Latest news with #Sahpra
The Citizen
08-08-2025
- Health
- The Citizen
Weighing in: How South Africa's Ozempic attraction measures up globally
A doctor stated that although Ozempic has been available in South Africa for several years, its popularity has recently surged due to social media and celebrity influence. The lure of a shortcut, combined with the power of influence, could be fuelling South Africa's growing attraction to Ozempic. A recent report ranked South Africa fifth on a list of nations attracted to Ozempic based on metrics used to gauge interest in the medication. Despite researchers factoring in obesity rates, professionals have warned that Ozempic is not designed to treat obesity, but is a type 2 diabetes medication that requires a tailored diagnosis. Ease of Ozempic access Hailed as a weight-loss wonder drug, Ozempic is a semaglutide that increases insulin secretion, slows gastric emptying and reduces appetite. Researchers from Journo Report compiled data from 18 countries ranking internet search volumes, media mentions, obesity rates and regulatory restrictions. South Africa was the only African nation mentioned in the research report, which featured five countries from Asia and Oceania, four from the Americas, and eight from Europe. Ireland topped the charts based on interest, access and demand, with South Africa coming in fifth behind the United Arab Emirates (UAE), Mexico and Canada. 'South Africa also offers a relatively open regulatory environment, allowing broader access to Ozempic than many developed nations,' stated researchers. Of the nations analysed, France, Spain and Australia had the most stringent access regulations, while Mexico, South Africa and the UAE were at the opposite end of the regulatory scale. Ozempic is a schedule four medication, but South Africans were increasingly obtaining the product 'off-label'. Researchers stated that the UAE and Mexico had high rates of interest and easy access, while Canada's universal healthcare system allowed for easy distribution for diabetes, but limited access for weight loss. Local obesity rate South Africa's obesity rate of 32.8% was 7% higher than the average but lower than Ireland, the UAE and Mexico, and well below the US, which tipped the statistical scales at 45.6%. Obesity refers to an individual with a body mass index — a calculation using height and weight to estimate body fat — of 30 or higher. The report showed that Ozempic had a relatively small media presence in South Africa, averaging roughly 375 media mentions per month, compared to the 150 000 per month in the US. Based on internet behaviour, the Netherlands, Ireland and the United Kingdom (UK) had the highest per capita search volumes with 1 913, 1 844 and 1 733 searches per 100 000 people, respectively. The United States (US) and Australia registered 1 323 and 1 633 Ozempic-related internet searches per capita, but, like the UK, have stricter access, pushing them down the overall table. ALSO READ: Falsified Ozempic products flood the market, Sahpra urges caution Data from the World Obesity's Global Obesity Observatory shows South Africa has a growing overweight and obese population. In 1998, only 10% of men were considered obese, with 28% of women meeting that description. By 2022, those numbers had risen to 15% and 41%, respectively. Temporary results Medical practitioner Dr Marlin Mackay said Ozempic had been in the South African market for several years, but had only recently seen a rise in popularity due to social media prominence. He stated that initially there was a shortage of stock, but that supply has since caught up with demand. ALSO READ: How to treat diabetes McKay confirmed there were no generics on the market, only fake copies that were not approved by the South African Health Practitioners Regulatory Authority. 'Firstly, Ozempic is meant for type 2 diabetes and is not supposed to be a treatment for obesity,' said McKay, stressing that obesity is a chronic condition that requires long-term treatment. 'Patients need to be counselled and treatment needs to be individualised. 'Ozempic should not be used as a quick fix,' warned McKay. He warned that those with a family history of thyroid cancer should not use Ozempic and that a professional diagnosis should be obtained to 'understand the mechanisms' of their own bodies. McKay stressed that any weight-loss results would be temporary unless the underlying conditions are properly addressed. 'What patients don't realise is that as soon as they stop using it, there will be corresponding weight gain,' the doctor concluded. NOW READ: Billions' worth of weight loss and diabetes medications reached SA shelves and patients in 2024
The Citizen
29-07-2025
- Business
- The Citizen
Fake licence and ballooned budget: PwC report places IDT seniors at centre of R800m oxygen tender
