A review and analysis of new Italian law 219/2017: ‘provisions for informed consent and advance directives treatment’
Marco Di Paolo, Federica Gori, Luigi Papi, Emanuela Turillazzi
BioMed Central Medical Ethics, 4 March 2019; 20(17)
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.

Ethical governance of the medical research: clinical investigation and informed consent under the new EU Medical Devices Regulation (2017∕745)
Olimid DA, Olimid AP, Ifrim Chen F
Romanian Journal of Morphology and Embryology, 1 Jan 2018, 59(4):1305-1310
Purpose
The paper focuses on the ethical appraisal of the clinical investigations (CIs) and the informed consent within the new European Union (EU) legislation on medical devices (MDs). The Regulation (EU) 2017∕745 of the European Parliament and of the Council was adopted on 5 April 2017 and entered into force on 25 May 2017, repealing the Council Directives concerning Medical Devices 93∕42∕EEC and the Active Implantable Medical Devices 90∕385∕EEC.
Background
For the past thirty years, the EU legislation on MDs has been updated by several directives: Council Directive 90∕385∕EEC on Active Medical Devices (1990); Council Directive 93∕42∕EEC on Medical Devices (1993) and Council Directive 98∕79∕EC on In vitro Medical Devices (1998) aiming to frame the MDs market development.
Content
From the ethical perspective, the present article investigates the new rules concerning the CIs of the MDs for human use and accessories for such devices conducted in the EU by highlighting new regulatory aspects: (1) the framework of the clinical evaluation and CI; (2) the relevant definitions; (3) the ethical principles related to CIs; (4) the informed consent; (5) the role of the national ethics committees.
Conclusions
Although the new guidelines enable an extension of the definition of “medical device” and the harmonization of the rules for “the placing on market and putting into service of the medical devices”, it also regulates the MDs industry to ensure clinical benefits for patients and high standards of quality and safety.

The Universal Declaration of Human Rights at Seventy: Progress and Challenges [Full text]
S. İlgu Ozler
Ethics & International Affairs, Winter 2018 (Issue 32.4) December 2018
Abstract
Now is a good time to take stock of the global progress made toward achieving the ideals enshrined in the Universal Declaration of Human Rights (UDHR), which was passed by the UN General Assembly seventy years ago. Though the UDHR has played a vital role in advancing human rights globally, threats to human rights are ever present. Two issues in particular stand out as barriers to further progress. The first is state sovereignty, which presents a fundamental challenge to any effort to establish universal norms. Without strong global institutional mechanisms to ensure implementation, UDHR’s impact remains limited. The second major concern is the “siloing” of human rights efforts, whereby civil and political rights have been given primacy over social and economic rights. Emphasis on some principles to the exclusion of others undermines the comprehensive advancement of human rights. The current state of affairs is a product of the collective failure to address human rights holistically and to implement real monitoring and accountability measures for states, which are directly charged with upholding them within their borders.