Introduction

Law 24/2017 (on rules regarding the safety of treatments and patients and medical malpractice) was approved on March 17 2017.

In addition to setting out the legal scope for the safety of medical treatments and patients, the law provides the scope for imposing an effective risk management policy on healthcare personnel and prescribes risk allocation standards in the case of damages arising from medical treatments.

The law aims to:

  • clarify liability for healthcare organisations (eg, hospitals and health and social care facilities) and healthcare professionals, with the exception of cases where agreements are reached with patients directly; and
  • build an efficient protection system for at-risk patients through the introduction of effective and mandatory insurance policies.

With regard to the criminal liability of medical staff, Article 6 of Law 24/2017 establishes new provisions for involuntary manslaughter (Article 589 of the Penal Code) and involuntary injury (Article 590 of the Penal Code) that result from medical malpractice. It also provides for situations of impunity when these events occur despite the guidelines being followed (Article 5).

Civil liability of medical staff and services

Article 7 of Law 24/2017 establishes key provisions for the civil liability of medical staff and services. It provides for a double regime of civil liability: on the one hand, it refers to the contractual liability – pursuant to Articles 1218 and 1228 of the Civil Code – of public and private healthcare and freelance healthcare professionals who reach agreements with patients directly. On the other hand, it refers to the liability, pursuant to Article 2043 of the Civil Code, of healthcare professionals who are employed by medical organisations, but do not reach agreements with patients directly.

Therefore, the liability of medical staff is now considered non-contractual liability, with all favourable consequences for staff relating to the term of action and the burden of proof.

Under the law, damages are based on compensation for non-economic injuries, as set out in the Code of Private Insurance. Contractual liability for private and public healthcare is determined pursuant to Articles 1218 and 1228 of the Civil Code. Article 9 of Law 24/2017 limits the right of medical services to reimburse medical staff in the case of fraud or serious negligence to triple their total annual salary.

Insurance system

Article 10 of Law 24/2017 concerns mandatory insurance at the expense of those responsible for compensating damages suffered by patients (ie, private or public healthcare and staff). The law provides for the possibility of self-insurance for healthcare services (with limitations). Another new provision concerns the potential for damage claimants to commence action directly against an insurance company.

New procedure

Under Article 8 of Law 24/2017, patients who claim damages must commence a preventive expert testimonial proceeding pursuant to Article 696bis of the Civil Code before a competent judge or initiate mediation proceedings pursuant to Article 5(1)bis (Law of March 4 2010/28). Further, participation in proceedings is mandatory for all parties, including insurance companies.

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For further information on this topic please contact Costanza Mariconda at Mariconda e Associati Studio Legale by telephone (+39 02 795 212) or email (costanza.mariconda@studiomariconda.com). The Mariconda e Associati Studio Legale website can be accessed at www.studiomariconda.com.