A massive and much-anticipated phase 3 trial of an experimental tuberculosis (TB) vaccine is set to proceed after funding for it has been secured from two large philanthropies. Wellcome and the Bill & Melinda Gates Foundation (BMGF) Wednesday announced they’d be investing a combined $550 million into the trial – around $150 million from Wellcome and the remaining from the Bill & Melinda Gates Medical Research Institute, a nonprofit subsidiary of the BMGF.
The vaccine, called M72/AS01E or just M72, made headlines in September 2018 when it was found to offer 54% protection against pulmonary TB disease in a phase 2B trial. That trial, of around 3 300 people, was conducted in South Africa, Zambia, and Kenya. Final results from that study were published in the New England Journal of Medicine in 2019 – efficacy in these final results was down to around 50%.
Medicines and vaccines are typically only brought to market once safety and efficacy have been confirmed in a large phase 3 trial. In this case, the phase 3 trial is set to have around eight times as many participants as the phase 2B trial.
26 000 study participants
“Conducted in collaboration with an international consortium of TB clinical investigators, the trial will enrol approximately 26 000 people, including people living with HIV and without TB infection, at more than 50 trial sites in Africa and Southeast Asia,” Wellcome and BMGF said in a statement announcing the trial.
They said the trial will “assess the candidate vaccine’s efficacy at preventing progression from latent TB infection to pulmonary TB”. In an online media conference on Wednesday Trevor Mundel, President for Global Health at BMGF, clarified that while most study participants will be people with latent TB infection, 4 000 people without TB infection would also be recruited. This is because establishing evidence of the vaccine’s safety in people without latent TB infection will be important if the vaccine is to be rolled out in areas with high background rates of TB without first having to test everyone for latent infection. “You’d want to be comfortable with vaccinating everyone in the community,” he said, “So we need to have that safety data in the uninfected as well in order to be able to have that usage, which will be the easiest way to use the vaccine at the end of the day.”
Mundel said that the study is scheduled to start early in 2024 and that it is expected to last for four to six years. Exactly how long the study will take will depend largely on how long it takes for 150 study participants to develop active TB – the number required for the study to have sufficient statistical power. By comparison, recruitment for the phase 2B trial started in 2014 and the first findings from that study were published in 2018.
According to the statement, additional details about the trial design and participants will be announced in the coming months.
Given that the phase 2B trial was partially conducted in South Africa and the country has substantial TB clinical trial capacity, it is almost certain that some of the 50 trial sites will be in South Africa – although know specific trial sites have yet been announced.
As pointed out in the statement, the only TB vaccine in use today, bacille Calmette-Guerin (BCG), was first given to people in 1921. It helps protect babies and young children against severe systemic forms of TB but offers limited protection against pulmonary TB among adolescents and adults. If the findings from the phase 3 trial of M72 are positive, m72 will become the first new TB vaccine in over a hundred years to be proven safe and effective.
According to the most recent figures from the World Health Organization (WHO), around 304 000 people fell ill with TB in South Africa in 2021. While TB rates are declining, they are declining relatively slowly and according to the most recent WHO World TB Report, a major technological breakthrough such as a new vaccine will be needed if ambitious TB control targets are to be met.
Announcement welcomed
“We’ve waited a long time for this study, so are happy to see the Bill & Melinda Gates Foundation and Wellcome taking up this important task,” said Patrick Agbassi, chair of the Global TB Community Advisory Board, in a comment included in the Wellcome/BMGF statement. “The question now becomes how we can enroll 26 000 people most quickly and ensure that all populations at risk of TB will ultimately be able to benefit from access to what could be the first new TB vaccine in over 100 years. A robust community engagement programme will be key, as will taking on studying this vaccine in younger adolescents, pregnant women, people with prior history of TB, and other key groups often underrepresented or left out entirely of TB trials and the benefits of scientific progress.”
Mark Harrington, executive director of New York-based advocacy organisation Treatment Action Group (TAG) said, “TAG welcomes this historic investment in TB vaccine development by Wellcome and the Bill & Melinda Gates Foundation. A Phase III clinical trial of the M72/AS01E TB vaccine candidate is a long-awaited milestone. We hope this funding commitment sparks governments and other funders to substantially increase investments in the TB vaccine pipeline, which contains a number of promising candidates in addition to M72/AS01E but faces a dire financial shortfall.”
“This Phase III trial,” Harrington said, “will take several years to complete. We encourage the Gates Foundation, Wellcome, GSK, country governments, and other partners to use this time to lay the groundwork for eventual vaccine adoption by ensuring the availability, affordability, and acceptability of M72/AS01E should it prove safe and effective.”
Initial development of M72 was driven by the pharmaceutical company GSK with support from several governments, philanthropies, and research organisations. The vaccine contains the M72 recombinant fusion protein, which the Wellcome/BMGF statement explains is derived from two Mycobacterium tuberculosis antigens (Mtb32A and Mtb39A) combined with the GSK proprietary Adjuvant System AS01E. According to the statement, GSK will continue to provide the adjuvant for the vaccine’s further development and potential launch.
NOTES: (1) The BMGF is mentioned in this article. Spotlight receives funding from the BMGF, but is editorially independent – an independence that the editors guard jealously. Spotlight is a member of the South African Press Council. (2) A representative of the Global TB Community Advisory Board is quoted in this article. Spotlight editor Marcus Low was previously a member of the Global TB Community Advisory Board.
The Passing of the National Health Insurance Bill on 12 June 2023 by parliament has many stakeholders in the healthcare industry concerned as to what the implications are. The reality is that there is a long and challenging process ahead, and the NHI Bill has many years to go before all of its provisions could be implemented.
