Mother, father, son and the Italian Law 40/2004. No 'delete' key.

Assisted reproductive technology (ART) has emerged in recent years as a point of significant innovation in the medical field but is also controversial from a bioethical and legal standpoint. In the Italian context, this matter is regulated by Law 40/2004, which specifically requires that informed consent should be obtained from both members of a couple before proceeding with any ART procedure. This consent is deemed irrevocable at the moment of egg fertilization. Recently, a ruling by the Italian Constitutional Court on this matter elicited controversy. The decision permitted embryo transfer even in a case of parental separation, notwithstanding the father's explicit opposition. The Court emphasized the priority of the woman's psychophysical health over the man's, highlighting the traumatic consequences of interrupting the undertaken path. As a result, both the man's right to self-determination regarding the decision to become a father and the need for informed consent at every stage of medical procedures have been downplayed. Moreover, the extensive utilization of procedures like embryo cryopreservation, with associated parental implications, particularly concerning the time frame and the actuality of informed consent, is posing challenges to the initial application framework of Law 40/2004. The objective of this Commentary is to scrutinize and discuss the issues mentioned above.

[Medico-legal considerations and occupational medicine issues regarding the targeted employment of disabled persons: regulatory review, current social and medical operational guidelines and current application phenomena]. / Considerazioni medico-legali e di medicina del lavoro in merito al collocamento lavorativo mirato dei soggetti disabili: disamina normativa, attuali orientamenti operativi socio-sanitari ed odierne fattualità applicative.

SUMMARY: The Authors examine developments in Italian legislation concerning compulsory work placements for disabled people, comparing them to those of other countries, and focusing in particular on the operational aspects of the assessment committees set up under Italian legislative decree 68/1999; these commissions are tasked with a global assessment of the disabled individual, using multiple socio-health and occupational medicine perspectives, as well as through a conclusive medico-legal assessment. The work focuses on the delicate role played by these committees in adequately weighing up the residual working capacity of the disabled individual in order to place him/her in the most appropriate and least aggravating workplace in terms of the disorders they are affected by; this is possible by transferring the socio-work profile drawn up by the evaluation committee into the context of the labour market. Finally, the Authors try to highlight how this task has become even more difficult due to the economic and labour crises that have affected several of the employment sectors in Italy in recent years.

A review and analysis of new Italian law 219/2017: 'provisions for informed consent and advance directives treatment'.

BACKGROUND: In December 2017, Law 219/2017, 'Provisions for informed consent and advance directives', was approved in Italy. The law is the culmination of a year-long process and the subject of heated debate throughout Italian society. Contentious issues (advance directives, the possibility to refuse medical treatment, the withdrawal of medical treatment, nutrition and hydration) are addressed in the law. MAIN TEXT: What emerges clearly are concepts such as quality of life, autonomy, and the right to accept or refuse any medical treatment - concepts that should be part of an optimal relationship between the patient and healthcare professionals. The law maximizes the value of the patient's time to decide. Every patient is allowed to make choices for the present (consenting to or refusing current treatment) as well as for the future, conceived as a continuation of the present, and to decide what comes next, based on what he/she already knows. The law identifies three distinct but converging paths towards the affirmation of a care relationship based on reciprocal trust and respect: the possibility to consent to or refuse treatment, the shared care planning, and advance directives. CONCLUSIONS: The fundamental point to emerge from the new Italian law is that consensus is an essential connotation of the treatment relationship. Consensus is not limited to the acceptance/rejection of medical treatment but is ongoing. It is projected into the future through shared care planning and advance directives which act as tools for self-determination and the manifestation of the beliefs and preferences of persons unable to express their will. These principles are in line with the idea of appropriate care as evaluated from two different perspectives, one of scientific adequacy and the other commensurate with the individual's resources, fragility, values, and beliefs. Surely, however, the new law is not the end of the matter on issues such as conscientious objection, which is deeply rooted within the Italian cultural and political debate. In this regard, healthcare institutions and policymakers will be called upon to develop and implement organizational policies aimed at the management of foreseeable conscientious objection in this field.

A New Law of Advance Directives in Italy: A Critical Legal Analysis.

This article analyses new legislation regulating advance directives in Italy. On 14 December 2017, the Italian Senate passed a Bill regulating end-of-life decisions by codifying patients' rights to self-determination. It is the first law governing advance directives in the Italian legal system. This article studies and critically examines the two types of advance directives through an Italian legal perspective - living wills and nominations of a surrogate. It also applies a legal comparison approach. In its conclusions, this article advances some policy suggestions.

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.

The micropolitics of choice in Italy: How the law affects lesbian and bisexual women's daily life.

