1. What Is the Gelli-Bianco Law and Why Was It Enacted?
In 2017, Italy passed a major healthcare reform: Law No. 24/2017, known as the Gelli-Bianco Law, after its sponsors. The main goal was twofold: on one hand, to reduce defensive medicine, the tendency of doctors to prescribe unnecessary tests or treatments just to avoid medical malpractice lawsuits and on the other, to clarify the liability system in cases of medical error or patient harm.
Before this law, case law generally treated the doctor’s liability as contractual, based on the so-called “social contact” with the patient. In practice, doctors were treated as if they had signed a contract with each patient, even without a written agreement. This favored patients in civil claims but also had side effects: many doctors, fearing lawsuits, practiced with excessive caution or avoided risky but necessary procedures.
The Gelli-Bianco Law sought to restore balance, reducing litigation and allowing doctors to work more confidently.
2. Doctor and Facility: A Dual-Track Liability System
The reform introduced a key concept: the distinction between a doctor’s liability and that of a healthcare facility, whether a public hospital, private clinic, or medical center. From that moment, doctors and institutions were held accountable under two parallel frameworks:
Doctors’ Liability
Doctors are now liable under tort law (Article 2043 of the Italian Civil Code) that states that anyone who causes unjust damage to another is obliged to compensate for it. This means that the patient must prove three things:
(1) the doctor acted negligently,
(2) that there is a causal link between the doctor’s conduct and the damage, and
(3) that the damage actually occurred.
The statute of limitations is five years.
Healthcare Facility Liability
Contractual Law (Article 1218 of the Civil Code): A facility-patient contract, explicit or implicit, is established as soon as the patient is admitted or receives treatment. In this case, the facility must prove it acted properly, and met all professional and organizational standards.
The statute of limitations is ten years.
In short, if something goes wrong during treatment, a patient can take legal action against the doctor, the facility or both but must follow different legal procedures for each.
3. Why the Law Establishes a “Dual Track” System
The new framework is often called a “dual track” system because it provides for two coexisting types of liability: tort liability for doctors and contractual liability for facilities. This model aims to balance interests: protecting patients while shielding professionals from unfounded claims.
Moreover, the legislator wanted to emphasize the primary role of healthcare institutions, now considered directly responsible for everything that happens within their premises.
4. Organizational Fault and Patient Safety
One of the most innovative aspects of the Gelli-Bianco Law is the recognition of organizational fault. This means that a healthcare facility can be held liable not only for doctors’ mistakes but also for broader system failures such as:
- Understaffing or poor coordination,
- Outdated, insufficient or inadequate equipment,
- Lack of safety or hygiene protocols, or
- Ineffective emergency management.
In other words, if a patient is harmed not because the doctor erred, but because the hospital failed to provide adequate resources or support, the liability lies with the facility.
The law therefore promotes a culture of safety, requiring all healthcare facilities to adopt clinical risk management systems. These include ongoing staff training, quality control of medical equipment, and specialized teams dedicated to monitoring and preventing medical errors.
5. Burden of Proof: Who Must Prove What
The Gelli-Bianco reform also clarified how the burden of proof works in medical malpractice disputes:
When suing a doctor: The patient must prove that the doctor acted negligently, that the conduct caused harm, and that the damage is attributable to the doctor. This is a heavier burden than before; it is no longer enough to say “I was treated poorly” – the patient must demonstrate it through expert opinions, medical documentation, and witness testimony.
When suing a healthcare facility: The burden shifts – the hospital or clinic must prove that it complied with all standards, provided qualified staff, and had adequate tools. In this case, the patient is in a stronger position, as they only need to show that harm occurred during hospitalization or treatment.
6. A New Paradigm for Italian Healthcare: A Shift Toward Preventative Healthcare and Shared Responsibility
The Gelli-Bianco Law is not just a regulation on liability, it represents a cultural shift in healthcare. Its underlying message is clear: patient safety is achieved through prevention, not punishment.
For this reason, the law promotes:
- Transparency in reporting adverse events (errors, complications, incidents);
- Ongoing training for doctors in ethics, communication, and risk management;
- Collaboration among hospital administrators, doctors, and patients to build a culture of trust and accountability, rather than one dominated by litigation.
Through this approach, the right to health guaranteed by Article 32 of the Italian Constitution, goes beyond assigning blame. It’s about prevention and partnership, a balance between patient protection and professional peace of mind, while encouraging a healthcare system where safety, transparency, and continuous learning reduce the risk of harm before it occurs. It fosters a system no longer driven by fear of sanctions, but one built on organization, competence, and trust.