PAREA contributed to the European Commission’s consultation on the forthcoming Biotech Act

This new initiative aims to strengthen Europe’s competitiveness in biotechnology - a field increasingly recognised as strategic for Europe’s economic sovereignty, innovation leadership, and resilience. The consultation invited stakeholders to identify barriers in the EU’s regulatory and investment environment and propose actions to unlock the next wave of biotech innovation.

In our submission, we made one central point: Europe cannot build a competitive biotech ecosystem without addressing the innovation crisis in mental health.

Mental health is not just another health policy area. It is the foundation of human capital, shaping learning, productivity, and social cohesion - the very capacities that drive Europe’s competitiveness. Yet psychiatry remains the most structurally neglected area of medical research. A handful of companies developing psychedelic therapies - among the most promising frontiers in mental health - have advanced to Phase 2 or 3 trials in Europe, compared to dozens in the United States.

Meanwhile, the U.S. FDA has granted Breakthrough Therapy designations to six psychedelic compounds, offering accelerated pathways to approval.

Europe risks falling behind because companies are not knocking on EMA’s door - a signal that the EU needs smarter incentives and clearer frameworks, not passive optimism.

Our submission calls for a European Mental Health Moonshot - a mission-driven initiative that treats mental health as the infrastructure of human potential, on par with Europe’s investments in clean energy, semiconductors, digital transformation etc.

The Moonshot would:

- Mobilise high-risk, high-reward research funding

- Build the workforce and care capacity for implementation, and

- Pilot regulatory sandboxes for psychedelic therapies to safely bridge research and delivery.

We argue that strategic autonomy begins with inner autonomy. By investing in mental health innovation now, the EU can address a pressing social need while reinforcing its global competitiveness and resilience.

The full submission is available here.