Psychiatric advance directives (Ulysses Contract): the need for a specific law and a criteria proposal for its introduction.

AIM: Advance healthcare directives in the psychiatric field raise more concerns and controversies compared to their use in other medical branches. We discuss the role of advance directives in this field and suggest a criteria proposal for the settlement of a comprehensive regulation on the matter. METHODS: We analyse the existing law and discuss the ethical points in the Italian context and, in comparison, with the United Kingdom context. RESULTS: Numerous studies have highlighted that psychiatric patients experience advance directives as an instrument to participate in therapeutic decision-making. Regarding the usefulness of advance directives, Italy and the United Kingdom did not approve deontological rules or laws. The United Nations Commission states that, based on the principles of the Convention on the Rights of Persons with Disabilities, it is necessary to respect the spatient's will, even if it is biased by psychic disorders. CONCLUSIONS: The Convention does not consider advance directives; instead, they just suggest using some support to have the patient regain their competence. In case this is unsuccessful, it is necessary to appoint a substitute decision-maker to express, even in the light of the advance directives, the will that the patient would have expressed if he had been competent.

The choice of Caesarean section between clinical indication and patient autonomy: The physician between rock and hard place.

RATIONALE, AIMS AND OBJECTIVES: Caesarean delivery carries a higher risk of short- and long-term complications for both mother and baby than vaginal delivery. However, over the past two decades, data show a considerable increase in requests for Caesarean sections. This manuscript analyses the case of Caesarean Section on maternal request without a clinical indication from a medico-legal and ethical perspective. METHOD: Medical associations and bodies databases were searched for published guidelines and recommendations on the use of caesarean sections on maternal requests. As derived from the literature, medical risks, attitudes, and reasons for this choice have also been summarized. RESULTS: International guidelines and medical associations recommend strengthening the doctor-patient relationship by setting up an information process to make the pregnant woman understand the danger of Caesarean delivery without clinical indications and to make her consider whether she can survive natural childbirth. CONCLUSION: Caesarean section on maternal request and without clinical indications is an emblematic case of how the physician could be between two opposing interests. Our analysis shows that if the woman's rejection of natural birth persists and clinical indications for Caesarean delivery are lacking, the physician must respect the patient's choice.

The Moral Bindingness of Advance Directives.

Professor Latham has written a thought-provoking commentary1 on my paper about advance directives.2 I am grateful for this opportunity to integrate the debate on the moral binding nature of these manifestations of will.

Body donation in Italy and the issue of consent: Operational suggestions.

The authors aimed to analyze the Italian law of 10 February 2020, n. 10, which governs the post mortem donation of one's body and tissues for training, educational and scientific research purposes. The different models of consent set forth in this set of norms are discussed, reaching the conclusion that the most suitable option for balancing the interests at stake is the one that authorizes all uses of the body for the sole purposes expressly permitted by the donor. After briefly laying out the current legislation on the subject, particularly regarding the ways of expressing consent, the authors highlight how the legislation enacted by Italian lawmakers is meant to codify the absolute preeminence to the donor's right to self-determination.

Late termination of pregnancy in case of congenital CMV infection: ethics, medicine and law.

This paper provides a recent legal case which calls into discussion the women's safe access to voluntary termination of pregnancy (VTP) after the first 90 days. On 15 January 2021, the Italian Supreme Court sentenced a physician to damage compensation because he did not correctly inform the patient, in her 22nd week of pregnancy, about the risks to the fetus relating to an infection from cytomegalovirus (CMV). The option for VTP was not offered since, at the time of the woman's request, medical investigations did not show the evidence of fetal malformations, neither there were concrete risks for the life of the mother, as Italian law requires. The baby was born with severe brain injuries. The case is noteworthy because it offers a new precedent to extend legal requirements for late VTP. The impact of this decision must be tested in the clinical practice. Further studies are necessary to evaluate possible law amendments extending access conditions for this practice and new policies promoting the strengthening of informative and assistance procedures, including psychological help, to the pregnant woman are needed, as well.

The March 2021 Italian constitutional court ruling on surrogacy: a prelude to common European legislation for the sake of reproductive health?

