2 February 2026 – In keeping with its commitment to patient-centered care and equitable access to innovative cancer treatments, RGCC has announced the initiation of legal proceedings to address the long-standing lack of access of thousands of EU patients to EMA-approved Advanced Therapy Medicinal Products (ATMPs).

Despite the existence of a clear European legal framework for nearly two decades, including Directive 2004/23 and Article 28 of Regulation (EC) No 1394/2007 governing the hospital exemption, several EU Member States, particularly in Southern and Eastern Europe, have failed to implement these provisions. As a result, ATMPs remain unavailable in a number of countries, and the establishment of essential cell and tissue biobanks has therefore been obstructed. This ongoing non-compliance has led to unequal access to advanced therapies among EU citizens and constitutes a serious violation of the fundamental right to health.

While some Member States, such as Germany, Austria, and the Netherlands, have successfully implemented the necessary regulatory frameworks, others, including Greece and Poland, have not, leaving patients without access to potentially life-saving treatments. This regulatory fragmentation has deprived a large number of patients of therapeutic opportunities, in some cases with fatal consequences. The situation has persisted largely unnoticed by the wider European public, despite its profound human and ethical implications.

Over the past several years, RGCC has repeatedly sought clarification and resolution from national competent authorities, often receiving minimal or no response. As these efforts failed to produce meaningful progress, RGCC proceeded to submit documented cases and supporting evidence to National Competent Authorities (NCA), the European Medicines Agency (EMA), the European Commission, the EU Ombudsman, and the EU Commissioner for Health and Animal Welfare.

“Our position has always been clear: patients must come first,” said Dr. Ioannis Papasotiriou, Founder and Director of RGCC. “We consider this action an ethical obligation toward the patients who trust us. Equal access to advanced therapies should not depend on geography. We are committed to constructive collaboration with authorities and stakeholders to ensure that these rights are upheld across the European Union.”

Through this initiative, RGCC seeks to promote transparency, accountability, and collective action toward a fair, unified, and legally compliant approach to healthcare access across the EU, ensuring that innovative therapies are available to all patients who may benefit from them, regardless of their country of residence.

 

This press release reflects updated information and replaces the version published on 13 November 2025.

 

About RGCC International:

RGCC was launched in 2004 by genetics pioneer Dr. Ioannis Papasotiriou who believes that the key to effectively treating cancer lies in personalized medicine. Today, RGCC is a leading innovator in the field of oncology diagnostics. Using world-leading technology, equipment, and innovative techniques, our team of scientists has developed a range of liquid biopsies that help physicians track cancer progression and tailor treatment plans based on individual patient profiles.

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