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ANC and its Ministers Reject Reports of NHI ‘Concessions’

On February 17, 2025February 17, 2025 By ModernMedia

Photo by Hush Naidoo Jade Photography on Unsplash

By Chris Bateman

Recent media reports over the future of NHI have been contradictory and hard to make sense of. Spotlight chased up those in a position to know where things stand – it seems the ANC has not in fact made any major concessions on NHI. There is however agreement that medical schemes won’t be phased out in the next few years, something that likely wouldn’t have happened in any case given the poor state of the economy and the long timeline for NHI implementation.

The ANC is holding firm on the NHI Act with Health Minister Dr Aaron Motsoaledi and the National Health Department “unaware of any compromise deals”, and the President’s office saying engagement with Business Unity SA (BUSA) is “ongoing”.

In spite of recent media reports to the contrary, neither President Cyril Ramaphosa nor Motsoaledi have conceded to any BUSA proposals on amending sections of the NHI Act. BUSA is the country’s apex business association and represents the banking, mining, and retail sectors, including the Health Funders Association, the Hospital Association of South Africa, and the Innovative Pharmaceuticals Association of South Africa.

BUSA, and several other critics of the Act, have argued that provisions should be removed that prohibit medical schemes from covering any health services covered by the NHI fund. The NHI Act has not yet been promulgated. If promulgated in its current form, the role of medical schemes will be dramatically reduced.

The DA’s spokesperson on health, Michele Clarke, told Spotlight that at the establishment of the recent GNU-convened Medium Term Development Plan (MTDP), agreement was reached that the health department would “not de-establish medical aids during the current government’s term of office”.

Spotlight understands that this amounts to a commitment not to promulgate the relevant sections of the Act in the next few years – it does not amount to a commitment to remove those sections from the act.

This is a pyrrhic victory, given that the implementation of NHI was always going to be a long-term project and that even in the most pro-NHI scenarios, the effective phasing out of medical schemes in the next few years was highly unlikely. There are also four legal challenges being brought on procedural and constitutional grounds that may further delay things.

Mist of confusion

Last week’s mist of confusion lifted when both the Presidency and Dr Stavros Nicolaou, speaking to Spotlight on behalf of BUSA, said no concessions have been made on NHI. Motsoaledi’s office also flatly denied reports that there had been any ANC or GNU compromise to remove parts of the NHI legislation that would render medical aids almost obsolete. The Spokesperson for the National Department of Health, Foster Mohale, added that he was unaware of any MTDP agreement on medical aids.

Vincent Magwenya, a spokesperson for the president, told Spotlight he was “unaware of any process leading to the amendment of the NHI Act”, claiming that Maropene Ramokgopa, Minister in the Presidency responsible for Planning, Monitoring and Evaluation, was misquoted last week.

She was quoted in news reports as saying the ANC and the DA had reached an “unofficial understanding on the NHI” following an ANC compromise to remove parts of the NHI legislation that would collapse medical aids. “Ms Ramokgopa tells me she was misreported,” said Magwenya.

Chris Laubscher, the DA’s communications head, told Spotlight: “There was never confirmation by [DA leader who is also Minister of Agriculture] John Steenhuisen that the NHI in its entirety had been excluded from the government’s Medium Term Development Plan.”

The new MTDP has not yet been made public.

Charity Ophelia McCord, the spokesperson for Steenhuisen, said the MTDP had yet to be completed and passed, but was on the Cabinet agenda for Wednesday, February 12. Spotlight was not able to verify if this was discussed.

Meanwhile, Mohale said both the health department and the minister were unaware of any compromise deal, “thus the implementation of the NHI Act continues as per the plans”.

Cannot be changed over night

If at some point the NHI Act is to be amended, the process is likely to take several years, according to Professor Olive Shisana, Social Policy Special Advisor to Ramaphosa on the NHI and health systems strengthening.

“Any process for changing an enacted law normally goes through Parliament, including an amendment from the executive,” Shisana explained. “There would first have to be consultation with the public before it even got to Parliament. Then, when it gets to Parliament there’s more consultation, this time in each of the provincial legislatures, after which it goes to the Portfolio Committee on Health which also takes written submissions. The committee then decides whether to submit it to the National Assembly. If the National Assembly passes it, it goes to the National Council of Provinces which considers each province’s input. Government took five years to get this NHI Act in place, so you can imagine it might take about as long to get parts of it excised or reversed. That’s the normal route it would have to take, I’m afraid.”

