Governance of biological sample sharing in health research: Material transfer agreements in Zambia and South Africa – necessary but not sufficient?

The transfer of biological materials is pivotal in health research, especially in clinical trials conducted in sub-Saharan Africa (SSA). Standard material transfer agreements (MTAs) have been developed to exercise due diligence during the transfer of biological materials. Recent controversial conduct in research in SSA highlights the need for robust regulation, especially concerning biological sample transfer. This study evaluated the sufficiency of Zambia’s existing regulations concerning MTAs using the South African regulatory framework as a comparator. A qualitative study approach was adopted utilizing a desk review. Thematic analysis was conducted using relevant, publicly accessible national regulatory documents. All necessary approvals were obtained. Both countries have established provisions for MTAs in health research, although the legal status of the respective provisions differ. Zambia’s MTA is based on the National Health Research Act No. 2 of 2013 and mandates that while samples and data remain the property of the Zambian government, research participants must share in future benefits that arise. In contrast, South Africa’s MTA (2018) is a framework agreement, outlining the contractual aspects of biological sample sharing in research. It highlights ownership of samples as resting with the “donor,” benefit sharing, an ongoing consent process, secondary use of materials and dispute settlement. Both nations emphasize intellectual property rights, privacy with respect to samples and associated data. In Zambia, it is a legal requirement for contracting parties to sign a MTA. Ownership of biological samples vests with the Zambian government. On the other hand, the South African MTA (2018) is regarded as a regulatory framework and is contentious especially with respect to ownership and inclusion of the REC as a contractual party. In both countries, enforcement and implementation remain critical concerns in collaborative research involving sharing of biological samples. Consequently, the MTAs need to be reviewed. Reaching consensus is a research ethics imperative.