Medical malpractice: the Gelli-Bianco Law of 2017 regulates the liability of doctors and healthcare facilities. Here is how it works.
The doctor–patient relationship, regardless of any formal contract, is based on implicit trust and reliance, which places the doctor in a position of responsibility even in the absence of an express agreement.
Law No. 24 of 8 March 2017, known as the Gelli-Bianco law, reformed the system of healthcare liability in Italy, introducing a legislative framework aimed at ensuring the safety of care, preventing healthcare risks and managing disputes concerning damage compensation.
The underlying purpose of the law is to ensure that patients feel protected and that accessing healthcare is a path to better health rather than a risk. It therefore provides concrete instruments to address situations of medical malpractice.
What Is the Gelli-Bianco law?
In Italy, Law No. 24 of 8 March 2017, known as the Gelli-Bianco law, redefined the professional liability of healthcare practitioners and introduced provisions on the safety of care.
The legislator's main goal was to improve healthcare safety and regulate the liability of healthcare professionals, while also protecting them by providing a clearer legal framework compared with the past.
Although the Balduzzi Decree of 2012 already dealt with medical liability, the Gelli-Bianco Law strengthened and clarified its provisions, eliminating interpretative uncertainties. It focused on protecting patients, while also ensuring greater safeguards for healthcare professionals.
Specifically, the Gelli-Bianco Law introduced Article 590-sexies into the Criminal Code, better defining which guidelines are relevant for excluding liability. These must be published by authorised bodies and suitable for the specific case.
The Balduzzi Decree had excluded criminal liability for minor negligence if the doctor followed guidelines and applied good practices.
Today, doctors have clear guidelines to follow: if they comply, they may be exempt from liability for minor negligence.
In this context, specific insurance policies have become mandatory for healthcare facilities and professionals (something the Balduzzi Decree had only envisaged).
In addition, the Gelli-Bianco Law introduced a compulsory conciliation attempt, which must take place before any legal action can be brought.
Gelli-Bianco: safety of care and patient protection
The Gelli-Bianco Law places the principle of healthcare safety at the centre, as an integral part of the right to health.
This may seem self-evident in a modern society, yet the law intervened to curb the phenomenon of defensive medicine and to provide a clearer framework for medical liability.
Healthcare facilities are required to implement organisational measures and clinical risk prevention protocols, so that patients are increasingly protected.
Within this framework, the role of the Ombudsman for the Right to Health was also introduced, tasked with monitoring and protecting patients in cases of healthcare dysfunctions.
According to the law, doctors and healthcare professionals must follow clearly defined rules:
- Protocol: a rigid scheme, where unjustified deviations entail liability for lack of skill.
- Good practices: behaviours based on scientific evidence and adaptable in different contexts.
- Guidelines: systematised recommendations aimed at optimising care.
Defensive medicine
Defensive medicine refers to the set of medical practices, whether proactive or restrictive, adopted by doctors not for the patient's benefit but solely to protect themselves from potential legal actions (complaints, claims for damages) following alleged or possible errors.
It manifests as:
- Positive defensive medicine: excessive prescription of tests, treatments, or specialist visits.
- Negative defensive medicine: refusal to provide care or tests, even when necessary, in order to avoid legal risks.
The ombudsman for the right to health
Article 2 of Law No. 24/2017 ("Provisions on the safety of care and of the assisted person, as well as on the professional liability of healthcare practitioners") created the figure of the Ombudsman for health, responsible for investigating reports of healthcare dysfunctions.
In cases of medical malpractice, patients may file a complaint with the Ombudsman for the Right to Health, established at the regional and provincial level within the office of the Civil Ombudsman.
The Civil Ombudsman receives, including digitally, documents related to the report and, if it finds the report substantiated, intervenes to protect the infringed right, exercising powers and procedures established by regional or provincial legislation.
Since its use is optional and not all Regions have chosen to adopt it, this remedy is not available to all.
Differences between the Balduzzi Decree and the Gelli-Bianco Law
Here are the main differences between the two laws:
- Before (Balduzzi Decree 2012): doctors were not criminally liable for minor negligence if they complied with guidelines and good practices.
- After (Gelli-Bianco Law 2017): Article 590-sexies of the Criminal Code was introduced, regulating in greater detail cases of non-punishability for lack of skill, removing the distinction between minor and gross negligence.
