On 1 April 2017 Law no. 24 dated 8 March 2017 (the so-called “Legge Gelli”) came into force; this law amends the legal framework relating to civil and criminal liability of the medical profession in Italy, which had been outlined by the Legislator only a few years ago with Law no. 189 of 8 November 2012 (the so-called “Legge Balduzzi”).

The so-called Balduzzi Law

According to Article 3, paragraph 1 of the above-mentioned Law, “the medical professional that carries out his activity, following the guidelines and best practices confirmed by the scientific community, does not respond to the crimes committed with slight negligence".

According to the interpretation of the Supreme Court (Suprema Corte di Cassazione) this provision of the Balduzzi Law did not consider slight negligence as criminal when widely accepted medical guidelines or general therapeutic best practices are used. According to this provision, the crimes of manslaughter (section 589 of Italian Criminal Code) and personal injury (section 590 of the Italian Criminal Code) are not generally applicable and can only be considered in case of gross negligence, even if committed while respecting scientific guidelines.

The limitation of the doctor’s liability, as outlined by this law, also considered cases of professional negligence characterized by carelessness or imprudence.

The so-called Gelli Law

The new Gelli Law has significantly impacted the controversial issue of medical liability, including significant amendments (for both criminal and civil aspects) with the introduction of a new autonomous offence of “criminal liability of the medical professional” under the new Article 590-sexies of the Italian Criminal Code.

Article 6 of the Gelli Law introduces Article 590-sexies of the Italian Criminal Code, which constitutes a new crime only for healthcare professionals. It is a "special rule" with respect to the traditional crimes of personal injury and manslaughter even though the sanctions provided for by the Italian Criminal Code are the same.

However, the real importance of the new provision consists in the specific exemption from punishment included in the second paragraph of Article 590-sexies of the Italian Criminal Code, which excludes criminal responsibility of healthcare professionals in relation to the offences covered therein when the event is the result of inexperience, in the case that the guideline recommendations are adhered to, or when the best clinical practices are respected and - in any case – if these are adequate, in relation to the particularities of the specific case.

The exemption from punishment, as outlined by the new Article. 590-sexies Italian Criminal Code, does not contain references to slight negligence, the degree of the negligence being indifferent.

Additionally, careless and imprudent conduct, previously not excluded from the scope of the exemption from punishment provided by the Balduzzi Law, is implicitly excluded from sec. 590-sexies, paragraph 2 of the Criminal Code, which expressly considers that the incident occurred as a result of inexperience.

Therefore, for the purpose of the special exemption from punishment, the following circumstances, must be simultaneously present:

  • It must be verified that is a result of inexperience;
  • The recommendations provided for by the guidelines (as defined and published by law) or, failing these, the clinical best practices have been complied with;
  • The recommendations contained in the guidelines are appropriate with regards to the specificity of the concrete case.

It should also be noted that Article 6 of the Gelli Law expressly abrogates Article 3, paragraph 1, of the Balduzzi Law, which provided the exemption from punishment for the health professional who acted with slight negligence and had followed the guidelines and best practices suggested by the scientific community.

Finally, it is noted that, according to the case law, for events which took place before 1 April 2017, pursuant to Article 2 of the Criminal Code, the provision of the abrogated art. 3, paragraph 1 of the Balduzzi Law can still be applied, which is evidentially considered favorable.