Towards inclusive EU governance of neurotechnologies

Drawing on an extensive literature review, sustained interaction with experts across various disciplines and contexts, and the outcomes of two workshops jointly organised by CFG and IoNx, this discussion paper argues for the need for neurotechnology governance frameworks that are adaptive, conceptually sound, inclusive, and anticipatory.

We provide a description of the ethical issues raised by neurotechnology and an analysis of key conceptual grey areas. Then, we turn to governance, presenting a case study and four scenarios to show that existing fragmented regulatory frameworks are insufficient to keep pace with the rapid advancements and expanding applications of these technologies. We conclude with the following recommendations for EU neurotechnology governance:

1. Anticipatory policymaking

Fostering safe innovation and use through forward-looking policy

Keeping up with the rapid pace of innovation in the field of neurotechnology requires good foresight. Anticipatory governance enables policymakers to design more adaptive and future-proof regulations that can respond to future developments. Furthermore, by proactively evaluating potential risks and opportunities, the EU can target investments in technologies that not only advance innovation but also uphold ethical and regulatory standards. This proactive approach could support a sustainable ecosystem for neurotechnology, positioning the EU as a leader in neurotechnology while safeguarding the public and upholding trust and societal values.

2. Inclusive and participatory policymaking

Building trust and democratic legitimacy through meaningful stakeholder engagement

Leveraging the full toolbox of participatory mechanisms for broad public engagement will strengthen transparency and public trust in neurotechnology and its governance. Involving a broad range of stakeholders, including scientists, industry leaders, ethicists, patients, and the general public, supports a collaborative process where societal values and concerns are embedded into policy frameworks, enhancing  their responsiveness to society’s needs and their alignment with societal values.

3. Clear and harmonised policymaking

Frame concepts responsibly and illuminate grey areas

Responsible conceptualisation would promote clarity and consistency across jurisdictions, reducing regulatory fragmentation and making it easier for innovators to comply with standards. It would also enable ethical alignment and the protection of fundamental rights like privacy and  autonomy, no matter where the technologies are developed or used. Additionally, it would support cross-border collaboration and foster a thriving European neurotechnology ecosystem through a genuine Single Market, reinforcing the EU’s leadership in this rapidly evolving  field.