Distal Horizons: An investigation of the justifiable downstream limits to the positive protection of traditional knowledge associated with genetic resources within drug discovery

International initiatives, such as the Nagoya Protocol to the United Nations Convention on Biological Diversity (the Protocol), have created (or are creating) “access and benefit sharing” rights which seek to ensure that genetic resources and traditional knowledge associated with such genetic resources (“TKAGR”) cannot be used without the consent of rights holders. These initiatives (including the Protocol) are unclear on how far non-consensual “use” extends to man-made downstream derivatives of the products of genetic expression. It also gives no guidance as to the degree to which control over TKAGR should extend throughout the drug discovery process. This work demonstrates how such TKAGR entering into a drug discovery process will be diluted with other information, used as an inspiration for further research, or for the development of research tools which may, in turn, lead to further discoveries and highlights how useful drugs may be very distal from the original inspiration provided by the TKAGR. This work also examines the causal link between an original piece of TKAGR and remote “downstream” uses of that information within drug discovery. It identifies “serendipitous” discoveries of unexpected second uses as a potential point at which the causation in law link to distal use may potentially be broken. This thesis examines the high level normative justifications for these rights, and in particular uses consequentialist/utilitarian, contribution/desert claims and distributive justice (Rawlsian maximin) claims to test their justifiable scope.