The Physician-Assisted Suicide Pathway in Italy: Ethical Assessment and Safeguard Approaches

Despite being immediately effective, Italian Constitutional Court Decision no. 242/2019 does not impose the healthcare facility’s duty to provide a service but merely the verification of the patient’s condition with the opinion of the geographically competent ethics committee. The analysis of the aforementioned cases clearly brings to light several critical issues. First of all, there is an overlap in the responsibility of two distinct subjects, the public National Health Service facility and the geographically competent committee. Both must carry out an assessment, the public healthcare facility must verify compliance with the legal requirements and the ethics committee must express an opinion; however, the form and specific subject-matter of this opinion are not clearly defined.

In the first case cited, that of FC, the territorial ethics committee issued an assessment based on the documentation and the collegial report received from the healthcare facility. The intervention of the committee took the form of a “second consultation”: the regional health service carried out the necessary checks on the patient and the ethics committee confirmed the satisfaction of the required conditions. This appears to be the same action performed twice, a double check; however, the Court does not seem to ask the ethics committee to verify the clinical condition of the patient, a task which is entrusted to the healthcare facility.

In the third case, that of A., on the other hand, the ethics committee commented on palliative care approaches and family and home care support, expressing a negative opinion on the request and referring the question back to the facility. Since the opinion of the ethics committee is not binding and given the positive verification of the conditions established by the Constitutional Court, it is likely that this patient will be able to proceed with his intent and obtain non-punishable aiding of suicide. The ambiguity of the procedural significance of this geographically-competent ethics committee opinion and its shortcomings as a mechanism for protecting the interested parties emerge clearly in this case.

In the current Italian legislative framework, there are forty Territorial Ethics Committees “CETs” and three National Ethics Committees “CENs,” which are mainly responsible for evaluating clinical trials and investigations with medical devices. As provided by the Decree of January 30, 2023, they can also perform advisory functions in relation to ethical issues related to research and clinical care activities. These organs are comparable to Research Ethics Committees (RECs) or Institutional Review Boards (IRBs), which apply, in Europe and the United States, respectively, with primary responsibility for reviewing clinical research protocols.

Requests for assisted suicide can originate from very demanding clinical cases. Research Ethics Committees do not meet patients and do not have a realistic chance to do so as a collegial body, so they do not seem to be in the best position to evaluate, for example, the patient’s decision-making capacity. It is not mandatory to include a psychiatrist or a physician experienced in palliative medicine in the composition of such committees. The specific reference of the Court’s 2019 Decision No. 242 appears to be to these bodies.

In Italy, alongside the CETs and CENs, there is also a network of different Committees that deal with ethical consultations. They have different names in the different regions of the country, such as Ethics Committee for Healthcare, Ethics Group, and Clinical Practice Ethics Committee (De Panfilis, et al. 2019; Picozzi and Gasparetto 2020). In their daily practice, they perform various functions, such as promoting the humanization of personal care, respect, and dignity, examining the ethical aspects associated with the planning and allocation of resources, service organization decisions and developing education and awareness initiatives for healthcare professionals and citizens. They can also be called upon as an advisory body with respect to complex clinical cases that pose ethical dilemmas.

Following the Court Decision no. 242, at the request of the Ministry of Health, some regions identified these Clinical Practice Ethics Committee as the bodies eligible for examining requests for assisted suicide (Petrini 2020). Recently, however, the Italian National Bioethics Committee, which performs both advisory functions to the government, parliament, and other institutions, referred to Territorial Ethics Committees (CETs) as the bodies “competent to express an opinion on assisted suicide” (Italian National Bioethics Committee 2023).