A forensic report has found that the IDT awarded a major oxygen plant contract to an unqualified company using a fraudulent Sahpra licence. The Independent Development Trust (IDT) awarded a multi-million oxygen plant project tender to a company that did not have a valid South African Health Products Regulatory Authority (Sahpra) license. This is according to a report by auditing firm PricewaterhouseCoopers (PwC), which looked into the R836-million oxygen plant tender to supply oxygen systems to 60 state hospital facilities across the country. Fraudulent license submission exposed The report was released by Public Works and Infrastructure Minister Dean MacPherson at a media briefing in Pretoria on Tuesday. It revealed that Bulkeng Pty Ltd fraudulently submitted a Sahpra license that belonged to a different company. IDT, the government's built environment project management agency, awarded Bulkeng a R428 million tender on behalf of the Department of Health to install pressure swing adsorption (PSA) oxygen plants. 'Bulkeng Pty Ltd submitted a Sahpra license belonging to Atlas Copco Industrial SA without the knowledge or consent of Atlas Copco. This was a clear misrepresentation. In simple language, it's called fraud,' MacPherson said. Furthermore, Bulkeng has a Construction Industry Development Board grading threshold of R200 million, which means it did not qualify to be awarded a project of that value. Additional contractors lacked Sahpra approval MacPherson said the report also revealed that seven other companies were awarded contracts without valid Sahpra licences. ALSO READ: Macpherson suspends all EPWP funds to municipality 'The service providers that were appointed on the panel were, however, not required to provide evidence that they meet the Sahpra requirements as set out in the Infrastructure Programme Implementation Plan,' the minister said. Project costs soared without explanation Another alarming finding was that a R216 million budget ballooned to R592 million without justification. MacPherson said the Department of Health requested to approve increased funding for the rollout and implementation of the plant projects to R590 million—more than double what the original starting estimate was. 'This project was therefore increased by a staggering 174% from the initial estimated budget.' He said the international financing organisation Global Fund and the health department approved the increased budget, despite one of the initial conditions in 2022 being that the total cost of the project would not exceed R216 million. The report also singled out Dr Molebedi Sisi, IDT's general manager of supply chain management, for his 'role in misleading internal stakeholders and failing to act in accordance with his responsibilities'. MacPherson said Sisi advised against cancelling the Request for Quotation Process of the tender bidding, despite clear warnings from the Department of Health. 'He assured the [IDT] CEO and evaluation committees that the procurement process was compliant, when in fact key regulatory requirements such as valid Sahpra licences had not been enforced.' ALSO READ: 'Extend that apology to black South Africans,' says ActionSA over Macpherson's hobo comment Instead, both the CEO, Tebogo Malaka, and Sisi approved contracts, he said. IDT executives named for misleading and inaction The report revealed that Malaka failed to exercise oversight and relied entirely on internal supply chain management staff to assure her that the processes had followed proper procurement protocol. 'She did not verify any of the documentation. She did not act on any of the red flags raised by the Department of Health.' PwC investigation followed media exposé As a result of these findings, the minister said disciplinary action was recommended against the senior officials involved. The Department of Public Works appointed PwC to conduct a full independent forensic investigation into the PSA oxygen plant on 15 January, following a related exposé by the Daily Maverick three months prior. MacPherson said investigators conducted over 40 interviews with departmental officials, IDT executives, contractors and oversight stakeholders over six months. They reviewed more than 90 procurement documents and analysed financial records. The minister said he was already aware of the long-standing and serious allegations of financial misconduct and corruption at the IDT from the moment he stepped into his role. NOW READ: Minister hails SIU's R67 million recovery from 'corrupt' state contractor
News24
17-07-2025
- Health
- News24
Mpox vaccines rolled out in SA amid increase in cases
Around 10 500 mpox vaccines will be rolled out, the Department of Health has said. The vaccines have been supplied by the Africa Centres for Disease Control. The rollout comes amid an increase in cases in Gauteng and the Western Cape. The Department of Health is rolling out vaccinations against Mpox, amid a rise in cases. The vaccinations will target the most affected provinces: Gauteng, Western Cape and KwaZulu-Natal. The department received 10 500 doses of the mpox vaccine, Imvanex, as a donation from the Africa Centres for Disease Control to combat outbreaks on the continent. The South African Health Products Regulatory Authority (Sahpra) authorised the importation of the vaccine through a Section 21 process, which covers the sale and use of medicines not yet registered in South Africa, said department spokesperson Foster Mohale. The rollout comes after two laboratory-confirmed cases were recorded in Gauteng and the Western Cape. The cumulative number of confirmed cases recorded this year is now 10. The two new cases include a 32-year-old from Cape Town and a 45-year-old from Johannesburg. Both of them had no travel history, said Mohale. 'Vaccination helps to control the spread of this preventable and manageable disease, with vaccinated individuals being protected from becoming infected and from developing severe complications. Vaccination can be accessed at some public health facilities, travel clinics, and private providers in the above-mentioned provinces,' he added. Mohale urged the public to be 'extra vigilant of mpox symptoms' and to consult their nearest health facility about vaccinations if they suspect they are at risk of mpox infection. 