At the onset of the COVID-19 pandemic the South African government published "special regulations" to contain the spread of the disease. These actions were taken under special powers granted by the Disaster Management Act.
In April 2022, South Africa's President Cyril Ramaphosa announced an end to the crisis management mode the country had been in for two years. Now processes are underway to embed some of the special regulations into the country's general health regulations related to notifiable medical conditions.
Notifiable medical conditions are conditions, diseases or infections that pose an immediate and significant risk to public health. The diseases are categorised based on the severity of the threat they pose. Each disease is designated a reporting time and a set of conditions aimed at controlling its spread. Novel influenza viruses such as SARS-CoV-2, and diseases such as viral haemorrhagic fevers, including Ebola and malaria, are already on the list.
The Department of Health has published proposed regulations and invited public comment to incorporate the COVID special regulations into the general health regulations.
We have concerns about the proposed regulations. These concerns are based on our involvement in the health care sector and regulatory issues relating to South Africa's management of the COVID-19 pandemic.
Our first concern is that several proposed amendments could limit constitutional rights. Second, special regulations for a specific disease can't be applied generally to all notifiable diseases. Finally, the proposed regulations resemble a haphazard cutting and pasting of the emergency regulations. It's as though the drafters didn't first read what's already in place.
Below we highlight some of our concerns; our analysis is not an exhaustive detailed critique of the entire proposed regulation package.
Regulation 15 deals with mandatory medical examination, prophylaxis, treatment, isolation and quarantine of confirmed cases, carriers and contacts. The eight sub regulations in the proposal are redundant for the most part. Current regulations already set out several conditions that must be fulfilled before someone can be compelled by court order to undergo examination, admission to a health establishment or mandatory prophylaxis, treatment, isolation or quarantine. In our view, nothing additional is needed.
Two of the proposed regulations could be valuable additions if phrased differently. These relate to the designation of quarantine facilities and the criteria for self-quarantine and self-isolation. Criteria for self-isolation or self-quarantine include access to the internet as well as a private physician to report symptoms daily. But conditions in South Africa make it impossible for millions of people to comply with this because they don't have access to the internet or a private physician. Regulation 15G also requires self-isolation or self-quarantine facilities to provide primary healthcare services, emergency medical services, and forensic pathology services. These requirements do take into account the fact that these services aren't available when a person self-isolates at home.
Proposed regulation 15H deals with contact tracing. This section was copied directly from the COVID-19 regulations. Personal data collection and contact tracing are not a trivial matter. They involve constitutional rights, privacy and bioethics concerns. Constitutional rights can only be limited under exceptional conditions. The proposed regulations cannot exist outside the requirements of the Protection of Personal Information (POPI) Act.
When personal data, including DNA samples, are collected during a pandemic and kept for future research and teaching, the owners of the biological material and data should be protected against victimisation and exploitation. Protection may include:
- Anonymising the data so that it cannot be linked to a particular individual.
- Restricting the collection and use of genetic data to cases where explicit informed consent has been given and the intended use is specified.
- Data subjects should be able to verify the accuracy of their data on file or request the deletion of their data if they so wish.
- Researchers should be prevented from monetising data without patient consent.
There are other examples where Covid regulations have been directly copied over into the proposed regulations. These relate to public places and attendance of funerals and gatherings and travel regulations. These will simply create confusion when applied to all notifiable diseases.
There are opportunities to improve the existing general regulations based on lessons learned during the pandemic. But legislators should carefully consider the healthcare, legal and ethical implications, and citizens' constitutional rights. These are protected under Section 27 of the country's Constitution (the Bill of Rights).
Great care should be taken to ensure that wording is not obscure or ambiguous. It should not be the duty of the courts to, post facto, interpret acts and regulations. Overall, no regulation limiting any fundamental human right should be activated unless supported by clear evidence. This should be accompanied by a transparent risk and benefit analysis that shows such measures are necessary.
Rather than merely copying the COVID-19 regulations, the Department of Health should apply the lessons learned during the past two years to develop meaningful new ones. These should address the surveillance and control of notifiable medical conditions to prepare the country for future pandemics. In addition, the department should invest time to construct general regulations that allow broader interpretation.
A valuable contribution could be to clearly define how outbreaks, epidemics and pandemics would be dealt with on a town, city, district, provincial and national level. Transparent criteria should be defined for various levels of control. The criteria should be based on reasonable measures such as the number and severity of cases, hospitalisations and deaths per million population and the treatment capacity in that specific geographic area.
Ignatius Michael Viljoen, PhD Candidate Cell and Gene Therapy Regulation. Institute for Cellular and Molecular Medicine,, University of Pretoria; Marietjie Botes, Post Doctoral Fellow, University of KwaZulu-Natal, and Michael Sean Pepper, Director, Institute for Cellular and Molecular Medicine & SAMRC Extramural Unit for Stem Cell Research & Therapy, University of Pretoria