In summary:
- Criminal liability → linked to lack of skill, assessed on the basis of guidelines.
- Civil liability → distinguished between healthcare facilities (contractual liability) and individual doctors (non-contractual liability).
The main innovations Introduced by the Gelli-Bianco Law
The Gelli-Bianco Law introduced significant changes in medical liability, making doctors liable for gross negligence in cases of damage.
- Official guidelines, which allow doctors to act consistently, may only be drafted by accredited bodies.
- Clearer distinction between the contractual liability of healthcare facilities and the non-contractual liability of healthcare professionals.
- Mandatory conciliation attempt before initiating legal action.
Key areas of reform include:
- Criminal liability
- Insurance obligations and the Guarantee Fund
- The role of healthcare facilities
- Patient protection
Criminal Medical Liability
- Gross negligence liability: a doctor may be punished for manslaughter or negligent personal injury only if the harmful event is attributable to gross negligence, not to minor negligence, provided that guidelines and good clinical practices were followed.
Insurance Obligations and the Guarantee Fund
- Mandatory insurance coverage: healthcare facilities and professionals are required to take out insurance policies covering civil liability towards third parties.
- Guarantee Fund: a Guarantee Fund for Victims of Medical Malpractice has been established to intervene when insurance is insufficient to compensate the patient's damage.
The role of healthcare facilities
- Adherence to guidelines: healthcare facilities are required to adopt adequate tools for monitoring compliance with guidelines and good practices.
- Right of recourse: if the facility compensates the patient, it may seek recourse against the doctor to recover the sums paid, proportionate to the doctor's responsibility.
Patient protection
- Greater certainty and prevention: the law aims to strengthen patient protection, making the healthcare system more attentive to preventing errors and providing greater certainty in the event of damage.
- Access to compensation: with mandatory insurance and the Guarantee Fund, injured patients are always ensured a party to turn to for compensation.
These innovations directly affect malpractice compensation claims, offering patients quicker and more reliable instruments.
Conditions of Admissibility for Compensation Actions
The Gelli-Bianco Law established specific conditions of admissibility for actions seeking damages in cases of medical liability.
The injured party must first attempt a mandatory conciliation procedure, either through:
- Preventive Technical Consultancy (ATP) under Article 696-bis of the Code of Civil Procedure, or
- Mediation under Article 5, paragraph 1-bis, of Legislative Decree No. 28/2010.
These procedures are designed to limit litigation and speed up compensation.
Both are mandatory before a compensation claim can be filed.
Failure to attempt one of these procedures—each of which must be initiated within specific time limits—renders the claim inadmissible. The objection may be raised by the defendant or ex officio by the judge.
If the admissibility condition is not met, the defendant must raise the objection of inadmissibility at the first hearing, otherwise the judge may raise it ex officio.
This requirement does not apply to actions for recourse, which may be brought by the healthcare facility or its insurer against the doctor.
Find out how to claim compensation for medical malpractice in Italy.
Preventive Technical Consultancy (ATP)
In this procedure, the judge appoints a medical panel (a forensic doctor and one or more specialists in the relevant field) to assess the clinical situation and determine the causal link between the conduct and the damage.
The purpose of the consultancy is to facilitate an attempt at conciliation between the parties, which may result in a written record with the effectiveness of an enforceable title.
If conciliation fails, or if the procedure is not concluded within the six months provided by law, ordinary proceedings may be initiated.
Mediation (under Legislative Decree No. 28/2010)
Mediation is a procedure aimed at reaching an agreement between the parties through direct discussion, assisted by a mediator.
It promotes direct dialogue to reach a shared solution, potentially within shorter timeframes.
If mediation fails, the claim may then be brought before the court.
Criminal Liability of Doctors
Under the Balduzzi Decree, criminal liability was excluded for minor negligence, provided that guidelines and good practices were followed.
The Gelli-Bianco Law instead provides for a cause of non-punishability for lack of skill, on the condition that:
- the lack of skill caused the harmful event;
- guidelines (or, in their absence, good practices) were followed;
- the guidelines were suitable for the specific case.
There is no longer a distinction between minor and gross negligence: even in cases of gross negligence, lack of skill may be non-punishable if the above conditions are met.
However, imprudent or negligent conduct remains punishable, regardless of guidelines.
Civil liability of doctors
- Public and private healthcare facilities are obliged to take out insurance covering civil liability towards third parties and their own staff.
