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

Abstract

In 2018, the South African Minister of Health gazetted a material transfer agreement (SA MTA) that must be used as a framework whenever a researcher based in South Africa is involved in the transfer of human biological material. The SA MTA therefore impacts not only on the South African research community, but also its international research partners. The SA MTA has been portrayed in a positive light by Labuschaigne et al. in a recent article. By contrast, in this present article, the position taken is that the SA MTA is deeply problematic, and it is argued that Labuschaigne et al. have erred with regard to three key propositions of their account of the SA MTA. The first proposition, namely that a Health Research Ethics Committee should be a party to a material transfer agreement, as contemplated in the SA MTA, is shown to be unfeasible. Similarly, the second proposition, namely that under the SA MTA a research participant retains proprietary rights in donated human biological material, is shown to be legally untenable. The third proposition, namely that the arbitration option in the SA MTA (which allows parties to opt out of the jurisdiction of South African courts) is both necessary and adequate, is shown to be false. Not only is the claim that the arbitration option is required by international collaborators contradicted by Labuschaigne et al.'s own example, but the present SA MTA's dispute resolution provisions are shown to be inadequate. In this light, a more appropriate solution in respect of dispute resolution is proposed. In the interest of both the South African research community and their international research partners, the South African Minister of Health is called upon to engage in open public consultation on the SA MTA and to fundamentally revise it as a matter of urgency.

Forcing a square into a circle: why South Africa’s draft revised material transfer agreement is not fit for purpose

“…In 2018, the South African Minister of Health published a standard material transfer agreement (MTA) in the Government Gazette and gave notice that research institutions sharing human biological material for health research or clinical trials must use this MTA (SA MTA) ( Material Transfer Agreement for Human Biological Materials, 2018 ). The SA MTA was controversial from the outset ( Thaldar, 2020 ; Thaldar et al, 2020 ). The notion of the state in a supposedly open and democratic society, forcing the use of a single template onto everyone is clearly suspect.…”

Towards a data transfer agreement for the South African research community: The empowerment approach

“…Furthermore, it has been highlighted in the literature that the SA MTA is in conflict with other pieces of legislation administered by the Minister of Health. [6][7][8][9] The minister made the SA MTA compulsory to use for all providers and recipients of 'biological material for use in research or clinical trials under the auspices of the Health Research Ethics Committees' . In other words, the SA MTA is compulsory when biological material is shared for purposes of health research or clinical trials.…”