinations throughout the non-occupied territory, the pace of vaccination has been significantly reduced. CONCLUSION: Ways of overcoming the adverse socio-legal problems of vaccination and related background phenomena are to conduct quality information campaigns to inform the public about the benefits and safety of vaccination, counter misinformation, increase the availability of vaccines with a choice of vaccines from different manufacturers, and increase the effectiveness of criminal legal counteraction to forgery of documents confirming vaccination. After the imposition of martial law in Ukraine, there has been a change in the focus of public attention to solving vital problems, which, along with the transfer of anti-coronavirus restrictions to the status of recommendatory, creates danger of significant reduction in vaccination.

ENSURING THE CITIZENS' RIGHTS AND FREEDOMS IN CASE OF COVID-19 VACCINATIO IN THE PUBLIC HEALTH SYSTEM.

OBJECTIVE: The aim: To study the legal and regulatory framework for ensuring the right to health of patients depending on the legal status of coronavirus vaccines in different countries as an essential element influencing the right to public health and other rights of citizens. PATIENTS AND METHODS: Materials and methods: In this paper, we study the legal norms and scientific positions on the above issue using generalized information from scientific journals that use scientific methods from a medical and legal point of view. This article is based on dialectical, comparative, analytical, synthetic, and complex research methods. Using the above methods, we studied the attitudes of different categories of citizens to vaccination against coronavirus disease through questionnaires on the following issues: attitudes to vaccination in general; motivation for vaccination, in case of consent to vaccination; reasons for refusal of vaccination. The case-law of the European Court of Human Rights on vaccination and ensuring the rights of citizens to health care was also analyzed. RESULTS: Results: Proper legal regulation of the right to health depending on the legal status of the vaccines is important in order to implement restrictive measures to combat COVID-19 and, accordingly, to prevent the possible spread of a pandemic in the public health system. CONCLUSION: Conclusions: Ensuring the right to health and applying restrictive measures to prevent the spread of a pandemic is an essential element of the public health system. However, the question of the legal status of vaccines is crucial to prevent the spread of the disease. That is, it is essential to go through all the stages of clinical trials for the vaccines used. Their safety and effectiveness and proving the fact that the harm of vaccination is much less than the harm of the spread of coronavirus disease. In the process of ensuring the right to health, including by making compulsory vaccination against COVID-19, legal framework and practice are critical components that aim to minimize the potential hazards that threaten the health and lives of the population.

LEGAL AND PRACTICAL PROBLEMS OF USE OF ARTIFICIAL INTELLIGENCE-BASED ROBOTS IN FORENSIC PSYCHIATRY.

OBJECTIVE: The aim: This research aims to analyze the possibilities of using artificial intelligence-based robotics in forensic psychiatry to assess the public hazard of a mentally disabled or suffering from a mental illness to improve the legal framework governing the use of compulsory medical measures. PATIENTS AND METHODS: Materials and methods: This study is based on the Republic of Latvia and Ukraine's regulatory acts and the juridical practice of the Republic of Latvia. Dialectical, comparative, analytic, synthetic, system analyses, and sociological research methods were used. CONCLUSION: Conclusions: Different automated systems, including artificial intelligence-based robotics, can and should be used in forensic psychiatry. The last one would effectively improve the process of achieving goals in forensic psychiatry and help prevent subjective errors. At the same time, the application of artificial intelligence-based robotics in forensic psychiatry requires uniform medical and legal criteria to prevent violation of human rights.

ILLEGAL INTERNET PHARMACIES AS A THREAT TO PUBLIC HEALTH IN EUROPE.