Putting all the challenges and debate aside, Jacqui Nel, business unit head of healthcare at Aon South Africa, highlights the salient points that are at the heart of the matter. “First and foremost, I would like to affirm that the private healthcare sector needs to focus all its efforts on objectively collaborating with all parties concerned to achieve a stronger and affordable healthcare solution for all South Africans. The concept and ideals of providing universal health coverage should not be in dispute.”
“The overarching principle of the NHI bill is to provide universal health coverage and social solidarity, providing all citizens with access to the same essential health care benefits, regardless of their financial means,” she adds.
However, the road to successfully implementing NHI is a long and costly one, with many experts saying it can take up to 15 years to achieve, if not more. Purely from a legislative point of view, there are no less than 11 pieces of legislation that will need to be amended to align with NHI objectives, and this is an onerous process.
This includes:
National Health Act
Mental Health Care Act
Occupational Diseases in Mines and Works Act
Health Professions Act
Traditional Health Practitioners Act
Allied Health Professions Act
Dental Technicians Act
Medical Schemes Act
Medicines and Related Substances Act
Nursing Act
And various Provincial Health Acts.
The first of many court cases are already making headlines. “On the constitutional front, one of the 11 pieces of legislation requiring amendment is the National Health Act, which governs the ‘Certificate-of-Need’ (CoN), a piece of legislation that would dictate to private sector doctors where they are permitted to practice and what services they may provide. This ‘CON’ is essential to government to control doctors under the NHI plans and is being challenged by trade union Solidarity and six other parties,” says Nel.
About the NHI Bill
The NHI Bill lays out the duties and functions of the NHI Fund, which are primarily to strategically purchase health care services based on the principles of social solidarity. All permanent residents and citizens will be eligible as beneficiaries of the “Fund” as it is referred to; and temporary residents and foreigners will have access to emergency medical treatment and access to other health services as determined through a mandatory travel insurance.
“The Bill states that eligible beneficiaries will be able to access health services through registering as a user of the “Fund”. Each member will have a number that is unique to them and their dependents. The Fund will then reimburse health care providers directly for services rendered, provided they have met the accreditation requirements. It is envisaged that comprehensive health services benefits must be made available and these services will be determined by the Benefits Advisory Committee,” explains Nel.
The Bill also refers to the establishment of the ‘Board of the Fund’, and the remuneration and reimbursement of the members of the Board which will be determined by the Minister of Health in consultation with the Minister of Finance. “There are various other functions of the fund for which further administrative departments will need to be set up to address planning, benefits design, price determination, accreditation, purchasing and contracting, payments, procurements, performance monitoring and a risk and fraud prevention unit,” says Nel.
However, there are major points of concern that remain and will need to be addressed to facilitate any implementation of the NHI into South African society, which include:
Ministerial powers, good governance and accountability.
Role of the different spheres of government.
Role of medical schemes.
Tax implications for taxpayers, both from an employee and employer perspective.
NHI funding models – increased taxes?
Health financing expertise.
Training of healthcare providers – consequence management.
Service delivery at state facilities and healthcare facilities.
Infringement on the right of choice.
Lack of detail around major parts of the NHI Bill.
In summary, this Bill is the roadmap to NHI, but many other pieces of legislation will have to be amended, and a crucial element is currently still missing which is the cost of NHI and what the basket of services will include. “To enable the NHI will require an appropriation bill from National Treasury to detail how the NHI is going to be funded. However, detail on this has been slim, while government’s finances are heavily constrained and look likely to worsen in the future with various global and local factors coming into play,” says Nel.
“We fully expect that there are going to be significant challenges to the many technical and restrictive provisions contained within the NHI Bill, and these challenges may well alter its entire substance, and there is also the prospect of political shifts that could have a material impact on health policy going forward. We simply do not see any material shifts to the private healthcare sector anytime soon,” Nel explains.
What is certain is that the Bill in its current shape and format is unlikely to remain as it is today. “While the NHI Bill raises serious concerns, there is no disputing the need for structural change. There will be much debate and negotiation in the years ahead in unpacking the strengths and weaknesses of current public and private healthcare systems, and we look forward to a rational and workable solution to the achievement of better healthcare and to assist in a workable solution for all South Africans,” Nel concludes.
A number of service providers have voluntarily ended their contracts with the Gauteng Department of Health to provide food to hospitals. In response, Gauteng Health is looking at a multi-vendor approach to tackle the problem which it blames on vendors being unable to fulfil their orders.
Meanwhile, Gauteng continues to battle with surgical and cancer treatment backlogs. R784 million has been allocated to this end, with a portion allocated to cancer treatment services, some of which will be outsourced to the private sector and some of which is going to new radiotherapy equipment.
This year has seen a number of Gauteng hospitals battling to secure their food supplies. Responding to SA parliamentary questions, Gauteng Health MEC Nomantu Nkomo-Ralehoko wrote that 26 out of 34 Gauteng public hospitals have been affected by food shortages.
“The shortages were mostly due to suppliers not being paid, contracts expiring, or companies not delivering. It was so bad for two hospitals, Bronkhorstspruit and Lenasia South, they had to borrow food from other hospitals!” said DA Shadow MEC for Health, Jack Bloom, who posed the questions.
Hospitals have being going through long stretches of not being able to provide full meals: at George Mukhari Hospital, chicken, fish and frozen vegetables were unavailable for four months, and there was no milk from February to May. The petty cash budgets are woefully insufficient to cover the gap: Kalafong hospital can only spend R2000 a day, not nearly enough to feed its 700 patients, reports SA People.
According to News24, Gauteeng Health spokesperson, Motalatale Modiba, said that the main problem was down to vendors struggling to fulfil their orders on time.
Currently, Gauteng health is running a tender to outsource oncology services for the Charlotte Maxeke and Steve Biko hospitals. The outsourcing programme should be able to ensure that patients who are currently awaiting treatment in the public sector will be able to access private sector treatment instead.
