THE CONCEPT OF MEDICAL LAW AND ITS PLACE IN THE SYSTEM OF BRANCHES OF LAW

Abstract

The scientific work is devoted to the legal nature and regulation of medical law as a branch of law. There is little scientific literature and judicial practice on medical disputes in Georgian realities. Therefore, the study aims to intensify discussion in this direction. The problem becomes even more relevant in the context of technological development in the medical field. The purpose of the research is to determine the object of regulation of medical law, the place of medical law in the legal system, and the relationship between medical law and medical ethics. To achieve this goal, it is necessary to answer the following questions: What relations are included in the scope of regulation of medical law? What is its method of regulation? Where is the place of medical law – is it included in civil law, is it part of criminal and administrative law, or does it represent a certain unity of all three areas? From this point of view, the subject and method of regulating medical law should be studied. Also of interest is a brief analysis of documents reflecting the international context in the medical field, especially in the area of protecting the personal autonomy of the patient. Research confirms that medical law is an interdisciplinary field. It includes law and other branches of science, such as bioethics, medicine, and psychology. Thus, there is a close relationship between medical law and medical ethics. It is also possible that a violation of medical ethics entails a violation of the law and corresponding liability. In addition, it appears that medical law includes parts of public (administrative) law, criminal law, contract law and tort law. The role of contract and tort law in effectively protecting the interests of the patient is special.

Keywords: Medical Law, Medical Ethics, Interdisciplinary Sphere, Administrative Liability, Private legal Responsibility.

 Introduction

Medical law is considered a new branch of law for Georgian reality. Over the years, it has been integrated into other fields, so medical law as an independent field in Georgia has not received much attention until now. Perhaps one of the reasons for this was the lack of research and judicial practice on various issues of medical law in Georgian reality. However, this situation is slowly improving in our country, and medical law is becoming increasingly widespread as an independent branch of law. It is impossible to do otherwise since medical law is in no way inferior in importance to other branches of law.

In addition, in the context of technological development in the medical field, the need to pay more attention to protecting human rights has become on the agenda. This concerned the use of assisted reproductive technologies and taking into account the specifics of surrogacy in the medical field. Accordingly, the study aims to determine the place of medical law in the legal system. To achieve this goal, the following tasks are set: first, it is necessary to determine the subject of regulation of medical law and then clarify the method of regulating medical law. With their help, it is determined which relations are included in the scope of regulation of medical law and how medical law regulates these relations. This is a necessary condition for determining the legal nature of medical law - medical law is included in civil law, is part of criminal law and administrative law, or represents a specific unity of all three branches. In this way, it is possible to determine the features and principles of medical law and its place in the legal system.

Moreover, medical law is often discussed in close connection with medical ethics. It is sometimes equated with medical ethics, although experience today has shown that medical law has acquired a completely different meaning. Therefore, it is necessary to determine both the subject of regulation of medical law and the connection between medical law and medical ethics. In this context, it remains to be seen whether there have been any fundamental changes in patient advocacy that have highlighted the distinctive nature of medical law as a field. Therefore, conducting a brief analysis of sources at the national level and international contextual documents in the medical field will be interesting. It is also worth noting the approaches and postulates of the European Court of Human Rights regarding protecting the patient’s personal autonomy in the medical field.

Considering the specifics of research, normative-dogmatic, comparative, analysis and synthesis, and historical methods are used. With their help, various aspects of the problem, which have not yet received due attention, were highlighted.

1. Medical law and medical ethics

1.1. Area of regulation of medical law

From a semantic point of view, “medical law” includes two terms: “medicine” and “law”. Therefore, if they are briefly discussed, the essence of “medical law” can be easily established.

Medicine is a science. Science can be viewed as an organized body of knowledge. The method of science is descriptive. He investigates facts, processes natural phenomena and, therefore, tries to bring the facts into a system. Like ethics, law is prescriptive (evaluative) in nature. It sets the rules for human behavior.[1] Accordingly, the law determines what a person’s behavior should be. The term “medicine”, or more precisely “human medicine”, broadly includes all activities used to identify, treat and, if possible, cure and prevent human diseases. Scientific medicine is based on a wide range of other sciences, such as chemistry, physics, biology, psychology, sociology and others.[2] The main task of medicine is to care for health. Health is always related to a person’s ability to function well physically and mentally, and to reach their full potential.[3]

Thus, medical law is an independent branch of law that regulates the activities of a doctor, his professional functions, the relationship between doctor and patient and its derived consequences. This is a special branch of law that provides the human judicial protection in the field of medical practice and methods of human treatment, establishing the basic principles of the right to health care.[4]  In addition, medical law is a set of norms that define the organizational, structural, and general legal relations of people carrying out sanitary and anti-epidemic measures, as well as other actions related to preventive and therapeutic care. The object of medical law is legal relations that arise during the implementation of preventive, therapeutic, sanitary and regulatory acts that determine the legal status of the participants in these relations.[5]

Medical law is a young and rapidly developing industry that combines legal norms governing relations in healthcare and other related issues.[6] However, expressing cases in medical practice in medical categories is problematic. The law may not separate these categories and there is a need to convey them in legal language, after which their use by law enforcement officer will be permitted. For example, a surgery performed without error according to medical standards may subject the physician/clinic to liability if a court finds that the physician or clinic is liable without fault. However, it is first necessary to establish whether the transplant is a thing in private law or a blood product stored in a blood bank, according to Article 1009 of the Civil Code. Without clarifying this issue, it is impossible to determine the degree of its deficiency, etc. In Georgia, this problem is clearly visible, which harms all parties in this relationship and highlights the vicious aspects: clinics and doctors resort to different methods of protection, for example, using unacceptable standard conditions to exclude liability as much as possible. However, the court then declares such conditions invalid due to inadmissibility. In addition, patients are unaware of when they can seek compensation from a doctor or clinic, which increases the number of frivolous claims and waste of time and financial resources for both parties.[7] However, the subjects of medical law are interdependent: the medical institution, healthcare workers and patients. A medical organization is an entity that provides medical services to patients. The health care professional has professional knowledge, and the patient is subject to treatment.[8] Therefore, it is critical that each branch of medical law work properly to protect the primary beneficiary of health care services — the patient.