OBJECTIVE: The aim: This article aims to raise awareness and stimulate serious discussion about the dangers of illegal Internet pharmacies for patient safety and public health, the necessity to improve legal instruments, and unite the efforts of governments, professional organizations, and civil society for combating this activity. PATIENTS AND METHODS: Materials and methods: This study is based on the Medicrime Convention, empirical and analytical data of the WHO, Interpol, Europol, NABF, Directive 2011/62/EU of the European Parliament and of the Council of June 8, 2011, the regulatory acts and juridical practice of Ukraine, experts interview of pharmacy practicians, analysis of websites. Totally 18 laws and papers, 34 court judgments, 50 websites were analyzed, six experts were interviewed. Dialectical, comparative, analytic, synthetic, system analyses and sociological research methods were used. RESULTS: Results: Illegal Internet pharmacies are widespread in Europe, especially during the COVID-19 pandemic. This black market poses a severe threat to patient safety and public health as falsifying, substandard, and smuggled medicines are sold through these channels. Without any exception, all illegal pharmacies sell prescription drugs without any prescriptions. Regulatory and protective legal instruments at the national and international levels are insufficient to counter the Internet trade in medicines. CONCLUSION: Conclusions: The widespread proliferation of illegal Internet pharmacies in Europe requires European states to work together to protect patient safety and public health. A legal mechanism needs to be established to exchange information and combat illegal pharmaceutical activities on the Internet at the international level. At the national level, it is necessary to strengthen control over the wholesale of prescription medications to prevent them from entering the black market.

LEGAL MEANS OF ENSURING COMPETITION IN PHARMACY.

OBJECTIVE: The aim: To research the consequences of pharmacy chains monopolization and establishment of legal means of neutralization of such consequences. PATIENTS AND METHODS: Materials and methods: The study is based on acts of the European Union, the United States, and Ukraine and international regulations and documents on health care. The study's materials were the results of a questionnaire survey of managers and specialists in a pharmacy on marketing contracts. The views of scientists on the above issue were also studied. The study analyzes generalized information from scientific journals using scientific, legal methods. Among the main research methods are systematic approach, analytical, statistical, comparative, dialectical, graphical, and a questionnaire survey of respondents. RESULTS: Results: Consolidation of massive pharmacy chains leads to an artificial increase in drug prices by almost 50 percent, which significantly reduces their availability to patients, and in many cases, makes treatment impossible due to lack of funds. CONCLUSION: Conclusions: As a result of further monopolization of the pharmacy market, the pharmaceutical industry, small pharmacy enterprises, and the complete distribution of medicines will be destroyed.

Medical and procedural-legal aspects of inpatient and outpatient forensic psychiatric examination.

OBJECTIVE: The aim: The aim of the study is to define the legal framework of forensic psychiatric examination commissioned by the court in relation to the competence of medical practitioners and the position of the subject as a patient in the process of forensic psychiatric examination in order to determine the correlation of special legal regulation with criminal and civil procedure regulation and to make proposals for the enhancement of the legal regulation. PATIENTS AND METHODS: Materials and methods: This study is based on the analysis of international law, medical civil procedure and criminal procedure legislation, juridical practice, medical law legal doctrine. The following methods were used in this research: the method of interpretation of legal norms, analysis of legal acts, and the induction-deduction method, upon which the conclusions were drawn and recommendations were provided. CONCLUSION: Conclusion: The current regulatory framework does not provide for the procedure by which the subject's medical treatment is conducted during forensic psychiatric examination, nor does it determine the criteria for the admissibility of treatment of the persons concerned and the extent of treatment. During the examination, the medical practitioner who is in the expert's procedural position in relation to the subject under examination in the particular examination should not carry out the treatment of the subject.

Falsification of medical products: criminal law mechanism combating threats to public health.

OBJECTIVE: 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. PATIENTS AND METHODS: 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: 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. CONCLUSION: 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.

Improper healthcare marketing: German and Ukrainian experience in prevention.