In their announcement, Gauteng Health stated: “We recognise the urgency of the situation and want to assure the public that we are committed to handling the outsourcing of radiation oncology sources diligently and are nearing implementation.”
The open tendering process will last 14 days, and is divided into categories for oncology specialists, treatment services and radiation planning services.
The department has already procured 4 Llinac machines, and has recently closed a tender for a Brachytherapy, and have advertised a tender for another Linac machine for Charlotte Maxeke. Ongoing investigations by Spotlight have also revealed that the oncology procurement process is lagging behind. The GDoH aims to have the first treatments under the outsourcing programme to start in August 2023.
This is a pseudo-colored image of high-resolution gradient-echo MRI scan of a fixed cerebral hemisphere from a person with multiple sclerosis.
Credit: Govind Bhagavatheeshwaran, Daniel Reich, National Institute of Neurological Disorders and Stroke, National Institutes of Health
Multiple sclerosis (MS), an unpredictable, often disabling disease of the central nervous system with symptoms ranging from numbness and tingling to blindness and paralysis,1 is estimated to affect 2.8 million people around the world.2 Most people with MS are diagnosed between the ages of 20 and 50 years, with at least two to three times more women than men being diagnosed with the disease.1
Non Smit, Chairperson of Multiple Sclerosis South Africa, stresses the importance of generating extensive awareness to reach individuals with MS as well as healthcare providers and therapists. “This inclusive approach aims to establish a support system and platform that addresses crucial issues such as treatment accessibility, advocacy, epidemiology, and financial assistance,” says Smit.
The progress, severity, and specific symptoms of MS in any one person cannot yet be predicted; the disease varies greatly from person to person, and from time to time in the same person.1 Although MS can be very debilitating, it is estimated that about two-thirds of affected persons are still able to walk, although many may need an aid such as a cane or crutches.1
Dr Andile Mhlongo, Medical Advisor, Specialty Care at Sanofi South Africa, says: “There are no hard and fast rules about what life with MS will mean for each patient, because everybody experiences MS differently, depending on which part of the brain is affected. Symptoms range from problems with mobility to problems with vision, extreme tiredness and thinking – but these are just a few examples. It mostly affects young people, and if untreated can have a devasting impact on the lives of patients and their families.”
In terms of diagnosis, in early MS elusive symptoms that come and go might indicate any number of possible disorders. Some people have symptoms that are very difficult to interpret. While no single laboratory test is yet available to prove or rule out MS, magnetic resonance imaging (MRI) is a great help in reaching a definitive diagnosis.2
MS comes in several forms, including clinically isolated syndrome, relapsing-remitting MS, secondary progressive MS and primary progressive MS.3 The course is difficult to predict: some people may feel and seem healthy for many years after diagnosis, while others may be severely debilitated very quickly. Most people fit somewhere in-between.3
Clinically isolated syndrome (CIS) is the first episode of neurological symptoms experienced by a person, lasting at least 24 hours. They may experience a single sign or symptom, or more than one at the same time. CIS is an early sign of MS, but not everyone who experiences CIS goes on to develop MS.3
In relapsing-remitting MS (RRMS) people experience attacks or exacerbations of symptoms, which then fade or disappear. The symptoms may be new, or existing ones that become more severe. About 85% of people with MS are initially diagnosed with RRMS.3
Secondary progressive MS (SPMS) is a secondary phase that may develop years or even decades after diagnosis with RRMS. Most people who have RRMS will transition to SPMS, with progressive worsening of symptoms and no definite periods of remission.3
Primary progressive MS (PPMS) is diagnosed in about 10–15% of people with MS. They have steadily worsening symptoms and disability from the start, rather than sudden attacks or relapses followed by recovery.3
While there is no medicine that can cure MS, treatments are available which can modify the course of the disease. Sanofi has been a partner in the MS community since 2012, through the introduction of two treatments. One of these is an oral formulation for patients with relapsing forms of MS and the other is an infusion therapy for patients with rapidly evolving, severe relapsing-remitting MS.
“Sanofi continues to be a partner through research and development to bring about therapies to improve the management of this disease. Sanofi also supports various initiatives that bring education to patients and healthcare providers and the MS community in general,” says Mhlongo.
Advances in treating and understanding MS are being achieved daily and progress in research to find a cure is encouraging. In addition, many therapeutic and technological advances are helping people with MS to manage symptoms and lead more productive lives.2
Amid skyrocketing youth unemployment, healthcare, a vast sector which touches all of our lives at some point, seems a sensible space for young people to set their sights on for opportunities. From clinical sciences to pharmacy, there is a myriad of careers in the healthcare ecosystem, but there are also factors preventing this potential from being unleashed, writes Bada Pharasi, CEO of The Innovative Pharmaceutical Association South Africa (IPASA).
A career in health has long been seen as a symbol of success in South Africa. The no-nonsense nurses in our communities, the hard-working doctors and the knowledgeable pharmacists have long represented those who had “made it”.
For many of us, these were the lucky ones who had found a career path that was both rewarding and respected. This has also been the way that South Africans view the myriad of the less visible jobs in healthcare (lab technicians, pharmacist assistants, dieticians, the list is endless).
Bada Pharasi, Chief Executive Officer of IPASA
As South Africa grapples with the highest unemployment rate1 in the world, with youth unemployment being the biggest concern (currently at more than 60%2), it’s not difficult to see why the healthcare system with its vast range of careers would present a solution. Careers in health not only benefit young people looking for a start in life, but they also build South Africa’s capacity to provide care for millions who desperately need it.
As young people search for the stepping stones to long, rewarding careers, many will be advised by well-intentioned family and friends to seek a future in healthcare. And it’s not bad advice.
