A 63-year-old man with known type 2 diabetes mellitus was admitted to the emergency department (ED) for shortness of breath and oxygen desaturation. He had cough and fever during the week before. Vaccinated against SARS-CoV-2 (two doses: last dose 3 months before admission). At presentation, he had fever (38.0 °C), heart rate was 94 beats per minute, blood pressure 160/80 mmHg, and a respiratory rate of 30 breaths per minute; the oxygen saturation was 78% while breathing ambient air. A reverse-transcriptase-polymerase-chain-reaction assay was positive for SARS-CoV-2 RNA. The patient was admitted to the medical ward and his clinical conditions rapidly worsened. The patient refused non-invasive mechanical ventilation and became progressively more reluctant to comply with the physician’s prescriptions. Despite the need for high flow oxygen to maintain an acceptable O2 saturation, he expressed the will to be discharged. The patient was evaluated by several physicians, including a psychiatric and medical legal counseling, and the risks associated with the refusal of medical care were carefully and repeatedly explained. The patient’s daughter further tried to convince him to accept medical treatment including not invasive ventilation, but the patient signed a voluntary discharge form and left the hospital ward.
The next day, the patient was taken to the ED in critical conditions. He had acute respiratory distress syndrome (ratio of partial pressure arterial oxygen and fraction of inspired oxygen, PaO2/FiO2: 238), acute renal failure (serum creatinine 3.15 mg/dL, Na+ 126 mmol/L, K+ 6.48 mmoL/L) with metabolic acidosis, and severe laboratory alterations (plasma glucose 858 mg/dL, white blood cells count 12,880/mm3, and C-reactive protein 126 mg/L). He was admitted to the COVID-19 semi-intensive-care unit and gave written informed consent to non-invasive mechanical ventilation and medical treatment. The conditions of the patient remained critical for several days. A progressive improvement of respiratory failure and of the metabolic alterations were observed, and after 30 days, it was possible to move the patient to a rehabilitation unit.
Informed consent and refusal of medical treatment
The Charter of Fundamental Rights of the European Union states that “in medicine and biology, in particular, must be respected: the free and informed consent of the person concerned, in accordance with the procedures laid down by law”. It should be stressed that what should become the “Bill of Rights” of the European Union under the Lisbon Treaty has expressly recognized the principle of voluntary treatment, which is based on the recognition of the moral and personal choices. The Charter is used as an interpretative aid by the Court of Justice of the European Union and, according to the Italian Constitutional Court, is “expressive of principles common to European legal systems” .
A second authoritative support for the principle of consensus stems from the so-called Oviedo Convention, adopted in the Council of Europe on 4 April 1997 . Article 5 of the Oviedo Convention expressly provides that “an intervention in the field of health can only be carried out after the person concerned has given free and informed consent” .
In Italy, Law no. 219 of 22 December 2017 , in Article 1, makes informed consent the central, binding, and essential argument, stating that “No medical treatment may be initiated or continued without the free and informed consent of the person concerned, except as expressly required by law”.
One of the key concepts is the affirmation of the indisputable and absolute freedom of the patient to choose, independently whether to start or stop at any time any type of medical treatment through their informed consent.
Informed consent shall be considered valid if information is communicated, for example on the state of health and future prognosis, to a patient of legal age, time, and space-oriented, which has the ability to self-determination and to make a voluntary choice .
Already in 2007, the Court of Cassation, with the judgment n. 21,748, stated that “Informed consent is, as a rule, the legitimacy and basis of medical treatment: without informed consent, the intervention of the doctor is, apart from cases of compulsory medical treatment or in which a state of need occurs, certainly illicit, even when it is in the interest of the patient; the practice of free and informed consent represents a form of respect for the freedom of the individual for the pursuit of his best interests. The informed consent has as correlated the faculty, not only to choose between the various possibilities of medical treatment, but (…) also to eventually refuse the therapy and to consciously decide to interrupt it, in all the phases of the life (…)” . Moreover, reference is made to the exception of compulsory medical treatment or to the state of necessity that would make the treatment lawful without consent but, as the rule states, where there is a will (therefore also a refusal), this will must be respected.
Law 219/2017 , of course, addresses in several parts the problem of the refusal of the subject to certain choices. In particular, the law (Article 1, paragraph 6) states that “the physician is required to respect the willingness expressed by the patient to refuse medical treatment or to renounce the same and, as a result of this, is free from civil or criminal liability”.
In 2018, the Council of State in the “Request for an opinion on informed consent and advance processing provisions” established that with that legislation “(…) in addition to being informed, the right to refuse, in whole or in part, any diagnostic test or medical treatment (…)” .
It is, therefore, to balance the need to save the life of the person, or at least to avoid the establishment of permanent damage, with the subject itself expressly stated, including an explicit refusal to carry out maneuvers or therapies or interventions when it is in danger of life, even if such treatments could save it.
