Governance of technologies
Examining Article 13 of the Oviedo Convention in the light of developments in gene editing technologies
In its statement of December 2015 on gene editing technologies, the Committee on Bioethics made a commitment to examining the ethical and legal challenges raised by genome editing technologies in the light of the principles laid down in the Oviedo Convention. To this end, this action necessitates an examination of the practical and legal implications of Article 13 of the Oviedo Convention as it relates to the use of gene editing technologies in the context of research, and of clinical applications of gene editing in somatic cells and the germline. The examination may indicate a need to clarify or amend Article 13.
Embedding human rights in the development of technologies which have an application in the field of biomedicine
Technological innovation often creates its own dynamic. Major technological breakthroughs in fields such as artificial intelligence, genome editing, and neurotechnology have the potential to advance biomedicine and healthcare. However, uncertainty exists about the impact and direction of these developments. For example, artificial intelligence is increasingly proficient in diagnostics but depends on massive amounts of patient data which may impact on transparency and patient trust, thereby necessitating the provision of guidance for healthcare professionals. Genome editing techniques which introduce inheritable changes in the human genome raise serious concerns about the possibilities of irreversible harm to future persons. Developments in neurotechnologies, such as deep brain stimulation, brain-computer interfaces, and artificial neural networks, raise the prospect of increased understanding, monitoring, but also of control of the human brain, raising issues of privacy, personhood, and discrimination.
The role of governance in biomedicine is often restricted to facilitating the applications of technology and to containing the risks that come to light. In this way, human rights considerations will only come into play at the end of the process, when the technological applications are already established, and the technological pathways often have become irreversible. To overcome this problem, there is a pressing need to embed human rights in technologies which have an application in the field of biomedicine. This implies that technological developments are from the outset oriented towards protecting human rights. For that reason, governance arrangements need to be considered, which seek to steer the innovation process in a way which connects innovation and technologies with social goals and values.
- Set up a drafting group
To provide clarifications on the terms “preventive, diagnostic and therapeutic” and to avoid misinterpretation of the applicability of this provision to “research”.”