The legal literature notes that next to the concept of “medical law” the broader term “health law” is used. Health care law regulates not only medical activities but also the procedures that must be carried out, the necessity of the procedure and the requirements for the specialists performing it. Health law covers a wide range of rules relating to health care, procedural issues and the organization of public health systems.[9]

Thus, medical law is a branch of law that regulates the rights of representatives of the medical industry, providers and consumers of medical services, patients and doctors. Compared to medical law, health law covers a broader area of rules relating to human health. Health law governs human health procedures that involve fundamental human rights and legal claims. Thus, there are differences between medical law and health law. Indeed, medical law and health law are often considered separately, but they should not be strictly separated since both disciplines contribute to the humanization of law.[10]

Therefore, the principles of medical law are social justice, humanism, equality, legality and unity of rights and responsibilities.[11]

1.2. The essence of medical ethics

Medical ethics is a medical deontology that includes moral principles for determining values and making appropriate decisions in medical practice. It includes a set of ethical standards and rules of conduct for medical personnel. Deontology is the principles of performance of professional duties, professional ethics and behavior by medical personnel, aimed at obtaining maximum benefit from treatment. Such attitudes promote a sense of respect and dignity.[12]

Medical ethics is closely related to law, but law and ethics are not identical. In many cases, ethics provide higher standards of behavior than laws. However, laws vary from country to country, and ethics extend beyond national borders. To meet patients’ expectations, healthcare professionals need to possess medical knowledge and practice the core values of the field, as well as demonstrate special concern for the patient, his capabilities and autonomy. Thus, there are many similarities between medicine and law, and they often overlap. Medicine cares about people’s lives and health in a different way, and law – in a different way. Lawyers and doctors study the general doctrines of forensic and legal medicine during their studies.[13]

Ethical approaches may involve deciding the ideal course of human behavior, while law sets minimum acceptable standards. Likewise, something can attract legal sanctions without being unethical. For example, if a physician acts on behalf of a private patient, he may be in breach of contract by choosing not to treat that patient. There may be an ethical reason for this. For example, if another patient needed urgent care, this may not always justify a breach of contract from a legal perspective.[14] However, when it comes to a tragic collision, equal interests collide, and the decision must be made in favor of one of them at the expense of an unlawful attack on the benefit of the other.[15]

2. 2. The relationship of medical ethics with medical law

There is a clear connection between medical law and medical ethics.[16]  Medical law is a legal discipline, the subject of regulation of which is a narrow range of relations, in particular, it extends to the relationship between the patient and medical personnel or medical activities.[17] The legal basis of medical law was created in the period after the Nuremberg trials, which gave impetus to its development. Articles of the Nuremberg Code restricted experiments on humans that could harm their psychosomatic state or lead to death.[18]

Medical ethics and medical law are complementary; The legal force of the rules of medical ethics is recognized by the courts, and failure by medical professionals to comply with these rules entails sanctions. Therefore, it is indisputable that medical ethics is considered a source of medical law. When the principles of ethics and rules of conduct in the medical field are illuminated by legal norms, these two areas intersect, that is, to a certain extent, a symbiosis of bioethics and medical law arises.[19]

Violation of medical ethics rules can also trigger legal liability. The fact is that by violating any principle of medical ethics, the violator can be held accountable. For example, this action may be the basis for administrative/disciplinary liability and private legal liability for violation of the patient’s personal independence (Article 1007 of the Civil Code, Law “On Health Protection”).

In addition, the doctor may be found guilty as a result of violating the duty to comply with medical standards.[20] Georgian case law explains this: by acting in accordance with medical standards, the doctor does not violate any obligations and is not accused. A doctor is liable for breach of duty only if the harm caused to the patient is caused by an error in treatment. If a doctor does not know a matter individually or shows professional weakness, this does not excuse him. This is due to the fact that a doctor violates mandatory medical care even when the doctor violates his duty to improve his education and qualifications and, therefore, does not have modern knowledge of medical science.[21] Thus, the cause of a medical error can be objective and subjective. Objectively, let’s say, there is a lack of scientific knowledge about the disease. The subjective cause of a medical error may be a consequence of the lack of experience of a particular doctor.[22]

Thus, there may be inconsistencies and similarities between a physician’s legal responsibilities and ethical responsibilities, but a physician is required to follow both the law and the guidelines of professional ethics. Even if a physician finds it difficult to comply with the law because it conflicts with his ethical beliefs, the physician is obligated to comply with the law.[23] Thus, the mentioned position overlaps with the principle: Fiat lex, pereat mundus, because “even if the whole country falls, the law must be observed!”[24]

3. 3. Principles of medical law and medical ethics

There are four principles of ethics: Beneficence, nonmaleficence, autonomy and justice. The first two can be traced back to the time of Hippocrates “to help and do no harm”, while the last two arose later. Percival’s book on ethics, published in the early 1800s, emphasized the importance of the goal of protecting the interests of the patient, while autonomy and justice were not discussed at the time. Over time, however, both autonomy and justice were recognized as important ethical principles. In modern times, Beauchamp and Childress’s book Principles of Biomedical Ethics is considered a classic, providing insight into the application of these four principles and alternative approaches.[25]

During the Enlightenment, there was still an opinion that it was necessary to lie to a patient so that it would be easier for the doctor to care for the patient. In the 1800s, medical professionals were divided over whether a patient should be informed of a poor prognosis. Most doctors at that time were against informing patients about their condition. [26]

Later, the situation changes, and today, telling the truth is the most important component of the relationship between doctor and patient. Without this element, the doctor loses the patient’s trust. An autonomous patient not only has the right to know his or her diagnosis and prognosis but also has the opportunity to refuse disclosing this information. However, the doctor must know which of these options the patient prefers. In the United States, it is now the norm to provide patients with complete information regardless of the severity of the disease, but this was not the case previously. For example, 88% of doctors surveyed in 1961 indicated that they preferred to disclose their diagnosis.[27] This changed in 1979 when 98% of doctors surveyed supported disclosing the diagnosis to patients.[28]

