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Inside The Box with Dr Andy Gray | Are Complementary Medicines Effectively Regulated in South Africa?

#InsideTheBox is a column by Dr Andy Gray, a pharmaceutical sciences expert at the University of KwaZulu-Natal and Co-Director of the WHO Collaborating Centre on Pharmaceutical Policy and Evidence Based Practice. (Photo: Supplied)

By Dr Andy Gray for Spotlight

The regulation of complementary and alternative medicines in South Africa has been hotly contested in recent decades, including in court rooms. In his latest column for Spotlight, Dr Andy Gray unpacks the legal background and the current state of this still unfolding regulatory saga.

Multivitamin and mineral supplements are commonly found in many South African retail outlets, from pharmacies to health shops and supermarkets. Some outlets will stock a wider range of medicines, perhaps on shelves marked as “complementary”, or among other non-prescription medicines available for self-service.

Are these medicines regulated in the same way as other medicines, including those available on prescription?

The concept of a “call-up notice”

When South Africa’s medicines legislation was first passed in 1965, there were already many medicines on the local market which had not been assessed for safety, efficacy or quality. As all such medicines could not be immediately “called up” for registration, a stepwise approach had to be followed.

Between 1967 and the mid-1980s, medicines were identified for registration by pharmacological classification. The remnant of that approach is still evident in section 14(1) and (2): of the Medicines and Related Substances Act, 1965:

(1) Save as provided in this section or sections 21 and 22A, no person shall sell any medicine, … which is subject to registration by virtue of a declaration published in terms of subsection (2) unless it is registered.

(2) (a) The Authority may from time to time determine that a medicine, …, or class or category of medicine, … or part of any class or category of medicine, … mentioned in the declaration, shall be subject to registration in terms of this Act.

(b) Any such declaration may also relate only to medicines, … which were available for sale in the Republic immediately prior to the date on which it comes into operation in terms of paragraph (c) or only to medicines, … which were not then so available.

The declaration that a category or class of medicine is subject to registration is referred to colloquially as a “call-up notice”. A notice could be applied to those medicines already marketed, or only to those not yet marketed. Medicines which were already marketed but exempted from a full registration process were then regulated as “old medicines”. They are still subject to control according to their scheduling status and their production still needs to be in accordance with Good Manufacturing Practice. In time, new brands of some of the “old medicines” have been registered.

By the mid-1980s, the process of working through the pharmacological classifications was concluded. Thereafter, every new medicine would need to be registered before being marketed. In other words, a manufacturer or importer would need to provide sufficient evidence of the medicine’s safety, efficacy and quality to justify registration.

However, an important exception was created in 1986, which exempted homeopathic medicines from the full registration process. Two important restrictions were included. Firstly, no medical claims could be made for the medicine. Secondly, the following wording was to be included on the label of such medicine: “Homeopathic Medicine” and “WARNING: Use only as directed by a medical practitioner, pharmacist or homeopath”. The provision applied to homeopathic mother substances and so-called “minute-dose forms” made in accordance with homeopathic principles.

Broadening the scope of complementary medicines

Homeopaths are one of several complementary and traditional health professions regulated by the Allied Health Professions Council of South Africa. Medicines legislation has been amended to accommodate this wider range of complementary and traditional medicines.

A separate South African Health Products Regulatory Authority (SAHPRA) web site is dedicated to what are termed Category D medicines, also known as complementary medicines.

The General Regulations issued in terms of the Medicines Act includes a definition of complementary medicines which has two components: health supplements and medicines used in accordance with a “discipline as determined by the Authority”. The pharmacological classifications listed in Annexures 1 (human) and 2 (veterinary) medicines list the “disciplines” as Aromatherapy, Homeopathy, Phytotherapy, Traditional Chinese Medicine, Unani Medicine, Western Herbal Medicine, Combination Products and Other Herbal. The Annexures also list the types of health supplements, including amino acids, mineral, probiotics and vitamins. Two elements are important here – the nature of the substance included in the complementary medicine and the claims made in relation to that medicine.

Since 2013, the intention has been to progressively bring all complementary medicines under effective regulation, using a risk-based approach to identify those requiring registration and full assessment of safety, efficacy and quality data. The first pharmacological classifications identified were those claiming antiviral properties, and those intended to treat diabetes, cardiac conditions and cancer. However, no complementary medicines have yet been registered and the initial “call-up notices” have been repealed.

Like much of South Africa’s medicines regulatory space, this process has been affected by litigation. A challenge of the complementary medicines regulatory scheme by the Alliance of Natural Health Products (South Africa) was finally decided by the Supreme Court of Appeal in 2022. The court confirmed the finding that SAHPRA should have no regulatory power over substances and preparations that did not meet the definition of a medicine. A preparation that seeks to supplement a diet or provide a nutritional benefit is not a medicine, but a foodstuff. Draft amendments to the 2017 General Regulations, informed by the court judgment, were published for comment in March 2023, but have yet to be issued in final form.

Not a total lack of regulation

The hiatus in finalising regulations does not mean, however, that there is no regulatory control over complementary or Category D medicines. The initial “roadmap” outlined in the 2013 regulations has been replaced by a series of guidelines. The progressive, developmental approach to the regulation of complementary medicines remains in place, albeit delayed and as yet incomplete.

The overall roadmap was updated in 2021. All manufacturers, wholesalers or distributors of complementary medicines are required to be licensed by SAHPRA, but this process relies on an applicant’s “attestation of compliance with minimum requirements at the time of application and the payment of the required licence application, and desktop evaluation fees”, rather than the full Good Manufacturing Practice inspection applied to manufacturers of other medicines. However, SAHPRA reserves the right to conduct inspections where warranted. A similar approach is applied to the regulation of medical devices and diagnostic tests.

In the meantime, while no complementary or alternative medicines have been registered by SAHPRA, there is relatively strict regulation of what companies can say about the unregistered complementary medicines that they market in South Africa.

As with the 1986 exclusion for homeopathic products, all category D products which have not been registered have to include the following statement on the label: “This unregistered medicine has not been evaluated by the SAHPRA for its quality, safety or intended use”. The guideline also distinguishes between low risk and high-risk claims, in either labelling or advertising. Low risk claims are those for general health enhancement without any reference to specific diseases; health maintenance; or the relief of minor symptoms (not related to a disease or disorder).

The guideline is specific about a widely used wording: “Unregistered complementary medicines making use of the terms “Clinically proven” or any similar expression … shall also be considered to be HIGH RISK and may be subject to individual call-up in terms of section 14(2) of the Medicines Act.” Examples of acceptable low risk claims are provided, such as “Helps enhance/promote joint health”. Further guidance on the evidence to be relied upon for low risk and high-risk claims has been provided for the discipline-specific complementary medicines.

Manufacturers and importers of health supplements are only allowed to make low risk claims, and the relevant guideline provides Annexures (from Annexure A to O), showing the allowable levels and claims for each type of supplement. For example, a single component vitamin B3 (nicotinamide) product sold for adults may not contain more than 500mg per dose, and can only make a claim of “Helps to metabolise carbohydrates, fats and proteins”, “Contributes to normal growth and development” or “A factor in the maintenance of good health”.

A key document is the current guideline on the regulation of discipline-specific complementary medicines. An additional guideline was updated in 2022, which provides guidance on caffeine, menthol, camphor and cannabidiol. Low-dose cannabidiol can be sold as either a discipline-specific complementary medicine or a health supplement. At a dose not exceeding 20mg per day or 600mg per pack, it can be sold as a Schedule 0 product.

As no complementary medicines have yet been registered, none have as yet been specifically included in any of the Schedules, and they are therefore assumed to be controlled as Schedule 0 products, which can be sold in any retail outlet. One exception would be any injectable product, as those are automatically included in Schedule 3 and are prescription-only.

Important sources of information

The SAHPRA complementary medicines website provides a crucial resource which can be accessed by the public. The list of licensed complementary medicines manufacturers, importers and exporters is accessible here. There are currently 117 entries on the list. Each entry also provides a list of the products provided by that licensed entity, with details of ingredients, recommended doses and intended uses, whether discipline-specific or health supplement. The entire database is also searchable.

The site also enables anyone to lodge a complaint about a complementary medicine, including anonymous complaints.

Gaps in the system

While some progress has been made, the regulatory scheme for complementary medicines remains incomplete. Apart from finalising the regulations after the court challenge, a risk-based “call-up” process still needs to commence. Moving from an attestation process to confirmation that every manufacturer has met current Good Manufacturing Practice standards is still necessary.

Currently, the proprietary (brand) names used for complementary medicines are not pre-approved by SAHPRA, and many are in contravention of the naming guidelines applied to other medicines.

Effective oversight of advertising and marketing practices remains elusive, not only in respect of complementary medicines.

The dictum traditionally applied to consumer goods of “let the buyer beware” (in Latin, “caveat emptor”) is no longer considered appropriate. The Consumer Protection Act, 2008 seeks to protect the public against unsafe products and unfair marketing. Medicines are treated as a special category of goods, deserving closer regulatory control. The remaining gaps in the medicines regulatory system need to be plugged. One very particular gap, which has never been adequately addressed, is the regulation of African traditional medicines, which are not currently captured in the definition of Category D medicines.

 – Gray is a Senior Lecturer at the University of KwaZulu-Natal and Co-Director of the WHO Collaborating Centre on Pharmaceutical Policy and Evidence Based Practice.

Disclosure: Gray serves on three technical advisory committees at the South African Health Products Regulatory Authority.

*This column was published by Spotlight – health journalism in the public interest. Sign up to the Spotlight newsletter.

What the Public Protector’s Food Safety Investigation Reveals About Gauteng’s Public Health Early Warning System

Environmental Health Practitioners regularly test drinking and recreational water to detect contamination and help prevent diseases such as cholera and typhoid. (Photo: Unsplash)

By Christina Pitt for Spotlight

From inspecting spaza shops to monitoring water quality, Environmental Health Practitioners help prevent disease before outbreaks occur. A Public Protector investigation reveals why Gauteng municipalities are struggling to deliver these essential public health services. The investigation also helps clarify what is at stake in South Africa’s local government elections in November.

Environmental Health Practitioners (EHPs) operate as the public health system’s early warning system. They are responsible for identifying and managing environmental health risks before they become public health emergencies.

Whether inspecting food premises, monitoring water quality or investigating environmental health hazards, their work is designed to avert illness. These preventative functions form part of the municipal health services that local governments are required by law to provide and what will be at stake in the local government elections in November.

The importance of these largely invisible health services came into sharp focus when Public Protector Advocate Kholeka Gcaleka released preliminary findings of an investigation into Gauteng’s food safety system on 17 July 2026.

The probe followed a series of food poisoning incidents involving children in 2024. Among the most high-profile was the death of six children who allegedly consumed contaminated food bought from a spaza shop in Naledi, Soweto.

