Ten years into the Cross-Border Health care Directive: unfulfilled promises and future pathways

person on wheelchair

Why has the ambitious EU Directive on Cross-Border Health care failed to ensure the rights of every person living in Europe, and in particular people with rare diseases – and where do we go from here?

This year marks the tenth anniversary of the adoption of the EU Directive on patients’ rights in cross-border health care.

To provide a response reflecting the position of the rare disease patient community in Europe, EURORDIS-Rare Disease Europe carried out extensive consultation with people living with a rare disease and patient advocates through EURORDIS’ survey programme Rare Barometer Voices and webinars, including online consultations with Rare Disease National Alliances, European Federations, and patient advocates in European Reference Networks.

From the individual stories to the general reflections, the inputs that we had received brought us to the conclusion that ten years after its entry into force, the Directive has failed in its mission to facilitate access to safe and high-quality cross-border health care and promote patient rights abroad.

And here are three reasons why:

  • The burden of accessing cross-border health care weighs heavily on the patient

To access cross-border health care, the patient is responsible for overcoming many of the bureaucratic and financial obstacles, such as the transfer of highly complex medical records and data abroad or the need to pay upfront for the treatments for which they may not even be reimbursed. But, more importantly, few people with rare diseases, nor their healthcare professions, are even aware that accessing health care abroad is an option due to a lack of adequate information about their conditions and mechanisms to access knowledge to support them. [1]

  • The best interests of people with rare diseases are not put first

One of the most cited barriers to accessing healthcare in another country was imposed by clinicians or competent national bodies in the home country, who refused to accept that better treatment or expertise may be available elsewhere, even when peer-reviewed literature proved the opposite. The legal certainty of accessing healthcare in another EU country is very weak, leaving the granting of patients’ rights extremely unpredictable and varying significantly from one Member State to another. Prior authorisation, the approval needed from the patient’s Member State to access healthcare varies significantly, meaning some patients face unjustified obstacles from national authorities or responsible health insurers. As such, people living with a rare disease experience an exacerbated vulnerability in the healthcare systems in addition to those caused by their conditions.

  • An adjusted ambition of European Reference Networks 

European Reference Networks, a critical pillar of the Directive, are one of the greatest achievements that the rare disease community has ever accomplished, bringing together hundreds of experts and offering a 'once-in-a-lifetime' opportunity to drive forward improvements in healthcare systems capacities and capabilities in the field of rare diseases and allow expertise to travel when patient travel is not required. However, in the past four years, the Networks have had to adjust their ambition, to a large extent due to the level of investment that they have received, resulting in its inability to deliver high-quality, accessible, and cost-effective healthcare for all rare disease patients and help Member States with insufficient numbers of patients or expertise to provide highly specialised services of high quality. 

The revision of cross-border health care coupled with a bigger, overall legislative reform

We have a unique opportunity to reconsider and redesign, where necessary, the policy and legal framework for access to cross-border healthcare in Europe to ensure it is delivering for all people living with a rare disease. EURORDIS has set out clear recommendations to be considered in any future revision or redesign of the Directive. These include:

  1. Improved process of accessing healthcare in another country, e.g. by defining EU-wide guidelines for competent national authorities and addressing the accessibility of treatments through a single European pathway;
  2. Sustainable and consolidated European Reference Networks, through, for example, their integration into national health systems and greater investment to enable ERNs to operate more flexibly and effectively;
  3. A whole-system response to meet the rare disease patient population’s evolving needs to overcome fragmentation and inequalities in access;
  4. Adoption of Europe’s Action Plan for Rare Diseases, an overarching, cohesive framework to address the remaining unmet needs and inequities all along the patient journey and leave no one living with a rare disease behind.

Cross-border healthcare is a system that needs to work for people living with a rare disease. And while the review of the current state of the Directive is in itself a significant development, it should not be decoupled from the overall revision of the rare disease strategy, as echoed by the EU Court of Auditors report and acknowledged by the Commission in the same document.

We encourage EU policy makers to turn this review into a proposal of concrete actions and measurable goals with uniquely high community added value to facilitate access to safe and high-quality cross-border health care and meet the high unmet needs of people living with a rare disease in Europe.

[1] Rare Barometer Voices, "The future of rare diseases: Leaving no one behind!"

 


Stanislav Ostapenko, Communications Manager, EURORDIS

Page created: 16/09/2021
Page last updated: 16/09/2021
 
 
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