OBJECTIVE: Introduction: Improper healthcare marketing is a part of institutional corruption in the pharmaceutical markets, which causes significant harm to public health. Legal measures are an importent component of the mechanism for preventing this phenomenon. The aim: The purpose of the article is to raise awareness and stimulate serious discussion about the necessity to improve the preventative role of law in the field of healthcare marketing by adjusting liability for offenses in this area. PATIENTS AND METHODS: Materials and methods: This study is based on the analysis of international law, medical and criminal legislation, juridical practice, criminal and medical law legal doctrine, physicians survey results and expert interviews. Dialectical, comparative, analytic, synthetic and system analyses research methods were used, also for interpretation purposes. RESULTS: Results: The study showed the effectiveness of the US fight against improper healthcare marketing by applying millions and billions of fines to the largest pharmaceutical companies in the world, which led to a reduction in corruption in this sphere. Legal restrictions on the activities of medical sales representatives of pharmaceutical companies are justified by the Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, as well as in the German legislation (Medicinal Products Act). An analysis of Articles 299a and 299b of the German Criminal Code (StGB), as well as the practice of their application, showed their effectiveness. Still, there are problems in delimiting these offenses from the legal provision of drug information. The lack of anti-corruption regulation of drug promotion in Ukraine negatively affects the situation in this area. CONCLUSION: Conclusions: The legal mechanism for the prevention of improper healthcare marketing at the national level should include the following measures: a) strict legal regulation of the rules for the promotion of medicines; b) anti-corruption restrictions on the activities of medical sales representatives of pharmaceutical companies; b) the criminal liability of pharmaceutical companies for corruption in the implementation of healthcare marketing; c) the criminal liability of representatives of pharmaceutical companies and Healthcare professionals (HCPs) for active and passive briberies; d) legal support for professional self-regulation aimed at creating ethical standards of conduct in the pharmaceutical markets.

Medical negligence subject to criminal law.

OBJECTIVE: Introduction: Legal liability for medical negligence should contribute to the protection of patients' rights to life and health. At the same time, unreasonably strict sanctions against physicians should be analyzed much closely. More balanced model of such liability requires serious in-depth research. The aim of the article is to stimulate discussion about the necessity to improve the criminal legislation and judicial practice of criminal liability execution. PATIENTS AND METHODS: Materials and methods: This study is based on the analysis of international law, WHO documents, jurdicial practice and statistics, criminal and medical law legal doctrine (29 laws and papers, 97 court judgments were analyzed). Dialectical, comparative, analytic, synthetic and system analysis research methods were used, also for interpretation purposes. CONCLUSION: Conclusions: An effective legal mechanism should ensure the timeliness and thoroughness of the investigation and prosecution of each case of medical negligence to prevent the recurrence of such consequences in the future. Legal liability (civil, disciplinary or criminal) for medical negligence is a necessary part of this mechanism. The inevitability of criminal punishment rather than its severity should be recognized as a core for the medical negligence prevention concept. That's why the long-term imprisonment for medical negligence as a form of punishment should be recognized as socially unreasonable, it cannot improve the protection of patients' life and health but leads to significant negative social complications instead.

Legal protection of public health through control over genetically modified food.

OBJECTIVE: Introduction: Science is constantly being developed which leads to both positive and negative changes in public health and the environment. One of the results of scientific progress is introduction of food based on genetically modified organisms whose effects on human health, to date, remain scantily studied and are ambiguous. The aim: to determine how human health can be influenced by food production based on genetically modified organisms. PATIENTS AND METHODS: Materials and methods: international acts, data of international organizations and conclusions of scientists have been examined and used in the study. The article also summarizes information from scientific journals and monographs from a medical and legal point of view with scientific methods. This article is based on dialectical, comparative, analytic, synthetic and comprehensive research methods. CONCLUSION: Conclusions: Genetically modified organisms are specific human-made organisms being a result of using modern biotechnology techniques. They have both positive and negative effects on human health and the environment. The main disadvantage is not sufficient study of them in various spheres of public life.

Reproductive function: the protection of the rights of the people which are sent to the area of the fighting.

