Tag: Spotlight

Categories : Medical Industry Respiratory DiseasesTags :

Pretoria Company Aims to Lead SA in Making Key TB Drug Ingredients

On By ModernMedia
Source: Unsplash CC0

By Catherine Tomlinson

Though several South African companies are producing HIV and TB medicines, the active ingredients that go into these medicines are usually imported from India or China. Now, a local company is planning to break new ground by making the active ingredients for two important TB medicines in Pretoria. We zoom in on the company’s efforts and outline some of the obstacles to getting such local production off the ground.

South Africa has a relatively robust pharmaceutical sector. Approximately 60% of the medicines sold in South Africa are locally produced, according to Dr Senelisiwe Ntsele, writing in an opinion piece for the Department of Trade, Industry and Competition (dtic).

But most of the time we are not producing these medicines from scratch. In fact, like most countries in the world, we mostly import the ingredients that make the medicines work – commonly referred to as active pharmaceutical ingredients, or APIs. In addition to APIs, medicines contain other inactive substances that maintain their form and structure and assist in their delivery: such as binders, stabilisers, and disintegrants.

Around 98% of the APIs used in locally formulated medicines are imported and South Africa spends around R15 billion a year importing APIs, according to Ntsele.

Government has tried to address South Africa’s dependence on imported APIs as part of its broader strategy to bolster the local pharmaceutical industry, which is identified as a priority sector for investment in the country’s Industrial Policy Action Plan. Several government departments provide support to the local pharmaceutical sector, including for local establishment of API manufacturing capacity. These departments include the dtic, the Department of Science and Innovation (DSI), the Technology Innovation Agency (TIA), and the Industrial Development Corporation (IDC) – South Africa’s development finance instrument.

In a bid to reduce the country’s reliance on imported APIs, Ketlaphela – a state-owned API manufacturing company – was announced in 2012. The plan was that Ketlaphela would produce APIs used in HIV medicines, but after multiple setbacks the initiative never got off the ground. Spotlight reported on the history of Ketlaphela in more detail here.

Turning to the private sector

Less well known than Ketlaphela, are government’s efforts to support API manufacturing capacity in the private sector. One private company that has received such government support and seem set to start delivering is Pretoria-based Chemical Process Technologies Pharma (CPT Pharma) that was established in 2014.

CPT Pharma is a subsidiary of Chemical Process Technologies, a company with many years of experience in chemical manufacturing and synthesis, including manufacturing of APIs for animal medicines. Human medicines, CPT Pharma’s core business, have stricter production management and quality control standards than those for animal medicines.

Dr Hannes Malan, Managing Director of CPT Pharma, told Spotlight that the company has 14 APIs in its pipeline, with a strong focus on TB medicines.

CCPT Pharma is a subsidiary of Chemical Process Technologies. (Photo: Supplied)

In 2023, the company secured a license from USAID to produce API for rifapentine, a drug widely used for TB prevention, and in 2022 they secured a licence from the Medicines Patent Pool to produce API for molnupiravir, a treatment for COVID-19. Malan pointed out that these two licenses were agreed with organisations aiming to expand the presence of API manufacturers in Africa – unlike typical arrangements driven by pharmaceutical companies looking to secure their own supply chains.

“For all the other APIs that we’re working on [beyond molnupiravir and rifapentine], we’re either working on technical packs [technical information about the API] that were available in the public domain or technologies that we’ve developed ourselves,” said Malan.

“Our approach has always been to look at the molecules, look at the market value, look at the technology, and then see if there’s an opportunity for us to develop technology that allows us to produce these compounds cost competitively,” he said.

“We really believe that to be competitive and independent, you have to have your own technology. Doing a technology transfer from Big Pharma does not make you independent,” Malan added.

How to fund it all?

In 2017, the company completed a pilot plant for making APIs. Then in 2020 it received approval from the South African Health Products Regulatory Authority (SAHPRA) to produce APIs for human use. The plant was built for R50 million, funded jointly by the IDC, TIA, and CPT Pharma.

Malan said that that the IDC and TIA also supported trial runs to test CPT Pharma’s manufacturing processes and technology. These tests included several APIs in development, such as isoniazid, a drug commonly used to prevent and treat TB.

The company has also secured funding from several international donors. The Gates Foundation provided support to develop manufacturing technology for the anti-malarial drug amodiaquine, as well as tuberculosis medicines bedaquiline and pretomanid. GIZ, a German development agency involved in a European Union project to boost vaccine and health product production in Africa, supported the company’s work on molnupiravir and dolutegravir – a widely used HIV medicine. USAID and the DSI are supporting the company’s work on developing rifapentine API manufacturing capacity.

Most of this financial support has been in the form of grants.

Still building new plants

While CPT Pharma has secured local and international funding to help construct a pilot plant and to develop its API manufacturing technology and processes, Malan said more investment is needed to support the construction of two commercial-scale manufacturing facilities: an isoniazid API manufacturing plant and a multiple API manufacturing facility.

Construction of the isoniazid manufacturing plant has already commenced using existing land and infrastructure with support from the IDC, but it is short of around R20 million to complete it, said Malan.

Although the plant is not yet operational, he said a company has already expressed interest in buying CPT Pharma’s locally produced isoniazid API. This company, said Malan, is contracted to supply isoniazid to government. The plan is to initially supply the company with isoniazid API produced at its pilot plant

Malan said the commercial plant, when built, will be able to manufacture enough isoniazid API to supply around 60% of local demand.

Things are less far down the road with plans for a plant to produce multiple different APIs at commercial scale, and more work is needed to understand the financing requirements for this type of facility, said Malan. “We want to do a bankable study and a concept design for such a plant,” he said. Based on CPT Pharma’s own experience, published data, and the required complexity and capacity of the plant, Malan said it is estimated that construction for the multi-API plant will cost around US$100 million or R1.8 billion.

Plans to commercialise

Meanwhile, the company is moving forward with plans to commercialise isoniazid and rifapentine API from its pilot plant. Isoniazid and rifapentine is increasingly used together as TB preventive therapy.

“For rifapentine, our pilot plant is seen as the commercial plant,” said Malan. “At this stage, we can use the pilot facility and the pilot reactor to produce enough rifapentine to get into the market and to grow the market.” But in the long term he said the company hopes to transfer rifapentine manufacturing to a larger commercial plant.

The company is also planning to apply for World Health Organization (WHO) pre-qualification status for its rifapetine API. The goal is to conduct demonstration runs in the pilot plant by June 2025 and validate the WHO pre-qualification application in September 2025.

If achieved, WHO pre-qualification of CPT Pharma’s rifapetine API would show that the company’s APIs meet high-quality standards. It would also allow CPT Pharma to supply rifapentine API to companies producing medicines for the broader African market, for which a significant proportion of medicines are procured by donors requiring WHO PQ approval.

Note: The Gates Foundation is mentioned in this article. Spotlight receives funding from the Gates Foundation. Spotlight 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.

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Categories : Ethics and LawTags :

Critics Raise Alarm over Leadership Issues at Gauteng Health Department

On By ModernMedia
Nomantu Nkomo-Ralehoko is the MEC for Health and Wellness in Gauteng. (Photo: GautengHealth/X)

Several opposition politicians and commentators have flagged what appears to be chronic leadership problems at the Gauteng Department of Health.

Criticism of leadership and governance at the Gauteng Department of Health (GDOH) is amping up as the department repeatedly makes headlines for questionable appointments. This unfolds alongside a damning auditor-general report, all while hospitals and clinics across the province grapple with ongoing challenges.

Arguably, the most controversial appointment is that of Arnold Malotana. He was quietly named head of department shortly after the May 29 national elections, following a year of serving in an acting capacity. Malotana has been with the department in various positions since 2008, according to his LinkedIn profile.