PURPOSE: Surrogacy is an arrangement by which a surrogate mother bears a child for another couple or person, and is often thought of as a form of 'treatment' for couples (or even individuals) with fertility or sterility issues. Still, surrogacy entails ethical issues related to gender, fundamental human rights, exploitation and inequality. MATERIALS AND METHODS: Starting from the Italian state of affairs, the authors have set out to briefly expound upon such complexities, taking into account relevant jurisprudence on the subject, with a particular focus on inter-country surrogacy and second-parent adoption, which can themselves engender significant legal dilemmas. When residents of countries where surrogacy is banned travel abroad and hire a surrogate, that may lead to considerable legal hurdles as well. RESULTS: In Italy and elsewhere, the courts have all too often had to fill the vacuum left by the lack of targeted legislation. The Italian Constitutional Court has recently urged lawmakers to enact new legislation to uphold the minor's best interests. In fact, while some countries recognise the surrogate as the legal parent, others ascribe parenthood to the commissioning parents. That discrepancy can lead to a 'clash of laws', resulting in children ending up stateless and unable to maintain an already established family relationship. CONCLUSIONS: Just like fundamental protection of human rights and public health, the regulation of revolutionary technologies that change the very notion of reproduction, parenthood, and human identity needs to be governed by uniform standards, shared at least by nations which espouse common core values.

Does the EU COVID Digital Certificate Strike a Reasonable Balance between Mobility Needs and Public Health?

The need to fight a highly aggressive virus such as SARS-CoV-2 has compelled governments to put in place measures, which, in the name of health protection, have constrained many freedoms we all enjoy, including freedom of movement, both nationally and within the European Union. In order to encourage and facilitate the return to free movement, the European Parliament has launched a "COVID-19 digital certificate". A spirited debate centered around the use of this certificate is still ongoing among scholars, many of whom have pointed out the uncertainties relative to COVID-19 immunity, privacy issues and the risk of discriminatory effects. The authors, while highlighting some critical aspects, argue that the COVID digital certificate in its current approved version can effectively help prevent the spread of the infection and promote free movement, while upholding the right to health as much as possible. However, they also stress the need for a thorough information campaign to illustrate the advantages and limitations of this document in order to avoid creating a false sense of security in the public opinion, who may wrongly assume that the emergency has been overcome for good.

COVID-19: when health care resources run short, how to pick who should (not) get treated?

The World Health Organization had long warned of the onset of a pandemic that could throw national health systems into a major crisis, even in wealthy developed nations. Nonetheless, almost a year and a half after its appearance, Covid-19 continues to make painful triage choices necessary in granting access intensive care. Based on the opinions of numerous ethics committees and scientific societies, the article aims to illustrate the difference between the utilitarian-collectivist approach and the ethical approach, which inspired the guidelines drawn up in Italy in 2021 by SIAARTI in collaboration with SIMLA. Only medical parameters should be evaluated to establish the prognosis through which to identify the patients to be treated as a priority. Otherwise, the patient's interest is subordinated to that of the community. But moral judgment cannot concern only the choices of doctors. According to the principle of beneficence, hospital directors and national and local health policy managers must also take action, in particular to eliminate waste of economic resources so as to allocate more of them to health protection, especially in consideration of the predictability with which infection rates increase, and in light of the fact that immunization through vaccination is only temporary.

Is the Right to Abortion at Risk in Times of COVID-19? The Italian State of Affairs within the European Context.

The COVID-19 health emergency has thrown the health systems of most European countries into a deep crisis, forcing them to call off and postpone all interventions deemed not essential or life-saving in order to focus most resources on the treatment of COVID-19 patients. To facilitate women who are experiencing difficulties in terminating their pregnancies in Italy, the Ministry of Health has adapted to the regulations in force in most European countries and issued new guidelines that allow medical abortion up to 63 days, i.e., 9 weeks of gestational age, without mandatory hospitalization. This decision was met with some controversy, based on the assumption that the abortion pill could "incentivize" women to resort to abortion more easily. In fact, statistical data show that in countries that have been using medical abortion for some time, the number of abortions has not increased. The authors expect that even in Italy, as is the case in other European countries, the use of telemedicine is likely to gradually increase as a safe and valuable option in the third phase of the health emergency. The authors argue that there is a need to favor pharmacological abortion by setting up adequately equipped counseling centers, as is the case in other European countries, limiting hospitalization to only a few particularly complex cases.

The highly complex issue of conscientious objection to abortion: can the recent European Court of Human Rights ruling Grimmark v. Sweden redefine the notions of care before freedom of conscience?