OBJECTIVE: Introduction: The issues of problems of the legal regulation of posthumous reproduction in Ukraine and foreign countries are analysis in the article. The author substantiates the necessity in the creation and acceptance of the State Program of the retrieval of reproductive cells in people who are sending to the area of the fighting. The aim:the purpose of our work is a comprehensive study of post-mortem (post-mortem) reproduction and substantiation of the possibility and necessity of adopting a state program for the selection of reproductive cells of individuals who are sent to a combat zone to ensure their full social protection and assistance in the realization of the right to fatherhood or motherhood. PATIENTS AND METHODS: Materials and methods: the experience of certain countries is analyzed in the research. Additionally, we used statistical data of international organizations, conclusions of experts and foreign legal acts dealing with posthumous reproduction and auxiliary reproductive technologies, judicial practice, doctrinal ideas and views on this issue. RESULTS: Review: there are medical (practical) preconditions for the introduction of posthumous reproduction programs. Among them is the technology of obtaining reproductive cells (post-mortem too), their preservation and successful subsequent use. In addition, foreign experience shows the success of the application of these technologies and the real guarantee of full implementation of the range of rights to the family, fatherhood or maternity. CONCLUSION: Conclusions: we note the urgent need to develop and adopt a state reproductive cell selection program for individuals who are sent to the combat zones (according to a model that exists in such countries as the USA and Israel).

Legal aspects of cancer deseases prophylactics: patients rights context.

OBJECTIVE: Introduction: In accordance with Resolution on Cancer Control WHA58.22 Cancer prevention and control The Fifty-eighth World Health Assembly it is obvious technology for diagnosis and treatment of cancer is mature, and that many cases of cancer may be cured, especially if detected earlier Some key points on concept of legal regulation of abovementioned sphere is a base of this study. However, the problems of using an effective mechanism for protecting the rights of patients in certain types of disease, in particular cancer patients, by providing early diagnosis, are not fully developed by medical law specialists. The aim of the article is to determine the means of ensuring the right to health and life of cancer patients in particular through early diagnosis. PATIENTS AND METHODS: Material and Methods: This study is based on regulation acts, World health report (2013), The Fifty-eighth World Health Assembly, WHA58.22 Cancer prevention and control, Universal Declaration of Human Rights, International Covenant on Civil and Political Rights, International Covenant on Economic, Social and Cultural Rights, European Convention for the Protection of Human Rights and Fundamental Freedoms, Charter of Fundamental Rights of the European Union, research papers and views of progressive-minded people in this sphere. Article is grounded on dialectical, comparative, analytic, synthetic and comprehensive research methods. RESULTS: Review: Most countries have declared a compliance of their national legislation with international standards regarding the right to life and health. The analysis of the abovementioned international acts in context of protection of the rights of patients with cancer leads to the conclusion that countries that have undertaken international legal obligations to protect the right to life are required to take the necessary measures to ensure the effective treatment of cancer patients. Taking into account that the lack of such treatment due to the specificity of the disease entails the death of the patient, the state inaction in this area should be regarded as a violation of a human right for life. Absence of state's policy in terms of early detection of cancer brings a huge problem of human rights violation and providing the standards of fundamentally different approach of the European Union countries could become a great solution. CONCLUSION: Conclusions: Individual states do not pay sufficient attention to the need of effective public health policy. In today's world, there are objective prerequisites for changing the system of protection of patients' rights and, consequently, for changing views on health protection in general, especially in the part of functioning of diagnostic procedures system. Formation of a state policy on ensuring the rights of citizens to health and life, taking into account the various consequences of such a policy, cannot be narrowed down only to the proclamation of such rights, but also requires planning and development of relevant state programs. Failure by the state to provide the proper organization of health care through the establishment of early diagnosis for cancer patients, considering wide incidence and mortal danger of cancer in case of late diagnosis, should be considered as a violation of human rights. It also does not conform to ECHR practice in terms of provisions of Articles 2, 3 and 8 of European Convention.

Medical device software: defining key terms.

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