SIU investigation

Malotana has been implicated in a case being investigated by the Special Investigating Unit (SIU). It relates to the alleged manipulation of supply chain processes in 2016 and 2017 in favour of a company called BAS Medxpress (BAS Med). It has been alleged that Malotana and two senior officials – Edgar Motha and Sheriff Lecholo – took bribes to the tune of R8 million. The case made headlines a year and a half ago when amaBhungane lifted the lid on an affidavit from a whistleblower, who himself was part of the alleged tender-rigging scheme. The SIU investigation was however only ordered by presidential proclamation this November. According to amaBhungane’s reporting last year, all those implicated in the matter have denied wrong-doing.

SIU spokesperson Kaizer Kganyago said the probe will focus on two supply contracts – one for plastic containers and another for orthopaedic instruments – to determine if any actions broke laws, policies, or Treasury or health department rules, and whether they may be fraudulent.

“Such conduct may include manipulation of the department’s supply chain management processes by service providers, suppliers, officials, or other third parties, often in collusion with departmental employees or those in entities under its control, to secure undue benefits for themselves or others. This can result in unauthorised, irregular, or fruitless and wasteful expenditure incurred by the department, its entities or the State,” he said in a statement.

Questions over qualifications

Malotana has also been under separate investigation regarding his qualifications when his appointment as head of department was made. His LinkedIn profile lists his education as two years (2013 – 2014) at the Durban Institute of Technology and a master’s degree in public management from Regenesys Business School, with no dates provided.

Earlier this year, Jack Bloom, a DA member in the provincial legislature, wrote to the Public Protector to ask that they investigate Malotana’s appointment. Public Protector passed the matter to Parliament’s Portfolio Committee for Public Service and Administration. In turn, the committee chair requested the Public Service Commission (PSC) to investigate.

In mid-November, the PSC “reportedly” cleared Malotana on the allegations relating to his qualifications and appointment. The PSC report was leaked to The Star newspaper with the complainants – the DA – as well as the portfolio committee chairperson not yet having had sight of the report. Spotlight also hasn’t yet been able to access a copy.

According to The Star, the PSC found that a master’s degree was not explicitly listed as a required qualification, and as a result, the commission found that Malotana did meet the requirements.

Bloom told Spotlight: “It’s highly irregular that the PSC report is leaked to a specific newspaper.”

Meanwhile, the SIU investigation continues, and the DA has reiterated its call for Gauteng Premier Panyaza Lesufi to remove Malotana from his post. Heads of departments are appointed by provincial premiers.

The Office of the Premier did not answer Spotlight’s questions about Malotana or the SIU investigation. However, according to a statement from the DA, Lesufi said in a Gauteng Legislature meeting last week that he would wait for the SIU investigation to be completed before taking any action against Malotana.

Millions spent on suspended staff

In September, responses to questions posed by Bloom in the Gauteng Legislature revealed that the provincial health department spent over R13 million on salaries for nine suspended staffers in recent years. Among these were Advocate Mpelegeng Lebeloane, former chief director of legal services, who received R4.7 million while on suspension from July 2019 until 2023. He was later reinstated and then retired in July 2024.

Bloom said in a statement at the time: “Three senior staff were suspended since 26 January 2022 for alleged financial misconduct concerning the refurbishment of the Anglo Ashanti Hospital. One has recently resigned, but more than R6 million has been spent so far on their salaries in this inexcusably long-running matter.”

The other staff members had been suspended on a range of charges, including sexual assault, assault and a job-selling scam.

Bloom said the long delays in concluding disciplinary processes smacked of a failure of accountability and were a drain on taxpayers’ monies and resources.

Spotlight put questions to the health department about its mechanisms and processes to ensure efficient and appropriate disciplinary action. The department’s spokesperson Motalatale Modiba said the cases in question “cut across various departments”. He added: “The employees were suspended with full pay and the delays mainly had to do with ongoing SIU investigations.” This includes cases that were “handled through the Office of the Premier”.

Hospital CEOs

Also on Bloom’s radar are the appointments of Dr Nthabiseng Makgana, Dr Lehlohonolo Majake, and Dr Godfrey Mbara to positions of CEOs of Chris Hani Baragwanath, Steve Biko and George Mukhari academic hospitals respectively.

The appointments were made in March, and health MEC Nomantu Nkomo-Ralehoko responded to Bloom’s questions about them in October. Bloom highlighted irregularities, noting that none of the three appointees met the requirement of 8 to 10 years of experience for hospital CEO roles, while one also didn’t have the required education qualification level. These are contraventions of regulations, according to Bloom, adding that he is still to see proof of qualifications, as he’s requested.

Another high-profile appointment under scrutiny has been the redeployment of Dr Nozuko Makabayi – the former CEO of the Rahima Moosa Mother and Child Hospital. A doctor’s open letter in June 2022 exposed poor conditions at the hospital, leading to a Health Ombud investigation. The damning report criticised Makabayi for several failings, including being absent from work for nearly 100 days without explanation. The Ombud recommended that Mkabayi be removed as CEO, but she was shifted within the department to serve as acting director responsible for HIV and Aids, STIs and TB.

Bloom’s follow-up questions to Nkomo-Ralehoko brought to light that Makabayi has not been reporting for work, due to mental health stress, but continues to receive her salary. “This is outrageous. After all the trouble she caused, she is now on a long running paid holiday at taxpayers’ expense. If she can’t do any useful job, she should be medically boarded and leave the department,” he said in October.

“There has not been a permanent HR director for years in the department and the systems of appointments follow a consistent pattern of people placed in acting positions, protecting interests, and ensuring cadre deployment rather than service delivery,” Bloom told Spotlight.

“We have the wrong people in these key positions by design. We are talking about control, looting and siphoning of one of the largest budgets in the province,” he alleged.

Modiba said that “relevant bodies are investigating” and pertaining specifically to Makabayi, he said “internal processes are unfolding” but cannot be released to the media because of an “employer-employee clause”.

Scathing Auditor General report

Recently, the Gauteng Department of Health received another scathing report from the Auditor-General for the 2023/24 financial year.

The department underspent by R1.1 billion, including R590 million underspent on the National Tertiary Service Grant intended for specialised medical treatment. This in spite of backlogs and long patient waiting lists. In addition, the report showed that the health department racked up R2.7 billion in irregular spending, R17 million in wasteful spending, and lost another R2.7 billion in income.

Action SA member in the provincial legislature Emma More described the performance of the department as “clearly lacking effective leadership and management”.

She slammed the health department for providing incorrect and misleading statistics, as highlighted by the auditor-general. “For an institution like the [Gauteng] Health Department to provide such misleading information undermines public confidence in it and compromises the lives of our citizens in this province,” More said. “It is unacceptable that while our healthcare facilities are under-resourced and struggling to meet the needs of the population, significant portions of the budget are being wasted or mismanaged.”

Responding to More’s comments,  Modiba said that the department had spent 98.9% of its budget allocated for 2023/2024. He said that of the 1.1% (R1.1 billion) under expenditure,  R580 million has already been provisionally approved by Treasury to be carried over to the current fiscal year, subject to audited financial statements.

“While the department aims to spend every allocated cent, achieving this goal is not always feasible due to various factors impacting the operational environment. For instance, some of the money was committed to purchase orders or invoices that could not be processed within the previous financial year leading to a rollover of funds. The amount covers grants for human resource training, national tertiary services, district health programmes and the national health insurance,” Modiba said.

A ‘structural’ problem

Professor Alex van den Heever, chair of social security systems administration and management Studies at Wits University’s School of Governance, said the health department’s leadership crisis at its core is a structural one.

“South Africa has a huge pool of talent, and we are not short on good managers or people who understand health, and how to run a health service – but these are exactly the people the [Gauteng] department of health don’t want,” he said.

