Protecting Patient Access to Clinical Trials in Europe

An all-encompassing revision of pharmaceutical laws from the European Commission aims to make medications more available, accessible and affordable. But these revisions could have unintended consequences for patients’ access to clinical trials and new treatments.

Stakeholders and experts from across the region discussed those unintended consequences during a recent Global Campaign for Clinical Trials webinar. The event was hosted by the European Alliance for Patient Access.

The webinar featured presentations from several experts and patient advocates:

  • Elizabeth Kuiper, Associate Director and Head of the Social Europe and Wellbeing programme at the European Policy Centre, stressed the importance of finding the balance between innovation and patient access. With the development of new treatment technologies and therapies, it is more important than ever to ensure that policies encourage innovation and protect patient access.
  • Annette Bakker, PhD, President of the Children’s Tumor Foundation and Chair of CTF Europe, discussed innovative solutions her organisation has been working on to accelerate the path to approval in clinical trials. Making sure that patients are active participants throughout the clinical trial design allows for patients to buy into the process. It also ensures that patients’ needs and experiences are incorporated into the development process.
  • Patrick Stockebrandt, Dr. iur., Head of Division at the Centre for European Policy, explained that revisions to the EU pharmaceutical legislation could impact the EU’s global competitiveness in clinical research. To make the EU a more attractive market for clinical research, he said, it is important to: enhance cooperation within the EU on health policy matters, reduce bureaucracy costs, improve digitalisation, and accelerate regulatory administrative decisions.
  • Julie Spony, Policy Officer at the European Patients’ Forum, responded to the presentations by offering a patient perspective on these policy issues. The revisions to the EU pharmaceutical legislation, she explained, are a unique opportunity to make clinical trials more patient centred and to improve patient access to safe, effective and high-quality medicines.

Ensuring the protection of patient access to clinical trials, and thus new treatments, must remain the priority as policymakers continue to discuss these proposed revisions.

To learn more about the proposed revisions to the EU pharmaceutical legislation, read the Global Alliance for Patient Access’ recent policy brief or view the full recording of the webinar.