However, both the DA and BUSA are adamant that the Act needs to be changed.

Clarke said the DA remained of the view that “multiple parts of the [Act] remain problematic and dangerous for the future of healthcare in South Africa”.

She added: “The DA wants the model underpinning the NHI to be completely reworked and multiple problematic clauses amended by Parliament to ensure that the healthcare model is protected and strengthened.”

BUSA met with Ramaphosa in September last year and tabled a proposal which included striking Section 33 – which effectively collapses private medical aids as they now exist, creating a single national fund – from the NHI Act. It also calls for the implementation of mandatory health insurance which it is argued will take pressure off the public health system and bolster existing medical aids. The president has since passed it on to Motsoaledi’s office.

Neither BUSA nor the responding government parties have given any indication of when they might next meet or pronounce on the proposal.

Rejection of NHI

Meanwhile, the United Healthcare Access Coalition (UHAC), a grouping claiming to represent 80% of all private healthcare stakeholders, lodged a detailed alternative proposal with the president’s office. This entirely rejects the NHI and focuses on rehabilitating the healthcare system based on a synthesis of far-reaching recommendations which various commissions and experts have made over several decades, including the Taylor Commission and the more recent Health Market Inquiry (HMI).

In January this year, Motsoaledi promised to pronounce on the implementation of the HMI recommendations from 2019 “within weeks”. As reported by Business Day, there indeed seems to now finally be some movement on the HMI recommendations with Minister of Trade Industry and Competition Parks Tau having gazetted an exemption that newly opens the door for tariff setting in the private health sector – a move that may help rein in runaway healthcare costs.

UHAC spokesperson Dr Aslam Dasoo described their report as “everything that the NHI is not”.

“Our health pathway requires easy legislative changes and is within current fiscal constraints. We can start the process immediately. It requires a change in governance structure of the provincial health systems where politicians relinquish all direct authority over health care institutions and instead focus on strategic policy,” he previously told Spotlight.

In an online briefing launching the UHAC on Wednesday, February 12, Dasoo warned all parties in the GNU to “consider their options” as they would be “held jointly responsible” should the NHI be implemented to the detriment of South Africa.

Another UHAC executive member and CEO of the SA Private Practitioners Forum, Dr Simon Strachan, said the focus of their universal healthcare plan was on providing equitable, implementable, and sustainable healthcare.

“We need to ensure that those who can look after themselves, do (financially), while subsidising those who cannot afford to. It’s one hundred percent dependent on improving health service delivery within the public sector and creating a competitive market for people to decide where and how they access healthcare,” he said.

The UHAC coalition includes NGO’s, patient advocacy groups, the SA Medical Association, the South African Private Practitioners Forum, and the Progressive Healthcare Forum.

Asked what UHAC’s “Plan B” was if they “hit a brick wall” on their detailed proposals, Dasoo said the GNU was obliged to respond to such a widely representative proposal “otherwise they’re not fit to govern”.

Referring to the ANC, he said the party “neglected the two major healthcare systems, allowing real degradation of the public sector and an unregulated private sector with no market growth, resulting in prices going up”. He added: “If there’s any brick wall, it’s the one they’ve built.”

Republished from Spotlight under a Creative Commons licence.

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Categories : Healthcare Politics and RegulationsTags : 14/2/25 aid cuts international aid SpotlightLeave a comment

No Clear Government Plan Yet to Confront US Aid Cuts

On February 14, 2025February 14, 2025 By ModernMedia

By Ufrieda Ho

South Africa’s National Department of Health is still to outline a clear contingency plan as a United States (US) funding freeze puts lives at risk, spells job losses, and presents threats to keeping HIV and TB under control.

The ripple effects of US President Donald Trump’s 90-day freeze of funding on foreign aid programmes have hit South Africa hard. The damage is being counted at multiple levels – even as some limited funding flows are being restored.

For the country, the fallout has heightened civil society’s calls for a prompt, implementable plan to fill the gaps in care and services. Also needed, they say, is clarity on longer-term strategies for greater self-sufficiency in the country’s HIV responses as donor-funded models look increasingly precarious. Such an argument for increased independence in Africa and the global south was made by president of the South African Medical Research Council (SAMRC), Professor Ntobeko Ntusi, writing in the journal Nature.

South Africa should have been better prepared and not caught off guard to be left in the position it now finds itself in, some beneficiaries of US-funded projects told Spotlight. They were speaking on condition of anonymity, given the risk of public comments jeopardising their prospects of having their funding restored.