The paternalistic approach to medical practice requires critical analysis in connection with technological and economic progress. This is due to the fact that the educational and socio-economic status of the population has improved, signs of globalization have appeared, and special attention has been paid to the patient as an individual, not as a group member. Accordingly, respect for the principle of autonomy imposes a duty on the physician to disclose to the patient medical information and treatment options necessary for the patient’s self-determination. In doing so, protecting autonomy serves to ensure informed consent, fairness, and confidentiality.[29]

Each of the four principles of ethics is considered a duty that must be fulfilled, unless, in a particular case, it conflicts with another principle. In such a conflict, the physician must determine the actual duty to the patient since the weight of the competing obligations will be assessed in light of their content and context. For example, a patient is in shock and is receiving emergency fluid resuscitation. Insertion of an indwelling intravenous catheter caused pain and swelling. Here, the principle of “do good” prevails over the principle of “do no harm”. However, we are often dealing with a more complex case. For example, this happens when a competent patient refuses medical intervention necessary to save life (for example, installing a ventilator) or asks to be brought to death (withdrawal of artificial ventilation). Ethical dilemmas are best seen when the principles of beneficence and autonomy collide. Good deeds have played a historical role in traditional medical practice. However, if this approach were to prioritize patient autonomy, it would be paternalistic, making the doctor-patient relationship similar to a father/mother relationship with a child. The father/mother can deny the child fulfilment of his wishes and can also influence the child in various ways - non-disclosure, manipulation, lies, coercion, etc. Accordingly, the parent determines what is best for the child. This is the essence of paternalism. Paternalism can be mild or severe. In soft paternalism, the doctor acts based on the principle of “doing good” (sometimes also “doing no harm”) if the patient is not autonomous or essentially non-autonomous. For example, a person has cognitive dysfunction due to a serious illness, depression, or drug addiction.[30]

Soft paternalism is associated with difficulties since it is difficult to determine whether the patient was not autonomous in deciding and also whether the action was ethically justified, corresponding to what the doctor considered valuable for the patient. In strict paternalism, the physician’s actions for the patient’s benefit are opposed to the voluntary decision of the autonomous patient, who is fully informed and competent. Therefore, this action is unjustified from an ethical point of view. At the other end of the scale of hard paternalism is consumerism, a rare and extreme form of patient autonomy in which the doctor’s role is limited to providing medical information, all possible options and treatments, while the fully informed patient chooses one of the available options. In this model, the role of the physician is limited; This approach does not allow the full use of the doctor’s knowledge and skills for the benefit of the patient, is tantamount to abandonment of the patient and is therefore ethically unjustified.[31]

4. 4. Interdisciplinary nature of medical law

Medical law is an interdisciplinary (interdisciplinary) area of law. Medical law is at the crossroads of areas of law. It includes aspects of public law as well as civil and criminal law and cannot avoid the influence of European law.[32]

It is believed that medical law is an area in which the law particularly encourages good behavior. Medical law has largely developed by borrowing principles from other areas of law, such as torts and criminal law. The term “medical law” is used to refer to a wide range of legal relationships. Medical law governs tort liability, sometimes contract liability, as well as tort and criminal liability for treatment without appropriate consent, criminal liability for manslaughter and medical manslaughter - euthanasia (which is considered murder in England) and assisted suicide. In addition, medical laws criminalize breach of confidentiality, abortion, use of body parts, including organ donation, and death. Also, criminal law applies even in cases of cessation of treatment and refusal of treatment to a patient who cannot make a decision. In short, medical law applies to a person’s entire life, from birth to death. Many of the issues discussed by medical lawyers have serious ethical implications. It is, therefore important to distinguish between legal and ethical issues.[33]

In addition, medical law is considered a complex legal interdisciplinary field because it integrates bioethics, health law, criminal and civil codes, health care and quality of life; He also perceives health as a medical, social and legal category.[34] Medical law is a comprehensively developed branch of law, which includes legal norms governing public relations in the field of medical activity. Accordingly, the subject of medical law is social relations arising in the process of carrying out medical activities. Medical activities are those that include the provision and organization of medical services, ensuring the sanitary and epidemiological well-being of people, and conducting medical examinations.[35]

Medical law has certain features that distinguish it from other branches of law. The following features of medical law are noteworthy:

1. It is mixed because it contains public and private law forms, rules of substantive and procedural law (law of evidence, civil procedural and criminal procedural law);


2. Medical law is dynamic, since the rules governing medical professionals must always be able to adapt to the necessary new diagnostic, treatment and diagnostic procedures;


3. However, it is objective in the sense that the law determines its sequence;


4. Medical law is largely imperative. The legal norms included in it are of an ethical, moral and fundamentalist nature, although they cannot be excluded by special agreements of the parties, especially when it comes to public order and health.[36] In the case of mandatory rules, the parties do not have the opportunity to deviate from this rule and arrange relations differently.[37]

The role of international acts in regulating these relations is special. The International Covenant on “Economic, Social and Cultural Rights” should be noted among the important international legal acts. The first paragraph of Article 12 of this pact recognizes the contracting states as “the right of everyone to the highest quality of physical and mental health.” Such a right would not be realized if it depended on chance and unforeseen processes in the human body. The right to health, enshrined in the International Covenant, allows individuals to freely make decisions regarding their bodies and health. This relates to the provision of consent for medical procedures.[38]

In addition, it is worth noting the European Convention on Human Rights, which protects the personal autonomy of the patient under Article 8. Even if the patient’s refusal of a particular medical intervention leads to death, carrying out a medical procedure without the consent of a mentally healthy and adult patient entails a violation of his rights to physical integrity, which violates Article 8 of the European Convention on Human Rights.[39]

Patient autonomy is a form of autonomous rights associated with informed consent. When giving informed consent, several rules must be observed simultaneously: voluntariness, capacity to make decisions, disclosure of information about the patient’s health status, the patient must have the ability to understand, and he must be able to make decisions.[40]

