Advanced Therapy Medicinal Products (ATMPs) represent a paradigm shift in healthcare by offering new way to help patients, addressing the root causes of diseases and potentially curing patients. By giving the possibility of a one-time treatment, these innovative products result in an added value for patients, their families, healthcare systems and society. In recent years, there have been many scientific breakthroughs, leading to an increasing number of ATMPs being developed and brought to patients, including the potential for use in more prevalent conditions.

Over 15 years ago, the EU was a pioneer in the field of ATMPs in terms of their development, authorisation, and regulation, promoting patient access to these life-changing therapies. (1) Despite its head start and strong scientific outputs, the EU is now facing a declining attractiveness for ATMP development as other regions – mainly the US and Asia – are consolidating their leadership in the sector.

As a key driver of health innovation, the field is of strategic importance to the EU’s competitiveness, open strategic autonomy, and resilience. (2) To regain its leadership in the development and deployment of breakthrough therapies, the EU must build on the historic momentum and ensure legislation focus on accelerating the translation of science into therapies for a wider patient. With this paper, EuropaBio puts forward recommendations to improve the EU’s attractiveness for ATMPs developers by:

• Realising the EU potential for ATMP R&D by ensuring sufficient funding for innovation and a supportive legislative framework for biotech innovators of all sizes.
• Improving the EU clinical trials ecosystem by addressing existing challenges to streamline and speed up trials to incentivise ATMPs creation and development.
• Recognising the unique value proposition of ATMPs and work towards the sustainable integration of ATMPs into healthcare systems across the EU, embracing flexible and inclusive approaches to HTA, pricing & reimbursement to enable faster and easier access for European patients.

(1) Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004

(2) COM(2024) 137 final

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