NRL: brain death criteria should not be in the form of a legal act

In the opinion of physicians, it should be up to medical experts to determine these criteria, as it is now, where more than 30 experts who have developed these procedures are listed under the announcement of the Minister of Health dated December 4, 2019 on the manner and criteria for determining permanent irreversible cessation of brain function with the criteria for determining brain death.

We publish the content of the post below:

In connection with the Ombudsman's statement of August 28, 2023 (mark: V.7018.2.2014.AM) on the position of the medical self-government as to whether the procedures for determining permanent irreversible cessation of brain function and irreversible cardiac arrest preceding organ procurement should be regulated in an act that is a source of universally binding law, the Supreme Medical Council adopts the following:

The regulation on the determination of brain death previously was contained in Article 9, paragraphs 1-5 of the Law of July 1, 2005 on the collection, storage and transplantation of cells, tissues and organs. The provision of Article 9 of the aforementioned law stated as follows:

1. The harvesting of cells, tissues or organs for transplantation is permitted once permanent irreversible cessation of brain function (brain death) has been established.
2. The criteria and method of determining permanent irreversible cessation of brain function shall be determined by specialists in relevant fields of medicine appointed by the minister responsible for health, taking into account current medical knowledge.
3. The Minister of Health shall announce, by means of a proclamation, in the Official Journal of the Republic of Poland "Monitor Polski", the criteria and method of determining permanent irreversible cessation of brain function.
4. Permanent irreversible cessation of brain function shall be declared unanimously, on the basis of the criteria referred to in paragraph 3, by a committee composed of three physicians with specialization, including at least one specialist in anesthesiology and intensive care and one specialist in neurology or neurosurgery.
5. The commission referred to in paragraph 4 shall be appointed and its chairman appointed by the head of the treatment entity or a person authorized by him.

The provisions of Article 9(1)-(5) of the Law of July 1, 2005 on the Collection, Storage and Transplantation of Cells, Tissues and Organs were repealed by Article 2 of the Law of February 24, 2017 amending the Law on the Profession of Physician and Dentist and the Law on the Collection, Storage and Transplantation of Cells, Tissues and Organs (Journal of Laws of 2017, item 767). At the same time, the same law added a new Article 43a to the Law on the Profession of Physician and Dentist of December 5, 1996, which now regulates brain death. The provision of Article 43a of the Law on the Profession of Physician and Dentist states:

Article 43a

1. Statement:
2. permanent irreversible cessation of brain function (brain death),
3. irreversible cardiac arrest preceding organ procurement

- shall be carried out after the specialists referred to in paragraph 5 or 6 have carried out the procedure in accordance with current medical knowledge, taking into account the manner and criteria referred to in paragraph 3.

1. The method and criteria referred to in paragraph 3 shall be determined in accordance with current medical knowledge medical knowledge by specialists in relevant fields of medicine appointed and dismissed by the minister responsible for health.
2. The minister in charge of health shall announce, by means of a notice, in the Official Journal of the Republic of Poland "Monitor Polski", method and criteria for determination:
3. permanent irreversible cessation of brain function (brain death);
4. irreversible cardiac arrest preceding organ procurement.
5. The minister in charge of health, at least once every 5 years, shall entrust specialists in relevant fields of medicine appointed and dismissed by the minister with the task of assessing the compliance of the manner and criteria referred to in paragraph 3 with current medical knowledge.5
6. Permanent irreversible cessation of brain function (brain death) is declared unanimously by two specialists with a second degree of specialization or a specialist title, including one specialist in anesthesiology and intensive care or neonatology, and the other in neurology, pediatric neurology or neurosurgery.
7. Irreversible cardiac arrest preceding organ procurement is unanimously confirmed by two specialists with a second degree of specialization or a specialist title, one of whom is a specialist in anesthesiology and intensive care or neonatology, and the other in emergency medicine, internal medicine, cardiology, pediatric cardiology or pediatrics.
8. The finding of permanent irreversible cessation of brain function (brain death) or irreversible cardiac arrest preceding organ procurement is tantamount to a finding of death.

