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EVIDENCE-BASED MEDICINE AS PATIENT's PROTECTION MEASURE in JUDICIAL PRACTICE DOI: 10.36740/Wlek202012216

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EVIDENCE-BASED MEDICINE AS PATIENT's PROTECTION MEASURE in JUDICIAL PRACTICE DOI: 10.36740/Wlek202012216 © Aluna Publishing Wiadomości Lekarskie, VOLUME LXXIII, ISSUE 12 PART 2, DECEMBER 2020 REVIEW ARTICLE EVIDENCE-BASED MEDICINE AS PATIENT'S PROTECTION MEASURE IN JUDICIAL PRACTICE DOI: 10.36740/WLek202012216 Volodymyr A. Zhuravel¹, Galina K. Avdeeva², Mykyta O. Sokolenko² ¹NATIONAL ACADEMY OF LEGAL SCIENCES OF UKRAINE, KHARKIV, UKRAINE ²RESEARCH INSTITUTE FOR THE STUDY OF CRIME PROBLEMS OF NATIONAL ACADEMY LEGAL SCIENCES OF UKRAINE, KHARKIV, UKRAINE ABSTRACT The aim: To identify the role of evidence-based medicine, its principles and approaches to patients' rights protection and the provision of medical service optimization, the skills of medical staff improvement, increasing the objectivity of court decisions in cases of non-providing quality care or death. Materials and methods: The authors used the decisions by the European Court of Human Rights (ECtHR) on the statements of victims of unprofessional actions by doctors, international and domestic regulations on patients' rights, statistics on the results of criminal proceedings on violations of patients' rights over the past 5 years, case law of criminal and civil jurisdiction in this category of cases, the results of surveys of prosecutors, as well as the results of research by scientists in the field of medical law and criminalistics. The research is carried out on the basis of a harmonious combination of philosophical approaches, general scientific and special methods of scientific knowledge, the complex of which is chosen taking into account the goals and objectives, object and subject of research. Conclusions: In order to implement the patients' rights by legal means in accordance with the Convention for the Protection of Human Rights and Fundamental Freedoms, the European Charter of Patients' Rights and other international regulations in the field of medicine, the authors argue the need for greater implementation of evidence-based medicine into the practice of medical institutions as a means of improving the level of medical care and an obvious source of relevant information for litigation to protect the rights of patients and doctors. For patients' rights protection in the diagnosis and treatment of diseases, it is proposed to regulate a set of such measures: 1) to include in the educational programs of pharmacy and medicine such disciplines as «Evidence-Based Medicine» and «Rights of the patient and medical worker's rights»; 2) to oblige the doctor to explain to the patient or to his/her representative the differences of treatment protocols, to provide information to patients about official sources, which contain information on unified and updated treatment protocols and diagnosis of certain diseases, to obtain informed consent by the patient (his/her representative) on certain medical guideline; 3) to recognize medical guidelines as sources of law in criminal and civil proceedings as a kind of benchmarks for clarifying and assessing the facts of non-performance or improper performance of professional duties by a medical or pharmaceutical worker, violation of patients' rights, as well as means for doctors' legal protection and etc. KEY WORDS: health care, patient's rights, medical law, clinical protocols, medical standards Wiad Lek. 2020;73(12 p. II):2795-2803 INTRODUCTION procedures and providers on the basis of adequate infor- A few international health care legal acts have been ad- mation». The right to freedom of choice in health care is opted in recent decades, in particular: Universal Declara- enshrined in the Civil Code of Ukraine (Part 2 of Article tion of Human Rights; Convention for the Protection of 284, Article 633), in the laws of Ukraine «Grounds of Human Rights and Fundamental Freedoms; International the legislation of Ukraine on health care» (clause «d» of Covenant on Civil and Political Rights; International Article 6, part 2 Article 34, Article 36, Article 38), «On Covenant on Economic, Social and Cultural Rights; Eu- Consumer's Rights Protection» (Article 21). ropean Social Charter (revised) (ETS N 163); Declaration The right to consent to medical intervention and the right of Lisbon on the Rights of the Patient, etc. Their norms to refuse medical intervention are enshrined in Article 4 of are included in the legislation of many countries around the European Charter of Patients' Rights. Also, this right is the world, including Ukraine. Thus, some provisions of enshrined in the Constitution of Ukraine (Part 3 of Article these regulations are contained in the Constitution of 28, Part 1 of Article 29), the Civil Code of Ukraine (Parts Ukraine, Civil, Family and Criminal Codes of Ukraine, 3, 4, 5 of Article 284, Part 4 of Article 286, Article 289), laws of Ukraine «Grounds of Ukrainian legislation on Law of Ukraine «Grounds of the legislation of Ukraine on health care», «On ensuring the sanitary and epidemio- health care» (Articles 42, 43, 44). logical well-being of population», «On the personal data In view of the above, it is important for Ukraine to ac- protection», protocols, standards and other legal acts in tively take the necessary organizational and legal measures the field of health care. Article 5 of the European Charter aimed at improving the quality of medical services, pro- of Patients' Rights states that «Each individual has the tecting the rights of patients from unprofessional actions right to freely choose from among different treatment by doctors, including by appealing to the courts. 