One of the first acts President Trump took on assuming office again on January 20, 2025, was to unilaterally withdraw the United States from the World Health Organization (WHO). Trump complained of the WHO’s “mishandling” of the COVID pandemic, influence by other countries, and the US financial support was excessive compared to China, which “has 300 percent of the population of the United States, yet contributes nearly 90 percent less to the WHO.”
The WHO released a statement, expressing its regret at the decision and pointing out its importance: “WHO plays a crucial role in protecting the health and security of the world’s people, including Americans, by addressing the root causes of disease, building stronger health systems, and detecting, preventing and responding to health emergencies, including disease outbreaks, often in dangerous places where others cannot go.”
The organisation also took aim at Trump’s criticism of its lack of reforms: “With the participation of the United States and other Member States, WHO has over the past 7 years implemented the largest set of reforms in its history, to transform our accountability, cost-effectiveness, and impact in countries. This work continues.”
Critics say that the move would only hand China the opportunity to effectively take control of global health if it chooses to becomes the WHO’s main contributor: though the US is the single largest contributor, it contributed only $1.3 billion in the 2022-23 biennium. An affordable amount compared to the vast sums both countries spend on their militaries. While the WHO did lavish praise on China, many experts saw it as undue and perhaps concerning – but China’s contribution, while currently small, is rising: $86 million in the 2018-19 biennium. After the US, the next largest contributors are Germany ($856 million) and the Bill and Melinda Gates Foundation ($830 million).
The Society for Healthcare Epidemiology of America (SHEA) stressed the importance of global health cooperation. In a statement, the organisation wrote: “It is essential that the United States continues our connection with the WHO to coordinate surveillance, monitoring, detection, prevention, research, and response to public health threats including outbreaks, antimicrobial resistance and high consequence pathogens such as viral haemorrhagic fevers (Ebola, Marburg), Mpox, and highly pathogenic avian influenza (eg, H5N1).”
Indeed, Trump may not simply be able to withdraw by presidential decree; since the US joined the WHO by an act of Congress, it would likely take congressional approval to leave it and Trump may face a lawsuit over this.
Trump previously announced his intention to withdraw the US from the WHO in 2020, something which Gostin et al. warned in The Lancet would not work out well for the US and the world. “Withdrawal from WHO would have dire consequences for US security, diplomacy, and influence. WHO has unmatched global reach and legitimacy.” Additionally, they warned of the sheer difficulty of such a messy divorce: “The US administration would be hard pressed to disentangle the country from WHO governance and programmes.”
From the NHI Act to major advances in HIV prevention, it has been another busy year in the world of healthcare. Spotlight editors Marcus Low and Adiel Ismail recap the year’s health developments and identify some key trends in fewer than 1000 words.
For a few weeks in June, it seemed that the surprising outcome of South Africa’s national and provincial elections would usher in far-reaching political and governance changes in the country. As it turns out, some significant changes did come, but not in the health sector.
Rather than a new broom, it was déjà vu as Dr Aaron Motsoaledi returned as Minister of Health – he was previously in the position from 2009 to 2019. In both Gauteng and KwaZulu-Natal – the country’s most populous provinces – ANC MECs for health from before the elections kept their jobs. The ANC garnered well under 50% of the votes in both of those provinces and nationally and accordingly had little choice but to form national and provincial coalitions.
To be fair, five of the nine MECs appointed after the elections were new, but these changes were mainly in the less populous provinces.
Policy-wise, the trajectory also remains much as it was a year ago. Two weeks before the elections, President Cyril Ramaphosa signed the National Health Insurance (NHI) Act into law (though most of it has not yet been promulgated). While Ramaphosa has since then asked Business Unity South Africa (BUSA), the country’s largest employer association, for new input on NHI and while talk of mandatory medical scheme cover had a moment in the headlines, there is no solid evidence that the ANC is open to changing course – if anything, Motsoaledi has doubled-down in the face of criticism. The Act is being challenged in various court cases.
The sense of discord in healthcare circles was further deepened in August when several organisations distanced themselves from Ramaphosa’s updated Presidential Health Compact. The South African Medical Association, the South African Health Professionals Collaboration—comprising nine associations representing over 25 000 public and private healthcare workers—and BUSA all declined to sign the accord. BUSA accused government of “unilaterally” amending the compact “transforming its original intent and objectives into an explicit pledge of support for the NHI Act”.
Away from these reforms, a trend of health budgets shrinking year-on-year in real terms continued this year. This funding crunch, together with well-documented shortages of healthcare workers, has meant that even well-run provincial health departments are having to make impossible trade-offs – that while governance in several provincial health departments remains chronically dysfunctional. This was underlined by a landmark report published in July that, among others, highlighted leadership instability, lack of transparency, insufficient accountability mechanisms, and pervasive corruption. New reports from the Auditor General also didn’t paint a pretty picture.
Gauteng health has again been in the headlines for the wrong reasons. The provision of cancer services in the province remains mired in controversy as the year comes to an end, with plans to outsource some radiation services to the private sector apparently having stalled, despite the health department having the money for it. A deal between the department and Wits University was also inexplicably derailed. With high vacancy rates, serious questions over senior appointments, reports of corruption at Thembisa Hospital, and much more, it seems that, if anything, governance in the province has gotten even worse this year.
In a precedent-setting inquest ruling in July, Judge Mmonoa Teffo found that the deaths of nine people moved from Life Esidimeni facilities to understaffed and under-equipped NGOs “were negligently caused by the conduct of” former Health MEC Qedani Mahlangu and former head of the provincial health department’s mental health directorate Dr Makgabo Manamela.
Outside our borders, Donald Trump’s election victory in the United States is set to have far-reaching consequences. A return of the Global Gag Rule seems likely, as does major changes to the Food and Drug Administration, the President’s Emergency Plan for AIDS Relief, and the National Institutes of Health – the latter funds much HIV and TB research in South Africa.
Away from politics and governance, the biggest HIV news of the year came in late June when it was announced that an injection administered every six months was extremely effective at preventing HIV infection. It will likely be several years before the jab becomes widely available in South Africa.
Another jab that provides two months of protection per shot is already available here, but only to a small number of people participating in implementation studies.
It is estimated that around 50 000 people died of HIV related causes in South Africa in 2023 and roughly 150 000 were newly infected with the virus (reliable estimates for 2024 will only be available in 2025). A worrying one in four people living with HIV were not on treatment in 2023. There was an estimated 56 000 TB deaths and around 270 000 people fell ill with the disease. While these HIV and TB numbers have come down dramatically over the last decade, they remain very high compared to most other countries.
There are some concerns that a new TB prevention policy published in 2023 is not being universally implemented. We have however been doing more TB tests, even while TB cases are declining – as we have argued, this is as it should be. Also positive, is that a massive trial of an TB vaccine kicked off in South Africa this year.
With both TB and HIV, South Africa is making progress too slowly, but we are at least trending in the right direction. With non-communicable diseases such as diabetes, there are unfortunately signs that things are getting worse. As we explained in one of our special briefings this year, our diabetes data in South Africa isn’t great, but the little we have painted a worrying picture. As expected, access to breakthrough new diabetes and weight loss medicines remained severely constrained this year, largely due to high prices and limited supply.
