Brussels, 7 March 2024
Question for written answer E-000732/2024 to the Commission
Rule 138
Eva Kaili (NI)
Ethical and legal aspects of brain chips.
The company Neuralink[1] recently announced that it had implanted a microchip in the brain of a human patient. Previous implants have helped disabled people regain some motor[2] or visual functions[3].
The latest implant differs significantly from earlier ones in which microchips transmitted wireless commands from the brain to the body’s organs, legs, or optic nerves. In contrast, the latest microchip implant, the first of its kind, primarily targets people unable to use their limbs and enables users to control their phone or computer by thought.
Microchip implants are therefore a revolutionary technology that is expected to have both positive and negative social, ethical, legal and practical impacts. These include bioethical issues, challenges for human rights and accountability issues. Consequently:
- What measures does the Commission intend to take to ensure compliance with the principles of human dignity, the fundamental rights of people, and especially patients?
- How will equal access to technology be ensured to provide equal care?
- What legislative initiatives will be taken to prevent abuse of such technology and ensure accountability?
Submitted:7.3.2024
- [1] https://www.theguardian.com/technology/2024/jan/29/elon-musk-neuralink-first-human-brain-chip-implant.
- [2] https://www.bbc.com/news/science-environment-65689580.
- [3] https://www.theguardian.com/science/2019/jul/13/brain-implant-restores-partial-vision-to-blind-people.
Answer given by EU Commissioner Kyriakides on behalf of the European Commission
27 May 2024
Implantable medical devices fall into the scope of Regulation (EU) 2017/745 on medical devices[1] (MDR) and must comply with its general safety and performance requirements.
Devices intended to be implanted in the brain of human patients, being in contact with the central nervous system, are classified in the highest risk class (III) taking into account the intended purpose of the devices and their inherent risks. Therefore, the applicable requirements are especially stringent.
Ethical aspects of the use of medical devices are not specifically regulated in the MDR. However, it requires that any clinical investigation with a medical device, which is mandatory to gather pre-market clinical data for implantable and class III devices, is designed and conducted in such a way that the rights, safety, dignity and well-being of people participating in the clinical investigation are protected. Clinical investigations are subject to scientific and ethical review, performed by ethics committees in accordance with national law.
The ongoing CORE-MD project[2], set up to improve methods for clinical investigation and evaluation of high-risk medical devices, in the framework of the EU Horizon 2020 project, will deliver an ethics charter for the use of high-risk devices.
The European Group on Ethics in Science and New Technologies (EGE)[3] has set up a Working Group on ethics and governance of neurotechnology to issue policy recommendations by beginning of 2025.
The Commission is cooperating with the Council of Europe, and the Organisation for Economic Cooperation and Development (OECD) in the context of the recommendation on Responsible Innovation in Neurotechnology[4], towards the development of a robust international framework in that regard.
[1] Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC. ELI current consolidated version: https://eur-lex.europa.eu/eli/reg/2017/745/2023-03-20?locale=en
[2] Coordinating Research and Evidence for Medical Devices (CORE-MD): https://www.core-md.eu/. It has received funding from the European Union’s Horizon 2020 research and innovation programme.
[3] https://research-and-innovation.ec.europa.eu/strategy/support-policy-making/scientific-support-eu-policies/european-group-ethics_en
[4] https://www.oecd.org/science/recommendation-on-responsible-innovation-in-neurotechnology.htm