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Inside The Box with Dr Andy Gray | How Can We Know that Medicines Sold in Pharmacies Are of Good Quality?

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#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)

8th May 2026 | Andy Gray

We can generally trust that the medicines we buy at pharmacies contain what they are supposed to and that they were manufactured according to good quality standards. In his latest column, Dr Andy Gray zooms in on the regulatory scaffolding that enables this trust.

One of the health-related Sustainable Development Goal targets is to achieve “universal health coverage, including financial risk protection, access to quality essential health-care services and access to safe, effective, quality and affordable essential medicines and vaccines for all”. The word “quality” appears twice in that target description, as a requirement for the healthcare services delivered, and as an essential element of the medicines and vaccines made available.

‘Quality cannot be tested into a product’

There is a truism in the pharmaceutical industry that quality cannot be tested into a product. Instead, quality is assured by the implementation of a pharmaceutical quality system, referred to as current Good Manufacturing Practice (cGMP).

The primary legal enablement is provided by the Medicines and Related Substances Act, 1965. Section 1(3) of the Act states: “In determining whether or not the registration or availability of a medicine is in the public interest, regard shall be had only to the safety, quality and therapeutic efficacy thereof in relation to its effect on the health of man or any animal, as the case may be.” Evidence for safety and therapeutic efficacy is provided by well-conducted clinical trials. There is a difference, however, between registered medicines and complementary medicines. The latter require a warning on their labels stating: “This unregistered medicine has not been evaluated by the SAHPRA for its quality, safety or intended use”. Complementary medicine manufacturers are being progressively brought in line with GMP.

Evidence of quality is not reliant only on retrospective data, on tests conducted on the medicines used in the clinical trials, and the design of the dosage form to be sold, but also on the means to ensure that every batch made will deliver the same results. By requiring that every manufacturer of a medicine is licensed by the South African Health Products Regulatory Authority (SAHPRA), the Authority can ensure compliance with GMP. The ultimate sanction for not meeting GMP standards is withdrawal of licensure and therefore an immediate stop to all manufacturing activities.

New guidelines

SAHPRA updated its GMP guidelines in April 2026. The guideline defines GMP as “a set of principles and procedures that, when followed, ensure that medicines and related substances are of high quality, safety and efficacy”, and as a “system that ensures medical products are consistently produced and controlled according to quality standards”. Echoing the truism, it states that GMP is “designed to minimise the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product”.

GMP requires the manufacturer to provide detailed description of the systems to be implemented to document every step in the manufacturing process and the control measures in place to ensure quality. These step-by-step descriptions have to cover every component included in the medicine and its packaging, the premises and equipment used, as well as the training and accreditation of the staff involved in the production process. A risk-based approach is used, for example differentiating between sterile and non-sterile production processes. Quality control testing during the production process is critically important.

GMP places a lot of emphasis on the capability of key personnel, but also the way in which authority and responsibility is assigned, accepted and documented, and how each person fits into the management decision-making process. For example, SAHPRA’s GMP guidelines differentiate between the Head of Quality Control, who “should have the authority to establish, verify and implement all quality control procedures such as authority over quality decisions, oversight of testing and results, approval of quality control documentation, laboratory management, validation and method control”, and the Head of Quality Assurance, who “should be part of the decision-making process in all matters that affect the quality of products including development, laboratory, storage, distribution, vendors and third-party contractors”. All staff engaged in production have to be trained on the principles of GMP and the specific duties assigned to them. Continuing training is required, with documented training programmes, training records, and checks to confirm that procedures are being followed.

What if medicines are made outside of SA?

That all sounds straightforward, if the manufacturer is located in South Africa and can easily be accessed by a SAHPRA GMP inspector. However, the majority of medicines consumed in South Africa are imported, and even those that are made locally mostly rely on imported active pharmaceutical ingredients or drug substances.

International standards for GMP have a long history. The first draft document was prepared by the World Health Organization (WHO) in 1968. Since 1969, compliance with WHO GMP has been the basis for the WHO certification scheme on the quality of pharmaceutical products moving in international commerce. However, there has been criticism of the scheme, as certificates can be issued by national regulators that are not considered to meet acceptable maturity standards.

Although there is provision for exceptions, medicines imported into South Africa have to be subjected to post-importation identification and assay (testing of what it contains) by a local, accredited laboratory, or samples have to be returned to the manufacturer or an overseas testing laboratory.

SAHPRA is a member of two key organisations that are advancing harmonisation of regulatory standards. The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) publishes extensive quality guidelines. ICH Q10, for instance, describes the requirements for a Pharmaceutical Quality System.

SAHPRA is also a member of the Pharmaceutical Inspection Co-operation Scheme (PIC/S), which aims to pursue the “development, implementation and maintenance of harmonised GMP standards and quality systems of inspectorates”. Apart from its work on harmonising GMP standards, PIC/S enables the training of GMP inspectors and the voluntary sharing of GMP inspection reports. PIC/S membership requires an assessment of a regulator’s inspectorate systems and procedures, so provides a quality check at that level. South African GMP adopted the PIC/S GMP guide in 2006, updating that status in 2017.

SAHPRA’s GMP inspectors are not confined to working only within the boundaries of the country. They also inspect pharmaceutical production plants in other countries and work together with the WHO prequalification programme to extend their reach. That said, even the best-resourced regulatory authorities are struggling to cover a globalised pharmaceutical industry, with many facilities located in China and India. A recent commentary in the New England Journal of Medicine pointed out how few foreign plants making generic medicines had been inspected by the Food and Drug Administration, and the problems they encountered when conducting inspections, calling for improved post-marketing surveillance.

The public, patients and health professionals can therefore make a reasonable assumption that medicines produced in a cGMP-compliant production facility meet the required quality standards. However, that is insufficient on its own. Mature regulators are also required to have effective post-marketing vigilance systems in place. Apart from adverse event reporting, these systems should also enable the reporting of quality problems with medicines.

Substandard or falsified medicines

Effective surveillance of the pharmaceutical market assists in the identification of substandard or falsified (SF) medicines. The necessary control measures also have to be in place to enable recalls and the destruction of identified SF medicines.

