[Capacity and right to therapeutic self-determination in law no. 219/2017. The case of persons with psychiatric and cognitive disorder.] / Capacità e diritto all'autodeterminazione terapeutica nella legge n. 219/2017. Il caso delle persone con disturbo psichiatrico e cognitivo.

Law no. 219/2017 represents Italy's most comprehensive regulatory framework aimed at enabling the exercise of the right to therapeutic self-determination and ensuring its best expression even for people without legal or natural capacity, through the tools of informed consent, shared care planning and advance care directives. Nevertheless, some criticalities affect the wording of the law, characterised by a promiscuous and heterogeneous use of the terms referring to capacity and by their interpretability. These criticalities may compromise the benefits of the law provisions at the implementation level, with particular reference to persons who may have a condition of limited capacity due to a psychiatric or cognitive disorder. We analysed the concept of capacity in the law and its critical aspects, both on a hermeneutical and applicative level. The analysis shows the difficulty of reconciling the rigidity of the legal categories of capacity with the changing and multifaceted nature of the clinical conditions. We underlined that possible correctives can come from both the healthcare contexts and legal practitioners and must be aimed at achieving maximum approximation between the formal plan of the law and the real contexts of care.

Italian law n. 219/2017 on consent and advance directives: survey among Ethics Committees on their involvement and possible role.

BACKGROUND: On December 2017 the Italian Parliament approved law n. 219/2017 "Provisions for informed consent and advance directives" regarding challenging legal and bioethical issues related to healthcare decisions and end-of-life choices. The law does not contain an explicit reference to Ethics Committees (ECs), but they could still play a role in implementing the law. METHODS: A questionnaire-based survey was performed among the ECs of the Italian Institute for Research and Care belonging to the Network of neuroscience and neurorehabilitation, with the aim of (1) knowing whether the ECs participated and, if so, how in the process of implementation of law n. 219/2017 in the referring institutes; (2) investigating the point of view of the ECs regarding their possible involvement in the process; (3) exploring the contribution ECs can provide to give effective implementation to the law principles and provisions. RESULTS: Seventeen ECs out of thirty took part in the survey; the characteristics of the responding and non-responding committees are similar, so the responding ECs can be regarded as representative of all ECs in the Network. Nine ECs did not discuss the law in anyway: the main reason for this is that the referring institutions (6) and the health care professionals (3) did not ask for an EC intervention. Nevertheless, the large majority of the ECs believe that their involvement in the implementation of the law as a whole is appropriate (8) or absolutely appropriate (6), while 3 of them are neutral. No EC believes that the involvement is inappropriate. The aspect of the law on which the 14 ECs converge in considering the EC involvement appropriate/absolutely appropriate is the one related to the health facilities obligation to guarantee the full and proper implementation of the principles of the law. CONCLUSIONS: Our survey confirms that ECs believe they can play a role in the implementation of law n. 219/2017, although this does not entirely correspond to what the committees have actually done in reality. This role could be better exercised by ECs specifically established for clinical practice, which would have a composition, functioning and a mandate better suited to the purpose. This supports the call for a national regulation of ECs for clinical practice.