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Biomedical Ethics and Human Rights in The Context of Innovation and Information Development of Society

The article is devoted to the issues of biomedical ethics and human rights in the conditions of innovation and information development of society. The factors of the emergence of modern biomedical ethics under the evolution of biology and medicine, including innovative technologies. Under "biomedical ethics," the branch of knowledge is considered, which is a system of ethical and legal norms that regulate relations in the field of biomedicine, a set of moral principles, norms and rules that medical professionals should observe in the course of professional activity. Sources of biomedical ethics are singled out: national legislation in the field of medicine; international medical law regulating legislation; international ethical (deontological) codes containing recommendations on medical ethics; national ethical (deontological) codes of professional ethics of medical staff. The basic functions of biomedical ethics are disclosed: informational, axiological (value), communicative, preventive. The issue of ratification by the Verkhovna Rada of Ukraine of international acts as a condition for ensuring the protection of human rights is explored. The expediency of adopting a special law "On the Protection of Patients’ Rights", which determines the legal, economic and organizational foundations for the protection of the rights and legitimate interests of patients, including biomedical ones, is substantiated. The need to overcome the gaps in the legislation of Ukraine by unifying and developing concepts in the field of biomedicine, the normative consolidation of ethical requirements for medical staff and the implementation of biomedical research and medical practice, as well as the responsibilities of patients, is emphasized. The emphasis placed on the need to improve the domestic health care model through the introduction of a publicprivate partnership in healthcare. The importance of creating a system of organizational and legal measures to improve control over the implementation of laws and regulations on the observance of the legality of processing personal data through the establishment of rules of legal responsibility, the provision of the use of electronic services in order to implement the rights of patients, the development of criteria-signs of the concept of "personal data". The prospect of further research on biomedical ethics and human rights through the improvement of legal theory and legal practice is determined. It is concluded that fundamental human rights should remain the basis for solving existing ethical and legal problems in the field of biomedicine.


[I] INTRODUCTION
The problem of biomedical ethics and human rights is relevant given the international and regional trends, as well as the European integration obligations of Ukraine. The Association Agreement between Ukraine and the European Union consolidated the course of Ukraine's integration into the European Union, including in the health sector. In particular, the Association Agreement in Chapter 22 "Public Health" stipulates that the parties develop cooperation in the field of health care in order to increase its level of safety and health protection as a prerequisite for sustainable development and economic growth (Association Agreement, 2014).
The modern medical industry of Ukraine is in a state of transformation and needs to improve the legal theory and practice, development of the legal doctrine of medical law, implementation of international law, and overcoming the gaps in Ukrainian legislation. One of the priority programs of state development is reform of the health care system, as defined in the Strategy for Sustainable Development "Ukraine 2020", the purpose of which is a fundamental, systemic reform, aimed at creating a patient-centered system that can provide Ukrainian citizens with health care at the level of developed European countries (About the Sustainable Development, 2015).
The confirmation of the need for reforming the health sector is the results of the survey "Health Index. Ukraine -2018 "about the attitude, experience and behavior of medical care users and those who do not use it. The study was conducted from June to July 2018 by the Kyiv International Institute of Sociology in cooperation with the Social Indicators Fund with the support of the International Renaissance Foundation. According to the results of the study, Ukrainians are not satisfied with the health care system and medical services provided in Ukraine. However, there are some changes in this area. Thus, 62.2% of Ukrainians in 2018 are satisfied with the medical assistance they got during the year; in 2017 and 2016, the average level of satisfaction was 62% and 55%, respectively. These data not only illustrate how the implementation of medical reform in different regions affects the health care users, but also contributes to the adoption of sound decisions by all those involved in the development of health policies at the national and local levels (Stepurko, et.el, 2018).
The evolution of biology and medicine, including new technologies, has led to significant advances, but it raises problems of ethical and legal content in protecting the rights and dignity of the individual. In the development of biotechnology there are problems of transplantation, the use of new reproductive technologies, implantation, abortion, surrogate motherhood, euthanasia, etc. Widespread use of biotechnology in the medical sector can lead to a violation of human rights. It seems to us that there is an issue of legal regulation of biomedical ethics in order to ensure the realization and protection of human rights.