The WHO Global Benchmarking Tool (GBT) requires evidence that “Legal provisions and regulations authorize market surveillance and control activities which include product sampling from different points of the supply chain.” SAHPRA does not operate its own testing laboratory, but contracts with a WHO -prequalified facility at North-West University. Proactive sampling of medicines from all points in the distribution chain needs to be strengthened, as part of the National Action Plan to combat SF medicines.

Despite the existence of a Global Surveillance and Monitoring System for SF medical products (both medicines and devices), quantifying the scale of the problem remains challenging. Medical product alerts have been issued in every WHO region, affecting every type of medical product, not only generic medicines. They have been identified in countries with well-resourced, mature regulatory systems and in countries that lack such capacity. Nonetheless, transparent reporting of problems identified, corrective actions taken and regulatory interventions can help to build confidence that quality assurance systems are not only working, but are seen to be working. Quality should not have to be assumed without assurance that effective systems are in place and appropriately monitored.

*Dr 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. This is part of a series of columns he is writing for Spotlight.

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

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.

Read the original article.

Categories : Expert Opinion Metabolic DisordersTags :

South Africa’s Weight-loss Revolution is Testing Medical Discipline

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Photo by I Yunmai on Unsplash

One in every two South African adults is considered overweight or obese. It is not surprising, then, that potentially lifesaving prescription-based metabolic medicines are surging in popularity. The challenge: demand is rising faster than the clinical structure needed to support it, leaving many patients unsure what responsible, medically supervised care should look like.

It is a concern Dr Gerhard Vosloo, a prominent sports, exercise, and lifestyle physician, says he is encountering more frequently in clinical practice. “Expectations are becoming unreasonably high, while few understanding the level of medical oversight required to manage these therapies responsibly. It’s just not as simple as prescribing an aggressive regime and standing back.”

To address issues in today’s weight management sector, Dr Vosloo established Dr GL Vosloo Medical Practice, managed by BioWell, as a formal online medical practice built around sound clinical judgment, structured care, and meaningful patient oversight. He says, “We’re building a model – one that could serve as a stable structure for the wider industry, where sound medical judgment is consistently prioritised over the public’s growing appetite for weight loss drugs.”

The danger of normalising prescription therapy

Dr Vosloo cautions that the rapid rise of these medicines in the mainstream is oversimplifying a highly complex subject and making pharmaceutical use seem routine, when it should remain a final option after disciplined nutrition- and exercise-led approaches have been fully explored.

“Misinformation spreads like wildfire online. People are starting to view prescribed medicines as a routine diet option, when they should be a last resort. Pharmaceuticals are powerful tools for people who struggle to lose weight, but they should be introduced only when medically appropriate, and only after nutrition, exercise, and appropriate supplementation have been fully explored.”

He maintains that prescribed medicines should form part of a structured metabolic management programme that, when used correctly, will reduce cardiometabolic risk, improve insulin sensitivity, regulate appetite, and support meaningful body composition change. The goal is to improve metabolic health under disciplined supervision, and when treatment is not medically necessary, doctors must refuse to prescribe.

“Clinical eligibility must be determined by medical rationale,” he says. “A patient’s preference for medication, emotional pressure to start treatment, or the ability to pay cannot override clinical judgement. Where medical need is absent, a BioWell doctor will decline to prescribe and direct the patient to a non-pharmaceutical, doctor-supported metabolic management pathway.”

Dosing with discipline

Beyond unnecessary prescribing practices, Dr Vosloo stresses that the industry is undermined by over lenient dosing habits. As practiced on the BioWell platform, dosing decisions should instead follow a conservative model guided by clinical responses and tolerability rather than speed of weight loss. The objective is to protect overall health while supporting steady progress that the body can sustain.

“An unfortunate consequence of aggressive dosing is the loss of muscle mass. It’s easier for the body to draw from muscle than it is to mobilise fat, particularly when calories and protein are low – a hallmark of aggressive dosing protocols. The nutritional and training commitment needed to offset muscle loss under more radical regimens are difficult to manage for most people. It’s far safer and more sustainable to take low doses over a longer period.”

“BioWell doctors are more measured in our approach. Conservative dosing and escalation protocols help keep muscle loss to a minimum, while structured nutrition and exercise support plans strengthen the muscular system. This also reduces the risk of nutritional deficiency and limits the physiological stress that often accompanies poorly managed treatments.”

The end goal, Dr Vosloo explains, is to safely and gradually bring South Africa’s obesity crisis under control without creating any additional harm. “Prescription-based metabolic medicine is an undeniably powerful tool in the fight against obesity – one we cannot afford to lose. It’s a lifeline for people battling weight-related illness, but it’s also become a dangerous crutch for those willing to gamble with their health just to lose a few kilograms quickly. If we want to change the health trajectory of millions, we need to rein in aggressive dosing practices and establish a common-sense structure across the sector.”

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Beware the Salt Trap: Why South Africa’s Heart Health Depends on More Than Regulation

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Credit: Pixabay CC0

While South Africa was among the first countries to introduce mandatory salt reduction targets in processed foods, health experts warn that hypertension remains a major public health concern. The reason is increasingly clear, the problem is no longer only what is manufactured, but how people eat every day.

As World Salt and Hypertension Awareness Week (4–29 May) approaches, the focus should shift from reformulated products to daily behaviour change. High salt intake causes the body to retain excess fluid, which increases the volume of blood in the system and places greater pressure on the artery walls, directly leading to the development of hypertension.

“While the policy has successfully reduced hidden salt in many staple foods, it has not yet shifted South African taste preferences.,” says Lizeth Kruger, Clinic Executive at Dis-Chem. “We are still reaching for the shaker out of habit, and that’s where the real danger lies.”

Hypertension remains one of South Africa’s leading risk factors for heart disease and stroke, often progressing silently until complications arise. According to the Heart and Stroke Foundation South Africa, more than one in three adults lives with high blood pressure, a ‘silent killer’ that accounts for roughly half of all strokes and 40% of heart attacks in the country.