As a sector that can generate employment opportunities at both ends of the value chain – from highly skilled specialists in technology and research to those who operate in palliative or frail care environments2 – the recent effects of the Covid-19 pandemic underscored the essential value and role that healthcare workers play in bolstering South Africa’s socio-economic and overall health resilience.
Human resource gaps in healthcare are clear
In 2020, the Hospital Association of South Africa suggested that there was a shortage of between 26 000 and 62 000 professional nurses and this shortage is expected to increase to between 305 000 and 340 000 by 2030 as the country’s population continues to grow. Alarmingly, estimates suggest that only 26 ,000 will be trained by then3.
South Africa also has less than one doctor per 1000 patients4. In a country with serious disease burdens, the situation is far from ideal.
The need for long-term planning
A challenge often cited when posts are frozen in healthcare is funding. While there are undoubtedly funding constraints in the healthcare system, it seems unlikely that the addition of funds will solve the challenge. It’s worth rethinking the way the human resources pipeline in South Africa is structured and where the bottlenecks lie.
South Africa’s history of inequality, which is deeply entrenched in the country’s healthcare system, has created the twin challenge of a shortage of skills and inadequate capacity to manage and distribute those skills to where they’re most needed. There are also policy bottlenecks that can hinder progress.
For instance, while complementing the qualification with some kind of work experience and community service spent in the public sector is an applaudable initiative, it becomes counterproductive when there aren’t enough posts in the public sector to place people coming out of training institutions. This, in turn, limits the number of professionals who can qualify, adding incrementally to the shortage of personnel every year.
Similarly, the cap on the number of personnel that the Nursing Council can accredit per year may limit the number of posts needed, but it doesn’t help address the shortage of nurses in South Africa.
The burden of disease in South Africa, coupled with the uneven spread of healthcare facilities means that it’s also a singularly challenging environment to work in. This means that retention policies, and initiatives that prioritise the well-being of healthcare workers are also important considerations.
It’s worth noting that over the past few decades, there have been a number of well-considered human resources strategies for the healthcare system in South Africa5. Unfortunately, these have suffered from inadequate implementation. This long-term planning and implementation is critical.
Ultimately, it means ensuring that we’re able to encourage young people to take up these worthy careers with the guarantee that once they qualify, their skills will be put to good use.
As the National Department of Health prepares to move South Africa toward the National Health Insurance scheme, the question of staffing becomes even more critical. It’s going to call for long-term strategies that will need to be implemented over generations.
South African scientists – notably, the team headed by Professor Tulio de Oliveira – were thrown into the global spotlight through their pivotal role in detecting and monitoring the emergence of new variants of SARS-CoV-2 – the Beta variant in 2020 and Omicron in 2021. De Oliveira is now at the University of Stellenbosch, but for much of the pandemic headed the KwaZulu-Natal Research Innovation and Sequencing Platform (KRISP).
The country’s advanced genomic sequencing capabilities and proactive surveillance efforts allowed for the early identification of the variants and the discoveries played a crucial role in alerting the global scientific community to the potential for viral mutations and the need for enhanced monitoring.
Now, scientists worldwide believe it is critical to continue investing in genomics to support disease control in public health in South Africa and the broader continent.
What is genomics?
The World Health Organization (WHO) defines genomic surveillance as “the process of constantly monitoring pathogens and analysing their genetic similarities and differences”. It is done through a method known as whole genome sequencing, which determines the entire genetic makeup of specific organisms or cell types. This method is also able to detect changes in areas of genomes, which can help scientists to establish how specific diseases form. The results of genomic sequencing can also be used in diagnosing and treating diseases.
Genomic sequencing enables scientists to read the DNA and RNA of pathogens and understand what they are and how they spread between people – and to develop vaccines and other measures to deal with them.
The US Centers for Disease Control (CDC) explains, “All organisms (bacteria, vegetable, mammal) have a unique genetic code, or genome that is composed of nucleotide bases (A, T, C, and G). If you know the sequence of the bases in an organism, you have identified its unique DNA fingerprint or pattern. Determining the order of bases is called sequencing. Whole genome sequencing is a laboratory procedure that determines the order of bases in the genome of an organism in one process.
“Scientists conduct whole genome sequencing by following these four main steps:
DNA shearing: Scientists begin by using molecular scissors to cut the DNA, which is composed of millions of bases (A’s, C’s, T’s, and G’s), into pieces that are small enough for the sequencing machine to read.
DNA barcoding: Scientists add small pieces of DNA tags, or bar codes, to identify which piece of sheared DNA belongs to which bacteria. This is similar to how a bar code identifies a product at a grocery store.
DNA sequencing: The bar-coded DNA from multiple bacteria is combined and put in a DNA sequencer. The sequencer identifies the A’s, C’s, T’s, and G’s, or bases, that make up each bacterial sequence. The sequencer uses the bar code to keep track of which bases belong to which bacteria.
Data analysis: Scientists use computer analysis tools to compare sequences from multiple bacteria and identify differences. The number of differences can tell the scientists how closely related the bacteria are, and how likely it is that they are part of the same outbreak…”
Time to expand
At a recent conference held at Stellenbosch University’s new state-of-the-art Biomedical Medical Research Institute, de Oliveira stressed that African and other experts should now build on their success in COVID-19 genomics to expand to other pathogens such as influenza, H5N1, and climate-amplified pathogens.
John Sillitoe, the Director of the Genomic Surveillance Unit at the Wellcome Sanger Institute in the United Kingdom, agreed.
“It is important now to focus on endemic diseases so we can improve our understanding and control of endemic diseases. We should also be looking at TB, particularly with the increased prevalence in drug resistance and reduced response to drugs. For other African countries, malaria should be a key focus area. We know that drug resistance now is spreading into Africa from South East Asia and understanding the right combination of drugs to use is something that is easily identifiable through genomic surveillance.”