PURPOSE: The article aims to elaborate on two recent European Court of Human Rights (ECtHR) decisions which have rejected, on grounds of non-admissibility, the appeals by two Swedish midwives who refused to carry out abortion-related services, basing their refusal on conscientious objection, and to expound upon the legal and ethical underpinnings and core standards applied to the framing process of such a ECtHR decision. MATERIALS AND METHODS: By drawing upon relevant recommendations from international institutions, the authors have aimed to assess how the ECtHR rationale could affect the balance between CO and patient rights; searches have been conducted up until December 2020. RESULTS: In both decisions the European Court has asserted that the right to exercise conscientious objection must give way to the protection of the right to health of women seeking to have an abortion. CONCLUSIONS: ECtHR judges concluded that the failure to provide for a right to conscientious objection does not constitute, in fact, a violation of the more general right to freedom of thought, conscience and religion, if provided for by a state law to protect the right to health. The legal ethical and social ramifications of such a decision are of enormous magnitude.

Freedom of Scientific Research and Embryo Protection Under Italian and European Court of Human Rights' Jurisprudence. Brief European Legislation Overview.

The paper addresses the issues of admissibility of human embryo research and the legal protection to be recognized, in light of the growing importance that scientific research has been gaining in the clinical and biomedical fields of embryonic stem cells for therapeutic purposes. As for human embryo experimentation, particularly on cryopreserved supernumerary embryos, European legislation varies, since the European Court has granted member States a wide margin of appreciation. Some countries, including Italy, have strict legislation protecting embryos from the fertilisation stage, whereas others have taken permissive approaches, allowing experimentation until 14 days after fertilisation. Science, however, has shown that the 14-day limit can be moved. The author finds it necessary to achieve broad international consensus and shared regulations. Lawmakers, however, need to balance respect for the principle of life, represented by the embryo, against scientific needs, in order to devise sound regulations safeguarding both apparently conflicting fundamental values.

Physical Restraint in Psychiatric Care: Soon to Fall Out of Use?

International directives all recommend that using restraints on psychiatric patients should be avoided, yet scientific literature shows that such practices are still largely in use. This article aims to lay out strategies that could be put in place in order to gradually discard the use of restraints, particularly through a "restraint-free" approach, nursing, logistic-environmental pathways, and locally centered health care provision. All such tools have proven valuable for the purpose of safeguarding the health of psychiatric patients. Hence, the failure to put in place such measures may lead to litigation and lawsuits against physicians and particularly health care facilities. Undoubtedly, the ability to effectively implement such methods largely depends on the financial resources available, which in countries such as Italy are poorer than in others. Still, the risk of being sued and held professionally liable may constitute a factor in raising awareness among operators, facilities, and public health care management, leading to the implementation of policy changes aimed at minimizing the use of restraints.

CoViD-19 and psychiatry: can mental illness justify further exceptions to the obligation to stay at home?

INTRODUCTION: To face the CoViD-19 pandemic, the italian government has approved regulations which state, with no exceptions, that it is considered offence for people tested positive to the virus to leave their house, whereas other people are allowed to leave their house for proven needs such as work, health or emergencies. METHODS: The authors contextualize these regulations with European and international sets of principles, in the light of the characteristics that some psychiatric disorders can present. OBJECTIVES: Evaluate if such European principles need to be implemented with further specific exceptions to the obligation to stay at home for some people with mental disorders. RESULTS AND DISCUSSION: Prohibition to leave the house can aggravate mental disorders, resulting in the concrete risk of harmful actions, in particular in psychotic and bipolar patients, even with mild excitement, depressed patients, or in cases of delusional patients, resulting from uninterrupted cohabitation with emotionally significant family members. Even the health of subjects with anxiety pathologies, or with different forms of mental retardation can be prejudiced by forced permanence at home. From numerous provisions of the European Convention for the Protection of Human Rights and of the Charter of Fundamental Rights of the European Union there emerges that collective health must be balanced with individual health and with the dignity of the human person. CONCLUSIONS: As the European and international provisions are hierarchically above the national provisions, the latter should be interpreted so that the non-compliance to the obligation to stay at home: a) does not constitute offence for a person tested positive to the virus, if therapeutic treatments resulting in hospitalization are deemed necessary; b) it does not constitute administrative offence if the subject proves, based on clinical and factual documented evidence, that leaving the house is necessary to avoid recrudescence of mental disorder. In addition, for evaluation purposes, particular attention should be paid to the severity of psychiatric illness in the specific case. In order to distinguish suitable subjects from those not suitable for home isolation, the reference criterion cannot be the only diagnostic element, but it will be necessary to take into account above all the severity of the condition. In the absence of such a qualitative assessment, there would be a risk of unfounded infringements of the obligation to stay at home.

Euthanasia and physician-assisted suicide for patients with depression: thought-provoking remarks.

