The regulation of neurotechnology: the neurorights bill in Mexico

Innovative neurotechnologies, such as diffusion tensor imaging, transcranial magnetic stimulation, transcranial direct-current stimulation, deep brain stimulation, and brain-machine interfaces, undoubtedly have potential societal benefits; however, global concerns exist over scarce legal protection of human dignity and fundamental freedoms associated with neurorights, defined as “the ethical, legal, social, or natural principles of freedom or entitlement related to a person’s cerebral and mental domain; that is, the fundamental normative rules for the protection and preservation of the human brain and mind”. On July 17, 2024, Mexico introduced the General Law on Neurorights and Neurotechnologies (GLNN) bill, led by Senator Alejandra Lagunes Soto Ruiz, that includes 92 new articles and 35 amendments to existing national regulations (including the General Health Law)4 and the creation of a national Commission of Neuroethics and Neurolaw as the fundamental advisory body. A multidisciplinary group of experts (including KH-F, JMM, AB, EG-L, JÁM, LRSH, and JAAO), drafted this bill following high ethical and human rights standards. Here, we share some of the challenges, contents of the bill, and implications of the GLNN for mental health in Mexico.

The main challenge of the development of the GLNN was to articulate the actual contents of the bill, and the required measures in the national health system to ensure safety, efficacy, equity, autonomy, and non-discrimination (including algorithmic bias) while addressing the potential mental health impact of use of neurotechnology, regardless of its scope of application. We considered Mexican sociocultural realities, including resistance to accepting a biological basis for mental disorders and the perception of mental health as a luxury rather than a right, both reflected in the scarce resources and legislation allocated to mental health care and research in the country. To guarantee proper supervision of the GLNN and minimise corrupt practices, specific responsibilities were assigned to different inter- institutional regulatory bodies, including the Ministry of Health, The Federal Commission for Protection from Sanitary Risks, and the National Institute for Transparency, Access to Public Information and Personal Data Protection.

Another challenge was to incorporate neurorights into the bill by combining the ethical, legal, medical, and sociocultural concerns related to this concept. As such, in the bill neurorights are defined as “human rights and principles oriented at safeguarding the dignity of persons in relation to the anatomy and physiology of the central and peripheral nervous systems, their mental [cognition, emotional regulation or behavior in terms of psychological, biological or developmental processes] and cerebral [electrical and chemical signals through neurons that control sensory, motor, cognitive and behavioral responses] activity, as well as the information derived from them, against any form of use, evaluation, treatment, intervention, manipulation or neurotechnological exploitation”.

Consequently, content integrated specifically into General Health Law had three priorities: safety and efficacy of neurotechnologies, training of health-care professionals and members of ethics committees, and protection of patients. To prevent counterfeiting or adulteration of neurotechnology, safety measures and sanctions were incorporated that are related to the acquisition, development, use, risk management, auditing, and registration of devices, strengthening the measures added in the GLNN. Neurotechnology was included in articles related to the regulation of the human genome, aligning this technology with the regulation of advanced technology in health.

Regarding health-care professionals using neurotechnology, the GLNN mandates that they must undergo training on neurotechnology, neuroethics, and human rights to guarantee high standards of clinical care and research, according to the criteria that will be developed by the national Commission of Neuroethics and Neurolaw. For hospital bioethics committees and research ethics committees, an extension was made to Article 41 Bis of General Health Law, and now these committees must include neurotechnology and neuroscience professionals as members. Also, these individuals must have training in neuroethics or neurolaw as a requirement for membership (current regulation requires training only in bioethics). The training for health-care professionals and the committee members is not yet specified because this will be one of the tasks of the national Commission of Neuroethics and Neurolaw.

The GLNN mandates the State’s health-care system to enforce patients’ rights to health and autonomy and to minimise inequalities in access to neurotechnology for assessment, diagnosis, treatment, rehabilitation, and ongoing medical care. The State must offer the option of availability and accessibility of neurotechnology within the health-care system. The GLNN incorporates rules for non-discrimination in access to health insurance and mental health protection, thereby mandating changing the policies of private health insurance companies. To reinforce patient autonomy and protection, the GLNN mandates the introduction of specific informed consent for the collection of neural data and to inform individuals about specific concerns related to novel neurotechnology, such as the unknown potential side-effects. It requires the establishment of an ethics committee in facilities using neurotechnology and the integration of cyberneurosecurity into these technologies to protect neural data. Cyberneurosecurity is defined in the bill as “an integrated and systematic set of tools, policies, security measures, and best practices specifically designed to ensure the integrity, confidentiality, and availability of the interaction between neurotechnologies, users and the neural data obtained from these technologies”. The GLNN also specifies that commercialisation should be addressed exclusively to health-care professionals to restrict the use of neurotechnology to medical purposes, as is done with other medical devices such as portable electroencephalography and ultrasound sonography medical devices.