Ultimately then, at the end of 2024, South Africa is still faced with chronic healthcare worker shortages, severe governance problems in several provinces, and major uncertainties over NHI – all while HIV and TB remains major public health challenges, though a shift toward non-communicable diseases is clearly underway.
By Prelisha Singh, Partner, Martin Versfeld, Partner and Alexandra Rees, Senior Associate, Webber Wentzel
Robust contestation on how to best fulfil the fundamental rights of South Africans complements and strengthens our constitutional democracy. Recent debate has centred on the effective realisation of the right to access healthcare, which the state is required progressively to realise for all South Africans, irrespective of their background and income.
The right to access healthcare came into sharp focus on 15 May 2024, when President Cyril Ramaphosa signed the National Health Insurance (NHI) Act into law, prompting the initiation of constitutional challenges by concerned stakeholders. The most recent of these was filed on 1 October 2024 in the North Gauteng High Court, Pretoria by the South African Private Practitioners Forum (SAPPF), represented by Webber Wentzel.
According to the government, the NHI Act is intended to generate efficiency, affordability and quality for the benefit of South Africa’s healthcare sector.
An assessment of South Africa’s current healthcare landscape shows a stark difference between private and public healthcare. The country has a high quality, effective private healthcare offering. However, it is currently inaccessible to the many South Africans who cannot afford private care or medical aid payments. Public healthcare, on the other hand, is understaffed, poorly managed and plagued by maladministration and limited facilities.
The NHI Act has been positioned as the vehicle to address this disparity and a desire to take steps towards achieving universal healthcare in South Africa. But a closer reading of the Act highlights numerous problems with its content and implementation design. The absence of clarity, detail or guidance contained in the Act makes it impossible to assess how the Act will actually be implemented (or, by extension, what the effects of this implementation will be).
This is particularly concerning given that years have passed since the economic assessments, on which the Act was based, were undertaken. Also problematic is the apparent lack of consideration given by the government to submissions made by affected stakeholders during multiple rounds of constitutionally required public participation.
SAPPF underscores these deficits in seeking both to have the President’s decision to assent to the Act reviewed and set aside, and the Act itself declared unconstitutional.
President Ramaphosa was obliged, in terms of sections 79 and 84(2)(a) to (c) of the Constitution, not to assent to the Act in its current form. Section 79 requires the President to refer back to Parliament any bill that he or she believes may lack constitutionality. In this case, it is difficult to conceive how the President, or any reasonable person in the President’s position could not have had doubts regarding the constitutionality of the NHI Bill. The decision by the President to sign unconstitutional legislation into law, instead of referring it back to Parliament for correction, is also irrational.
The President’s duty properly to have referred the NHI Bill back to Parliament is affirmed by the fact that the President is enjoined, by section 7(2) of the Constitution, to respect, protect, promote and fulfil the rights contained in the Bill of Rights.
SAPPF’s application demonstrates that the NHI Act, in its current form, infringes upon the rights to access healthcare services, to practice a trade, and to own property. Patients, including those using private healthcare, will be forced to use a public healthcare system that currently fails to meet its key constituents’ needs. Practitioners’ rights to freedom of trade and profession will be infringed upon, and the property rights of medical schemes, practitioners, and financial providers will be unjustifiably limited.
On its current text, the Act could make South Africa the only open and democratic jurisdiction worldwide to impose a national health system that excludes by legislation private healthcare cover for those services offered by the state – notwithstanding the level or quality of case.
Concerns regarding the rights infringements in the NHI Act are exacerbated by its lack of clarity and the fact that crucial aspects of its implementation are relegated to regulations, with no clear guidance provided in the Act itself.
For example, section 49 provides that the NHI will be funded by money appropriated by Parliament, from the general tax revenue, payroll tax, and surcharge to personal tax. However, this stance does not reconcile with section 2, which provides that the NHI will be funded through ‘mandatory prepayment’, a compulsory payment for health services in accordance with income level. Crucially, the extent of the benefits covered by the NHI’s funding mechanism and its rate of reimbursement, which impact affordability and the provision of quality healthcare, remain unknown.
The Act is, at best, a skeleton framework, seemingly assented to in haste. It is conceptually vague to the extent that the rights it seeks to promote will, in fact, be infringed if implemented. This renders the Act irrational, in addition to its other constitutional defects.
The NHI Act represents a radical shift of unprecedented magnitude in the South African health care landscape. This should be – and is required to be – underpinned by meaningful public participation, up-to-date socio-economic impact assessments and affordability analyses and final provisions that provide a clear and workable framework for implementation.
It is not sufficient for these vital issues to be addressed after the fact. Further engagements with stakeholders and the solicitation of proposals by the government cannot be used to splint broken laws. Collaborative engagement, including the solicitation of inputs for meaningful consideration, should take place during the law-making process, not after its conclusion.
A shift of the magnitude proposed by the Act, absent compliance with the structures of the law-making process and adherence by the state to constitutional standards, including rights protections, would be detrimental to the entire healthcare sector – public and private – and not in the best interests of patients and practitioners.
Notwithstanding the legal contestation surrounding the Act, it and the laudable goals underlying it can also be a watershed. The achievement of universal health coverage is an opportunity for the different stakeholders in South Africa’s healthcare system to meaningfully collaborate and inform well-supported, factually informed, rational and genuinely progressive legislative steps by the state.
Given the questions surrounding the Act and the evident need it seeks to address, the space exists for healthcare stakeholders to align around shared goals and values. They can leverage their available resources to design a healthcare system that serves all of South Africa’s people fairly and equitably, using the significant existing resources invested in the country’s healthcare sector.
The South African Health Products Regulatory Authority (SAHPRA) encourages members of the public to always report any suspected side effects they may experience from taking medicines, vaccines and/or using medical devices, to help make medicines safer for everyone. While humanity benefits greatly from medicines in the treatment of illness and management of certain conditions, medicines may at times cause side effects. However, the risk of side effects and severe harm can be drastically reduced by taking medicines correctly and following the advice of a healthcare practitioner.
SAHPRA, together with over 90 other medicines and health products regulators as well as healthcare organisations globally, is participating in the annual #MedSafetyWeek awareness initiative, which takes place between 4 and 10 November 2024, under the theme “the importance of using medicines in the right way to prevent side effects, and to report side effects when they do occur”.
The awareness initiative is spearheaded by the Uppsala Monitoring Centre under the auspices of the World Health Organisation (WHO) Programme for International Drug Monitoring, a programme whose member organisations work nationally and collaborate internationally to monitor and identify adverse effects of medicines and vaccines, to reduce risks to patients, and to establish worldwide pharmacovigilance standards and systems.
During this #MedSafetyWeek and beyond, SAHPRA is calling upon patients, caregivers and healthcare professionals to utilise its reporting tools to report all suspected side effects and adverse reactions.
SAHPRA Chief Executive Officer, Dr Boitumelo Semete-Makokotlela, indicates that handling and storing as well as taking medicines as directed by a healthcare professional is key in reducing the incidence of adverse reactions. “Research shows that about half of all side effects are preventable. Patient safety is our top priority and during #MedSafetyWeek, we wish to remind patients to take their medicines as instructed and healthcare professionals to review therapies as well as each patient’s unique health conditions before prescribing or dispensing medicines,” says Dr Semete-Makokotlela.