Kruger says a shift in everyday eating habits could reduce excess salt intake

1. Automatic salt shake

Many people add salt before tasting their food, even when meals have already been seasoned during cooking or processing.

2. Hidden salt in everyday staples

Stock cubes, processed meats, margarine and sauces remain significant sodium sources, especially when used frequently in daily cooking.

3. Convenience meals and takeaways

Ultra-processed foods and fast meals are often high in sodium, with a single serving sometimes approaching or exceeding the recommended daily limit.

4. A conditioned taste for salt

Long-term high-salt diets have shaped taste preferences, making fresh, whole foods seem bland and reinforcing reliance on added seasoning.

5. Unnoticed snack intake

Savoury snacks, biltong and crackers contribute meaningful sodium but are often not counted in daily intake.

Small changes, meaningful impact

Kruger says reducing salt intake is less about strict diets and more about changing repeat behaviours.

“Small, consistent adjustments can make a real difference over time,” she explains.

  • Tasting food before adding salt is a simple first step, as many meals are already seasoned. Rinsing canned foods such as beans or corn can also reduce sodium content.
  • Flavour can be enhanced using alternatives such as garlic, lemon juice, herbs and black pepper, while checking labels for lower-sodium options helps guide better choices.

A shared responsibility

“Regulation has laid the foundation, but the final step is ours,” Kruger advises. “By becoming more aware of everyday habits, we can reduce the risk of hypertension, stroke and heart disease in our homes.”

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Joint Effort is Key to Sustainable Healthcare Reform

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By Gale Shabangu, Chairperson, Hospital Association of South Africa (HASA)

Recently, President Cyril Ramaphosa made an important decision: to pause the promulgation of the National Health Insurance (NHI) Act until the Constitutional Court has ruled on the pending challenges to Parliament’s role in passing the Act. In doing so, he affirmed that due process must guide reform.

It is a reminder that healthcare reform is not a race to the finish line, but a journey that requires careful pacing, broad consultation and respect for the voices of South Africans. Reform at this scale is like tending a vast garden: every seed must be planted with foresight, every path cleared with care, so that the harvest nourishes all.

Families already feel the strain of rising costs – electricity, food, borrowing – and medical contributions that climb steadily. Yet even in this pressure, there is resilience. South Africans have always found ways to adapt, to share, to build together. Healthcare reform must honour that spirit, ensuring affordability is not a privilege but a shared foundation.

The private healthcare system is a necessary and valuable part of the scaffolding of our healthcare system, sustaining capacity that millions rely on. Unfinished reforms, such as risk equalisation, mandatory membership, and base benefit packages, remain like bridges half‑built. Completing them would stabilise participation and strengthen the entire ecosystem.

If private participation declines, demand does not vanish – it shifts. Public hospitals, already carrying immense responsibility, would feel the weight. Yet here lies the opportunity: to recognise that public and private healthcare are not adversaries but allies. The public sector anchors universal access; the private sector provides funded capacity that absorbs demand and sustains innovation. Together, they form a single ecosystem, each part vital to the whole.

Healthcare reform is about weaving our systems together into a fabric strong enough to carry us all.

As the President recently noted, readiness is central to bringing legislation into effect. Readiness is not bureaucracy – it is the heartbeat of reform. It signals that change must be feasible, not forced; sustainable, not symbolic. That is a hopeful message, because it means reform will be paced by practicality, not politics.

The path forward is clear and promising: complete outstanding reforms in medical schemes, strengthen risk pooling, invest in primary care and prevention, and sequence structural changes responsibly. These steps are not obstacles – they are stepping stones toward a healthier, more equitable South Africa.

Healthcare reform is a national undertaking and a shared responsibility. Government, funders, providers, employers and civil society are all custodians of this commitment. What matters now is how we act, with realism, collaboration and a clear focus on strengthening what already works.

Equitable access to quality healthcare is our shared goal. Achieving it requires evidence, readiness, and respect for complementarity. With stability, sustainability and collaboration as our compass, South Africa can build a healthcare system that is workable and inspiring – a system that reflects the resilience, dignity and hope of its people.

Healthcare requires stewardship. With stability, sustainability, and collaboration guiding reform, South Africa can build a system that works for everyone. And with optimism guiding reform, I believe we can build a system that works for everyone – today, tomorrow and for generations to come.

Categories : Expert Opinion Healthcare Politics and RegulationsTags :

Leadership, Transparency and Culture Shifts Are Key to Improving Public Sector Healthcare Quality

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COHSASA CEO, Jacqui Stewart (left), moderates the panel discussing “Quality in the Public Sector”. From left:  Dr Siphiwe Mndaweni, CEO of the Office of Health Standards Compliance (OHSC), Professor Sabelile Tenza, Associate Professor, Patient Safety and Healthcare Quality, North-West University, Professor Sibusiso Zuma, Chair of the Department of Health Studies at UNISA and Dr Arthur Manning, CEO of Rahima Moosa Women and Children’s Hospital.

Strong leadership, functional governance and an honest culture of reporting are among the critical factors needed to improve and sustain quality care in South Africa’s public health sector, experts said during a panel discussion at the Hospital Show Conference hosted by COHSASA in Sandton recently.

The session, moderated by COHSASA CEO Jacqui Stewart, brought together senior voices from regulation, academia and hospital management to unpack the persistent gaps – and opportunities – in public sector healthcare delivery.

Professor Sibusiso Zuma of UNISA set the tone, noting that quality varies widely across public hospitals and is often determined by how effectively leadership teams work together.

“In my experience, the level of care depends on how heads of departments—nursing, pharmacy and clinical leadership , function as a team,” he said. “They need to identify problems  and address them collectively. Management must also be visible, regularly engaging with what is happening on the ground.”

Dr Siphiwe Mndaweni, CEO of the Office of Health Standards Compliance (OHSC), reinforced the central role of leadership and governance structures, drawing on inspection findings.

