Intended for healthcare professionals


Italy recognises patient safety as a fundamental right

BMJ 2017; 357 doi: (Published 22 May 2017) Cite this as: BMJ 2017;357:j2277
  1. Tommaso Bellandi, deputy director1,
  2. Riccardo Tartaglia, director1,
  3. Aziz Sheikh, professor of primary care research and development, co-director2,
  4. Liam Donaldson, professor of public health3
  1. 1Centre for Clinical Risk Management and Patient Safety, Florence, Italy
  2. 2Centre of Medical Informatics, Usher Institute of Population Health and Informatics, University of Edinburgh, UK
  3. 3London School of Hygiene and Tropical Medicine, London, UK
  1. tommasobellandi{at}

A new law takes a bold step towards enhancing patient safety

On 8 March 2017 Italy enacted a new law on patient safety and health professionals’ responsibilities.1 It begins by recognising that “Patient safety is a fundamental right of each individual within any healthcare service and it is a primary goal of the national healthcare service.” This is a bold step, by a G8 country, towards the goal of reducing avoidable harm in healthcare.

National and regional patient safety programmes started in Italy around a decade ago. The first step towards the new law was an agreement between the national government and the regions in 2008, which required the establishment of a patient safety incident reporting system in each hospital; a local and regional clinical risk management function; and the creation of a national repository of safety practices. The second step, a year later, was the introduction of mandatory monitoring of sentinel events and claims, a key component of the legislation.

An assessment of the economic burden of unsafe care was another driver of the new law. Compensation attributable to adverse events in Italy amounts to around €1 billion (£843m; $1.1bn) each year.2 An estimated additional €10bn a year is spent on defensive medical practices (around 10% of the total national healthcare expenditure of €112bn).3

The new law establishes three fundamental principles: first and foremost, it recognises that safety is a right for everyone accessing health services. Secondly, the law establishes that, if guidelines and safe practices recognised by Italy’s Istituto Superiore di Sanità (National Institute of Health) have been followed, a healthcare professional is protected from prosecution even if there is an adverse outcome; finally, action against healthcare professionals will be possible only in cases of malice or gross negligence.

The intervention of the courts in cases of medical error and avoidable harm has caused widespread concern internationally. It contributes to “blame culture” and may lead to patient harm through defensive practices.4 The new law helps to create a safe space for clinicians where “the minutes and the documents resulting from the management of clinical risk cannot be acquired or used as part of legal actions against healthcare professionals.”

However, the retention of the potentially ambiguous term “gross negligence” as grounds for action has led to healthcare professionals in other jurisdictions being convicted of manslaughter in circumstances that many would see as system failures.56 Also, uncritical emphasis on compliance with clinical guidelines may be seen as an indirect way of limiting clinical freedom or patient preference when, for example, trying to personalise care through shared decision making. The Italian law seeks to balance support for evidence based practice with collaborative personalised care.7 It recognises that clinical management may deviate from the relevant guidelines in the best interests of an individual patient. This is especially important where rigid adherence to guidelines could potentially harm a patient.

The new law also broadens the professional and scientific base for involvement in the prevention of harm. It states that the coordinating role in risk management can be undertaken by doctors and other employees of health facilities (such as psychologists, sociologists, engineers, nurses, or pharmacists) if they have adequate training and at least three years’ experience.

An important limitation is the missed opportunity for fuller involvement of patients and families—for example, the role that they could play in incident reporting and in the development of guidelines and safety practices. Nothing is said about improving communication between patients and health professionals, despite communication failures being a leading cause of adverse events and litigation. Italy is still far from patient centred in its approach to informed consent and clinical pathways, as reported by the European Health Consumer Index.8 Also, the public authorities responsible for incident reporting systems and the monitoring of safety practice should have had their independence from hospital management and other health systems established.9

After Denmark in 2004,10 Italy is only the second country to have a comprehensive law on patient safety, bringing together patients’ rights to safe care, transparency of processes and outcomes, and fair compensation in case of harm, with the protection of health professionals’ liability when they comply with guidelines and safe practices, as well as a safe space for reporting and learning from adverse events. Other countries, such as the US, have separate acts for adverse events reporting11 and liability protection,12 while in most countries patient safety is simply part of national programmes or policies and not covered by a specific, comprehensive law (for example Australia, Brazil, Canada, France, Germany, Spain, and the United Kingdom).

More than 25 years after the Harvard Malpractice Studies first focused international attention on the iatrogenic harm to patients1314 it is encouraging that the Italian government has committed itself to enhancing patient safety, with a law endorsed by leading scientific societies and patients’ associations. It is important that the impact of this new legislation is carefully evaluated—both anticipated and unanticipated consequences—and that other countries consider following suit with their own legal initiatives to advance patient safety.


  • Not commissioned, peer reviewed

  • We have read and understood the BMJ Group policy on declaration of interests and declare the following interests: Tommaso Bellandi gives occasional paid lectures for a commercial company offering training in patient safety


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