“Why would they want a Babita Deokaran [an acting chief financial officer who was assassinated in August 2021 after flagging what appeared to be corruption at Tembisa Hospital] or someone who is actually going to root out the nonsense or someone who is going to properly manage patient care?” Van den Heever asked.

Describing the department’s leadership as an “hourglass model”, Van den Heever said at the top are leaders with all the power, but little focus is on delivery. The pressure falls on an overstressed, underfunded middle management with limited decision-making power, which then trickles down as problems for those at the bottom.

He added: “Hospitals can’t afford this kind of leadership, they fall apart. There is no strategy behind anything, so no maintenance, proper training and supervision of staff or clinical governance. Problems aren’t solved, they’re hidden.”

Spotlight questioned the department’s alleged failure to attract “fit for purpose” candidates, resulting in more leadership and governance challenges for the department that filter down to hospital and clinic level.

In response, Modiba stated that, for the first time since 2006, they have reviewed organisational structures, which have now been submitted to the Office of the Premier.

“This is a major step towards ensuring that the Gauteng Department of Health has a structure fit for purpose that is geared to meet the service needs of the growing Gauteng population. Furthermore, a service provider has been appointed for the next three years to conduct ‘personnel suitability checks’. This will assist the department in its recruitment of suitably qualified employees who will be able to contribute meaningfully towards the achievement of the organisation’s strategic objectives,” he added.

Offering a solution to fix some of the challenges crippling the health department, Van den Heever said that changing leadership structures to orient towards service delivery could mean better governance and management, improved staff motivation, renewed public confidence and ultimately better patient care. This, he said, would require the decentralisation of powers so that competent people can take charge in hospitals, make impactful decisions about appointments and budgets, and be accountable for pockets within a complex provincial health system.

Republished from Spotlight under a Creative Commons licence.

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Categories : General Interest Medical IndustryTags :

The High Cost of Having Too Few Pharmacists in SA

On By ModernMedia
Photo by National Cancer Institute on Unsplash

By Chris Bateman

It’s acknowledged in key policy documents, well known at the coalface and much ventilated in the media: South Africa’s public healthcare system has too few healthcare workers, especially medical doctors, certain specialists, and theatre nurses. Less recognised however is the shortage of public sector pharmacists. We lift the lid on this until now largely hidden problem – and its impact.

There are too few public sector pharmacy posts across South Africa to deliver a comprehensive service, with no clear staffing norms, and an uneven distribution of pharmacists, especially in rural districts. This contributes in part to medicine stockouts and the emergence of deadly hospital-acquired drug-resistant infections.

This is according to Dr Andy Gray, a senior lecturer in the Division of Pharmacology at the University of KwaZulu-Natal’s School of Health Sciences and co-head of the World Health Organization Collaborating Centre for Pharmaceutical Policy and Evidence Based Practice. His views are echoed by at least two other key local stakeholder organisations.

Flagging the alarming rise in resistance to antimicrobials – an urgent global public health threat – driven by the misuse of antibiotics in hospitals and ambulatory care, Gray told Spotlight that there are not enough pharmacists to intervene if they see inappropriate use of medicines.

“This just continues without any effort to fix it. Inadequately trained and understaffed prescribers are working under immense stress, so they are prone to use the wrong medicines at the wrong time with the wrong doses,” he said. “There are also very few microbiologists and certainly not enough pharmacists at the bedside. They’re not doing what’s necessary to ensure the proper use of medicines – for example, better control over antimicrobials.”

The excessive dependence on antibiotics has resulted in the emergence of antibiotic-resistant bacteria, commonly known as superbugs. This is called bacterial resistance or antibiotic resistance. Some bacteria are now resistant to even the most powerful antibiotics available.

South Africa has been ranked 67th out of 204 countries for deaths – adjusted by age per 100 000 people – linked to antimicrobial resistance. It has been estimated that around 9 500 deaths in the country in 2019 were directly caused by antimicrobial resistance, while 39 000 deaths were possibly related to resistant infections.

The National Department of Health warned in a background document that rising antimicrobial resistance and the slow-down of new antibiotics could make it impossible to treat common infections effectively. This could also lead to an increase in the cost of healthcare because of the need for more expensive 2nd or 3rd line antimicrobial agents, as well as a reduced quality of life.

Low numbers

Gray said that while not matching the paucity of public sector doctors and nurses, pharmacists stand at 24% of the staffing levels calculated as necessary to deliver a comprehensive service.

“We need just over 50 pharmacists per 100 000 uninsured population as a target, but we’re sitting at around 12,” he said.

Gray said the SA Pharmacy Council (SAPC) has no data on the total number of pharmacists actually working in the country, or the number working in particular settings. A SAPC spokesperson said they had only provincial statistics, but could not track pharmacist movements.

“You can’t use their database to find out how many pharmacists are working where. The Health Systems Trust SA Health Review Indicator chapter has figures of public sector pharmacists per province and per 100 000 uninsured population,” Gray pointed out.

As at February 2024, there were 16 856 pharmacists registered in South Africa, (working and not working), excluding the 971 community service pharmacists.

The 5 958 pharmacists employed in the public sector represents the full complement of funded posts, but it is well below the number needed – and varies dramatically between provinces. While almost all funded posts are filled, Gray said the number of posts is less than needed to deliver a comprehensive, quality service.

Taken across South Africa’s population of around 62 million, there are around 28 registered pharmacists (working or not working), per 100 000 people (insured and uninsured). According to data from 2016, the mean global ratio stands at 73 per 100 000.

“We’re better than many other African countries, but that’s cold comfort,” said Gray.

Increases spread unevenly

There are some positives. The number of pharmacists in the public sector has grown since 2009, rising from five to 12 per 100 000 uninsured people by 2023. However, the ratio varies markedly by district – for example: from 15 in the best-served Western Cape district to a mere three in the poorest served Northern Cape district.

Gray said the more rural districts suffer the most when it comes to understaffing of pharmacists and this contributes to medicine stockouts. While the causes of medicine stockouts are complex, one of the major contributors is the refusal of suppliers to deliver any more stock until accounts are paid.

Understaffing of pharmacists often results in nurses managing patients without any pharmaceutical oversight, Pharmaceutical Society of South Africa Executive Director, Refiloe Mogale, told Spotlight. She associates such task-shifting with medicine misuse and inappropriate prescribing, noting that while it’s a vital strategy in budget-tight environments, medication errors are on the rise. This, she argues, could be solved by ensuring appropriate pharmaceutical personnel are placed to support primary healthcare facilities – such as pharmacist assistants.

“A Primary Care Drug Therapy (PCDT) trained pharmacist can diagnose, treat, and dispense medications. So, this is not as much about task-shifting as about the pharmacist providing comprehensive care. These PCDT pharmacists can do family planning, screening for diabetes, hypertension, and other clinical tasks that take the burden off doctors. We need more of them,” she said.

‘No clear staffing norm’

Addressing the human resources quandary, Gray said the core problem had always been that the number of pharmacist posts per hospital or clinic were not evenly distributed. “There’s been no clear staffing norm. The old ‘homeland’ hospitals are likely to be under resourced with pharmacists and pharmacists’ assistants. Posts are poorly distributed and by global standards, we’re nowhere near where we should be,” he said.

The National Department of Health’s most senior pharmacy official Khadija Jamaloodien agreed that pharmacy posts should be distributed better. But she said work protocols dictate that state pharmacists must visit each clinic in their district at least once per month. She said there are 3 000 primary healthcare facilities in the country and 6 000 (albeit maldistributed) public sector pharmacists.

Nhlanhla Mafarafara, President of the SA Association of Hospital and Institutional Pharmacists, told Spotlight too many of the almost 6 000 pharmacists in the public sector are doing stock management, dispensing, administration and management work in hospitals and pharmaceutical depots. He says the numbers do not necessarily reflect pharmacists in clinical or patient facing areas.