“Where leadership is weak or absent, quality suffers,” she said. “Infrastructure is another major challenge. Many facilities are old, and maintenance budgets are often diverted elsewhere, meaning planned upkeep simply does not happen.”

She added that even basic resources remain a concern. “Without essentials like soap, effective infection prevention and control is impossible.”

Dr Mndaweni also highlighted shortcomings in clinical governance, linking these directly to rising litigation. “Facilities may have clinical committees on paper, but if they are not meeting to interrogate lapses in care, the system fails.”

Security risks, poor community engagement and underutilised strategic plans further compound the problem. “Too often, documents are developed and then filed away. Facilities lose sight of their strategy and have no real understanding of patient satisfaction.”

However, she noted that where leadership is engaged – actively interacting with staff and patients – outcomes improve significantly.

Responding to questions on balancing regulatory compliance with quality improvement, Dr Arthur Manning, CEO of Rahima Moosa Mother and Child Hospital, argued that compliance should be seen as a starting point rather than an endpoint.

“Standards are a benchmark, but they are not the ceiling,” he said. “Our experience shows that it is possible to move beyond them.”

Professor Zuma agreed, cautioning against a compliance-driven mindset that fades once certification is achieved. “Facilities often put in intense effort to meet regulatory requirements, then step back afterwards,” he said. “Quality improvement cannot be a once-off exercise or confined to a single ‘quality person’. It must be everyone’s responsibility.”

He advocated for broader training in Total Quality Management and regular six-monthly audits involving all staff. “Quality must be continuous,” he said.

Professor Sabelile Tenza of North-West University pointed to a deeper cultural issue undermining progress: performative compliance.

“There is a tendency to be compliant on paper rather than in practice,” she said, citing research in which hospitals borrowed equipment to pass inspections, only to return it afterwards.

She described a culture of concealment, where staff hesitate to report shortages or failures. “There is fear of exposing the truth, even to boards that could advocate for improvements,” she said. “If we remove that fear, we can move forward.”

Professor Tenza also raised concerns about the reporting of adverse events, stressing the need to protect healthcare workers. “Clinicians ask why they should report incidents when they see no feedback or improvement,” she said.

She criticised the gap between policy and practice around “Just Culture” frameworks. “We talk about it, but confidentiality is not adequately protected. Without anonymity, reporting systems will not work “The focus should be on the incident, not the individual,” she said. “That is how  a learning culture is created.”

Although the National Department of Health has developed free online reporting tools, uptake remains low. Professor Tenza said the system needs to be more user-friendly and accessible via mobile devices, with less duplication between paper and digital processes.

“The focus should be on the incident, not the individual,” she said. “That is how systems learn.”

Dr Mndaweni acknowledged that regulation can be perceived as punitive but stressed that enforcement is a last resort. “The OHSC is designed to support compliance and improvement, not punishment,” she said. “But where there is persistent non-compliance, enforcement becomes necessary—even to the point of revoking a facility’s licence to operate.”

She added that the regulator is repositioning itself to play a more active role in quality improvement, rather than acting solely as an enforcer.

Dr Manning rejected the notion that compliance and quality improvement are competing priorities. “Regulatory standards define the minimum acceptable level of care,” he said. “Meeting them should be business as usual. The real goal is to exceed them – there should be no trade-off.”

Categories : Expert Opinion Obstetrics & GynaecologyTags :

How Women Are Harmed When Clinicians Rely on the Lab More Than the Patient

On By ModernMedia
Photo by Karolina Grabowska on Pexels

Across the world, countless women enter perimenopause only to be told that “everything is normal” because their blood tests do not match their symptoms.

This is one of the most damaging failures in modern women’s health. Perimenopause is not a laboratory diagnosis. It is a clinical diagnosis, made by listening to the woman and recognising the pattern of hormonal transition. Yet many clinicians continue to rely on FSH, LH and oestrogen levels – tests that were never designed to diagnose perimenopause and are physiologically incapable of doing so.

1. Hormone levels in perimenopause are wildly erratic

Oestrogen does not decline smoothly. It surges, crashes, and oscillates unpredictably. FSH and LH follow the same chaotic pattern. A single blood test captures only a moment in this turbulence. It cannot represent the hormonal instability that defines the transition.

This is why women with severe vasomotor symptoms often have “normal” results, while women with mild symptoms may show “abnormal” ones.

Erratic physiology produces erratic numbers. The numbers do not reflect the suffering.

2. Lab ranges do not correlate with symptoms

Laboratory ranges were created for research and population studies – not for diagnosing perimenopause. They do not account for:

  • daily hormonal swings
  • stress
  • sleep deprivation
  • illness
  • cycle timing
  • individual sensitivity to hormonal change

A woman may be drenched in night sweats, unable to sleep, emotionally unstable, and struggling to function – yet her blood tests may look “normal”. This leads to the most common and harmful phrase in women’s health: “Your results are normal, so this is not hormonal.”

3. The harm of relying on lab results

When clinicians wait for “abnormal” results before offering help, women suffer. They are:

  • dismissed
  • misdiagnosed
  • told they are anxious or depressed
  • denied treatment
  • left to struggle through years of avoidable distress

Or are treated inappropriately for life with antidepressants, mood stabilisers, axyiolytics and sedatives. These do little to address the underlying problem but create another set of problems: addiction and a range of side effects. This is not medicine. This is neglect disguised as protocol.

Suffering is prolonged because clinicians rely on lab results rather than the woman’s symptoms. Treating the lab instead of the woman is a betrayal of clinical responsibility.

4. The only test worth doing

There is one test that adds value: TSH and T4 – to exclude thyroid disease, which can mimic some perimenopausal symptoms. Beyond this, further hormone testing wastes time, money, and emotional energy.

5. The clinical truth

Perimenopause is diagnosed by listening to the woman, not by chasing fluctuating hormones. If she has:

• hot flushes

• night sweats

• irritability

• emotional instability

• sleep disturbance

• cycle changes

— she is in perimenopause, regardless of what the blood tests say.

The woman’s story is the evidence.

The numbers are often unreliable and misleading tools.