- The facility's recourse against the doctor is limited: it may only be exercised in cases of intent or gross negligence, and within a capped amount.
Comparison with the Balduzzi Decree:
- Under Balduzzi, doctors were criminally liable for minor negligence, but civil liability remained even in the case of criminal exemption, and judges had to consider it when awarding compensation.
- Under Gelli-Bianco, a clear distinction is drawn:
- Contractual liability of the healthcare facility: subject to a more favourable burden of proof for patients, with a 10-year limitation period.
- Non-contractual liability of the individual healthcare professional (employee or contractor): subject to a 5-year limitation period.
Healthcare facilities bear the "full control of risk": patients typically sue the facility directly, which may then seek recourse against the doctor in cases of intent or gross negligence.
Liability is divided according to each party's role in risk and control.
Guidelines ensure stronger protection for patients, guaranteeing treatment in line with the best scientific practices.
The Gelli-Bianco Law thus defined the nature of civil liability:
- Healthcare facility → contractual liability (Articles 1218 and 1228 of the Civil Code).
- Individual doctor → non-contractual liability (Article 2043 of the Civil Code), except in cases of a direct contract between doctor and patient.
Damage compensation and the role of insurance
The law refers to the Private Insurance Code, establishing:
- Mandatory insurance policies for healthcare facilities and professionals.
- Recourse by the facility against the doctor only in cases of intent or gross negligence.
This ensures more reliable compensation mechanisms for patients, with faster settlement times.
The Insurance Decree
On 1 March 2024, seven years after the Gelli-Bianco Law was enacted, the implementing decree under Article 10, paragraph 6, concerning insurance, was published in the Official Gazette.
This so-called Insurance Decree finally established the details and requirements for insurance policies covering healthcare facilities and professionals.
Insurers were granted two years to adapt existing policies.
Key provisions of the Decree:
- Insurance coverage: extended to include both contractual liability (towards third parties and service providers) and non-contractual liability of healthcare professionals, including freelance services performed within facilities.
- Coverage limits: minimum thresholds ranging from €1 million to €5 million per claim, depending on the type of facility and activity, adjustable annually based on the performance of the Healthcare Liability Guarantee Fund.
- Alternative forms of coverage: facilities may, by resolution, adopt alternative measures (e.g. self-insurance) but must establish a dedicated risk fund and reserve for compensation.
- Premium variation: premiums may be adjusted at each renewal, based on the facility's actual claims data (frequency and severity), ensuring risk is managed with accurate information and enabling targeted preventive measures.
- Transparency obligations: facilities must disclose data on compensation paid in the previous five years, increasing transparency towards patients.
- "Claims Made" model: coverage applies to claims filed during the validity of the policy, for events occurring during the same period, up to 10 years prior to expiry. This prevents liability for past events, provided the policy was active at the time of the claim.
- Extended run-off cover: insurance protection continues for 10 years after ceasing practice, covering late claims.
- Insurer's right of withdrawal: limited to cases of gross negligence by the insured, proven by a final court ruling.
National guidelines system
The National Guidelines System (SNLG) for clinical practice and public health was established by the Ministry of Health to provide healthcare professionals and caregivers with access to national guidelines.
It is managed by the Istituto Superiore di Sanità (ISS) through the National Centre for Clinical Excellence, Quality and Patient Safety (CNEC).
SNLG guidelines serve as the benchmark for assessing the correctness of medical conduct and establishing liability.
Difference between individual medical liability and healthcare facility liability
The law clearly distinguishes:
- Healthcare facility liability → contractual, with a 10-year limitation period.
- Doctor's liability → non-contractual, with a 5-year limitation period, unless a direct contract exists with the patient.
Compensation for foreign patients in Italy
The Gelli-Bianco Law applies to all patients receiving healthcare in Italy, regardless of nationality or residence status.
It regulates the civil and criminal liability of healthcare professionals and facilities operating in Italy.
If a foreigner (tourist, worker, student, temporary resident, returning emigrant, or medical tourist) suffers harm due to malpractice in Italy, they may invoke the same protections as Italian citizens, including in the event of death.
This is because the rights to health and compensation derive from Article 32 of the Constitution and from general principles of civil and criminal liability, which do not distinguish between Italians and foreigners.