'Priority will be given to people at a higher risk of contracting the virus, including those who came into close contact with people who tested positive, people with multiple sexual partners and travellers going to areas where there is an outbreak of mpox. Where indicated, vaccination will be offered to pregnant women and children older than two years,' he said. He added that the National Control Laboratory had tested the vaccine to establish its safety and efficacy before its release on the South African market, and that it was found to be safe. Mohale said: As with any vaccine, some people may experience mild to moderate side effects after being vaccinated. This is a normal sign that the body is developing some level of immunity to prevent the severity of the disease if infected. 'Several countries, including the Democratic Republic of Congo, Nigeria, Uganda, the United States, Canada and European countries, have utilised the mpox vaccine to control the spread of the disease,' Common side effects that might be experienced following immunisation include pain, redness, swelling and itching at the injection site; muscle pain; headache; nausea; and fever. However, most side effects disappear on their own within a few days without treatment. These side effects can be managed by having enough rest, staying hydrated and taking medication to manage pain, if needed. Mohale said the number of mpox vaccine doses allocated to South Africa was limited, and quantities would be issued in a phased approach, prioritising outbreak hotspots, and based on vaccine availability. READ | Mpox outbreak: New variant, local transmission sparks concern among Gauteng health officials In March, health authorities said an outbreak of mpox cases in Gauteng was being driven by a new variant, and healthcare officials say they are concerned by signs that there could be a local transmission of the virus. News24 previously reported that, in February and March, seven cases were confirmed in Gauteng in two distinct clusters. While the first cluster could be traced to a patient with an international travel history, the second cluster showed no travel history or links to the first patient. The World Health Organisation's epidemic, preparedness and response team leader, Dr Joseph Wamala, added that more than 130 000 cases, with 300 deaths, had been reported across 131 countries. In February alone, 3 000 new cases were reported, with the majority of those from Africa. While this represents a month-on-month decrease of 18%, the drop could be due to conflict in the DRC disrupting testing, as well as the cancellation of funding to African countries.
Daily Maverick
16-07-2025
- Health
- Daily Maverick
SA gets R520m to buy twice-a-year anti-HIV jab — but there's a snag
The money is not nearly enough to put two to four million people per year in South Africa on the lenacapavir jab, and even if it were, the country's health system won't be able to roll out the medicine that fast, scientists and policymakers say. South Africa has accepted an offer of just over $29-million (about R520-million) from the Global Fund to Fight Aids, TB and Malaria to buy the twice-a-year anti-HIV jab, lenacapavir, that research shows could help to end Aids in the country, says Health Department spokesperson Foster Mohale. But there's a snag. The country isn't getting extra money from the fund to buy the medicine; it has to use cash from a grant that it has already been awarded and that was cut by 16% in June. Moreover, the fund, at this stage, won't tell the Health Department – or any of the other eight countries it has selected for early roll-out – how much they're paying lenacapavir's maker, Gilead Sciences, for the product. Boitumelo Semete-Makokotlela, the CEO of the country's medicine regulator, the South African Health Products Regulatory Authority, Sahpra, told Bhekisisa it is aiming to have lenacapavir registered in South Africa before the end of the year. According to the Health Department's head of procurement, Khadija Jamaloodien, the lenacapavir funds from the Global Fund will become available in October, when the roll-out period of South Africa's next grant, known as Grant Cycle 7, kicks in. But roll-out – likely to be in early 2026 – can only start once Sahpra has registered the medicine, the country's essential medicines list committee has reviewed and recommended lenacapavir, procurement processes are in place and health workers and clinics have all they need to hand the drug safely to patients. Two studies released in 2024 showed the medicine completely protects young women from contracting the virus and works almost as well for men, transgender and gender-nonbinary people. In fact, a modelling study shows that if between two and four million HIV-negative people in South Africa use the jab every year over the next eight years, the medication could end Aids as a public health threat by 2032. Ending Aids as a public health threat means reaching a stage where fewer people are getting newly infected with HIV than the number of people with HIV who are dying (increasingly for other reasons than HIV, for example old age). According to the latest Joint United Nations Programme on HIV and Aids (UNAids) report, which was released last week, 170,000 people were newly infected with HIV in 2024, while there were 53,000 Aids-related deaths. The Global Fund money for South Africa is, however, not nearly enough to put two to four million people per year in South Africa on the lenacapavir jab (see price explanation below) – and even if it were, the country's health system won't be able to roll out the medicine that fast, scientists and policymakers say. Will the US help to pay for the jab? The fund's offer follows