The Implementation of the European Charter of Patients’ Rights in Hungarian and Romanian Healthcare Legislation With Special Emphasis on Informed Consent
Author(s)
Árpád Antal, MSc1, Attila Dénes Orbán, MSc2, Kinga Szentendrey, MD2, Eniko Pap, MD2, Áron Csaba Jakab, MSc2, Eniko Fulop, MSc2, Imre Boncz, MSc, PhD, MD3, István Ágoston, JD, PhD4.
1University of Pécs, Faculty of Health Sciences, Pécs, Hungary, 2Doctoral School of Health Sciences, University of Pécs, Pécs, Hungary, 3Institute for Health Insurance, University of Pécs, Pécs, Hungary, 4University of Pécs Faculty of Health Sciences, Pécs, Hungary.
1University of Pécs, Faculty of Health Sciences, Pécs, Hungary, 2Doctoral School of Health Sciences, University of Pécs, Pécs, Hungary, 3Institute for Health Insurance, University of Pécs, Pécs, Hungary, 4University of Pécs Faculty of Health Sciences, Pécs, Hungary.
OBJECTIVES: Patient rights play a decisive role in the healthcare systems of developed countries. The objective of our research was to present and compare the legislation on patient rights in Hungary, Romania, and at the European level, with special emphasis on informed patient consent.
METHODS: The legislative documents examined in this study included the European Charter of Patients' Rights (Rome, 2002), Hungary's Act CLIV of 1997 on Health, and Romania's Law No. 46/2003 on Patients’ Rights. Legal texts were sourced from the Hungarian Collection of Effective Legislation (https://net.jogtar.hu/), Romania’s official legal portal managed by the Ministry of Justice (https://legislatie.just.ro/), and the official legal website of the European Union (https://eur-lex.europa.eu/). The retrieval and analysis of legal documents took place between May and June 2024. A document analysis methodology was applied to explore the emergence and representation of patients' rights within these regulatory frameworks.
RESULTS: Patient rights are regulated differently in each jurisdiction. The European Charter lists 14 rights, Hungarian law defines 9, and Romanian legislation includes 6. All three sources, with minor variations, guarantee the right to: information, consent, data protection, and access healthcare. Specific rights which are different: European Charter: rights to preventive examinations, free choice, timely care, high-quality services, safety, innovation, pain avoidance, the right to complain, and the right to compensation; Hungarian legislation: the right to leave the hospital and the right to human dignity; Romanian legislation: the right to be forgotten and the right to procreation.
CONCLUSIONS: Core rights—information, consent, data protection, and access—form a common European minimum. The European Charter offers broader, patient-centered, and quality-oriented expectations. Hungary emphasizes human dignity, free departure, and patient rights enforcement, while Romania focuses on ethical and reproductive rights.
METHODS: The legislative documents examined in this study included the European Charter of Patients' Rights (Rome, 2002), Hungary's Act CLIV of 1997 on Health, and Romania's Law No. 46/2003 on Patients’ Rights. Legal texts were sourced from the Hungarian Collection of Effective Legislation (https://net.jogtar.hu/), Romania’s official legal portal managed by the Ministry of Justice (https://legislatie.just.ro/), and the official legal website of the European Union (https://eur-lex.europa.eu/). The retrieval and analysis of legal documents took place between May and June 2024. A document analysis methodology was applied to explore the emergence and representation of patients' rights within these regulatory frameworks.
RESULTS: Patient rights are regulated differently in each jurisdiction. The European Charter lists 14 rights, Hungarian law defines 9, and Romanian legislation includes 6. All three sources, with minor variations, guarantee the right to: information, consent, data protection, and access healthcare. Specific rights which are different: European Charter: rights to preventive examinations, free choice, timely care, high-quality services, safety, innovation, pain avoidance, the right to complain, and the right to compensation; Hungarian legislation: the right to leave the hospital and the right to human dignity; Romanian legislation: the right to be forgotten and the right to procreation.
CONCLUSIONS: Core rights—information, consent, data protection, and access—form a common European minimum. The European Charter offers broader, patient-centered, and quality-oriented expectations. Hungary emphasizes human dignity, free departure, and patient rights enforcement, while Romania focuses on ethical and reproductive rights.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
HPR205
Topic
Epidemiology & Public Health, Health Policy & Regulatory, Health Service Delivery & Process of Care
Topic Subcategory
Health Disparities & Equity, Insurance Systems & National Health Care
Disease
No Additional Disease & Conditions/Specialized Treatment Areas