This article stems from three years of fieldwork (2015-2017) in the context of a five-year-long, European-Research-Council-funded research project called INTIMATE-Citizenship, Care and Choice: The Micropolitics of Intimacy in Southern Europe, a comparative qualitative study that involves three countries (Italy, Portugal, and Spain) and studies intimate citizenship and the micropolitics of daily life of LGBTQ people. The article focuses specifically on the Italian case and shows how non-heterosexual women deal with the scarce legislative protection Italy grants. Our aim is to reflect upon the reciprocal influence of different axes from public and private spaces and on how they impact the micropolitics and the daily choices of our lesbian, bisexual, and pansexual participants. More specifically, considering the lack of legal and social recognition of lesbian experiences in Italy, we will focus on the different strategies of reaction, assimilation, and resistance employed by participants in their private and public life. The three-year-long fieldwork covered the period between the proposal of the bill on same-sex civil unions and the first year after Act 76/2016 came into force. This allows us to sketch a brief diachronic analysis of its functioning, in particular from the perspective of the very subjects it impacts.

Informed Consent and Advance Care Directives: Cornerstones and Outstanding Issues in the Newly Enacted Italian Legislation.

This article's authors delve into, and comment on, some of the key provisions within law no. 219, passed in 2017, which came into full effect in 2018. The legislation presents several innovative aspects: (a) communication time is equated to care; (b) patients may turn down lifesaving treatments, yet doctors must put in place all suitable support processes, from a psychological standpoint as well, in order to make sure that patients make informed decisions in full awareness; (c) refusal to treatment may be expressed prior to the onset of the disease making the patient incapable, as long as the advance directive is laid out by a mentally capable adult who has been provided with all relevant medical information available as to the consequence of a refusal to undergo a given treatment; (d) artificial nutrition and hydration are tantamount to treatment; thus, they may not be carried out and kept in place in absence of valid consent; (e) patients may appoint a healthcare proxy holder, tasked with interacting with doctors and caregivers and expressing consent or refusal; (f) patient will, whether current or advance, must be complied with even under emergency or urgency conditions, provided that clinical conditions and circumstances make it possible to acquire it; (g) doctors may disregard advance directives only when specifically provided for by the law; (h) patients may not demand treatment deemed to be illegal or running counter to ethical codes or scientific evidence. The new legislation, therefore, is meant to uphold the right to exercise self-determination as well as the patient's quality of life, yet ensuring that doctors remain fully capable of making the decisions that they are best positioned to. Summary: The Italian Parliament has for the first time regulated the issue of consent and refusal of healthcare treatments, whether currently expressed or advance. This article elaborates on recent Italian legislation that details a patient's right to consent to or refuse treatment in advance, including refusal of artificial nutrition and hydration, the duty of doctors in the event of an emergency, the shared planning treatment, the role of durable power of attorney, and advance healthcare directives.

Emergency contraception in adolescents. A grey area in Italian legislation.

OBJECTIVE: To explore Italian legislation and the social climate regarding the issue of emergency contraception (EC) in adolescents. RESULTS: In recent years, in Italy, we have seen changes in the law and in attitudes towards EC. Since 2016, EC has been approved for sale as a non-prescription drug to women over the age of 18. However, the requirement for a prescription is still in force for women under 18. This raises questions such as the minor's ability to consent to family planning services to prevent pregnancy, and whether physicians require parental consent before providing an EC prescription to minors. This article explores these issues within the social and legislative context of adolescent reproductive health care, demonstrating a need for EC among Italian adolescents. CONCLUSION: Making EC difficult for minors to access seems to respond to a political stance that clashes with existing social needs and with medical evidence that shows that EC is safe and reliable for use in adolescents, and that the increased use of EC has no negative effects on regular, ongoing contraceptive use or encourages risky sexual behaviour. Future interventions by Italian policy-makers should target these themes in order to make EC easily available to adolescents throughout the country.

Italian law on medically assisted reproduction: do women's autonomy and health matter?