Dr E.V. Rapiti • April 2026

www.drrapiti.com

Categories : Expert Opinion Healthcare Politics and RegulationsTags :

As NHI Stalls, the Real Debate Is About Trade Offs

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ANC President Cyril Ramaphosa, with Minister of Health, Dr Joe Phaahla and his deputy Dr Sibongiseni Dhlomo, during the signing into law of the National Health Insurance Bill. (Photo: @MYANC/Twitter)

By Thoneshan Naidoo

Healthcare funding is always about trade-offs, writes Thoneshan Naidoo, CEO of the Health Funders Association. The hardest question in healthcare is not what we would like to provide, he argues, but what we can provide sustainably, fairly and at scale.

South Africa’s healthcare debate is shifting and perhaps for the first time in years, it is becoming more honest.

With the National Health Insurance (NHI) Act tied up in legal processes and no credible funding pathway emerging from the 2026 Budget, the conversation is moving away from sweeping promises about the future to a more immediate and uncomfortable question. That is how do we fund healthcare today, and what trade-offs are we willing to accept?

At the centre of that reality is a part of the system that is often misunderstood and frequently criticised – medical schemes.

They are often portrayed as profit driven and exclusionary. In reality, they are not for profit, member owned entities built on a simple but powerful principle, social solidarity. Simply put, members pool their contributions so that those who are healthy today help fund the care of those who are sick.

In practice, around 80% of members claim less than they contribute in any given year. Their contributions help fund the care of the 20% who need it most. That is not exploitation. It is the very definition of risk pooling, and it is the same principle that underpins universal health coverage.

But solidarity comes with trade-offs.

Every Rand paid out in benefits in excess of a member’s monthly contributions is funded by other members. That means decisions about what is covered, how much is paid, and when limits apply are not arbitrary. They are the result of difficult choices about what the overall pool can afford.

These trade-offs become most visible in moments of tension, when a claim is limited, a treatment is excluded, or a dispute arises. To the individual, the system can feel uncaring. But at a system level, the alternative, unlimited funding for every possible intervention, is simply not sustainable.

Even prevention, often presented as an obvious solution, is not as straightforward as it seems.

Take colorectal cancer screening. An inexpensive test such as a faecal immunochemical test can help detect disease early. But many false-positive results lead to follow up procedures like colonoscopies, even when no serious condition is ultimately found. At the same time, some cases are still missed and only diagnosed later, when treatment is more complex and more expensive.

The question is not whether prevention is valuable, it is how to fund it at scale in a way that balances early detection, over treatment and cost.

These are not abstract policy debates but are real world funding decisions that affect millions of people.

And they are taking place in a system under pressure.

Medical scheme membership is voluntary, so younger and healthier individuals often delay joining until they need care. This drives up costs for those already in the system. At the same time, schemes are required to cover a comprehensive set of 270 Prescribed Minimum Benefits, which raises the baseline cost of cover.

The result is a system that works well for those inside it but remains out of reach for many.

This is South Africa’s so-called “missing middle” – millions of working people who earn too much to qualify for public support, but too little to afford private cover. They are left exposed, paying out of pocket, and navigating a fragmented system while waiting for reforms that may still be years away.

As the NHI debate continues, this gap can no longer be treated as a future problem. It is a present reality.

The risk is that the debate remains stuck in ideology. That private healthcare is painted as inherently problematic, or that structural reform alone will resolve access challenges.

Neither is true.

Healthcare funding is always about trade-offs. There are no perfect systems, only different ways of balancing access, quality and affordability within finite resources.

If South Africa is serious about expanding access to healthcare, the debate must move beyond rhetoric and toward practical solutions.

These include using spare capacity in private facilities to treat public patients, and allowing medical schemes, through targeted regulatory reform, to offer affordable primary healthcare cover for people who are currently excluded. Done properly, this could unlock access to private healthcare for more than 10 million uninsured South Africans at a cost of as little as R400 per person per month. Combined with existing tax credits, the impact on a family’s take home pay could be close to negligible. By providing access to preventive and primary care through the private sector, they would reduce pressure on overcrowded public facilities and ease waiting times. Importantly, a strong focus on prevention and early intervention would reduce the need for costly hospitalisation over time.

Medical schemes are well placed to deliver these options, given the principles of social solidarity, community rating and cross-subsidisation that underpin their design. This approach is aligned with the Sustainable Development Goals and the core principles of universal health coverage, and could serve as a practical transitional step as South Africa moves towards the full implementation of National Health Insurance.

After all, the hardest question in healthcare is not what we would like to provide. It is what we can provide sustainably, fairly, and at scale.

*Naidoo is CEO of the Health Funders Association, an industry group that represents several medical schemes and medical scheme administrators in South Africa.

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.

Read the original article.

Categories : Expert Opinion Respiratory DiseasesTags :

South Africa Can End TB by Replacing Stigma with Early Action

On By ModernMedia
Dr Jessica Hamuy Blanco, Product and Clinical Risk Executive at Dis-Chem

As the world marks World TB Day on 24 March under the theme “Yes! We can end TB!”, South Africa faces a clear challenge turning awareness into early action.

“TB is all around us,” says Dr Jessica Hamuy Blanco, Product and Clinical Risk Executive at Dis-Chem. “Many people don’t realise that exposure is common. The bacteria can lie dormant for years and only become active when the immune system is compromised.”

Despite widespread awareness, a critical gap remains between what people know about TB and how quickly they act on symptoms. This gap continues to shape outcomes for thousands living with this preventable and curable disease.

According to the World Health Organisation (WHO), approximately 249 000 people in South Africa developed tuberculosis in 2024.

TB remains close to home

Although preventable and curable, TB continues to spread quietly often because symptoms are ignored and treatment is delayed.

“People don’t always recognise the signs early enough or know where to seek help,” says Dr Hamuy Blanco. “This is where informed, trusted healthcare makes the difference.”

South Africa remains one of the countries hardest hit by TB globally. The disease is closely linked to HIV, with weakened immune systems increasing the risk of TB becoming active. At the same time, socio-economic realities such as overcrowding and limited access to healthcare continue to drive transmission.