The immediate need is to ensure that the country’s overburdened and under-resourced public clinic system is able to absorb the tens of thousands of people living with HIV who will have to use public facilities. This is partly because the NGOs they have relied on have been forced to close shop – virtually overnight. Clinics catering to specific groups, such as men who have sex with men, have been particularly hard hit.

South Africa is the largest global recipient of President’s Emergency Plan for Aids Relief (PEPFAR) funds. These funds make its way to South Africa through the United States Agency for International Development (USAID) and the Centers for Disease Control and Prevention (CDC). Through PEPFAR, USAID has been funding and supporting local NGOs and our Department of Health for around two decades. According to USAID’s website, it invested $5.6 billion (roughly R100 billion at the current rand/dollar exchange rate) between 2004 and 2020 towards prevention and treatment of HIV and TB in South Africa.

Trump’s initial executive order, signed on 20 January, halted funding received via USAID. USAID is an agency of the US government that now falls under the State Department under the leadership of Secretary of State Marco Rubio. Since taking office, Trump has slated USAID as “corrupt” and run by “radical left lunatics”.

The Washington head offices of USAID were closed on Friday 7 February as per Trump’s orders and even as the 90-day review period had just got underway, signage on the building was being removed or taped over. Trump’s actions have now been challenged in courts with successful temporary blocks to his orders to place 2 200 USAID workers in the US on paid leave and to reinstate 500 US-based staff who were already placed on administrative leave from when the order was first signed. The situation is highly fluid and several court actions remain in progress.

Some limited relief

In South Africa, NGOs that received USAID funding remain largely in limbo. Although the United States mission in South Africa confirmed that some PEPFAR-funded services could continue in the country, it is subject to some relatively strict limitations and with no assurances of longer term support. As is clear from reporting by Bhekisisa, the process to get at least some funding to flow again to PEPFAR-supported projects is not straight forward.

There was some good news this week linked to PEPFAR-funding channelled through the CDC – a US federal agency under the Department of Health and Human Services. Following a court order, organisations getting these funds should for now be able to continue their work. However, the court process is far from over and the future prospects of NGOs that depend on CDC funds remains precarious.

Given these ongoing uncertainties and severe disruptions to cash flows, Spotlight understands that some large NGOs may have to close down, while others may have to drastically reduce their services. As reported by Spotlight and GroundUp, several NGOs have appealed to the private sector for assistance. As it stands, thousands of people employed or contracted by local NGOs face the loss of their jobs, cut-backs and deepening anxiety over income security. These people include community health workers, peer counsellors, patient navigators, community activists and advocates, support and administrative staff members, and contract workers who keep these organisations functioning.

At stake too are specialised services for so-called key populations such as sex workers, men who have sex with men, the LGBTQI+ community, and people who use drugs. Until recently, a focus on improving services for key populations was generally accepted, including by PEPFAR, to be the right strategy given the disproportionate risk of HIV infection in these groups. But under the Trump administration’s “anti-woke” agenda, it seems likely that many services aimed at key populations are set to be defunded.

A White House media note on 29 January made clear the US’s stance: “The previously announced 90-day pause and review of U.S. foreign aid is already paying dividends to our country and our people. We are rooting out waste. We are blocking woke programs. And we are exposing activities that run contrary to our national interests. None of this would be possible if these programs remained on autopilot.”

A timeline of the US aid cuts

20 January

90-day pause

In an executive order, US President Donald Trump orders a 90-day pause in US foreign development for “assessment of programmatic efficiencies and consistency with United States foreign policy”.

26 January

USAID funding paused

US Secretary of State Marco Rubio pauses all US foreign assistance funded by or through the State Department and US Agency for International Development (USAID) for review.

28 January

Waiver issued

Subject to certain conditions, Rubio issues a waiver stating: “Implementers of existing life-saving humanitarian assistance programs should continue or resume work if they have stopped.”

1 February

Waiver clarified

The extent of the January 28 waiver is clarified in a memo from the US Department of State.

5 February

Health portfolio committee briefing

South Africa’s Health Minister Dr Aaron Motsoaledi briefs Parliament on the US funding cuts and their impact on healthcare services.

7 February

South Africa singled out

In an executive order applying only to South Africa, Trump orders that “the United States shall not provide aid or assistance to South Africa”.

10 February

Waiver still applies

The US mission in South Africa releases an FAQ in which they state that PEPFAR activities that fall under the limited waiver will resume despite the February 7 executive order.