“The reality is that pharmacists are restricted to trying to get drug stock in and out,” Gray observed.

However, the lack of pharmacists and pharmacist assistants at clinics and hospitals means timely and/or knowledgeable ordering often results in shortages of essential medicines, something all experts interviewed for this article agreed on.

Mafarafara said that by defining what services a pharmacist should render and what’s needed to enable a quality service, more realistic staffing numbers could be reached. Pharmacies are central points in all hospitals, with closure for even an hour crippling a hospital. Thus, adequate staffing is critical to ensure uninterrupted access to good quality pharmaceutical care.

South Africa, Mafarafara added, was far behind many other countries in the effective use of pharmacists’ clinical expertise in leading evidence-based care in hospitals. “I’d even go so far as to say doctors should be stopped from dispensing in favour of pharmacists to improve quality of patient care,” he said.

‘If you don’t have a pharmacist, nothing gets done properly’

Jamaloodien said the cost of having too few pharmacists is more far-reaching than just antimicrobial resistance. “You can have stock outs because there’s nobody to manage the supply chain. In my experience, if you don’t have a pharmacist, nothing gets done properly,” she said.

Her solutions? Compliance with the “comprehensive and robust” evidence-based standard treatment guidelines, access to an updated and well-maintained cell phone-based application that gives everybody access to the latest information and medicine changes – and more attendance by all healthcare professionals of webinars held after every medicine’s committee meeting, plus clinicians regularly reading drug update bulletins to keep up with new medicines.

Republished from Spotlight under a Creative Commons licence.

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Categories : Expert Opinion Healthcare Politics and RegulationsTags :

NHI Offers an Opportunity to Boost Primary Healthcare – We Must Seize it

On By ModernMedia

By Russell Rensburg

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.

Republished from Spotlight under a Creative Commons licence.

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Categories : Healthcare Politics and Regulations HIVTags :

Efficacy of 6-monthly HIV Prevention Jab Confirmed in Second Major Study

On By ModernMedia
Photo by Raghavendra V Konkathi on Unsplash

By Elri Voigt

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.

The new results come hot on the heels of findings from PURPOSE 1 – previously reported on by Spotlight and published in one of the world’s top medical journals: the New England Journal 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.

Republished from Spotlight under a Creative Commons licence

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Categories : Healthcare Politics and Regulations Medical IndustryTags :

NHI Act Offers no Answer to High Medicines Prices

On By ModernMedia
Photo by Gustavo Fring:

By Fatima Hassan

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.

Republished from Spotlight under a Creative Commons licence.

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Categories : Expert Opinion Healthcare Politics and RegulationsTags :

Mandatory Health Insurance for SA is an ‘Upgrade’ on NHI, Proponents Say

On By ModernMedia
Photo by Hush Naidoo Jade Photography on Unsplash

By Chris Bateman

The idea of mandatory medical scheme coverage for employed people has made a comeback after the case for it was made at a recent conference. The policy move was previously on the cards in South Africa but faded after the ANC opted for National Health Insurance (NHI) at its 2007 national congress where Jacob Zuma was elected as the party’s new leader. Chris Bateman unpacks how a system with mandatory medical scheme membership for the employed might work and asked local experts whether it represents a viable alternative to government’s NHI plans.

A vigorous public debate has ensued since outgoing Netcare CEO, Dr Richard Friedland, on behalf of the Hospital Association of South Africa (HASA) delivered a strongly argued case for a return to what he described as the original ANC healthcare plan. He was speaking on “Viable and Near-term Opportunities to Providing Enhanced Healthcare in South Africa,” at HASA’s annual conference in Sandton held early in September.

Since then, the leadership of Business Unity SA (BUSA) met with President Cyril Ramaphosa and Health Minister Dr Aaron Motsoaledi, and his deputy and other senior officials, in mid-September to discuss “matters of concern” related to the NHI. The President requested BUSA to put forward specific proposals on “the remaining matters of concern” as a basis for re-engagement.

Some observers have suggested to Spotlight that these consultations are a first sign of government openness to changing or tweaking its NHI plans. But whether this means the door is actually open for a system of mandatory health insurance, or for mandatory health insurance as a stepping-stone toward NHI, is still unclear.

The NHI Act, that was signed into law by Ramaphosa in May, envisages a single-payer system where medical schemes are only allowed to cover health services that are not covered by the NHI fund.

How mandatory health insurance would work

Under mandatory health insurance, everyone who is in formal employment, or who earns above a certain threshold, would be forced by law to be a member of a medical scheme. This will result in medical scheme membership swelling substantially and some pressure being taken off the public healthcare system. It is also expected to result in medical scheme premiums being reduced because more healthy, younger people will join the schemes. People who are unemployed or who cannot afford health insurance will still be dependent on the public healthcare system.

Friedland said such mandatory healthcare insurance will triple the medical scheme market from 9.2 million to potentially 27.5 million beneficiaries over time and reduce those dependent on the state from 53.8 million to 35.5 million. In so doing, it would boost public healthcare per capita spending by 52%, (from R5 054 to R7 659), without any additional funding of the public sector budget, alleviate the strain on public hospitals and clinics, shorten waiting lists, and free up money to hire more staff and improve infrastructure. He said it is a “far faster and more efficient tool” for achieving health equity.

Responding to the counter argument that a mandatory health insurance system would entrench existing health inequalities, Professor Alex van den Heever, Chair of Social Security Systems Administration and Management Studies at the University of the Witwatersrand, said the opposite is true. “It accelerates convergence between the two systems faster than the NHI proposals,” he told Spotlight.

The relief for people who can afford medical scheme cover could also be significant. Friedland said mandatory medical scheme membership would bring more young and healthy people into the system, thus reducing the cost of monthly premiums by 25% to 30%.

Mandatory contribution schemes for civil servants have been implemented in more than half of the countries in Africa, while Thailand and many other Asian countries have started with mandatory cover for the formal sector before expanding to the non-formal sector. Such systems with what amounts to many medical schemes, rather than a single large fund, are also in place in several European countries, including the Netherlands and Germany.

Not a new idea

Mandatory health insurance, or an expanded role for medical schemes, are by no means new ideas in South Africa. Friedland told Spotlight that the ANC government’s own broad ranging 2002 inquiry into the various social security aspects of the South African health system concluded that national health insurance or the complete nationalisation of the private sector, could not be seriously considered as a reasonable option. (The inquiry itself was based on the Health Subcommittee Findings of the Committee of Inquiry into a Comprehensive System of Social Security.)

That 2002 report concluded: “National health insurance is not an option that emerges overnight as an alternative to social health insurance. Instead, it becomes feasible within market economies where formal employment levels are high. Prior to this, mixed systems are inevitable.”

One indication of how committed government was to such a mixed system with an expanded role for medical schemes in the early and mid-2000s, is the fact that the legislative framework to enable the expansion of medical scheme coverage was incorporated into the 2008 Medical Schemes Amendment Bill. That bill did not go as far as making scheme membership mandatory, but a mandatory system was clearly a next step on the reform agenda, as outlined in the very wide-ranging 2002 Taylor report on social security in South Africa. But presumably because of the NHI proposals, the 2008 amendments were allowed to lapse – and the scaffolding for a progressive expansion of medical scheme coverage collapsed.

There have since been several committees of inquiry and technical processes that validated an ongoing role for medical schemes, of which the Competition Commission’s Health Market Inquiry (HMI), that ran for five years (2014 to 2019), was the most technically detailed, consultative and authoritative. The HMI report did not recommend that medical scheme membership be made mandatory for people who are employed, but it did recommend a continued role for medical schemes and suggested that the most viable path to NHI may well involve first fixing the regulation of medical schemes.