The patient must be provided with appropriate conditions and sufficient time to analyze the information provided by the clinic since voluntary consent excludes the manifestation of will through the influence of unreasonable pressure or other circumstances. The fact is that if a patient is given information between medically uncomfortable (medicated) sleep sessions while in a state of severe stress and fatigue, he is unlikely to make an informed decision.[41] The patient can ask for advice from relatives, whose opinion will influence his choice. However, if these prompts for the patient are not orders but additional information for making a decision, then his final decision (choice) will be autonomous. Also, the patient may or may not agree with the proposal to accept the doctor’s opinion. If the patient expresses his consent, he accepts the doctor’s proposal as his own decision, therefore, the decision made by the patient will be independent.[42]

In addition, the influence of European law can be observed in the field of medical law. European law includes rules related to health protection, which relate to improving the living and working conditions of the contracting states. European law sets the policies of member states towards improving the quality of public health, disease control, health education and other issues.[43] Therefore, this guideline guides Member States in the healthcare field.

Medical law belongs to the category of complex industries, so the legal regulation methods will differ depending on the nature of social relations. For example, since most relations developing in the healthcare sector are civil, the method of legal regulation, in this case, is based on licensing norms. If medical law deals with criminal relations, then the methods of their regulation are focused on prohibitions and in the case of administrative legal relations - on mandatory rules.[44]

The existence of mandatory norms in medical law should be natural since medical law is, first of all, an area of public law in a broad sense. For many health law mandates, be it hospital sector, medical contract law, professional law, medicines, medical devices and pharmaceutical law, it is necessary to understand both the public law structure and the public law regulations. It is more acceptable if this part of medical law is considered commercial administrative law.[45]

For example, the use of medical services and the procedure for reimbursement by the state are based on strict adherence to mandatory rules. This involves providing the authority with real information about the correct execution of medical documentation and services provided by the medical institution and the emergence of an obligation for compensation from the administrative body within the framework of the state program when such information is submitted. The discovery of a significant discrepancy in the information provided may be a prerequisite for the clinic to refuse a refund or demand a refund of money already paid. In Georgia, the “State Agency for the Regulation of Medical Activities” is responsible for verifying medical records. In particular, his competence includes confirming the discrepancy between the patient’s medical records and the diagnosis and intervention communicated in the alert system. One case established that the discussion of these issues is the subject of the study of administrative law.[46]

Additionally, careful medical record-keeping is vital to improving a patient’s health status. This is especially true when the participation of one medical institution is not enough to treat the patient, and the additional involvement of another medical institution is necessary. In this case, to improve the patient’s health status in the shortest possible time, it is important to convey as much information as possible from one medical institution to another. This problem is due to the fact that the timely exchange of information is followed by the effective conduct of primary medical examinations in a short time and the timely determination of necessary further medical measures. This also applies to an unspecified diagnosis, the provision of information about which allows the second medical institution to narrow the scope of possible medical diagnoses as much as possible and make an accurate diagnosis in a much shorter time by conducting the necessary examinations. If the exchange of information between medical institutions does not occur in full, this creates a risk that the necessary medical measures will not be carried out in a timely manner for a patient transferred to a second medical clinic. This is because the medical institution is forced to go through the same path that the first medical institution has already gone through when examining a patient admitted to it to establish a diagnosis. The patient’s health status is reflected in the medical record, which is the basis for issuing a health certificate. This report is then sent to the medical facility where the patient is transferred. Thus, the Cassation Chamber of Georgia noted that the reflection of any type of diagnosis (specified or unspecified) in the medical record is of decisive importance in the patient’s recovery process, and violation of this rule for preparing a medical record creates a real danger of a serious end to the medical case. Based on the above, in one of the cases, it was established that both the failure to issue a notification about the patient’s health status at the time of discharge and the failure to take into account the therapist’s diagnosis (unstable angina or acute pneumonia) and the cardiologist’s diagnoses (unstable angina) in the final clinical diagnosis, depending on their significance, create professional misconduct on the part of an administrative body. Grounds for applying a fine. In this case, the person’s state certification was suspended for several months, and he was ordered to undergo a two-month vocational rehabilitation course in emergency medicine. In these circumstances, the Professional Development Council of the Ministry of Health is considering the possibility of using Articles 207 and 208 of the General Administrative Code of Georgia to pay compensation to the victim. According to part one of Article 208 of the said Code, the state is responsible for damage caused by a government body, as well as by its official or other civil servant or civil servant of this body (except a civil servant defined in part 2 of this article) in the performance of their official duties.[47]

One question is interesting here: some medical institutions cannot provide several services because the institution does not have a specific tool equipment or there is no specialist. However, it is with their help that a final diagnosis should be made. Perhaps a specific test or examination of a medical device was carried out in one medical institution, a second medical operation was necessary in another medical institution, and the final diagnosis was made by a doctor at a third medical institution based on the research of two other medical institutions. If tests performed at other medical institutions led to an incorrect diagnosis by a doctor at a third medical institution, would all three be held responsible for the result if the doctor at the third medical institution correctly assessed the tests available to him, but made an incorrect diagnosis because of incorrect earlier tests?

The fact is that an error made in one medical institution can directly lead to an incorrect result in another institution - an incorrect diagnosis. Accordingly, a logical chain is established between studies in different medical institutions, which in many cases is associated with deviations or inaccuracy of the practitioner. In this case, it is better for a medical institution not to carry out such activities for which it does not have the appropriate professional equipment and does not have a specialist in the relevant field. In addition, if there is no other decision, another medical institution can take on the role of “assistant” and provide medical services, but under these conditions, it is necessary to ensure both the conduct of qualified research and the provision of complete and reliable information to the doctor of the medical institution making the diagnosis. Otherwise, the risks of avoiding responsibility and medical negligence are high. According to Article 1007 of the Civil Code, harm caused to human health during treatment in a medical institution (due to surgery, incorrect diagnosis, etc.) is compensated on a general basis. However, the person who caused the damage may be released from liability if he proves that he is not responsible for the damage caused. Accordingly, the above example gives rise to the following difficulties: the doctor of a third medical institution must prove the absence of his guilt to exclude his liability. In addition, it will be difficult for the victim to determine the person responsible.

