The appearance of several cases in the European Court of Justice dealing with the requests of European citizens claiming the reimbursement of cost for healthcare services received in other MS than their MS of affiliation, most famously the Kohl and Decker case in 1998 and the Watts case in 2006, created the need for a European legal framework on planned cross-border healthcare.
Thus, after a consultation on the issue, the European Commission adopted a proposal for a Directive on «the Application of Patients’ Rights in Cross-border Healthcare» in 2008, which was voted in the European Parliament on 19th of January 2011 and published as Directive (2011/24/EU) in the Official Journal of the European Union on 4th of April 2011, with a transposition date for MS the 25th of October 2013.
The Directive covers all healthcare services provided by health professionals to patients to assess, maintain and restore their health, including the prescription and dispensation of medical products and medical devices. Services of long-term care to support people in their daily routines, organ transplants or national vaccination campaigns are excluded.
Main Aims of the Directive:
The Directive clarifies patients’ rights to access safe and good quality treatment across EU borders, and be reimbursed for it. Its main aims are the following:
1. The provision of clear rules and reliable information to patients for exercising their rights to access and reimbursement for healthcare received in another EU Country.
2. The provision of information on safety and quality of cross- border healthcare to the patients, which will enable them to make informed choices before going abroad for healthcare.
3. The establishment and assurance of formal cooperation between health systems.
4. The strike of the right balance between maintenance the sustainability of health systems while protecting patients’ right to seek treatment outside their home country.
Main Provisions of the Directive:
The Directive includes provisions that will enable the application of patients’ rights on a cross border perspective, the main of which are as follows:
1. Information to Patients: Setting up National contact points, which will enable patients’ make informed decisions through the provision of information on rights, entitlements, reimbursement, quality and safety standards, healthcare providers and restrictions on their right to practice, appeal and complaint procedures, mechanisms for seeking remedies and legal and administrative options to settle disputes, contact details of National Focal Points in other MS, accessibility of hospitals for persons with disabilities.
2. Reimbursement of cross-border healthcare: Member states are required to provide clear information to patients on what care is reimbursed and to what levels.
3. Prior authorization: certain cross-border healthcare may be subject to prior authorization by the Member-State of affiliation, which is obliged to put in place a system of prior authorization with precise list of health services that are subject to prior authorization.
4. Administrative procedures: the Directive sets rules for administrative procedures linked to cross-border healthcare, and in particular for reimbursement, prior authorization requests and submission of complaints. The information on these procedures shall be made publicly available.
5. Safety, quality and continuity of care: cross-border healthcare has to be provided to patients in accordance with the quality and safety standards and guidelines in place in the MS of treatment. For the reason of continuity, patients who have received treatment in another MS are entitled to a record of the treatment and prescriptions issued abroad must be recognized in accordance to the Implementing Directive 2012/52/EU on «laying down measures to facilitate the recognition of medical prescriptions issued in another MS».
6. Patients with rare diseases: the Directive contains provisions to address rare diseases and the Commission will support MS in cooperating with each other to develop better capacity for the diagnosis and treatment of rare diseases through European Reference Networks.
7. Cooperation between health systems: the Directive includes provisions which enrich the cooperation among National Health Systems, through European Reference Networks, Health Technology Assessment and e-Health. Specifically, the provisions on European Reference Networks will bring together specialized centers across Europe helping health experts to disseminate information and expertise; the provisions on Health Technology Assessment introduce a permanent EU structure of cooperation to help decision-makers to make the right decisions on health investment and spending; and the provisions on e-Health consist a first step towards «interoperability» of ICT for health at EU level for safety and quality of care, continuity of care and health research.