EUCOPE Resources / News - June 7, 2022

?️Sounds of Science – Episode 6 on Cross-Border Healthcare

Sounds of Science – Episode 6

Overcoming Barriers: Improving Access for Rare Disease Patients through Cross-Border Healthcare

The Cross-Border Healthcare Directive (Directive 2011/24/EU) marked a milestone for European patients. It created a legal framework for the patient’s right to seek healthcare in another Member State and to be reimbursed. This built on the so called ‘S2’ Regulations which served as an earlier framework to allow patients to receive healthcare in other Member States. It also provided a legal basis for enhanced European cooperation in key areas of healthcare – including quality and safety, Health Technology Assessment and eHealth, and rare diseases.

On May 12, the Commission published their long-awaited evaluation of the Cross-Border Healthcare Directive. The report outlines several areas for improvement but does not call for a reopening of the Directive, which would be a political decision as well. As more Advanced Therapy Medicinal Products (ATMPs) have become available across Member States, it is still unclear whether the Directive and the S2 Regulations make access to such transformative treatment abroad more accessible.

In this podcast, we address a number of complex issues with a lot of terminologies so today we’ll be discussing cross-border healthcare (CBH) in a holistic manner. The speakers will be able to clarify the concept of CBH and the Directive itself.

To help reflect on the Commission’s report and discuss the challenges and opportunities available to improve access for rare disease patients through cross-border healthcare, our special guests are:
  • Thomas Bols, Head of Government Affairs and Patient Engagement, PTC Therapeutics
  • Victor Maertens, Government Affairs Manager, EUCOPE

You can listen to Episode 6 and all other Sounds of Science episodes using the links below:

Episode Highlights

Thomas Bols, Head of Government Affairs and Patient Engagement, PTC Therapeutics

“”One very positive outcome of the directive was of course the establishment of the European reference networks. They really are centers of expertise throughout Europe. These centers are really great around disease knowledge and the diagnosis of diseases. They could possibly play an even more important role in treatment.”

“Not every country will have the healthcare system in place to administer these innovative and transformative gene therapies. So you will have a few central and specialized treatment centers scattered around Europe, all of the patients reside in other Member States. So this adds to the problem that not only do patients need to go abroad to be diagnosed but also to receive treatment.”

Victor Maertens, Government Affairs Manager, EUCOPE

“The fundamental difference between the Directive and the Regulation is the Directive requires prepayment, but has a more clear pathway. On the other hand, the Regulation allows Member States to accept patients that don’t pay for the treatment themselves, rather but it it’s a transfer between two member states. Nevertheless, it’s a murkier and less clear pathway to treatment that needs approval beforehand.”

 “We’d like to see the European Commission issuing some guidelines that set acceptable and harmonized review and approval timelines, in order to expedite treatment in the EU.”