Delayed diagnosis means individuals remain infectious for longer, placing families and communities at greater risk.

Early detection can change outcomes

Detecting TB early remains one of the most effective ways to reduce its spread and improve recovery. Treatment typically involves a six- to nine-month course of antibiotics, with strong success rates when completed. However early symptoms are often missed.

“The signs can be missed or ignored,” explains Dr Hamuy Blanco. “A persistent cough, fatigue, night sweats or weight loss are easy to dismiss as stress or a lingering illness. That delay gives TB time to spread.”

Creating space for early conversations, whether at a clinic, pharmacy or with a nurse can make the difference between early intervention and prolonged illness.

Finishing treatment is non-negotiable

Another major barrier to ending TB is interrupted treatment. Many patients begin to feel better within weeks and assume they are cured, while others struggle with side effects or the practicalities of repeated clinic visits.

“When treatment is stopped too soon, the bacteria are not fully eliminated,” says Dr Hamuy Blanco. “This is how drug-resistant TB develops, which is far more difficult and costly to treat.”

Supporting patients through the full course of treatment is essential, with clear communication and ongoing support improving adherence.

Bringing care closer to people

“Accessible healthcare is critical in closing the gap between awareness and action”, says Dr Hamuy Blanco. Retail health clinics and digital health platforms are increasingly helping to make care part of people’s everyday lives.

These routine touchpoints create opportunities for people to ask questions, seek advice and act early helping to normalise testing, reduce stigma and support patients throughout their treatment journey.

“Care needs to fit into people’s daily lives,” she adds. “It should be easy to access, easy to understand and supportive from start to finish.”

Turning intent into impact

TB is both preventable and curable, yet it continues to claim lives because of delayed action and incomplete treatment.

“Ending tuberculosis takes more than medicine. It requires a human-centred approach that supports people from early testing through to completed treatment. By breaking down stigma and acting sooner, South Africa can move from awareness to impact,” she concludes.

Categories : Expert Opinion Respiratory DiseasesTags :

To Eliminate TB, We Need to Make Testing More Accessible and Affordable

On By ModernMedia
Tuberculosis bacteria. Credit: CDC

By Yogan Pillay and Gaurang Tanna

New TB tests have massive potential for South Africa’s struggle to get to grips with the age-old disease. Making the most of these new tests will require both ambition and smart implementation, argue Gaurang Tanna and Dr Yogan Pillay.

Every day, more than 140 people die from tuberculosis (TB) in South Africa, yet TB is both preventable and curable. Too many people are tested too late, allowing the disease to spread silently through communities and turning a curable illness into a fatal one.

Unlike most other diseases, anyone can contract TB – the bacteria are airborne and just the act of breathing makes us vulnerable to contracting TB. The risk of TB is higher for people with suppressed immunity, malnutrition, or living with cancer or HIV.

Reducing deaths from TB depends on earlier diagnosis, yet many people are diagnosed late, often after prolonged illness, and only once they reach hospitals with advanced disease. There are some opportunities for improvement. Firstly, we need to address persistent weaknesses in where and how TB tests are offered. Secondly, we need to address delays in care seeking, and missed opportunities for testing within health facilities. Finally, we need to close the operational barriers that impede testing. An added challenge that the TB disease presents is that it is often present without any symptoms.

In recent years, South Africa took important steps to strengthen its TB response and intensified efforts to find people with the TB disease through implementation of Targeted Universal TB Testing (TUTT). TUTT is a strategy that promotes systematic testing among high-TB risk groups, like people living with HIV, household contacts of individuals with TB, and people with previous TB, irrespective of symptoms.

South Africa now conducts approximately 3.6 million TB tests annually, representing a 50% increase compared to pre-COVID pandemic testing. However, we need to scale this up considerably if we are to reach the more than six million people living with HIV currently receiving HIV treatment in South Africa as well as all those with TB symptoms who are often missed at facilities.

The Department of Health has announced a national goal of conducting 5 million TB tests annually. Public-facing dashboards have been implemented to track TB testing and diagnosis, allowing the public to monitor performance across provinces and districts, strengthening transparency and accountability.

Structural barriers to TB testing

Despite strong commitments, TB testing in South Africa continues to face several structural constraints.

First, the cost of molecular diagnostics limits the scale of testing. Current molecular TB tests cost approximately R230 per test.

Second, inefficient clinic workflows reduce testing coverage. In busy primary healthcare facilities, this leads to missed TB testing, contributing to prolonged diagnostic delays during which transmission continues and disease severity worsens.

Third, many patients, especially children and people living with HIV, can’t produce sputum, which current tests require, further reducing testing coverage.

Fourth, people with the highest burden of TB, particularly men, often do not attend government clinics. Men account for a disproportionate share of TB in South Africa but remain underrepresented in testing programmes, contributing to delayed diagnoses and ongoing transmission.

Evolving and strengthening testing capabilities in line with the ambitions of the next phase of TB control in South Africa requires leveraging emerging diagnostic tools and redesigning how TB testing is delivered.

New diagnostic tools create new opportunities

Just recently, the World Health Organization updated its recommendations on TB diagnostics, endorsing the use of near-point-of-care tests and use of tongue swabs for people who cannot produce sputum to expand access to TB diagnostics and improve diagnostic efficiency. These new tools provide an opportunity to rethink how testing is organised across the health system.

Tongue swabs offer a promising alternative sample type, enabling testing among patients who cannot produce sputum. It has also been demonstrated to be more acceptable for patients and providers and is easier to collect in clinics.

At the same time, near-point-of-care molecular platforms (such as Pluslife, a test that has been approved by the South Africa’s health products regulatory body) offer the potential to diagnose TB closer to the patient. It substantially reduces costs, to about one-third the cost of current molecular tests, while demonstrating comparable diagnostic performance for TB, making large-scale expansion of TB testing more accessible and affordable. By delivering results rapidly, within an hour, this technology could enable a test and treat approach. TB testing, diagnosis, and treatment initiation could all happen during a single primary healthcare visit. This would reduce the time to start treatment and limit the number of patients lost between diagnosis and treatment.

