According to the new article 590-sexies of the Criminal Code,the doctor isno longer punishable for cases of manslaughter or second degree assault committed when working as a healthcare professional if the case occurred “due to incompetence” and he/she complied with the “recommendations set forth by the guidelines as defined and published pursuant to the law, or, when these are not present, with good clinical practices”, provided that “the recommendations set forth by the above-mentioned guidelines prove adequate in relation to the specificities of the case in hand”.

With this law, the law-maker has confirmed the existence in our penal system of a special justification for the medical profession, simultaneously revoking Article 3, paragraph 1 of the so-called Balduzzi decree (decree-law no. 158 of 13 September 2012, converted by Italian law no. 189 of 8 November 2012),which back in its time had already envisaged the non-punishable nature of the actions of healthcare professionals who, “when performing their activity, comply with guidelines and good practices accredited by the national and international scientific community”, except in cases of negligence or wilful misconduct.

The doubt: what are the differences in the scopes of application of the “Gelli-Bianco” law and the “Balduzzi decree”?

The two laws have a similar rationale but, since they use different terminology, they implicate a different extension of the area of medical justification, obliging us to settle several doubts regarding interpretation, especially those of an inter-temporal nature. Indeed, it is known that a revoked criminal law does not always then disappear from the legal system: instead if it is more favourable than the law replacing it, it remains in place to regulate all the situations which may have arisen when it was in force. By contrast, any new replacement law that may have more favourable contents that those of the abrogated law, should also have ex post factovalidity.

In such a state of uncertainty, the need has arisen to rebuild the new paradigm of medical liability by analytically comparing the two lawsvalid over time, so that the more favourable one for the doctor in practical terms could always be applicable. The latter operation is to be conducted with consideration of the fact that, compared to the Balduzzi law, Article 590-sexiesof the Italian Criminal Code presents two important differences:

• The introduction of the restriction with regard to “incompetence” as the only case in which the doctor could potentially be excused;

The disappearances of all references to the degree of gravity of the incompetence, with the resulting doubt about whether the doctor who has committed an error with grave imprudence can also consider themselves as being excused.

The response of the Joint Divisions

Understandingly, the intervention of the Court of Cassation was immediately requested regarding this matter, and it provided, with judgement no. 8770 of 2018 issued to the Joint Divisions, an initial authoritative interpretation of Article 590-sexiesof the Italian Criminal Code and its scope.

The Joint Divisions firstly confirmed that the new medical justification cannot be invoked – given the clear formulation of Article 590-sexies of the Italian Criminal Code – in any cases of blame due to negligence or imprudence, albeit slight. Limited to the events occurring prior to the entry into force of the reform, that is before 1 April 2017, for these cases the more favourable Balduzzi law shall be applicable, according to which justification was instead possible.

With regard to the disappearance of all references to the level of blame in Article 590-sexiesof the Italian Criminal Code, the Joint Divisions instead considered it fitting to assign an interpretation of the law based on the constitution: in this sense, the Court ruled that the notion of “slight negligence”, even if not expressly cited, must be considered a criterion for the application of the justification implicit in the new legal precept. Therefore, the possibility that justification may be applicable to all cases of grave incompetence shall be excluded.

In conclusion: the criminal liability of the doctor today

The conclusion to be drawn from this, according to the Supreme Court, is that health professionals are liable, from the perspective of negligence, for cases of death or personal injuries resulting from them exercising medical or surgical duties, when:

-   the event occurred due to negligence or imprudence, albeit slight;

-   the event occurred due to incompetence, albeit slight, when the case in question is not regulated by the recommendations of the guidelines or by good clinical practices;

-   the event occurred due to incompetence, albeit slight, with regard to the identification and choice of inadequate guidelines or good practices for the specificities of the case in question;

-   the event occurred due to serious incompetence, when executing recommendations, or following guidelines or adequate good clinical practices, bearing in mind the level of risk to be managed and the specific technical difficulties of the medical procedure.

Our final interpretation of this system leads us to conclude that the Gelli-Bianco reform has not fully succeeded in its intention to offer doctors a clear law capable of preventing the phenomenon of defensive medicine: for some aspects, and in particular with regard to the newly-introduced distinction between cases of incompetence and those of imprudence or negligence, their appears to be some uncertainty regarding the scope of application, which will concede ample operational room for jurisprudential discretion.