BACKGROUND: In Italy in 2004, a very restrictive law was passed on medically assisted reproduction (MAR) (Law 40/2004) that placed Italy at the most conservative end of the European spectrum. The law was widely criticized and many couples seeking MAR brought their cases before the Italian Civil Courts with regard to pre-implantation genetic diagnosis (PGD), donor insemination and the issue of consent. Ten years on, having suffered the blows of the Italian Constitutional Court, little remains of law 40/2004. DISCUSSION: In 2009, the Constitutional Court declared the maximum limit of the number of embryos to be produced and transferred for each cycle (i.e. three), as stated in the original version of the law, to be constitutionally illegitimate. In 2014, the same Court declared as unconstitutional the ban on donor insemination, thus opening the way to heterologous assisted reproduction. Heterologous MAR is therefore perfectly legitimate in Italy. Finally, in 2015 a further ruling by the Constitutional Court granted the right to access MAR to couples who are fertile but carriers of genetic diseases. However, there is still much room for criticism. Many couples and groups are still, in fact, excluded from MAR. Same-sex couples, single women and those of advanced reproductive age are, at the present time, discriminated against in that Italian law denies these subjects access to MAR. The history of Law 40/2004 has been a particularly troubled one. Numerous rulings have, over the years, dismantled much of a law constructed in violation of the rights and autonomy of women and couples. However, a number of troubling issues still exist from what is left of the law and the debate is still open at national and transnational level regarding some of the contradictions and gaps in the law highlighted in this article. Only by abolishing the final prohibitions and adopting more liberal views on these controversial yet crucial issues will Law 40/2004 become what it should have been from the start, i.e. a law which outlines the 'rules of use' of MAR and not, as it has been until now, a law of bans which sets limits to the freedom to reproduce.

Female genital cutting: a survey among healthcare professionals in Italy.

This study aims to evaluate the knowledge of female genital cutting (FGC) in a tertiary teaching hospital in Italy. A survey questionnaire on FGC was given to paediatricians, nurses, midwives, gynaecologists and residents in paediatrics and gynaecology in a tertiary teaching hospital in Italy. The results of the survey were then analysed. The results showed that 71.5% (73/102) of healthcare professionals dealt with patients presenting with FGC. Gynaecologists (83%) and paediatric nurses (75%) were the only ones who declared to be aware of Italian law on FGC. In detail, 55% of midwives, 50% of paediatricians, 50% of paediatrician residents and 28.5% of gynaecological residents were aware of this law. The general knowledge of Italian National Guidelines on FGC is even worse: most professionals are not aware of protocols of action. Considering the increasing extension of FGC due to immigration, improvement of care through specialised education of healthcare providers is mandatory.

Reiterative changes in the Italian regulation on IVF: the effect on PGD patients' reproductive decisions.

National legislations represent one of the main factors influencing access to assisted reproduction treatment. The Italian situation in the last decade is an example of how the treatment of patients for preimplantation genetic diagnosis (PGD) was more dependent on regulators than on medical choices. This report analysed how the changes in Italian regulation affected the number of PGD referrals to this study centre, as well as their decision to opt for cross-border reproductive care (CBRC). The analysis showed that during the period in which PGD was actually not performed because of the restriction imposed by the Italian law on IVF (from 24 February 2004 to 7 May 2009) there was a significant decrease in the number of referrals asking for PGD (2.5% of total referrals) compared with the previous years (3.3%; P < 0.025) and following years when PGD was legalized (5.1%; P < 0.001). The number of couples opting for CBRC had an opposite trend, reaching a maximum when PGD was banned from Italian centres (55 couples), whereas after the readmission of PGD, only eight couples went abroad for treatment. Concomitantly, since May 2009, the proportion of couples performing a PGD cycle in this centre has constantly increased.

Telemanagement and Radiology: current structure, opportunities and new horizons.

Background: Telemedicine is a method of providing remote services in compliance with data security, with a significant positive impact on healthcare, in which Teleradiology means the electronic transmission of radiographic images from one geographical area to another. In this context, the term "telemanagement" shows a real remote management of a diagnostic examination, concluded by the production of telereport and telediagnosis. Materials and Methods: On the basis of Italian position papers, National guidelines and current Laws, a careful analysis of multiple aspects was carried out, in order to understand the current obligations and application limits. Discussion and Conclusion.: Proper radiotelemanagement requires a shared operating protocol within the structure, which integrates verification and safety procedures, periodic checks and adequate resources. In addition, practical interface between the involved figures must be properly established. Then, guidelines highlight the "standard" radiological procedures that can be performed in the absence of the specialist: in ordinary hospitalization, it is allowed to perform Telemanagement procedures only within "standard" procedures; in emergency setting, the only limit is placed in case of administration of contrast agent. No provisions have been approved for teleradiological work in private settings. Finally, inter-company procedures are only provided for screening programs. In this context; potential negative implications are the risk of substitution of health professionals, as well as ethical issues related to data security, patient's consent and quality of the doctor-patient relationship. In an effort of optimism aimed at the future, we want to express our propensity towards a universe with lots of potential that, over time, will emerge in its concreteness.

Access to medical-assisted reproduction and pgd in Italian law: a deadly blow to an illiberal statute? commentary to the European Court on Human Rights's decision Costa and Pavan v Italy (ECtHR, 28 August 2012, App. 54270/2010).