The imperative method is a method of power instructions, which is characterized primarily by power relations. Regarding medical activities, these legal relations relate to healthcare institutions, their individual (structural) divisions, entrepreneurs, etc., compliance with government regulations (for example, licensing, standardization, and certification). The dispositional method assumes the legal equality of participants in legal relations. Thus, the patient has the right to make decisions in many cases involving medical interventions. In this situation, a specific method of legal regulation of the relationship between the patient and the doctor, inherent only in medical law, can be established; this is the method of prioritizing the opinion of the patient or his representative regarding medical intervention.[48]

Healthcare law as a part of administrative law has been little studied in the legal space of Georgia. Healthcare legislation performs the most important function of maintaining order in the health care system. There is no unified codification of healthcare law in Georgia. Accordingly, here are presented, on the one hand, numerous legislative or by-laws in force in this area, and on the other hand, various sectoral laws that contain many health protection standards and/or regulations related to health care law. According to Article 1 of the Law of Georgia “On Health Protection”, this law regulates relations between government bodies and individuals and legal entities in the field of protecting the health of citizens.[49]

The Law of Georgia “On Health Protection” is the most important legal document, according to which the general postulates of the principles of state policy in the field of health care, the rights of citizens, management, organization and financing of the health care system, medical activities and establishes the organizational and legal regulation of medical institutions and other issues. Health policy is directly related to health care management. This law provides for health policy objectives related to the legal regulation of health care. When implementing the law by the executive branch of the country, the law is aimed at implementing many strategic plans and achieving corresponding results.[50]

The Ministry of Labour, Health and Social Protection of Georgia is an administrative body with the authority to ensure the management of the entire healthcare management system and the implementation of related policies through public administration mechanisms. In addition, the law “On Medical Activities” was separately adopted, which regulates the legal relationship between the subject of independent medical activity, a paramedic and government bodies, individuals and legal entities (Article 2). This law establishes the right to independent medical practice, continuing medical professional development, state certification, professional responsibility and other issues. Also, the Law of Georgia “On Public Health” aims to promote public health and establish a healthy lifestyle; Providing a safe environment for the health of humans and others. This law also clearly defines public health principles and government responsibilities. These laws, among other laws, relate to medical law as part of administrative law.[51]

The judicial practice of Georgia has shown that the issue of issuing a certificate is the subject of consideration by the Chamber of Administrative Cases. The right to independent medical practice is granted to a person by the Professional Development Council by issuing a state certificate. To issue a certificate, it is necessary to comply with the conditions established by the Law of Georgia “On Medical Activities”. A medical institution may use dismissal from a medical institution as the maximum disciplinary sanction against a subject of medical activity, and the most severe measure of liability determined by the Council is the revocation of a state certificate, in particular, a ban on the right to independent medical practice.[52]

In addition, to qualify harm caused by an illegal, guilty action on the part of an administrative body, it is necessary to clarify the functional load of the concept of “execution of official duty”, which means the process of exercising public law powers.[53]  As can be seen from the above, medical law is not limited to administrative law. Medical law deals with a wide range of different areas of law: criminal law, human rights law, tort law, contract law, public law, civil law and family law.[54]

The role of contract law in protecting the interests of the victim in medical disputes is special. The rules of contract law governing contractual obligations are specific, taking into account their characteristics. However, Article 326 of the Civil Code provides for another possibility, according to which the rules on contractual obligations apply to other non-contractual obligations unless otherwise follows from the essence of the obligation.[55] This norm is successfully used in judicial practice in qualifying disputes arising from harm to the life and health of a patient by medical personnel and medical institutions. This obligation arises due to a violation of the absolute right of the victim, is of a non-contractual nature and is aimed at compensation for property or moral damage. Accordingly, contractual damages statutes are used in the recovery of injurious damages.[56]

The fact is that the conclusion of an agreement does not exclude the occurrence of tort liability. To determine the legal nature of the obligation, it is crucial to clarify what legal fact is the basis for the occurrence of damage - violation of the terms of the contract or infringement of absolute property and non-property rights by illegal actions.[57] The purpose of Article 1007 of the Civil Code is to expand tortious liability for compensation for harm arising from contractual obligations between a medical institution and a patient. The general basis for regulating tort liability is Article 992 of the Civil Code. That is why Article 1007 of the Civil Code is considered an exception to tortious obligations.[58]

Conclusion

It seems that medical law is an interdisciplinary field since it includes law and other fields of science, such as bioethics, medicine, and psychology. As for the place of medical law in the system of branches of law, medical law cannot be linearly attributed to only one branch of law. This branch of law includes parts of public (administrative) law, criminal law, contract law and tort law. It can be said that medical law, in a general sense, is a hybrid version of public and private law. Therefore, medical law should be considered as a complex branch of law.

Research confirms that medical law includes both permissive and prohibitive and mandatory norms. The dispositional part of medical law is related to civil law, and imperative and prohibitory norms are related to public law (administrative law and criminal law). The administrative-legal part of medical law includes rules for certification, revocation of a certificate, proper documentation of health status, pharmaceutical activities, and other rules. The private law part of medical law extends to the governing rules of contract law or tort liability.

However, medical law is closely related to, but not limited to, medical ethics. In addition to medical ethics, medical law includes other components. Violating the law may result in sanctions on the violator, although it cannot be considered unethical. In addition, it is possible that an unethical action will lead to a violation of the law and, accordingly, legal liability (whether administrative or civil liability). Accordingly, which method of legal regulation (dispositional or imperative) will be used in medical law directly depends on the nature of social relations.

It should be noted here that private law’s role in medical law is special. The fact is that in the medical field, both contract and tort law can be applied. This becomes even clearer if we consider that, according to Article 326 of the Civil Code, the rules on contractual obligations also apply to other non-contractual obligations unless otherwise follows from the essence of the obligation. Thus, the protection of the patient’s private law claims is ensured by contract and tort law rules.