The global nature of biomedical issues and human rights monitoring require the creation of a national legal framework for biomedical ethics, in particular rules and regulations that regulate the conduct of biomedical research and medical practice, the protection of human rights and its legitimate interests.

[II] MATERIALS AND METHODS
This work use international and national legislation published on the official websites of international institutions: the World Health Organization, the Council of Europe, the UN General Assembly, the European Court of Human Rights; bodies of state power of Ukraine: the Verkhovna Rada of Ukraine, the Cabinet of Ministers of Ukraine, the Ministry of Health; research medical institutions.. Materials of bioethical forums and conferences held in Ukraine and abroad are also used, the results of the sociological survey "Health Index. Ukraine -2018 ", the work of the NGO" Foundation for Medical Law and Bioethics of Ukraine ". This work also uses general-scientific, philosophical and specialscientific methods (comparative, historical, statistical, sociological and other).

[III] RESULTS
Positioning of bioethics as a science was most closely related to the process of ethical substantiation of human rights. The beginnings of bioethics take on the 60's -the beginning of 70's of the twentieth century in the United States, then spread to Western Europe, now bioethics is global in nature. In the scientific circle the term "bioethics" was introduced by the American scientist V. R. Potter (2002), having determined that the science of survival should be not just a science, but a new wisdom that should combine the two most essential and needed elements -biological knowledge and universal values.
In scientific literature, the concept of bioethics is wide. In particular, bioethics is tried to be identified with medical ethics due to the restriction of its content to the ethical problems of relations in the relationship between patient-patient. A broader understanding of bioethics combines the axiological, social problems that are associated with the health system and the relation of man to animals and plants. Thus, bioethics examines the moral (ethical) problems caused by scientific and technological progress in the field of medicine and biology and require moral and legal regulation.
As you know, all the provisions of ethics and medical deontology before the end of the twentieth century traditionally based on morality, moral codes, medical traditions, public opinion, etc., were recommendatory, optional and relying only on the theory of good. Currently, biomedical ethics is a new step in the ethics and deontology of a doctor, which introduces fundamentally new directions in the development of the field of study in modern research sphere. Thus, in biomedical ethics, most of the provisions are of a legal nature and therefore need to be consolidated at the level of legislation. The need for institutional support for ethics and the recognition of laws by the natural components of biomedical ethics is due to the fact that during the development of biotechnology and the intensification of modern biotechnological activities, norms of traditional ethics, in particular medical and biological ones, are losing their effectiveness, and the institute of ensuring the efficiency and the possibility of ethical procedures need a combination of morality and right. After all, biomedical ethics is a science of morality, through which guarantees of human security are established, moral and ethical barriers are created, supported by legal acts. The purpose of bioethics is to prevent harm to a person in need of medical care and to protect rights and interests. Analysis of scientific research allows to distinguish 5 factors of the emergence of modern biomedical ethics: 1) the rapid development of fundamental science in the second half of the XX century. (decoding the structure of the human genome, opening the L-dopa and its significance in memory functions, the pathogenesis of Alzheimer's disease); 2) the introduction of new theoretical discoveries in medical practice (transplantology, cloning warm-blooded, growing tissues and organs, etc.); 3) unpredictability or uncertainty about the consequences of the widespread use of medical achievements (availability of human cloning to well-off segments of the population, and poor people will act only like donors of organs, availability of medicine will be only for rich); 4) Humanity has witnessed tragedies as a result of neglect or underestimation of the principles of humanity, ethics, morals and law in medicine (experiments on humans during the Second World War, the use of a sedative drug thalidamide in Germany led to the birth of several thousand freethinkers) (Lopukhin, 2001); 5) taking into account the religious point of view about the beginning of life in medical practice (for example, if one considers a person as a biological being -without a soul, the beginning of the right to life arises from the moment of birth (Ukraine); however, most European countries recognize the moment of the emergence of the right to life from the moment of fertilization (Hungary, Slovakia, Czech Republic), which testifies to the recognition of the bioethical principle of obligatory respect for the life of an unborn child) (Bulets, 2007).
