Utilization of genetic information for medicines development and equitable benefit sharing

Abstract

Advances in genomic research have significantly enhanced modern drug development. However, equitable benefit sharing of the results of scientific advancement has not always been achieved. This paper shows how molecular biology has modified medicines development while also leaving open significant challenges for benefit sharing. Presented here is a conceptual modeling describing the processes in genetic-related medicines development and how these are related to specific ethical considerations. The focus is on three important areas: 1) population genetics and the need for discrimination prevention; 2) pharmacogenomics and the need for inclusive governance; and 3) global health to be achieved in open science frameworks. Benefit sharing is taken as the ethical value that underlies all these aspects. The implementation of benefit sharing requires a value shift in which the outcomes of health science are not viewed simply as trade commodities but also as a “global public good”. This approach should lead to genetic science to contribute to promoting the fundamental human right to health to all members of the global community.

Declaration of Helsinki: ethical norm in pursuit of common global goals

“…The debate on placebo control raised a norm in the 2000 version of the DoH regarding the right of trial participants to post-trial access to interventions proven to be effective. This was to avoid injustice and exploitation of the host community of a placebo trial in low- and middle-income countries (LMICs), which may not have access to a high-priced intervention that has been shown to be effective ( 33 , 34 ). In subsequent revisions, it also came to be a pragmatic guideline requiring to describe a plan for post-trial access in the study protocol and informed consent form.…”