Adopted by the OECD Council on 11 December 2019, the OECD Recommendation on Responsible Innovation in Neurotechnology is the first international standard in this domain. It aims to guide governments and innovators to anticipate and address the ethical, legal and social challenges raised by novel neurotechnologies while promoting innovation in the field.
The Recommendation embodies nine principles, which focus on:
Furthermore, the Recommendation seeks to provide guidance at each step of the innovation process – e.g. research, technology transfer, investment, commercialisation, regulation – so that benefits are maximised and risks minimised. It articulates the importance of:
The need for an international standard for responsible innovation in neurotechnology
Novel neurotechnology offers significant potential for the promotion of health, well-being, and economic growth. Mental health is an increasingly important public health concern in OECD Member countries and beyond.Mental and neurological disorders (e.g. Alzheimer’s disease and other dementias) cause great human suffering and are increasingly recognised as major causes of death and disability worldwide. They often remain untreated and impose significant economic and social welfare costs, elevating their importance to the highest national and international policy levels.
Neurotechnology is redefining what is possible in terms of monitoring and intervention in clinical and non-clinical settings, with great promise for improving mental health, well-being and productivity. Spearheaded by large national and international flagship initiatives in brain science and fuelled by a clear medical need, research both in the public and private sector has made considerable advances. In particular, the convergence between neuroscience, engineering, digitalisation, and artificial intelligence (AI) is becoming a key driver of innovation and will disrupt existing practices as well as traditional boundaries between medical therapies and consumer markets.
At the same time, neurotechnology raises a range of unique ethical, legal, and societal questions that potential business models will have to address. These questions include issues of (brain) data privacy, the prospects of human enhancement, the regulation and marketing of direct-to-consumer devices, the vulnerability of cognitive patterns for commercial or political manipulation, and further inequalities in use and access. Governance issues surrounding neurotechnology affect the entire innovation pipeline, from fundamental brain research, cognitive neuroscience, and other brain-inspired sciences to questions of commercialisation and marketing.
In order to respond to these issues, the OECD, through its Working Party on Biotechnology, Nanotechnology and Converging Technologies (BNCT), has been pursuing a five-year project focusing on developing a set of principles for responsible innovation in neurotechnology. These aim to assist governments and innovators in addressing and anticipating the governance challenges raised by mental and neurological disorders and novel neurotechnologies.
THE DEVELOPMENT OF THE RECOMMENDATION THROUGH A FIVE-YEAR PROCESS
Between 2015 and 2019, the BNCT conducted the project “Neurotechnology and Society” with the objective to:
The Recommendation developed out of a step-wise process of structured consultation and engagement with policymakers, key stakeholders and civil society. A steering group composed of BNCT delegates and appointed experts oversaw a series of workshops featuring experts from different disciplines and sectors, including government, academia, healthcare, civil society, business and philanthropy. The steering group provided guidance throughout the project, including in the textual development of principles for responsible innovation in neurotechnology and their embodiment in the Recommendation.
IMPLEMENTATION AND DISSEMINATION OF THE RECOMMENDATION
The implementation of the Recommendation will be supported by the development of practical tools and guidance. A collection of examples of best practices and lessons learned in the field of neurotechnology and other emerging technologies will be developed to assist adherents in the project of implementation.