But surveillance is also about being ready for the next pandemic.
“There’s that classic line that, ‘diseases take no notice of national borders’,” Sillitoe said in an interview. “So, it is really important that we can get as wide a picture of surveillance as possible to identify something new emerging as soon as possible.”
Marco Salemi, Professor of Experimental Pathology at the Department of Pathology, Immunology, and Laboratory Medicine at the University of Florida College of Medicine, said Africa and the world need to be “proactive, rather than reactive” in the battle against future epidemics. He said the world is currently focused on monitoring the COVID-19 pandemic. “But we forget this is this huge reservoir of pathogens out there which we know so little about and which can become more and more of a threat, especially because of climate change – so we need to understand more about all these pathogens in the wild, in animals, and their potential to jump to humans, especially with the rate of globalisation on the planet … Events of zoonotic transmissions will become more and more frequent. We need to face it.”
Building capacity
De Oliveira is of the view that Africa could, in the next few years, potentially, “leapfrog over the rest of the world” in genomic surveillance, thanks to its success in COVID-19 genomics and its experience in using genomics to monitor other pathogens over the past 20 years.
We won’t be starting from scratch.
The use of genomics in infectious diseases started in the mid-eighties during the HIV epidemic, when scientists realised HIV was a complex virus that existed in many different sub-types. Scientists around the world started using genomic tools to sequence the HIV virus, track its origin, and trace the way the virus disseminated.
Genomics has, however, changed dramatically since the 1980s.
“There have been many attempts… to use genomics for public health purposes, but the key factor that was always missing was the ability to generate DNA sequencing in real-time,” said Salemi. “Real-time means there is an epidemic, with cases happening today – and we need to generate sequences within one or two days and then to analyse the genomic data and then to have actionable information that can be immediately transmitted to the public health authorities so that they can act within a few days.”
“Now the technological and computational limitations of the past few years have been overcome, and, as was clearly shown during the COVID-19 pandemic, we have machines that can generate literally thousands of sequences, like coronavirus sequences, in less than one day, or even within a few hours. At the same time, we have high-performance computer clusters, and super calculators that are capable of analysing this data in a very short time,” he said.
These technical advances would, of course, be of little value without people to use them and develop them further.
“Investment has been made on the continent in infectious disease surveillance and genomics surveillance specifically, and so we have lots of experts on the continent who know a lot about infectious diseases and how viruses work, and why it’s important to look at the genomics to trace when there is going to be a new outbreak,” says Professor Zané Lombard, Principal Medical Scientist in the Division of Human Genetics at the University of the Witwatersrand. “South Africa’s role during COVID-19 showcased what can happen quickly and effectively for public health interventions if you have the right experts with the right platform and expertise and infrastructure in place to do that kind of surveillance.”
De Oliveira and his team have worked closely with the Africa Centres for Disease Control and Prevention (Africa CDC) to scale genomic surveillance on the continent and have actively collaborated with other African countries to share expertise, resources, and genetic data in a bid to foster a continent-wide approach to genomic surveillance.
They have also helped set up large genomics facilities in Zimbabwe, Mozambique, and Botswana.
The Africa CDC, through its Pathogen Genomics Initiative (Africa PGI), has, for the past few years, been building a continent-wide genomic disease surveillance network. In 2019, when the PGI started its work, only seven of the African Union’s 55 member states had public health institutions with the equipment and staff to do genetic sequencing. Today, 31 African nations are able to do genetic sequencing for surveillance of COVID, malaria, cholera, Ebola, and other diseases.
De Oliveira said the continent’s experience in genomic surveillance of pathogens in Africa evolved to “unheard-of” levels during COVID. “We’ve been trying to advance genomic surveillance in Africa for the past two decades, and when the pandemic came, we had the right expertise to deal with viruses and respiratory pathogens such as tuberculosis, so we were able to pivot for SARS-CoV-2. In the end, South Africa and Africa became an example to follow for the whole world.
“All the investments we have made in genomic surveillance for COVID can now be leveraged and advanced to other areas of genomics in Africa… including for rare diseases, for cancer diagnostics, and human genomics. Finally, we have the tools and the equipment, as well as the support, to do advanced genomics in Africa, as we have dreamt of doing for the last twenty years.”
What it means in practical terms
Asked what it means, practically, to build capacity for genomics research, Lombard said one aspect is the establishment of strong laboratories. “Historically, if infrastructure was not available locally, researchers would partner with international labs and send their samples to have their sequencing done there. The problem with that was that expertise in using [that] technique was not being built locally,” she said. “It is really important to train the right people who know how to do the laboratory experiments but also to interpret the data correctly.
“It’s not only about building the infrastructure in the labs but also about training the individuals and making sure there are job opportunities locally for them,” she said.
Turning to the machines used in genomics, Lombard said, “The most popular machine these days is called a next-generation sequencer. These can read the whole DNA sequence of a virus.”
Salemi added, “Some of these sequencers are very large and some are even little portable boxes. Some can sequence thousands of samples at a time, while others are capable of sequencing a few dozen samples at a time. The samples, depending on the virus (or pathogen) being tested for, are taken from blood samples, nasal swabs, or sputum from patients, from faeces, urine, or from the skin.
“The BMRI (at Stellenbosch University) – which has the largest sample storage capacity in the southern hemisphere – can store five million samples at minus 80 degrees. If someone wants to build a lab that includes top-of-the-line computational capacity, it will cost anything from $40 million (over 700 million), but to start a small operation to do a few hundred sequences of a virus every week, $100 000 to $200 000 (roughly R17 million to R34 million) is enough, which has been done in many different African countries during the pandemic.”