SAHPRA calls upon the South African public and healthcare professionals to use either the MedSafety App or the eReporting portal both accessible on the SAHPRA website to report suspected side effects from health products. All reports are assessed and examined by SAHPRA to determine the correct steps to protect medicine users in South Africa from harm. The purpose is to gain better knowledge about known side effects and to discover new ones. This can result in warnings and changes to how a medicine is used. SAHPRA’s MedSafety App and eReporting portal can be used for reporting suspected adverse drug reactions from medicines, vaccines, herbal products, biological medicines and any quality issues relating to health products.
Bada Pharasi, CEO of The Innovative Pharmaceutical Association of South Africa (IPASA)
Imagine a healthcare system which ensures that every patient’s voice helps shape their treatment, where barriers to life-saving care are dismantled, and where innovation is driven by meaningful collaboration. In South Africa, this vision is no longer a distant aspiration; it’s an urgent mission to create a system that truly serves its people, writes Bada Pharasi, CEO of the Innovative Pharmaceutical Association of South Africa.
South Africa’s healthcare system stands at a critical crossroads. Despite remarkable medical advancements, countless patients remain on the sidelines, hindered by financial, regulatory, and logistical barriers. Today, there’s an opportunity to reshape this reality by building a patient-centred healthcare model that expands access, amplifies patient voices, and creates strategic partnerships.
Empowering patient voices
In a truly inclusive healthcare system, patients aren’t just recipients of care; they are active contributors. By integrating patient perspectives into decision-making, healthcare becomes more responsive to those it serves.
Through collaborations with patient advocacy groups, educational campaigns, and year-round initiatives, there’s a growing movement to create an environment in which patients feel heard and empowered to influence the care they receive. While events such as World Patient Safety Day help highlight the importance of prioritising patient needs, the goal is to make this a constant focus, not just an annual observance.
Key prerequisites for achieving this are efficient regulatory frameworks, impactful public-private partnerships, rare disease management, and a true commitment to innovation.
Streamlined regulatory partnerships
Timely access to groundbreaking treatments depends on efficient regulatory frameworks. Collaborating closely with regulatory authorities such as the South African Health Products Regulatory Authority (SAHPRA) is pivotal in expediting access to new therapies.
Such partnerships ensure that treatments meet rigorous safety standards while streamlining approval processes so that life-changing therapies reach patients without unnecessary delays. Maintaining high standards for post-market safety also strengthens public trust and reinforces the resilience of the healthcare system.
Public-private partnerships: Catalysts for innovation
Expanding access to quality healthcare in South Africa demands strong public-private partnerships (PPPs) that leverage both public resources and private sector innovation.
Collaborative efforts with the Department of Health and other key stakeholders maximise impact by ensuring that resources are effectively allocated and that patients benefit from the latest treatments. These alliances are vital for achieving universal health coverage (UHC) under the National Health Insurance (NHI) framework, helping to ensure that equitable, high-quality healthcare becomes a reality for all.
Closing gaps in rare disease management
For patients with rare diseases, access to treatment is often riddled with obstacles, from limited therapies and high costs to a lack of awareness. Multi-stakeholder collaborations, including advisory boards initiated by organisations such as Rare Diseases South Africa, bring together patients, healthcare professionals, and industry experts to advocate for better support and access to treatments.
This prioritisation of open communication and patient-centred outcomes offers hope to rare disease patients who, through these partnerships, gain better access to essential treatments and the support they deserve.
Breaking down barriers to innovation
The drive for a more accessible healthcare system also requires addressing policy barriers. Streamlined processes, simpler registration pathways for new drugs, and patient-centred reimbursement policies ensure that patients receive the right treatment at the right time.
Working alongside policymakers, healthcare providers, and civil society, a concerted effort is being made to create a system in which innovation and equity go hand-in-hand to provide better outcomes and quality of life for all South Africans.
Shaping the future of healthcare
The future of South Africa’s healthcare lies in a system that prioritises patients, breaks down barriers, and capitalises on partnerships to make innovation accessible.
The call to action is clear: build a healthcare ecosystem that is dynamic, inclusive, and adaptable to ensure that every South African has access to the care they need. By promoting patient voices and ensuring collaboration across sectors, we can transform South Africa’s healthcare system to be more responsive, resilient, and equitable – a system that truly serves its people.
To see National Health Insurance primarily as the setting up of a state-run medical aid scheme risks underplaying its massive potential to restructure how public healthcare services are organised and funded, and with that, its potential to boost the delivery of primary healthcare services in South Africa, argues Russell Rensburg.
It has been 30 years since South Africa emerged from centuries long racial suppression and state-sponsored apartheid and took her place among the community of sovereign, democratic nations. In 1996, we adopted the final Constitution, in which we committed to addressing the injustices of the past and building a society based on social justice and human dignity. That promise is carried through in the Bill of Rights, which under Section 27 includes the right to healthcare, food, and social assistance. The right to access healthcare services, like many socio-economic rights, is subject to the state taking reasonable legislative and other measures within available resources to progressively realise the right.
Pursuant to this, the National Health Act, which provides the framework for a structured uniform health system within the country, was adopted in 2003. The Act assigns the minister of health the obligation to ensure the provision of essential health services, which must include primary healthcare services. But, to date, no health minister has published regulations that define the exact scope of essential health services, nor has a framework been offered for the development of a defined package of care to be provided within the resources available.
The result is that, despite significant investments in public funded healthcare, the system and the services it provides has largely been shaped by existing infrastructure inequity. Put differently, health investments have typically gone where the infrastructure exists, rather than being guided by providing a defined package of primary healthcare services in all the places where it is most needed.
In the near term, the health system faces several immediate challenges. Per capita spending is declining. Spending is biased towards hospitals, with 42% of the national health budget spent on central and provincial hospitals. Another problem is that health service planning and budgets do not sufficiently account for our changing demographic profile – life expectancy has increased and we have a growing population of young people.
The National Health Insurance (NHI) Act is an attempt to address this through the establishment of the national health insurance fund, which initially will be the only purchaser of public sector healthcare services. Broadly, the NHI aims to pool funds to provide access to good quality, affordable healthcare services for all South Africans and certain foreign nationals, based on their health needs and irrespective of their socio-economic status.
This shift marks a substantial change from the existing setup, where 85% of the national health budget is allocated at the provincial level. In South Africa, the share provinces get of the national budget is largely determined by the equitable share formula. The health component of the formula includes a number of variables to account for healthcare need, including premature mortality (as a proxy for unmet need ), multi index deprivation (to account for social determinants of health such as poverty ), income, housing, and measures of sparsity (to account for rurality). But the biggest driver of funding is historical utilisation, which shapes resource allocation at the provincial level. The result is that the funding is overly focused on providing care under the existing systems, rather than progressively expanding access to healthcare, and boosting access to primary care in particular.
In short, NHI represents a major shift away from this paradigm by which provinces receive healthcare funds via the equitable share and based on historic spending.
How it will work
Under NHI, the public sector will budget according to level of care, initially prioritising the district health system through the establishment of district health management offices. These offices will support contracting units for primary care, which will comprise a district hospital, community health centres , primary healthcare clinics, and ward based outreach teams as well as provisions for integrated practice comprising GPs, pharmacists, dentists, and rehab professionals (occupational health, physiotherapy, and speech therapy). The district health management offices will be responsible for the achievement of health outcomes in districts.
