EU Medical Law
The EU Competence in Health
Article 168 of the Treaty on the Functioning of the European Union (TFEU) confers on the EU a limited competence in public health. The Union may complement, coordinate, or support national health policies while respecting the member states’ responsibility for the organisation and delivery of health services and medical care. Article 168 expressly excludes any harmonisation of national health laws. EU action nevertheless significantly affects health through internal market legislation, including the regulation of pharmaceuticals, medical devices, and cross-border health care, as well as through the Charter of Fundamental Rights, Article 35 of which recognises the right to access preventive health care.
Cross-Border Health Care
The Directive on Patients’ Rights in Cross-Border Healthcare 2011/24/EU establishes the right to receive health care in another member state and to be reimbursed up to the level of coverage in the home state. Hospital care and highly specialised care require prior authorisation, while other care may be reimbursed directly. The directive clarifies the responsibilities of the member state of treatment and the member state of affiliation. The European Health Insurance Card (EHIC) entitles holders to necessary medically necessary care during temporary stays in other member states.
CJEU Jurisprudence
The Court of Justice of the European Union (CJEU) developed the right to cross-border health care before the directive. In Kohll v Union des Caisses de Maladie (Case C-158/96, 1998) and Decker v Caisse de Maladie (Case C-120/95, 1998), the Court held that prior authorisation requirements for non-hospital care outside the home state violated the free movement of services and the free movement of goods. In Watts v Bedford Primary Care Trust (Case C-372/04, 2006), the Court confirmed that the right to cross-border health care under Article 56 TFEU extends to hospital care, subject to the requirement of prior authorisation where justified by overriding reasons of general interest.
Regulation of Medicinal Products
The European Medicines Agency (EMA) administers the centralised authorisation procedure, which is mandatory for innovative drugs, orphan medicinal products, and certain other categories. A single authorisation is valid in all member states. The mutual recognition procedure and the decentralised procedure apply to other products, with coordination by the Co-ordination Group for Mutual Recognition and Decentralised Procedures (CMDh). Clinical trials are governed by Regulation 536/2014, which harmonises authorisation and reporting requirements through the Clinical Trials Information System (CTIS). Orphan medicinal products benefit from incentives under Regulation 141/2000, including market exclusivity. Paediatric medicines are regulated under Regulation 1901/2006, requiring paediatric investigation plans for new products.
Medical Devices
The Medical Devices Regulation (MDR) 2017/745 and the In Vitro Diagnostic Medical Devices Regulation (IVDR) 2017/746 replaced the previous directives, introducing stricter pre-market assessment, enhanced oversight of notified bodies, and increased transparency through the European Database on Medical Devices (EUDAMED). The regulations reclassify many devices into higher risk categories and require clinical evidence for conformity assessment.
Health Data and GDPR
The General Data Protection Regulation (GDPR) 2016/679 applies specifically to health data, which constitutes a special category of personal data under Article 9. Processing of health data is generally prohibited unless an explicit legal basis applies, including explicit consent, the provision of health care, public health reasons, or scientific research. Member states may introduce further conditions and limitations. The GDPR grants data subjects rights of access, rectification, erasure, and data portability regarding their health data.
European Reference Networks
The Directive 2011/24/EU established European Reference Networks (ERNs) for rare and complex diseases. ERNs bring together specialised health care providers across Europe to pool knowledge, develop diagnostic and treatment guidelines, and facilitate cross-border consultations. The ERN framework enables the exchange of patient data for clinical purposes within the GDPR framework and promotes equity of access to highly specialised care.