Legal problems of bioethics were studied by P. Witte, M. Medvedev, S. Stetsenko, A. Abashidze, G. Tereshkevich, E. Tarasyants, N. Sedov, A. Ovsyuk, P. Tyshchenko and others. Problems of human rights in medical field were investigated by such Ukrainian scientists as O. Kashintseva, B. Ostrovska, I. Senyuta, T. Kharatyan, V. Chebotarev, and others. Problems of bioethics are multidisciplinary and interdisciplinary, they are studied by physicians, ecologists, biologists, philosophers and lawyers, and representatives of religious denominations. The subject of this study is biomedical ethics -a branch of knowledge that is a system of ethical and legal norms that regulate relations in the field of biomedicine, a set of moral principles, norms and rules that medical professionals should observe during their professional activities. These norms and principles are enshrined in relevant international and national laws (conventions, declarations, charter, laws and by-laws) which are dynamic, since they are updated in accordance with the socio-economic conditions of society, state policy and public opinion.
At the present stage, two aspects of bioethics are distinguished, one of which is related to the ethical problems of medicine, the other -with ethical issues in relation to human beings (Kuzminskaya, Prikhodko, 2016).
A generalized analysis of the international legal aspects of ethics and law in the field of biomedical research has shown that scholars hold predominantly three models of interaction between bioethics and law. The first model is a sociological one, which consists in the fact that the role of law is almost eliminated, as the supporters of this concept believe that it is unable to resolve ethical dilemmas. The second is formalism, which emphasizes the fact that law plays a leading role in the regulation of any bioethical issue, by imposing severe sanctions for violating the established prescriptions. And the third model is liberal; she says that the law consolidates only some general bioethical principles (Medvedeva, 2009).
An important role in the formation of bioethical norms and human rights played by international institutions. Among all the international legal acts that establish the rights and freedoms of man and citizen and, accordingly, the right to health care, the acts of the World Health Organization, the World Medical Association, the UN General Assembly, the Council of Europe, the European Union and many other international organizations..
One of the most authoritative documents in the legal regulation of bioethics is the Convention for the Protection of Human Rights and Fundamental Freedoms (1950), the 1997 Convention on Human Rights and Biomedicine and the Additional Protocol to the Convention on Human Rights and Biomedicine in the field of biomedical research. These documents are aimed at protecting human dignity, human rights and freedoms, and preventing misuse of the achievements of biology and medicine. Significant achievement of the 1997 Convention is Art. 29, according to which the European Court of Human Rights can draw conclusions on legal issues relating to the interpretation of its provisions which are of a recommendatory nature.
An important source of international bioethical law is the Universal Declaration on Bioethics and Human Rights, which sets out the basic principles of bioethics, officially recognizes bioethics as a global knowledge industry that needs legal support.
The source of biomedical ethics can be divided into 4 groups: 1) national legislation in the field of medicine, which provides legal regulation of medical relations; 2) international legislation regulating the medical sector, which includes conventions, declarations, additional protocols to declarations; 3) International ethical (deontological) codes containing recommendations for medical ethics; 4) national ethical (deontological) codes of professional ethics of medical staff.