2795 Volodymyr A. Zhuravel et al. THE AIM etc.), which regulate legal relations in the field of medical To show the advantages of evidence-based medicine, to services provision. argue the need for more active implementation in medical The methods of theoretical analysis and synthesis were practice of unified and local clinical protocols developed used while studying the content of legal norms and con- and approved on the basis of evidence-based medicine and cepts contained in international legal acts, Criminal and existing international standards, which should be consid- Civil Codes of Ukraine, the Law of Ukraine «Grounds of ered in judicial practice as benchmarks to compare doctors' Ukrainian legislation on health care», in scientific papers activities while providing medical care for the treatment by foreign and domestic researchers, in verdicts, decisions of one or another disease. To identify factors that hinder and court rulings on cases of violations of patients' rights. or prevent the implementation of clinical protocols in The method of systematic analysis was used to determine medical practice as a means of realizing the patient's and the content of the human right to health care, the right to doctor's right to a fair and effective justice. To assess the consent to medical intervention (application of diagnostic, impact of the absence of such protocols on the objectivity prevention or treatment methods) and the right to refuse of a court decision on non-provision or improper provision medical intervention and determining ways to implement of medical care. To propose a set of measures that will help it in Ukraine. to the patients' rights protection. Formal-legal analysis of international and Ukrainian leg- islation on health care and patients' rights protection gave an ability to identify the inherent shortcomings and contra- MATERIALS AND METHODS dictions of legal acts and to formulate proposals to improve In order to achieve the objectives of the study, 25 judgments legal regulation, in particular, on the need for establishing a of the European Court of Human Rights on applications of regulation on strict compliance with treatment recommen- victims of improper provision of professional duties by a dations which are contained in clinical protocols approved medical or pharmaceutical worker, statistics on the results on the basis of the principles of evidence-based medicine. of criminal proceedings on violations of patients' rights By using the comparative-legal method, the experience of over the past 5 years, the results of questionnaire of 128 certain countries in implementing and exercising the princi- prosecutors, 195 criminal court verdicts and 275 decisions ples of evidence-based medicine was studied. Other separate and rulings by civil courts were analyzed. They were ac- scientific methods of cognition, in particular formal-logical cessed through the official websites of the European Court (for typification of medical errors and their consequences), of Human Rights (ECtHR) and the Judicial Administration functional (while identifying the influence of local clinical of Ukraine. In particular, the decision of the European protocols on process of collecting and an estimation of Court of Human Rights «Case of Arska v. Ukraine» of the facts of non-performance or improper performance of 5 December 2013 on application №45076/05 (violation professional duties by medical or pharmaceutical worker, vi- of Article 2 of the Convention - inconsistency with the olation of patients' rights), sociological (while analyzing the clinical protocols of doctors' actions to establish the pa- results of activities by monitoring groups to identify facts of tient's mental health and his/her ability to make decisions non-performance or improper performance of professional independently) [1]; decision on application № 4605/05 duties by a medical or pharmaceutical worker, assessing the «Case of Petrova v. Latvia» of 24 June 2014 (violation of level of latency of such offenses), etc. Article 8 of the Convention - transplantation of organs (kidneys and spleen) without the consent of the mother of the deceased in a traffic accident, his mother learned REVIEW AND DISCUSSION eight months after the death of her son about the fact of Life and health of every person is the main asset of man- transplantation) [2]; decision on application №10060/07 kind. Healthy nation problems have not only socio-political «Case of Bataliny v. Russia» of 23 June 2015 (violation of but also economic significance. Thus, Belarusian econo- Article 3 of the Convention - testing of a new medicinal mists have calculated the economic damage caused to the product on a patient without one's consent) [3] and others.
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