How to handle consent and medical procedures in Italian

In Italy, handling consent for medical procedures is governed primarily by Law No. 219/2017, which establishes that no medical treatment can be started or continued without the free and informed consent of the patient, except where otherwise provided by law. This law emphasizes that consent is not just a one-time acceptance or refusal but an ongoing process involving the patient’s right to be fully informed about the treatment, its risks, benefits, and alternatives. Informed consent is anchored in the constitutional rights to personal freedom and dignity, making it essential that healthcare providers respect patient autonomy in all healthcare decisions.

The key points for handling consent and medical procedures in Italy include:

• Consent must be free, informed, and explicit before any medical treatment is administered.
• Patients have the right to refuse treatment, and this refusal must be respected even if it leads to adverse outcomes.
• The law encourages shared care planning and recognizes advance directives, enabling patients to express their wishes for future treatment decisions.
• For minors or individuals unable to consent, guardians or legally authorized proxies make decisions in the patient’s best interest while considering the patient’s will where possible.
• Healthcare providers are legally responsible for ensuring patients understand the treatment, its risks (even unforeseeable ones), and benefits before obtaining consent.
• Written consent is often required, especially for surgical and invasive procedures, but the essential element is the patient’s understanding and agreement, not just the signature.
• The communication process with the patient must be professional, comprehensive, and ongoing.

This framework aims to build a trust-based care relationship that respects patient autonomy and dignity in all medical processes in Italy. ^{1, 2, 3, 4, 5, 6}

References

• A review and analysis of new Italian law 219/2017: ‘provisions for informed consent and advance directives treatment’

• Advance Treatment Provision (DAT): Italian Legislation in the European Context. A Comparative Analysis

• Informed Consent and Advance Care Directives: Cornerstones and Outstanding Issues in the Newly Enacted Italian Legislation

• Consent and Complications in Health Care: The Italian Context

• Consent and Complications in Health Care: The Italian Context

• Informed consent and Italian physicians: change course or abandon ship—from formal authorization to a culture of sharing

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

• Compassionate use programs in Italy: ethical guidelines

• Does written informed consent adequately inform surgical patients? A cross sectional study

• Self-determination, healthcare treatment and minors in Italian clinical practice: ethical, psychological, juridical and medical-legal profiles

• Italian law on medically assisted reproduction: do women’s autonomy and health matter?

• Towards the implementation of law n. 219/2017 on informed consent and advance directives for patients with psychiatric disorders and dementia. Physicians’ knowledge, attitudes and practices in four northern Italian health care facilities

• Informed consent in veterinary medicine: legal and medical perspectives in Italy.

• The will of young minors in the terminal stage of sickness: A case report

• The New Italian Guidelines for Assisted Reproduction Technologies (ART): Ethical and Medico-Legal Issues

• Information obligation in surgery