Mental health innovation in the European Biotech Act: closing Europe’s access and competitiveness gap

Hosted by MEP Romana Jerković, S&D, Health Committee SANT Vice-Chair
Organised by PAREA, GAMIAN-Europe, and European College of Neuropsychopharmacology

Moderated by Dominic Giannini, Health Reporter at POLITICO Europe.

Europe is facing a major mental health challenge, but mental health innovation is still too often treated as a secondary issue in health and competitiveness policy. New treatments remain limited, access is uneven, and Europe is falling behind in translating promising science into patient benefit.

The European Biotech Act is one of the EU’s key initiatives to strengthen Europe’s biotechnology and health innovation ecosystem. It aims to remove barriers that slow down the development, testing and uptake of innovative health technologies. As such, the Act could become an important tool for addressing one of Europe’s largest unmet health needs.

This event will explore why mental health innovation should be part of the Biotech Act and how the Act’s existing instruments could support responsible development and access. These include regulatory sandboxes, strategic mapping and foresight, high-impact projects, investment mechanisms, support networks, data infrastructure, and repurposing and off-patent innovation.

Following opening remarks by MEP Romana Jerković, Matthew Paris, Vice-President of GAMIAN-Europe, will present the patient perspective on unmet needs and access gaps. Tadeusz Hawrot, Founder and Executive Director of PAREA, will present policy recommendations for the Biotech Act, and Prof. Andreas Reif, President of the European College of Neuropsychopharmacology, will discuss why Europe needs mental health medicines innovation.

The speakers will then be joined by Camille Roux, Policy Manager at Mental Health Europe, for a panel discussion and questions from the in-person and online audience.

The discussion will also consider what makes some mental health treatments different from more conventional product pathways. This is especially relevant for complex treatments such as psychedelic therapies, where outcomes may depend not only on the product itself, but also on the conditions of administration, the patient’s mindset and treatment environment, the subjective experience during the dosing session, psychological support, professional training and safe implementation in health systems.

The event comes at an important stage in the EU policy process. The European Parliament plenary vote on the Biotech Act may take place at the turn of the year, while Member State negotiations are expected to be advancing in parallel. The discussion will therefore address both the Parliament’s work and the wider Council process.

During the event, PAREA will also launch a policy brief focused specifically on the European Biotech Act, presented as part of Tadeusz Hawrot’s contribution, setting out how mental health innovation can be reflected in the file and why this matters for Europe’s health innovation and competitiveness agenda.

📅 17 November 2026 | 🕒 15:00-17:00 CET |📍 European Parliament, Brussels & Online