Clinic workflows need to be redesigned

Patients presenting with TB symptoms often move through multiple stages of the clinic process – registration, triage, waiting areas, and clinician consultations – before TB testing is considered. Improving TB testing requires services redesign for patient convenience and accessibility, and to be much more systematic. A few simple changes could be introduced.

Firstly,  introduce a fast-track TB queue, allowing individuals to register digitally and drop off samples without completing a full clinic visit.

Secondly, embed TB symptom screening and sample collection at triage or vital-sign stations. Any patient reporting TB symptoms – cough, fever, night sweats, or weight loss – should have a sample collected while waiting to see a clinician.

Thirdly, for people living with HIV,  introduce twin TB testing with annual viral load test (or CD4 for newly diagnosed patients) to systematically test all people living with HIV.

Lastly, we could equip facilities with a near-point-of-care testing platform, like Pluslife, to deliver results before the clinical consultation, allowing TB to be diagnosed rapidly and at lower cost to the health system. It would enable patients to start treatment on the same day.

These approaches could directly address the most persistent diagnostic and linkage gaps in South Africa’s TB programme.

Extending TB testing beyond clinics

New diagnostic platforms also enable TB testing to move beyond government clinics.

A substantial proportion of individuals with TB, particularly men, do not present to clinics and delay seeking care. Near-point-of-care molecular platforms could enable TB testing through alternative delivery channels, including community settings (such as taxi ranks), community pharmacies, workplace clinics, and households through community health worker programmes.

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Expanding testing beyond clinics will help identify TB earlier among populations that remain underserved by current services.

From policy ambition to implementation

South Africa’s progress over the past four years demonstrates that intensified testing strategies such as TUTT can help increase TB diagnosis. Sustaining this momentum will require redesigning primary health care services to fully use these emerging diagnostic tools. Three priorities should guide this transition.

First, TB sample collection workflows in clinics should be redesigned to ensure that every symptomatic and at-risk person is tested for TB.

Second, new diagnostic tools should be deployed, including the use of tongue swabs for people who cannot produce sputum, as well as low cost near-point-of-care molecular tests to simplify testing and treatment initiation pathways.

Third, TB testing should be expanded through alternative delivery channels to reach people who do not routinely access government clinic services, especially men, who are less likely to seek care in these settings.

By aligning ambition and new technologies with service redesign, South Africa can significantly reduce diagnostic delays, decrease deaths due to TB and accelerate progress towards TB elimination.

*Tanna is a senior programme officer for TB, and Dr Pillay is the director of HIV and TB delivery at the Gates Foundation.

Disclosure: Spotlight receives funding from the Gates Foundation but is editorially independent – an independence that the editors guard jealously. Spotlight is a member of the South African Press Council.

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.

Read the original article.

Categories : Expert OpinionTags :

Global Health Infrastructure is Changing. Why Getting it Right Matters for SA

On By ModernMedia
Countries like South Africa benefited in very concrete ways from multilateral forums. Photo by Kindel Media

By Marcus Low

Funding cuts over the last year or so have created a crisis for multilateral health institutions. Which institutions emerge from this crisis, and in what form, will have real consequences for the health of people in South Africa, argues Spotlight editor Marcus Low.

In recent weeks, there has been a glut of articles from global health big-hitters, all concerned with how multilateral health institutions should, or should not be re-designed. These include articles from Philippe Duneton, Executive Director of UNITAID, Sania Nishtar, CEO of GAVI, and one co-authored by, among others, Anders Nordström, a former acting Director-General of the WHO, Helen Clark, a former New Zealand Prime Minister, and Peter Piot, the driving force behind UNAIDS from the mid-90s to 2008.

The immediate cause of all this debate is the stark reality that funding for multilateral health institutions have been cut dramatically in the last year, mainly, but not exclusively, due to the United States’ retreat from such international forums in favour of bilateral agreements. Even before the funding cuts, the financial outlook at entities like the World Health Organization (WHO) and UNAIDS was bleak. Over the last year, it has tipped over into outright crisis.

The WHO has already undertaken drastic organisational restructuring. Last year, a UN document raised the possibility of “sunsetting” UNAIDS by the end of 2026. It is likely that we will see several more organisations shrinking or disappearing altogether in the coming years.

Why does this matter?

The multilateral health institutions we’ve had in recent decades have not been perfect. They were often overly politicised, fraught with power imbalances, and not always capable of responding quickly and effectively to health emergencies.

But even so, it is unequivocally true that when it comes to healthcare, multilateralism has yielded many tangible benefits that are helping keep people alive. In a world where every country stands alone, these benefits will simply fall away.

There are many examples of such benefits. The WHO’s treatment guidelines for diseases like HIV and TB are public goods that are invaluable in many countries – here in South Africa they were particularly important as an antidote to the crackpot science that flourished in the period of state-sponsored AIDS denialism. The sharing of genomics data between countries was critically important at the height of the COVID-19 pandemic. Over an even longer period, the sharing of data on influenza strains has enabled the rational selection of vaccine components for each hemisphere each year. Medicines regulators in different countries increasingly share some of their work in order to speed their processes up and avoid duplication.

This year, a new HIV prevention injection containing the antiretroviral lenacapavir is being rolled out in South Africa and several other countries, largely with the help of the Global Fund, another international entity. A stable supply of low-cost lenacapavir should be available in around a year or two from now, due to market-shaping work done by UNITAID, the Gates Foundation, the Clinton Health Access Initiative, and Wits RHI. Such market-shaping often involves committing ahead of time to purchase certain volumes of a product to incentivise manufacturers to invest in production capacity, thus kick-starting the market for the product.

Then there is the recent history of how rapidly a new antiretroviral medicine called dolutegravir was rolled out in South Africa from 2019 – today over five million people here are taking it. The Geneva-based Medicines Patent Pool (MPP) negotiated licenses that allowed generic competition to start years earlier than would otherwise have been the case. That enabled the low prices and supply security that has facilitated the massive uptake of dolutegravir here and in dozens of other countries.