Training is key
While all the scientists interviewed agreed that laboratories are important in building capacity for genomics research, they stressed that what is really needed is to train more individuals.
“More people need to be trained in genomics but also in bioinformatics, which is a really important component of this work. The technology component is becoming very smart and automated, but the data being generated is becoming more and more complex, with bigger data sets. Dealing with these,” Lombard said, “requires special data analysis skills and bioinformatics skills. The field of bioinformatics will need investment so that we can deal with the deluge of data that will come out.”
She said South African and other African universities are taking this skills need seriously, with many initiatives to offer undergraduate and post-graduate training programmes in these areas.
Salami agreed. “The most important part of building capacity is the human training. I find it naïve and sad when I hear politicians talking about building top-of-the-line laboratories, when, what they really need to do is to start building human capacity. Africa is an amazing reservoir (from which to build these skills) because 50 percent of the continent [are] people who are less than 30 years old. There are about 27 excellent laboratories all over Africa. We need to start creating a strong next generation of scientists.”
In support of this, de Oliveira is trying to raise 100 million dollars to implement real-time genomic research to enable the African continent to respond to new epidemics.
He said during COVID, the Network for Genomics Surveillance was founded and funded by the Department of Science and Innovation and the South African Medical Research Council (SAMRC). This funding was until 2021.
The Centre for Epidemic Response and Innovation, which is led by de Oliveira and forms part of the BMRI, is funded by the Africa CDC, the WHO, the Rockefeller Foundation, and the Elma Foundation. These funders support the work in South Africa and in other African countries, as well as the SA government. The BMRI was mostly funded by Stellenbosch University to the effect of R900 million, while the Department of Higher Education provided about R300 million. CERI occupies one floor of the BMRI.
In de Oliveira’s words, “This truly is the genome era for Africa.”
Gut Microbiome. Credit Darryl Leja National Human Genome Research Institute National Institutes Of Health
Diarrhoeal disease outbreaks are on the increase in South Africa owing to unsafe or unhygienic water sources, which is being compounded by the effects of loadshedding.1 Equally, the deadly floods that affected particularly the Eastern Cape and KwaZulu-Natal in April last year damaged an already ailing sewerage and water system, with millions of litres of untreated sewage spilling onto beaches, rivers, harbours and the ocean in and around Durban.2
This has resulted in an increased incidence of gastroenteritis, which is caused by intestinal infection owing to the contamination of food, water or hands.3 Acute-onset vomiting and diarrhoea is second only to respiratory illnesses as a cause of childhood deaths worldwide.3
Diarrhoea accounts for 19% of deaths of under-fives in South Africa and for 46% on the African continent.4 Acute diarrhoea has several risks and complications, and may lead to life-threatening dehydration and electrolyte disturbances.3 When diarrhoea is not halted, there is a risk of disturbed digestion and absorption of nutrients with nutritional deterioration.3
Guidelines published in the South African Medical Journal (SAMJ) state that acute diarrhoea is predominantly a problem of fluids and feeding – both being heavily dependent on the caregiver’s understanding and reactions.3
It is vital that healthcare practitioners and caregivers understand the ‘what’ and the ‘how’ of oral rehydration therapy (ORT) and re-feeding, and that they are given guidance on the need to seek further help in the event of the following:3
• Ongoing vomiting despite small fluid sips, especially if associated with abdominal distension or pain
• Persisting fever after 24 hours of ORT
• Increasing lethargy and failure to feed
• Deteriorating hydration and failure to pass urine
• Presence of blood in the stools
• Diarrhoea persisting for more than 1 week.
Momeena Omarjee, Consumer Healthcare Country Head: Scientific Affairs, at Sanofi South Africa, outlines an ambitious campaign by Sanofi in partnership with non-profit organisation (NPO), Save the Children, to impact over 2 000 000 lives by 2025, through education on hygiene and nutrition and improved access to water.
“Sanofi is committed to ensuring that no child dies of a preventable disease. Since October 2022, Sanofi has donated 15 water tanks and 14 hand-washing stations to Early Childhood Development centres in KwaZulu-Natal communities in need, to ensure access to clean, drinkable water. This will help to curb the prevalence of diarrhoea and diarrhoea-associated deaths in children under five, which are entirely avoidable,” says Omarjee.
“Children living in poverty-stricken environments are approximately 10 times more likely to die from diarrhoea than their more privileged counterparts.5 Providing adequate access to clean, drinkable water and quality early childcare and development will impact the lives and health of so many vulnerable children,” says Omarjee.
Several studies have shown that probiotics shorten the duration of diarrhoea and prevent recurrence of other episodes.6 Furthermore, probiotics can prevent diarrhoea from infection in infants with malnutrition.6
The World Gastroenterology Organisation states that oral administration of probiotics shortens the duration of acute diarrheal illness in children by approximately 1 day.7 There is also evidence of efficacy in adults or children who are receiving antibiotic therapy, for prevention of antibiotic-associated diarrhoea.7
“Healthcare professionals should encourage parents to give children a daily, regular probiotic, which could go a long way in preventing diarrhoea and illness,” concludes Omarjee.
Wittenberg, DF. 2012. Management guidelines for acute infective diarrhoea/gastroenteritis in infants. SAMJ, vol. 102, No. 2.
Awotione, O.F., et al. 2016. Systematic review: Diarrhoea in children under five years of age in South Africa (1997-2014). Tropical Medicine and International Health, 21(9), 1060-1070.
Chola, L., et al. 2015. Reducing diarrhoea deaths in South Africa: costs and effects of scaling up essential interventions to prevent and treat diarrhoea in under five children. BMC Public Health, 15, 394.
Solis, B. et al. 2002. Probiotics as a help in children suffering from malnutrition and diarrhoea. European Journal of Clinical Nutrition, 56, S57-59.
