The European Health Data Space cannot stand without a solid foundation of patients’ rights protection

"The whole framework of the European Health Data Space (EHDS) cannot stand without a solid foundation of patients' rights protection. For this reason, we welcome and commend the Polish institutions for the high political value of their decision to include the topic of patients' rights in the Programme of the Polish Presidency of the Council of the European Union, effectively placing it at the centre of the European political agenda. As highlighted in the recently published White Paper “Healthcare Policy Recommendations”, the commitment to adopt concrete measures toward the official recognition of the European Charter of Patients' Rights - originally drafted in 2002 by Active Citizenship Network together with civil and patients’ organizations from across Europe - marks a pivotal step forward". This was the message delivered by Mariano Votta, Director of Active Citizenship Network, during the celebration of the 19th European Patients’ Rights Day.

Hosted by MEP Brando Benifei (S&D, Italy), the high-level conference took place on 15 May 2025 at the European Parliament in Brussels, under the patronage of the Polish Presidency of the Council of the European Union, and as always, organised by Active Citizenship Network (ACN), the EU branch of the Italian NGO Cittadinanzattiva. [Click Here to access the event programme.]

"The Polish Presidency’s decision is both timely and necessary. Without a unified, standardised framework for patients’ rights across the EU, the European Health Union will remain incomplete, missing its crucial ‘leg of rights’. This also applies for the full implementation of the EHDS, which directly involves core rights enshrined in the Charter: access, innovation, privacy, consent, safety, and personalisation of care."

He concluded, "The European Health Data Space introduces a key principle: data altruism. At ACN, we are committed to advancing this further - moving from 'data altruism' to 'data solidarity', to ensure data serves the public good while respecting patients’ rights."

This high-level event, realized in the framework of the European Year of Digital Citizenship Education, gathered policymakers, patient advocates, researchers, institutions, and industry leaders to explore the transformative potential of health data sharing for patients, healthcare systems, and medical research in the European Union.

The event showcased real-world initiatives - like the IHI FACILITATE project (FrAmework for ClInicaL trIal participants’ daTA reutilization for a fully Transparent and Ethical Ecosystem) on returning individual clinical trial data to participants, the EU-funded PROPHET project on personalized prevention, and Data Saves Lives – addressing concretely ethical, legal, and social implications of and responsible health data reuse, spotlighting the importance of returning value to patients and enabling better healthcare decisions. Emphasis was also placed on privacy and consent frameworks that protect individuals while enabling innovation. In particular, Fulvia Raffaelli, Head of Unit C1 Digital Health, represented the European Commission-DG SANTE, while the EU Parliament was represented by the former EU Health Commissioner MEP Vytenis Povilas Andriukaitis (S&D Group, Lithuania), MEP Tomislav Sokol (EPP Group, Croatia), MEP Brando Benifei (S&D Group, Italy). The last two are co-chairs of the MEP Interest Group “European Patients' Rights & Cross-Border Healthcare” officially presented on the occasion of the Day for its third consecutive term.

Participants discussed the need for the EHDS to create clear rules that support research, uphold patient rights, and ensure data security. The discussions reinforced the importance of involving patients and civil society in EU health policymaking.

The conference was held in the framework of the FACILITATE project and was made possible with the unconditional support of Pfizer, Boehringer Ingelheim, and Viatris. Media partners included Health Europa, TrendSanità-Policy and Procurement in HealthCare and Medvix Publication, publisher of the peer-reviewed Journal of Medical and Clinical Case Reports.

The Polish Commissioner for Patients' Rights, also known as the Patient Ombudsman, gave the honorary patronage to the event.

The initiative builds on a tradition established by the European Charter of Patients’ Rights, drafted in 2002 by Active Citizenship Network together with Civil Society Organizations (CSOs) and Patients’ Advocacy Groups (PAGs) from different EU Member States. Since then, the European Patients’ Rights Day has served as a platform to advance citizens’ involvement in shaping EU health policies.