Regulating human genomic research in Africa: why a human rights approach is a more promising conceptual framework than genomic sovereignty

Abstract

This article revisits the debate on the regulation of human genomic research, with a focus on Africa. The article comprehensively examines the concept of genomic sovereignty, which was invoked mainly in the global South as a conceptual framework for state regulation of human genomic research. It demonstrates that genomic sovereignty has no utility value in human genomic research as it violates the rights of individuals and researchers. By analysing Mexico’s regulatory approach based on genomic sovereignty and a divergent regulatory approach, viz Finland’s human genomic research framework, we show that a human rights approach is more promising as it aligns with the state obligations under the right of everyone to participate in and benefit from scientific progress and its applications in international human rights law. We conclude by recommending that African states should anchor regulation of human genomic research on a human rights framework based on the right to science.

Open science and human genetic data: recommendations on South Africa’s Draft National Open Science Policy

“…For example, if, hypothetically, private research company X is the owner of the genetic data of thousands of South Africans, a policy that proposes that all genetic data of South Africans ought to be made public property effectively proposes that the state ought to expropriate private research company X’s property. This may require an excessive amount of state resources to accomplish, which raises the question of whether the policy objectives (such as greater accessibility of the genetic data) cannot be attained through different means (than making all genetic data of South Africans public property) ( Kabata and Thaldar, 2023 ). However, apart from briefly referring to a “traditionally” held legal view regarding human biological samples , the ASSAf report does not present legal analysis on whether human genetic data satisfy the criteria for ownership in South African law.…”

“…By contrast, open science entails access to research results—including human genetic data— free of access barriers ( Steger and Hantho, 2019 ; Crow and Tananbaum, 2020 ). As recently argued by Kabata and Thaldar (2023) , the idea of state sovereignty over human genomic (or genetic) data may seem superficially attractive, but has no actual utility to African states. Instead, the authors suggest a human-rights-based approach to the governance of human genetic data that focuses on everyone’s right to science , which is aligned with promoting open science ( Kabata and Thaldar, 2023 ).…”

Editorial: Toward a better understanding and application of benefit sharing in genomic and global health research

“…This lack of clear regulations on GBR is reported to be a general concern in African countries as echoed in reviews, including a recent review by Ali and his colleagues ( Mulder et al, 2017 ; Ali et al, 2021 ). As developments in this regard emerge, African regulators have been cautioned to consider regulations that balance the need to provide adequate protections for researchers and participants from Africa, while facilitating international research collaborations ( de Vries et al, 2017 ; Kabata and Thaldar, 2023 ).…”