Abstract
Introduction:The transfer of biological materials is a pivotal aspect of health research, especially in clinical trials conducted in Africa. Globally, standard material transfer agreements (MTAs) have been developed in an effort to standardize the transfers of biological materials. Recent controversial conduct in research in sub-Saharan Africa highlightsthe need for robust regulation, especially concerning biological sample transfer. The question remains whether these new regulations in African countries are sufficient to ensure ethical conduct.
Methods:This study evaluated the sufficiency of Zambia's existing legislation concerning MTAs using South African laws and guidelines as comparators. A qualitative study approach was adopted utilizing a desk review. Thematic analysis was conducted after extracting information from relevant national legal documents thatare publicly accessible. Necessary permissions and approvals were obtained before conducting the research.
Results: Thisstudy determined that Zambia and South Africa (SA) have established regulations for transfer of biological materials in health research. Zambia's framework is based on the National Health Research Act No. 2 of 2013 and MTA regulations of 2018. This Act emphasizes the importance of consent when extracting tissue or blood, and mandates that samples and data remain the property of the Zambian government. In contrast, South Africa's guidelines stemmed from the National Health Act 61 of 2003 and regulations SAMTA 2018, detailing an ongoing informed consent process and protection of donor data privacy.
South Africa provides a more detailed account of benefit sharing, whereas Zambia adopts a more generic approach. The South African framework offers specific guidance on the secondary use of materials and custodianship.
Both nations emphasize intellectual property rights but to differing extents. However, ambiguities persist in both countries regarding the details of benefit sharing
Conclusion:
The study revealed that Zambia and South Africa have established detailed legal frameworks governing the transfer of biological materials in health research incorporating consent, national sovereignty and protection of privacy. However, the effectiveness of their enforcement and implementation remains a critical concern, particularly in addressing ambiguities related to benefit sharing, ownership, custodianship, and intellectual property rights.