International Legal Approaches to Neurosurgery for Psychiatric Disorders.

Neurosurgery for psychiatric disorders (NPD), also sometimes referred to as psychosurgery, is rapidly evolving, with new techniques and indications being investigated actively. Many within the field have suggested that some form of guidelines or regulations are needed to help ensure that a promising field develops safely. Multiple countries have enacted specific laws regulating NPD. This article reviews NPD-specific laws drawn from North and South America, Asia and Europe, in order to identify the typical form and contents of these laws and to set the groundwork for the design of an optimal regulation for the field. Key challenges for this design that are revealed by the review are how to define the scope of the law (what should be regulated), what types of regulations are required (eligibility criteria, approval procedures, data collection, and oversight mechanisms), and how to approach international harmonization given the potential migration of researchers and patients.

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Copyright © 2021 Chandler, Cabrera, Doshi, Fecteau, Fins, Guinjoan, Hamani, Herrera-Ferrá, Honey, Illes, Kopell, Lipsman, McDonald, Mayberg, Nadler, Nuttin, Oliveira-Maia, Rangel, Ribeiro, Salles and Wu.

Déclaration de conflit d'intérêts

JF receives book royalties for Rights Come to Mind: Brain Injury, Ethics and the Struggle for Consciousness from Cambridge University Press. CHa was part of an unrelated advisory board for Medtronic. BK is a consultant with Medtronic and Abbott, has fellow funding from Medtronic, Abbott and Boston Scientific, and holds an MJFF grant. HM receives consulting and intellectual licensing fees from Abbott Neuromodulation. BN has implanted devices, which were generously provided by Medtronic, for deep brain stimulation (DBS) in patients suffering from obsessive compulsive disorder (OCD). Medtronic provided BN grants for research, education and traveling. BN held the Medtronic Chair for Stereotactic Neurosurgery in Psychiatric Disorders at KU Leuven as well as a Chair for Neuromodulation, an endowment from Medtronic. BN co-owns a patent on DBS in OCD. AJO-M is recipient of a grant from Schuhfried GmBH for norming and validation of cognitive tests, and is national coordinator for Portugal of a Non-interventional Study (EDMS-ERI-143085581, 4.0) to characterize a Treatment-Resistant Depression Cohort in Europe, sponsored by Janssen-Cilag Ltd, and a trial of psilocybin therapy for treatment-resistant depression (EudraCT NUMBER: 2017-003288-36), sponsored by Compass Pathways Ltd. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.