12 February

CDC grants reinstated

The grants of NGOs receiving support through the CDC are reinstated following a court order issued in a US court.

Crisis of fear, silence, and uncertainty

Spotlight understands that staff of affected NGOs have essentially been forbidden from speaking publicly about the 90-day funding freeze. Many declined to speak on the record to Spotlight, even anonymously – too afraid it might affect the decision on their funding after the 90-day review period.

According to an FAQ by the US mission in South Africa that was published on February 10, they have been communicating with the South African government, though it is not clear when this happened. Five days earlier on 5 February, Health Minister Dr Aaron Motsoaledi told Parliament’s Portfolio Committee that he had not had any official communication from the US government on the matter.

Figures from Motsoaledi’s presentation showed that in 2023/2024, PEPFAR funding to South Africa’s health department amounted to 17% of its spending on HIV. Funding totals R4.6 billion for staffing and R2.9 billion for running costs for NGOs. These NGOs include organisations working directly with people living with HIV, mobile units and youth organisations and programmes. PEPFAR focuses on the 27 districts in South Africa with the highest disease burden.

The health department did not respond to Spotlight’s questions on contingencies, or details of next steps to fill the funding gaps or how capacity and resources will be redirected to avert catastrophe. Motsoaledi did not give any of these details in his presentation to Parliament either.

What he did say was that since Trump’s executive order came into place, the health department had hosted a meeting with the provincial leads on HIV and TB; conducted assessments on the immediate impacts of the executive order; met with people living with HIV and engaged with SANAC to finalise a sustainability framework.

A collective of activist organisations, including the Health Justice Initiative, SECTION27, the Cancer Alliance, Treatment Action Campaign, Sweat, PSAM and the African Alliance, have pressed the Department of Health to create an “urgent co-ordinated emergency plan” along with an increased budget to avert a looming disaster.

The activists highlighted that despite the announcement by the Trump administration that some NGOs could apply for a waiver, many have had no practical way to do so without ways to communicate with their USAID contacts. This as USAID employees were placed under a work stop order and were shut out of their offices and denied access to their work emails.

The appeal from the collective also extends to protecting the work of academic and clinical research in the fields of HIV, TB, and cervical cancer that will also be affected by the funding freeze. As Spotlight reported, around 28% of the South African Medical Research Council’s budget for 2025/2026 was set to come from the United States government.

An ‘unreal world’

Professor Linda-Gail Bekker, chief executive officer at the Desmond Tutu Health Foundation, said Trump’s actions put in jeopardy the goal to finally have epidemic control of HIV – and right at the final hurdles.

“We have made amazing progress. And thank you to PEPFAR that helped us to get this far, but the work is not over. For the US to pull out at this point is a massive loss of investment; it’s also regression. It’s like getting to the end of a book but having the last chapters torn out before you can read it,” said Bekker.

She said PEPFAR funding has made it possible to build a formidable cohort of lay and professional people trained and dedicated to their roles that supported public healthcare in the most critical ways.

“These are individuals who distribute antiretrovirals, distribute pre-exposure prophylaxis, find and trace individuals who’ve been lost to care. They take services into communities, to outside of the health facilities, and made the effort to go the last mile to find those individuals – that is how you close down the epidemic,” Bekker said.

Her caution too is that loosening a grip on HIV control means potential surges in tuberculosis. “HIV and TB track together all the time, and an HIV epidemic that is once again out of control, almost certainly means what will follow is a TB epidemic that is out of control,” Bekker said.

Trump has created an “unreal world”, said Dr Andy Gray of the University of KwaZulu-Natal, who has also worked with the World Health Organization (WHO) in various capacities over two decades. “People are being held to ransom; and people are scared.”

“We have always been used to the oscillation between the United States’ Republican and Democratic administrations; things may be a little uncomfortable or there may be some disruption, but not this ‘let’s burn down the house’ approach taken by the Trump administration,” he said.

“There is no consideration of human rights or for human beings anywhere in the world, including America,” he added, pointing out too that the CDC has for the first time in 60 years been instructed to cease publishing weekly mortality and morbidity data, despite a breakout of avian flu (H5) in the country.

For Gray, South Africa’s strategic health response in the wake of this crisis should be to shift from a donor-funded model. His concern, however, is that with a stretched South African purse and with competing priorities, the HIV response will slip down the list.

