Advanced Therapy Medicinal Products (ATMPs) have represented the new paradigm in healthcare since the beginning of the new millennium. Cellular and gene therapies and regenerative medicine address the root causes of diseases and may allow curing patients based on just a one-shot treatment. This adds value for patients, their families, healthcare systems and society. While Europe held a leading position at the beginning of ATMPs’ development over 15 years ago, the EU attractiveness for ATMP development has declined compared to other regions, such as the US and Asia.

A position paper by EuropaBio summarised the recommendation of the industrial representative to support the role of ATMPs as a key driver of health innovation. According to the document, the EU must build on the historic momentum and ensure legislation focuses on accelerating the translation of science into therapies. Sufficient funding for innovation and a supportive legislative framework for biotech innovators of all sizes would be needed to realise the EU potential for ATMP R&D. The EU clinical trials ecosystem should also be improved by streamlining and speeding up trials. The unique value proposition of ATMPs should also be recognised, and sustainable integration of ATMPs into healthcare systems across the EU should be achieved.

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