the body's announcement on 9 July that it has the 'ambition' to finance enough lenacapavir for two million HIV-negative people – in the low- and middle-income countries it supports – over the next three years. But fulfilling this ambition will depend on whether the governments of wealthy countries give enough money to the fund in its next replenishment round. The US government's Aids fund, Pepfar, was originally going to help to pay to roll out lenacapavir in poorer countries. And, although some activists say it's still possible for the US administration to come on board (lenacapavir is mentioned in President Donald Trump's budget proposal for the next financial year, but is understood to be only for pregnant and breastfeeding women), it's not clear at all how this might happen after the Trump administration's drastic cuts to funding for HIV projects in countries like South Africa this year. The Global Fund's offer, however, is a way to get branded, 'bridging' doses from Gilead to South Africa while the world waits for cheaper generics to become available around 2027. 'We now stand at a moment of reckoning and a moment of choice,' Mitchell Warren, the executive director of the international advocacy organisation, Avac, told Bhekisisa at the 13th conference on HIV science in Kigali this week. 'While a lot of the choices over the last six months have been made by an American politician [Donald Trump] who doesn't care about the pandemic or science generally, our choice is to make decisions based on the science that we all now know. Which is that lenacapavir is our most potent opportunity.' Countries have to budget just under R600 per dose Jamaloodien, however, cautions further discussions with the Global Fund and Gilead will be needed about the governance around the pricing of the product. 'We have a transparent pricing system, guided by the Public Finance Management Act. Even if we procure medicine with Global Fund money, we have to follow the same rules that the Treasury requires us to follow with tenders, which includes revealing the price at which the medicine is bought,' Jamaloodien says. In a Global Fund letter sent in early July to the nine early roll-out countries (South Africa, Zimbabwe, Eswatini, Lesotho, Zambia, Mozambique, Kenya, Uganda and Nigeria) the fund asked the governments to budget for $60 (about R1,076) per patient per year ($30, or R576, per six-monthly dose), to buy lenacapavir. But in the document, which Bhekisisa has seen, the fund makes it clear that the amount 'reflects the country contribution only, to be used for budgeting purposes, and should not be considered the product price'. Jamaloodien has confirmed to Bhekisisa that the Health Department did receive such a letter. The letter also says that the gap between the price that the fund pays Gilead per patient per year and the $60 that countries will pay for with their Global Fund grants, will be covered by private sector funding, which Hui Yang, the fund's head of supply operations, confirmed to Bhekisisa will be paid for by a $150-million (about R2.68-billion) donation of the UK-based Children's Investment Fund Foundation to the Global Fund. Furthermore, says Jamaloodien, South Africa's letter instructs the country to submit its first order, for planning purposes, by 30 September under an 'agreed procurement mechanism'. Why does Gilead not want to talk about LEN's price? Lenacapavir, also referred to as LEN, was registered for HIV prevention – also called PrEP – by the US medicines regulator, the Food and Drug Administration, on 18 June and is sold in that country for $28,218 (about R505,269) per person per year under the trade name Yeztugo. The US is the only country in which LEN has been registered so far as PrEP. For low- and middle-income countries such as South Africa, Gilead, however, said it will have a 'not-for-profit' price such as the one they negotiated with the Global Fund, but isn't allowing the fund to make it public. Several scientists and activists at the HIV science conference have, however, told Bhekisisa the rumoured not-for-profit price that Gilead has negotiated with the fund is $100 per person per year, and Avac confirms it in its analysis of events. But neither Gilead or the Global Fund have confirmed this amount. If South Africa budgets for $60 per person per year, the $29.2-million that the Global Fund says we can use to buy lenacapavir translates to putting and keeping about 400,000 people on the medicine over three years (Global Fund grants run for three years at a time). Gilead argues that, because the not-for-profit price is based on the actual cost of making lenacapavir, and shipping it to countries, it can't declare that cost. 'Gilead doesn't publicly disclose manufacturing costs for any of our medications,' Caroline Almeida, Gilead's head of public affairs, told Bhekisisa in Kigali. But activists don't buy this argument. 'Gilead's secrecy will obstruct civil society activism for lower drug prices and keep prices high in middle-income countries [such as South Africa] where Gilead negotiates prices directly,' the Health Justice Initiative and other activist groups said last week. Avac has identified 16 top lenacapavir markets, of which South Africa is, by far, the largest because of the country's high number of new HIV infections. The country's 170,000 new infections in 2024 is 13% of the 1.3 million new HIV infections around the world in 2024. And research released by Wits RHI on Tuesday in Kigali shows South Africans are open to using the jab: 56% of just more than 1,700 participants in a survey in Tshwane, Mthatha and Gqeberha, who were already using public sector HIV prevention services, said they would take a lenacapavir shot. But for LEN to be affordable, activists argue, Gilead needs to be open about its price. 'Such secrecy undermines the power of buyers to negotiate affordable prices and violates the human rights of all people to access information and lifesaving tools,' activists said in last week's press release. Warren concludes: 'Pricing transparency has been a long-standing challenge, as companies try to balance their commercial pricing and marketing strategies with their global public health strategies. We clearly need a new model or compact for pricing that helps break the cycle of small thinking and limited impact.' DM