In theory, this will allow for healthcare priorities to be shaped at the district level and for services to be more responsive to the healthcare needs of communities. For example, a district like OR Tambo could prioritise more resources towards addressing maternal mortality by expanding ante-natal services or developing responses to address the health access gaps for older people in rural areas. In urban districts, like the City of Johannesburg, it could prioritise expanding access to reproductive health services by contracting in private health providers who are better placed to respond to the needs of working women. Ultimately, such a shift to a more responsive and more localised health system could also help increase uptake of TB and HIV prevention and treatment services across the board.
How to get the ball rolling
Reorientating our health system towards primary healthcare will be a difficult and time-consuming process, given the complex nature of health systems. But, there are things we can do right away to get things moving. We don’t have to wait for full implementation of NHI.
The current District Health Programme Grant can be expanded to enable provinces to increase primary healthcare services. The grant currently focuses on resourcing the country’s response to HIV, which seems to have reached a plateau with fewer people initiated on treatment. Contracting in private providers using this grant could improve service accessibility for testing, reproductive health services and routine healthcare for the working poor. Indeed, contracting in non-state healthcare providers, such as healthcare NGOs, pharmacies, and GPs, can significantly improve the patient experience and help build the public trust that is needed for NHI. As we repurpose the District Health Programme Grant, we can also start building the systems we will need for the district health management offices envisaged under NHI, thus helping to ease the transition when it comes.
The biggest immediate opportunity however lies in improving the accessibility and acceptability of district health services for the working poor. A study by the Bureau of Market Research at UNISA estimated that around 75% of working people in South Africa earn less than R6 000 a month. The current structure of publicly funded primary healthcare services do not respond to their routine needs, which include accessing family planning, seeing a GP when ill, a dentist to address oral health issues or access to rehab services. Apart from meeting the needs of these people, expanding service points, particularly in urban areas, can also improve disease surveillance through increased testing, and increased uptake of HIV prevention and treatment services.
There are more areas where we can make progress now that will ease the transition to NHI. For example, the current National Tertiary Services Grant, with an allocation of R15 billion, can be used to support a deep dive into what services our hospitals offer, what resources they are allocated and why, and how all of that lines up with the health need in our districts. The data isn’t currently there to really know whether we are getting value for money from our public hospitals. As with primary care, we need to get a clearer understanding of the need and start re-engineering the system so that we are in a better position to meet that need as we start implementing NHI.
Ultimately then, it is limiting to think of NHI exclusively as the establishment of a state-run medical aid scheme – as it is often portrayed in the media. A public discourse dominated by debates over the future of medical schemes risks obscuring the substantial potential NHI offers for improving and restructuring how public health services are organised and funded. The reality is that with NHI, we have an opportunity to shift the focus of our healthcare system toward primary healthcare and in the process to make our health system much more efficient and equitable. It is imperative that we do whatever is needed to deliver on that potential.
*Rensburg is Director of the Rural Health Advocacy Project.
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.
Family physicians undergo an extra four years of training, with an emphasis on clinical governance and knowledge of social factors influencing people’s health. Photo by cottonbro studio
By Chris Bateman
Around twenty years ago, family physicians seemed set to take up roles as critical cogs across South Africa’s public healthcare system, but in the years since, doctors trained in this speciality have largely been underutilised. That is now finally set to change, according to the Department of Health, Chris Bateman reports.
The National Department of Health has signalled that they want to see more family physicians appointed as clinical managers tasked with leading multi-disciplinary district hospital teams. This follows years of lobbying by the South African Academy of Family Physicians (SAAFP) advocating for the greater utilisation of family physicians in the country’s public healthcare system.
The SAAFP has long argued the cost and clinical effectiveness of these “super generalists”, who undergo an extra four years of training, with an emphasis on clinical governance and knowledge of social factors influencing people’s health. And it seems their patience has been rewarded with a five-year district health blueprint from government.
This was confirmed to Spotlight by Dr Luvuyo Bayeni, Chief Director of Human Resources for Health at the National Department of Health.
Advocates for the speciality argue that family physicians have been neglected, with posts thin on the ground and their potential contribution under-estimated. The discipline was registered with the HPCSA in 2007.
Professor Bob Mash, Distinguished Professor at Stellenbosch University where he heads the Division of Family Medicine and Primary Care, describes the specialty as “one of the most underutilised solutions to many of the problems facing district health service delivery”. Mash is the immediate past president of the SAAFP.
Bayeni, a former clinician/administrator in the Eastern Cape, was appointed to lead the health department’s human resource operations in July last year. Since then, he attended the last two annual SAAFP conferences and has been meeting regularly with the academy’s leadership.
With austerity measures being the catch-all rebuttal by provincial heads of department whenever the wisdom of freezing posts is questioned, Bayeni is trying to persuade his provincial counterparts to adopt a policy of appointing family physicians to clinical manager posts as a highly cost-efficient move, citing successes in the Western Cape. The idea is that family physicians are able to quickly diagnose and treat patients while mentoring junior colleagues. They also help design or tweak hospital and referral clinic systems for efficiency and identify preventative health interventions at community level.
Blueprint approved
In a wide-ranging interview with Spotlight, Bayeni said his family medicine oriented blueprint had been approved by the Presidency’s Department of Policy Planning, Monitoring and Evaluation for inclusion in all future health indicators. His plan is to initially get family physicians as clinical managers into all medium to large district hospitals (150 beds and above), before ensuring they are placed in every health district, including at lower level hospitals and community health centres, at all times leading a multi-disciplinary team.
“Instead of waiting for HR plans and organograms, this is going into the mid-term framework for monitoring. It’s a strategic opportunity, where we ask ourselves, ‘how do we define a multi-disciplinary team for a district hospital?’ and then work through and with them. We’ll define and map where our priority district hospitals are, starting with the medium to large district hospitals,” he said.
Bayeni said he met with his provincial counterparts and military health service chiefs last week, (14-18 October), where he said he was going to, “make sure they all know about this. Organograms are all fine and well and necessary, but I want this top of mind when they consider them.”
“Personally, by April next year, (the new financial year), I want to see more family physicians being appointed, either in the district or in the position of clinical managers wherever there are vacancies. I’ll ask the provinces to help me with monitoring and evaluation,” he said.
He said his ambition is to change the mindset of provincial healthcare leaders “wherever necessary” about family physicians being regarded as “just another specialty” when creating and enumerating posts.
Positive responses
Several top family medicine academics and clinicians around the country who have been at the forefront of providing data and lobbying for a more pragmatic healthcare delivery approach, welcomed the renewed focus on family physicians.
Professor Steve Reid, a veteran rural family physician and head of Primary Health Care at the University of Cape Town (UCT), told Spotlight the main problem was what he called a framing issue.
“The way we think about medicine is to just go to the doctor and get it sorted, rather than how a huge number of diseases can be managed and prevented early on – it’s been a major shift over the last fifty years. I mean we now have studies that link pre-natal health to later chronic diseases. The whole idea of social medicine went out of vogue, and the idea that health has far more to do with the social determinants of health than it has to do with the health system had too little purchase,” he said.
Reid observed that no family physician can work in isolation – they made the most difference when they had a multi-disciplinary team around them.
