Reforma practicii medicale: abordare istorică, responsabilităţi legale, legislaţie actuală

 Medical practice reform: historical approaches, legal responsibility, current legislation

First published: 04 martie 2021

Editorial Group: MEDICHUB MEDIA

DOI: 10.26416/ORL.50.1.2021.4224


Legal liability for medical errors is an old concept, with a history that can be traced back to the Hammurabi Code in 2030 BC. Because medical practices had to be conducted to a high standard of care, some ethical and moral benchmarks were established from the beginning. The study, through a historical approach, presents the evolution of these values, along with medical scientific progress, towards the principles of bioethics. In the modern era, with the increase in the responsibility of the medical act, these principles are transformed into laws, outlining the legal responsibility. The natural consequence of this huge vulnerability is the need of adequate education and training of medical staff (university and postgraduate) in the legislative field, to allow them fulfill their profession effectively in the workplace while respecting the rights of patients. 

ethical and moral norms, legal responsibility, bioethics, malpractice, medical practice reform, medical legislation


Responsabilitatea juridică pentru erorile medicale este un con­cept vechi, cu o istorie care poate fi urmărită până la Codul lui Hammurabi, în 2030 î.Hr. Deoarece practicile medicale tre­bu­iau să se desfăşoare la un standard de îngrijire înalt, de la în­ce­put au fost stabilite unele repere etice şi morale. Articolul de faţă, printr-o abordare istorică, prezintă evoluţia acestor va­lori, odată cu progresul ştiinţific medical, către principiile bio­eti­cii. În epoca modernă, odată cu creşterea responsabilităţii ac­tu­lui medical, aceste principii sunt transformate în legi, con­tu­rând responsabilitatea juridică. Urmarea firească a acestei vul­ne­ra­bi­li­tăţi uriaşe apărute o reprezintă educaţia şi formarea adecvată a personalului medical (universitară şi postuniversitară) în do­me­niul legislativ, pentru a le permite să-şi îndeplinească profesia în mod eficient la locul de muncă, respectând în acelaşi timp şi drep­tu­rile pacienţilor.

Introduction: overview of the context

An in-depth analysis of the knowledge of the legislative framework of the medical system has generated great concerns regarding the vulnerabilities of doctors in medical practice(1,3). These are mainly due to the ignorance and noncompliance with the current legal requirements which, on one hand, are recently introduced, and on the other hand, have not been the subject of some forms of organized professional training of doctors.

It is recognized that the legislative novelties regarding the medical act represent an unfamiliar territory for many doctors, but also for medical educators(2,4). Their medical practice is largely based on “customary law” passed down through generations of professionals, without verifying the validity of this information or the consequences of noncompliance with these legal provisions.

Being a qualitative approach, we used the document analysis method, a descriptive method, taking into account all categories of data in the literature, giving to the interested party a better understanding of the final objective of the paper: how these ethical and moral concepts (basic elements of professional responsibility) have undergone these transformations that have finally led nowadays to a legislation that regulates the medical practice.

The evolution of the medical legislative norms – historical approach

The ancient writings of the great civilizations have shown us the constant concern for the correct use of medical knowledge of the time, with the clear intention of healing patients.

The Code of Hammurabi (king of Babylon in the 18th century BC) has spoken of medical liability, showings us that severe punishments could be applied, with criminal character (cutting hands for blindness caused by a faulty eye operation) or civil character (monetary or slave compensation)(5).

The biblical books and the Talmud, among the ancient Jews, tell us that, in addition to the fact that Jewish doctors had to prove medical studies, the doctor could not perform an intervention without the patient’s consent and had a huge responsibility for both him and the patient’s family. Ancient China had an interesting way of physician liability. The patient paid the doctor while he was healthy, but stopped paying when he became ill, and the method proved to be a successful preventive measure.

The first piece of information that we have about the doctor cames from antiquity, when he was seen as a healer, he had an image of “sacred aura”, and no one could judge his behavior. Thus, Sir William Osler, a remarkable figure in the history of medical education, described Imhotep as “the first figure of a physician to stand out clearly from the mists of antiquity”. His medical practices deviated from the use of magic and prayer used by other Egyptian healers and were obviously more advanced at the time(2).

Ancient Greece is highlighted by two philosophers whose views still represent the core of health policies in the world. Thus, Plato, a follower of preventive medicine, considered that the physician should be exonerated from liability if the patient’s death occurred without him wanting it. Instead, Aristotle, being a follower of medical responsibility, demands that the doctor should be judged only by his confreres.

Obviously, the Hippocratic tradition of over 2000 years through the Hippocratic Oath (which is still symbolically uttered at the end of medical studies) and the application of the principle Primum non nocere can no longer be enough to regulate medical practice. Moreover, we learned that Hippocrates’ recommendation was: “Perform your medical duties calmly and adroitly, concealing most things from the patient while you are attending to him. Give necessary orders with cheerfulness and sincerity, turning his attention away from what is being done to him; sometimes reprove sharply and sometimes comfort with solicitude and attention, revealing nothing of the patient’s future or present condition, for many patients through this course have taken a turn for the worse”(6).

By 1803, Thomas Percival, in Medical Ethics, describes a type of behavior, recommended as a practice, by which the physician only reveals to the entourage information about the disease – only if necessary he would inform the patient.

