Human Material Transfer Agreement

As explained in the background, the protection of personal data is governed by a specially designed status, POPIA [21]. The SA MTA can complement POPIA and facilitate its implementation. In cases where a supplier in South Africa intends to transmit human biological material or related data to a recipient in a foreign country and the foreigner does not provide an « adequate level of protection for the processing of personal data, » the supplier must obtain prior authorization from the information regulator for the proposed transfer ([21] Section 57,1.1.d)). In such cases, one solution would be to contractually bind the foreign recipient to certain POPIA-based conditions – in fact, identify and include all POPIA provisions that are relevant to the transfer of human biological material or related data as contractual terms in an MTA. In this context, a revised SA-MTA could play an important role; it would be very useful for the South African research community if the relevant provisions of LA POPIA can be merged by experts in data protection legislation, be formally approved by the information regulator and be incorporated as standard terms into a revised SA-MTA. We propose that the Minister of Health consider launching such a project. Mahomed S, Labuschaigne M. The role of research ethics committees in South Africa, when human biological material is transferred between institutions. S Afr J Bioethics and law. 2019;12:84-7.

The MTA SA requires that the distribution of benefits between the supplier and the recipient be « discussed and negotiated » before material can be transferred ([13] paragraph 7.1). This request is vague: the words « discussed and negotiated » do not mean the same thing as « an agreement. » In fact, the words « discussed and negotiated » do not really require agreement on the distribution of benefits. We propose that the parties to an MTA ensure that they have effectively agreed on the sharing of benefits prior to the signing of the MTA and that they adhere to and integrate their benefit-sharing agreement between the MTA. In the interest of legal security, we propose to amend the SA-MTA to replace « discussed and negotiated » with the term « agreed. »