Both the previous legal regulation placed in the Law of July 1, 2005 on the collection, storage and transplantation of cells, tissues and organs, and the current legal regulation placed in the Law on the Profession of Physician and Dentist actually impose an obligation on the Minister responsible for health to announce in an official publication, the "Monitor Polski," the criteria and method for determining brain death. This is prejudiced by the fact that the term "the Minister shall announce" is used.

In the proceedings before the Constitutional Court initiated by the Ombudsman's motion of December 7, 2015 to declare the incompatibility of Article 9(3) of the Act of July 1, 2005 on the procurement, storage and transplantation of cells, tissues and organs, insofar as it authorizes the minister responsible for health to announce, by way of a proclamation, the method of ascertaining permanent irreversible cessation of brain function, with Article 38 in connection with 31(3) and Article 87(1) of the Constitution of the Republic of Poland. 1 of the Constitution of the Republic of Poland revealed the incompatibility of the positions and assessments of the participants in the proceedings - insofar as the Prosecutor General shared the view that Article 9(3) of the Act of July 1, 2005. on the collection, storage and transplantation of cells, tissues and organs, insofar as it authorizes the minister responsible for health matters to announce, by means of a proclamation, the manner in which permanent irreversible cessation of brain function is determined, is incompatible with Article 38 in connection with Article 31(3) and Article 87(1) of the Constitution, the position of the Speaker of the Sejm was different. This proves that the matter covered by the inquiry is complex, and, in addition, concerns an issue of great social importance, namely, the determination of when a person's life ends.

In view of the lapsing of Article 9(3) of the Act, the Constitutional Court discontinued the proceedings conducted under case number K 42/15, so there was no ruling that would finally resolve this constitutional-legal issue.

The Supreme Medical Council does not have the authority of a constitutional court and does not undertake to resolve the significant constitutional doubts raised by the Ombudsman in the previous proceedings before the Constitutional Court, which have probably remained largely valid also under the current legislation. However, the medical self-government presents its view of the issue raised through the prism of the expectations of the medical community with regard to the creation of norms regulating the medical profession.

To begin with, it is worth noting that the determination of brain death is one of the activities that should be included among the elements included in the practice of the medical profession. According to Article 2(1) of the Law of December 5, 1996 on the professions of physician and dentist, the practice of the medical profession consists in the provision of health services by a person with the required qualifications, confirmed by appropriate documents, in particular: examination of the state of health, diagnosis and prevention of diseases, treatment and rehabilitation of patients, providing medical advice, as well as issuing medical opinions and judgments. The determination of death, as referred to in Article 43 of the Law on the Profession of Physician and Dentist, and the determination of permanent irreversible cessation of brain function (brain death) or irreversible cardiac arrest preceding organ donation, as referred to in Article 43a of the Law on the Profession of Physician and Dentist, should be considered broadly as the issuance of a medical judgment, i.e., a document that states a specific clinical condition regarding the patient's health. Since the pronouncement of death and the determination of permanent irreversible cessation of brain function (brain death) or irreversible circulatory arrest preceding organ donation are among the activities of the medical profession, they are subject to regulation under Article 4 of the Law on the Profession of Physician and Dentist. This provision stipulates that a doctor is obliged to practice his profession in accordance with the indications of current medical knowledge, the methods and means available to him for the prevention, diagnosis and treatment of diseases, in accordance with the principles of professional ethics and with due diligence. In light of this provision, the doctor should perform diagnostic, therapeutic and judgmental activities guided by the current state of medical knowledge. Ethical standards for physicians look at this issue in a similar way - Article 4 of the Code of Medical Ethics imposes an obligation on physicians to act in accordance with contemporary medical knowledge.