It is worth dwelling briefly on the meaning of an ethical consultation. It is not easy to define what a consultation process is, indeed there may be several ways to describe and conceive it. It is also not easy to answer the question: “what makes a case moral?” The question can be answered, for example, by stating that a case is moral when it involves issues relating to a patient’s self-sufficiency or competence in the informed consent process or end-of-life choices (Pedersen et al. 2010). Every moral act is such in relation to the good or evil of the action itself. It is possible to evaluate a clinical act with regard to i) to the agent’s intention, ii) to the scientific quality or adherence to the scientific gold standard, and iii) to compliance with the law. It is beyond the scope of this article to enter into the specific nuances of the meaning of the morality or ethics of a medical act or to analyse the methodology of ethical evaluation (Tambone and Ghilardi 2016). However, it is useful to clarify the terminology used. In this paper, ethical evaluation in the context of a clinical case means the activity of asking questions, scrutinizing, and discussing a situation that poses uncertainties, in order to identify the best course of action. This evaluation aims to find a solution in order to act in the best possible way having weighed up all the factors involved. Clinical ethics support, an activity of the aforementioned Clinical Practice Ethics Committees, begins when a professional encounters a problem with a practice and doubts the right course of action. A good example are the ethical dilemmas that can arise in healthcare facilities associated with respect for the patient’s self-sufficiency on the one hand and active intervention for the patient’s well-being on the other (Hartman, et al. 2019). The consultation arises from a spontaneous request associated with a need and cannot be imposed. No such ethical consultation for clinical practice can be imposed on a physician regarding a request for assisted suicide unless the physician requests it him/herself. If a physician is not uncertain about the situation in which he/she is about to act, for example, he/she undoubtedly believes that all the conditions required by law are met, he/she will not need any ethical consultation. This is because ethical consultation, by its very nature, is not a control mechanism, rather a support mechanism for complex decisions. Indeed, it is not binding and does not entail legal responsibility on the committee’s part.

Current PAS laws usually include advisory mechanisms but with a different meaning; neither elsewhere in Europe nor in the United States is there any involvement of ethics committees for clinical practice. The “consultant” is usually a specifically trained second physician who must consult with the patient and state in writing that the treating physician’s judgment has been formulated with due diligence. This is to ensure that the doctor who intends to perform the procedure has not overlooked anything (Ron, et. al 2012). The consultation of a second doctor in requests for euthanasia has the purpose of providing a control mechanism, and of monitoring and safeguarding the quality of the practice. Nevertheless, the consultation is generally not binding and the final legal responsibility lies with the physician performing the assisted suicide, who can, as a matter of fact, decide not to follow the advice, provided the reasons for this decision are stated.

A second point of interest for further research concerns precisely the role of the physician. The reference here is practical and legal responsibility rather than moral responsibility, a broad theoretical topic that is outside the scope of this discussion. In the current Italian scenario, the patient must apply not to a doctor but to the public facility to carry out the verification of the requirements. Such a facility may not know the patient at all. The individual must then independently find a doctor willing to support him/her in his intent of death. The process is therefore highly bureaucratized, fragmented, managed by the courts, to which people turn for quick answers, and outside the scope of a doctor–patient relationship of trust and care. Individual requests for medical assistance for suicide are complex in origin and require respect, careful attention, and open and sensitive communication in the clinical setting (Materstvedt, et al. 2003). Which physician should provide information to the patient (diagnosis, prognosis, treatment options), discuss eligibility, advise families, prescribe the lethal drug, and offer support during administration? Are they ready to participate in the process? The absence of guidelines places the physician in a difficult position and makes the whole procedure unclear. As noted, although there is an abundance of literature discussing the ethical issues, there is relatively little literature addressing the medical aspects of providing aid in dying. In countries where legislation is in place, the roles and responsibility of healthcare professionals and other supporting non-governmental associations is well defined (Stephen 2007). A general practitioner with whom the patient has a personal and long-standing relationship is in a better position to judge whether a patient meets the required criteria for care. However, physicians are burdened with decisions that, particularly in complex cases, can go beyond normal medical practice and constitute a moral dilemma (Snijdewind, et al. 2018). Their role must be carefully determined in order to protect both sides of the relationship—doctor and patient. Some scholars have also proposed the establishment of systems that remove the physician from direct involvement in the process. In this case, the physician would only be in charge of diagnosis and prognosis, while a central mechanism would have to confirm the authenticity and eligibility of patient requests, dispense drugs, and monitor demand and use (Prokopetz and Lehmann 2012). Given their pivotal role, in-depth analysis and empirical research into physicians’ attitudes are critical when jurisdictions move from a lawless to an enforcement context. The design of legislative models must take into account the organizational and cultural context and the concerns of physicians (Rutherford, et al. 2021; Zworth, et al. 2020).

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