Rather than focusing only on the poisoning incidents themselves, the Public Protector’s office examined whether Gauteng’s municipalities were adequately delivering the municipal health services responsible for regulating food safety and hygiene standards in the informal business sector.

As the local government elections draw closer, we unpack how municipalities use environmental health services to prevent harm and protect public health, and find out what happens when that system comes under strain.

To start with, we need to understand what municipal health services are, the responsibilities assigned to municipalities by law, and how those services are intended to function.

What are municipal health services?

Food safety is just one of many municipal health services.

Professor Jaap de Visser, National Research Chair in Multilevel Government, Law and Development at the Dullah Omar Institute at the University of the Western Cape, points to the National Health Act for the full list.

The Act defines municipal health services by naming nine preventative functions, including food control, water quality monitoring, waste management, vector control, and environmental pollution control.

These services are primarily delivered by municipal officials called EHPs. How they perform this work is outlined by the National Environmental Health Norms and Standards.

For example, EHPs routinely collect drinking and recreational water samples for laboratory testing to detect contamination and reduce the risk of waterborne diseases such as cholera and typhoid.

This table below illustrates the key functions they perform to prevent disease before people become ill.

The National Environmental Health Norms and Standards requires EHPs to adopt a preventative, risk-management approach. In practice, this means rather than inspecting every premises equally, they prioritise activities and facilities that pose the greatest risk to public health.

“Higher-risk premises, for example, those handling high-risk foods, with a history of non-compliance, would be inspected more frequently and receive more intensive oversight,” explained National Department of Health spokesperson Foster Mohale. “Conversely, lower-risk premises with a strong record of compliance may be inspected less frequently, allowing EHP resources to be directed where they are most needed.”

EHPs also have enforcement powers when they identify breaches of prescribed health standards. They can issue compliance notices, requiring owners or operators to correct a problem within a specified period.

Their work also includes routine inspections, environmental health surveillance, investigating complaints, and educating communities and businesses.

Who is responsible for municipal health services?

Schedule 4B of the Constitution assigns municipal health services to local government, explains De Visser.

Which municipality is responsible for delivering these services depends on where you live.

In metropolitan municipalities such as Johannesburg, Tshwane and Ekurhuleni, the municipality is responsible for providing municipal health services within its boundaries.

In non-metropolitan areas, the Municipal Structures Act provides that district municipalities are generally responsible, while local municipalities perform the function only where they have been authorised to do so in terms of the Act.

Although municipalities deliver these services, the National Health Act requires them to work as part of a coordinated health system. It establishes District Health Councils to support coordination between national, provincial and local government.

According to Mohale, municipal health services are intended to function as an integrated three-tier system in which national, provincial and district environmental health units work together to deliver municipal health services.

“Working together, these structures are intended to create a coordinated system in which national government sets the policy and regulatory framework, provinces provide oversight and technical support, and district structures coordinate and strengthen implementation at municipal level,” he said.

Food safety provides a useful example of how that system operates in practice.

From farm to fork

Food microbiologist and food safety expert Professor Lucia Anelich says South Africa follows a “farm to fork” approach, with different institutions responsible for different stages of the food chain.

The Department of Agriculture oversees food safety at the production stage by regulating agricultural pesticides and veterinary medicines as well as food safety in abattoirs.

Once food enters the retail environment, the Department of Health, through municipal EHPs, is responsible for inspecting food premises, checking how food is prepared and enforcing food safety requirements.

The Department of Trade, Industry and Competition provides an additional layer of oversight by inspecting certain imported food products at ports of entry, overseeing product recalls and investigating consumer complaints.

When food contamination is suspected, those responsibilities overlap as the relevant authorities work together to trace the source, remove contaminated products, and prevent further illness. The agencies involved depend on where the suspected source lies within the food chain.

The Public Protector’s Gauteng food safety investigation examined whether the preventative systems intended to identify and manage these risks before outbreaks occurred were functioning as intended.

A break in the chain

The level of coordination required for food safety is not the type of thing that happens by chance.

That is why District Health Councils are tasked with strengthening planning, oversight and coordination between national, provincial and local government.

According to Mohale, these structures are intended to provide a forum for regular engagement between stakeholders, monitor the implementation of environmental health programmes and “ensure that food safety risks are identified and managed proactively.”

Yet, the Public Protector identified a significant weakness in Gauteng’s food safety system with the absence of functioning District Health Councils.

Without them, coordination between different spheres of government becomes more difficult, weakening oversight, planning, and the implementation of municipal health services.

Delivering these services also depends on whether municipalities have enough EHPs to carry out routine inspections.

EHP employment gaps

One of the Public Protector’s clearest findings was that Gauteng municipalities lack sufficient EHPs to carry out their statutory functions.

As of October 2025, every municipality fell short of the World Health Organisation (WHO) and the National Environmental Health Norms and Standards benchmark of one EHP for every 10 000 people.

Johannesburg had the largest absolute number of EHPs, with 240 practitioners serving a population of 4.8 million people. This gave it a ratio of one EHP for every 20 000 people, or 50% of the recommended benchmark.

Meanwhile, Ekurhuleni and Tshwane had fewer than one-quarter of the recommended number of EHPs.

According to City of Johannesburg spokesperson Nthatisi Modingoane, its current staffing complement is 213 EHPs, with eight funded vacancies. Despite ongoing recruitment, the City estimates that each EHP is still responsible for about 28 000 residents — almost three times the benchmark.

City of Ekurhuleni spokesperson Zweli Dlamini said the municipality now employs 98 EHPs, up from 94 during the Public Protector’s investigation. However, he acknowledged that the municipality still has a shortage of 309 EHP posts, leaving it well below the recommended staffing benchmark.

The City of Tshwane did not respond to Spotlight’s requests for updated staffing figures.

“The entire province is functioning at less than a third of the required EHP staffing capacity,” Gcaleka said about her findings, warning that the shortage threatens equitable access to environmental health services.

Anelich explained that staffing shortages are compounded by the breadth of EHPs’ responsibilities.

“EHPs are trained broadly, including water quality control and pollution monitoring — not only food,” she said.

“These people have multiple roles to play, which makes it very difficult for the system. We should have EHPs dedicated to food safety so municipalities can regulate food safety more effectively, particularly in the informal sector.”

The National Environmental Health Norms and Standards require EHPs to inspect high-risk food premises at least once every quarter. Maintaining those inspection frequencies becomes increasingly difficult when each practitioner is responsible for far more people than the recommended benchmark.

The capacity constraints extended beyond municipalities. The Public Protector found that the Department of Agriculture had filled only 27 inspector posts, which it described as insufficient to regulate agricultural pesticides effectively, weakening another part of the food safety chain.

But increasing staffing capacity depends on whether municipalities have the financial resources to create and sustain these posts.

Money troubles

The Public Protector also found that municipalities were not allocating enough funding to municipal health services, limiting their ability to recruit and retain EHPs.

Municipal health services are funded primarily through the local government equitable share. This is money allocated by National Treasury and transferred to municipalities to help provide basic services. Municipalities also use revenue from rates and taxes.

Because the equitable share is an unconditional grant, municipal councils decide how much funding is allocated to environmental health alongside their other constitutional responsibilities.

Although the National Department of Health is not responsible for funding municipal health services or employing EHPs, Mohale said it continues to support initiatives aimed at helping municipalities recruit, retain and train EHPs.

He also said the department engages with National Treasury and the Department of Cooperative Governance and Traditional Affairs to prioritise the appointment of EHPs and address staffing shortages.

The human cost

These system weaknesses had visible consequences on the ground. During blitz inspections cited by the Public Protector, EHPs repeatedly identified expired food, unlabelled products, poor hygiene, rodent infestations, and unsafe storage practices.

The Public Protector also found low levels of compliance with spaza shop licensing requirements.

Only 5% of spaza shops in Ekurhuleni were licensed or permitted, compared with 14% in Johannesburg and 30% in Tshwane, according to Gcaleka’s speaking notes. Across Gauteng, the compliance rate was 28%, meaning that for every licensed spaza shop, almost three were operating without the required license or permit.

“So many spaza shops aren’t licensed, so EHPs don’t even know where to look,” Anelich said.

“We can send EHPs into informal settlements to look for them, but that’s not a great use of resources that are already stretched.”

She also said the deaths highlighted what can happen when food safety systems fail. Adding that South Africa’s burden of foodborne disease remains poorly documented, making it difficult to understand the full scale of the problem.

A systemic failure

The Public Protector found that the problems extended beyond individual incidents.

In her speaking notes, Gcaleka says that the underlying governance weaknesses, severe staffing shortages, inadequate funding for municipal health services and capacity constraints in other parts of the food safety system were “not incidental, but systemic and far-reaching”.

She therefore made the preliminary finding that Johannesburg, Ekurhuleni, Tshwane, Sedibeng and West Rand had failed to properly enforce food safety and hygiene standards in the informal food sector.

As voters prepare to elect new local governments in November, the findings highlight a core municipal responsibility: preventing public health risks before they become public health crises.

This article was first published by Spotlight – health journalism in the public interest. Sign up to the Spotlight newsletter.

Dr Hermann Reuter Says the Biggest Battle after HIV in SA is Addiction – and It Is Being Ignored

Dr Hermann Reuter founded SAHARA, a non-profit organisation in George that provides support groups and free medication for people affected by harmful substance use. (Photo: Nasief Manie/Spotlight)

By Sue Segar for Spotlight

Dr Hermann Reuter did pioneering work treating HIV in the early 2000s in Cape Town and in the rural Eastern Cape. Today, his focus is substance abuse, which he believes is the country’s biggest health issue after HIV. Spotlight spent time with him to learn about his work in the Garden Route city of George.

On a Tuesday afternoon, just before 14:00, Jodie Fonseca, walks into a small consulting room inside the Central Clinic in the Garden Route town of George.

The 37-year-old, who says she has been addicted to heroin for 20 years, is here to fetch her supply of medication used to treat her substance use disorder. The slight, weary looking woman is welcomed warmly by two men as she takes her seat.

“How’s it going?” says Dr Hermann Reuter, a bespectacled man with a strong German accent. He’s wearing a T-shirt with the words Substance Survivor on the front. He looks at her file and dispenses tablets into a bottle.

Brian Faul, a volunteer behavioural change counsellor, chats and jokes with Fonseca. He describes himself to us as a recovering alcoholic, sober for 26 years.

Outside the consulting room, a line of about 30 people, needing help with substance use, have gathered in the narrow corridor in this typical inner-city government clinic. They range from gaunt older women in trackpants to young men in frayed hoodies. Some are seated and others stand patiently waiting.

Reuter hands Fonseca a bottle of pills. “See you next month for your medication,” he tells her.

