by Dr Claire Skentelbery, Director General, EuropaBio, and
Adrien Samson, Healthcare Biotechnology manager, EuropaBio

Adam is a 76-year-old Polish citizen who suffers from the late-stage Alzheimer and travels once a month to Germany for an advanced treatment. This treatment, which is not available in his country allow him to respond better to the environment, carry on a conversation with his family, and at least partially to control his movement.

He is one of 200,000 patients (0.05% of the EU population) who every year seek healthcare abroad under the framework of the Cross-border Healthcare Directive (Directive 2011/24/EU), principally in a neighbouring Member State to their country of residence. In 2019, 290,890 patients sought healthcare in another Member State.

The Directive aims to guarantee EU patients’ right of access to safe and high-quality healthcare across national borders within the EU/EEA, their rights to be reimbursed for such care, and to facilitate the cross-border exchange of and access to patients’ data.

The Directive’s contributions to improve the treatment of rare disease patients is well recognised. The 24 European Reference Networks (ERNs) have had a positive impact for patients by facilitating the exchange of knowledge and best practices across the EU, although they could be further improved and expended.

In fact, the Directive has delivered a limited positive impact for many patients. Such was the conclusion of the European Court of Auditors in 2019 and of many citizens who received healthcare under the Directive.

Patients are required to deal with a complex system of lengthy administrative procedures to determine whether their treatments are eligible and often have to seek prior authorisation, for which national procedures differ widely. Patients must also bear the upfront cost of their treatment and may not be reimbursed its full cost, excluding many European citizens from the equality of access that Europe strives to achieve in healthcare.

The Directive is an essential tool for Europe to improve patients’ access to specialised treatments such as advanced therapy medicinal products (ATMPs) and orphan medicines for whom cross-border treatment is often the only available solution.

These innovative treatments, based on genes, tissues, or cells, are the next generation of care and build on Europe’s excellence in research and innovation. Unlike many current medicines, they offer the prospect of curing diseases like Alzheimer’s for the first time or effectively treating cancers with single or small number of treatments. Yet, ATMPs require a level of expertise and infrastructure, including manufacturing, processing, and healthcare delivery that is not available in all 27 EU countries, and will never be viable to do so, particularly for rare diseases.

As such, patients often need to seek cross-border care through the Coordination of Social Security Regulations, an equally complex and restrictive system, due to the necessity to request prior authorisation, that does not provide reimbursement for all costs associated with the treatment, such as travel and accommodation further adding to patients’ burdens.

All these administrative complexities added to different national rules and procedures for eligibility of treatments only delay patients access to life-saving treatments and increase the burden on themselves and their families.

As the European Commission finalises its first evaluation of the Cross-Border Healthcare Directive after more than 10 years, it has the opportunity to strive for an ambitious and future-ready Directive. A revision can address shortcomings linked to ease and equality of access, and patient empowerment through a well-functioning and integrated EU cross-border healthcare framework which harnesses Europe’s clinical excellence. Harmonised and simplified administrative procedures, including for payment and reimbursements, expanded and better integrated ERNs, and easier access to cross-border clinical trials are objectives that can be achieved by revising the Directive.

If the European Health Union born out of the COVID-19 pandemic is to succeed, it needs to bring real benefits to citizens across Europe. Guaranteeing simpler and wider access to care, in particular for innovative treatments, is where the EU can excel and bring significant added value from integration and collaboration.