Public health emergency preparedness and response in South Africa: A review of recommendations for legal reform relating to data and biological sample sharing

• Author: M Steytler,D W Thaldar
• DOI: 10.7196/SAJBL.2021.v14i3.772
• Published date: 01 December 2021
• Date: 01 December 2021
• Pages: 101-106

December 2021, Vol. 14, No. 3 SAJBL 101

REVIEW

The COVID-19 pandemic has highlighted the importance of public

health emergency preparedness. To effectively respond to and

manage such health epidemics, as well as natural disasters, it is

imperative that governments and private institutions engage in

public health research. In the context of the pandemic, public health

research and innovation necessitates the collection and sharing

of human biological material (HBM; such as saliva, cell samples or

DNA), personal data (such as COVID-19 test results) and geospatial

surveillance data (such as the proximity of houses in specific

geographical areas). For research purposes, HBM and data are often

shared between institutions and governments around the world. The

pandemic has accelerated the need for such sharing – the pooling of

resources is beneficial for producing meaningful research. The need

for efficient collection and sharing of HBM and data emphasises the

significance of effective regulation of these activities. Various scholars

have investigated the South African (SA) legal scheme regulating

the sharing of HBM and data, revealing certain pre-existing flaws

that have been emphasised by the COVID-19 pandemic.[1-14] These

flaws hinder SA’s response to the current pandemic and to future

public health emergencies and natural disasters. This article focuses

on the regulation of the sharing of HBM, geospatial data and

personal information in light of the current pandemic’s acceleration

of the need for researchers to rapidly share these resources in

order to engage in important public health research. The article

reviews and integrates the analyses, and presents the different legal

recommendations for legal reform to improve SA’s response to future

pandemics and disasters.

Background

The COVID-19 pandemic has emphasised the need for expedient (and

legitimate) sharing of HBM and, in turn, has revealed pre-existing

inconsistencies and shortcomings in the law. One shortcoming is the

lack of legal clarity regarding the susceptibility of HBM to ownership,[1,8]

which in turn leads to uncertainty about many aspects of research,

such as rights in inventions based on such HBM.[1] Legal uncertainty is

detrimental. The Nuffield Council of Bioethics states that:

‘the need to clarify the law is important insofar as its uncertainty

may impede legitimate treatment, teaching, study or research or

even, at worst, may encourage illegitimate uses of human tissue’.[15]

The clarification of the lawfulness of using and sharing HBM

for research purposes[1] is important, not only because of the

development of biobanks in many African countries,[9] but also

owing to the need for rapid and efficient HBM sharing to facilitate

crucial international collaborative research related to COVID-19 and

future pandemics. In order to ensure that HBM is being collected,

used and shared lawfully, the legal position on the susceptibility of

HBM to ownership must be clarified.[1]

The COVID-19 pandemic has also highlighted the need to use

technology to assist in disease detection and prevention through

This open-access article is distributed under

Creative Commons licence CC-BY-NC 4.0.

Public health emergency preparedness and response in

South Africa: A review of recommendations for legal reform

relating to data and biological sample sharing

M Steytler, LLB, LLM; D W Thaldar, BLC, LLB, MPPS, PhD, PGDip

School of Law, College of Law and Management Studies, University of KwaZulu-Natal, Durban, South Africa

Corresponding author: D W Thaldar (ThaldarD@ukzn.ac.za)

COVID-19 exposed flaws in the law regulating the sharing of data and human biological material (HBM). This poses obstacles to the epidemic

response, which needs accelerated public health research and, in turn, efficient and legitimate HBM and data sharing. Legal reform and

development are needed to ensure that HBM and data are shared efficiently and lawfully. Academics have suggested important legal

reforms. The first is the clarification of the susceptibility of HBM and HBM derivatives to ownership, including, inter alia, the promulgation

of a revised version of the South African Material Transfer Agreement (SA MTA) by the Minister of Health. This would remove uncertainty

regarding the current SA MTA’s perpetual donor ownership clause. The second is the development of data trusts, the adoption of open access

to research data, and the creation of an African ‘data corridor’. This would ensure that data are protected while allowing for the efficient

transfer of data between researchers for the collective good and in the interest of the public. The third is the amendment of the Space

Affairs Act to extend the powers of the Council of Space Affairs to include the management of data collected through the utilisation of Earth

observation and geographical information systems. This would ensure the protection of outer space data, legislating its use and sharing

once it lands on Earth. The implementation of these legal reforms and developments will better prepare SA to face future epidemics from a

health research perspective.

S Afr J Bioethics Law 2021;14(3):101-106. https://doi.org/10.7196/SAJBL.2021.v14i3.772