Bibliography

Normative material:

1. Civil Code of Georgia, 1997 June 26, N786-II.


2. Law of Georgia “On Health Protection”, 1997 December 10, N1139-I.


3. Law of Georgia “On Medical Activity”, 2001 June 8, N904-II.


4. Law of Georgia “On Public Health”, 2007 June 27, N5069.

Scientific literature:

1. Bichia,, (2022). Golden Rules for Informed Consent in line with the practice of the European Court of Human Rights, Collection of articles: “Protection of human rights: international and national experience”, ed. Korkelia K., Tb., p. 180. (in Georgian).


2. Bichia,, (2021). Specifics of Compensation for Damages Caused by a Medical Institution: Theoretical and Practical Aspects, “Justice and Law”, №2, pp. 90, 96. (in Georgian).


3. Bichia, M., (2020). Legal Obligational Relations, Handbook, 3rd ed., p. 41. (in Georgian).


4. Bichia, M., (2019). Features of Protecting the Patient’s Personal Autonomy and of Giving Informed Consent (Georgian and European Approaches), Journal “Law and World”, №12, p. 52. (in Georgian).


5. Gabunia, L., Khetsuriani, Sh., Gamkrelidze, N., Gumbaridze, L., Varazi, E., (2019). Medical deontology and prevention of iatrogenic diseases, Tbilisi State Medical University, collection of scientific papers, N53, p. 29. (in Georgian).


6. Gordeladze, D., Chachibaya, T., (2005). Bioethics and Medical Law, Tb., pp. 32-33. (in Georgian).


7. Talakvadze, A., Gotsadze, T., Bokeria, I., Bakakuri, N., Skhvitaridze, Z., Gzirishvili, D., (2011). Overview and legal analysis of healthcare legislation, Tb., p. 76. (in Georgian).


8. Kvantaliani, N., (2014). Patient’s rights and foundations of civil liability of health care personnel, Tb., p. 55. (in Georgian).


9. Kvantaliani, N., Rusiashvili, G., (2022). General systematics of the doctor's civil liability and the meaning of the doctor’s fault, “Georgian-German Journal of Comparative Law”, No. 1, pp. 1-2. (in Georgian).


10. Makaradze, D., Khazaradze, G., (2014). Responsibility of the administrative body in health protection law, Tb., pp. 72-75. (in Georgian).


11. Sukhitashvili, T., Sukhitashvili, D., (2011). Competition of contractual and tort liability claims, “Justice and Law” magazine, N3(30), pp. 71-72. (in Georgian).


12. Turava, P., Tskepladze, N., (2010). Handbook of General Administrative Law, Tb., p. 146. (in Georgian).


13. Turava, M., (2010). Criminal law, overview of the general part, 8th edition, Tb., p. 243. (in Georgian).


14. Alekseeva, I. M., Alekseev, A. G., Anischenko, M. A., (2016). Medical Law, Zaporozhye, p. 6. (in English)


15. Bakshi, PM. (1993). Law and Medicine, Lucknow, p. 2, 6. (in English).


16. Bydlinski, P., (2007). Grundzüge des Privatrechts fȕr Ausbildung und Praxis, 7., wesentlich ȕberarbeitete Auflage, Wien, S. 13. (in German).


17. Bock, K. D., (1993). Was ist Medizin? In: Wissenschaftliche und alternative Medizin, Heidelberg, S. 7, https://doi.org/10.1007/978-3-642-78170-4_2 (in German).


18. Carmen, M. G. Del, Joffe, S., (2005). Informed Consent for Medical Treatment and Research: A Review, The Oncologist, No. 10 (8), p. 637. (in English).


19. Deutch, E., Spickhoff, A., (2014). Medizinrecht, Arztrecht, Arzneimittelrecht, Medizinproduktrecht und Transfusionsrecht, 7. Auflage, Heidelberg, p. 191. (in German).


20. Ivanovic, S., Stanojevic, C., Jajic, S., Vila, A., Nikolic, S., (2013). Medical Law and Ethics, Acta Medica Medianae, Vol. 52(3), pp. 67-68. (in English).


21. Foster, C., Herring, J., (2021). The Law as a Moral Agent: Making People Good, Springer, p. 63. (in English).


22. Jackson, E., (2015). The relationship between medical law and good medical ethics, Journal of medical ethics, 41 (1), p. 97. (in English).


23. Janda, C., (2022). Medizinrecht, 5. Auflage, München, pp. 27-28. (in German).


24. Janda, C., (2019). Medizinrecht, 4. Auflage, München, pp. 27-28. (in German).


25. Herring, J., (2022). Medical law and ethics, 9th edition, Oxford, p. 2. (in English).


26. Herring, J., (2012). Medical law and ethics, 5th edition, Oxford, pp. 2-3. (in English).


27. Murray, P. M., (1990). The History of Informed Consent, The Iowa Orthopedic Journal, Vol. 10, p. 104. (in English).


28. Novack, D.H., Plumer, R., Smith, R.L., Ochitill, H., Morrow, G. R., Bennett, J. M., (1979). Changes in physicians’ attitudes toward telling the cancer patient, The Journal of the American Medical Association, Vol. 241, no. 9, p. 898. (in English).


29. Poscher, R., (2014). Human Dignity as a taboo, translated by Bichia, M., Journal “Justice and Law”, №2(41), p. 61. (in Georgian).


30. Radišić, J., (2007). Medicinsko pravo. Belgrade: Nomos, p. 24. (in English).


31. Ratzel, R., Luxenburger, B., (2008). Handbuch Medizinrecht, Saarbrücken, S. 3-4. (in German).


32. Varsi Rospigliosi, E., (2003). Medical Law: Perú, International Encyclopedia of Laws, Netherlands, p. 43. (in English).


33. Sibilla, B., (2011). Medical Error in Ukraine, Med. & L, Vol. 30, Issue 1, p. 43. (in English).


34. Todorovski, N., (2018). Medical Law and health law – is it the same? Acta Media Mediane, Vol. 57(2), pp. 34, 38. https://Doi:10.5633/amm.2018.0206 (in English).


