This rapid situational analysis was conducted during October 2020 to gain insight into the current situation with respect to access to quality health technologies (PPE, diagnostic tests, ventilators) for COVID-19 in South Africa, as well as potential barriers and enablers to access to health technologies currently under development (vaccines, treatments). The situational analysis further sought to understand how regulatory frameworks, health financing, local manufacturing capacity and domestic research activities impact/may impact health technology access in the country.Final Situation Analysis EACT South Africa 15 Nov 2020-1
You may download the situation analysis here
Data for the situational analysis was collected through in-depth interviews with key informants, stakeholder engagement, and an extensive review of grey literature related to health technology development and access in South Africa. Five in-depth interviews were conducted with key informants actively involved with or leading government’s efforts to respond to COVID-19 and deliver needed health technologies (this input is referred to in the report as interviewee input). Input was also sourced from stakeholders (civil society members and PHM partners and colleagues) through phone and email communication (this input is referred to in the report as stakeholder input).
The purpose of this situational analysis is to inform and strengthen civil society’s engagement towards ensuring that health technologies for COVID-19 are broadly and equitably accessible in South Africa, including for marginalised and vulnerable groups.
The report is organised in two sections:
- The first section gives an overview of the current situation with regards to access to health technologies (and key services) for COVID-19 in South Africa
- The second section explores how South Africa’s research, development, and manufacturing capacity, as well as legal frameworks and process for protecting intellectual property and regulating health technologies impact/may impact access to COVID-19 health technologies in the country.
Health technology access barriers identified and described in the report are summarised in Table 1 (see page 6). The table also identifies potential areas for community monitoring or advocacy towards improving equitable access to COVID-19 health technologies in South Africa.
Since the appearance of SARS-CoV-2 in late 2019, the novel virus has rapidly spread across the globe and caused a staggering toll in terms of loss of life and health impairment. By end-October 2020, more than 43 million cases of COVID-19 were confirmed and over a million deaths were reported.
COVID-19 and its responses have also significantly disrupted routine health care services—including childhood vaccinations, HIV, and TB services—and upended economic systems—severely increasing economic vulnerability and food insecurity. Morbidity and mortality due to increased economic hardship and disruption of regular health services may surpass and outlast morbidity and mortality due to COVID-19.
Effective health responses and access to health technologies for COVID-19 are critical to reduce COVID-19 illness and death, enable broader health service functioning, and repair damaged industries and economies. While country responses to COVID-19 have significantly varied, access to health technologies have fallen into long entrenched patterns of inequality both between and within countries.
High-income countries (HICs) have pushed aside the needs of low- and middle-income countries (LMICs) in seeking to secure health technologies for their own populations. In the early months of the pandemic, wealthy countries used their financial and political strength to secure and hoard critical personal protective equipment (PPE) and diagnostics for their populations. As the development of vaccine candidates has progressed, wealthy countries have pre-bought vaccine supply at-risk—impeding efforts by the World Health Organisation (WHO) to facilitate equitable distribution of vaccines (once available) across all countries.
Within South Africa, access to COVID-19 health technologies has also been stratified across income levels, due to existing inequities in the distribution of critical resources between the public and private health sectors. The private health sector which serves around 15 percent of South Africa’s population and consumes around 50 percent of health spending in the country is significantly better resourced than the public sector to respond to COVID-19. At the start of the pandemic, two-thirds of the country’s ventilators and over 80 percent of the critical care bed capacity was located in the private sector.,
Significant work has been undertaken by government agencies to prepare and enable South Africa’s public health sector to respond to the pandemic, with support from local industry and other stakeholders. The public sector brokered a deal to procure critical care beds from the private sector, supported the ‘National Ventilator Project’ which developed and distributed 20,000 CPAP machines across the country, and is supporting local development and commercialisation of COVID-19 tests and test materials. Government is also supporting local trialling of COVID-19 treatments and vaccines, which will provide important evidence on their effectiveness in local populations.
South Africa has also been an international leader in seeking to ensure that commercial monopolies and barriers to knowledge do not impede the development of and access to health technologies for COVID-19. In this vein, South Africa (together with India) has asked the World Trade Organisation (WTO) to grant a waiver to allow countries to not grant or enforce patents on COVID-19 health technologies throughout the pandemic, stating that “The waiver should continue until widespread vaccination is in place globally, and the majority of the world’s population has developed immunity”.
On 16 October, South Africa told the TRIPS Council that “the COVID-19 pandemic is a clarion call for us to answer to the better angels of our nature”, adding “Given this present context of global emergency, it is important for WTO Members to work together to ensure that intellectual property rights such as patents, industrial designs, copyright and protection of undisclosed information do not create barriers to the timely access to affordable medical products…to combat COVID-19”.