Van den Heever said South Africa needs to quickly return to the pre-2008 reform trajectory to help stabilise the health system, “before more harm is done”. Government needs to summon up the political will to address the systemic governance failures of the public health system, removing the “bad actors and provincial cabals” that were destroying the integrity of South Africa’s free public health services, he added.

Better regulation also needed

For a system of mandatory health insurance to work, medical schemes will have to be more effectively regulated. Here the HMI report found that government had dropped the ball. It attributed the private health market failure and rampant medical inflation directly to government neglecting to regulate the private healthcare industry.

Health actuarial consultant, Barry Childs, joint CEO of Insight Actuaries and Consultants, told Spotlight private healthcare sector reforms urged by the HMI were ignored, resulting in ongoing confusion, high costs, complicated products and waste, among other problems. “Our incomplete medical scheme regulation keeps costs up, (for example anti selection, Prescribed Minimum Benefits), with benefits out of reach of most. We still don’t have a proper framework for lower cost-lower benefit products for those who cannot afford medical schemes,” he said.

The HMI report recommended a framework that went “way beyond naïve approaches to price control”, said Van den Heever, and addressed the powerful incentive structures driving unproductive forms of competition. In addition, he said, the industry-wide pooling approaches (risk equalisation and social reinsurance) followed international best practice and fully addressed issues of pooling fragmentation.

In the five years since the publication of the Commission’s HMI report, none of its major recommendations have been implemented.

Jobs and taxes

One common thread running back to the 2002 report, is the idea that South Africa is not economically ready for NHI and that a mixed system, possibly with mandatory health insurance, is more compatible with the current realities of high unemployment and a relatively small tax base.

“The root cause of inequity and inequality is not just a new form of apartheid. The real reason is the catastrophic level of unemployment. Until we address that, we will not solve an entire range of inequities, including food security, housing, education, and healthcare,” said Friedland.

On joblessness, Childs said South Africa was on track with the rest of the world’s growth up to 2008 but thereafter flat lined for over a decade. “We have dramatically underperformed the rest of the world and our peer group of middle-income countries in long term economic growth.”

In South Africa, unemployment is at an extremely high 33.5%, while in 2002 it was at 26%.

“If an NHI was unaffordable in 2002, how much more so is it today?” Friedland asked. He said that in this context, strong partnership, collaboration, and co-operation between the public and private sector is needed to bridge the polarisation that has arisen.

Analysis commissioned by BUSA found that raising the extra R200bn the health department says it needs to fund NHI would entail unrealistic and unaffordable tax hikes. It would either increase personal income tax by 31%, push VAT from 15% to 21.5%, or require the collection of a payroll tax of R1 565 per month from everyone in formal employment.

Van den Heever said that while government has a discretion to increase tax rates to any level it chooses, it cannot control the resulting amount of funds raised. He said that once tax capacity is reached, a hard ceiling on government revenue results at any given level of economic growth. The only way to grow revenues thereafter is through economic growth, failing which, revenues stagnate beyond government control.

The “big idea”, he said, was that new taxes would fund the move of medical scheme members to the public sector, in the form of a single NHI Fund, such that both public sector and medical scheme populations were covered in the same system – with net gains in coverage for both.

However, contrary to what was “correctly understood” from 1994 to the 2002 Taylor Commission, “the maths for such an approach, just does not add up”, said Van den Heever.

“The fastest way to de-segment the system is to allocate all new government revenues arising from economic growth to the people who need it most. This is not what the NHI proposals envisage. They want to dilute the public spend by trying to cover higher income groups. It is dangerous magical thinking that allows government to avoid dealing with the complex problems of the health system. Government needs to get back to its day job and do the heavy lifting needed to get our health system working again.”

Government response

Spotlight shared an earlier draft of this article with the National Department of Health for comment. While the department did not comment directly on mandatory health insurance, Foster Mohale, the department’s Director of Communications, emphatically reiterated their support for NHI and the NHI Act that was signed into law in May.

“There is no better time than now to reform South Africa’s health system. It is time to do away with the apartheid type of health system, and to reconfigure it into one that ensures that every South African gets the health care that they need, when they need, where they need and without incurring financial hardship. With the enactment of the NHI Act, the time for piecemeal approaches that retain benefits for the few and leave the majority to the whims of the market is no more,” Mohale told Spotlight.

He said that many countries, including Japan and the United Kingdom, have implemented health system reforms directed at achieving universal health coverage during times of crisis and low economic growth. “Therefore, to say that South Africa must sit and wait for some oracle numbers to emerge before instituting NHI is merely to argue that we must consciously let those that are carving profits and dividends from the anomalies that characterise our health system to continue. This is an irresponsible position that the Department cannot adopt as health is a constitutionally enshrined right for every South African, not just a privileged few,” he said.

On the questions of taxes, Mohale said: “We will not delve into the projected tax implications because we believe this is a matter that squarely falls under the purview of the National Treasury and the Minister of Finance. Suffice to say at the right time, and after necessary deliberations through formal government structures and processes, any information relating to this will be communicated to the public for comments prior to finalisation.”

Note: The 2002 Tailor report titled ‘Transforming the present – Protecting the future’ is not readily available online. There is this PDF version (unfortunately not searchable and with poor accessibility). For ease of use, we have created a Word version of the document that you can access here. Health is discussed in chapter 8.

Republished from Spotlight under a Creative Commons licence.

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Categories : Mental HealthTags :

SA Has the Third Highest Suicide Rate in Africa – There are Steps We can Take to Tackle it

On By ModernMedia
Photo by Alex Green on Pexels

By Vincenzo Sinisi

South Africa has the third highest suicide rate in Africa and Africa has higher rates of suicide than any other continent. In the wake of World Suicide Prevention Day on September 10th, clinical psychologist Vincenzo Sinisi asks what can be done to bring down suicide rates.

Africa is currently the region with the highest suicide rate worldwide, according to the World Health Organization (WHO). This is driven by a combination of factors, including poverty, unemployment, and untreated mental health issues.

South Africa, with a suicide rate of 23.5 per 100 000 people, ranks third worst on the continent. South Africa is closely followed by Lesotho and Eswatini – countries where limited access to mental health services exacerbates the issue.

Age and gender impact suicide risk. In South Africa, for instance, suicide has been rated as the fourth leading cause of death among people aged 15 to 24, reflecting the devastating mental health toll on young people. The gender disparity is stark – men are four to five times more likely to die by suicide than women. However, women tend to report twice as many suicide attempts as men, indicating a significant gap in prevention efforts targeting both genders

Why is it happening?

While suicide is a global challenge, it manifests differently across Africa due to a variety of factors – these include economic hardship, mental health stigma, and the scarcity of healthcare resources.

Mental healthcare in Africa is severely underfunded. Many African countries have an insufficient number of mental health professionals – sometimes as few as one psychiatrist per 500 000 people. This is compounded by widespread mental health stigma, which prevents many people, particularly men, from seeking help. In some African cultures, suicide is stigmatised to the extent that it is linked to supernatural beliefs, such as curses or sorcery. These deep-seated cultural beliefs often lead to underreporting of suicide cases and contribute to delayed intervention.

In addition to cultural taboos, socioeconomic stressors like unemployment, poverty, and housing insecurity further drive suicide rates across the continent. In South Africa’s townships, the levels of indebtedness and joblessness create a cycle of despair that feeds into psychological distress, ultimately increasing the risk of suicide.

In South Africa, the impact of socioeconomic instability on mental health is evident, particularly in rural and impoverished urban areas. The link between unemployment and mental health distress is well-documented, and for many, this distress leads to thoughts of suicide. In economically deprived areas, suicide prevention efforts are often undermined by poor access to healthcare and low mental health literacy. As economic hardship worsens, so does the mental health of affected populations.

