EU must advance brain science technology while ensuring citizens’ safety, say experts

New technologies are constantly challenging and pushing the legal boundaries. While the European Union is proud of its global leadership on fundamental rights, the evolution of brain science is testing long-held assumptions.

While much work has been done on the right to privacy about machine learning and artificial intelligence, a whole new field of debate around new and emerging neurotechnologies has come to the fore.

The ICFG International Centre for Future Generations is a think tank focused on enabling decision-makers to anticipate and govern the societal impacts of rapid technological change. At the end of October, the ICFG organised an event with Euractiv to discuss the consequences of neurotechnology’s rapid evolution on the EU regulatory landscape.

Fundamental rights, fit for purpose?

Central to the discussion was the question of whether existing fundamental rights protections are fit for purpose or do we need new human rights frameworks and rights for the brain.

The panel represented a range of stakeholders, including researchers, policymakers, industry representatives and ethicists. They discussed the current state of neurotechnology development, potential benefits and risks and the need for inclusive, proactive governance frameworks.

The debate focused on the rapid evolution of neurotechnology and the regulatory and ethical challenges it presents, particularly around issues of mental privacy, data collection, and consent. There was a clear consensus that neurotechnologies intersect with various EU legislative and policy initiatives, and a comprehensive and integrated approach will be necessary for the EU to establish a legal framework governing these technologies.

Antonia Mochan, Deputy Head of the EU Policy Lab, Joint Research Centre, European Commission, focuses on foresight and emerging technologies more broadly, she explained the challenges.

“Technological development moves really fast these days – something that seemed like science fiction last year could be fact next year. By exploring the possible impact of emerging technologies, foresight can help us grasp the potential of the future and make decisions for how we live there,” she said.

Balancing rapid innovation, ethics

Other panellists also highlighted the difficulty in balancing rapid innovation with robust ethical and safety standards.

In essence, neurotechnology is where neuroscience meets technology, including all the tools and methods that are used to improve our understanding of how the human brain functions, as well as what can be done to improve or repair the brain’s capacities.

These advancements are opening new possibilities across various aspects of life, from healthcare to daily activities.

Javier Castillo, Head of Quality and Regulatory at INBRAIN Neuroelectronics, brought more than 10 years of experience in the MedTech regulatory environment to the discussion as well as practical examples. “INBRAIN is currently evaluating the safety and performance of our technology in First in Human clinical investigation in the UK,” he explained. “Our novel material, Egnite, a Graphene-based electrode material embedded in a thin film, is being used as a brain mapping electrode in tumour resection surgeries.”

Incorporating AI

This material, he said, along with other novel technologies such as AI, “is being used by INBRAIN to decode neural signals and create breakthrough therapies for Parkinson’s Disease.”

He conceded that “more broadly, therapeutic Brain-Computer Interfaces incorporating artificial intelligence, a key enabler to improve patient’s lives, may represent a challenge from a regulatory, cybersecurity and ethical standpoint.”

Virginia Mahieu, Neurotechnology Director at ICFG, is a neuroscientist by training and previously worked in the European Parliamentary Research Service as a strategic foresight analyst focusing on the nexus of technology, health, and mental health.

Mahieu remarked: “To ensure that the benefits of neurotechnologies are harnessed in the best interest of society, the EU needs to put forward a strategy that promotes responsible innovation and market introduction while ensuring clear and robust guardrails to protect mental privacy, individual autonomy, and freedom of thought.”

Certain applications of neurotechnology could pose more challenges related to fundamental rights than others, such as concerns about mental surveillance or consent to the collection and processing of brain data. The EU will need to identify potential gaps in existing fundamental rights protections and address them to ensure neurotechnology advances responsibly.

Guillerme Wood, Professor of Neuropsychology at the University of Graz, is part of the neuro rights movement examining fundamental rights for the brain. In his study for STOA, he argued we don’t need novel rights specifically for the brain – our current rights are sufficient, he said. Many on the panel agreed while all said there was a need for a coordinated, strategic EU approach to neurotechnology governance rather than piecemeal regulation.

Integrating ethics principles 

The panellists emphasised the importance of integrating ethics and responsible development principles from the start rather than treating them as afterthoughts. They also highlighted the need for diverse voices and perspectives to shape the governance process. A key element of the EU’s approach will be engaging stakeholders and ensuring inclusiveness in discussions on the regulation and application of neurotechnology.

Ricardo Chavarriaga, Lead Responsible AI Innovation at the ZHAW School of Engineering, Head of the CAIRNE office in Switzerland and member of the EBC-led Task Force on the European Charter for the Responsible Development of Neurotechnologies, joined the discussion shedding light on the task force efforts to build on existing mechanisms of governance and complements existing legislation through a multistakeholder process.

Completing the panel, Arleen Salles, Senior Researcher, Neuroethics and Philosophy, Institute of Neuroethics, examined the fundamental reasons behind why we need ethical regulation and the importance of responsible conceptualisation and attention to framing in the ethical and regulatory discussion.

Salles observed that: “Creating neurotechnology governance that can navigate the ethical and regulatory grey areas — between medical and non-medical uses, empowerment and vulnerability, among others — requires a strong commitment to anticipation, meaningful engagement, and responsible conceptualisation and framing.”

The discussion underscored the complexity and urgency of developing appropriate regulatory and ethical frameworks to harness the benefits of neurotechnology while mitigating potential harms, the importance of anticipating future developments and unknown risks through foresight and stakeholder engagement, and the challenges around defining and regulating “brain data” and ensuring equitable access to neurotechnologies.

This article follows the policy debate ““ supported by ICFG.

[Edited By Brian Maguire | Euractiv’s Advocacy Lab ]