This article provides an account of the European Court on Human Rights' Second Section decision in the case Costa and Pavan v Italy. The judgment found that the Italian Statute on Assisted Reproduction (Law 40/2004), and particularly its prohibition to use in vitro fertilisation and pre-implantation genetic diagnosis (PGD) to prevent the birth of children affected by genetically transmissible conditions, breached Article 8 of the European Convention on Human Rights (ECHR). In fact, the statute in question permits only infertile people to access medically assisted reproduction techniques and forbids PGD and embryo selection. The Court regarded that the rationale of these prohibitions-identified by the Italian Government with the need to prevent eugenic practices as well as to protect the health of the unborn and of the woman-was at odds with the fact that Italian law allows pre-natal screening and therapeutic abortions in case foetal abnormalities are diagnosed. In order to clarify the decision's significance, the paper goes on to analyse the rationale of Law 40/2004 in the Italian legal and political context. Emphasis is placed on the fact that this statute is extremely controversial at domestic level, because many of its provisions-including those considered by the Strasbourg Court-are inherently contradictory and contrast with the settled constitutional principles on abortion, as many domestic authorities highlighted. In this context, should the commented decision be confirmed by the Grand Chamber, it may provide a basis to bring consistency back to the Italian regulation of assisted reproduction. Finally, the paper considers the appeal lodged by the Italian Government to the Grand Chamber, and in particular the contention that the European Court had failed to respect Italy's margin of appreciation. In this regard, it is argued that, under Law 40/2004, individuals face illogical and discriminatory restrictions to their right to private and family life and that therefore, even if an outright violation of Article 8 ECHR could not be found, there appears to be at least a breach of Article 8 in conjunction with Article 14 ECHR.

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.

Survey on health students' knowledge and perception on body donation for scientific research, education, and training after specific Italian law no. 10/2020.

BACKGROUND: Practicing on the human body was considered extremely relevant for health professionals' education, but a drastic reduction was observed due to an increase in alternative virtual and multimedia means, and, in Italy, also due to a lack of regulation. Italian Law 10/2020 regulates body donation for research and training through an advanced directive for post-mortem body donation. METHODS: A cross-sectional study was carried out to investigate the law knowledge and body donation perception of health students of any degree courses enrolled at the University of Pavia, Italy, in 2021, through ad hoc web questionnaire. RESULTS: 485 students participated to this survey; median age was of 21 years (25th-75th percentiles, 20-23), 73.2% were females, and 62.5% were medical students. Among them 14.9% knew the Italian law 10/2020. Age was the only variable associated with students' knowledge of the law. Further, 8.3% reported the current availability of cadaveric practice, 85.6% of health students acknowledged usefulness of cadaveric practice, with a significant difference between medical and non-medical students (71.4% vs 28.6%, p < 0.001). Overall, 59.7% would donate their body, rising to 62.7% with reference to specific law regulation, with 30.5% and 28.7% undecided, respectively. 51.3% of participants answered not practicing religious faith, 82.9% with Catholic families, without significance on the knowledge of the law. CONCLUSIONS: Poor knowledge of the law compared with great interest and acknowledged cadaveric practice usefulness highlighted the need for better information, especially among health students, where critical discussion could be more valuable. Then, there arises the urgent need to fill the gaps within university studies and syllabuses, to relaunch the central role that cadaveric practice and research had in the education of health professionals. Consequences on basic and specific health students' skills, on health education quality in general, and further on health professionals' expertise must be carefully considered.

Legal and Ethical Issues Regarding Minors in the Italian Coronavirus Flu Emergency.

On February 21, 2020, Italy became one of the countries hit by an epidemic of the new coronavirus that causes "severe acute respiratory syndrome coronavirus 2" (SARS-CoV-2). Even a month before that, however, the Italian government began issuing a series of decrees and ordinances aimed at the containment of the virus in Italy, the first of them on January 25, 2020. The COVID 19 infection has been faced as an epidemic through measures to enforce a high degree of isolation. These regulations hold for minors, as well, with consequent difficulties for this age group. While at the moment young people appear to be the least vulnerable to the severe complications of COVID 19, the psychological problems that may be brought on by pandemic-related restrictions should be taken into serious consideration.

What People Search for When Browsing "Doctor Google." An Analysis of Search Trends in Italy after the Law on Pain.

