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On 1 March 2024, Decree No 232/2023 (the “Decree”) implementing Article 10(6) of Law No 24/2017 (the “Gelli-Bianco Law”) was finally published, almost 7 years after the enactment of the law regulates medical malpractice in Italy.
The Decree regulates the content and requirements of insurance policies for healthcare facilities and health professionals, setting:
(i) the minimum mandatory standards for insurance policies for (a) public and private healthcare facilities; (b) private healthcare professionals; and (c) employed healthcare professionals (covering the recovery action)
(ii) the minimum mandatory standards for self-insurance; the provision for healthcare facilities of a risk fund and reserves in relation to reported claim; the rules for the transfer of risk in the event of a contractual takeover by an insurer;
Coverage trigger
Policies shall be drafted in the claims made form, providing the insured with a ten-year retroactivity period and a ten-year ERP period after termination of professional activity.
The Decree defines "Claim" as:
- the written request for damages made by third parties for the first time during the policy period or the ERP, including the summon of the insured as a civil liable party in criminal proceedings;
- under policies covering the recovery action, the recovery/subrogation/administrative liability action as well as the invitation to provide clarifications of the Public Prosecutor of the Court of Auditors and the written request for recovery notified by the health facility and a written request from the health facility holding the insured liable for gross negligence following a final judgment;
The Decree specifies that facts other than those listed above shall not to be interpreted as Claim.
Policy limit
The Decree also provides for minimum policy limits, which will have to be updated accordingly by insurers. These are (in EUR):
| health professionals (private): | per claim | In the aggregate |
| without surgical, orthopaedic, anaesthesiological and childbirth activities | 1,000,000 | 3,000,000 |
| with surgical, orthopaedic, anaesthesiological and childbirth activities | 2,000,000 | 6,000,000 |
| Health facilities: | ||
| outpatient clinics and analysis laboratories (without dentistry) | 1,000,000 | 3,000,000 |
| healthcare facilities that do not perform surgical, orthopaedic, anaesthesiological and childbirth activities, as well as residential and semi-residential social care facilities and dental facilities | 2,000,000 | 6,000,000 |
| healthcare facilities performing surgical, orthopaedic, anaesthesiological and childbirth activities | 5,000,000 | 15,000,000 |
| health professionals (public): | three times the gross remuneration (pursuant to Article 9 (5)(6) of Gelli-Bianco Law) | |
| liability towards employees (RCO): | ||
| 2,000,000 | 2,000,000 |
Direct action against the insurer
The entry into force of the Decree determines the applicability of the direct action of the damaged party against insurers, provided for by Article 12 of the Gelli-Bianco Law.
Through direct action, the damaged party has the option to seek compensation directly against the insurer of the healthcare facility and/or of the healthcare professionals, within the policy limit.
The insurer may only raise against the damaged party certain coverage issues specifically indicated in the Article 8 of the Decree, such as:
- damages arising from activities not covered by the policy;
- conducts giving rise to liability and claims for compensation made outside the policy period, retroactivity period and ERP;
- SIR and deductibles;
- non-payment of the premium.
According to the Article 12(3) of the Gelli-Bianco Law, the insurer has a right of recovery against the insured if there are additional coverage issues other than those indicated above.
Entry into force
The Decree will become effective on 16 March 2024, and insurers must adjust their policies to comply with the new standards by 16 March 2026 (within 24 months).
Direct action will be enforceable immediately upon the decree's entry into force, hence from 16 March 2024.
You can find the Decree on the website:
https://www.gazzettaufficiale.it/atto/serie_generale/caricaDettaglioAtto/originario?atto.dataPubblicazioneGazzetta=2024-03-01&atto.codiceRedazionale=24G00032&elenco30giorni=true