Yet, despite South Africa’s leadership in seeking to address intellectual property (IP) access barriers at an international level, domestic reform of the country’s patent laws to improve health technology access, which has been the subject of a sustained campaign by civil society organisations, remains overdue and sluggish. The country’s response to COVID-19 has also faltered in other critical areas. Procurement of PPE has been mired in corruption and shortages and poor-quality PPE have placed health care workers’ lives at risk. Further, despite massive efforts by the South African Health Products Regulatory Authority (SAHPRA) to rapidly establish and enforce systems to ensure the safety and efficacy of COVID-19 health technologies, slow regulatory processes have impeded the introduction of and access to critical health technologies—the National Ventilator Project reportedly ‘missed the peak’ due to slow regulatory guidance and approval of CPAP machines.
Lessons from experiences to date can help South Africa prepare for a potential second and any subsequent surges in infections, strengthen its ongoing response to COVID-19, and prepare for the mammoth task of procuring and delivering COVID-19 vaccines in the face of significant and daunting unknowns.
Civil society has a critical role to play in ensuring that lessons are learnt from responses to date and that shortcomings are addressed, including through: challenging legal barriers to health technology access; highlighting incoherence between South Africa’s statements regarding IP at an international level and domestic laws and policies; engaging with the rapidly changing regulatory environment for medical devices and demanding greater transparency from the regulator; challenging procurement processes that enable corruption; and holding corrupt officials to account. Civil society is already making important contributions in these areas through the Fix the Patent Laws Coalition, the Moral Call Collective, #orangemaskfridays, the C19 Peoples Coalition and other community initiatives.
Civil society also has a role to play in monitoring health technology access and raising awareness of shortages and quality challenges. While this report is focused on access to medical technologies, the availability of running water and soap at health facilities is also critical to prevent the spread of COVID-19 and other pathogens.
Fear of contracting COVID-19 has impeded access to and reduced uptake of other critical health services such as TB and HIV services, and childhood vaccines. Civil society can play an important role in mitigating these disruptions through engaging communities on the science of COVID-19 and monitoring and reporting health facilities not implementing proper precaution and hygiene measures—as done by the Treatment Action Campaign in the Eastern Cape.
Finally, as government grapples with difficult decisions about who will get first access to vaccines, civil society must ensure that community voices and preferences are heard and accounted for in the rollout plan, and that the most marginalised and vulnerable members of community are protected. World Health Organization. WHO Coronavirus Disease (COVID -19) Dashboard. https://covid19.who.int/.  Khan M, et al. Mitigating the impact of COVID-19 on tuberculosis and HIV services: a cross-sectional survey of 669 health professionals in 64 low and middle-income countries. medRixv Preprint. 13 October 2020. https://doi.org/10.1101/2020.10.08.20207969.  Bradley J, In Scramble for Corovirus Supplies, Rich Countries Push Poor Aside. New York Times. 9 April 2020. https://www.nytimes.com/2020/04/09/world/coronavirus-equipment-rich-poor.html.  Cowan K, Evans S. Just 207 critical care beds and 350 ventilators added to public hospitals during lockdown. News24. 7 June 2020. https://www.news24.com/news24/southafrica/investigations/exclusive-just-207-critical-care-beds-and-350-ventilators-added-to-public-hospitals-during-lockdown-20200607.  van den Heever A. South Africa sets aside more money for COVID-19 but lacks a spending strategy. The Conversation. 29 June 2020. https://theconversation.com/south-africa-sets-aside-more-money-for-covid-19-but-lacks-a-spending-strategy-141619.  CPAP (or continuous positive airway pressure) machines use air pressure to keep airways open and can be used to deliver supplemental oxygen to patients. Unlike ventilators, CPAP machines do not require intubation (inserting a tube through the mouth into the airways).  Knowledge Ecology International. WTO TRIPS Council (October 2020): South Africa issues clarion call urging support for TRIPS Waiver Proposal. 16 October 2020. https://www.keionline.org/34235.  Knowledge Ecology International. WTO TRIPS Council (October 2020): South Africa issues clarion call urging support for TRIPS Waiver Proposal. 16 October 2020. https://www.keionline.org/34235.  Fix the Patent Laws. A Timeline of Intellectual Property Reform in South Africa. 2017. https://www.fixthepatentlaws.org/wp-content/uploads/2017/10/IP-reform-timeline-2017-continuous.pdf  SAHPRA, or the South African Health Products Regulatory Authority is the national regulatory body responsible for ensuring the safety and efficacy of medicines and medical devices used in South Africa.  Stakeholder interview  Khan M, et al. Mitigating the impact of COVID-19 on tuberculosis and HIV services: a cross-sectional survey of 669 health professionals in 64 low and middle-income countries. medRixv Preprint. 13 October 2020. https://doi.org/10.1101/2020.10.08.20207969.  Mbovane T. Dire conditions in Eastern Cape clinics made worse by pandemic. GroundUp. 24 August 2020. https://allafrica.com/stories/202008240941.html.