“Remember, we’re always here if you have issues. We’re an open door, hey.”

Faul urges Fonseca to return to the clinic on Friday, when he runs group and individual counselling sessions for people with addiction.

Fonseca is here to attend a weekly outpatient service, run by the NGO Smoking and Alcohol Harms Alleviation and Rehabilitation Association (SAHARA). Founded in George by Reuter five years ago, the NGO offers free medical-assisted outpatient rehabilitation, and counselling in the form of support groups to people with substance addiction.

Currently, these services are not offered in the public healthcare system in George, but thanks to a relationship with the Western Cape health department, SAHARA uses a consulting room in Central Clinic for a few hours to run the Tuesday methadone programme and the Friday counselling services. On Wednesdays, through a similar arrangement, the NGO runs a programme in Thembalethu clinic.

An addict since 17

Desperate to “get away from the heroin”, Fonseca, a mother of three, tells Spotlight she moved to George from Johannesburg a few months ago.

“Johannesburg was just a battle. I ended up on the streets and lost everything,” she says. “The lifestyle and the familiarity just kept my boyfriend and I in the cycle. Heroin is so easily accessible up there. I’d just had enough. I wanted to get on the methadone programme.”

Fonseca says while it was a struggle for her to get onto a programme in Johannesburg, it was smooth sailing in George with Reuter helping her on her first visit to the clinic. “I was amazed and grateful, actually speechless,” she says. “I walked in and said to him, ‘I can’t carry on in this lifestyle. I feel the next time I pick up I’ll … make sure it’s a deadly dose’.”

Fonseca says the counselling sessions have been helpful too. “Brian downloaded a breathing app to help with my anxiety. It calms me and helps me sleep,” she says.

She dreams of a normal life, back with her children and to spend time with her mother, “my rock”, who she says is in poor health.

Fonseca is by no means alone in having become addicted to heroin. As previously reported by Spotlight, rates of heroin use in South Africa have been on the up. It is estimated that a few hundred thousand people in the country take the drug every day.

A stream of people with substance-use disorders

Next to enter the consulting room are a father and his teenage son. One can sense the love between them, but there’s tension. It’s their first visit, and they’re here because the son wants to quit his marijuana habit. The concerned father asks Reuter to test his son’s urine to check whether his son is using other drugs, like crystal meth, on top of marijuana. The son insists he only uses marijuana.

Intervening gently, Reuter says there’s no need for a urine test. “The treatment for cannabis (marijuana) and crystal meth is the same; there will be no benefit from additional information,” he says. The dad nods. Both agree to return to the clinic for more counselling.

Next to see Reuter are Peter-John Truter and his twin brother, Kenneth, both 36, and addicted to heroin. They tell Spotlight their mother died of breast cancer when they were three-months old and they were lovingly raised by a relative in Mitchells Plain, Cape Town. Initially hard-working and sporty children, they started using “weed, alcohol, ecstasy and tik” as teenagers, before discovering heroin in their 20s.

“Drugs took over the Cape Flats. Wherever you went, people were drinking, smoking tik or whatever. It’s the weekend thing. Our area became infected with heroin. We moved from smoking to mainlining (injecting),” says Peter-John.

The brothers tried rehab several times. Their heartbroken adoptive mother sent them to George, thinking there were no drugs there. They found dealers immediately. Both are now on the methadone programme and sometimes attend counselling.

Next in the small consulting room is a young man who’s addicted to the medication Tramadol.

“I started taking it for toothache and got up to 20 tablets a day. It made me feel good, like I was on drugs, but I started passing out in the street,” he says.

Reuter explains that the treatment for Tramadol addiction is the same as for heroin addiction. Both drugs are opioids.

“No cold turkey with methadone”

Reuter explains that heroin addiction is treated with methadone Opioid Substitution Treatment (OST). Methadone is a synthetic opioid that is typically taken once a day.

“It sits on the same receptor as heroin, so people don’t suffer withdrawal. There’s no cold turkey or cramping. They can go back to normal life quite quickly if they stick to this,” he says.

The first six months of the treatment is usually “a bit up and down”, Reuter says, but the programme has seen most addicts moving back into their homes and into jobs.

“Most people on the programme stop the methadone at some stage, so you won’t see them here anymore. The people you see here today are those who are still on the street and struggling – or who started recently,” he says.

It’s clinic closing time but a few people still need support. Reuter, undaunted, carries his box of medication and continues outside. A small group of users join him.

There we meet Sarah Lessing who says she has been clean from heroin for four years since joining Reuter’s programme. She’s brought two youngsters who live in the mountains outside George.

“In George, there’s unfortunately nowhere for people without a support system to go,” says Lessing. She recalls how she decided to give up heroin, after her partner who also used heroin died. “I had to literally walk past my dealer to get to the taxi to go to Dr Reuter’s clinic.” Fully recovered, she feels part of his “lifesaving” mission to work with other people struggling with addiction.

Thembalethu’s Wednesday clinic

The next morning, Reuter is working in George’s Thembalethu clinic. The service here is offered every Wednesday for people struggling mainly with alcohol and nicotine use.

The first hour is spent with community health workers. SAHARA has been sub-contracted to manage about 65 health workers from five clinics in the district trained in substance use, as well as mental healthcare. Reuter says that, with substance use and mental health issues at crisis levels, it is essential health workers have this capacity added to their skillset.

As part of a Western Cape government youth wellness and substance prevention programme called Planet Youth, the community health workers will be working with schools in their areas to link health and education; and to teach people about the dangers of alcohol and cigarettes.

“Now that we are entrusted with community health workers, we want to expand their scope of practise, so they support the schools, including the relationship between the schools and parents,” says Reuter.

Soon after 09:00, a stream of service users has entered the consulting room. There’s an old man with a walking stick, a few middle-aged women, and some very young people.

Switching from English to Afrikaans to isiXhosa, Reuter greets every person. “You are taking a big step today … we can help you with these tablets, and with our support group,” he says.

A 29-year-old woman tells Spotlight she’s been smoking cigarettes since she was 17. She’s lost count of how many cigarettes she smokes daily and says she feels sick all the time. “It doesn’t even help my stress,” she says.

A man who works as a painter says he hopes to give up alcohol and smoking. “I’ve been smoking since 1984. At weekends, I drink and smoke till I’m dizzy. I don’t even have tastebuds till Wednesday or Thursday,” he says.

More and more people arrive. Reuter listens to each one, and packs medicines for each. For nicotine, he’s got bupropion, and when funds are sufficient, varenicline. “Bupropion helps quit smoking by reducing cravings and withdrawal symptoms. Varenicline is a nicotine receptor blocker. It reduces withdrawal symptoms and reduces enjoyment of smoking,” he explains. He says it’s safe to use these with other medications and during pregnancy but people who have epilepsy must be properly consulted.

For those wanting to reduce alcohol use, he prescribes diazepam and naltrexone. “Diazepam reduces withdrawal symptoms by working on the GABA (gamma-aminobutyrid acid) system, which is the main inhibitory neurotransmitter in the central nervous system… Naltexone blocks the euphoria caused by alcohol-induced endorphins,” he explains.

David Nongogo says he joined Reuter’s programme about five years back and is now a regular at the clinic to encourage others. “It took me only three weeks to get off smoking and drinking,” he says.

“I won’t ever go back there. There’s a drink they make in the township, called ‘iginja’ made from a powder you brew into alcohol. If you drink it, you don’t even know when you need to urinate. You just urinate. I found myself there. If it wasn’t for the programme, I wouldn’t be here,” he says.

Reuter’s public health journey

Well-known for his groundbreaking work in HIV treatment and activism, Reuter graduated in medicine from Stellenbosch University in the early nineties. Politically involved from an early age, he worked for the Treatment Action Campaign (TAC) in the Western Cape in the late nineties. He then ran HIV treatment programmes in Khayelitsha, Cape Town and Lusikisiki in the rural Eastern Cape for Medecins Sans Frontieres (MSF). He also ran HIV services for the health department in KwaZulu-Natal. In 2004, Reuter received the Rural Doctor of the Year Award from the Rural Doctors Association of Southern Africa (RuDASA) for his efforts in providing HIV medicines in remote areas of the country. In 2020, Reuter published this moving article looking back at the role of some key people in the struggle for antiretrovirals in South Africa.

Reuter moved to George in 2015 where, besides running SAHARA, he works as Community-Based Education Coordinator in the Garden Route, for the Division of Primary Health Care in the Department of Family, Community and Emergency Care of the Faculty of Health Sciences at the University of Cape Town.

Reuter’s passion these days is what he calls the “neglected problem” of substance abuse which, he says, is the country’s second biggest health issue after HIV. He says the health system carries the high costs of the harm and illness caused by substance misuse. He argues that it is more cost-effective to treat addiction before it takes hold. This, he feels, should be done at primary care level, as opposed to dealing with the fallout in public hospitals.

He says government should carry the cost of substance abuse medications and points out that the public health system does not currently provide methadone or other medications for treating substance abuse as they are not on the essential medicines list, and clinics are not authorised to keep them on site.

The public health system does not currently provide methadone, a synthetic opioid typically taken once daily, or other medications used to treat substance use disorders. (Photo: Nasief Manie/Spotlight)

“So, I arrive with my stock, hand it out, and monitor people to ensure they are safe on the medication,” says Reuter. “I am registered as a dispensing doctor so can buy the medication wholesale and distribute it.” His funding comes from a charity in Canada called Child.

George, he says, is no different from any other town in South Africa.

“Over weekends, the hospital is overwhelmed with trauma cases … clearly linked to alcohol abuse. Like other hospitals, we see numerous people with complications arising from smoking, like cardiovascular issues, lung disease, and cancer.”

He continues: “I see families in tears every week, saying ‘our child is stealing and doing drugs, and is not our child anymore’.”

Treat the substance use, not the repercussions

Reuter says he became disillusioned with medicine when he realised he was just working at the tail end of people’s misery. “I knew that the social context in which people lived needed to change. Rather than putting a plaster on much bigger problems, issues should be dealt with much earlier,” he says.

He is disappointed that more doctors are not advocating for medications for treating substance abuse to be made available in government facilities.

“It reminds me of the early days of HIV. We knew there were medicines that worked and not many doctors were prepared to stand up and advocate for it,” he says.

Reuter says that the government’s approach to tackling substance use is not ideal. He explains that the Department of Social Development is tasked with issues relating to substance abuse.

“But substance use is a medical problem. There are many social causes and social problems caused by it. The Department of Health should be dealing with it because the complications down the line are so expensive, and [they do end up] paying for all of them. We should be medically treating substance users to save the health department from these costs,” he says.

A few positives

On the plus side, SAHARA’s integration of its services into the local clinics is yielding results. Community health worker at Thembalethu clinic, Gcobisa Kraai, says she is learning so much about the treatment of substance abuse. “I can see the community really wants this service. Substances are killing our communities,” she says.

