PAREA calls for mental health innovation to be included in the European Biotech Act

PAREA has submitted formal recommendations to the European Commission’s public consultation on the upcoming European Biotech Act, urging policymakers to ensure that mental health innovation is explicitly reflected in one of the EU’s most important emerging health and industrial policy initiatives.

The European Biotech Act aims to strengthen Europe’s competitiveness in biotechnology and advanced therapies by simplifying regulation, accelerating clinical trials, supporting biotech investment, improving coordination across member states, and creating tools such as regulatory sandboxes for innovative treatments. The initiative forms part of the Commission’s broader effort to prevent Europe from falling behind the United States and China in biotechnology, life sciences, and health innovation.

In its submission, PAREA argues that mental health represents one of the clearest examples of market and regulatory failure in European health innovation. Despite the scale of unmet need and the enormous social and economic burden of mental health conditions, psychiatric innovation continues to lag behind other therapeutic areas in terms of investment, clinical development, and regulatory support.

PAREA’s recommendations call for mental health to be recognised as a strategic area within the Biotech Act and for the Act’s proposed tools—including clinical trial sandboxes, strategic projects, investment mechanisms, and data infrastructure—to be made accessible to complex mental health innovations. This includes treatments that combine pharmacological and non-pharmacological elements, structured therapeutic support, and real-world implementation requirements that do not fit conventional product-only development pathways.

The submission also highlights the need for stronger European infrastructure for brain and mental health data, implementation research, workforce development, and risk-tolerant investment. PAREA argues that strengthening Europe’s capacity in mental health innovation is not only a public health priority, but also a major competitiveness opportunity for the EU.

The full submission is available here.