Then, against the background of a total lack of legal regulation regarding medical practice, the 20th century witnessed the atrocities committed during and after World War II, in which we recall here only two of them, with a strong resonance in the world: the Nazi experiments on prisoners of war, and the Tuskegee Syphilis Study of the US Health Service, conducted between 1932 and 1972.

In recent years, the unprecedented evolution of science has attracted the emergence of a similar phenomenon in terms of morality and ethics, stimulating reflection on the destinies of humankind. As there is a broadening of moral norms and principles applicable to current medicine, there is a real revolution in the concepts of life and human.

Although medical malpractice lawsuits began to appear in the 1800s (in the United States), it was not until the 1960s that a wave of medical malpractice lawsuits appeared in court. The growth was caused by the new and more complex treatments with higher iatrogenic risks and by the changing legal perspective which, on one hand, facilitated the access of injured patients to trials and, on the other hand, changed the rules of legal liability of medical staff(7).

Medical practice reform is the product of political processes, through which doctors and medical organizations consider most accusations to be false and harmful to the medical system, while patients’ supporters consider that the system of allegations of malpractice discourages medical error and negligence, and compensation is well deserved by the injured patients(8).

Thus, in 1970, in the midst of the crisis of the system, a new research entity appeared – bioethics, a multidisciplinary field, involving philosophers, lawyers, doctors, nurses, representatives of civil society, anthropologists, and established a set of moral principles that described a minimum of moral obligations regarding the behavior of the medical staff(9). These principles, proposed by Tom L. Beauchamp (also considered “the father of bioethics”) and James F. Childress, corresponded to the common moral norms of society and were represented by:

The principle of autonomy. This principle translates into the patient’s ability to act autonomously, informed and based on his own decisions, being the basis of the “informed consent” in the practice of the doctor-patient relationship. Another reflection in the medical legislation of this principle refers to the confidentiality of medical data.

The principle of non-injury. This principle (associated in medical ethics with the principle Primum non nocere) is transposed in the obligation of medical practice within the limits of competence conferred by the doctor’s specialty.

The principle of benefit represents the obligation of the doctor to intervene for helping or preventing the occurrence of an illness.

The principle of justice. Quite controversial, the idea of social justice is based on the minimum requirement attributed to Aristotle: “equals must be treated equally, unequals must be treated unequally”. This principle is called “formal justice” because it does not indicate criteria for determining whether two people are equal or what are the characteristics of the equal treatment.

Even today, in this context, the obvious increasing differences in the significance on legislation compared to the moral and ethical aspect in ordinary clinical practice can be considered appropriate elements of future university curricula(10).

A huge step in this evolution from ethical, moral norms to legislation is the fact that in all international declarations of university programs and accreditation programs of medical institutions, we find the need for medical staff to present solid knowledge about medical legislation and its understanding(11,12).

Thus, in the USA around the 1970s, 40 of the 101 (39.6%) medical schools reported the teaching of legislative notions. In 1987, this kind of academic courses were taught in 54 of the 127 medical schools. Today, due to the growth of legal issues in medical practice, these courses are offered in all 127 medical schools, being present in all school curricula, optional (in 54 programs) or compulsory (74.8%)(13,14).

In the UK, we find these curricular structures in 32 medical schools, and the General Medical Council (GMC), since the 1990s, requires doctors to have knowledge of medical legislation and to respect it in their medical practice. These standards can be met only if the teaching and learning of the medical legislation in medical schools are fundamental and they have integrated both vertically and horizontally this obligation to teach in the school curriculum(15).

In Australia and New Zealand, the standards require the knowledge of the legal responsibilities of the medical profession, and physicians must be aware that the law regulates the professional practice(16). In Canada, you must know in detail the notions of legislation related to practice. The content of these legislative notions focuses on: confidentiality, consent, avoidance of discrimination, patients’ access to data(17,18).

In Romania, the lack of knowing the legal regulations introduced in the medical practice represents a significant barrier for the medical personnel(19-22). This is the main reason for introducing the elements of specific legislation and medical malpractice in the university training program within the Faculty of Medicine of the “Carol Davila” University of Medicine and Pharmacy from Bucharest, being the only university in the country that reported these compulsory courses in preclinical education (first year of the study).


In this context, as a need for regulation, medical legislation appears practically based on all four principles of bioethics. If bioethics tells us what ethical principles should guide the medical staff in their relationship with patients, the medical legislation tells us what legal provisions medical staff should follow in dealing with patients.

The failure to comply with them has completely different consequences: if an ethical norm is not followed, you can at most be criticized by colleagues, while if the medical legislation is not followed, a juridic liability can be attracted, with serious consequences on the medical staff. From a certain perspective, the observance of the notions of medical legislation represents even a measure of the quality of the medical act, becoming a reference for the accreditation of medical institutions.

In Romania, performing the medical act implies sometimes risks of medical malpractice by not knowing and not respecting the legal framework applicable to medical practice. Having no access to recent information, medical practice is based on “custom” passed down through generations of professionals, without anyone verifying the validity of this information. This is easy to understand, because until now there was no training in the university or postgraduate program about medical legislation, moreover, the legislation in Romania is very young. 


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