Over the past decade, global pharmaceutical research has grown rapidly. However, despite the relentless search for new medicines around the world, all too often the people benefiting from that research are not here in Europe. According to an IQVIA report published by EFPIA in October 2024, there are 60,000 fewer clinical trial places available to patients in Europe.

This means our patients do not have the earliest possible access to innovative medicines, while our health systems and economies lose out on the investment associated with clinical trials. At a time when EU competitiveness is coming into sharper focus, we have some catching up to do.

As I noted when that report was launched, European trials are hampered by a slow and fragmented ecosystem. It is imperative that Europe takes every opportunity to harmonise and simplify its processes. There are specific measures the EU can take to become more attractive for clinical research including a new multi-stakeholder initiative that aims to unlock cross-border trials.

Making it easier for European patients to access trials

Access to clinical trials is uneven across Europe: patients in some countries have access to trials while others do not. In broad terms, larger countries like Germany and Italy tend to have more trials than, for example, Austria or Croatia.

That would matter slightly less if patients in Austria could easily participate in trials in Germany. However, while there are instances in which patients join trials in Member States other than the one in which they live, it is far from straightforward. Indeed, cross-border access to trials is generally facilitated on a case-by-case basis. That makes the system slow, bureaucratic and somewhat arbitrary.

As things stand, taking part in a trial in another Member State raises a range of questions for individual patients. These include how to manage the costs of travel and care in another EU country, and whether the patient will have adequate follow-on treatment in their home country when the trial ends.

Patients and health professionals need easy access to information about ongoing trials and who is entitled to sign up for trials in neighbouring countries. It is vital that trials are more embedded in the care system and easier to navigate.

The EU has a Cross-Border Healthcare Directive, but it does not address clinical trials. The Clinical Trials Regulation does little to facilitate cross-border participation. Even the European Reference Networks, designed to connect people with rare diseases with highly specialised centres of excellence, focus on care rather than research.

What can be done now?

There are two steps policymakers can help to address this uncertainty.

• Issue guidance for patients, health professionals, trial sponsors, ethics committees, liability insurance companies and healthcare providers to clarify and help interpret existing EU law in this area. This is a matter of urgency.
• Identify the best legislative framework for regulating cross-border access to clinical trials – and to begin the process of writing legislation, whether that means revising the Cross-Border Healthcare Directive or including this in the upcoming Biotech Act.

Healthcare partners also have a role to play. That is why the European Forum for Good Clinical Practice (EFGCP) and EFPIA are leading a multi-stakeholder initiative – EU-X-CT – to address barriers to cross-border trials in the EU. Over a hundred members, including patients and patient organisations, have signed up to this project, indicating a strong appetite for progress.

The project has already begun mapping the status of cross-border clinical research conditions in EU Member States to help understand the legal, ethical, financial, logistical and operational barriers that must be overcome.

Last April, EU-X-CT organised a public stakeholders’ forum at which a six-point action plan was published. The outcome of the forum and the results of stakeholder surveys have prompted the development of new draft recommendations that aim to shape future guidance. These recommendations, now open for public comment until 10 March 2025, will be officially endorsed at an event in June.

I would urge all stakeholders to participate in this consultation to ensure their views are taken into account as we move ahead together to break down barriers to clinical trial participation.

Facilitating cross-border clinical trials is a complex challenge, but solving it benefits all EU stakeholders. Patients in Europe need early and equal opportunities to access innovative therapies; trial sponsors need patients to participate in research; and the EU needs to become globally competitive in clinical trials. Let's work together to give more Europeans access to clinical trials.