Reuter says last year his NGO treated 2 400 people for smoking, 1 400 for alcohol use, with more than 50 people on methadone. “Our budget cannot treat more people, so we restrict clinics where we work so that we have medication for the whole year,” he says. “If we had more funding, we could be at more clinics.”

This article was first published by Spotlight – health journalism in the public interest. Sign up to the Spotlight newsletter.

Reforming Prescribed Minimum Benefits Is the First Step to Affordable Medical Cover

Dr Katlego Mothudi is the Managing Director of the Board of Healthcare Funders, an industry representative body for medical aid schemes, administrators and managed care providers.

By Katlego Mothudi

With plans in motion to roll out universal health coverage in South Africa, Dr Katlego Mothudi, of the Board of Healthcare Funders, argues that revising the compulsory prescribed minimum benefits that medical schemes must provide can be a tool to deliver meaningful improvements today while laying the foundations for a more sustainable healthcare system.

South Africa’s journey towards universal health coverage will not be defined by a single policy or piece of legislation, but by the practical reforms that make quality healthcare more accessible and affordable for more people. Achieving this goal requires, among other things, tackling structural barriers that continue to drive up the cost of medical scheme cover and place private healthcare beyond the reach of millions of people in South Africa. One of the most important, yet often overlooked, barriers is the outdated framework governing prescribed minimum benefits (PMBs).

PMBs are the set of conditions and services that every medical scheme is legally required to cover, regardless of the plan a member chooses. Their existence is critical, created with the intention of ensuring scheme members do not lose access to catastrophic care in the event of serious illness. PMBs ensure that members are not reliant on an over-burdened public sector during medical emergencies. And although this principle remains important, the framework has not kept pace with South Africa’s changing disease burden, evolving models of care, or the cost of delivering healthcare.

20 years of PMB limbo

Regulations made under the Medical Schemes Act require PMBs to be reviewed every two years. This must be carried out by the Department of Health together with the Council of Medical Schemes, provincial health departments and other stakeholders. In practice, this has happened only once, more than 20 years ago.

The current review process has been underway for close to a decade without conclusion. As a result, the outdated PMB framework has become one of the most significant contributors to medical scheme costs and thus an inefficient health policy. Actuaries advise that roughly 60% of a scheme’s budget goes towards funding PMBs before any other benefit is considered. This used to be approximately 40% when the PMB was amended in 2003.

The consequences of this laborious review process directly impact household budgets. The most basic scheme cover now costs a single beneficiary in the region of R1 600 a month, with a family of three facing around R4 000. For most working people in South Africa, that is simply unaffordable, and it is a significant reason why medical scheme membership has stagnated even as the population has grown. Furthermore, South Africa’s healthcare “missing middle” has grown to an estimated 8 million people who access private healthcare, paying out-of-pocket, without belonging to a medical scheme.

An out-of-date framework

If the PMB list were redesigned today, using current clinical evidence, the country’s evolving disease burden, and the realities of healthcare affordability, many of its benefits would likely look very different. The current framework no longer reflects what the system can sustainably provide. And because it consumes such a large portion of every scheme’s budget, it crowds out the very things that would make cover more affordable and more useful – primary care, early intervention and prevention.

At a recent Board of Healthcare Funders conference, Dr Fatima Hoosain, a specialist breast and endocrine surgeon, set out the numbers plainly: a mammogram and ultrasound cost in the region of R2 500. Left undetected until the disease has progressed, that same patient may require R100 000 in radiation therapy, R200 000 in chemotherapy, and, for HER2-positive cancers which typically can quickly spread from the breasts to other areas of the body, roughly R7 000 every three weeks for a year in targeted biological therapy. Early detection does not only save lives, but it is also, by a wide margin, the cheaper pathway. From a cardiology perspective, Dr Martin Mpe, president of the South African Heart Association, made the same point at the conference. He argued that the cheapest way to treat a heart attack is to prevent it, and that the system needs to start rewarding prevention rather than paying only for treatment after the fact.

Rather than expanding access, an outdated PMB framework has unintentionally limited it.

A PMB framework anchored in 1999-era diagnosis-and-treatment logic has little room for rewarding the prevention and early detection that would keep patients out of the expensive end of the system altogether. Importantly, reform does not mean stripping away protection. It means modernising the list so that mandatory cover reflects today’s clinical realities. It also means rethinking how the package is defined. The current approach is built around a long, condition-by-condition diagnostic list, a modern framework could instead focus on the essential health services people need most, including preventative care, primary healthcare services, medicines on an essential medicines list, and diagnostics on an essential diagnostics list. It could also emphasise the areas where the disease burden is greatest.

A core service package

This aligns closely with the Board of Healthcare Funders’ (BHF) recent commitment to explore a Core Service Package as a practical step towards universal health coverage. By focusing on the services that deliver the greatest health benefit within available resources, such an approach would place prevention and patients at the centre of the health system while creating greater flexibility to expand affordable access.

The BHF has previously worked to operationalise South Africa’s national Essential Medicines List (EML) within the private funding environment, partnering with MediKredit in 2021 to launch a NAPPI-coded mapping tool that helps funders align benefit design and claims systems with the EML, improve medicine access, and reduce out-of-pocket costs. This existing groundwork offers an affordable, prevention-oriented foundation on which a modernised PMB package could be built.

The evidence of where the current framework falls short is already available. Annually, the Council for Medical Schemes reports on out-of-pocket expenditure, which exceeded R40 billion last year. When people spend that much of their own money on healthcare, over and above their contributions, they are pointing directly to where their cover is failing.

A broader set of changes

PMB reform does not stand alone, and it will not by itself fix affordability. It is the entry point to a broader set of changes that reinforce one another. The most important of these is regulated tariff reform. South Africa currently lacks a transparent, predictable mechanism for setting provider prices, and this absence has driven costs upward for years. Allowing schemes and willing providers to negotiate fair tariffs, within a properly regulated framework, published for transparency, would bring discipline and predictability to pricing and give members clarity on what they are paying for.

Alongside this, permitting schemes to offer low-cost benefit options, a subset of the proposed revised PMBs and based on services rendered in the public sector clinics, would extend affordable, primary-care-based cover to millions of people in South Africa who currently fall outside the system and pay out-of-pocket for private care.

None of these reforms require new legislation or a wholesale restructuring of the health system. They can be pursued within the existing regulatory framework, and PMB modernisation is the logical place to begin, because it addresses the highest single cost in every member’s contribution and unlocks the room to fund better, more preventive care.

For members, this shift would be felt less as a change to their PMB entitlements and more as a change in what their contribution actually buys before a crisis ever occurs. Money currently locked into funding late-stage, high-cost treatment for conditions that could often have been caught earlier could instead support routine age- and risk-appropriate cancer screenings, cardiovascular risk assessments and blood pressure checks, diabetes screening and management support, and the kind of primary care consultations that catch problems while they are still cheap and simple to treat. None of this is about giving members less. It is about intervening earlier, so that fewer members ever need the R100 000 radiation course, the R200 000 chemotherapy regimen, or the cardiac admission that better screening or blood pressure control could have prevented.

There is an understandable reluctance to reopen the PMB framework, given how long the review has already taken and how contested the terrain can be. The longer reform is delayed, the greater the affordability pressures on households and the greater the strain on the broader health system.

Reforming prescribed minimum benefits is ultimately about far more than updating a list of conditions. It is about creating the flexibility to expand access, strengthen prevention and make medical scheme cover affordable for more people in South Africa.

*Mothudi is the Managing Director of the Board of Healthcare Funders, which represents around 45 medical aid schemes in South Africa, including GEMS and Bonitas.

*This piece was published by Spotlight – health journalism in the public interest. Spotlight aims to deepen public understanding of important health issues by publishing a variety of views on its opinion pages. The views expressed in this article are not necessarily shared by the Spotlight editors.

People with HIV Are Living Longer but Have Fewer Years of Good Health – New Guidelines Aim to Change That

Taking antiretroviral therapy as recommended has expanded the lifespan of people with HIV. (Photo: Unsplash)

By Elna Schütz for Spotlight

South Africa’s first set of clinical guidelines focused on older people living with HIV has been released. They offer practical steps in a resource-strained health system to take care of an ageing patient population.  

The guidelines from the Southern African HIV Clinicians Society were published in the Southern African Journal of HIV Medicine. A dozen experts from institutions around the country gave input from disciplines like infectious diseases and palliative care.  

The guidelines are particularly important in South Africa since the country has an ageing population of people living with HIV. Many of these people would only have started treatment relatively long after they contracted the virus, largely because of the government’s reluctance to make antiretroviral treatment available in the early 2000s. The sooner people start treatment after infection, the better their long-term prognosis tends to be. 

In 2025, there were around 1.9 million people over the age of 50 living with HIV in South Africa, according to Thembisa, the leading mathematical model of HIV in the country. This is 24% of the estimated 7.9 million HIV positive people in the country. The 1.9 million figure is more than double the 800 000 people over 50 who were living with HIV in 2015. This number is projected to rise to over 3.6 million by 2035.  

Most people over the age of 50 who are living with HIV contracted the virus before they turned 50. The increase depicted in this graph is thus mainly a function of people who are already living with HIV ageing into the over 50 age group. Some people over 50 do become newly infected with HIV, but those numbers are comparatively small.

The changing make-up of the population of people living with HIV, coupled with the fact that antiretroviral therapy has been crucial for clearing and suppressing HIV in the body was a core driver for developing the new guidelines, Dr Camilla Wattrus, the Clinical Director at the Southern African HIV Clinicians Society, tells Spotlight. She is one of the guidelines’ authors. 

“Antiretroviral therapy has expanded the lifespan of people with HIV, but we must now also consider how to preserve the ‘health span’ in this group,” says Wattrus.

She explains that this means increasing the years that are spent in good health with a good quality of life.  

Another co-author of the guidelines, Nomathemba Chandiwana, Chief Scientific Officer at the Desmond Tutu Health Foundation, points out that after antiretroviral treatment was introduced in South Africa, the life expectancy of people living with HIV increased dramatically. “We didn’t think people would live as long as they have now, so that’s been a big success,” she says. “But now we have new problems.” 

Chandiwana says that older people living with HIV have around 16 fewer years in good health than people without HIV. The 16-year figure (technically 15.3) seems to originate in a study published in 2020 in the JAMA medical journal that compared the health and lifespans of insured people with and without HIV in the United States. For people with HIV who started antiretroviral treatment when they were still healthy (CD4 countes above 500), the difference in healthy years was 9.5 years.  

Another broad concern is that clinicians may be focused on HIV-related issues like viral suppression for these patients and not be sufficiently aware of other ageing-related developments. People with HIV get the same ageing related diseases as other people, but there is evidence that they tend to get them earlier. 

