Abstract
BackgroundWhenever 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 bodyThe 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.ConclusionsWhile 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.
Highlights
We offer a legal analysis of the South African (SA) material transfer agreement (MTA), concentrating on its substantive fit with the broader legal environment in South Africa and on the clarity and legal practicality of its terms
The Minister might have had other reasons for promulgating the South African Minister of Health (SA MTA) as has been suggested in the academic literature. These reasons include the following: (a) There is a history of accusations of unethical or illegal conduct by health researchers regarding the use of South African – and more generally African – human biological material [28]; (b) there is a movement against so-called ‘research imperialism’ that refers to situations where researchers in the Global North undertake research in the Global South but do not share the benefits of that research in a fair way with research participants and scientific collaborators in the Global South [28]; (c) many cultures in South Africa attach particular significance to human biological material [29]; and (d) MTAs used in the international sphere are perceived not to address legal concerns specific to South Africa [29]
Main text we offer a legal analysis of the SA MTA, concentrating on its substantive fit with the broader legal environment in South Africa and on the clarity and legal practicality of its terms
Summary
It seems reasonable to entertain the notion of a national standard MTA that addresses the legal concerns specific to South Africa, that is respectful of local culture and that assists generally South African research institutions and their international collaborators in complying with the law and share the benefits of research in a fair way. The manner in which it has been put into practice by the SA MTA is deeply problematic in terms of its substantive fit with the broader legal environment in South Africa, its clarity and its legal practicality. Some of the issues are complex and require consultative processes with stakeholders and others, to develop comprehensive solutions, most of the issues that we have identified in the SA MTA as problematic can be resolved immediately through relatively simple amendments by the Minister. Author details 1School of Law, University of KwaZulu-Natal, Durban, South Africa. Author details 1School of Law, University of KwaZulu-Natal, Durban, South Africa. 2African Health Research Flagship, University of KwaZulu-Natal, Durban, South Africa. 3Faculty of Law, University of Pretoria, Pretoria, South Africa. 4Centre for Ethics and Philosophy of Health Sciences, Faculty of Health Sciences, University of Pretoria, Pretoria, South Africa. 5Division of Law, Abertay University, Dundee, Scotland, UK
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