Labelling family physicians “boundary-spanners par excellence”, he said “they join the dots rather than work in silos like other specialties who tend to guard their turf jealously.”
“Brazil is a middle-income country just like South Africa and their simple model of one doctor, a nurse and four to six community health workers per 4 000 population has got 80% of their population covered, including vast urban areas like Sao Paulo and Rio de Janeiro,” he said. In South Africa’s case, having a family physician as the leader will further enhance this model.
‘Around 400 needed’
Mash said South Africa’s previous health policies saw family physicians as a sub-specialty of internal medicine or as specialists who should work at tertiary hospitals and within primary care teams. Currently, chiefly due to the lack of posts, only a third of family medicine graduates were retained in the public sector, with ten percent emigrating and eleven percent giving up medicine altogether. Most were employed in the Western Cape, where the health system had committed to appointing family medicine practitioners at district hospitals and primary care facilities, Mash added.
The SAAFP recommends a mid-term goal of one family physician at every district hospital, community health centre or sub-district.
To achieve this, said Mash, another 400 family physicians are needed, but at current training rates this could take up to two decades, (not accounting for the current shortage of posts).
He agreed with Public Health Medicine Specialist Tracey Naledi, that only when there’s wider and stronger investment in primary healthcare across provinces will better deployment of Family Medicine practitioners begin to make a real difference to district level health and wellness. Naledi is Associate Professor in Public Health Medicine and Deputy Dean of Social Accountability and Health Systems at UCT’s Faculty of Health Sciences.
Naledi said that while there are many highly skilled veteran ‘utility’ Medical Officers in the district health system, the greater utility of family medicine is in clinical governance, health systems strengthening initiatives and capacity development. Besides teaching, monitoring, and evaluating healthcare delivery, she said family physicians also more appropriately and timeously refer patients to secondary and tertiary care.
Specialist support
“The family physicians should not just be seeing sixty patients at their door daily. They are specialist support – the Medical Officers should be calling them for advice. If family physicians were optimized, we’d see far less referral to tertiary level services,” she said.
The problem is structural, she believes.
“There are not enough human resources for health in general, so at district level people get pulled into doing what’s needed on the shop floor. There’s not enough time to do the strategic work,” she said.
“You can’t just talk about family medicine without talking about full staff requirements. When a family physician goes on outreach, it should not just be about dealing with difficult cases but building the capacity of the outlying areas. They need to ask themselves what they’re leaving behind. Otherwise, you’re cleaning the floor but not closing the tap,” she added.
Mash agreed that family medicine practitioners are “not the magic bullet – but introducing them into district health services can go quite a way towards strengthening the system”.
“We’ve trained them to work independently, to be the senior clinician with the full spectrum of needed skills, on top of which they provide the confidence for the doctors who are there to practice the skills they have. It’s very reassuring having a senior person to help if things go wrong, so it’s a combination of increased confidence and bringing in additional skills,” he said.
“A primary health nurse and community health worker can provide coverage and connection to the community, but a [family medicine] FM practitioner brings in a level of expertise so the team has both coverage and quality,” he added.
History and training
As Mash tells it, from the nineties into the first decade of the 2000s, no medical schools exposed undergraduates to Family Medicine. However, nearly thirty years on, curricula have completely turned around.
Mash says some twenty to thirty family medicine practitioners graduate from the ten South African campuses every year, among the chief disincentives to the specialisation being the paucity of available posts. He said it’s critical to create more family medicine posts “if we are to attract people into that career path. If managers believe a family physician’s contribution is worthwhile, they can outmanoeuvre these restrictive budgets.”
He said public health was being “hugely damaged” by an austerity mindset.
Professor Shabir Moosa, Family Physician in the Department of Family Medicine at Wits University, suggested offering a two-year distance learning diploma in family medicine to get family medicine practitioners into practice faster and then offering in-service further tuition to a full post-graduate degree. Moosa is a former President of the World Organization of Family Doctor’s Africa region.
“Right now, you have family physicians in community healthcare centres which see a thousand people a day. Their job is capacity building, but they’re stuck with menial tasks. Also, right now qualified Family Medicine practitioners, at Wits at least, have a thirty percent teaching commitment so they’re being pulled in many different directions.”
Like Mash, he said “turnstile leadership” in the provinces wrecked progress while leadership in primary healthcare at district and lower levels was mainly by nurses, who were uncomfortable sharing space with family physicians whom they saw as a “power threat”.
Moosa says most family medicine practitioners in rural South Africa (with the exception of the Western Cape), are foreign qualified doctors who found studying it an “easy entrance route”. He takes issue with the emphasis on training family physicians exclusively for use in rural areas, saying that with accelerating urbanisation, this is short-sighted.
Parallel with clinical associates
Associate Professor Tasleem Ras, President of the SAAFP and Postgraduate Programme Director of Family Medicine at UCT, drew a parallel with clinical associates which some provinces had adopted and others not, saying they had no career pathways which has become “a political hot potato”. (Spotlight previously reported under the under-utilisation of clinical associates here and here.)
Ras was alluding to the provincially disparate usage of both categories of healthcare professionals. In the case of family physicians at least, senior medical officer and registrar posts are being creatively used by some provinces to place them, with salary adjustments built in. Clinical associates have no such luxury.
Naledi says she suspects that healthcare delivery leaders in individual provinces have widely differing views on how to use family physicians, with commensurately differing patient care outcomes. She says the grading of healthcare facilities by the Office for Healthcare Standards Compliance eloquently illustrates an overemphasis on curative service-based funding, with lower-level primary healthcare facilities scoring worst, followed by secondary or district hospitals with tertiary hospitals scoring the highest. Unless this changes, she says “we will continue failing to get bang for buck”.
She adds: “If you look at the district health system, it doesn’t have the full cadre of staff. I mean palliative care, mental health, dental services – these are all structural and broader resource issues for me. You can’t look at family medicine in isolation.”
The argument is that building more capacity for prevention and health promotion would begin to dismantle a self-perpetuating cycle of predominantly curative services. Family medicine training, Naledi says, focuses a lot more on the social determinants of health, prevention, rehabilitation, and palliative care. “It’s not just about clinical abilities but about them being family and community doctors,” she adds.
In June, we heard what could be this year’s biggest HIV breakthrough: a twice-yearly injection can prevent HIV infection. Findings from a second large study of the jab has now confirmed that it works. Elri Voigt goes over the new findings and unpacks the licenses that are expected to facilitate the availability of generic versions of the jab in over a hundred countries, including South Africa.
The second of two pivotal studies of a six-monthly HIV prevention injection containing the antiretroviral drug lenacapavir has confirmed that the jab works remarkably well.
The first study, called PURPOSE 1, found that the jab is safe and highly effective at preventing HIV infection in women. The second, called PURPOSE 2, found the same for cisgender men, transgender men, transgender women and non-binary people who have sex with men assigned male at birth.
Interim findings from PURPOSE 2 were presented last week at the HIV Research for Prevention (HIVR4P) conference in Lima, Peru.
The researchers compared the safety and efficacy of lenacapavir injections every six months to a daily HIV prevention pill – a combination of emtricitabine and tenofovir disoproxil fumarate, called F/TDF. The results have not yet been published in a peer reviewed journal, but is expected to be soon, according to Principal Investigator for PURPOSE 2 Dr Colleen Kelley, a professor of medicine at Emory University’s School of Medicine.