We know from Thembisa model outputs that on average, people living with HIV today are slightly more likely to die of non-HIV-related causes than AIDS. According to the model, there were 53 000 HIV-related deaths in the year from mid-2024 to mid-2025. This is a thousand fewer than the 54 000 people with HIV who died of non-HIV-related causes over the same period.  

What is in the new guidelines  

The new guidance states that it is designed to:  

  • Raise healthcare workers’ awareness of the needs and concerns of the population of people living with HIV who are 50 years and older.  
  • Inform healthcare workers about an ageing-related approach to older people with HIV.  
  • Highlight good practices to help healthcare workers provide optimal care for this population. 
  • Provide resources about ageing with HIV for healthcare workers, their patients and their patients’ carers.  
  • Guide clinical settings in implementing geriatric care into HIV clinical practice.  

The clinical advice in the guidelines follow the World Health Organisation’s (WHO) principles for Integrated Care for Older People (ICOPE), which emphasises prevention prior to frailty, person-centred assessment, and the involvement of healthcare workers other than doctors.  

The guidelines cover a thorough list of challenges faced by older people with HIV that need to be monitored and addressed. For instance, physiologically, there is a risk of comorbid conditions like hypertension and cancer, and an increased risk of complications from polypharmacy, when more than five medicines are used concurrently. Social and behavioural challenges include that older people are perceived to be less likely to get infected with HIV and therefore have lower rates of HIV testing and use of HIV prevention tools. 

This population is also at risk of being disregarded or not fully cared for in the healthcare system. The guidelines give examples such as restricted mobility access to health facilities and healthcare workers being unaware of the HIV-related risks in older people. “The health system needs to be equipped to manage their needs in a holistic and integrated way, and that is what this guideline aims to support,” says Wattrus. 

The guidelines include a comprehensive schedule of what need to be assessed and screened and at what regularity. There is a particular focus on geriatric syndromes like frailty, cognitive impairment, and managing comorbid non-communicable diseases. 

“The idea is that every visit with an older patient involves more than just routine HIV care and that it becomes a conversation about how that person is functioning and living,” says Wattrus.  

The guidelines also emphasise how care can be offered by a variety of healthcare providers, depending on the resources available. “Recommendations enable task-shifting, which is a practical necessity in a country where specialists such as geriatricians are scarce, and the bulk of HIV routine care is delivered by healthcare workers at primary care level,” says Wattrus.  

Even though the guidelines focus on overall health in older people living with HIV, managing HIV is, of course, a part of this. It cautions that “CD4 recovery may be slower and blunter compared to younger individuals,” but viral suppression is still the primary treatment goal.  

The crucial factor here is to choose the correct antiretroviral treatment regimen for the patient. For instance, popular tenofovir disoproxil fumarate (TDF) combinations should be avoided in people at risk of or with osteoporosis, bone fractures, or renal impairment. Regimens with tenofovir-alafenamide or abacavir may be better, though the latter is contraindicated if there is high cardiovascular risk. 

The new local guidelines hit largely the same notes as a major commission on HIV and ageing that was published by the journal Lancet HIV to coincide with the AIDS 2026 conference taking place in Rio de Janeiro, Brazil. 

“Supporting healthy ageing requires more than sustained viral suppression; it requires care that is informed by what matters most to the individual, with attention to maintaining physical and mental function, minimising healthcare complexity, and addressing multimorbidity, polypharmacy, stigma, and social determinants of health,” the commission found. 

Simple systems, big change   

Apart from giving healthcare workers a framework for giving better care to older people living with HIV, the guidelines advise how this larger change in the health system can happen for this growing older population. “What is great is that most of the recommendations are not complicated or expensive,” says Wattrus.  

She explains that the sensitisation and training of healthcare workers, especially in primary care, is a crucial first step. If they know how to, they can easily incorporate brief screenings, such as those for frailty, into normal appointments. For example, as Chandiwana points out, several geriatric tests need only a chair for the patient to sit down on and get up from. She says it is easier to do these things for people with HIV during their existing appointments, compared to people without HIV who may not be visiting health facilities for regular screenings. 

Another relatively easy adaptation is to simply make healthcare services easier to access. “This can be done by having appointments aligned across conditions, fewer unnecessary referrals and genuine attention to broader aspects of their health such as poverty, isolation and limited mobility,” she says. 

Chandiwana also suggests that one could consider rolling out geriatric care health cards to track screening, as is often done with children. She would also like to see more community buy-in, in a similar way as there was during the earlier part of the HIV treatment roll-out. For instance, she suggests community health clubs and increased health literacy efforts around ageing.  

Avoiding problematic polypharmacy, says Wattrus, is another low-cost, high-yield strategy that does not require specialist input. “Routinely reviewing medication lists, identifying unnecessary drugs, and checking for interactions is straightforward and can make a significant difference,” she says. 

More specialists would of course help. Chandiwana says there are fewer than 50 geriatric specialists in the country. She says there is also a much wider need for geriatric-specific training across the healthcare system, including for primary care nurses and community healthcare workers. 

Lastly, Chandiwana says the guidelines offer a much-needed look into the unique challenges and needs of older people with HIV as an opportunity for the government to act to prevent a future problem. “So that investment in having scalable, simple systems for people who are ageing, both with HIV and without, I think, would be fantastic, but that needs money,” she says.

*This story was published by Spotlight – health journalism in the public interest. Sign up to the Spotlight newsletter.

AIDS 2026: Momentum Builds for Monthly HIV Prevention Pill, but Key Data Not Yet in

By Marcus Low for Spotlight

If an HIV prevention pill that provides a month of protection at a time performs well in two ongoing clinical trials, it could become the next big thing in HIV prevention after the lenacapavir injection. A new licensing agreement is paving the way for South Africa’s Aspen Pharmacare to produce the pill should the study findings be positive and the drug be registered.

In June, South Africa’s health department started rolling out the six-monthly lenacapavir HIV prevention injection to around 10% of public sector clinics. While the rollout of this jab still has a long way to go, the next generation of HIV prevention products is already on the horizon.

Two of those new products stand out. One is a new formulation of lenacapavir that looks as if it can provide 12 months of protection at a time. While results so far are promising, the pivotal data on this once-yearly HIV prevention jab is only expected in a year or two.

The other product that has many people in the HIV world excited is a monthly HIV prevention pill that contains a highly potent antiretroviral medicine called alimatravir (it was previously called MK-8527). It starts working within around an hour after someone takes it and appears to provide a month of protection at a time. One benefit of the pill, compared to the lenacapavir injection, is that it would be easier to distribute at scale, given that there is no need for a nurse to administer an injection.

As Spotlight reported in some depth last year, alimatravir looked very promising in a phase 2 study, although for now the jury is still out on the drug’s safety and efficacy. It is currently being evaluated in two pivotal phase 3 clinical trials called EXPRESSIVE-10 and EXPRESSIVE-11. Both these studies started last year and are expected to be completed by around mid-to-late 2027. Medicines are typically only registered for use after positive results in such phase 3 studies.

“The monthly pill offers an alternative for people who would like a long acting, less frequently dosed PrEP but not needle friendly … so it really is about giving more options especially on the pill side,” Professor Linda-Gail Bekker, primary investigator in South Africa on the EXPRESSIVE-10 study, told Spotlight. “You could imagine that just having to remember to take a small easy to swallow pill on the day you pay your bills monthly could be very easy for people. We understand that the packaging is also going to be very user friendly- looking more like a gum packet than a bottle of antiretroviral pills which may also reduce stigma.” (PrEP refers to pre-exposure prophylaxis like HIV prevention pills or injections.)

Licence to make generics 

The prospects for future access to alimatravir got a major boost last week when the pharmaceutical company Merck (known as MSD outside of the United States and Canada) announced that it granted licences to seven different companies to produce generic versions of the monthly pill. One of the seven companies is South Africa’s Aspen Pharmacare. The others are Uganda’s Quality Chemical Industries Limited, Kenya’s Universal Corporation Ltd, and Aurobindo, Cipla, Emcure and Viatris in India.

Early responses to the licences have mostly been positive.

Having a generic company with a licence in South Africa is excellent news, said Bekker.

“It is particularly exciting to see manufacturers in Kenya, South Africa and Uganda included in these licenses,” Mitchell Warren, Executive Director of AVAC (a global HIV advocacy group), told Spotlight by e-mail. “These are the first generic PrEP licenses in East and Southern Africa, meaning manufacturing can happen where trials are happening, where need is greatest and where we have the largest PrEP markets.”

“Through our agreement with MSD (Merck), we have the opportunity to support the future supply of an innovative HIV prevention option while strengthening local pharmaceutical manufacturing and healthcare resilience across the continent,” Stephen Saad, Aspen Group Chief Executive, said in a media statement. Under the agreement, the company says it will receive a technical package from Merck, together with licensing rights covering 129 countries, including all African countries.

Speaking to Spotlight, Stavros Nicolaou, Aspen’s Head of Strategic Trade, described alimatravir as “ground-breaking and a potential game-changer”. He commended Merk for starting the licensing process so early. He framed the licence as an important step forward for both South Africa’s HIV response and for local production of antiretrovirals, although he also raised concerns about the procurement of locally manufactured antiretrovirals – the percentage of South Africa’s antiretroviral tenders awarded to local manufacturers has been trending downward.

According to earlier reporting by Business Day, Nicolaou has declined to give any indication as to a potential price for the pill, but he did tell the publication that they could potentially supply it for both South Africa’s public and private sectors.

There are indications that a relatively low price is on the cards. Research being presented at AIDS 2026 this week found that alimatravir could be mass produced and sold at a profit for as little as $15 (around R250 to R300) per person per year. This is less than half the $40 per person per year that South Africa is expected to pay for generic lenacapavir injections in a year or two from now.

“Merck expects to provide initial supply and continue supplying product as needed while licensed generic manufacturers complete development, obtain the necessary regulatory approvals and prepare to provide supply in the licensed territories. The goal is to help avoid delays in access by providing an initial supply pathway until generic manufacturing capacity is established and brought online,” the company said in a media statement.

Earlier licensing 

The timing of the licensing announcement is somewhat unusual – such announcements are typically only made after phase 3 trials have been concluded and it is confirmed that the drug is safe and effective.

“Granting licensing agreements to generic manufacturers while clinical trials are still enrolling, before it is known if the product is effective, should significantly reduce the time to market for the product,” Warren said in an earlier AVAC media statement. “The timeline announced today gives us ample opportunity to work with ministries of health, donors, communities, and Merck to plan for broad access to the monthly PrEP pill.”

