EuropaBio welcomes the publication of the evaluation of Directive 2011/24/EU on the application of patients’ rights to cross-border healthcare (Cross-Border Healthcare Directive) on 12 May 2022. The Directive is an essential tool to improve patient access to high-quality care, especially to specialised treatments such as advanced therapies and orphan medicines. EuropaBio believes that a well-functioning EU cross-border healthcare framework is necessary to enable patient access to specialised treatments and novel therapies when these are not available in their home country.
EuropaBio takes notes of the findings of the evaluation of the Directive and acknowledges that the Directive has facilitated access to cross-border care to some extent, and that the European Reference Networks bring a real EU-added value. Nonetheless, the evaluation reveals the limited success of the Directive to date, as exemplified by the small number of EU citizens aware of and making use of possibilities offered by the Directive, the disproportionate administrative burden, and continued uncertainty about costs abroad and reimbursement. After more than ten years, the Directive’s objectives have not been fully realised for the benefit of patients, and serious gaps remain.
EuropaBio regrets the lack of ambition for the Directive and urges the European Commission to revise the Directive to address the shortcomings highlighted by the evaluation. It is necessary to address persisting barriers, such as long approval times, fragmented payment and reimbursement processes, difficult access to clinical trials, and disjointed implementation that hinders patients’ access to excellence of care and innovative therapies. In addition, EuropaBio calls upon the Commission to convene a structured dialogue with the Member States and other stakeholders to ensure better functioning of the Directive’s implementing measures.
EuropaBio shares the Commission’s objective to improve access to innovative therapies and medicines across the EU and believes that a revision of the Directive to improve cross-border healthcare would help to achieve this objective. EuropaBio is committed to engage with the European Commission, policymakers, and other stakeholders to discuss ways to make the cross-border healthcare mechanisms work better for patient access to advanced therapies in the EU.