In the PURPOSE 1 study, none of the 2 134 people receiving the lenacapavir injection got HIV during the study. In PURPOSE 2, there were two HIV infections among the 2 179 people receiving the injection. These numbers are dramatically better than those for HIV prevention pills and for people in the communities where the study was done who were not receiving prevention injections or pills.
These findings mean the evidence is now in place for the manufacturer, Gilead Sciences, to file with regulatory authorities to register lenacapavir injections for HIV prevention. Such registration is required before the jab can be marketed for prevention. Lenacapavir injections are already registered in some countries as a last resort treatment for HIV, but not yet in South Africa.
“Now that we have a comprehensive dataset across multiple study populations, Gilead will work urgently with regulatory, government, public health and community partners to ensure that, if approved, we can deliver twice-yearly lenacapavir for PrEP worldwide, for all those who want or need PrEP,” Daniel O’Day, the chairperson and Chief Executive Officer of Gilead said in a press release. (PrEP, or pre-exposure prophylaxis, refers to taking antiretrovirals to prevent HIV infection.)
Top line findings
The interim results presented at HIVR4P by Kelley, showed that when compared to the background HIV incidence calculated in the study, lenacapavir reduced HIV infections by 96%. And when compared to the F/TDF prevention pill, the injection reduced HIV infections by 89%.
Among the 3 265 participants enrolled in the study, 11 people acquired HIV- two of the 2 179 people who were assigned to the lenacapavir arm and nine of the 1 086 participants assigned to the prevention pill arm. This translated to HIV incidence of 0.93 per 100 person years in the prevention pill arm compared to only 0.1 per 100 person years in the lenacapavir arm.
This was compared to the background incidence, which was determined when screening eligible participants for HIV. Out of 4 634 people screened for the study, 378 or 8.2% were diagnosed with HIV. Based on further laboratory testing, it was estimated that of those 378 people, 45 or 11.9% recently acquired HIV (classified as being within the last 120 days or so). This latter group provided the background HIV incidence, which was estimated to be 2.37 per 100 person years.
This is a novel study design, Kelley told Spotlight, because this calculation was used to estimate the HIV incidence that would have occurred in a placebo group without actually enrolling a placebo group.
“It’s no longer ethical to have a placebo group in HIV PrEP trials because we know that we have effective PrEP agents,” she said. “Yet, it’s almost essential to have a placebo group when you design a clinical trial so that you can really say how effective your medication, your new agent is [compared] to having nothing.”
When asked at a press conference about the two breakthrough infections in the lenacapavir arm, Kelley said the analysis for this is ongoing and will hopefully be available at a future conference and in a journal soon. She said that the two breakthrough infections in the lenacapavir arm were detected by routine testing during the study.
Principal Investigator for PURPOSE 2 Professor Colleen Kelley at the 5th HIV Research for Prevention Conference in Lima, Peru. (Photo: Nicole Bergman/IAS)
Kelley added that around 90% of participants in the two study arms were able to receive their injection on time. “So, we at least know that the injections were delivered in a timely fashion for almost all participants,” she said.
Whether or not the two infections occurred in people who had received the jabs on time and according to the study protocol will be closely watched as more study details is shared in the coming months.
To be enrolled in the study, participants had to meet several criteria. They had to be older than 16, never received HIV prevention injections before, weigh more than 35kg, have good kidney function, not have been tested for HIV in the last 12 weeks, and had to have been sexually active in the last 12 months.
All study participants were given a pill a day and an injection, those in the lenacapavir arm received two 1.5 ml lenacapavir injections every six months and a daily placebo pill, while those in the prevention pill arm received the daily F/TDF pill and a placebo injection every six months.
The study was conducted across seven countries, with 6 sites located in South Africa and others in Argentina, Brazil, Mexico, Peru, Thailand, and the United States, according to study data on Gilead’s website.
Safety data
Overall, Kelley said lenacapavir was safe and well-tolerated despite some side effects, mainly related to the injections. A total of 43 people dropped out of the study due to side effects.
The most common adverse event in the study was injection site reactions. There were more injection site reactions in the lenacapavir arm compared to the prevention pill arm. 29 people dropped out of the study because of these, 26 in the lenacapavir arm and 3 in the prevention pill arm (people in this study arm received placebo jabs).
The most common injection site reaction were subcutaneous nodules – these are harmless, usually invisible, small lumps under the skin. Nodules occur because lenacapavir is injected under the skin where it forms a drug depot. Injection site reactions and nodule size decreased with subsequent injections. This side effect and trend of decreasing reactions was also noted in the PURPOSE 1 study. Other injection site reactions were pain and erythema which is a type of skin rash.
According to Kelley, there were no serious adverse events related to injection site reactions.
When injection site reactions are excluded, according to Kelley, the other adverse events were similar across both arms, with 74% of participants in each arm experiencing an adverse event. The majority were mild or moderate.
Seven participants in each study arm dropped out due to side effects that weren’t related to injection site reactions. Those who discontinued from the lenacapavir arm will be given prevention pills for a year. This is done to protect these participants, Kelley explained, from potentially acquiring HIV when lenacapavir levels wane, as well as to reduce the risk of potential drug resistance developing.
There were a few serious adverse events, although Kelley told Spotlight she does not currently have any additional information on what these were. She explained that a serious adverse event is generally classified as something like hospitalisation, a life-threatening condition, an important medical event or adverse pregnancy outcome.
“Usually when we look at something like this, we look at the rates compared in the two arms of the study and it was 3% in the LEN [lenacapavir] arm and 4% in the F/TDF arm, so they were equal, essentially the same in both study arms,” Kelly said.
There were six deaths during the study, but none were related to the study drugs.
Next steps for lenacapavir
Now that the interim results have been announced, both studies have been unblinded and entered an open-label phase where participants have the choice of switching to or continuing with the injection.
Professor Linda-Gail Bekker, the Chief Executive Officer at the Desmond Tutu Health Foundation, recently said on a webinar hosted by the South African Health Technologies Advocacy Coalition, that study participants are now able to use the PrEP option they’d prefer – either oral PrEP or the injection. This means all participants will be able to access lenacapavir through the studies if they wanted to use it.
But it will likely be a while before anyone outside of these studies can access lenacapavir as HIV prevention.
“This is an incredible intervention. Now we have to make sure everyone can get it and that’s going to be the most important next step, ensuring that everyone who needs this drug has access,” Kelley told Spotlight.
Gilead’s generic licensing agreement and pricing
What we do know so far about the next steps for lenacapavir is that the process to allow for generic manufacturing has started. This month, Gilead released its voluntary licensing agreements with six generic companies for manufacturing cheaper versions of lenacapavir.
Dr Andrew Gray, a senior lecturer in Pharmacology at the University of KwaZulu-Natal, told Spotlight that no South African firms have been included in the voluntary licenses – four of the generic licensees are in India, one is in Pakistan, and one is in Egypt.
“In essence, they [the generic companies] are allowed to sell their generic versions in a number of identified countries, specified by Gilead,” Gray said. The agreement lists 120 countries, including South Africa.
Gilead itself will also be prioritising the registration of lenacapavir in 18 countries, which it said represent about 70% of the HIV burden in the countries named in the license. The list includes South Africa, Uganda, and Botswana. Gilead says it will start filing for registration with regulatory authorities by the end of the year.