Gray said that better self-sufficiency comes from eliminating waste, investing in employing the right people in the right jobs as well as investing in efficient systems.

He added that National Treasury will have to redirect money for the interim shortfall left by the US funding freeze, and provinces will have to step up by getting their houses in order.

South Africa, he warned, should ready itself for the “worst case scenario” once the 90-day review period is up.

SANAC response

The South African National AIDS Council (SANAC) role is meant to bring together government, civil society and the private sector to create a collective response to HIV, TB and STIs in South Africa. But if there is a crisis strategy from the council, it has not yet been announced.

SANAC head of communications, Nelson Dlamini, said that they have been left in a position of not being able to engage publicly because they haven’t had any direct communication with PEPFAR’s and USAID representatives based in Pretoria.

“PEPFAR is a government-to-government agreement and there ought to be official communication with the government of South Africa so we know what this means for our working relationship, but nothing has been forthcoming,” said Dlamini. “SANAC is a co-ordinator so we have to still coordinate. We are engaging in the background with relevant structures but we can’t say we are doing X, Y, Z till we have a sit down with PEPFAR,” he said.

Republished from Spotlight under a Creative Commons licence.

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Categories : Healthcare Politics and Regulations HIVTags : 12/2/25 budget cuts clinical trials HIV prophylaxis international aid South Africa Spotlight USA

SA Health Research Facing Catastrophic Financing Cuts

On February 12, 2025February 12, 2025 By ModernMedia

Professor Ntobeko Ntusi is the president and CEO of the South African Medical Research Council. (Photo: SAMRC)

By Catherine Tomlinson

Cuts to United States funding of health research could have “catastrophic” consequences, says Professor Ntobeko Ntusi, who is at the helm of the country’s primary health research funder. He says the South African Medical Research Council is “heavily exposed” to the cuts, with around 28% of its budget coming from US federal agencies.

After an unprecedented two weeks of aid cuts by the United States government that left HIV programmes and research efforts across the world reeling, the Trump administration took the drastic step of freezing aid to South Africa in an executive order on 7 February.

The order – which is a directive to the executive branch of the US government and holds the weight of law – was issued to respond to what the White House called “egregious actions” by South Africa. It specifically points to the Expropriation Act and the country’s accusation of genocide against Israel at the International Court of Justice as the primary reasons for the funding freeze.

While there are some limited wavers and exceptions to the cuts, Spotlight understands that these have so far been poorly communicated and many HIV services remain in limbo.

The funding cuts, following an earlier executive order issued on 20 January, are interrupting critical health research underway across South Africa and will ultimately undermine global efforts to stop HIV and TB.

The US is a major source of financing for health research in South Africa. Many of the country’s research institutes, groups, and universities receive funding from the US through the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), USAID, and the President’s Emergency Plan for Aids Relief (PEPFAR).

Over the past few weeks, these funding sources have come under siege by the Trump administration resulting in a gaping, and most likely insurmountable financing gap, for many health research endeavors in the country.

US spending accounts for just over half (55%) of all spending on global health research around the world. In 2022, the super power spent $5.4 billion on global health research, according to Impact Global Health – an NPO that tracks health research spending.

While the US gives money to global health research through several different government departments and programmes, the largest source of funding for global health research is the NIH. The NIH contributed 65% of global financing for HIV research between 2007 and 2022, according to Impact Global Health and 34% of tuberculosis research financing in 2023, according to New York-based policy think tank, the Treatment Action Group.

South Africa has the biggest HIV epidemic in the world in absolute terms and is among the top 10 countries in terms of TB cases per capita.

Catastrophic consequences

“South Africa is the biggest recipient of NIH funding outside of the US”, Professor Ntobeko Ntusi, president and CEO of the South African Medical Research Council (SAMRC), told Spotlight. “[T]he consequences will be catastrophic if [funding] is stopped… for science that is important for the whole world,” he said.

South Africa plays a critical role in advancing HIV science, said Ntusi, adding that “many of the major trials that have advanced our understanding of both the effective strategies for HIV management, as well as understanding the mechanisms of disease emanated from South Africa”.

People in the US, for example, are now able to access long-acting HIV prevention shots, largely because of research that was conducted in South Africa and Uganda. Research conducted in South Africa has also been critical to validating new tuberculosis treatments that are currently the standard of care across the world.

Heavily exposed

Stop work orders were sent to research groups receiving USAID funding at the end of January. These stop work orders coupled with the halting of funding have already interrupted critical HIV research efforts, including efforts to develop new vaccines against HIV.