The Southern African HIV Clinicians Society has just released their updated 2023 guidelines for Antiretroviral Therapy in Adults. These updates reflect the changing treatment paradigms of the current era, specifically the consolidation towards dolutegravir- and darunavir-based treatment regimens, rather than efavirenz- or lopinavir-ritonavir based ones.
They are optimised for accessibility and are available in a PDF format for download, or are viewable as an online version directly on the website. The online version is in an easily navigable form, with the menu guiding readers to the different modules.
The new guidelines also incorporate numerous other changes to ensure that they stay up-to-date and helpful to the healthcare workers who use them. Some of the key changes include:
• Recommendation to shift most patients to a dolutegravir-based regimen if possible.
• For patients requiring a protease inhibitor (PI), recommendation for darunavir as the PI of choice, and for lopinavir/ritonavir to only be considered where a PI is required to be co-administered with rifampicin-based tuberculosis treatment.
• New recommendations on the move away from routine use of zidovudine (AZT) in second-line therapy in favour of recycling tenofovir or, inpatients with renal dysfunction, abacavir.
• Advice on how to assess the increase in serum creatinine seen with dolutegravir/tenofovir fixed dose therapy.
• Guidance on the role of tenofovir alafenamide; TAF.
• Inclusion of enhanced baseline screening for tuberculosis and sexually transmitted infections.
• Expansion of the module on HIV and mental health.
While many antiretroviral therapy (ART) guidelines are available internationally, the current guidelines have been written to address issues relevant to Southern Africa. Only treatment and diagnostic options available in Southern Africa are included. These guidelines also consider affordability because of the region’s low- and middle-income countries. The guideline authors also recognise and addressed the need to bridge the gap in treatment recommendations between public and private sector programmes, as many patients transition between the two sectors for treatment.
By Martin Versfeld, Prelisha Singh, Glenn Penfold & Robert Appelbaum, Partners at Webber Wentzel
With the National Health Insurance Bill having recently been approved by the National Assembly, many questions and concerns about the practical implementation of the scheme remain unresolved.
The National Health Insurance Bill (the Bill) was recently adopted by the Parliamentary Portfolio Committee on Health and was approved by National Assembly on 14 June 2023. It will now be tabled before the National Council of Provinces.
The Bill provides for the establishment of the National Health Insurance Fund (the Fund) aimed at promoting the laudable purpose of universal access to quality health care. It is envisaged that the Fund will purchase health care services and products from accredited health care service providers and health establishments (including hospitals) (which we refer to, collectively, as “service providers”), including private service providers that choose to contract with the Fund.
Many stakeholders and experts have raised concerns that the National Health Insurance (NHI) scheme envisaged in the Bill is simply unaffordable, particularly as it would require an extensive administrative apparatus. A related concern is the extent to which the NHI will rely on the public health care system to deliver services, and the capacity of that system to provide an acceptable quality of services. Given the dire state of public health care in our country, it is surprising that the Government persists with plans to spend vast resources on implementing the NHI. Those resources would greatly improve the delivery of quality health care – and universal access to that care – if they were deployed directly in the public health sector.
In view of the questions about the affordability of the NHI, the provisions of the Bill providing for the income of the Fund are of particular interest. Clause 49 states that the Fund’s chief source of income will be money appropriated annually by Parliament. This must be appropriated from collections of, among others, general tax revenue, a payroll tax and a surcharge on personal income tax. This taxation regime is, however, difficult to reconcile with clause 2, which states that the Fund will be funded through “mandatory prepayment” (a term that is defined as “compulsory payment for health services before they are needed in accordance with income levels”), and clause 55(1)(t), which empowers the Minister to make regulations on “all fees payable … to the Fund”.
One of the challenges in interrogating the NHI scheme envisaged in the Bill is that it leaves many of the key issues to be determined later. For example, the extent of the benefits to be covered by the Fund and the rate of reimbursement – both of which are crucial to assessing both the affordability of the NHI and its impact on the provision of quality health care – are not yet known (eg see clause 10(1)(g)). The Bill also leaves a broad range of matters for the Minister of Health (the Minister) to prescribe through regulations. These matters include the rules on portability, which will allow patients to be treated by service providers other than those with whom they are registered (clause 7(2)(b)); the referral pathways between service providers (clause 7(2)(d)(ii)); the coding systems to be employed (clause 39(5)(b)); the relationship between the Fund and medical schemes (clause 55(1)(n)); and “the scope and nature of prescribed health care services and programmes and the manner in, and the extent to which, they must be funded” (section 55(1)(w)).
The Bill’s preamble states that its purposes include to “create a single framework … for the public funding and public purchasing of health care services, medicines, health goods and health related products” and to “eliminate the fragmentation of health care funding”. A key question that arises is what role medical schemes will continue to play and, indeed, whether they will be able to continue to exist. Clause 33 of the Bill stipulates that, once the Minister has determined that the NHI has been fully implemented, medical schemes “may only offer complementary cover to services not reimbursable by the Fund”. Similarly, clause 6(o) states that users of health care services are entitled to “purchase health care services that are not covered by the Fund through a complementary voluntary medical insurance scheme”. In other words, medical schemes may not cover health care services that are covered by the Fund. Since the Fund is intended ultimately to cover a comprehensive range of benefits, the Bill envisages that the businesses of medical schemes will shrink dramatically which may, of course, threaten their continued existence. This regime is likely to face constitutional challenge, including on the basis that it infringes: (a) the right to access health care services, by forcing many people who currently access private medical care via medical scheme funding to rely on what is currently a woefully inadequate public health care system; (b) the property rights of medical schemes and their administrators; and (c) the right to freedom of trade, occupation and profession.
