As highlighted in the recently published White Paper “Healthcare Policy Recommendations” [3], the commitment to adopt concrete measures toward the official recognition of the European Charter of Patients' Rights [4]-originally drafted in 2002 by Active Citizenship Network [5] together with civic organizations from across Europe-marks a pivotal step forward. This was the message delivered in occasion of the celebration of the 19th European Patients’ Rights Day [6].

Figure 1: The Save The Date Realized In The Occasion Of The Annual Celebration At The EU Parliament Of The European Patients’ Rights Day, 15th May, 2025.

Hosted by MEP Brando Benifei (S&D, Italy) [7], 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 [8].

Figure 2: The Honorary Patronage Gave By the Polish Commissioner for Patients' Rights, Also Known As the Patient Ombudsman, To the Event Organized At the EU Parliament by Cittadinanzattiva-Active Citizenship Network.

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 it’s crucial ‘rights pillar’. This also holds for the full implementation of the European Health Data Space, which directly involves core rights enshrined in the already mentioned European Charter of Patients' Rights [9]: access [10], innovation [11], privacy [12], consent [13], safety [14] and personalisation of care [15].

This high-level event, realized in the framework of the European Year of Digital Citizenship Education [16], 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 [17] on returning individual clinical trial data to participants, the EU-funded PROPHET project [18] on personalized prevention, and Data Saves Lives [19] – 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) [20], MEP Tomislav Sokol (EPP Group, Croatia) [21], 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 [22].

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. In particular, Civil Society Organizations (CSOs) and Patients’ Advocacy Groups (PAGs) agreed about the need to move from the key principle “data altruism” - officially introduced by the EHDS - to “data solidarity”, to ensure data serves the public good while respecting patients’ rights.

Each of the authors confirms that this manuscript has not been previously published by another international peer-review journal and is not under consideration by any other peer-review journal. Additionally, all of the authors have approved the contents of this paper and have agreed to the submission policies of the journal.

Authors’ contribution

Each named author has substantially contributed in managing the described initiative and drafting this manuscript.

Conflict of interest

To the best of our knowledge, the named authors listed on the first page declare that they do not have any conflict of interest, financial or otherwise.

Acknowledgements

The conference at the EU Parliament was made possible thanks to the EU-funded project FACILITATE (FrAmework for ClInicaL trIal participants' daTA reutilization for a fully Transparent and Ethical Ecosystem) and 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.

1. Digital transformation for better health and well-being in the European Region. Int J Med Inform. 2025.
2. Digital transformation for better health and well-being in the European Region. 2025.
3. Polish presidency of the council of the european union 2025. White Paper: Healthcare Policy Recommendations. 2025.
4. Cittadinanzattiva-active citizenship network: European Charter of Patients' Rights. Rome, November. 2002.
5. Active Citizenship Network is part of the Cittadinanzattiva APS legal entity and is one of the most widespread and flexible European networks which - in the recent years - has been able to involve in its initiatives hundreds of civic, patient and users' organisations coming from European and extra-European countries.
6. European Parliament, Brussels (Belgium)-Exploring the benefits of health data sharing for patients, healthcare systems, and medical research at the EU level. 2025.
7. Benifei B. Group of the progressive alliance of socialists and democrats in the european parliament.
8. Votta M, Vitale M, Morreale ME, Ferraiolo B. First civic survey on health personnel in italy. on the front line but in the shadows: behind the scenes of the national health service. 2024; 6.
9. European charter of patients' rights. 2022.
10. The patients’ right of access.
11. The patients’ right to innovation.
12. The patients’ right to privacy and confidentiality.
13. The patients’ right to consent.
14. The patients’ right to safety.
15. The patients’ right to personalized treatment.
16. Council of Europe: European Year of Digital Citizenship Education. 2025.
17. Pedro AA. Methodologies on collection and use of patient experience data for medicines’ regulatory assessment. 2022.
18. Project funded by the European Union.
19. Data Saves Lives is a multi-stakeholder initiative. Start-up funding for the initiative has been provided by the European Federation of Pharmaceutical Industries and Associations (EFPIA) and EIT Health as an unrestricted educational grant.
20. Andriukaitis VP. Group of the progressive alliance of socialists and democrats in the european parliament.
21. Tomislav Sokol. Group of the european people's party (Christian Democrats).
22. MEPs Interest Group. European Patients' Rights and Cross-border Healthcare.