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 benefitsharing
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.