Civil liability
- Healthcare facility (hospital, clinic, local health authority, accredited practice): contractual liability (10-year limitation).
- Healthcare professional (doctor, nurse, specialist): non-contractual liability (5-year limitation).
This means that a foreign patient may sue the facility directly in Italy. The facility may in turn seek recourse against the doctor only in cases of intent or gross negligence.
Legal remedies available under the law
- Mandatory mediation: patients must attempt mediation before starting civil proceedings.
- Direct action against the insurer: allows patients to claim compensation even if the facility is insolvent or uninsured.
- Guarantee Fund: covers malpractice damages that cannot be compensated due to insolvency or lack of coverage.
Foreign patients and access to justice
Foreign nationals enjoy the same right as Italians to initiate civil or criminal proceedings in Italy.
Possible difficulties are practical in nature:
- translation of medical records and documents;
- international notifications if the patient returns to their home country;
- coordination with foreign insurers, if the patient had private or travel health insurance.
Jurisdiction and compensation
- Jurisdiction: Italian courts are competent, as the wrongful act occurred in Italy.
- Compensation: calculated under Italian criteria (tables of the Milan or Rome courts), even if the patient resides abroad.
Potential conflicts of private international law may arise during enforcement, but EU treaties and international conventions facilitate recognition and recovery abroad.
Legal assistance in cases of medical liability
Dealing with a case of medical malpractice is never easy, not even on a personal level. For this reason, it is essential to rely on a professional who can provide advice and guidance.
Boccadutri Law Firm assists patients and families at every stage of the process:
- medical-legal assessment of the case;
- initiation of mediation or court proceedings;
- international support, with multilingual consultancy and offices in various cities worldwide.
Thanks to our experience, we can help you obtain the maximum compensation available.
If you believe you have suffered harm due to medical malpractice, contact the international Boccadutri Law Firm for tailored advice: our lawyers are ready to listen to you and protect your rights.
FAQs on the Gelli-Bianco Law
In which cases does the Gelli-Bianco Law apply?
It applies to all cases of alleged healthcare liability, both civil and criminal, whenever a patient suffers harm attributable to medical errors or omissions. It covers both Italian and foreign patients treated in Italy.
What are the main differences between the Balduzzi Decree and the Gelli-Bianco Law?
The Balduzzi Decree (2012) excluded criminal
liability for minor negligence if the doctor complied with
guidelines and good practices.
The Gelli-Bianco Law (2017) introduced Article
590-sexies of the Criminal Code, which more precisely regulates
non-punishability for lack of skill, removed the distinction
between minor and gross negligence, and established clear rules on
both civil and criminal liability.
What changes for those who want to claim compensation from a hospital or healthcare facility?
The patient may act directly against the facility, which is contractually liable with a 10-year limitation period. The doctor is liable on a non-contractual basis with a 5-year limitation, unless intent or gross negligence is involved. This simplifies matters for the patient, who has more guarantees of obtaining compensation.
Is a medico-legal assessment mandatory?
Yes. Medico-legal consultancy is essential to establish the causal link between the healthcare conduct and the damage suffered. It is required in both mediation and preventive technical consultancy (ATP) procedures, which are mandatory conditions before filing a civil lawsuit.
Does the Gelli-Bianco Law provide for a mandatory conciliation attempt?
Yes. Before bringing an action, it is mandatory to attempt mediation or preventive technical consultancy. These procedures reduce litigation and favour faster compensation.
What insurance obligations were introduced by the Gelli-Bianco Law?
Healthcare facilities and professionals must take out compulsory insurance to cover civil liability. A state Guarantee Fund also intervenes in cases where insurance is insufficient to cover patient damages.
Does the Gelli-Bianco Law also protect foreign patients?
Yes. The law applies to all patients treated in Italy, regardless of nationality or residence. Foreigners have the same rights as Italian citizens to bring legal action and obtain compensation.
How is compensation calculated in cases of medical malpractice?
Compensation is determined according to Italian criteria, using the tables of the Milan or Rome courts. Both economic damages (medical expenses, loss of income) and non-economic damages (biological and moral damage) are compensable.
What should a patient who believes they are a victim of malpractice do?
They should collect medical records, contact a lawyer specialising in medical liability, have the case assessed by a forensic doctor, and initiate mediation or ATP. In this process, the support of an experienced law firm is crucial to obtaining maximum compensation.
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.
