Governing Human Germline Editing Through Patent Law

Abstract

In the wake of the heritable human genome editing (HHGE) experiments carried out by He Jiankui in China, 1 widely condemned as unethical and scientifically ill grounded, attention has shifted to questions concerning hard law and regulation. The World Health Organization (WHO) recently released a report along with several auxiliary documents exploring international governance tools for human genome engineering. 2 However, as long as such governance occurs only at the national legal level, the possibility of medical tourism to circumvent domestic prohibitions remains a risk.The risk is not merely theoretical. As with the case of mitochondrial replacement techniques, patients have left their home country for seemingly more permissive regimes in Greece, Spain, Mexico, and Ukraine to access such therapy. 3 The 2019 announcement of possibly establishing a germline-editing clinic in Russia is a case in point. 4 One solution would be an approach like an international treaty on genome editing. But the most recent report from the WHO did not pursue that avenue.Instead, the WHO largely relied on national implementation of governance tools to provide a translational pathway for potential HHGE uses as well as a way to publicly disclose and report on uses that deviate from

Handle with Care: The WHO Report on Human Genome Editing

“…Nonetheless, the report does not immediately address concerns some have voiced about the propriety of patenting such technologies in the first instance 30 . Unlike the United States, most European countries prohibit patents on ethically controversial technologies thought to violate the ordre public , or public order, including patents directed to human embryonic stem cell lines.…”

“…Nonetheless, the report does not immediately address concerns some have voiced about the propriety of patenting such technologies in the first instance. 30 Unlike the United States, most European countries prohibit patents on ethically controversial technologies thought to violate the ordre public, or public order, including patents directed to human embryonic stem cell lines. Such rules seek to incorporate a moral valence to biotechnology patents, disallowing ownership over certain technologies that are thought to violateor come close to violating-aspects of human dignity.…”

Points to consider in the development of national human genome editing policy

“…As such, there is some indication of an appetite for self-regulation to ensure that the promise of genome editing is broadly shared. This has been referred to as ‘ethical governance by patent’ (Sherkow et al, 2021 ). Notably, however, some commentators have expressed unease about leaving such decisions to patent holders rather than to democratically elected governments (de Graeff et al, 2018 ).…”