What to do?

Preventing suicide in South Africa and on the African continent more broadly requires a multi-level strategy, combining grassroots initiatives with government support. Many successful interventions have originated from community-based programmes tailored to local needs and cultural contexts – there are after all large differences between countries and, for example, between urban and rural areas.

As a starting point, community involvement is crucial in creating a supportive environment for those at risk. By training community leaders, including traditional healers and faith-based leaders, to recognise signs of mental health struggles, these communities can provide immediate support. Peer support networks have also proven effective, especially in areas with limited access to formal healthcare services. Such networks empower individuals to check in on one another and provide emotional support in times of crisis.

For example, the South African Depression and Anxiety Group (SADAG) runs mental health education programmes across rural South Africa, equipping local leaders and volunteers with tools to recognise and respond to signs of suicide. These efforts are helping to reduce stigma and encourage early intervention in communities often overlooked by national healthcare systems.

While community-led efforts are invaluable, government policy is essential for creating systemic change. South Africa’s National Mental Health Policy Framework (2023-2030) aimed to integrate mental health care into the primary healthcare system. Still, its implementation has been slow, particularly in rural areas. Expanding this framework and ensuring proper funding for mental health initiatives must be a priority. (Spotlight previously reported on expert responses to the new mental health policy.)

Governments can also collaborate with NGOs and the private sector to expand mental health services.

Telehealth and digital solutions have for example emerged as potential tools for addressing mental health challenges, particularly in areas where access to mental health professionals is limited. Telehealth services enable patients in remote and underserved areas to consult with mental health experts without travelling long distances. This is especially helpful for individuals who might otherwise be unable to access support due to geographic or financial barriers. One such initiative I am involved with is TherapyRoute.com, a platform that connects people with therapists and psychologists across Africa and  that maintains a database of South African community health clinics.

Such a digital approach, though promising, still faces challenges. Internet access remains inconsistent in many parts of Africa, and telehealth services must continue to evolve to ensure they are accessible to most of the population. Increasing investment in digital infrastructure will be a critical part of expanding access to mental health services.

Practical strategies

Meanwhile, there are practical things we can do now. Suicide prevention is after all not the responsibility of healthcare professionals alone – everyone can contribute.

We can all be on the lookout for the warning signs. Sudden withdrawal from social activities, mood changes, declining self-care and hygiene, and expressions of hopelessness or helplessness (e.g., “I can’t go on” or “Everyone would be better off without me”) should never be ignored.

If someone you know appears to be at risk, ask direct questions about their mental health. Don’t be afraid to ask if they are considering suicide. Studies show that directly asking about suicide can reduce the risk of an attempt by giving the person a chance to talk about their feelings.

We can also respond as a community. We can organise peer support groups where people can check in on one another. Training community leaders, traditional healers, or local volunteers to recognise suicide risk and provide mental health first aid is another effective way to support those at risk. Running community-wide campaigns to raise awareness about mental health issues and reduce stigma can help normalize seeking professional help.

Governments also have a critical role to play. They must prioritise mental health by increasing funding for prevention and treatment programmes, particularly in rural and underserved areas. The success of such programmes depends heavily on their accessibility to people from all economic backgrounds.

In South Africa, government should focus on implementing the National Mental Health Policy Framework, ensuring it reaches the rural areas that are most in need. By integrating mental healthcare into primary healthcare services, as envisaged in the policy framework, more people will have the chance to receive timely care.

Ultimately, suicide prevention requires a multi-level approach, with involvement from individuals, communities, governments, and the private sector. By recognising warning signs, reducing mental health stigma, and expanding access to care through both in-person and telehealth services, we can make meaningful strides in reducing the suicide rate across Africa.

*Sinisi is a clinical psychologist and psychoanalyst in private practice in Cape Town. He is also a faculty member of the South African Psychoanalysis Association, The South African Psychoanalytical Initiative, and the Centre for Group Analytic Studies.

People in need of help can contact SADAG on the following helplines:

  • 0800 21 22 23 (8am to 8pm)
  • 0800 12 13 14 (8pm to 8am)
  • SMS: 31393

Also see this webpage for a longer list of helplines.

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.

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Categories : Diseases, Syndromes and Conditions HIVTags :

SA’s HIV Burden a Concern as New Mpox Strain Spreads in DRC – but Much Still Unknown

On By ModernMedia
Mpox (monkeypox) virus. Source: NIH

The African Centre for Disease Control and World Health Organization have raised the alarm following a drastic uptick in mpox cases. This surge is being driven by a new strain of the virus. Elri Voigt reports about what we know so far and potential implications for South Africa.

Mpox, a viral illness first identified in Africa in 1970, made headlines in 2022 when it spread across the globe for the first time. Since then, the outbreak has evolved, with multiple strains of the virus circulating in different countries. A new strain, known as clade Ib, first discovered in the Democratic of the Republic of Congo (DRC), is responsible for much of the most recent surge in mpox cases.

These recent developments are complex, and the situation is likely to change. This was the common theme of a special session on the mpox outbreak during the World Health Organization (WHO) Regional Committee for Africa meeting at the end of August. This session took place two weeks after the WHO declared the outbreak to be a Public Health Emergency of International Concern.

“We don’t have one outbreak. We have multiple outbreaks in one,” Dr Jean Kaseya, the Director General of the African Centre for Disease Control (CDC) remarked.

These outbreaks are caused by different clades of the mpox virus. Clades are a classification system based on the genetic similarities between different strains of a virus, explained Professor Tulio de Oliveira, Director of the Centre for Epidemic Response and Innovation (CERI) at Stellenbosch University (SU). “So, what it means is that when we see a genetic change [in a virus] that’s really visible and that may have impacted it, normally we call it a different clade or genotype or variant,” he said.

This is similar to classifying different strains of SARS-CoV-2 as variants, Dr Duduzile Ndwandwe, a molecular biologist working for Cochrane South Africa, an intramural research unit within the South African Medical Research Council, told Spotlight.

She explained that the different mpox clades and sub-clades have mutated so they have genetic differences but still fall under the umbrella of mpox.

“In a nutshell…it’s just talking about the differences in the genome sequence of the virus, how many mutations [it has] or how big the mutations are in that virus’s strain of mpox,” she said.

‘Jump in evolution’

Dr Aida Sivro, senior scientist at the Centre for the AIDS programme of Research in South Africa (CAPRISA), in 2022 told Spotlight that there are two clades of the mpox virus, which were then referred to as the Central African Clade (clade I) and the West African Clade (clade II).

Since then, clade I went through a big jump in evolution and a sub-clade emerged in the DRC, now called clade Ib, De Oliveira told Spotlight. The previous outbreak in 2022 was mostly driven by another sub-clade called clade IIb.

To further complicate matters, there’s a third strain of the virus also circulating – clade Ia.

At the moment, the DRC accounts for about 90% of mpox cases in the African Region, according to Dr Fiona Braka, the Emergency Response Manager for WHO’s AFRO region. She explained that right now the situation is not fully understood because a lack of diagnostics and testing capabilities is limiting understanding of the true burden of disease.

What we do know, she said, is that there are two distinct outbreaks in the DRC. Based on the information currently available, clade Ia is circulating in regions in the country where mpox is considered endemic and affecting mostly children. While clade Ib is spreading mostly among adults in the eastern provinces of South Kivu and North Kivu.

The clade Ib strain has since spread from the DRC to neighbouring countries Burundi, Rwanda, Uganda and Kenya, according to Braka. Sweden and Thailand have also identified one case each.

As of 1 September, the WHO reported that there have been 3 751 confirmed cases of mpox and 32 deaths across 14 countries in African in 2024 alone. But there are many more suspected cases of mpox that have not been tested.

