MedMal

Doctors' liability, why the new rules also protect patients

The new criminal shield does not affect the civil and deontological side: the white coat may therefore be exempt from criminal penalties for minor negligence but will still be obliged to pay damages for any professional errors

by Claudio Testuzza

24 November 2025

4' min read

Translated by AI

Versione italiana

4' min read

Translated by AI

Versione italiana

With Amendment 69.0.25 to the Financial Manoeuvre, tabled by Senator Michaela Biancofiore, paradoxically signalled as a priority by the majority, a conflict was opened with the medical trade unions and also with the National Federation of Physicians itself.

This is a proposal that, according to the medical world, would demolish the structure of the Gelli-Bianco Law, returning the civil liability of healthcare workers to an outdated model, with a return to direct contractual liability and a drastic weakening of the role of the structures. The amendment, it is believed, may be short-lived, since it has already been opposed in parliament even by the same group to which Senator Biancofiore belongs and by the Minister of Health himself, who will give a negative opinion during the debate. The question posed by the senator seems very improper at a time, however, that is favourable for the most correct definition of health liability

A 'Shield' for doctors

With the go-ahead given by the Council of Ministers on 4 September 2025, the issue of healthcare professional liability had returned to the centre of the regulatory debate. In fact, the draft proxy law on health professions, linked to the budget manoeuvre, introduces a 'conditional criminal shield', destined to profoundly affect the structure of health criminal law and overcome the sometimes ambiguous framework outlined by the Gelli-Bianco law (Law No. 24 of 8 March 2017).

The reform, which is awaiting final conversion, aims to make the limitation of criminal liability for healthcare professionals structural to cases of gross negligence only, provided that the professional has complied with accredited guidelines or good clinical-assistance practices appropriate to the concrete case. This is a significant step, which transforms into a permanent principle what, during the pandemic emergency, had been introduced as an exceptional measure with Law No. 76/2021 (the so-called 'Covid criminal shield')

The new balance of guilt

Article 590-sexies of the Criminal Code, in the post-Gelli-Bianco version, already excluded punishability for negligence due to malpractice, if the doctor had complied with guidelines or good practice. However, the rule left uncovered the hypotheses of negligence-imprudence, as well as generating application uncertainties on the concrete assessment of the degree of guilt. The new text intervenes in a clarifying and broader sense. Article 590-sexies, as reformulated, provides that the doctor is only criminally liable for gross negligence, provided that he has complied with appropriate clinical recommendations. At the same time, the new Article 590 septies is introduced, which requires the judge to make a 'contextualised' assessment of the conduct, considering: the scarcity of human and material resources; organisational shortcomings that could not be avoided by the individual operator; the complexity of the pathology or healthcare service; the lack or contradictory nature of scientific knowledge; the conditions of urgency or emergency and multidisciplinary cooperation.

This introduces a perspective more in line with operational reality, which avoids abstract judgments and allows a weighing of medical behaviour in the light of the structural and organisational context in which the event occurred.

No impunity

On the political-institutional level, the rationale of the rule is clearly expressed by Ministers Schillaci and Nordio: to reduce the 'pernicious' effects of so-called defensive medicine, a phenomenon that entails costs estimated at over 11 billion a year, in addition to lengthening waiting lists and weakening the efficiency of the National Health Service.

Limiting criminal punishability to cases of gross negligence does not, however, mean favouring impunity. As specified by the Government itself, the right of citizens to just compensation for damages remains intact, as does the possibility of instituting disciplinary or administrative proceedings against professionals.

Intoxicated liability

It is precisely this aspect that marks the balance of the reform. The new criminal shield does not affect the civil and deontological side of healthcare liability. The doctor may, therefore, be exempt from criminal penalties for minor negligence, but will still be obliged to compensate for damages resulting from any professional errors, even if only partially.

Administrative liability (for civil servants) and disciplinary liability before professional associations also remain.

The distinction between the levels of liability appears consistent with the principle of proportionality sanctioned by the Constitutional Court and reaffirmed by the jurisprudence of legitimacy, which requires a differentiation between punitive intervention and the reparatory instrument and the regulatory instrument of professional ethics.

Central insurance covers

In this context, insurance protections preserve and indeed strengthen their systemic function. In fact, the fact that criminal punishability for minor negligence no longer applies does not exempt the doctor from the economic risk associated with civil damages, nor from the legal costs associated with defending himself in the various proceedings. Therefore, the following remain unavoidable: professional liability policies, which are mandatory under the Gelli-Bianco law; gross negligence cover, which protects the public health professional when the administration claims for damages; and legal protection guarantees, which are also relevant in criminal and disciplinary proceedings. Insurance companies will probably be called upon to update their risk models and contractual clauses, taking into account the new regulatory perimeter of medical malpractice. The distinction between slight and gross negligence, in fact, could affect the ceilings, deductibles and premium assessment, depending on the degree of exposure of the professional.

Towards 'reasonable responsibility'

The 2025 reform marks an evolution of the system towards a more reasonable and contextualised healthcare liability, capable of balancing the public interest in safe care with the need to protect professionals from over-penalisation.
However, the conditional criminal shield is not a 'total shield'. The doctor continues to be liable in civil and disciplinary proceedings and must maintain behaviour in accordance with the guidelines, deontology and the diligence required in the specific case.

Ultimately, the real guarantee for the system lies not so much in exemption from punishment as in the certainty of rules, continuous training and adequate insurance cover. Only a conscious balance between the protection of the patient and the protection of the professional can guarantee a fairer, sustainable and humanly safe healthcare.