Warren told Spotlight that the small amount of active drug in alimatravir and the fact that it is an oral dose should make the technology transfer from Merck to generics quite quick. “The hope would be that genetic alimatravir reaches the market within months of the approval of the originator, compared to more than a year for lenacapavir,” he said.

Nicolaou was also upbeat about how quickly things are unfolding. He said that Merck’s decision to execute licences while the phase 3 clinical trials are ongoing allows for an earlier registration pathway (if phase 3 findings are positive, alimatravir will have to be filed for registration with regulators like the South African Health Products Regulatory Authority). He also pointed out that it is a small tablet and that it should be easier to manufacture than HIV prevention injections.

Nicolaou told Spotlight that the plan is for Aspen to do formulation of alimatravir in South Africa, but that they are not currently planning to produce the active pharmaceutical ingredient – this will likely be sourced from Chinese or Indian suppliers.

Some activist criticism 

But while the timing has generally been welcomed, there has also been some criticism over the licenses.

A statement from activist group HealthGap points out that Latin American countries like Brazil, Argentina, and Colombia are not included in the list of 129 countries covered by the license, even though some of the phase 3 trial sites for alimatravir are in these countries. The HealthGap statement calls for compulsory licenses to be issued.

In an earlier statement, Merck said that, in recognition of the significant unmet need in Latin America, “Merck is in active discussions with organizations, including Fiocruz (a key player in medicines production and procurement in Brazil), with a goal to enable rapid availability and broad supply of alimatravir in the region”.

Disclosure: The Gates Foundation has provided financial support for clinical trials of alimatravir. Spotlight receives funding from the Gates Foundation, but is editorially independent – an independence the editors guard jealously. Spotlight is a member of the South African Press Council. 

*This story was published by Spotlight – health journalism in the public interest. Sign up to the Spotlight newsletter.

Positive Interim Findings on New Once-weekly HIV Treatment Pill

Researchers have found that a new once-weekly antiretroviral formulation appears to be as effective as the daily pills. Photo by Danilo Alvesd on Unsplash

By Marcus Low and Elri Voigt

A new antiretroviral combination pill that is taken only once a week appears to work as well as daily pills at treating HIV. This is according to interim study findings to be presented next week at the AIDS 2026 conference in Rio de Janeiro, Brazil.

Almost all of the over six million people in South Africa who are currently taking HIV treatment are taking it in the form of one tablet taken once a day. These tablets contain a combination of three different antiretrovirals, most commonly dolutegravir, lamivudine or emtricitabine, and tenofovir.

Now researchers have found that a new once-weekly antiretroviral formulation appears to be as effective as the daily pills. The new pill contains only two antiretrovirals, islatravir and lenacapavir. A different formulation of lenacapavir is used in the six-monthly HIV prevention injections being rolled out at around 10% of public sector clinics in South Africa.

“I think this is the next treatment blockbuster,” Professor Francois Venter told Spotlight this week when asked about the new once-weekly pill. Venter is the Executive Director of the Ezintsha Research Centre at the University of the Witwatersrand. He was not involved in the studies of the once-weekly pill.

“Patients are crying out for less frequent dosing, and it does not have the fiddliness and complexity, the supply line, healthcare worker training, or resistance issues of the current or immediate next generation of injectables. Imagine dispensing the same number of tablets for 6 months as previously for a month. It looks cheap to make. Low- and middle-income countries really should be taking note,” he said.

Two studies

The findings to be presented in Rio are from the first 48 weeks of two relatively large, multi-country, phase 3 studies called ISLEND-1 and ISLEND-2. Both studies will continue for another 48 weeks. The final study findings will only be reported after the full 96 weeks are completed.

The two studies have similar designs. Both started out with people who were already on antiretroviral therapy and doing well on treatment (607 people in ISLEND-1 and 624 in ISLEND-2). The researchers then switched roughly half of the people in each study over to the weekly islatravir/lenacapavir pill. The outcomes of those who switched to the weekly pill were then compared to those who didn’t switch and simply kept taking the treatment they had been taking before.

A key difference between the studies is in the control groups. In ISLEND-1, the researchers specifically recruited just people who were taking the antiretroviral combination of bictegravir, emtricitabine, and tenofovir alafenamide. In ISLEND-2, they recruited people who were taking whatever the local standard of care was (which often differs between countries). Some of the many ISLEND-2 clinical trial sites are in South Africa where the standard of care is dolutegravir, lamivudine or emtricitabine, and tenofovir.

Another notable difference between the studies is that ISLEND-1 is double-blinded, whereas ISLEND-2 is an open label study. This means that in ISLEND-1 neither study participants or their doctors know which study arm they are on – this is achieved by also giving people on the weekly arm daily placebo pills and people on the daily arm pills that look like the weekly placebo. In ISLEND-2, people know what study arm they are on and there is no need for placebos.

Both studies have a non-inferiority design, which is to say their main aim is to establish whether the weekly pill is roughly as safe and effective as existing treatments. Such designs are commonly used in HIV treatment trials given that existing treatments are already very safe and effective. The potential step forward in this research is the weekly dosing, not improved safety or efficacy against HIV.

“Developing new antiviral HIV medications remains important in order to address pill fatigue, adherence challenges, broaden treatment, with the goal of ending the HIV epidemic,” Professor Jürgen Rockstroh, lead author of the presentation of the ISLEND-1 results at AIDS 2026, told Spotlight by e-mail.

What the researchers found

The short version, as described in a conference media release, is that in both studies the weekly pill was found to be “efficacious and well tolerated and statistically non-inferior” to the controls it was measured against. In other words, based on the 48-week data, the weekly pill is passing the test so far. The findings have also been summarised in a media statement by pharmaceutical company Gilead Sciences.

The key indicator that the researchers looked at was the proportion of people whose HIV viral load was not suppressed at 48 weeks (they used a cut-off of 50 copies per millilitre of blood). If antiretroviral treatment is working well in someone’s body, one’s viral load is typically suppressed below this level.

In ISLEND-1, zero of the people on the weekly pill had a viral load above the cut-off, while one person on the bictegravir, emtricitabine, and tenofovir alafenamide study arm was above the cut-off. In ISLEND-2, one person taking the weekly pill had a viral load above the cut-off, while four people on the standard of care arm were above the threshold. Given that outcomes on the weekly pill were technically better than for the controls, it should come as no surprise that the non-inferiority thresholds were met.

Though the once-weekly pill was well-tolerated, there are some interesting nuances in the safety data. In ISLEND-1, treatment-related adverse events were very similar between the two study arms. In ISLEND-2, however, treatment-related adverse events were reported in 18% of participants treated with the once-weekly pill compared to less than 1% receiving standard of care antiretroviral regimens. Among those receiving the weekly pill in ISLEND-2, the most common treatment-related adverse events reported were headache (5%), nausea (3%) and diarrhoea (3%). There were no red flags regarding more serious treatment-related adverse events.

“It is not uncommon to see a higher rate of treatment related adverse events in the experimental arm of an open label switch study due to reporting bias. That is, when someone knows they are on a new drug, they may be more apt to believe that any new symptoms are caused by the new drug,” Dr Amy Colson, a principal investigator for both ISLEND studies at a study site in Boston in the United States, explained to Spotlight. “Of note, all treatment related adverse events in ISLEND-2 were grade 1 or grade 2.  And importantly, the rate of treatment related adverse events in the ISLEND 1 study – which was a double-blind study – was nearly identical in the islatravir/lenacapavir and bictegravir/emtricitabine/tenofovir alafenamide arms which further supports that the discrepancy in ISLEND 2 may indeed be due in part to reporting bias in the open label study.” (Adverse events are graded from 1 to 4, with 1 being the least severe. Only grade 3 and 4 adverse events are considered severe.)

“It is too early to comment on how any safety signals from the ISLEND 1 and ISLEND 2 trials will impact eligibility for future studies or eligibility for treatment outside of clinical trials.  However, safety data at week 48 from both trials was reassuring.  The overall rates of adverse events, grade 3 adverse events, serious adverse events and discontinuations due to adverse events was highly comparable between islatravir/lenacapavir and comparator groups in both trials,” Colson said.

The early data from ISLEND-2 suggests that people who switched to the once-weekly pill prefer it to the daily treatments they were taking before. According to Colson, 78% reported that they were more or much more satisfied with the weekly pill relative to their prior daily treatment and 64% reported that their prior daily treatment was more of a burden than the weekly pill. More extensive data on people’s self-reported experience of the treatment will be reported on at a future conference.

The new weekly pill is not the first long-acting form of HIV treatment, although it is the first long-acting HIV treatment in pill form. HIV treatment injections administered every two months have been available in the United States for around four years. Spotlight has previously explored in depth why we do not have these HIV treatment injections in South Africa.

Next steps

In a media statement released early in June, pharmaceutical companies Gilead Sciences and Merck (called MSD outside of the United States and Canada) indicated that they plan to file the once-weekly pill with medicines regulators “globally”. Spotlight asked both companies whether this will include filing with the South African Health Products Regulatory Authority, but neither company answered this question. Gilead has the patent on lenacapavir and Merck on islatravir. ISLEND-1 and ISLEND-2 were sponsored by Gilead. Gilead has already filed a weekly lenacapavir pill, used for HIV prevention rather than treatment, for registration with the United States Food and Drug Administration.

The companies didn’t provide details in response to Spotlight’s questions on their pricing plans and whether they would license other companies, directly or through the Geneva-based Medicines Patent Pool, to produce generic versions of the pill.

“Merck and Gilead are committed to supporting global efforts to reduce the incidence and burden of HIV by bringing forward new treatments. This includes our joint investigational long-acting oral treatment option, ISL/LEN. The single-tablet regimen represents a potential step-change in HIV treatment by offering a once-weekly oral regimen that may broaden choice for people living with HIV,” a Merck spokesperson told Spotlight by e-mail. “We remain focused on advancing the development program. If approved, our decades of experience collaborating with a range of stakeholders will help us explore pathways with the goal of facilitating rapid uptake and broad access around the world.”

Republished from Spotlight under a Creative Commons licence.

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From Test Tubes to Treatment: Two TB Researchers on Getting the Ancient Disease Themselves

Mycobacterium tuberculosis drug susceptibility test. Photo by CDC on Unsplash

By Elri Voigt

Being a researcher who studies tuberculosis in the lab is one thing, having the TB bug in your lungs is quite another. Spotlight sat down with two of a relatively small number of people who have experienced both.

One morning in April, Constance Schreuder, a senior medical technologist at a large research group at the University of Cape Town, was called into the campus’s occupational health office. “I was thinking, did I do something wrong?” she recalls.

When she got to the office, she says the doctor immediately opened the window behind him. She wondered “what is going on now?”.

The doctor told her that she has tested positive for the very illness she’s been studying at the South African Tuberculosis Vaccine Initiative (SATVI) for over two decades.

