Medical liability: missing piece in the puzzle of a genuine European Health Data Space

The tragic case of the child who died in Naples as a result of an alleged chain of medical errors is a raw wound that demands deep reflection. In the face of such tragedies, justice for the victims and their families is a necessary and indispensable duty. However, as legislators, we have a duty to ask ourselves whether the current system of medical liability is truly protecting citizens or, on the contrary, ultimately compromising the quality of care. 

European fragmentation: an obstacle to health 

A recent study by the European Parliamentary Research Service (EPRS) confirms just how varied and worrying the situation is. In Europe, contrasting legal systems coexist: on the one hand, “no-fault” models, such as those in Sweden or France, which prioritise swift compensation for the patient without necessarily criminalising the doctor; on the other, systems such as the Italian one, where the pressure of criminal law is ever-present.

This fragmentation is not merely a legal issue; it is a structural constraint. If a doctor works constantly under the threat of legal action, the inevitable consequence is “defensive medicine”. The EPRS study highlights how this phenomenon not only drives up public costs but also deters young professionals from vital specialisms, such as surgery or obstetrics, creating a skills gap that threatens the future of our healthcare system. 

Beyond blame: the European Agency for Clinical Risk 

We cannot simply react to mistakes; we must prevent them. To do so, we need a significant improvement in institutional standards. My proposal is to work towards establishing a European Agency for the Prevention of Clinical Risk.

Just as the EMA currently monitors and mitigates risks associated with medicines at the EU level through systems such as EudraVigilance, we need a structure to collect comparable data on clinical incidents across Member States. A body capable of transforming errors from punitive events into opportunities for collective learning, identifying common best practices for patient safety throughout the Union. 

Artificial Intelligence: opportunities and new safeguards 

The situation is becoming even more urgent with the advent of Artificial Intelligence. As discussed recently in Brussels with leading experts, including Giulio Sozzi, Associate Professor at Saint Camillus International University of Health Sciences in Rome, and Vania Cirese, a lawyer specialising in health law, medical liability, European healthcare systems, and clinical risk management, AI will transform diagnostics and surgery. But without a clear liability framework—one that complements the AI Act and the product liability directives—we risk leaving doctors in legal limbo. Innovation must be supported by rules that clarify the doctor’s role as the final decision-maker and protect them from undue liability arising from non-transparent algorithms. 

Building the European Health Data Space (EHDS) 

The European Health Data Space project cannot be limited to the free movement of clinical data, however fundamental that may be. It must evolve towards the harmonisation of legal safeguards. There must be no “first-class” citizens or “second-class” doctors simply because of the border they operate across.

We must work towards a European system that: 

• Makes a clear distinction between human error and gross negligence, restricting the application of criminal law to cases of genuine intent or gross negligence. 

• Ensures that patients receive prompt and reliable compensation through guarantee funds, thereby reducing the need for lengthy and painful legal disputes. 

• Invest in risk management, ensuring that hospitals are places where safety is the result of shared protocols rather than individual courage alone.

Ensuring that doctors have a peaceful working environment does not mean granting them privileges; it means ensuring that patients receive more attentive, compassionate, and safer care. It is time for Europe to rise to this challenge and make the right to healthcare a uniform and protected reality across the continent.

*Valentina Palmisano is a Member of the European Parliament for laSinistra/M5S