Bioethical principles and norms are contained in the bioethical international, regional and national legal documents of specialized international and regional integration organizations, in the national legislation of different countries . In such conditions, the growing interconnection, both from the legal point of view (the responsibility of the doctor for the provision of poor quality medical care), and from medical (compliance with the doctor basic principles of biomedical ethics: respect for human autonomy, "no harm", truthfulness in providing information) get the concept of health care, medical care and biomedical ethics. Biomedical ethics is recognized in almost all countries by science that is designed to solve the ethical dilemmas of preserving the health and well-being of man, humanity and the environment, especially in the context of the intensive use of biomedical technologies (transplantation, human experiments, cloning, experimental medicine) through systematic and rational verification. Biomedical ethics or critical medical ethics has become a new kind of ethical "sensitive training" aimed at establishing medical-professional and ethical boundaries [6]. It means that the doctor can not do without the ethical and legal norms regulating the sphere of his activity. After all, for all participants in the process of granting or receiving medical care and medical services, it is important that these relationships do not go beyond the legal framework, therefore, the physician's proper knowledge of the relevant ethical and legal principles in the field of healthcare is necessary because of the lack of knowledge among medical workers is the cause of conflicts. All this testifies to the presence of ethics and the right of close interconnection, due to compliance with the requirements of physicians deontology, rarely arise disputes from relatives, and vice versa, in case of non-compliance with the requirements of deontology, even with proper treatment, there may be conflicts.
Formation and development of biomedical ethics are inextricably linked with the affirmation of human rights, with inalienable rights of the individual, including the rights of the patient. Consequently, biomedical ethics should be considered as one of the forms of protection of human rights, of its right to life, to health, to free self-determination of one's life.
Taking into account the purpose and tasks of biomedical ethics, the system of international and national norms regulating medical activities, it is possible to distinguish the following functions of biomedical ethics: 1) information providing legal and ethical information on the rights and obligations of the subjects of medical legal relations; 2) axiological (comprehansive), which involves the formation of a system of values among employees of medical institutions, their ethical rules of behavior; 3) communicative, which forms the principles and models of communication in medical legal relations in the coordinate system "patient doctor". 4) preventive, ensuring prevention of negative consequences of non-compliance of patients rights, prevention of violation of human rights.

[IV] DISCUSSION
The basic principles of the health care system are human security and quality medical care, which determine the content and purpose of normative acts and provide guarantees of compliance with them.
Biomedical rights include the following rights: the right to respect the anatomy of a human person, the right to receive information about the diagnosis and prognosis of their own state, the right of the patient to safety, the right to participate in making decisions about the choice of treatment methods, up to the refusal of treatment in general, and so on.
As the scientists point out, the dynamics of the biomedical industry and the expansion of the range of subjects of the application of the latest advances in this field in practice necessitate the introduction of clarifications and additions to international acts. The opinion of B. Ostrovska about the unification of the terminology of the 1997 Convention on Human Rights and Biomedicine (for example, the concepts of "man", "proper protection" of the embryo, personality of person, etc.) is relevant, in at least within the Council of Europe. So, from the definition of the universal concept of "man," scientist thinks, the further legal protection of his rights depends, as well as the correct understanding of the subordination of human rights, the correlation of fundamental rights with other rights (for example, the ratio of reproductive human rights to the right to life in the application of auxiliary reproductive technologies) (Ostrovska, 2017).
In recent years, many issues that were considered purely deontological, found their legal solution, that is, the moral regulation of medical workers' actions became legal. In particular, the question of the admissibility of euthanasia, which took place from the moral and ethical standpoint, as well as in terms of ending one's own life as a human right to worthy death (for example, the experience of the city of Mexico, where the Constitution was adopted in 2017, the rules of which are allowed by euthanasia for incurable patients) (Sovgyria, Yanchuk, 2018) in Ukraine is unambiguously resolved legal. Despite the fact that in some countries (Belgium, Canada, Luxembourg, the Netherlands, Switzerland, certain US states), "the murder of compassion" persists in practice, regardless of whether it is lawful or not, national law does not recognize any form of euthanasia , as discussed in Clauses 2 and 3 of Art. 52 Fundamentals of Ukrainian Health Law (Basics of the Legislation of Ukraine…, 1992).
