Italian Law Regulates Informed Consent

Studio legale Ferraro-Giove e Associati
INFORMED CONSENT IN ITALY
AN OVERVIEW
Marco Perini
Studio Legale Ferraro Giove e Associati
FGA
Barcelona, June 7th, 2018
Avv. Marco Perini

The informed consent in Italy is regulated by law n.
219/2017
According to the Italian legislation no medical treatment
can be started or continued without the free and
informed consent of the person concerned, except as
otherwise stated by law.
Studio legale Ferraro-Giove e AssociatiAvv. Marco Perini

The rulings delivered by the Supreme Court (no.
5444/2006) and the Constitutional Court (no. 438/2008)
in the second half of the 2000s, have paved the way for a
regulation implemented by the legislator for a new law by
the end of 2017.

The informed consent is the synthesis of three fundamental rights
established by the Italian Constitution
● self-determination provided for in Article 2;
● inviolability of personal liberty as "self-determination of human
beings over their own bodies" provided for in Article 13;
● the right to health provided for in Article 32;
together with the principles set out in articles 1, 2 and 3 of the
Charter of Fundamental Rights of the European Union.

8 key points to briefly address the new Law

1 - the law establishes that
an effective doctor-patient communication is part of the Care
process and the Cure.
Therapy and Trust are interconnected and both key to
patient-physician interaction. This relationship is based on
informed consent

There is a significant difference between communication and
information.

While information is a one-way process,
communication is a relational process:
Avv. Marco Perini

For the purpose of testing the correct communication between
doctor and patient,
the pre-printed form signed by the patient can be used for simple
interventions and is considered a valid information system in
Italian courtrooms.

On the other hand
for more complex interventions, this form is not sufficient and
proof of effective information must be provided in order to assess
the patient's specific knowledge. In such cases, the written
document is merely a piece of evidence, to be combined with a
testimonial evidence or with a recording/ videotaping of the
conversation, admissible and appropriate for probative purposes
in most relevant cases (Doctor’s responsibility, D. Condello, 2014).

2- every person has the right to know or not to know
the following information:
• health conditions
• diagnosis
• prognosis
• benefits and risks of screening tests and health treatments
• possible/viable alternatives
• consequences of any refusal / waiver of medical treatments or
and diagnostic tests

In the case of a dispute concerning the validity of consent, it is
therefore necessary to prove that such has been effectively
communicated patients.
Jurisprudence has so far been inclined to ask for much wider
information, stating that
the physician and the healthcare facility must prove to have provided
the patient "in a complete and exhaustive way with all available
scientific information on therapies to be implemented and/or surgical
intervention to be performed, explaining procedures and effects,
potential risks of failure (the risks and possibilities of success) as well as
any collateral inconveniences”(Supreme Court 24853/2010).

3 - Any diagnostic assessment or health treatment
(including artificial nutrition and hydration) can be:
• Accepted,
• Accepted and later refused or interrupted, as a whole or in part,
• Refused
If the patient withholds or withdraws from life-sustaining treatments,
the doctor should display related consequences and possible
alternatives and should ensure any possible support, including
psychological assistance.
The informed consent, together with the withholding or withdrawing of
life-sustaining treatments are then included into the medical record
and in the electronic health record.

4 - documenting the informed consent
Informed consent, acquired with most appropriate tools
according to the patient's condition, is documented in writing or
videotape and, in case of a person with disabilities, through
devices enabling him/her to communicate.

5 - Patients’ family members or persons of trust
can be involved in the care relationship
They may be referred to as the person in charge of receiving all or
part of the information or to give consent on behalf of the
patient .

6- Doctors must respect patients’ wishes
Patients can not request health treatments contrary to
• provisions of law
• professional ethics
• good clinical-care practices
Doctors have no professional obligations in the face of these
requests;
Doctors are exempted from civil or criminal liability for having
respected the patient's will.

7 - Any public or private healthcare facility is
obliged to ensure the full and correct implementation of
the principles of law
• providing patients with complete information
• providing healthcare personnel with the most appropriate training in
this respect (including provisions for effective communication with
patients, pain management and palliative care)
In situations of emergency or urgent need of care the doctor and the
medical staff ensure the necessary care process according to the
patient’s will, where his/her clinical conditions and circumstances make
it possible to acknowledge

8 – DAMAGES
Related to the missing/incomplete information to
patients:
The obligation to obtain the informed consent is not linked to the
positive outcome of a medical treatment.
The infringement of this obligation can lead to:

A) damage resulting from a violation of the right to self-
determination
harmful effects resulting from pain and from the infringement of
the right of self-determination
B) damage to health resulting from disabling consequences of
surgery
even if correctly performed

BURDEN OF PROOF IS ON:
1) THE HEALTHCARE PROVIDER
Must prove to have provided the patient with full information
about surgery/medical treatment and obtained a valid consent
from the patient

2) THE PATIENT
A) damage resulting from a violation of the right to self-
determination
Patients must prove physical and/or mental suffering, or other
damages linked to the infringement of self-determination.
This circumstance can be presumed - with no need of proof - only
if the damage is usual either statistically frequent outcome of the
infringement (Supreme Court - joint sessions 11th november 2008
n. 26972)(for instance, shock related to the birth of a baby affected
by serious malformations, avoidable through abortion, if timely
informed).

B) damage to health resulting from disabling consequences of
surgery
the patient must prove that:
- he/she would not have undergone surgery if properly informed
(Supreme Court 11950/2013) and
- that his/her condition would now be better without that
surgery, or
- that his/her condition would now be better if he/she had
undergone another treatment he/she was not informed of.
Therefore the lack of information caused damage (S.C.
26972/2008).

THANK YOU FOR YOUR KIND ATTENTION
Avv. Marco Perini

Italian Law Regulates Informed Consent

Recommended

Recommended

More Related Content

What's hot

What's hot (19)

Similar to Italian Law Regulates Informed Consent

Similar to Italian Law Regulates Informed Consent (20)

Recently uploaded

Recently uploaded (20)

Italian Law Regulates Informed Consent