35. Tonelli, M. R., Misak, C. J., (2010). Compromised Autonomy and the Seriously III Patient, CHEST, 137, 4, p. 926, DOI: 10.1378/chest.09-1574 (in English).


36. Varkey, B., (2021). Principles of Clinical Ethics and Their Application to Practice, Med Princ Pract, Vol. 30, p. 18-21 https://doi.org/10.1159/000509119 (in English).


37. Agievets,V. et al. (2022). Medical law: textbook, ed. Agievets S.V., Vasilevich G.A., Minsk, p. 8-9. (in Russian).

Court practice:

1. Decision No. BS-9(K-23) of the Administrative Affairs Chamber of the Supreme Court of Georgia dated May 1, 2023. (in Georgian).


2. Decision No. As-1169-2022 of the Civil Affairs Chamber of the Supreme Court of Georgia dated November 17, 2022. (in Georgian).


3. Decision No. BS-853(K-20) of the Administrative Affairs Chamber of the Supreme Court of Georgia of July 1, 2021. (in Georgian).


4. Decision No. BS-257-257(K-18) of the Administrative Affairs Chamber of the Supreme Court of Georgia of October 18, 2018. (in Georgian).


5. Decision of the Civil Affairs Chamber of the Supreme Court of Georgia dated May 25, 2010 (No. 1268-1526-09). (in Georgian).


6. Jehovah’s Witnesses of Moscow and Others v. Russia, no. 302/02, June 10, 2010. (in English).


7. Konovalova v. Russia, no. 37873/04, September 9, 2014. (in English).


8. A.S. v. Hungary, CEDAW/C/36/D/4/2004, 29 August, 2006. (in English).

Footnotes

[1] Bakshi, P. M., (1993). Law and Medicine, Lucknow, p. 2. (in English).

[2] Bock, K. D., (1993). Was ist Medizin? In: Wissenschaftliche und alternative Medizin, Heidelberg, p. 7, https://doi.org/10.1007/978-3-642-78170-4_2 (in German).

[3] Bakshi, P. M., (1993). Law and Medicine, Lucknow, p. 6. (in English).

[4] Varsi Rospigliosi, E., (2003). Medical Law: Perú, International Encyclopedia of Laws, Netherlands, p. 43. (in English).

[5] Alekseeva, I. M., Alekseev, A.G., Anischenko, M. A., (2016). Medical Law, Zaporozhye, p. 6. (in English).

[6] Gordeladze, D., Chachibaya, T., (2005). Bioethics and Medical Law, Tb., p. 32. (in Georgian).

[7] Kvantaliani, N., Rusiashvili, G., (2022). General systematics of the doctor's civil liability and the meaning of the doctor’s fault, "Georgian-German Journal of Comparative Law", No. 1, p. 1-2. (in Georgian).

[8] Alekseeva, I. M., Alekseev, A.G., Anischenko, M. A., (2016). Medical Law, Zaporozhye, p. 6. (in English).

[9] Todorovski, N., (2018). Medical Law and health law – is it the same? Acta Media Mediane, Vol. 57(2), p. 34. https://Doi:10.5633/amm.2018.0206 (in English).

[10] Todorovski, N., (2018). Medical Law and health law – is it the same? Acta Media Mediane, Vol. 57(2), p. 38. https://Doi:10.5633/amm.2018.0206 (in English).

[11] Alekseeva, I. M., Alekseev, A.G., Anischenko, M. A., (2016). Medical Law, Zaporozhye, p. 6. (in English).

[12] Gabunia, L., Khetsuriani, Sh., Gamkrelidze, N., Gumbaridze, L., Varazi, E., (2019). Medical deontology and prevention of iatrogenic diseases, Tbilisi State Medical University, collection of scientific papers, N53, p. 29. (in English).

[13] Ivanovic, S., Stanojevic, C., Jajic, S., Vila, A., Nikolic, S., (2013). Medical Law and Ethics, Acta Medica Medianae, Vol. 52(3), p. 67-68. (in English).

[14] Herring, J., (2012). Medical law and ethics, 5^th edition, Oxford, p. 3. (in English).

[15] Turava, M., (2010). Criminal law, review of the general part, 8th edition, Tb., p. 243. (in Georgian).

[16] Herring, J., (2012). Medical law and ethics, 5.th edition, Oxford, p. 3. (in English).

[17] Radišić, J., (2007). Medicinsko pravo. Beograd: Nomos, p. 24; Ivanovic, S., Stanojevic, C., Jajic, S., Vila, A., Nikolic, S., (2013). Medical Law and Ethics, Acta Medica Medianae, Vol. 52(3), p. 67. (in English).

[18] Gordeladze, D., Chachibaya, T., (2005). Bioethics and Medical Law, Tb., p. 33. (in Georgian).

[19] Ivanovic, S., Stanojevic, C., Jajic, S., Vila, A., Nikolic, S., (2013). Medical Law and Ethics, Acta Medica Medianae, Vol. 52(3), pp. 67-68. (in English).

[20] Deutch, E., Spickhoff, A., (2014). Medizinrecht, Arztrecht, Arzneimittelrecht, Medizinproduktrecht und Transfusionsrecht, 7. Auflage, Heidelberg, S. 191. (in German).

[21] Decision of the Civil Affairs Chamber of the Supreme Court of Georgia dated May 25, 2010 (No-1268-1526-09).

[22] See Sibilla, B., (2011). Medical Error in Ukraine, Med. & L, Vol. 30, Issue 1, p. 43. (in English); Bichia, M., (2021). Specifics of Compensation for Damages Caused by a Medical Institution: Theoretical and Practical Aspects, “Justice and Law”, №2, p. 90. (in Georgian).

[23] Jackson, E., (2015). The relationship between medical law and good medical ethics, Journal of medical ethics, 41 (1), p. 97. (in English).

[24] See Poscher, R., (2014). Human Dignity as a taboo, translated by Bichia, M., Journal “Justice and Law”, №2(41), p. 61. (in Georgian).

