Ethical assessment of the EU health policy under the Directive 2011∕24∕EU: approaching patients' rights and cross-border healthcare.

PURPOSE: The purpose of the present article is to discuss the ethical challenges of the European Union (EU) health legislation framing the patients' rights and the cross-border healthcare (CBHC). BACKGROUND: The paper reviews the EU main legislation in the field, namely the Directive 2011∕24∕EU (CBHC Directive) of the European Parliament and of the Council of 9 March 2011, on the application of patients' rights in CBHC. CONTENT: The aim of the study is to analyze the patients' rights and the CBHC, enhancing the healthcare support and coordination under this regulatory framework. An exploratory and descriptive analysis will be conducted based on these legal provisions by focusing the ethical choices, the ethical duty, the ethical reasons and the patients' rights. An introductory literature overview will be provided and an analysis of the recent data reports published by the European Commission (EC) on the application of the CBHC Directive will be detailed. Therefore, six main themes emerged: (i) the protection of the patients' rights; (ii) the examination of the ethical challenges to address the EU public health issues; (iii) the monitoring of the data reports on the operation of the CBHC Directive; (iv) the reimbursement of costs of CBHC; (v) the European reference networks (ERNs); (vi) the eHealth network and the health technology assessment (HTA). CONCLUSIONS: The paper reviews the existing legal framework aimed to support the Member States (MS) in achieving a harmonized implementation of the CBHC Directive. Hence, particular ethical issues will be developed under this regulatory framework.