The new informed consent of Law 219/2017

The Informed Consent is defined and governed, for the first time in Italy, by the Law 219/17 "Rules on informed consent and advance processing provisions" - also known as the Biotestamento law. In this law all procedural aspects of Informed Consent are regulated, and the 3 actors of this process are indicated:

1. patients,
2. medical team
3. health facility.

The roots of this law can be found in the Convention on Human Rights and Biomedicine (Oviedo Convention), at Charter of Fundamental Rights of the European Union and deontological codes of doctors and health professions, in compliance with principles of the Constitution (art. 2, 13 and 32), but until 2017 they had never been explicit and confirmed by specific legislation.

The essence and value of this law are expressed with a beautiful phrase: "communication time is healing time"(Article 1 paragraph 8), on which all health professionals should reflect every time they approach a patient. To this is added a further key concept, always referred to in Art. 1, the "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". The same article affirms the right of every person "To know their health conditions and to be fully informed, updated and understandable to you about the diagnosis, prognosis, benefits and risks of the diagnostic tests and health treatments indicated, as well as about the possible alternatives and consequences of 'possible refusal of medical treatment and diagnostic assessment or renunciation of the same ".  

Definition of informed consent in Law 219/2017

Medical Informed Consent is the process by which the Patient decides in a free and autonomous way after having been presented with a specific series of information, made understandable to him by the doctor or medical team, whether to start or continue the planned health treatment. It must be full, updated and understandable about the diagnosis, prognosis, benefits and risks of the diagnostic tests and health treatments indicated. It must specify the possible alternatives and the consequences of any refusal of medical treatment and diagnostic assessment or renunciation of the same.

L'Acquisition of Informed Consent"We can mean the expression, by the Patient, of theassent (which can be complete or partial), dissent o revokes, relating to what was proposed by the Doctor, at the conclusion of the entire informed consent process.

Such an acquisition is usually one company of the patient, but the law 219/2017 also provides other modalities - in order to allow the expression even by patients who are unable to sign.

An important point that our association particularly cares about is the right to refuse or revoke any diagnostic assessment or medical treatment indicated by the doctor for your pathology or the individual acts of the treatment itself. Each individual can truly feel free to accept medical treatment if he can refuse it. Acceptance, revocation and rejection are noted in the patient's medical record and electronic health record.

Law 219/2017 it also clarifies that those who must provide the information to the patient are the healthcare professionals who make up the healthcare team.

A particularly interesting point is the Informed Consent to the medical treatment of minors: it is expressed or refused by the exercisers of parental responsibility or by the guardian taking into account the will of the minor person, in relation to his age and degree of maturity and having as its purpose the protection of the mental and physical health and life of the minor in full respect of his or her dignity. However, the minor has the right, if appropriate to his understanding, to receive information on the choices relating to his own health.

Obligation of the Structure: information

Informed Consent information is a specific obligation of the health facility and the patient must understand and explicitly concern:

• Diagnosis
• Prognosis
• Benefits and risks of the diagnostic tests and health treatments indicated
• Benefits and risks of possible alternatives to diagnostic tests and indicated health treatments
• Consequences of any refusal / renunciation

In this regard, we answer the question we are often asked about Informed Consent: what happens if I refuse a certain health treatment? The answer is inherent in the Informed Consent itself and the answer to the question must be included in the same acceptance as the Informed Consent. To better understand this aspect, we quote all paragraph 3 of Art. 1 of law 219/2017:

"Everyone has the right to know le their health conditions and to be fully informed, updated and understandable to you about the diagnosis, prognosis, benefits and risks of the diagnostic tests and health treatments indicated, as well as about possible alternatives and consequences of any refusal of medical treatment and diagnostic assessment or renunciation of the same. "

It should be clear that the reference figure responsible for presenting the Informed Consent to the patient, or the medical team and / or health facility, are those who at the same time submit the Informed Consent, to make it complete, must also indicate what happens if is refused and they must do so both from a medical and legal point of view.

Types of information to combine in the Informed Consent

From the provisions of Law 219/17, it is noted that for an adequate informed consent from the patient 4 different types of information must be provided:

1. Specific Patient Information (Diagnosis)
2. Information relating to the treatments identified by the Doctor as most useful to the patient
3. Information on alternatives
4. Additional information (probable prognosis, consequences of refusal / revocation, any indications for psychological assistance provided for by art.1 paragraph 5)

Much of this information derives from guidelines set out in the law 8 law March 2017, n. 24 (so-called “Gelli-Bianco” Law), prepared by the Medical-Scientific Societies for each treatment / health assessment.

Obligation of the Doctor: to make the information understandable and useful

Making the information understandable, so that it is useful for the Patient to express his or her decision independently is the specific task and responsibility of the doctor and / or health team. This process is the heart of the new informed consent. It is in fact the key moment that allows both to establish a climate of trust between the doctor / health team and that patient, and to initiate an effective involvement of the person in his or her own therapeutic path, that is to start the "care relationship" in which the Patient is an active subject. So here's how the making information understandable becomes the key to placing informed consent at the basis of the "relationship of care and trust between patient and doctor".