PAUL ESSELAAR AND DONRICH THALDAR
The recent draft revision of South Africa’s standard Material Transfer Agreement (SA MTA) by the National Health Research Ethics Council (NHREC) may not yet be the subject of widespread public controversy, but it certainly warrants closer scrutiny and debate.
This new draft version of the SA MTA, intended for the transfer of human biological materials, epitomises the complexities and challenges at the intersection of legal compliance, scientific advancement and ethical responsibility.
It is imperative that the revision be brought to the public’s attention, as it has significant implications for the trajectory of South African scientific research in the global knowledge economy, especially considering the nation’s colonial history.
Inadequate Consideration of Pathogens in Human Biological Material
The draft SA MTA overlooks the intricacies associated with human biological material, particularly the presence of human pathogens. Consider, for example, the damage that a human biological sample containing the Ebola virus might wreak on the South African public if the material transfer is not handled properly and the virus escapes.
Human biological material that contains such harmful pathogens may qualify as “weapons and mass destruction” and fall under the purview of the Non-Proliferation of Weapons of Mass Destruction Act. The crucial aspect, however, is ignored in the draft SA MTA.
Such an omission is not merely a procedural oversight but a matter of grave concern, given the severe risks these pathogens pose, potentially escalating to public health emergencies if not properly managed and regulated.
Legal Ambiguities and Misalignment with Data Protection Standards
The mandatory nature of the SA MTA, coupled with its ambiguous provisions regarding permissible amendments, raises immediate practical concerns. Research organisations are legally bound to adhere to this template, yet the extent that the template can be modified remains unclear.
Such ambiguity not only creates operational hurdles but also legal uncertainties. For instance, the new draft SA MTA’s narrow definition of the legal phrase “becomes identifiable”, as pertaining to personal identification, stands in conflict with the same phrase in the Protection of Personal Information Act (Popia).
This contradiction is not merely a technical issue; it represents a deeper disconnect with current data protection principles, essential for maintaining international research standards.
This oversight in aligning the SA MTA with Popia reveals a larger missed opportunity. Instead of leveraging the MTA as a tool for harmonising South Africa’s legal framework with global data protection and privacy standards, the NHREC’s approach has inadvertently perpetuated legal incongruence.
The lack of collaboration with the Information Regulator, Popia’s implementation agency, further undermines the draft SA MTA’s effectiveness and relevance.
Emphasising Inclusivity and Stakeholder Engagement
The development process of the draft SA MTA also points to a systemic flaw in the NHREC’s approach: insufficient inclusive consultation. By limiting feedback to ethics committees and not engaging comprehensively with legal experts and the scientific community – the primary end-users of the SA MTA – the draft SA MTA risks being disconnected from the practical realities of scientific research.
The approach echoes historical instances where local expertise and knowledge were overlooked, a practice reminiscent of colonial administrative methods.
To rectify this, the draft SA MTA should be reimagined as a dynamic, evolving document, shaped by input from a broad spectrum of stakeholders, including the scientific community handling the materials. This would ensure that the eventual new SA MTA not only adheres to legal standards but also resonates with the practical needs of the scientific community.
Adopting such a collaborative and iterative approach to revising the SA MTA is more than a policy improvement; it is a step towards decolonising South Africa’s role in global health research.
It’s about transitioning from being a provider of raw materials to an equal stakeholder in shaping the ethical and legal norms governing their use. The shift is essential for South Africa to assert its rightful place in the international scientific arena, contributing not just materials but also intellectual leadership.
Elevating South Africa’s Role in Global Science Through the SA MTA
Bringing this issue to the forefront of public discourse is crucial. It is time for a broader debate on how South Africa can leverage policy tools like the SA MTA to enhance its scientific standing globally while upholding the highest ethical and legal standards.
The conversation is not just for ethics committees; it concerns all who are vested in the future of South African research and its role on the world stage. The revised SA MTA, therefore, should be seen not just as an ethics instrument, but as a reflection of South Africa’s aspirations and commitments in the realm of global scientific collaboration.
Paul Esselaar is an attorney in private practice, and an honorary research fellow at the School of Law, University of KwaZulu-Natal.
Donrich Thaldar is a professor at the School of Law, University of KwaZulu-Natal.