Part of Schreuder’s job involves working with post-mortem samples and tissues, as well as clinical trial samples sent from different TB research sites.

“We always protect ourselves by wearing the correct PPE [personal protective equipment]. So, we’re always safety first,” she says. “I was actually exposed [to TB] in the office where I sit. After all the years that I’ve been working in the lab.”

TB, caused by Mycobacterium tuberculosis, is typically spread when someone with the bacterium in their lungs coughs it up and those droplets are inhaled by others. The droplets are just the right size to hang suspended in the air, allowing TB to survive in a room for several hours.

Schreuder was confused by the diagnosis because she didn’t, and still does not, feel ill at all. She had been tested two months prior as a precaution after a PhD student in the lab had been diagnosed with TB and gotten very sick.

Her initial test results looked good. She had produced a sputum sample, a thick phlegm from the lungs, which was sent to the lab for molecular testing (using the GeneXpert platform). The test came back negative for TB DNA. She had also had a chest X-ray done, which showed no signs of TB in her lungs.

It was another test result that raised the alarm. In addition to the GeneXpert test, her sputum sample had been sent to be cultured. This involves putting the sample into a special tube, called a Mycobacteria Growth Indicator Tube (MGIT), and attempting to grow the bacteria if any is present. If TB bacteria has grown after around 50 days, then it means the TB bug was present in the sample. In Schreuder’s case, the TB bacteria did grow, although the bacterial count was low, a result in-keeping with her lack of symptoms.

Although she was sceptical of the result and wondered about a potential laboratory error, Schreuder’s thoughts immediately went to her close contacts – her 81-year-old mom who she sees on weekends, her pregnant daughter who lives nearby, and her son who lives with her. What did this mean for them, she wondered.

No one else from the office who had been tested showed any sign of TB disease, although Schreuder says that not everyone’s sputum sample had been cultured due to the cost of the test.

Only about one in ten people who are exposed to the bacterium will become sick with TB. In most people, the immune system contains and eventually starves the bacterium to death. In others, however, the bug survives inside the body and eventually causes illness, weeks, months, or even years later.

A silent form of TB

Schreuder very likely has what is called asymptomatic TB. This is a state where the bug is active in someone’s body, but it is not, or not yet, resulting in symptoms. There are many unknowns about this state, how much it actually contributes to TB transmission and how best to test for and treat it.

While there is much uncertainty about the prevalence of asymptomatic TB, some rough numbers exist. South Africa’s first National TB prevalence survey found that just over half of the participants with TB that was confirmed through molecular testing, did not report having any TB symptoms.

Schreuder says that she knew about TB symptoms but was under the impression that people had to show at least some symptoms if they were ill.

She says she was issued with a sick note, was told by the doctor at the occupational health office to go to a public healthcare sector clinic to get treatment, and that she was booked off for the next 14 days. People who are ill with TB generally become non-infectious after having taken TB treatment for around two weeks.

South Africa’s TB treatment guidelines does not recommend different treatment courses based on whether or not someone has symptoms. That means that Schreuder has to take the full six-month course of TB treatment.

‘I thought it was something very serious’

Schreuder’s experience is one side of the coin, the other side is a story from the same lab, one that may seem more familiar.

Tatenda Bvudzijena, an energetic young student, says he came to do his PhD at the SATVI lab because of the world class research that he felt he could learn a lot from. He shares an office space with several staff members at SATVI, including Schreuder. It was his TB diagnosis that had prompted the staff to get tested.

Bvudzijena describes himself as hard-working, so it was very unusual when he started feeling too tired to complete laboratory work near the end of 2025. He was finishing up the second year of his PhD at the time. He says he tried taking some vitamin B, but it didn’t help. Then he started to develop some of the typical symptoms of TB, persistent cough and weight-loss. The cough didn’t go away after he treated it with over-the-counter medicines.

“I had those coughing symptoms, then they disappear for a while, then it comes back again. It’s oscillating…coming back, stopping, coming back again,” he says.

Bvudzijena says a private sector doctor told him he might have asthma, but none of the medication he was prescribed – anti-inflammatories, cough syrup, antibiotics, and asthma pills – worked.

Meanwhile, he kept getting sicker.

“That’s when I was like, ‘no, this is not helping’. By that time, I had chest pains and I was losing a lot of weight,” Bvudzijena says. “I just remember back then I used to wear like a size 32 jeans…then I was wearing size 28…I was less than 55kg, but I used to be like 70kg,” he recalls.

He says he was starting to panic since the pain in his chest felt sharp. Gesturing to an area underneath his ribs on his left, he says: “I thought it was something very serious.” He adds: “At first I thought, maybe I could be having lung cancer, because I used to vape.”

Then, one Monday morning in February, Bvudzijena went to see another private sector doctor. This time he was immediately sent to get a TB test and a chest X-ray. “Your chest X-ray is showing symptoms suggestive of TB”, the doctor told him two days later.

Bvudzijena says he was both scared and relieved. He was relieved because TB can be cured and he did not have something incurable but also scared because seeing his own chest X-rays, he realised he was quite sick with TB.

Bvudzijena has to take the same six months course of treatment as Schreuder.

What taking TB treatment is like

In South Africa, “typical” or drug susceptible pulmonary (of the lungs) TB in adults is treated with a six-month treatment course – consisting of four drugs for two months and then two drugs for the next four months.

TB is mostly treated in the public healthcare sector, so even if someone has medical aid or access to private sector healthcare, they might still go to public sector facilities to get treatment.

TB treatment and diagnosis is covered under the minimum prescribed benefits for medical aid members. According to a notice by the Council for Medical Schemes, TB treatment can be made available to members of medical aid schemes through public sector clinics, but they should be given the option of getting their treatment through the private sector. Whether they can get treatment in the private sector is likely to depend on whether they can find a private sector doctor comfortable with treating TB and a pharmacy that stocks TB medicines.

Still showing no symptoms of TB when she started treatment, Schreuder says she was surprised to learn from the package insert that came with the medicine that the pills must be taken on an empty stomach. The initial two months is five tablets per day (dosage depends on a person’s weight), she explains grimacing.

She has had some side effects. At first, it was only constipation and her urine turning orange, a side effect of rifampicin, one of the four antibiotics used to treat drug-susceptible TB. But by the second month of taking the medication, she also started experiencing muscle and joint pains as well as burning feet.

Schreuder will start on the less intensive four remaining months of the course soon, when the regimen drops from four down to two antibiotics. But she worries about what the drugs might be doing to her body.

With TB already taking its toll on Bvudzijena, he says he started treatment knowing that he had to be serious about taking it as prescribed.

“I was in that situation whereby you know you’re very sick and based on the chest X-rays I was seeing, this [TB disease] was intensive. So like I had to take meds, I had to,” he says, tapping his finger on the table for emphasis.

He says he was surprised by the size of the tablets, eyes wide as he describes them. “They’re big! I’ve never seen something like that. It was my first time seeing a pill for TB,” he says.

For Bvudzijena, the side effects have been relatively mild, a runny stomach and a skin rash, as well as joint pain when he started the two-drug phase of treatment.

He says he started feeling better soon after starting treatment, got his appetite back, and his TB symptoms disappeared completely.

Two clinics, two different treatment experiences

But before they could start taking their treatment, Bvudzijena and Schreuder had to get access to the drugs, which was easier said than done.

Bvudzijena, upon getting his chest X-ray, says he was told nothing other than he needed to go to Groote Schuur Hospital. So he went, only to find that because Groote Schuur Hospital’s waiting rooms employ a triage system – where patients who are in the most critical condition are seen first – he’d likely have to wait several hours.

So, he left and later went to a doctor at another private hospital and got referred to see a specialist at that hospital. He says the specialist would have only been able to see him a week later. At his wits end, he went to campus health, who put him in touch with a nurse at a nearby public sector clinic.

Once at that clinic, he says he was well taken care of, got given a little green card, identifying him as a TB patient. This card is his ticket to travelling through the clinic quickly and not having “to wait in a long queue wearing a mask”.

“My only problem was from being diagnosed to getting help,” he says.

Schreuder, after being booked off, had Googled the nearest public sector clinic that offers TB treatment. The next day, on a rainy Friday, she drove from her home in Cape Town’s Northern Suburbs to a clinic in the Durbanville area.  She wore a clean mask she had found in a bag, a remnant of the COVID-19 pandemic.

“I actually was there 06:30 in the morning because I wanted to just get it over with and start with this medication because they say if you drink it for 14 days, then you’re not infectious anymore,” she says.

At the clinic, she says she was taken to a separate room to wait by herself, as it turns out for five hours. Eventually she says she was helped by a nurse, who filled out her paperwork and took another sputum sample.

Another hour later, she says she left with six packs of TB medication, enough for the first month of treatment. But she had to stop at a private sector pharmacy on the way home because the clinic was out of vitamin B6, which she had been told to take to help with the potential side effect of “pins and needles in your hands and feet”.

Her frustrations with the system would mount. At a subsequent clinic visit Schreuder discovered that her phone number hadn’t been captured, meaning she hadn’t received the test results from her second sputum test. When she asked for her TB medicines to be dispensed to her ahead of time since she was already at the clinic, she says she was told the medicines were out of stock.

When she arrived for her next appointment at 12:00 on a Friday in May, she says the clinic seemed empty. When she eventually found a nurse, she claims the nurse told her she was only working until 12:00, and that the rest of the staff had left to attend a party for someone who had resigned, and that Schreuder must come back on Monday. A frustrated Schreuder says she didn’t accept this and eventually the nurse agreed to give her the medication.

“What’s worrying for me,” says Schreuder, “is, I said to her, ‘I work in this clinical trial lab where we want to find a cure for TB. But are we going to reach a TB free world if it [the health system] works like this?’.”

What needs to change?

Both Bvudzijena and Schreuder say it needs to be made easier for people with TB to start and collect TB treatment. They suggest that private sector pharmacies could be a convenient alternative to public sector clinics. Bvudzijena adds that stable patients could also collect their medication from selected community pharmacies or other collection points closer to home, reducing unnecessary travel and long waiting times.

He also touched on the need for better, clearer information for people who have just been diagnosed with TB about where they need to go, what documents they might need and how to start treatment.

“When you’ve just been told you have TB, you’re already worried,” he says. “The last thing you need is to be sent from one place to another without knowing where to get help.” He adds that there needs to be better coordination between private healthcare providers and public clinics.

Both touched on the stigma associated with a TB diagnosis. Schreuder says she received support from family members but otherwise it felt like people were simply checking that she had been cleared to go back to work. Bvudzijena says overall the reaction to his diagnosis was mixed. Some people like his roommates and friends were supportive, but not everyone was so understanding. “It was tough,” he says.

Change in perspective

Bvudzijena says that getting sick with TB changed his perspective on the research he’s involved with.

