LAW ON INFORMED CONSENT AND DATESExtract from the Ministry of Health website

On 31 January 2018, Law no. 219 of 22 December 2017, containing "Rules on informed consent and advance directives for treatment", came into force. As recalled in Article 1, Law 219 "protects the right to life, health, dignity and self-determination of the person and establishes that no health treatment can be started or continued without the free and informed consent of the person concerned, except in cases expressly provided for by law", in compliance with the principles of the Constitution (Articles 2, 13 and 32) and the Charter of Fundamental Rights of the European Union.

The same article states the right of every person "to know his or her health conditions and to be informed in a complete, up-to-date and comprehensible manner regarding the diagnosis, prognosis, benefits and risks of the diagnostic tests and health treatments indicated, as well as regarding the possible alternatives and the consequences of any refusal of the health treatment and diagnostic test or of renouncing them".

INFORMED CONSENT

According to the Law, the relationship of care and trust between the patient and the doctor that is based on informed consent must be promoted and enhanced. The text regulates the ways in which such informed consent can be expressed:

"informed consent, acquired in the ways and with the tools most appropriate to the patient's conditions, is documented in written form or through video recordings or, for the person with disabilities, through devices that allow them to communicate. Informed consent, in whatever form expressed, is included in the medical record and in the electronic health record".

At any time the person can review his decisions. Refusal (not starting) or renunciation (interruption) concern all diagnostic tests and health treatments, among which the Law includes artificial hydration and nutrition.

THE DOCTOR

"If the patient expresses the waiver or refusal of medical treatments necessary for his/her survival, the doctor explains to the patient and, if the patient consents, to his/her family members, the consequences of this decision and the possible alternatives and promotes any action to support the patient, including by making use of psychological assistance services. Without prejudice to the possibility for the patient to modify his/her will, the acceptance, revocation and refusal are recorded in the medical record and in the electronic health record". "The doctor is required to respect the will expressed by the patient to refuse or renounce medical treatment and, as a consequence, is exempt from civil or criminal liability. The patient cannot demand medical treatments that are contrary to the law, professional ethics or good clinical-care practices; in the face of such requests, the doctor has no professional obligations". In emergency or urgent situations, "the doctor and the members of the health team ensure the necessary care, respecting the patient's will where his/her clinical conditions and circumstances allow it to be accepted".

The Law emphasizes that "the time of communication between doctor and patient constitutes treatment time".

PAIN THERAPY AND DEEP PALLIATIVE SEDATION

The law also addresses the issue of pain therapy, the prohibition of unreasonable obstinacy in treatment and dignity in the final phase of life.

According to art. 2, "the doctor, using means appropriate to the patient's condition, must work to alleviate his suffering, even in the case of refusal or revocation of consent to the medical treatment indicated by the doctor. To this end, appropriate pain therapy is always guaranteed, with the involvement of the general practitioner and the provision of palliative care as per Law 15 March 2010, n. 38.

In cases of patients with a short-term unfavourable prognosis or imminent death, the physician must refrain from any unreasonable obstinacy in administering care and from resorting to useless or disproportionate treatments. In the presence of suffering that is refractory to medical treatments, the physician may resort to continuous deep palliative sedation in association with pain therapy, with the patient's consent".

MINORS AND INCAPABLE

The minor or incapacitated person "must receive information on choices relating to his or her health in a manner appropriate to his or her capabilities in order to be able to express his or her will".

In such cases, informed consent is expressed or refused:

for the minor, by those exercising parental responsibility or by the guardian, taking into account the will of the minor himself, in relation to his age and degree of maturity;

for the interdicted person, by the guardian, having heard the interdicted person where possible.

The disabled person, however, can personally express his/her consent and special provisions are foreseen in the case in which a support administrator has been appointed.

ADVANCE TREATMENT PROVISIONS (ADPR)

A person's DAT (also commonly referred to as "biological will" or "living will") represents one of the novelties of the Law. For more information go to the page Advance Treatment Directives - DAT.

SHARED CARE PLANNING

Article 5 deals with a particular case of informed consent in which the doctor and patient can carry out a shared treatment plan in the case of "chronic and disabling pathology or one characterized by unstoppable evolution with an inauspicious prognosis".

TRANSITIONAL RULE

The provisions of the aforementioned Law shall apply to documents expressing the wishes of the person making the decision regarding health care, filed with the municipality of residence or with a notary before the date of entry into force of Law no. 219/2017.

ANNUAL REPORT TO PARLIAMENT

The Minister of Health shall transmit to the Chambers, by April 30 of each year, starting from 2019, a report on the application of the Law. The Regions are required to provide the necessary information by February of each year, on the basis of questionnaires prepared by the Ministry of Health.

ADVANCE TREATMENT DECLARATIONSTHE FIRST FREE INTERACTIVE APPLICATION IN ITALY

FOR COMPILING YOUR OWN ADVANCE DATA PROCESSING DECLARATIONS

Everything we know has a beginning and an end. Just as our life began with birth, it will end with death. This is inevitable. What can be largely avoided, however, is the multitude of physical, psychological, and emotional suffering of those who die and their families; but to do this, it is important to think about it first and get the right information.