It is clearly in South Africa’s interest to help keep mechanisms like the above going.

But to reduce the value of these institutions to purely the technical would miss the essence of what animates them in the first place. The reality is that multilateral health institutions have often been at their most effective when people were driven by the need to address urgent health needs, as for example in the early days of UNAIDS. The belief that people’s health matter, no matter who they are, or where they live – essentially a belief in human rights – can make the difference between an ineffectual bureaucracy and a vital health movement. Our current crisis is not only one of technical capacity, but also one where the animating power of human rights-based thinking is being challenged.

How then should we think about redesigning global health?

There are some tensions between fighting to keep what we currently have and embracing big reforms. For example, on the one hand, given the aid cuts of the last year, people have good reason to be concerned about the potential closure of UNAIDS being a precursor to the further unravelling of the global HIV response. On the other hand, there are legitimate questions as to whether UNAIDS is still fit for purpose, given how the HIV epidemic has changed over the last three decades.

One of the most useful contributions in how to think about all this comes from Nordström and his co-authors. They outline four key paradigm shifts that help bring the current moment into focus. Their paper is worth reading in full for the nuances, but here is a brief paraphrasing of the four paradigm shifts:

  • The first shift is about recognising the fundamental changes underway in the global burden of disease and in demography. In short, while the key threats in the last three decades were the infectious diseases malaria, tuberculosis, and HIV, they are increasingly being overtaken by non-communicable diseases (like diabetes and hypertension) and mental health disorders. This shift is not yet reflected in the architecture of multilateral health institutions.
  • The second shift relates to the recentring of power from Geneva in Switzerland and New York and Washington in the USA to countries and regions, giving rise to an increasingly multipolar world. “This shift does not imply that multilateral cooperation is obsolete,” write the authors, “however, it requires a clarification of which future functions should be performed at the global level, and which should be performed by national and regional bodies.”
  • The third shift refers to the growing push to modernise the landscape of global health institutions. The authors write: “Leaders from low-income and middle-income countries have repeatedly critiqued the dearth of systemic support, the inefficiencies of vertical initiatives, and the resource-intensive bureaucratic processes that accompany them”. Considering these external and internal pressures, they argue there is a need to move from a complex and competitive system to a simpler, needs-based, and agile system.
  • The fourth shift is linked to the declining relative importance of development assistance, coupled with countries’ rising commitments to increase domestic financing for health. Although some international support will remain essential for low-income countries and humanitarian responses, the authors argue that domestic resources must be the engine of a new ecosystem and ways of working together.

All of these shifts are now occurring within the broader geopolitical context of what Canadian Prime Minister Mark Carney recently described as a “rupture in the world order”. He stressed that the great powers have turned their backs on the rules-based world order and have “begun using economic integration as weapons, tariffs as leverage, financial infrastructure as coercion, supply chains as vulnerabilities to be exploited”. This shift can already be seen in the US’s pivot from multilateralism to bilateral health agreements.

As Carney put it: “The multilateral institutions on which the middle powers have relied – the WTO, the UN, the COP – the architecture, the very architecture of collective problem solving are under threat.”

He argues that middle-powers like Canada, and I’d argue South Africa should aspire to be part of this group, should chart a way forward where they are not overly reliant on super powers like the US and China. Avoiding such an over-reliance is of course also an obvious lesson to take from the US’s abrupt cuts to health aid last year.

Maybe a first harsh reality to come to terms with then is that the rupture that is taking place in global geopolitics is also occurring in the world of global health. To think that we can go back to the way the WHO or UNAIDS were twenty years ago, is wishful thinking. The “rupture” might take time to propagate, but it will extend all the way.

What then is to be done?

Carney also makes the point that the rules-based order wasn’t in fact working as well for everyone as we liked to pretend. To a lesser extent, something similar could be said for multilateralism in health. Getting things done was often hard, the politics was often tricky, and when it came to the crunch, say on something like patents on medicines, the US and Europe almost always held sway.

As outlined above, countries like South Africa benefited in very concrete ways from multilateral forums, but somehow those benefits were never widely appreciated. Ultimately, it is telling that so many national governments have failed to put up the money the WHO requires to do its work – even before the current US withdrawal.

Maybe then, to make a reset of multilateral health institutions a success, will require that governments reassess and newly appreciate why it is that we need multilateral health institutions in the first place.

This will require a thorough and honest assessment of what we have gained from these institutions in recent decades. Things like market-shaping, patent pooling, pooled procurement, sharing of genomics and other data, regulatory harmonisation, guideline development, research cooperation, and multilateral fund raising have all been important and will continue to be so. We must make sure that in whatever emerges in the next few years, we have multilateral mechanisms that can deliver in all these areas.

But we will have to accept that those entities might look quite different from what we’ve come to know in recent decades. There will certainly be areas in which we still need global institutions like the WHO, but for some issues we might get more done by working with coalitions of the willing, or collaborating at a regional level – as we’re already seeing with the African Medicines Agency (although South Africa rather inexplicably hasn’t yet ratified the related treaty).

The reality is that apart from governments just not being willing to spend more on health at the moment, the enabling geopolitical substructure that we’ve been relying on for decades has given way. In many respects, this has been a disaster for our common good, but it is also an opportunity to craft new and more fit-for-purpose multilateral health institutions that are animated by a shared commitment to human rights. This is an opportunity that countries like South Africa must grasp.

As Carney put it: “We know the old order is not coming back. We shouldn’t mourn it. Nostalgia is not a strategy, but we believe that from the fracture, we can build something bigger, better, stronger, more just. This is the task of the middle powers, the countries that have the most to lose from a world of fortresses and most to gain from genuine cooperation.”

*Low is the editor of Spotlight.

This article was jointly published with Health Policy Watch, a global health news platform.

Disclosure: The Gates Foundation is mentioned in this article. Spotlight receives funding from the Gates Foundation, but is editorially independent – an independence that the editors guard jealously. Spotlight is a member of the South African Press Council.

Republished from Spotlight under a Creative Commons licence.

Read the original article.