Implications for South Africa

De Oliveira said at this point, South Africa shouldn’t be overly concerned about mpox, but it should be alert. The best way to do this is to make sure the public know what the symptoms are so they can present for diagnosis and treatment if they suspect they have the virus.

In a similar vein, Ndwandwe said the public shouldn’t panic, but we as a country need to remain vigilant. She added that because clade Ib is spreading on the African continent, there is a risk of it spreading to South Africa through cross-border travel, making it a public health concern.

This year, 24 cases of mpox have been reported in South Africa. Three people have died, while 19 have recovered. Two people are still considered to have active disease, with the most recent case identified in early August.

But this doesn’t necessarily mean there aren’t more cases of mpox in the country. “What we do suspect is that we may have milder cases that are actually not reported,” Nevashan Govender, the operation manager of the Emergency Operations Center at the National Institute for Communicable Diseases (NICD) told Spotlight.

He said so far, all the cases in the country have been caused by clade IIb and no cases of clade Ib have been identified.

A polymerase-chain-reaction (PCR) test is the gold standard test used to determine whether someone has mpox. But genome sequencing would need to be done to identify what clade they have.

Lots of unknowns around new strain

At the moment, there are a lot of unknowns around clade Ib.

What is of concern, according to Braka is the severity of disease seen especially in people who are immunocompromised and in pregnant women and children. Ndwandwe added to this and said there is a concern that clade Ib has higher fatality rates than clade IIb.

De Oliveira cautioned against jumping to conclusions about the severity of this new clade without sufficient data. He said we don’t know for sure yet if clade Ib is causing more severe disease than IIb. What we do know from mpox in general, he said, is that when someone is immunocompromised in some way, they tend to develop more severe symptoms.

Govender echoed De Oliveira’s caution that we don’t yet know enough about clade Ib to say definitively if it is for example more transmissible than other clades

“It’s not to say that it isn’t [more transmissible], but there is just not a lot of evidence stating that it is absolutely true…There’s a lot of knowledge and information gaps,” he said.

The NICD in a recent update also stressed that there are a lot of unknowns about this new strain. It added: “South Africa continues to prioritise enhanced surveillance and raising awareness for mpox.”

The state of vaccines and treatment for mpox

Spotlight reported previously that the smallpox vaccine, which hasn’t been routinely administered in South Africa since the 1980s when smallpox was eradicated, is thought to offer some degree of protection against mpox. However, it’s difficult to predict just how much protection the smallpox vaccine would provide, Sirvo told Spotlight for that previous article.

There are currently three vaccines against mpox that have been approved in some countries, a spokesperson from the vaccine alliance Gavi told Spotlight. These are LC16m8, JYNNEOS and ACAM2000.

LC16m8 is a third-generation small pox vaccine manufactured by KM Biologics. According to WHO, from 2022 it had mainly been used in Japan.

The JYNNEOS vaccine is a third-generation smallpox vaccine, manufactured by Bavarian Nordic, Ndwandwe said, and it was used during the outbreak in 2022. She added that this vaccine is considered the preferred option due to its safety profile and targeted protection against mpox.

ACAM2000 is a second-generation vaccine for smallpox and manufactured by Emergent BioSolutions. But it was only approved by the FDA for use in those at high risk for mpox at the end of August this year. It was not widely used during the 2022 outbreak but was available in some places under a compassionate use protocol (a means of providing medicines or vaccines that have not yet been registered).

In 2022, the Centre for Disease Control (CDC) recommended that JYNNEOS be used as the primary vaccine against mpox because it was associated with fewer side effects than ACAM2000.

While these vaccines exist, it doesn’t mean everyone can access them easily. Countries on the African continent have so far relied on vaccine donations facilitated by the WHO, with an initial 10 000 doses expected to arrive in Africa sometime this month.

Vaccine manufacturers KM Biologics and Bavarian Nordic have submitted proposals to the WHO for emergency use listing (EUL), according to WHO Director-General Dr Tedros Adhanom Ghebreyesus. He added this will allow UNICEF and the vaccine alliance GAVI to buy the vaccines to supply to countries that haven’t issued their own national regulatory approval yet.

The treatment options for mpox are also limited. According to this WHO factsheet on mpox, some antivirals have received emergency use authorisation in some countries and are being evaluated in clinical trials. However, so far there is no proven effective antiviral treatment for mpox.

Tecovirimat, which was approved to treat smallpox, is one of these antivirals being evaluated. According to the CDC, studies in animals have shown the antiviral might help treat mpox but it is still considered an investigational drug for mpox. The drug has been used in some cases of severe mpox.

When asked about this, Ndwandwe agreed more research needs to be conducted to fully understand the evidence around using Tecovirimat. “But what we know now is that the fact that it was authorised for compassionate use, there is some benefit to using that treatment, given that there isn’t any other [treatment,” she said.

Mpox vaccine and treatment availability in South Africa

According to De Oliveira, a small batch of vaccines against mpox and an antiviral drug were made available to South Africa through donations during the outbreak earlier this year.

But the country would need more vaccines if cases increase to protect those at risk for severe disease.

At the moment, South Africa does not have access to any mpox vaccines and has asked for a donation of 40 000 vaccine doses, Foster Mohale, spokesperson for the health department told Spotlight. The country has requested the JYNNEOS vaccine, based on the recommendation by the National Advisory Group on Immunisation.

He added that South Africa’s request to its international partners and the WHO is ongoing support with access to tecovirimat should the need increase. He also requested the WHO’s assistance in procuring the 40 000 vaccine doses to vaccinate high-risk groups if mpox cases increase.

When asked if the department will be entirely reliant on donations of mpox vaccines or would seek to procure its own if cases increase, Mohale said it depends. “South Africa has been in communication with the vaccine manufacturer, Bavarian Nordic, and will consider procurement if needed,” he added.

Because there is a shortage of mpox vaccines and treatment and uncertainty about the sustainability of donated supplies, Ndwandwe said: “Our best defence at this point in time is to prevent [the spread of mpox cases] as much as possible and detect the cases as they start, early on.”

Symptoms of mpox

Govender said the NICD is urging people not to panic but to stay informed on the signs and symptoms of mpox using some of the accurate information available from either the National Department of Health or the NICD.

“The first line of defence for any public health emergency and outbreak comes from when people take initiative to protect themselves,” he said.

Mpox, which is spread by close contact, either household or sexual contact, with someone who has the virus, could initially manifest in flu-like symptoms or the characteristic mpox rash. These include a fever, sore throat, muscle aches, headaches and swollen lymph nodes, according to the WHO factsheet on mpox. The rash starts flat and then becomes a blister filled with fluid, which eventually dries and falls off. The rash can occur on someone’s palms or soles of their feet, face, mouth and throat and sometimes the genital areas.

Children, pregnant women and those who are immunocompromised are most at risk for developing severe disease or dying, the factsheet stated. This includes people living with HIV whose viral load is not well controlled.

Mpox is a virus and as with all viral infections it’s the immune system that fights it off, Ndwandwe explained. However, if someone is immunocompromised, so has a weakened immune system, there is a greater chance that the mpox virus will overtake their immune system and cause severe disease.

This is one of the reasons why we would be concerned about the disease in South Africa, Professor Helen Rees, the Co-Chair of the Incident Management Team (IMT) on mpox, previously told eNCA.

“We have many people living with HIV in the country, many of whom are on antiretroviral therapy, their immune system is good. But we have many others, who don’t know what their status is and might be vulnerable to severe mpox,” she said.

Republished from Spotlight under a Creative Commons licence.

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Categories : Ethics and Law Medical IndustryTags :

Fight Not Yet over as Case Against Vertex is Dropped After Cystic Fibrosis Medicine Price Cut

On By ModernMedia
Cheri Nel launched a court case against Vertex to force them to allow their generic cystic fibrosis drug to be imported into South Africa. Credit: Spotlight

By Catherine Tomlinson

Last year a South African woman took a multibillion-dollar United States pharmaceutical company to court with the aim of securing access to life-changing cystic fibrosis medicines. That case has now been dropped following a reduction in the price charged for the medicines in South Africa.