[25] Varkey, B., (2021). Principles of Clinical Ethics and Their Application to Practice, Med Princ Pract, Vol. 30, p. 18, https://doi.org/10.1159/000509119 (in English).

[26] Murray, P. M., (1990). The History of Informed Consent, The Iowa Orthopaedic Journal, Vol. 10, p. 104. (in English).

[27] Varkey, B., (2021). Principles of Clinical Ethics and Their Application to Practice, Med Princ Pract, Vol. 30, p. 20, https://doi.org/10.1159/000509119 (in English).

[28] Novack, D. H., Plumer, R., Smith, R.L., Ochitill, H., Morrow, G. R., Bennett, J. M., (1979). Changes in physicians’ attitudes toward telling the cancer patient, The Journal of the American Medical Association, Vol. 241, No. 9, p. 898. (in English).

[29] Varkey, B., (2021). Principles of Clinical Ethics and Their Application to Practice, Med Princ Pract, Vol. 30, p. 19, https://doi.org/10.1159/000509119 (in English).

[30] Tonelli, M. R., Misak, C. J., (2010). Compromised Autonomy and the Seriously III Patient, CHEST, 137, 4, p. 926, DOI: 10.1378/chest.09-1574 (in English).

[31] Varkey, B., (2021). Principles of Clinical Ethics and Their Application to Practice, Med Princ Pract, Vol. 30, p. 21, https://doi.org/10.1159/000509119 (in English).

[32] Janda, C., (2019). Medizinrecht, 4. Auflage, München, S. 27; Janda, C., (2022). Medizinrecht, 5. Auflage, S. 27. (in German).

[33] Foster, C., Herring, J., (2021). The Law as a Moral Agent: Making People Good, Springer, p. 63. (in English).

[34]  Gordeladze, D., Chachibaya, T., (2005). Bioethics and Medical Law, Tb., p. 32. (in Georgian).

[35] Agievets, S.V. et al., (2022). Medical law: textbook, ed. Agievets, S.V., Vasilevich, G.A., Minsk, p. 8. (in Russian).

[36] Varsi Rospigliosi, E., (2003). Medical Law: Perú, International Encyclopedia of Laws, Netherlands, p. 43. (in English).

[37] იხ. Bydlinski, P., (2007). Grundzüge des Privatrechts fȕr Ausbildung und Praxis, 7., wesentlich ȕberarbeitete Auflage, Wien, S. 13. (in German).

[38] Janda, C., (2019). Medizinrecht, 4. Auflage, München, S. 28. (in German).

[39] Jehovah’s Witnesses of Moscow and Others v. Russia, no. 302/02, 10 June, 2010. (in English).

[40] Carmen, M. G. Del, Joffe, S., (2005). Informed Consent for Medical Treatment and Research: A Review, The Oncologist, №10 (8), p. 637. (in English); Bichia, M., (2022). Golden Rules for Informed Consent in line with the practice of the European Court of Human Rights, Collection of articles: "Protection of human rights: international and national experience", ed. Korkelia K., Tb., p. 180. (in Georgian).

[41] Konovalova v. Russia, no. 37873/04, 9 September, 2014; Also, see A.S. v. Hungary, CEDAW/C/36/D/4/2004, 29 August, 2006. (in English).

[42] Bichia, M., (2019). Features of Protecting the Patient’s Personal Autonomy and of Giving Informed Consent (Georgian and European Approaches), “Law and World”, №12, p. 52. (in Georgian).

[43] Janda, C., (2022). Medizinrecht, 5. Auflage, München, S. 28. (in German).

[44] Agievets, S.V. et al. (2022). Medical law: textbook, ed. Agievets S.V., Vasilevich G.A., Minsk, pp. 8-9. (in Russian).

[45] Ratzel, R., Luxenburger, B., (2008). Handbuch Medizinrecht, Saarbrücken, S. 3-4. (in German).

[46] Decision No. BS-9(K-23) of the Administrative Affairs Chamber of the Supreme Court of Georgia dated May 1, 2023. (in Georgian).

[47] Decision No. BS-853(K-20) of the Administrative Affairs Chamber of the Supreme Court of Georgia of July 1, 2021. (in Georgian).

[48] Agievets, S.V. et al. (2022). Medical law: textbook, ed. Agievets S.V., Vasilevich G.A., Minsk, p. 9. (in Russian).

[49] Makaradze, D., Khazaradze, G., (2014). Responsibility of the administrative body in health protection law, Tb., pp. 72-73. (in Georgian).

[50] Talakvadze, A., Gotsadze, T., Bokeria, I., Bakakuri, N., Skhvitaridze, Z., Gzirishvili, D., (2011). Overview and legal analysis of healthcare legislation, Tb., p. 76. (in Georgian).

[51] Makaradze, D., Khazaradze, G., (2014). Responsibility of the administrative body in health protection law, Tb., pp. 74-75. (in Georgian).

[52] Decision No. BS-257-257(K-18) of the Administrative Affairs Chamber of the Supreme Court of Georgia dated October 18, 2018. (in Georgian).

[53] Turava, P., Tskepladze, N., (2010). Handbook of General Administrative Law, Tb., p. 146. (in Georgian).

[54] Herring, J., (2012). Medical law and ethics, 5.th edition, Oxford, p. 2; Herring, J., (2022). Medical law and ethics, 9.th edition, Oxford, 2022, p. 2. (in English).

[55] Bichia, M., (2020). Legal Obligational Relations, Handbook, 3rd ed., p. 41. (in Georgian).

[56] Decision No. As-1169-2022 of the Civil Affairs Chamber of the Supreme Court of Georgia dated November 17, 2022. (in Georgian).

[57] Kvantaliani N., Patient rights and the basics of civil liability of medical personnel, Tb., 2014, 55. (in Georgian).

[58] Sukhitashvili, T., Sukhitashvili, D., (2011). Competition of contractual and tort liability claims, “Justice and Law”, N3(30), pp. 71-72; Bichia, M., (2021). Specifics of Compensation for Damages Caused by a Medical Institution: Theoretical and Practical Aspects, “Justice and Law”, №2, p. 96. (in Georgian).