Intervention on the Human Genome: Re-examination Process of Article 13 of the Oviedo Convention - Conclusions and Clarifications

In 2021, the Council of Europe determined that it was necessary to clarify the provisions of the Oviedo Convention pertaining to human genome editing. These clarifications were designed to clear up ambiguity surrounding the applicability of Article 13 of the Oviedo Convention to research and in particular, the use of the terms “preventive, diagnostic and therapeutic.” The clarifications approved by the Steering Committee for Human Rights in the fields of Biomedicine and Health (CDBIO) specify that Article 13’s restrictions apply to human genome editing for both clinical and research purposes. They also explicitly prohibit the use of any genome edited gametes or embryos in reproduction, indicating a firm ban on heritable human genome editing. Consistent with the Explanatory Report of the original Oviedo Convention, the re-examination only permits genome editing of gametes and embryos in vitro and delegates approval of such experiments to appropriate research ethics and regulatory bodies. Finally, the re-examination clarifies that non-heritable genome editing may be used in research contexts aimed at treating diseases and disorders defined “in accordance with internationally accepted medical standards.”