In different European countries, the legal regulation of biomedical issues is different. Ukraine has established itself in the international legal space as a member state of the Council of Europe with loyal legislation on biomedical issues, in contrast to the national legislation of Germany, France, Italy. To ensure the protection of human rights, it is needed to ratify the following international acts by the Verkhovna Rada of Ukraine: the Convention on the Protection of Human Rights and Dignity regarding the Application of Biology and Medicine, the Convention on Human Rights and Biomedicine, the Additional Protocol to the Convention for the Protection of Human Rights and Dignity regarding the Application of Biological Evolution and medicine on the prohibition of cloning of human beings, the Additional Protocol to the Convention on Human Rights and Biomedicine in the field of biomedical research, etc. Currently, the legal protection of bioethical human rights in Ukraine is regulated mainly by the provisions of the Fundamentals of Ukrainian Health Law and civil law, which contain a number of rules of direct action for the protection of patients' rights. However, the list of patients 'rights stated in Ukrainian legislation does not comply with international standards, in particular, the list, which is defined by the European Charter of Patients' Rights (Glukhovsky, Angelov, Slabky, Belokon, 2012). Therefore, taking into account the strategic course of Ukraine's accession to the European Union, the urgent need is to adopt a special law that will determine the legal, economic and organizational foundations for the protection of the rights and legitimate interests of patients, the declaration of which is laid down in Art. 24-1 "Protection of the rights of patients" Fundamentals of Ukrainian legislation on health care. Also, in agreeing with O. Kovalenko, the law, with the aim of guaranteeing the rights of patients at an appropriate level along with the rights enshrined in the European Charter, should include the right to take preventive measures; respect for patient's time; innovation; avoidance of suffering and pain as possible; on an individual approach to treatment (Kovalenko, 2018). It is also desirable to directly affirm ethical requirements to doctors, to conduct biomedical research and medical practice, as well as the responsibilities of patients, in particular the duty to comply with medical prescriptions of a physician and the duty to comply with the internal rules of the health care institution.
According to Art. 24 of the Constitution of Ukraine, all citizens have equal constitutional rights and freedoms and are equal in front of the law, including the right to health care, medical care and health insurance (p. 49) (Constitution of Ukraine, 1996).
The concept of health, defined by R. Stefanchuk, as a personal non-property benefit and should be covered by the existing somatic and mental state of the organism's life, which is determined by the system of qualitative and quantitative medical indicators. At the same time, noting that today civil legislation should contain provisions that would guarantee to an individual not only the right to health protection, but would provide a real legal opportunity to carry out the maximum amount of actions (behavior) that is aimed at (in the quantitative and qualitative aspect) satisfaction of their interests in the aspect of their own health (Stefanchuk, Yanchuk, Stefanchuk, Stefanchuk, 2019).
In addition, in clause "i" of art. 6 Fundamentals of health care legislation provides the right to legal protection against any illicit form of discrimination related to the state of health.
An important aspect in the field of bioethical human rights, along with the improvement of the regulatory framework and the implementation of international bioethical principles and standards, is the provision of the right to health care and medical care.
We can agree with the definition of I. Senyuta of human right for health as a social (natural) phenomenon -a person's ability to use all social, primarily state, means aimed at preserving, strengthening, developing and, in case of violation, restoration of the maximum achievable level of physical and mental state of its body (Senyuta, 2006).
In the context of this question, it is necessary to create an optimal model of the functioning of the national health care system, the effectiveness of development strategy would depend on compliance with certain principles of public administration in this area. Accepting the opinion of O. Pundy (2017), such principles should include: the principle of priority, social orientation, balanced and proportional development, taking into account the level of development of the medical and demographic situation of the regions, optimality and efficiency, sustainable development, flexibility of levers. These principles can be considered as universal requirements for the implementation of the current needs for the organization of medical care in Ukraine and their compliance with the development of appropriate targeted and comprehensive programs that will enable the combination of national policies and strategies for the development of this area and will contribute to the formation of an optimal model for its functioning.