“What I realise now, after having TB, is that this research is about so much more than science. My work is focused on improving TB diagnosis so people can be diagnosed earlier, while many of my colleagues are working on better treatments and vaccines. After going through TB myself, I know how much that work can mean to someone who’s sick. It’s really going to change people’s lives,” he says.

To Schreuder, the experience has also been eye-opening but in a different way. She recounts some of the stories she heard while waiting at the clinic, a woman who has arrived at 05:30 but hours later still hadn’t been helped because her file was missing. A man who is afraid he’ll lose his job if he waits any longer. Patients sent to wait outside on cold benches and concrete floors, some looking very ill. Data from community-led monitoring group Ritshidze suggests that long waiting times is a common problem.

“I can fight my own battles, but what about all those that are too afraid to say something?” Schreuder asks.

Republished from Spotlight under a Creative Commons licence.

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The Charlotte Maxeke Fire Should Have Been a National Turning Point – Is SA Now Ready to Listen?

Charlotte Maxeke Johannesburg Academic Hospital. (Photo: Gauteng Department of Health)

By Haseena Majid and Mogie Subban

The fire that engulfed parts of Charlotte Maxeke Johannesburg Academic Hospital was never just a fire, it was a warning, argue Dr Haseena Majid and Professor Mogie Subban. Five years later, the real question they say is whether South Africa is prepared to listen.

The fire that ripped through parts of Charlotte Maxeke Johannesburg Academic Hospital in April 2021 should have been a national turning point. Instead, five years later, we were confronted with explosive findings from the Public Protector confirming that the Gauteng Department of Infrastructure Development and the Gauteng Department of Health delayed repairs, fought internally over responsibilities, and failed to spend almost half of the approximately R666.7 million budget allocated to restore the hospital.

The Public Protector’s report revealed that by March 2024, only about 49% of the ringfenced funds had been spent despite the hospital’s catastrophic service disruptions. At the same time, Charlotte Maxeke’s Head of Internal Medicine Professor Adam Mahomed, who lodged the complaint with the Public Protector, publicly described overcrowded wards, exhausted clinicians, and a hospital effectively surviving through improvisation rather than recovery.

These are not isolated failures. They point to deeper governance weaknesses within public administration.

The question that inevitably arises is how these failures have persisted for so long, given that South Africa’s governance framework is not lacking in legal safeguards.

South Africa’s governance framework already contains extensive mechanisms for oversight and accountability. Section 195 of the Constitution demands accountability, transparency and efficient resource use. Section 217 governs fair and cost-effective procurement. The Public Finance Management Act regulates expenditure and financial accountability. The Public Administration Management Act strengthened ethics, norms and oversight within public administration. The Auditor-General and Public Protector both play critical roles in identifying maladministration and safeguarding accountability. These frameworks are designed to ensure that information flows upward, warning signs trigger intervention and accountability occurs before systems fail.

Yet, the reality tells a different story. Five years after the Charlotte Maxeke fire, hundreds of millions of rand allocated for restoration remained underutilised. Procurement scandals at Tembisa Hospital allegedly operated for years before attracting national attention. Medicine stockouts continue despite multiple reporting structures. More than 240 000 people are reportedly waiting for cataract surgery in one province, while public hospitals continue to lose skilled personnel as infrastructure deteriorates.

Even more troubling is the time it takes before these failures become visible for some form of action to follow. The asbestos scandal in the Free State, corruption at Transnet and Eskom, and the alleged procurement networks at Tembisa all reveal the same pattern: accountability mechanisms kick in long after the damage has already been done.

These failures point to deeper systemic weaknesses. They reflect institutions that have struggled to respond effectively and correct themselves. And every delayed intervention carries human consequences. Cancelled operations, interrupted treatment, avoidable disability, burnout among healthcare workers, lost productivity and preventable deaths are not abstract administrative failures. They are the lived consequences of governance failure.

What to do

The question confronting South Africa is not whether another report or task team is required. The country has already produced no shortage of investigations, commissions and oversight findings. The real challenge is whether institutions are willing and able to act on what is already known.

A capable health system rests on several pillars: skilled staff, functioning infrastructure, sustainable financing, effective programmes, reliable procurement systems, coherent policy implementation and operational coordination. Yet even when these pillars exist, the entire structure remains vulnerable if the systems responsible for integration, oversight and accountability are weak.

Modern health systems are increasingly complex institutions requiring both clinical excellence and strong governance capability. Expertise in organisational systems, budgeting, monitoring and evaluation, procurement and institutional accountability should therefore be viewed not as alternatives to clinical expertise, but as interdependent capabilities essential for institutional resilience.

Money matters. Infrastructure matters. Human resources matter. Technology matters. But without institutions capable of coordinating, overseeing and acting, crises simply repeat themselves.

What South Africa needs is more than another cycle of crisis management. It needs a renewal of governance itself. That means stronger alignment between roles, competencies and institutional responsibilities, protected oversight pathways and consequence management that operates before catastrophe rather than after it. It means rebuilding a public service culture in which accountability is not treated as an inconvenience, but as the moral backbone of a constitutional democracy.

*Majid is a postdoctoral researcher at the University of KwaZulu-Natal specialising in public administration and systems governance. She is a Global Atlantic Fellow for Health Equity and Social Justice at Tekano. Her research focuses on stakeholder mapping, disaster resilience and strengthening governance systems through collaborative public-sector approaches. Subban is an Academic Mentor and Public Governance Expert, at the College of Law and Management Studies, University of KwaZulu-Natal.

Note: Spotlight aims to deepen public understanding of important health issues by publishing a variety of views on its opinion pages. The views expressed in this article are not necessarily shared by the Spotlight editors.

Republished from Spotlight under a Creative Commons licence.

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Provinces Owe the NHLS Billions, Patients Could Pay the Price. It’s Time to Crack the Whip

Through its countrywide network of quality-assured diagnostic laboratories, the NHLS is the sole provider of diagnostic pathology services to over 80% of the South African population. Photo by National Cancer Institute on Unsplash

Comment & Analysis

By Faith Muthambi

Provincial debt to the National Health Laboratory Service is not just a financial governance matter, but also a public healthcare service delivery risk that affects diagnoses, treatment, disease surveillance, and government’s ability to protect vulnerable patients, writes Faith Muthambi, chairperson of the Portfolio Committee on Health in the National Assembly.

When *Lungile Mbonambi, a hypothetical healthcare user, waits for a blood test at a public hospital, she is not thinking about all the zeros in provincial budgets or intergovernmental disputes. She is thinking about her health. Like some 80% of people in South Africa, she places her trust in the public healthcare system, the inner workings of which she will never see, and in laboratory professionals she will likely never meet. However, in using the system, she experiences its impact.

For her blood test, a nurse will draw the sample, seal the vial and send it to the closest National Health Laboratory Service (NHLS) facility. For patients, waiting for the results often feels uneasy and ridden with dread. In addition to the immediate health concern, patients also find themselves in the hands of a system that needs to function well, not only on paper and in policy, but also in the concrete reality of their particular case.

The NHLS plays a big role in public health in South Africa through epidemiology, surveillance and responding to public health outbreaks. Among other things, it is involved in HIV and TB programmes, conducting diagnostic tests for non-communicable diseases, and the screening for cervical cancer. In essence, contemporary healthcare would grind to a halt without the robust laboratory infrastructure that the NHLS provides.

Ballooning debt

Just recently at the end of May, the Portfolio Committee on Health in Parliament, which is tasked with overseeing the National Department of Health, met with representatives from the NHLS and all nine provincial health departments. The meeting revealed that outstanding debt to the NHLS had climbed to an imposing R11 billion as of March this year. Most of this debt stemmed from KwaZulu-Natal with around R3.94 billion, and Gauteng with roughly R3.3 billion, both of which include debt from previous years.

This meeting confirmed what many in the public health system have warned about for years. This outstanding debt is not merely a matter of the numbers not adding up, but is symptomatic of a serious failure in financial governance. Failing to pay or delaying payments for critical services already rendered to the public health system also reflects poor coordination among government departments and entities.

The consequences of this can be dire.

For the NHLS, without these funds, the institution cannot sustain research, do proper disease surveillance, detect outbreaks or monitor antimicrobial resistance, or upgrade equipment. When a laboratory cannot replace ageing instruments on time, fill critical posts, modernise information technology or plan procurement with certainty, it is felt in hospitals and clinics.

For patients, it means delayed diagnoses and disrupted care, and those living in rural and under-resourced communities often bear the brunt.

Time to act

Listening to presentations from all nine provincial health departments showed that this crisis can be prevented. There are provinces that are getting this right and paying their invoices to the NHLS within the required 30-day period. This shows that, even with budget constraints, laboratory services can be prioritised.

As Chairperson of the Portfolio Committee on Health, I have made it clear that it is now time to shift our oversight from concern to action that leads to actual consequences for those provinces that fail to pay their NHLS debts.

There had been instances in the past where National Treasury intervened by withholding or redirecting funds when provinces failed to fulfil their responsibilities. The committee may need to engage the National Treasury on ways to protect funding for laboratory services, including the possibility of direct transfers or ring-fenced funding where provinces fail to prioritise their obligations to the NHLS. The message is clear: We cannot allow a situation in which a province destabilises another public institution by failing to pay for services central to healthcare provision.

Our next step cannot be to just accept more vague commitments and assurances that the debt will be paid. Provinces with outstanding debt must provide clear repayment plans linked to strict timelines, while continuing to pay current invoices within the required period. The committee will request quarterly progress reports on payments made to reduce the debt, as well as on actions taken against officials involved in this non-payment.

We live in an era marked by emerging health threats and increasing demands on health services. It is therefore important to remind ourselves that health systems do not collapse overnight. They deteriorate gradually through deferred payments and normalised delays, among other things. By the time patients experience the full impact, the horse may have already bolted because we ignored the warning signs.

To be clear – this, here, is a serious warning sign.

Yet notwithstanding these pressures, laboratory professionals continue to demonstrate extraordinary commitment. Samples are being processed, and results are verified. I commend these public servants who work beyond ordinary expectations to protect the service. However, we cannot bank on this devotion to become a permanent substitute for responsible governance.

The decision before us is whether we allow patients’ experience of the public health value chain between health facilities and NHLS laboratories to continue to be determined by delay and uncertainty, or by a public health system that understands the seriousness of its responsibilities and acts accordingly.

Patients like Mbonambi are placing their trust in the state. We must do better.

*Muthambi is a Member of the National Assembly and Chairperson of the Portfolio Committee on Health.

Note: Spotlight aims to deepen public understanding of important health issues by publishing a variety of views on its opinion pages. The views expressed in this article are not necessarily shared by the Spotlight editors.

Republished from Spotlight under a Creative Commons licence.

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