Ntusi said that the SAMRC is currently “heavily exposed” to the halting of grants from USAID and the CDC, with research programmes supported by USAID and the CDC already being stopped.

The SAMRC’s research on infectious diseases, gender-based violence, health systems strengthening, as well as disease burden monitoring are also affected by the funding cuts.

“In addition to support for HIV research, we have significant CDC grant funding in our burden of disease research unit, the research unit that publishes weekly statistics on morbidity and mortality in South Africa,” said Ntusi. “Our health systems research unit has a number of CDC grants which have been stopped [and] in our gender and health research unit we had a portfolio of CDC funding which also has been stopped.”

Along with programmes being impacted by the halting of USAID and CDC funding, Ntusi said there will also be major staffing ramifications at the SAMRC as well as at universities.

He said that if funding from the NIH is stopped “there would be huge fallout, we just wouldn’t be able to cover the hundreds of staff that are employed through the NIH granting process”.

The SAMRC’s combined annual income from US grants (NIH, CDC and USAID) is 28% of its total earnings (including both the disbursement from the SA government as well as all external contracts) for the 2025/2026 financial year, according to Ntusi. “So, this is substantial – effectively a third of our income is from US federal agencies,” he said.

Pivot away from infectious disease?

In addition to the executive order freezing funding to South Africa, it is unknown whether the NIH will remain a dominant funder of global health. Robert F. Kennedy Jr., the US health secretary nominee, has called for cutting to the NIH’s infectious disease research spending to focus more on chronic diseases.

Looking beyond health, Ntusi said the executive order halting aid to South Africa will be felt across a range of different development initiatives such as water and sanitation, and climate change.

Republished from Spotlight under a Creative Commons licence.

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Categories : Healthcare Politics and RegulationsTags : 11/2/25 GroundUp international aid NGO Spotlight

Over 15 000 South African Health Workers’ Jobs are at Risk as US Cuts Aid

On February 11, 2025February 11, 2025 By ModernMedia

By Jesse Copelyn

If the US President’s Emergency Plan for AIDS Relief (PEPFAR) is halted, the South African public health system “will face a severe crisis” that could endanger millions of lives. This is according to a coalition of 17 health service organisations in South Africa, including large ones such as Anova Health, Health Systems Trust, TB HIV Care, The Aurum Institute and Wits RHI.

In a statement, they appealed to private sector donors and “high net-worth individuals” to help fund the shortfall caused by US aid cuts.

Read the statement

PEPFAR is a multi-billion dollar US initiative that supports HIV and TB-related health services around the world. In South Africa alone, over 15 000 staff (mostly health workers) are funded by PEPFAR, according to the national health department.

But a series of executive orders issued by US President Donald Trump has suspended some of this funding and the rest remains precarious. The orders include a 90-day pause on all US foreign development assistance and another that explicitly bars South Africa from aid (with some leeway allowed).

Some health service providers in South Africa continue to receive money from PEPFAR under a limited waiver that allows for the continuation of certain “life-saving HIV services”. But the waiver hasn’t protected all PEPFAR beneficiaries. As a result, some organisations have had to close their doors, while many others have had to curtail what they can provide.

The waiver doesn’t cover all health services, and many health programs that target high-risk groups (such as people who use drugs) have not been protected. This is even if they provide life-saving HIV services.

Services suspended for the most vulnerable

Under the waiver, PEPFAR can continue to fund programs that offer treatment and testing for HIV, including antiretroviral (ARV) services. Projects can also continue to provide condoms and HIV prevention medication, known as PrEP, but only to pregnant and breastfeeding women.

The waiver does not allow for continued funding of PrEP medication or condoms to anyone else. It also doesn’t cover crucial research, like population surveys which tell us how many people have HIV and where they’re located. Additionally, it doesn’t allow for continued funding of methadone maintenance programs for people who use heroin. This is despite the fact that this is the most effective way to help people to stop using heroin and to curb the sharing of drug needles (something which contributes to the spread of HIV).

Dr Gloria Maimela, who represents the coalition of organisations behind the statement, told GroundUp and Spotlight: “The staff who are providing [HIV] testing and treatment [are] back at facilities to provide those services, but staff that are providing other services not included in the waiver have been stopped, and are waiting for further guidance.”