Another crucial issue is how the Bill will regulate accredited service providers. Clause 39(2) imposes onerous requirements for accreditation, including the submission of a “budget impact analysis”. One area of concern, as mentioned above, is that the Bill does not clarify how reimbursement rates will be determined. Clause 10(1)(g) simply states that the Fund must set payment rates annually “in the prescribed manner and in accordance with the provisions of this Act”. Given its importance to sustainable access to health care, one would at least have expected the Bill to make clear that the payment rates must be set at a level that allows providers to cover their efficient costs and make a reasonable return. Another cause for concern is that clause 38(6) envisages that an accredited service provider must procure health-related products (including medicines and medical devices) according to the Fund’s formulary, and that suppliers listed in the formulary must deliver directly to the service provider or establishment. To the extent that this clause requires private service providers to procure from suppliers chosen by the Fund, this blurs the line between public and private procurement, reduces competition, and unduly restricts private service providers in the conduct of their business.
The role that the Bill contemplates for the Minister is also potentially problematic. For example:
Clauses 4(1) and 7(1) provide that the Fund must purchase health care services “in consultation with the Minister” (which our courts have held means that the Minister’s concurrence is required). It is wholly impractical to require the Minister to concur in the purchase of health care services.
It is unclear to us why the Minister must agree on detailed issues that require the application of clinical judgement, such as the benefits to be determined by the Fund’s Benefits Advisory Committee and the formulary to be employed by the Fund (clauses 25(5)(c) and 38(5)).
While seeking to secure universal access to quality health care is generally supported and rightly so, the Bill represents an over-hasty effort to fundamentally restructure the country’s public health service with potentially devastating consequences for healthcare providers and consumers alike.
On Tuesday, June 13, South Africa’s National Assembly approved the National Health Insurance (NHI) Bill, signing this new law into effect in the face of strong expert objections. The CEO of Discovery Health, Dr Ryan Noach, said that at the moment there is “no need to panic” over NHI, although overwhelming negativity was a major concern. . This was reflected in Quicknews polls results, with 98% of respondents expressing skepticism over NHI implementation.
Speaking in an interview with Newzroom Afrika, he responded to comments that the implementation of the NHI would devastate the private healthcare sector, which he said “sounds like a panicky reaction”.
While he did not say that NHI implementation would be without consequences, the chief executive of the country’s largest private medical scheme reminded viewers that, even with NHI as promulgated now, there was still a long way to go before there was any impact on private healthcare schemes or systems.
Health Minister Dr Joe Phaahla hailed the Bill: “This is one of the most revolutionary pieces of legislation presented to this house since the dawn of our democracy in 1994.” Briefing the media, he was bullish on existing issues of corruption and mis management in healthcare, saying “Those issues must be dealt with.” He pointed to a number of “good examples” of institutions.
But serious questions about the impact, implementation and feasibility of the extraordinarily expensive and far-reaching Bill have yet to be answered.
The impact of Section 33
Dr Noach noted that one important point regarding the Bill is Section 33, which “talks about the full implementation of NHI before any impact on medical schemes.” Essentially, the NHI would have to be fully in place before the healthcare and health insurance sectors would be affected.
He added that the Department of Health’s expected that NHI would take some 10 to 15 years to fully implement after its promulgation. Speaking with the experience of a scheme that provides for 4 million people, he said that it is already a huge amount of work, and the task of catering to the entire population of South Africa would be even greater.
Dr Noach notes that as for the necessary financing bill for the NHI, it is nowhere to be seen. Little said about it by the Treasury, which has only noted that it is “nascent”. As the population contributes GDP of 8.5% to healthcare, the assumption seems to be that this 8.5% would simply be redirected into a NHI scheme, which is not likely to happen.
Medical funds are contributed from medical schemes after tax, are well-protected by schemes, and as trust funds they essentially belong to the members. By law no-one can take away access to those funds: it would be like taking away people’s pension funds.
No parallel with any other country’s public health scheme
This singular NHI fund would essentially be a monopoly, and there were also no other examples of this to be found anywhere in the world. Even with the UK’s NHS, 12% of the population opts for private medical insurance. No other countries exclude by law the participation of private insurance and private funders. The annual spend would be R500bn to R700bn, and the NHI would disburse this to about 100 000 healthcare providers – assuming that the healthcare market would remain in its present form, which would likely suffer.
The biggest short term risk of the Bill would be the emigration of skilled healthcare professionals from a very negative sentiment emerging among in that grouping.
Meanwhile, those working in the public sector are battling under corruption and a lack resources while those in the private sector are extremely concerned. According to a Quicknews poll which ran for the month of June, 97.78% of the 90 respondents agreed with the South African Medical Association’s objections to the Bill.
In early 2022, a Quicknews poll had found that 81% of respondents had either considered emigrating due to the NHI Bill or were actively planning to do so.
Dr Noach says that “we are doing everything we can to calm the health professionals, partner them and work with them and reassure them, because we do believe that the outcome here could be optimistic.” A version of NHI would be welcomed.
As for the eventual fate of medical aid scheme under Section 33, once the Minister determines that NHI is fully implemented (and it is unclear how that would be determined), only those services not covered by NHI would be covered by medical aid schemes – though there is no indication at this stage of what would be covered.
An alternative approach to NHI
Before this can even be implemented, the government needs to find R200 billion to fix the public healthcare system, something which Dr Noach applauds as a priority.
He described an alternative NHI, with policy reform one in both private and public healthcare to create a “multi-funded environment”, something which Discovery’s actuarial work had found to be a better fiscal option. The NHI has many favourable qualities, which are smart and feasible, he continued.
The current monopolistic approach to NHI would create a single pot of money which would be the largest fund in the country by far – with its attendant risks.
Notes: Updated to reflect latest Quicknews poll results and to include Dr Joe Phaahla’s comments on the Bill.