The right to mental integrity as part of the integrity of the person (that also includes physical integrity), has traditionally been understood as a guarantee of access to mental health services, as established for example by EU Charter of Fundamental Rights.6 In Mexico, mental integrity was not previously included in national regulations, but the GLNN adopts Ienca and Andorno’s view to reconceptualise the right to mental integrity, anticipating and providing protection against injuries caused by neurodevice attacks; eg, directed energy weapons (concentrated electromagnetic energy). To do so, the bill introduces prison sentences for perpetrators of attacks using neurodevices by reforming the Federal Criminal Code.

The GLNN also addresses the use of neurotechnology beyond medicine. Equitable access to neuro- enhancement technologies, such as transcranial electric or magnetic stimulation, has been proposed to be a fundamental right, but this proposition has been criticised. The GLNN differentiates neurotechnological treatments from neuroenhancements (physical or cognitive), granting the Ministry of Health the power to regulate which non-therapeutic uses of neuroenhancements are permissible. The GLNN expressly prohibits the use of neurotechnologies for sports doping and for enhancing law enforcement. During discussions, the inclusion of neurotechnologies for military applications in the bill was driven by concern regarding their potential misuse or overuse: hence, the GLNN prohibits some uses in military applications and ensures alignment with international humanitarian laws. The GLNN does not cover the potential forensic implications of the use of neurotechnology for perpetrators and victims of crimes and human rights abuses. These should be explored for future normative endeavours because they might offer novel avenues for psychiatric applications addressed to these perpetrators and victims.

The GLNN sets an international precedent as a pioneering, extensive, ambitious, and comprehensive national general law regulating neurorights and neurotechnology, requiring the reform of other laws within the national regulatory system, specifically adapted to the Mexican context. Therefore, the GLNN can serve as a potential model for the realisation of regulatory frameworks on the protection of mental health and mental wellbeing in relation to the use of neurotechnology in medicine and other areas. That is, a possible model for a General Law that affects other laws in the system and that can be adapted to the context of each country.

KH-F, JMM, AB, EGL, JÁM, LRSH, and JAAO were part of the group of experts that drafted the GLNN bill, and they received no compensation for their contribution. LRSH is the General Director of Regulation and Consultation at the National Institute of Transparency, Access to Information and Personal Data Protection (INAI) but his contribution to the bill was made independently, providing support from the perspective of personal data protection in the context of neurotechnologies and neurorights. ALSR is Senator of the Republic, for the Senate of Mexico, and she proposed the GLNN bill and supervised the project. JAAO is an independent advisor and declares no competing interests.

Karen Herrera-Ferrá, *José M Muñoz, Anahiby Becerril, Eric García-López, José Ángel Marinaro,Luis Ricardo Sánchez Hernández,Jesús Alejandro Alonso Otamendi,

Alejandra Lagunes Soto Ruiz

jomuor@gmail.com

Asociación Mexicana de Neuroética, Mexico City, Mexico (KH-F, JMM, EG-L, JÁM); Institute of Neurotechnology and Law, London, England, UK (JMM); International Center for Neuroscience and Ethics, Tatiana Foundation, Madrid 28010, Spain (JMM); Mexican Academy of Cybersecurity and Digital Law, Mexico City, Mexico (AB); National Institute of Criminal Science (INACIPE), Mexico City, Mexico (EG-L); Department of Law and Political Science, National University of La Matanza, San Justo, Buenos Aires Province, Argentina (JÁM); National Institute of Transparency, Access to Information and Personal Data Protection, Mexico City, Mexico (LRSH); Mexico City, Mexico (JAAO); Senate of Mexico, Mexico City, Mexico (ALSR)

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Lancet Psychiatry 2024

Published Online October 8, 2024 https://doi.org/10.1016/ S2215-0366(24)00286-4