Italy adopted a law on chronic pain in March 2010, which focused on detection and management of this symptom, that affects approximately 25% of the population. The aim of this study is to analyze the interest of the Italian population in palliative care and chronic pain and to understand whether the Law 38/2010 made an impact on the internet search on chronic pain. Five research parameters were included using Google Trends (chronic pain, anti-inflammatory drugs, opioids, fibromyalgia, medical cannabis) from 2004 to 2019 using "joint point regression analysis." Comparisons of annual relative search volume (ARSV), average annual percentage change (AAPC), and temporal patterns were analyzed to assess loss or gain of interest in research of all the terms after adopting Law 38/2010; collected data were analyzed using Kruskall-Wallis test. The research trend of almost every word increased in time (AAPC > 0) with significant inflexion points after issuing law on chronic pain management in March 2010. Our results suggest the relevance of internet search engines, like "Doctor Google," to translate and share knowledge about specific conditions, diseases, and treatment alternatives, with a call to a raise in authoritative scientific voices on the topic, especially when it comes to widespread conditions like chronic pains.

Physician-Patient Relationship, Assisted Suicide and the Italian Constitutional Court.

In 2017, Italy passed a law that provides for a systematic discipline on informed consent, advance directives, and advance care planning. It ranges from decisions contextual to clinical necessity through the tool of consent/refusal to decisions anticipating future events through the tools of shared care planning and advance directives. Nothing is said in the law regarding the issue of physician assisted suicide. Following the DJ Fabo case, the Italian Constitutional Court declared the constitutional illegitimacy of article 580 of the criminal code in the part in which it does not exclude the punishment of those who facilitate the suicide when the decision has been freely and autonomously made by a person kept alive by life-support treatments and suffering from an irreversible pathology, the source of physical or psychological suffering that he/she considers intolerable, but fully capable of making free and conscious decisions. Such conditions and methods of execution must be verified by a public structure of the national health service, after consulting the territorially competent ethics committee. This statement admits, within strict and regulated bounds, physician assisted suicide, so widening the range of end-of-life decisions for Italian patients. Future application and critical topics will be called into question by the Italian legislator.

Corpses against science death: new Italian law titled 'Rules relating to the directives of one's body and tissues post-mortem for study, training, and scientific research purposes'.

The new Italian Law no. 10 of 2020, titled 'Rules relating to the directives of one's body and tissues post-mortem for study, training, and scientific research purposes' (10 February, 2020), has opened the doors to a new and clearer regimentation on body donation to science, according to the procedure already introduced by Law no. 219/2017 on the 'Rules relating to informed consent and advance directives of treatment'. The authors exposed some concerning regarding the application of the law, such as donation mistrust, also linked to our cultural heritage; the incomplete protection of minor and incompetent people; the complexity of an adequate information, which could undermine the informed consent; and finally, the fees overload for research institutes, with already exiguous budgets. Next, the authors analysed some positive aspects of the law and in primis the central role of corpses in scientifical knowledge and medical training. Moreover, a simple mechanism based on a conscious and pre-stated consent, registered in a database that follows European data protection Regulation, is discussed. Further, the procedure of the restitution of the bodies to their families, which represents a way to guarantee the relatives' commemoration, is also elucidated. In conclusion, the authors proposed a format of informed consent, to try a direct application of the law, thereby fastening the process of standardisation and centralisation of all the living wills. The authors optimistically investigated the opportunities offered by the law and encouraged a conscientious participation by citizens.

New Rules on Patient's Safety and Professional Liability for the Italian Health Service.

BACKGROUND: The phenomenon of clinical negligence claims has rapidly spread to United States, Canada and Europe assuming the dimensions and the severity of a pandemia. Consequently, the issues related to medical malpractice need to be studied from a transnational perspective since they raise similar problems in different legal systems. METHODS: Over the last two decades, medical liability has become a prominent issue in healthcare policy and a major concern for healthcare economics in Italy. The failures of the liability system and the high cost of healthcare have led to considerable legislative activity concerning medical malpractice liability, and a law was enacted in 2012 (Law no. 189/2012), known as the "Balduzzi Law". RESULTS: The law tackles the mounting concern over litigation related to medical malpractice and calls for Italian physicians to follow guidelines. Briefly, the law provided for the decriminalisation of simple negligence of a physician on condition that he/she followed the guidelines and "good medical practice" while carrying out his/her duties, whilst the obligation for compensation, as defined by the Italian Civil Code, remained. Judges had to consider that the physician followed the provisions of the guidelines but nevertheless caused injury to the patient. CONCLUSION: However, since the emission of the law, thorny questions remain which have attracted renewed interest and criticism both in the Italian courts and legal literature. Since then, several bills have been presented on the topic and these have been merged into a single text entitled "Regulations for healthcare and patient safety and for the professional responsibility of healthcare providers".