In addition, organisations that help key populations have not been protected by the waiver, according to Maimela. Key populations are groups that are more at risk of becoming infected with HIV, such as people who inject drugs, sex workers, transgender people, and men who have sex with men. South African policy documents and the World Health Organisation recommend that health programs focus on these groups since they’re more likely to acquire and transmit HIV.

Despite this, US-funded organisations that target key populations have been forced to shut their doors in South Africa. Maimela says that this is even in cases where they were offering the kind of life-saving ARV treatment covered in the waiver.

“For us, this is of grave concern,” Maimela says, “because we know that right now that is where most of the [HIV] infections lie”.

So far, organisations which provide HIV treatment and prevention services to LGBTI people have been forced to shut down, including the Ivan Toms Centre and Engage Men’s Health.

Additionally, GroundUp and Spotlight have identified two PEPFAR-supported harm reduction centres that have had to close. These centres provided methadone and clean needles to people who inject drugs (when drug users have access to clean needles, they’re less likely to resort to sharing them, which brings down HIV transmission).

Ricardo Walters, who provides consulting services to health service organisations across Africa, told Spotlight and GroundUp that a similar trend could be seen across the continent.

“Many organisations that were specifically offering services to key populations were not suspended; their project funding was terminated,” he said. “They will not be coming back.”

These organisations were assisting patients “who often could not access services in a general [health] setting”.

Walters says the reasons given for the termination of these programs vary across organisations and countries.

“Where there are reasons, it’s often [stated] that it’s because the program contains components of DEIA [Diversity, Equity, Inclusion and Accessibility] and gender ideology, which is directly from a previous executive order [in which the Trump administration terminated all federal funding for DEIA]. The terms are never defined … no one says don’t treat gay men.”

Appeal to private sector

Beyond the shuttering of existing organisations, providers that are covered under the waiver remain unsure about whether funding will restart after the 90-day period. Also large sections of the US aid establishment have been gutted.

The recent statement by health organisations argues that if this aid is terminated “patients, including children, will lose access to life-saving antiretroviral treatment, while thousands of healthcare workers will be unable to provide essential HIV care. The consequences will be immediate. Fewer people will receive timely testing and treatment, leading to more undiagnosed cases, rising infections, and the spread of drug resistance. Mortality will increase, opportunistic infections will surge, and TB rates will escalate – putting the entire population at risk.”

As such, the statement calls on private corporations, donors and philanthropists to assist in supporting these health services.

“We encourage people to get in touch with us,” says Maimela, “so that even as we hold dialogues with the government, [those people] could be part of [the conversation] and step in and say how they want to help.”

To find out how to support organisations that provide HIV and TB related health services in South Africa contact Gloria Maimela at gloriam@foundation.co.za.

Published jointly by GroundUp and Spotlight.

Republished from GroundUp under a Creative Commons Attribution-NoDerivatives 4.0 International License.

Categories : General Interest Healthcare Politics and RegulationsTags : 8/1/25 NHI South Africa Spotlight

Health in 2024: The Year in Fewer than 1000 Words

On January 8, 2025January 8, 2025 By ModernMedia

By Marcus Low and Adiel Ismail

From the NHI Act to major advances in HIV prevention, it has been another busy year in the world of healthcare. Spotlight editors Marcus Low and Adiel Ismail recap the year’s health developments and identify some key trends in fewer than 1000 words.

For a few weeks in June, it seemed that the surprising outcome of South Africa’s national and provincial elections would usher in far-reaching political and governance changes in the country. As it turns out, some significant changes did come, but not in the health sector.

Rather than a new broom, it was déjà vu as Dr Aaron Motsoaledi returned as Minister of Health – he was previously in the position from 2009 to 2019. In both Gauteng and KwaZulu-Natal – the country’s most populous provinces – ANC MECs for health from before the elections kept their jobs. The ANC garnered well under 50% of the votes in both of those provinces and nationally and accordingly had little choice but to form national and provincial coalitions.

To be fair, five of the nine MECs appointed after the elections were new, but these changes were mainly in the less populous provinces.

Policy-wise, the trajectory also remains much as it was a year ago. Two weeks before the elections, President Cyril Ramaphosa signed the National Health Insurance (NHI) Act into law (though most of it has not yet been promulgated). While Ramaphosa has since then asked Business Unity South Africa (BUSA), the country’s largest employer association, for new input on NHI and while talk of mandatory medical scheme cover had a moment in the headlines, there is no solid evidence that the ANC is open to changing course – if anything, Motsoaledi has doubled-down in the face of criticism. The Act is being challenged in various court cases.