For many years, the medical self-government has been observing the phenomenon of far-reaching "regulatoryinterference" by the legislator in the way doctors perform medical activities. Problems related to this have already been clearly signaled by the Supreme Medical Council in its Appeal No. 12/15/VII adopted on December 4, 2015, addressed to the Minister of Health. In this appeal, the Supreme Medical Council asked the Minister of Health to abandon the practice of setting standards of medical procedure in the form of regulations. The immediate reason for issuing the appeal was the then wording of Article 22 (5) of the Law of the Day on Medical Activity, which stipulated that "the Minister competent for health may determine, by means of a regulation, standards of medical conduct in selected fields of medicine or in certain entities performing medical activity, guided by the need to ensure the appropriate quality of health services." The Medical Council criticized the idea of introducing standards of medical conduct in the form of universally binding laws. In the opinion of the Supreme Medical Council, the determination of standards of medical conduct should be handled by the medical scientific community, which are competent bodies to pronounce on matters of medical practice. Standards of medical conduct must not have the character of universally binding regulations, but only recommendations and guidelines. Standards of medical conduct belong to the autonomous field of medical science and knowledge. Developed by relevant bodies of specialists in various fields of medicine, as knowledge advances, they are periodically modified and published as guidelines in specialized journals. Only organizational rules and equipment standards can be defined in the form of generally applicable laws. In an appeal dated December 4, 2015. The Supreme Medical Council pointed out that health care services should be provided in accordance with current medical knowledge, based on the professional experience of the doctor, with the methods and means available in a given situation, taking into account the situation of the patient and in agreement with the patient. Standards of conduct set by generally applicable regulations do not and cannot take into account all these circumstances.

The Supreme Medical Council took the position that instead of creating medical standards by regulation, the Minister of Health should consider specifying (e.g., in the Law on the Profession of Physician and Dentist) how to create and publicize recommendations, recommendations and guidelines that doctors and dentists could use.

Following the appeal of the Supreme Medical Council on December 4, 2015, the wording of Article 22(5) of the Law on Medical Activity was changed, which now no longer authorizes the Minister of Health to create, by means of regulations, standards of medical procedure, but only to determine, by means of regulations, organizational standards of health care in selected fields of medicine or in specific entities performing medical activity.

The medical self-government reiterated its position in this regard in Appeal No. 13/21/P-VIII of the Presidium of the Supreme Medical Council, dated November 19, 2021, on the discontinuation of defining guidelines and standards of medical conduct through legal acts and communications of state bodies. At that time, parliamentarians and the Minister of Health were asked to stop defining guidelines and standards of medical procedure through legal acts or announcements issued by state bodies. The determination of standards of medical procedure should be handled exclusively by the medical scientific community. Standards of medical procedure belong to the field of medical science and knowledge. The denial of the autonomous and solely based on the current state of medical knowledge nature of medical standards is the determination of them in the form of laws adopted by a majority of politicians in parliament or in the form of ministerial regulations, the content of which is also influenced by various political considerations, positions of groups of stakeholders in the health care system. Relating the above comments to the issue of determining brain death, it should be pointed out that on the basis of Article 43a of the Law on the Profession of Physician and Dentist, we are dealing with two issues that should be specified in the announcement of the Minister of Health. Article 43a (3) of the Law on the Professions of Physician and Dentist indicates that the Minister shall announce, by means of a proclamation:

1. criteria for determining permanent irreversible cessation of brain function (brain death);
2. The method of determining permanent irreversible cessation of brain function (brain death).

It should be assumed that the legislator's distinction between them is not accidental, so they are two different concepts and refer to two different scopes of meaning.

The criteria for brain death should be understood as clinical prerequisites, the occurrence of which makes it possible to diagnose permanent irreversible cessation of brain function, this includes negative prerequisites, i.e. circumstances whose occurrence prevents the determination of brain death.

Instead, the method of determining brain death may refer to a certain organization of activities, the order in which they are performed, where they are performed, and the people involved, all of which go toward confirming that the medical criteria for brain death have been met.