Cheri Nel, a Johannesburg-based investment banker, has dropped a potentially landmark court case against Vertex Pharmaceuticals. Nel was asking the Gauteng Division of the High Court in Pretoria to grant a compulsory licence to allow generic versions of a cystic fibrosis medicine called Trikafta to be imported into South Africa. No such compulsory licences on medicines have ever been granted in South Africa.

Trikafta, which was registered in the United States in 2019, has been hailed as a “miracle” treatment for cystic fibrosis, which causes severe damage to the lungs, digestive system and other organs in the body. The medicine is effective in treating around 90 percent of people living with the condition. It significantly improves the quality of life of people living with cystic fibrosis, eliminating many of its debilitating symptoms, while also slowing the disease’s progression and extending survival.

In February 2023, when Nel launched her lawsuit against the Boston-headquartered pharmaceutical company, the only way people in South Africa could access Trikafta was by travelling to Argentina to buy it from an Argentinian company selling a generic version of the medicine.

This is because Vertex, the company that holds the patents on Trikafta in South Africa, refused to register the medicine with the South African Health Products Regulatory Authority (SAHPRA) or identify a local distributor that could import unregistered Trikafta via Section 21 authorisations – a mechanism allowing importation of unregistered medicines.

The United States list price for Trikafta is currently over $300 000 (around R5.5 million at the current rand/dollar exchange rate) per person per year, which South Africans feared they would also have to pay if or when Vertex finally started supplying its medicine in the country. Researchers in the United Kingdom have estimated that Trikafta can be produced for under $6000 (around R110 000 at the current rand/dollar exchange rate) per person per year.

When Nel filed the case, generic Trikafta from Argentina – called Trixacar – was much cheaper than Vertex’s product (but still prohibitively expensive for many) at around $60 000, or almost R1 million per person per year. But the Argentinian company selling generic Trixacar faced potential patent infringement challenges if it shipped Trixacar to South Africa. Thus, the only way to get the medicine into South Africa at the time was to travel to Argentina to collect it. People living with cystic fibrosis in South Africa learnt how to do this through an informal network or Buyers Club of people around the world that were reliant on the Argentinian product.

Launching a legal case

Nel argued that Vertex was abusing its patents in South Africa by refusing to make Trikafta available in the country on reasonable terms, while also blocking other manufacturers from supplying the medicine in the country. If successful, Nel’s case would have allowed generic Trikafta to be shipped directly to South Africa, removing the need for travel to Argentina to access the medicine.

According to Nel, Vertex argued in the company’s answering documents to her legal filing that, as she was the only named applicant in the case, a compulsory licence for importation could only be considered for her.

Nel then worked with the South African Cystic Fibrosis Association (SACFA) to get other people living with cystic fibrosis admitted as co-applicants in the case. This process of seeking more people to join her case, she said, was time-consuming, difficult, and expensive, but more than 100 people were working towards being admitted as co-applicants before the case was dropped.

Under pressure, Vertex starts providing Trikafta in South Africa

As the case gained momentum and made headlines around the world, Vertex finally opened the door to allow some people living in South Africa to access their product.

In May 2024, Vertex identified Equity Pharmaceuticals as the local company through which Trikafta could be imported into South Africa via Section 21 authorisations. These authorisations are granted by SAHPRA to enable importation of an unregistered medicine and are meant to be used in exceptional circumstances to remedy the need for an unregistered medicine, such as when there is a shortage of the registered product.

While Vertex has not confirmed to Spotlight or stated publicly the price of Trikafta for people living in South Africa, Nel and Doctors Without Borders’ Candice Sehoma told us that the company is charging around R400 000 ($22 000) for a year’s supply of the medicine.

While still unaffordable for many and much higher than the estimated cost of manufacturing, the R400 000 price is drastically lower than the R5.5 million price charged in the United States and originally feared for South Africa.

It seems improbable that Vertex would have offered the much reduced price to people living in South Africa had Nel not launched the court case

Some medical schemes now paying for Trikafta

As emerged in April this year, Vertex reached an agreement with some medical schemes in South Africa to provide the medicine for people on top-end plans.

“Four private healthcare providers are currently funding Trikafta for eligible patients and we are open for conversations with more insurance companies,” Vertex’s spokesperson Daria Munsel confirmed to Spotlight.

The exact nature of the conversations and/or agreements between Vertex and medical schemes in South Africa however remains somewhat unclear.

Discovery Health‘s CEO, Dr Ron Whelan, told Spotlight it has engaged Vertex about the “benefits available” and “affordable access” of the class of medications that Trikafta falls in but there is “no specific commercial agreement in place” in South Africa.

He noted that Discovery Health Medical Scheme members on the comprehensive and executive plans have a suite of benefits available for the treatment of cystic fibrosis with medicines like Trikafta “of up to R400 000 per annum” for eligible people.

According to Vertex, uptake of its product has been swift and is already starting to make a difference in the lives of people living with cystic fibrosis in South Africa. “Over 100 South Africans with CF [cystic fibrosis] have been prescribed our triple combination treatment in just the first two months of the medicine being available,” said Munsel.

The cystic fibrosis registry, an initiative which seeks to identify and collect data on the outcomes of people living with cystic fibrosis in South Africa, identified 525 people living with cystic fibrosis in the country as of December 2020. Experts believe there are many more undiagnosed cases.

Why did Nel drop the case?

Not only is Vertex’s price for people in South Africa now lower than the 2023 price of Argentinian generics, but the cost of a year’s supply of generic Trikafta from Argentina have increased from around $60 000 to around $100 000 due to hyperinflation in that country.

With Vertex now offering a price lower than the cost of Argentinian generics, Nel decided that her legal case was no longer the best avenue to enhance access to the medicine. The aim of the case “was to get access to the medication… to put pills in patients’ mouths”, she told Spotlight.

Nel said it is now probably better to redirect efforts to getting government at national or provincial levels to buy the medicine for patients in the public sector.

“There is a lot of work still to be done… my efforts are still there, it’s just being redirected,” she said.

“The fact that Trikafta will now be available in South Africa at a much lower price compared to generic versions globally, certainly undercuts the legal case for a compulsory license,” said Tendai Mafuma of SECTION27, a public interest law centre. The Treatment Action Campaign and Doctors Without Borders, represented by SECTION27, were admitted as friends of the court in the case.

Why won’t Vertex register its product in SA?

While much has changed because of Nel’s legal action, Vertex has held fast on its refusal to register Trikafta with SAHPRA.

When asked about Vertex’s plans to register Trikafta in South Africa, Munsel said: “We strongly believe that this [Section 21 Authorisation] is the fastest and most efficient route to sustainable access in South Africa, which does not require a regulatory filing.”

While registering medicines can be onerous and time consuming, it is a routine practice required for pharmaceutical companies to operate around the world. Full registration also typically requires that safety, effectiveness and quality is more closely scrutinised than is the case with Section 21 authorisations.

Nel believes that Vertex has chosen not to register Trikafta in South Africa because of the price transparency requirements embedded in South African law. If other countries know what price South Africa is paying then they may also demand a lower price, she said.

The law requires that there is a transparent pricing system for medicines sold in the private sector, but these requirements do not extend to unregistered medicines imported through Section 21 authorisations, explained Mafuma.

Note: SECTION27 was involved in the court case that is the subject of this article. Spotlight is published by SECTION27, but is editorially independent – and independence that the editors guard jealously. Spotlight is a member of the South African Press Council.

Republished from Spotlight under a Creative Commons licence.

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