The sense of discord in healthcare circles was further deepened in August when several organisations distanced themselves from Ramaphosa’s updated Presidential Health Compact. The South African Medical Association, the South African Health Professionals Collaboration—comprising nine associations representing over 25 000 public and private healthcare workers—and BUSA all declined to sign the accord. BUSA accused government of “unilaterally” amending the compact “transforming its original intent and objectives into an explicit pledge of support for the NHI Act”.

Away from these reforms, a trend of health budgets shrinking year-on-year in real terms continued this year. This funding crunch, together with well-documented shortages of healthcare workers, has meant that even well-run provincial health departments are having to make impossible trade-offs – that while governance in several provincial health departments remains chronically dysfunctional. This was underlined by a landmark report published in July that, among others, highlighted leadership instability, lack of transparency, insufficient accountability mechanisms, and pervasive corruption. New reports from the Auditor General also didn’t paint a pretty picture.

Gauteng health has again been in the headlines for the wrong reasons. The provision of cancer services in the province remains mired in controversy as the year comes to an end, with plans to outsource some radiation services to the private sector apparently having stalled, despite the health department having the money for it. A deal between the department and Wits University was also inexplicably derailed. With high vacancy rates, serious questions over senior appointments, reports of corruption at Thembisa Hospital, and much more, it seems that, if anything, governance in the province has gotten even worse this year.

In a precedent-setting inquest ruling in July, Judge Mmonoa Teffo found that the deaths of nine people moved from Life Esidimeni facilities to understaffed and under-equipped NGOs “were negligently caused by the conduct of” former Health MEC Qedani Mahlangu and former head of the provincial health department’s mental health directorate Dr Makgabo Manamela.

Outside our borders, Donald Trump’s election victory in the United States is set to have far-reaching consequences. A return of the Global Gag Rule seems likely, as does major changes to the Food and Drug Administration, the President’s Emergency Plan for AIDS Relief, and the National Institutes of Health – the latter funds much HIV and TB research in South Africa.

Away from politics and governance, the biggest HIV news of the year came in late June when it was announced that an injection administered every six months was extremely effective at preventing HIV infection. It will likely be several years before the jab becomes widely available in South Africa.

Another jab that provides two months of protection per shot is already available here, but only to a small number of people participating in implementation studies.

It is estimated that around 50 000 people died of HIV related causes in South Africa in 2023 and roughly 150 000 were newly infected with the virus (reliable estimates for 2024 will only be available in 2025). A worrying one in four people living with HIV were not on treatment in 2023. There was an estimated 56 000 TB deaths and around 270 000 people fell ill with the disease. While these HIV and TB numbers have come down dramatically over the last decade, they remain very high compared to most other countries.

There are some concerns that a new TB prevention policy published in 2023 is not being universally implemented. We have however been doing more TB tests, even while TB cases are declining – as we have argued, this is as it should be. Also positive, is that a massive trial of an TB vaccine kicked off in South Africa this year.

With both TB and HIV, South Africa is making progress too slowly, but we are at least trending in the right direction. With non-communicable diseases such as diabetes, there are unfortunately signs that things are getting worse. As we explained in one of our special briefings this year, our diabetes data in South Africa isn’t great, but the little we have painted a worrying picture. As expected, access to breakthrough new diabetes and weight loss medicines remained severely constrained this year, largely due to high prices and limited supply.

Ultimately then, at the end of 2024, South Africa is still faced with chronic healthcare worker shortages, severe governance problems in several provinces, and major uncertainties over NHI – all while HIV and TB remains major public health challenges, though a shift toward non-communicable diseases is clearly underway.

Republished from Spotlight under a Creative Commons licence.

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Categories : Medical Industry Respiratory DiseasesTags : 9/12/24 pharmaceuticals Spotlight TB drugs tuberculosis

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

On December 9, 2024December 9, 2024 By ModernMedia

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 : 3/12/24 Gauteng Department of Health public health Spotlight

Critics Raise Alarm over Leadership Issues at Gauteng Health Department

On December 3, 2024December 3, 2024 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 : 25/11/24 healthcare workers pharmacists public health South Africa Spotlight

The High Cost of Having Too Few Pharmacists in SA

On November 25, 2024November 25, 2024 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 : 25/10/24 NHI primary healthcare public health Spotlight

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

On October 25, 2024October 25, 2024 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 : 18/10/24 HIV prophylaxis lenacapavir Spotlight

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

On October 18, 2024October 18, 2024 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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