In the opinion of the medical self-government, the criteria on which the determination of permanent irreversible cessation of brain function (brain death) depends should be exclusively a reflection of current medical knowledge. These criteria are subject to determination by the scientific medical community, and for this reason should not be given the rank of a universally binding legal act. A political act, such as legislation by Parliament (in the form of a law) or by the Minister of Health (in the form of a regulation), is not appropriate for determining the current state of medical knowledge. Establishing brain death criteria through an act of general applicability carries at least four risks:

First, the risk that in the lawmaking procedure, entities without sufficient medical knowledge and competence, including those representing politically motivated factors, will gain influence over the final content. Meanwhile, the promulgation of criteria for determining brain death should only be informative, illustrating the current state of medical knowledge, and not of a law-making nature.

Secondly, the criteria for determining brain death established by an act that is a source of universally binding law would be subject to interpretation like other provisions of law - so in the event of doubts of interpretation, the rules of interpretation developed for the interpretation of laws would become relevant (e.g., regarding the use of a particular conjunct "and" "or"), meanwhile, in the event of doubts about the criteria for determining brain death, reference should be made only to the achievements of medical knowledge based on expert studies by medical experts. In addition, it should be noted that defining the criteria for brain death in the form of an act that is a source of universally applicable law would result in the need to describe medical activities in accordance with the terminology used by the legal language, making the criteria for determining brain death much less clear and understandable to doctors. For example, the current Notice of the Minister of Health of December 4, 2019 on the manner and criteria for determining permanent irreversible cessation of brain function uses, among other things. such terms as: a) drugs - which would probably need to be replaced by referring to the grid of terms used in the Law on Counteracting Drug Addiction, such as narcotics, psychotropic substances, precursors, new psychoactive substances , b) tranquilizers - which should be replaced with the appropriate term from the Pharmaceutical Law, c) certain poisonous agents - which would need to be corrected taking into account the provisions of the Law of February 25, 2011 on chemical substances and their mixtures.

Third, there is a risk that formalized procedures for designing, reviewing and enacting legislation may not keep up with the current state of medical knowledge, and the legislation itself may thus become outdated, yet still be a source of law.

Fourth, it should be assumed that in the medical community, a universally binding legal act issued by the Minister of Health or by Parliament (if it concerns the establishment of the current level of medical knowledge on the criteria and method of determining brain death) will enjoy less authority than a study concerning the same matter signed by named experts in the medical field who, in developing guidelines, put their scientific reputation on the line. In setting the standard of medical knowledge, the strength of the authority of the dozens of experts from several medical fields who are part of the team of specialists who reached a consensus in drafting the current announcement of the Minister of Health dated December 4, 2019 on the method and criteria for determining permanent irreversible cessation of brain function is much greater in the medical community than the authority of a politician serving as Minister of Health.

Regarding the issue of the authority given by the law to the Minister of Health to determine the method of determining brain death, the Medical Council takes the position that an act that is a source of universally binding law can cover such issues that concern not so much the state of the art of a given medical service, but the organizational standards for its provision, including, among other things, determining the required equipment of a medical facility, the type of medical activity performed by a medical facility (outpatient, hospital), determinations as to the number and qualifications of medical personnel participating in the service, etc.

However, it seems that in such a special procedure as the determination of brain death, the two concepts mentioned in Article 43a of the Law on Physician and Dentist Professions, i.e., the criteria for determining brain death and the method of determining brain death, actually have a rather strong factual relationship, which makes it difficult to separate them in the practice of medical proceedings. This is also evidenced by the current announcement of the Minister of Health dated December 4, 2019 on the manner and criteria for determining permanent irreversible cessation of brain function.

In conclusion, it should be pointed out that the medical self-government is opposed to giving the criteria for determining permanent irreversible cessation of brain function (brain death) the character of an act that is a source of universally binding law. The determination of these criteria should belong to medical experts, as is currently the case, where under the announcement of the Minister of Health dated December 4, 2019 on the manner and criteria for determining permanent irreversible cessation of brain function the criteria for determining brain death are listed more than 30 experts who have developed these procedures.

The Supreme Medical Council is concerned that replacing the current guidelines developed by so many medical science experts with a piece of legislation could ultimately have the undesirable effect of undermining confidence in the very concept of brain death.