Legal Perspective

Medical research has made remarkable progress in the past decade, leading to innovative treatments that could save lives. However, legal and regulatory barriers often prevent patients across Europe from accessing these advancements through clinical trials. A 2024 report by IQVIA, published by the European Federation of Pharmaceutical Industries and Associations (EFPIA), highlights a troubling statistic: Europe currently lacks around 60,000 clinical trial spots. This shortage not only limits patient access to new treatments but also undermines Europe’s role in global medical research.

The Challenge of Unequal Access

Clinical trials in Europe are not evenly distributed. Larger countries like Germany and Italy host more trials, while smaller nations such as Austria and Croatia have far fewer opportunities. This imbalance raises concerns about equitable access to potentially life-saving research and conflicts with the principles of non-discrimination and equal treatment enshrined in EU law.

Although EU regulations, including the Clinical Trials Regulation (CTR) (EU No 536/2014), theoretically allow patients to enroll in trials outside their home country, practical implementation remains problematic. Patients encounter legal ambiguities regarding informed consent, liability, travel reimbursement, and post-trial care. Furthermore, inconsistencies between national legal frameworks hinder smooth cross-border participation. Without legal clarity and streamlined processes, many eligible participants remain excluded from clinical trials.

Legal and Regulatory Barriers

Several key legal obstacles must be addressed to improve cross-border access:

• Regulatory Fragmentation: Despite the CTR’s aim to harmonize clinical trial processes, significant differences remain in how individual Member States implement the rules. National ethical and legal requirements can create additional hurdles for both trial sponsors and participants.
• Cross-Border Healthcare Directive (2011/24/EU): While this directive governs patients’ rights to seek healthcare in another EU country, its applicability to clinical trials is unclear. Legal uncertainties regarding reimbursement and procedural alignment discourage participation.
• Liability and Insurance Issues: Differences in national liability frameworks create confusion over which country bears responsibility in case of adverse events. The lack of a unified insurance framework for cross-border trials further complicates matters.
• Data Protection and GDPR Compliance: Cross-border trials involve the transfer of sensitive patient data between jurisdictions, necessitating strict compliance with the General Data Protection Regulation (GDPR) (EU 2016/679). However, differing national interpretations of GDPR provisions add another layer of complexity.

Steps Toward a Solution

To overcome these barriers, policymakers and legal experts must take decisive action, including:

• Clarifying Legal Frameworks: The EU should establish clearer and more detailed legal guidance on cross-border clinical trial participation, including standardized processes for informed consent, liability allocation, and reimbursement.
• Revising the Cross-Border Healthcare Directive: Ensuring this directive explicitly covers clinical trial participation could provide a legal basis for easier access to trials in other Member States.
• Harmonizing Insurance and Liability Policies: A unified EU-wide framework addressing liability and insurance concerns for cross-border trials would create legal certainty for both sponsors and participants.
• Strengthening GDPR Compliance Mechanisms: Developing a standardized, trial-specific approach to data protection would ease legal burdens while ensuring patient privacy is maintained.

How EU-X-CT is Leading the Way

The EU-X-CT project is actively working to dismantle the legal, logistical, and ethical barriers that make cross-border clinical trials challenging. By mapping these obstacles, the project provides essential insights into how legal uncertainties impact patients and trial sponsors.

A significant achievement of EU-X-CT is its six-point action plan, introduced at the stakeholders’ forum last year. Additionally, a public consultation, open until March 10, 2025, invites stakeholders to contribute to the development of legally sound solutions that enhance patient access while maintaining the integrity of the trial system.

Why This Matters

This issue is not just about regulatory inefficiencies—it is a matter of fundamental patient rights and legal fairness. Ensuring equitable access to clinical trials across Europe requires a legal framework that supports patients, healthcare providers, and researchers alike. The ability to participate in cutting-edge medical research should not be determined by geographical or administrative obstacles but rather by medical necessity and ethical considerations.

If Europe aims to remain a leader in medical innovation, it must establish a clinical trial system that works for all patients, not just those in major research hubs. Legal reforms are essential to achieving this goal.

The need for improved legal and regulatory mechanisms to facilitate cross-border clinical trials in Europe is urgent. Policymakers, legal professionals, healthcare authorities, and industry leaders must collaborate to dismantle barriers and ensure patients across Europe have fair and timely access to potentially life-changing treatments. Initiatives like EU-X-CT and ongoing legal consultations present a critical opportunity to build a more inclusive and legally coherent clinical trial system. Now is the time to act, ensuring that European patients can fully benefit from the latest advancements in medical research without unnecessary legal roadblocks.

Article written by Momchil Denchev from Milanova & Partners