MEDICAL MALPRACTICE IN ITALY: what has changed after the Gelli's Decree
With the publication in the Official Gazette and the coming into effect of Law no. 24 dated March 8, 2017, and concerning the "Provisions for safety of treatment and the assisted person, as well as provisions for professional liability of medical professionals", the reform process for the criminal and civil responsibility of health operators comes to a close.
This measure of great importance covers a variety of themes and is intended to affect the responsibility of health operators, both from a criminal and civil point of view. Some of the most relevant themes are: safety of treatments and healthcare risks; responsibility of health professionals and the public or private healthcare institution; modes and characteristics of legal proceedings concerning the medical responsibility; the compulsory insurance (amtrust insurance); the creation of the Injured Parties Guarantee Fund, which will compensate the injured patient in case the amounts exceed the limits covered by the institution or professionals' Italy medical malpractice insurance policy.
The new position of Supervisor for the right to health has been introduced, and citizens may report to him eventual malfunctions in the system, in regard to the failure to observe the "Essential healthcare levels".
Moreover, the Centre for healthcare risk and patient safety management will be created on a regional level, while the National Observatory of healthcare safety good practises will be established on a national level.
MEDICAL MALPRACTICE IN ITALY: health professional civil responsibility
Thanks to this reform, the health professional civil responsibility will no more be considered as contractual but as non-contractual liability, in compliance with Art. 2043 of the Civil Code.
The difference is significant as compared with the past: in the past the doctor had to provide evidence that the harmful event happened for causes not related to him, however, following the reform, the burden of proof shall lie with the patient. The latter shall demonstrate the doctor's fault by providing evidence of the event (the injury), the cause (the doctor's fault), and the casual relationship between event and cause.
This new framework of health professional responsibility will have implications especially in terms of compensation.
Indeed, while in the past relevance was given to the direct relationship between the doctor and the patient, the first (despite being dependent upon the healthcare institution he was working for) could be directly called to account for the caused injury. The liability of the doctor and the institution was joint and several.
Following the reform, the patient right to obtain compensation is actually further guaranteed, to the extent the injured party may act directly against the healthcare institution, which is essentially more stable and solvent.
MEDICAL MALPRACTICE IN ITALY: health professional criminal responsibility
Within this new liability framework, a new Article, 590 sexies (criminal liability for death or personal injuries in the healthcare field) has been introduced in the Criminal Code.
Article 590 sexies includes those penalties for offences in compliance with Articles 589 and 590 of the Criminal Code, if the facts are committed within the performance of medical profession, besides paragraph 2 states the following: "If the event occurred due to incompetence, the punishability is excluded when recommendations provided by the guidelines are respected as defined and published in compliance with the Law, and in the absence thereof, by the good clinical practises, provided that the aforementioned guidelines are adequate to the the particular case".
No more differences among degrees of guilt.
In the past, the punishability occurred even in case of slight negligence, today this is no longer effective, with respect to the assessment of the medical criminal liability.
Article 590 sexies of the Criminal Code grounds the non-punishability on the following conditions:
- assessment of the event which caused the incompetence;
- respect of the guidelines;
- adequacy to the guideline particular case.
Therefore, on closer inspection, a new cause of non-punishability has been introduced in the Criminal Code.
The incompetence, which caused the patient's injury, shall be punishable only in those cases of gross negligence, to the extent the doctor is unable to provide evidence to have respected the guidelines as defined and published in compliance with the Law or by the good clinical practise,
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.