State of necessity
Article 54 of the Penal Code  states that “It is not punishable who has committed the fact for having been forced by the need to save himself or others from the present danger of a serious damage to the person, a danger he did not intentionally cause, nor otherwise avoidable, provided that the fact is proportionate to the danger”. In addition, the Code of Medical Deontology, the latest draft of which dates to 2014, Article 36 “Urgency and emergency assistance” states: “The doctor shall ensure the indispensable assistance, in urgency and emergency conditions, in compliance with the will if expressed or considering the statements anticipated treatment if manifested”.
The Law of 22 December 2017, referring to the situation of urgency or emergency, Article 1 paragraph 7 states: “In urgency or emergency situations, the physician and the members of the medical team shall ensure the necessary care, respecting the will of the patient where his clinical condition and circumstances allow it to be received”.
The state of necessity, as a cause of exclusion of the anti-juridical nature of the conduct, exists if the health care provider is faced with the need to save himself or others from the present danger of serious harm to the person, justifying his actions, even in the absence of the consent of the patient and provided that he has not manifested and is knowable an express written dissent (for example with the advance provisions of treatment) to the intervention of the health care professional.
The state of necessity can be expected when this is related to the current assessment of the need to perform interventions that are useful and essential for the patient, according to the best principles of the lex artis: this evaluation allows to consider “covered” the state of need for treatments that, even if not characterized by an absolute clinical emergency, are destined to become such in a very short time, or in the immediate future of the patient, and this makes the doctor’s assessment even more complex, which has to decide whether the intervention can be considered as not delayed.
The question arises as to whether the state of necessity operates as “existent” or “cause of justification”. Such a condition could be to remove the limit of consent, imposing an obligation to take action to protect the health of the patient, obviously not attenuating any unlawful behavior that the physician may have carried out, but by requiring the physician to justify that he had acted in a certain way just having evoked the state of necessity and having to justify it.
It is therefore appropriate to try to define the concept of “urgency” and “emergency” by identifying the differences. If the outcome under discussion is the survival of the patient, that is, immediate interventions are needed to ensure the favorable outcome and the vital signs are altered, it is called emergency. On the other hand, if the intervention must be prompt but not immediate, that is, it must be extendable in time, we speak about urgency. The distinction is inherent in the time needed for action and requires a technical assessment. Therefore, the evaluation of the extreme urgency of the intervention is imposed on the health care, but treatments that are not characterized by an absolute clinical emergency, but can become so in a very short time, can be included in the state of need, in the sense that they are destined to become unavoidable in the immediate future of the patient .
Moreover, the United Sections of the Criminal Court (18/12/2008–21/01/2009 No. 2437) maintained that the profession of doctor is a “public need”, and that is why, this activity does not need to legitimize itself a discriminating typed, such as the patient’s consent to treatment, which excludes the unlawfulness of conduct instrumental to medical treatment, although implemented according to the rules of the art and with favorable outcome for the patient . This rule stresses that the absence of consent, in the absence of explicit refusal, when the intervention has produced a benefit for the patient’s health does not incur the doctor criminal liability.
Application of the standard in clinical practice
The current legislation requires respect for the will of the patient able, but in case of refusal of treatment, the law asks additional attention to the physicians. It is not unusual, in fact, that in the departments of medicine and surgery, including the outpatient area, there are patients whose decision-making capacity can be compromised. Law 219/2017 (Article 1, paragraph 5) provides that if the patient refuses therapies or interventions, putting his life at risk, the doctor engages in further communication with the support of other professionals, informing the patient of the consequences, promoting every support action, and involving family members .
Judgment on the level of impaired capacity, which makes a patient incompetent to make therapeutic decisions, should ideally reflect the balance between respecting patient autonomy and protecting the patient from the consequences of a wrong decision .
Considering the possibility of fluctuations in the mental state of the patient and thus the level of his capacity, as well as the seriousness of possibly depriving him of the right to make decisions, where possible, it is essential that the assessment is carried out by at least two physicians at different times .
Any doctor should be able to assess a patient’s competence, while psychiatric counseling can be useful in particularly complex situations. Between 3 and 25% of requests for psychiatric counseling in hospitals involve questions about the competence of the patient to make decisions about treatment [20, 21].
Whichever approach to evaluation is used, clinicians should first ensure that patients have been provided with information that is relevant to making an informed decision about their treatment. Typically, such communication includes the nature of the patient’s condition, the nature and purpose of the proposed treatment, and the risks and benefits of the proposed treatment and alternative treatments, including the no-treatment option .
The expressed will of the subject must be clearly perceptible and there must be no doubt: consequently, even in cases of necessity, if the refusal were clear, the health workers could not intervene, giving precedence to the right to self-determination of the subject over the need to save his life. Once the patient has been warned of the consequences of his choice, the health professionals must nevertheless promote and support any supporting action, avoiding that the refusal of the treatments turns into a potential therapeutic abandonment (Article 2: “principle of not abandon”) .