TimesLIVE
16-07-2025
- Health
- TimesLIVE
SA gets R520m to buy the twice-a-year anti-HIV jab — but there's a snag
South Africa has accepted an offer of just over $29m (about R520m) from the Global Fund to Fight Aids, TB and Malaria to buy the twice-a-year anti-HIV jab, lenacapavir, that research shows could help to end Aids in the country, says health department spokesperson Foster Mohale. But there's a snag. The country isn't getting extra money from the fund to buy the medicine; it has to use cash from a grant that it has already been awarded and that was cut by 16% in June. Moreover, the fund, at this stage, won't tell the health department — or any of the other eight countries it has selected for early rollout — how much they're paying lenacapavir's maker, Gilead Sciences, for the product. Boitumelo Semete-Makokotlela, the CEO of the country's medicine regulator, the South African Health Products Regulatory Authority (Sahpra), told Bhekisisa it aims to have lenacapavir registered in South Africa before the end of the year. According to the health department's head of procurement, Khadija Jamaloodien, the lenacapavir funds from the Global Fund will become available in October, when the rollout period of South Africa's next grant, known as Grant Cycle 7, kicks in. But rollout — likely in early 2026 — can only start once Sahpra has registered the medicine, the country's essential medicines list committee has reviewed and recommended lenacapavir, procurement processes are in place and health workers and clinics have all they need to hand the drug safely to patients. Two studies released last year showed the medicine completely protects young women from contracting the virus and works almost as well for men, transgender and gender-nonbinary people. In fact, a modelling study shows that if between two and four million HIV-negative people in South Africa use the jab every year over the next eight years, the medication could end Aids as a public health threat by 2032. Ending Aids as a public health threat means reaching a stage where fewer people are getting newly infected with HIV than the number of people with HIV who are dying (increasingly for other reasons than HIV, for example old age). According to the latest Joint United Nations Programme on HIV and Aids (UNAids) report, which was released last week, 170,000 people got newly infected with HIV in 2024, while there were 53,000 Aids-related deaths. The Global Fund money for South Africa is, however, not nearly enough to put two to four million people per year in South Africa on the lenacapavir jab — and even if it was, the country's health system won't be able to roll the medicine out that fast, scientists and policymakers say. Will the US help to pay for the jab? The fund's offer follows the body's announcement on July 9, that it has the 'ambition' to finance enough lenacapavir for two million HIV-negative people — in the low- and middle-income countries it supports — over the next three years. But fulfilling this ambition will depend on whether the governments of wealthy countries give enough money to the Fund in its next replenishment round. The US government's Aids fund, Pepfar, was originally going to help to pay to roll out lenacapavir in poorer countries. And, though some activists say it's still possible for the US administration to come on board (lenacapavir is mentioned in President Donald Trump's budget proposal for the next financial year, but is understood to be only for pregnant and breastfeeding women), it's not clear at all how this might happen after the Trump administration's drastic cuts to funding for HIV projects in countries including South Africa this year. The Global Fund's offer, however, is a way to get branded, 'bridging' doses from Gilead to South Africa while the world waits for cheaper generics to become available around 2027. 'We now stand at a moment of reckoning and a moment of choice,' Mitchell Warren, the executive director of the international advocacy organisation, Avac, told Bhekisisa at the 13th conference on HIV science in Kigali this week. 'While a lot of the choices over the last six months have been made by an American politician [Donald Trump] who doesn't care about the pandemic or science generally, our choice is to make decisions based on the science that we all now know. Which is that lenacapavir is our most potent opportunity.' Countries have to budget just under R600 per dose Jamaloodien, however, cautions further discussions with the Global Fund and Gilead will be needed about the governance around the pricing of the product. 'We have a transparent pricing system, guided by the Public Finance Management Act. Even if we procure medicine with Global Fund money, we have to follow the same rules that the Treasury requires us to follow with tenders, which includes revealing the price at which the medicine is bought,' Jamaloodien says.
