EU directive on patients' rights to cross border healthcare
Authors: D. Horgan, D. Byrne, A. Brand
Journal: BMJ (2013)

The European Union’s latest bid to improve healthcare—the directive on patients’ rights in cross border care—provides a graphic demonstration of just how far Europe remains from any real coherence on health policy and on innovation. 2 The new rule is designed to clarify and reinforce citizens’ rights to choose where to seek medical treatment, and in what circumstances. But when it came into effect in October 2013, even the European health commissioner was unable to announce anything more than a theoretical achievement. “From today, all EU countries should have transposed” the directive into their national law, said Tonio Borg. The reality, as his officials were obliged to admit, is that few of the 28member states had actually done so 30 months after the EU agreed to the rule. The directive’s effectiveness depends on collaboration by member states at EU level. But such collaboration is in short supply when the EU tackles many aspects of health—a deficiency that threatens to turn this well intentioned initiative into a hollow gesture. As a result, the opportunities for patients to take advantage of the new measure are limited. The legislation could enable a shift away from national isolationism in health. The new rules are intended to make the EU’s famed internal market work for health for the first time, by strengthening the freedoms relating to movement of goods, people, and services. The vision is that patients could move around Europe to access safe and high quality cross border healthcare, accompanied by the free flow of their health data from one country to another. The technical provisions—if compliedwith—would also amount to a small revolution. Each country is meant to establish a national contact point that provides specified information to the public on care services and costs, so that citizens can make informed choices about where to seek care. “In order to ensure safe, high-quality and efficient cross-border healthcare,” new links are meant to be forged across borders between healthcare providers, purchasers, and regulators. Other explicit objectives include the development of European reference networks, especially for rare diseases, and interoperable e-health solutions. New “sustained structures” for cooperation on the evaluation of new health technologies could also “provide a better evidence base for optimal use of new technologies.” The directive also underlines that “a high level of human health protection is to be ensured in the definition and implementation of all union policies and activities.” In an ideal world this should provide new support for medical advances in EU policies on research, cohesion, competition, industry, and intellectual property. If only! It is nearly 50 years since the EU adopted its first legislation on drugs, but despite dozens of subsequent directives, regulations, and decisions, covering many thousands of pages, EU law remains a patchwork quilt of distinct policies on the conditions that underpin innovation and access. An attempt launched last year to bring clarity, and greater speed, to national mechanisms for pricing and reimbursement of drugs is now virtually condemned to extinction with the end of the current mandate of the European parliament next April. The blame lies not only with the current economic challenges facing member states but also with national insistence on retaining national methods. A parallel initiative to update and streamline the EU’s cumbersome rules on clinical trials is now similarly hanging by a thread in difficult negotiations between members of the European parliament and member states, again determined to retain their own ways of doing things. The accessibility of trial results has emerged during discussions about transparency in healthcare and the inequalities of patients’ access to treatments in different member states. This has led to calls by stakeholders for easily understood summaries of trial results to be made public through an EU database. Meanwhile, a contentious measure aimed at defending the privacy of European citizens from incursions by social media and search engines threatens to wrap personal medical information in such a complex web of data protection rules that it could inadvertently sabotage health research. This would have