Simultaneously with the reform of the legal mechanism of health care, there needs to change and an institutional mechanism for regulating relations in the medical sector. After all, most scholars emphasize that overcoming the crisis in healthcare in Ukraine is possible only through the use of a synthesized organizational and legal model for the provision of medical care (Punda, 2017). Strategic priority of the development of the domestic health care model can be the involvement of the private sector in the use and modernization of the existing medical infrastructure that is in state and communal ownership. It is a question of introducing a public-private partnership institution in the healthcare sector, which will allow additional public resources, including investments, to be made available to the public sector. Despite the fact that the possibility of using public-private partnerships in the field of healthcare is defined by the Law of Ukraine "On Public-Private Partnership" dated July 1, 2010 No. 2404-VI, the development of such relations between the state and the private sector in Ukraine so far is in the initial stage. The legal and regulatory framework for the regulation of publicprivate relations in the healthcare sector remains unformed, the circle of possible objects and subjects of such a partnership is underdeveloped, as well as the mechanism of responsibility and risk sharing between private and public partners. Another obstacle to public-private partnerships in the healthcare sector is the existence of contradictions between the mentioned law and the Constitution of Ukraine, which establishes rights for the free provision of medical care in public and communal health care institutions, as well as the impossibility of reducing the existing network of such establishments limiting the processes of privatization and concession of objects of this sphere.
In the conditions of the innovation and information development of society, there is a need to ensure the realization of the right of an individual to a secret about the state of health. The right to privacy and the protection of personal data are protected by legal instruments developed by the Council of Europe and the European Union (EU). The EU Charter clearly defines the right to data protection, considering it as a fundamental right (page 8). However, these rights are not absolute and may be limited. Any restrictions on these rights must be in accordance with the law, pursue a legitimate aim (goals) and be necessary in a democratic society. It is worth to pay attention to the scientific work of O. Chaban, in which the content of the right of an individual to a secret on the state of health is defined as the right to a secret about the state of health, the fact of applying for medical assistance and / or medical service, as well as other information that considered a medical secret (Chaban, 2018).
In the context of the development of the digital economy and society, in the context of the provision of biomedical rights, the issue of the introduction of the electronic healthcare system remains an indispensable and indispensable element of medical reform in Ukraine, as it involves the transfer of patient information to the electronic format and the replacement of paper cards for the integrated electronic cards. The procedure for the functioning of the electronic health care system and the procedure for the publication of information from the electronic health system by the National Health Service are determined by the Resolution of the Cabinet of Ministers of Ukraine "Some questions on the electronic health system" No. 411 dated April 25, 2018. In the long run, realization the act will provide patients with the opportunity to use electronic services to exercise their rights under the program of state guarantees of medical care of the population. At the same time, it should be noted that today one of the problems with the introduction of the electronic health system is the patient's access to complete information about health and the protection of personal data. This problem remains unresolved, as unlike the laws of most European countries, in which there is a division of personal data by the criterion of their "sensitivity" to data of a general nature (surname, name, patronymic, date and place of birth, citizenship, place of residence) and "sensitive" or vulnerable (information about health status, ethnicity, religion, identification codes or numbers, fingerprints, voice recordings, photographs, criminal record, etc.), such differentiation in Ukrainian legislation is missing, which means there is a significant gap. After all, the state of guaranteed personal data protection is provided precisely on the basis of the criteria-signs of the notion of "personal data", the safe keeping of these criteria-signs from third parties who do not have the authority to familiarize with them. So, for sensitive personal data, a higher degree of protection is foreseen. In particular, it is forbidden to collect, store, use and pass without the agreement of the data subject the most sensitive, and not all, personal data, without exception. Said proves the necessity of bringing the national legislation fully into line with European standards by implementing additional organizational and legal measures to improve the control over the implementation of laws and regulations in this field and to supplement their content with the provisions of the Regulation of the European Parliament and of the Council (EU) 2016/679 of April 27, 2016, which establishes more stringent standards related to the responsibility for the legality of the processing of personal data and focuses on such necessity of introduction of, if possible, larger amount of personal data, which must be protected.
According to T. Kharatyan, in order to prevent a rude violation of human rights and dignity in the legislation of Ukraine, the concepts related to biomedicine should be defined. In particular, issues of the legal status of embryos should be regulated, which would ensure their proper protection, stem cell use, therapeutic cloning, transplantation (including xenotransplantation), biomedical and genetic research, etc. The author proposes to prohibit at the national level activities aimed at deliberately introducing changes that can be inherited to the human genome and which, under certain conditions, can lead to the destruction of a person as a biological species (Kharatyan, 2019).
