International Standard Setting in Biomedicine – Foundations and New Challenges

This article examines current challenges for a normative framework regulating biomedicine, including those arising from the use of big data and machine learning tools, and from the use of the CRISPR/Cas-9 technology, as for instance gene drives. The article focusses on the question of legitimate standard setting and takes into account both “hard” and “soft” law as well as private rule making. This includes international treaties and declarations in the area of human rights law and environmental law, such as the International Covenant on Civil and Political Rights, the Cartagena Protocol on Biosafety to the Convention on Biological Diversity, the Rio Declaration on Environment and Development, and, more specifically, the UNESCO Declaration on Bioethics and Human Rights. The author argues that, as instruments of biotechnology and biomedicine merge, international environmental law has to be interpreted in the light of human rights law. In order to adapt to new challenges, the article calls for a humanisation of international environmental law and, because of the ongoing disruptive technological development, argues that further legitimate standard setting is required. Keywords: Biomedicine, Biotechnology, Gene Drives, Standard Setting, CRISPR/Cas-9, Artificial Intelligence