South Africa’s new standard material transfer agreement: proposals for improvement and pointers for implementation

Abstract

Background Whenever South African (SA) research institutions share human biological material and associated data for health research or clinical trials they are legally compelled to have a material transfer agreement (MTA) in place that uses as framework the standard MTA newly gazetted by the South African Minister of Health (SA MTA). Main body The article offers a legal analysis of the SA MTA and focuses on its substantive fit with the broader legal environment in South Africa, and the clarity and practicality of its terms. The following problematic aspects of the SA MTA are highlighted: (a) Where only data and no human biological material are transferred, the SA MTA does not apply, leaving a lacuna; (b) Health Research Ethics Committees are required to be parties to a MTA despite it being outside their legal mandate and undermining their oversight function; (c) the SA MTA’s consent provisions are not aligned with extant law; and, similarly, (d) its provision on donor ownership is misaligned with extant law; (e) its creation of fictitious performance can only cause frustration on the part of an injured party; (f) its benefit-sharing provision is vague and will have little practical effect; (g) its dispute-resolution provisions fail to adequately protect South African research institutions and research participants; (h) it fails to provide substantive guidance regarding intellectual property as its provisions relating to intellectual property may cause practical problems; and, finally, (i) its data privacy provision is insufficiently specific, is overbroad, and fails to provide terms that in general would facilitate the international sharing of human biological material and associated data in terms of existing privacy law. Conclusions While some of the problematic aspects of the SA MTA are intricate and require consultative processes with stakeholders and others, to develop comprehensive solutions, most of the problematic aspects can be resolved immediately through amendments by the South African Minister of Health. The formulation of such amendments is proposed and, where possible, interim measures are suggested that may ameliorate the problems presented by the SA MTA.

The role of Data Transfer Agreements in ethically managing data sharing for research in South Africa

“…[7] However, the template is limited when the transfers of data for research are contemplated, which may be because it was published prior to POPIA coming into effect. The template has received criticism [17] and the fact that it is a guidance document only may cause sections of it to be regarded as unimportant and excluded by researchers when completing it. [18] We therefore advocate that a national DTA, that is POPIA compliant, complement the current SAMTA with a view to having one consolidated document for the transfer of samples and data in the long term, and propose the following roadmap to achieve this.…”

Biobanks in the low- and middle-income countries of the Arab Middle East region: challenges, ethical issues, and governance arrangements—a qualitative study involving biobank managers

“…However, only four biobank managers in our study mentioned the use of such agreements when samples are exported internationally. Essential components to be included in MTAs have been identified [ 45 ], although some recommended items have proved to be problematic [ 46 ]. When sharing samples, unambiguous MTAs with precise specifications on how individuals' and communities' rights and interests can be protected are imperative.…”

“…Obtaining public trust encourages a donation to the biobank and public funding [ 45 ]. If the community becomes suspicious of the governance structures of biobanks, or if there is a general perception that biobanks do not support public needs and interests, biobank activities may be significantly hindered [ 46 ].…”

One material transfer agreement to rule them all? A call for revising South Africa’s new standard material transfer agreement

“…By contrast, I believe that the SA MTA is an overhasty regulatory attempt that is flawed in theory and likely to be inadequate in practice. Elsewhere, my co-authors and I analysed the SA MTA's substantive fit with extant law, its practicality and its clarity, and highlighted numerous problematic issues (Thaldar et al, 2020). The analysis in Thaldar et al (2020) forms the basis for the critique of the SA MTA in this article.…”

“…Elsewhere, my co-authors and I analysed the SA MTA's substantive fit with extant law, its practicality and its clarity, and highlighted numerous problematic issues (Thaldar et al, 2020). The analysis in Thaldar et al (2020) forms the basis for the critique of the SA MTA in this article. However, the problematic nature of the SA MTA extends to the way in which it was interpreted and defended by Labuschaigne et al In this present article, the main focus is on three key propositions in Labuschaigne et al's article.…”