Speaking about the provision of bioethical human rights at the present step of development, cannot be left aside the issues of awareness and competence development in this area, for both medical workers and for lawyers. The acquisition of high quality individualized learning tools has become available to all European lawyers and medical professionals through the European Human Rights Education Program developed in conjunction with the Council of Europe's Bioethics Committee in 2018, a free on-line HELP course on human rights in the field of biomedicine. This course covers the right to personal integrity in general, which traditionally covers the right to privacy and the prohibition of torture, as well as the right to personal integrity in specific areas of medicine and biology. Today, the implementation of the HELP program is taking place in 47 countries, members of the Council of Europe, in particular also in Ukraine, through the network of national educational institutions for judges, prosecutors and lawyers, the platform for e-learning and the definition of the methodology of human rights education (Open Free Online Course on Personal Injury Rights. (n.d.).

[V] CONCLUSION
The development of modern biotechnology not only opened up new opportunities for addressing humanity's problems, but also led to an increase in opportunities for bioterrorism and human rights violations. In today's conditions of innovation and information development, it becomes necessary to develop a theoretical and practical component of modern biomedical jurisprudence. The main factors of the emergence of modern biomedical ethics are: 1) rapid development of fundamental sciences in the second half of the XX century; 2) introduction of new theoretical discoveries in medical practice; 3) unpredictability or uncertainty about the consequences of widespread use of medical achievements; 4) ignoring or underestimating the principles of humanity, ethics, morals and law in medicine; 5) taking into account the religious point of view about the beginning of life in medical practice.
Biomedical ethics is a branch of knowledge that is a system of ethical and legal norms that regulate relations in the field of biomedicine, a set of moral principles, norms and rules that medical professionals must follow in the course of their professional activities. The norms and principles are enshrined in normative acts of international and national character (conventions, declarations, charter, laws and by-laws of the normative-legal acts). Among sources of biomedical ethics can be distinguished: national legislation in the field of medicine; international medical law regulating legislation; international ethical (deontological) codes containing recommendations on medical ethics; national ethical (deontological) codes of professional ethics of physicians.
In order to implement the norms of international law, the Verkhovna Rada of Ukraine should ratify a number of international acts in the field of biomedicine for the protection of human rights.
In order to improve the Ukrainian legislation in the field of biomedical ethics, we consider it necessary to adopt a special law on the protection of patients' rights that will determine the legal, economic and organizational foundations for protecting the rights and legitimate interests of patients, including biomedical rights.
In order to improve the legal regulation mechanism, biomedical rights require the development of a concept and category relating to biomedicine to prevent rude violation of human rights and dignity. In particular, issues of the legal status of embryos, the use of stem cells, therapeutic cloning, transplantation (including xenotransplantation), biomedical and genetic research, etc., should be regulated.
Priority direction of development of the national model of health care should be the involvement of the private sector in the use and modernization of the existing medical infrastructure, which is in state and communal ownership. We consider it necessary to introduce a public-private partnership institution in the field of health care, to improve the legal and regulatory framework for the regulation of public-private relations and the liability mechanism.
To improve the control over the implementation of laws and regulations on the legality of the processing of personal data that is subject for protection, it is important to create a system of organizational and legal measures by establishing rules of legal responsibility for their violation, developing criteria-signs of the concept of "personal data", providing patients with legislative level of possibilities for using of electronic services for the realization of their rights.
In addition, the ethical requirements for doctors, the implementation of biomedical research and medical practice, as well as the responsibilities of patients need to be standardized.
Based on information indicated above and given the gaps in Ukrainian legislation in the field of biomedical ethics, the prospect of further research on biomedical ethics through the improvement of legal theory and legal practice is possible.
Fundamental human rights should remain the basis for addressing the existing ethical and legal issues in the field of biomedicine.