Access to cross-border health care services for patients with rare diseases in the European Union

• Published in: Orphan drugs Vol. 4; p. 39
• Main Authors: Aagaard, Lise, Kristensen, Kent
• Format: Journal Article
• Language: English
• Published: Macclesfield Dove Medical Press Limited 01.01.2014; Taylor & Francis Ltd
• Subjects: Care and treatment; Case law; Costs; Drugs; Economic aspects; Health care industry; Health care policy; Hospitals; International aspects; Legislation; Medical diagnosis; Orphan drugs; Patients; Public health; Rare diseases; Regulation; Europe; Denmark
• ISSN: 2230-6161; 2230-6161
• DOI: 10.2147/ODRR.S58268

Directive 2011/24/EU may give patients in European Union (EU) member states the right to receive cross-border health care services in other member states reimbursed by their member state of affiliation. For patients with rare diseases, these patient rights could be of relevance, since diagnosis and treatment of rare diseases often requires specialized medical expertise that may not be available to patients in their member state of affiliation. Interpretations of directive 2011/24/ EU, and European case law showed that patients with rare diseases traveling to another member state with the sole purpose of requesting health care services are entitled to have their medical expenses reimbursed by their member state of affiliation if the national health care system cannot provide the required and necessary treatment on its territory within a time limit that is medically justifiable. The decision will be based on an objective medical assessment of the patient's medical condition, the patient's illness, and degree of the patient's pain or the nature of the patient's disability. For inpatients, prior approval from the patients' health insurance system is required. For outpatients, presumably no prior approval is required. However, if outpatient treatment involves the use of expensive equipment and medicines, such as orphan drugs or special training of the medical staff, the member state of affiliation can probably require prior authorization, but this issue remains unanswered. Member states are free to operate with national medication lists with different degrees of reimbursement. For orphan drugs not being reimbursed nationally, member states of affiliation are not obliged to pay for the treatment in another member state. Since directive 2011/24/EU was to be fully implemented in national law by October 2013, experience with this legislation is limited, and therefore future studies of the impact of the legislation on patients' rights in cross-border health care must be conducted. Keywords: orphan drugs, rare diseases, European Union, cross-border health care