It will be important to see how quickly Gilead seeks regulatory approval for lenacapavir with the South African Health Products Regulatory Authority (SAHPRA), Gray said. Registration with SAHPRA will be required before the injection can be rolled out in South Africa.
In putting together this timeline, we’ve spoken to several well-placed experts, but we stress that this is very much a back-of-the-envelope exercise and far from set in stone. (Infograph: Spotlight)
Some countries won’t be able to procure generics
Gilead received criticism for several omissions from the list of countries that the generic manufacturers can sell to. The US-based HIV advocacy group AIDS Vaccine Advocacy Coalition, among others, pointed out the exclusion of several countries which have high HIV incidence. Some of those countries participated in PURPOSE 2- namely Brazil, Argentina, Mexico and Peru.
A spokesperson from Gilead told Spotlight the manufacturer’s access policy included tailored approaches to ensure rapid and broad access of lenacapavir and it objectively considered the countries where a voluntary licence would provide the most benefit.
“Gilead’s voluntary licence primarily covers countries based on economic need and HIV burden, which are primarily low- and lower-middle income countries. The voluntary licence also covers certain middle-income countries with limited access to healthcare,” the spokesperson said.
Acknowledging that some middle-income countries do have a high HIV burden, Gilead is “exploring several innovative strategies to support access to LEN for PrEP (if approved), including tiered pricing, and are working with payors to establish fast, efficient pathways to help reach people who need or want PrEP”, said the spokesperson.
“Ensuring access in middle-income and upper-middle income countries, including those in Latin America, is a priority for Gilead. Planning for these countries, incorporating input from advocates and global health organizations, is ongoing and updates will be shared as discussions progress,” the spokesperson added. “Additionally, Gilead is committed to ensuring that individuals who participated in the PURPOSE studies have been offered and will be able to stay on open label lenacapavir until it is available in their country.”
The company’s decision to license generic manufacturers directly is at odds with earlier calls from several activist groups and UNAIDS to license via the UN-backed Medicines Patent Pool.
Pricing
It will also be important to see if Gilead will disclose a single exit price for the South African market, according to Gray.
In its press release announcing the voluntary licensing agreement, Gilead stated it will “support low-cost access to the drug in high-incidence, resource-limited countries through a two-part strategy: establishing a robust voluntary licensing program and planning to provide Gilead-supplied product at no profit to Gilead until generic manufacturers are able to fully support demand”.
It is too early in the process to reveal a price for lenacapavir yet, the spokesperson from Gilead told Spotlight.
“While Gilead prepares for global regulatory filings, it is too early to disclose the price of lenacapavir for HIV prevention. Our pledge is to price our medicines to reflect the value they deliver to people, patients, healthcare systems and society. For Gilead-branded lenacapavir, we do plan to price it at no profit to Gilead in 18 select high-incidence, resource-limited countries until generic manufacturers are able to fully support demand,” the spokesperson said.
Spotlight previously reported on research that estimated that if produced at sufficient volumes, the price of lenacapavir could be drastically reduced to levels likely considered affordable by the South African government. For instance, if enough volume was produced to supply 10 million people with PrEP, the price for the injection could be as low as $40 (under R800) per person per year. At the moment, Gilead supplies lenacapavir for HIV treatment in wealthy countries for about $40 000 per person per year.
Gilead’s lenacapavir product will be the first to register in South Africa and will almost certainly be the only lenacapavir product available here for several years – that is because it is expected to take generic manufacturers a few years before they can start producing generic lenacapavir. Based on calculations made for other PrEP products, it seems unlikely that the Department of Health would be willing to procure lenacapavir at a price significantly above R1 000 per person per year. The HIV prevention pill currently costs government around R800 per person per year.
The National Health Insurance Act does not deal with the systemic issues that cause high prices and inequity in medicine access, and government is not listening, argues Fatima Hassan.
As the department of health lunges forward with implementing a system of National Health Insurance (NHI), with business and other interests trying to thwart that, what lessons from the COVID-19 pandemic can help us to ensure health equity for all – for both users of the public and private health sectors?
A few key themes come to mind: market power, secrecy, transparency, accountability, timely access, and affordability.
COVID’s lessons
The human cost of COVID-19 globally was at least fourteen million people who died in just two years. In South Africa, COVID was the leading cause of death in 2020 and 2021, outstripping deaths due to other diseases in those years.
To mitigate the COVID pandemic and to move forward, we needed vaccines. Then, the creed of intellectual property fundamentalism preached to us by the ultra-wealthy and by pharmaceutical corporations was to tell us to monopolise and privatise the manufacture and supply of publicly created vaccines and medicines, while relying on voluntary market measures – not effective regulation or compulsory measures – to ensure access. That creed failed us.
At the time, agreements with private manufacturers for the supply of vaccines were entered into, and at the request of a very powerful industry, treated as a secret. The Health Justice Initiative (HJI) litigated to compel disclosure, and we won.
Our analysis showed a set of one-sided terms, including conditions that required Non-Disclosure Agreements with significant advance payments without legal obligations on suppliers in terms of delivery volumes or dates. The contracts provided sweeping indemnity terms, limits on international redistribution/donations, and overly broad intellectual property protections. We also found that in several instances, South Africa overpaid for vaccines compared to higher middle income countries.
Where we live
We live in a country with worsening health outcomes, a high burden of HIV and TB, and alarmingly high levels of gender-based violence.
Politically, we have had multiple health ministers in the space of just five years – even during a pandemic – due in part to corruption allegations and now, a new Government of National Unity (GNU). We have an unaccountable rotating door system for appointing ministers, deputy ministers, and health Portfolio Committee members, seriously blurring the Legislature’s oversight function. This is not good governance.
We have outstanding laws and regulations that could address some of the “now” issues but which are not being prioritised. For example, we are still subject to an apartheid-era Patent Law that is deferential to patent seekers, resulting in over patenting or evergreening. Vested interests, we believe, are blocking key amendments that would limit patent protection in favour of the public interest.
We do not have a robust local, properly state-subsidised health manufacturing industry in South Africa, often making us reliant on external manufacturers. We have xenophobia seeping into our health system, where patients have been attacked in state hospitals because of their nationality.
And on top of all of that, we have growing reports not just of provincial health product stockouts but also reports of widespread health sector tender corruption, and targeted assassinations of whistleblowers. Finally, given, among other things, our outdated patent system and inability to reign in medicine prices, our medicine costs are astronomical, needlessly (even when compared to other BRICS countries).
The NHI as the GNU’s test (and ours)
It is in this context, that even before the 2024 national elections, NHI has become a lightning rod of disagreement even within the GNU, including for business, creating a hostile climate for civic engagement. Sadly, the political gamesmanship over NHI especially at the Executive level, is coming across as unaccountable, arrogant, and non-engaging. This will not build our health system. In this debate, government has rarely admitted it made any mistakes so that is why it was surprising that in a recent Bhekisisa interview, the health minister conceded that restricting NHI basic health services (so non-emergency care) to South African ID holders may be self-defeating for public health. He said that that is a “mistake” that needs to be “rectified” in the NHI Act.
NHI and state-led procurement
The NHI Act envisages a single state procurement entity for all health products for NHI users (as selected by a benefits committee). In theory, this should provide greater negotiating power and leverage.
