Last August the draft decree (hereinafter the "Draft Decree") that should regulate coverage minimum requirements and general conditions of insurance policies underwritten by public or private healthcare and social-health facilities, and by healthcare professionals, was circulated, in implementation of article 10, paragraph 6 of Law n. 24 of 3 March of 2017 (better known as "Gelli Law"). It is still a provisional text that will have to be issued by the Minister of Economic Development in conjunction with the Minister of Health and the Minister of Economy and Finance, with the prior agreement at the permanent Conference for the relations between the State, the Regions and the autonomous Provinces, after consultation with Ivass, Ania and the major institutions representing the healthcare sector and the respective trade union organizations.

The Draft Decree aims at regulating: (a) the minimum coverage requirements for insurance policies covering public and private healthcare and social-health facilities and health professionals' liabilities, provided for in Article 10, paragraphs 1, 2 and 3 of Gelli Law; (b) the minimum requirements and the general operational conditions of the measures for the direct, full or partial assumption of the risk by the healthcare facility; (c) the rules regarding risk transfer in the event of a contractual takeover of an insurance undertaking; (d) the provisions requiring healthcare facilities to establish in the financial statement a specific risk fund and a claims reserve fund.

Although, as mentioned, this is a provisional draft, some provisions deserve particular attention.

Article 1 of the Draft Decree contains a list of definitions that- most likely – will affect the wording of the insurance policies that will be issued in implementation of Gelli Law and the above mentioned decree. In particular, the definition of claim expressly excludes hypotheses such as the request of the medical record, the execution of autopsy / judicial autopsy / autopsy referred to in Presidential Decree no. 285 of 1990, the lawsuit and the notice of investigation.

First paragraph of Article 3 provides that insurance policies must guarantee coverage to public and private healthcare and social health facilities for cases of contractual liability pursuant to Articles 1218 and 1228 of the Italian Civil Code deriving from material and non-material damages caused, willfully or with gross negligence, to third parties and employees by personnel operating in any capacity at the facility. It is moreover provided that these policies shall provide coverage for non-contractual liability (pursuant to art. 2043 of the Italian Civil Code) of health professionals, even in the event such professionals are chosen independently by the patient and not employed by the facility.
Article 1, letter f, also outlines the definition of "healthcare professional", namely "the professional who, by virtue of a qualifying title, carries out prevention, diagnosis, care, assistance and rehabilitation activities."

With regard to insurance coverage of the healthcare professional's administrative liability, article 3, paragraph 3 of the Draft Decree provides an obligation for Insurers to hold the doctor harmless from any administrative liability, recovery or subrogation actions brought against him pursuant to Article 9, sections 5 and 6 of Gelli Law, as well as from any direct action of the damaged party against the Insurer.

The aforementioned paragraph also provides that in the event of administrative liability, Insurers' recovery action may be brought against the Insured if the doctor has not regularly fulfilled the training and updating requirements for the three-year training period preceding the date of the event giving rise to liability.

It is questionable whether (i) of the failure of the doctor to comply with the training obligation constitutes a condition of "admissibility of the application" and whether (ii) the proof of non-compliance with the training obligation constitutes probatio diabolica for the insurer.

Article 3, paragraph 6, provides that in the event of joint and several liability of the insured, the insurance must cover the whole damage, without prejudice to the right of the insurer to subrogate in the recovery right against the parties who are jointly and severally liable.

After having identified the subject matter of the insurance coverage, attention should be put on its temporal effectiveness.
To this regard, art. 5 of the Draft Decree establishes that coverage is provided in the "claims made" form, thus confirming the timing requirements already provided for by art. 11 of Gelli Law and also providing that in the event of a series of claims the insurance policy will be triggered by the claim notified with the first claim.

The Law also provides that in case of "definitive termination of the health professional's working activity", including the self-employed professionals, a period of ultra-activity of the Policy is provided for in relation to claims notified for the first time within 10 years after the termination of the working activity and related to events giving rise to liability that occurred during the period of effectiveness of the policy, including the retroactivity period.

It should also be noted that the last paragraph of art. 5 in partial derogation to the provision of art. 1913 c.c., provides that, in the event of a claim, the insured must notify Insurers within 30 days from the date the claim was received by the insured or from the date in which the insured became aware of it.

Articles 5 bis, under the heading "Insurer's right of withdrawal", and 7, under the heading "Objections that may be raised", also deserve particular attention.

More specifically, article 5 bis provides that Insurers may withdraw from the contract only in the event of a repeated gross negligence conduct on part of the health professional, that is ascertained by a final decision leading to payment of compensation for damages. However, considering civil justice case-handling time, it is questionable whether this provision might be effectively applied to the short-term insurance policies.

Article 7 introduces a specific rule in relation to the objections that may be invoked by the insurer against the damaged party, and that can be raised only if expressly approved in writing by the insured.
More specifically the objections relate to: (a) harmful events deriving activities that are not covered by the policy; (b) events giving rise to liability that occurred and claims notified outside the period of effectiveness referred to in art. 5; (c) the policy limits in terms of quantum, such as the relevant deductibles or Self Insurance Retention (SIR) and; (d) the failure to pay the premium.

Interestingly, art. 4 of the Draft Decree provides a list of the policy limits, identified on the basis of the different risk classes and draws a distinction according to the type of activity carried out by the social-health facility or by the health professional.
The mentioned article indicates in relation to each risk class the minimum policy limits to be provided for each claim and insurance year 1.
In order to determine the annual limit, the criterion of three times the limit for each claim indicated in the relevant risk class applies.

The last paragraph of article 4 appears quite cryptic, where it states that the limits regulated by the mentioned article "are restated in relation to the performance of the Guarantee Fund for damages deriving from medical malpractice as regards the hypotheses referred to in art. 14, paragraph 7, letter a)" of the Gelli Law.
The Draft Decree does not provide any indication as to (i) the criteria to be followed to restate the limits on the basis of the Fund's performance and the (ii) frequency that should characterize the mentioned restatement.

Title III of the Draft Decree regulates other means to cover third party and employers' civil liability, that health facilities may adopt as an alternative form – in whole or in part – to insurance coverage, such as the establishment of a specific risk fund and of a claims reserve fund (i.e. direct assumption of the risk).

The Decree also regulates the takeover by the insurance companies in the management of the risks assumed by the healthcare facilities. To this regard, the healthcare facility will cover the risk directly assumed, i.e. the risk that is not covered by insurers until claims are closed.

Moreover, art. 16 of the Draft Decree provides that insurance companies and healthcare facilities will have to comply with the provisions of the decree that will be issued, within 12 months from its entry into force.

The Draft Decree, as said, merely constitutes – as of today – a "draft" and as such it will be subject to further interventions and amendments. Unfortunately we are not aware of when the Decree will be issued, but it can be assumed that, given the number of different institutions involved in the final text drafting process, it will still be necessary to wait a few more months if not next year.


1 The limits for each claim vary from a minimum of 1 million euro to a maximum of 4 million euro.

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.