Euthanasia and medical assistance in dying entail daunting ethical and moral challenges, in addition to a host of medical and clinical issues, which are further complicated in cases of patients whose decision-making skills have been negatively affected or even impaired by psychiatric disorders. The authors closely focus on clinical depression and relevant European laws that have over the years set firm standards in such a complex field. Pertaining to the mental health realm specifically, patients are required to undergo a mental competence assessment in order to request aid in dying. The way psychiatrists deal and interact with decisionally capable patients who have decided to end their own lives, on account of sufferings which they find to be unbearable, may be influenced by subjective elements such as ethical and cultural biases on the part of the doctors involved. Moreover, critics of medical aid in dying claim that acceptance of such practices might gradually lead to the acceptance or practice of involuntary euthanasia for those deemed to be nothing more than a burden to society, a concept currently unacceptable to the vast majority of observers. Ultimately, the authors conclude, the key role of clinicians should be to provide alternatives to those who feel so hopeless as to request assistance in dying, through palliative care and effective social and health care policies for the weakest among patients: lonely, depressed or ill-advised people.

Advance Healthcare Directives: Binding or Informational Value?

Advance directives entail a refusal expressed by a still-healthy patient. Three consequences stem from that fact: (a) advance refusal is unspecific, since it is impossible to predict what the patient's conditions and the risk-benefit ratio may be in the foreseeable future; (b) those decisions cannot be as well informed as those formulated while the disease is in progress; (c) while both current consent and refusal can be revoked as the disease unfolds, until the treatment starts out, advance directives become effective when the patient becomes incapable or unconscious; such decisions can therefore not be revoked at any stage of the disease. Therefore, advance directives are binding for doctors only at the stage of advance treatment planning, i.e., only if they refer to an illness already in progress.

The Right to Voluntary Termination of Pregnancy in Italy: Taking Stock Forty Years after the Enactment of Law no. 194/1978. Comparative Law-based Remarks.

Forty years after the enactment of Law no. 194/78 that governs voluntary interruption of pregnancy, Italy has been experiencing difficulties guaranteeing that patients gain access to abortion procedures in a timely fashion. Conscientious objection detracts considerably from the very effectiveness of the law, as pointed out by major European institutions as well. Hence, the network of family planning and counselling centres needs to be expanded and supported; such institutions, in fact, may go a long way in ensuring that women make the best, informed decisions. The author has set out to deal with those issues by means of a comparative analysis. He believes that Italian lawmakers ought to follow in the footsteps of other European countries in order to balance the rights of objecting gynaecologists against those of women who choose to have an abortion, despite the relatively small number of doctors willing to carry out the procedure.

A child of two mothers: what about the father? Italian overview.

Surrogacy techniques allow for the birth of children who are then raised by parents who may have no genetic or biological connection with them at all. Italian legislation on medically assisted procreation bans such practices, under national criminal codes, and yet the intended parents' ability to legally register children born abroad via surrogacy has not been affected by such legislation. Italian jurisprudence has acknowledged the parental status of same-sex couples, following the same path outlined by the European Court of Human Rights. The paper's author elaborates on court decision n. 145/2018, from the Naples Court of Appeals, which has stated that surrogacy children may be connected to their intended parents merely by virtue of "mental" elements, based on affection, harmony and listening enjoyed by the child within the family setting. The author is critical of that view, in light of conflicting research findings on children growing up in same-sex families. In that regard, the author argues that even though homosexual couples may well turn out to be good parents, families made up of fathers and mothers still constitute the best scenario for the children, from a social perspective. It is however necessary for lawmakers to step in and better regulate an utterly sensitive area of law, one that might engender adverse repercussions on the children's well-being, in terms of growth and psychological development, following their becoming part of homosexual families.

The Marco Cappato and Fabiano Antoniani (dj Fabo) Case Paves the Way for New Assisted Suicide Legislation in Italy: An Overview of Statutes from Several European Countries.

The article looks into the case involving Fabiano Antoniani, who, following a major road accident, was left tetraplegic. Marco Cappato drove him to a Swiss clinic where Mr. Antoniani took his own life by self-administration of lethal pentobarbital sodium. Cappato was put on trial, but the Italian Constitutional Court urged the Parliament to decriminalise assisted suicide in extremely serious cases. From a comparison with other European countries, approaches range from restrictive (banning both active euthanasia and assisted suicide), to entirely permissive. An intermediate approach only entails a ban on active euthanasia. It would be desirable to uniformise the diverse national statutes on a European level, which would make it possible for everyone to receive assistance towards ending their suffering, with limitations to incurable cases to be medically verified, and at the end of a path designed to ensure that patient freedom of choice is upheld at all time.