With the lessons of COVID and more recently Mpox, we can expect that may not be so. Even under NHI, there will be a scramble for much needed supplies, where South Africa will have to compete on the international market for often scarce and high priced supplies.
Thus, addressing the pharmaceutical industry’s power, and by virtue of that, the global and local medicine patent (reward) system and its abuse matters – but we need to do it now, not incrementally or at some later or undefined point.
For the NHI to financially sustain itself (and assuming here for a moment that it has sufficient funds to begin with), it will have to either overthrow or better regulate the current medicine over-patenting and pricing transparency system to survive, failing which, NHI money could dry up just on health products and medicine costs alone.
At present, South Africa on average pays more for medicines than comparator countries. Business is eerily silent about this aspect in its critique of NHI. Since medical schemes will continue to operate under NHI for some time, one would expect greater concern about the disproportionate use of scheme members’ resources in this respect too, from business.
On top of this, under an apartheid era drafted law (the Patents Act), South Africa is still also doling out patents allowing companies to evergreen their patents on several essential medicines including for TB and HIV, and cancer with limited regulatory and legal repercussions.
While the HJI vaccine procurement judgment should be having far-reaching implications, not just for the next set of pandemic procurement negotiations, but also for substantial state-led procurement due to take place under NHI, we would be naïve to think that the industry and powerful global and local actors in the pharmaceutical sector will change its ways for the better just because South Africa is implementing NHI.
The NHI, we are told, will be based on the principles of “universality and social solidarity” and will “unify” our health system. Yet, if we focus on just one aspect included in the Act – the medicine access system – it is a far cry from the promised system of unification. This is because it is drafted in a way that by our count and reading, creates at least four medicine access systems, operating in parallel (NHI for NHI users; Medical Schemes for scheme beneficiaries – while schemes are permitted to operate under NHI (could be decades); complementary cover via insurance coverage for NHI users; over the counter via out of pocket payments/insurance coverage for non-NHI users such as foreign workers, foreign students, resident non-nationals, etc.).
Either way, for all of its admirable “equity” intent, NHI in South Africa will be fully dependent on the global medicines access market whether we like it or not because we are not operating in a neutral, access friendly global system. Nor are we operating in a context where the executive has any real, public, and committed plan to drive down medicine prices before or while NHI is implemented – and without business interests interfering in the execution – it is leaving that totally to the market, to whimsical unenforceable donations and voluntary business conduct. That is not sustainable.
The President is fully aware of how the latter affected our vaccine access and procurement strategy and costs in the COVID-19 pandemic. What is he going to do about it?
NHI and “top-ups”
Under NHI, the Act will allow top-up products and complementary cover via insurance offerings to presumably fill the gap for those health products, services or medicines that the state may not select or include in the NHI Formulary because of affordability constraints. So how will those complementary cover products and medicines be priced and regulated? Will the current imperfect and expensive system, called the Single Exit Price System, for non-state medicines be used?
Imperfect, because in South Africa, public sector medicines prices are largely determined by the bids companies submit in response to advertised government tenders. In the private sector, companies are free to launch a medicine at any price, although once launched, annual price increases are regulated – so that every drug in the private sector has a single exit price. In rare cases, excessively high medicine prices have been challenged using competition law, but this is the exception.
There have been moves toward reference pricing – where maximum prices for specific medicines would be determined by reference to prices for that medicine in a basket of other comparable countries – but none of several rounds of regulations proposing such a system have been implemented, mainly because pharmaceutical companies usually litigate against the state to prevent it from implementing such a comparator system – in other words, like elsewhere, while we face exorbitant medicine costs, we also face powerful corporate lobbies that do not want proper transparent systems for setting medicines prices. This only serves a profiteering agenda.
NHI and medicine access questions
Just on the narrow point of medicine access under NHI there are critical issues that need to be clarified. They include the following:
Whether we can be guaranteed transparency and information, including about the deliberations of the various NHI ministerial advisory, benefit and selection committees, and procurement structures under the NHI – or will we have to litigate every access to information request, as we did in COVID?
How will the NHI Fund (Office of Health Products Procurement) negotiate with the global pharmaceutical industry without, for example, the bullying we witnessed in the COVID-19 pandemic?
And specifically for medicines and health products:
Will manufacturers be permitted to sell to health providers other than the state? If so, how will this be done, and how will the maximum price be determined or regulated?
Which medicines and health products will be covered under NHI benefits as part of the NHI Formulary and how will the price of those not covered (top-ups/complementary cover) be regulated?
What role will the current private sector pricing system play including the single exit price system – and how and when will it be amended?
As our country pushes ahead with the NHI, there are some immediate concerns like these that we believe will affect implementation.
Of course, we all support the vision of a unified, equitable health system. But aspirations aside, the NHI Act does not deal with the systemic issues that cause high prices and inequity in access. Instead of investing effort into systems that control prices better at the outset, it is investing in systems to deal with the consequences of unaffordable drugs, hoping for self-correction, all while deferring to powerful vested interests including business lobbies that have the President on speed dial.
Regulatory bodies and civil society actors can only take on the tip of the medicine pricing iceberg – the question to the President is, while the Executive dithers on amending keys laws including the Patents Act, under NHI: who exactly will fight for every single patient and for every single medicine?
Since the NHI Bill was signed into law, the President (and his Cabinet) are now duty bound to take constitutional steps to remedy the deficiencies in the NHI Act, and at the very least, to listen to all sectors, not just business.
*Hassan is director of the Health Justice Initiative. This piece is drawn from her key note address at the 2024 Annual David Sanders Lecture in Public Health and Social Justice hosted by the University of Western Cape’s School of Public Health and Peoples Health Movement 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.
The South African Health Products Regulatory Authority (SAHPRA) and the Australian Therapeutic Goods Administration (TGA) have signed a Memorandum of Understanding (MoU), which will strengthen collaboration between the two health product regulators.
The MoU builds on the existing relationship between the health products regulators to improve capabilities in the assessment of medical products and therapeutic goods and their monitoring for continued efficacy, safety and quality once they are registered.
Areas of cooperation
SAHPRA and TGA will engage in data sharing aimed at improving the regulatory functions executed by both regulators. This will particularly focus on the assessment and approval of medical products and therapeutic goods, their monitoring for continued efficacy, and the surveillance for safety and adverse reaction (event) concerns.
According to SAHPRA’s Chief Executive Officer, Dr Boitumelo Semete-Makokotlela, the agreement with the TGA expands the geographical reach for both regulators’ pharmacovigilance programmes and augments their internal expertise.
“This partnership enables us to rely on each other’s strengths and regulatory outputs in the evaluation of health products both before they are registered and once they are approved for public use. This would improve therapeutic outcomes for the populations we exist for and increase the robustness of our post-registration surveillance for efficacy, safety and quality,” says Dr Semete-Makokotlela.
Deputy Secretary at the Australian Government Department of Health and Aged Care and head of the TGA, Professor Anthony Lawler, said: “TGA is very pleased to have strengthened our collaborative relationship with SAHPRA with the signing of this international agreement. We look forward to working alongside our regulatory counterparts in South Africa to share important regulatory information to ensure the continued safety, quality and efficacy of therapeutic products approved for market.”
