Dr Yvonne Holt, Chief Medical Officer of Next Biosciences (left) with Kim Hulett, Founder and CEO of the company (right) celebrating 20 years of innovation and leadership in stem cell banking, genetic testing and regenerative medicine.
As Next Biosciences celebrates its 20th anniversary, the pioneering South African biotech company reflects on two decades of significant advancements in science and healthcare.
From its roots in medical innovation to its transformative contributions in regenerative medicine, genetic testing and wellness, Next Biosciences has not only shaped the local industry, but also positioned itself as a leader in Africa’s growing biotech sector.
Founded by Kim Hulett, an entrepreneur with a background in finance and technology, and Dr Yvonne Holt, the company has expanded its range of products and services that cover biologics, stem cells, exosomes, genetic testing, longevity and reproductive health.
“The journey of Next Biosciences has been about bringing cutting-edge science and technology to South Africa, and making advancements in health and wellness accessible,” says Dr Holt, Chief Medical Officer at the company. “Every innovation we develop is driven by our mission to positively impact people’s health with science, by transforming lives, improving health outcomes and shaping the future of medicine on the continent.”
With a team of 90, Next Biosciences stands as one of the country’s leading biotech innovators. Women make up 80% of the workforce, with 20% of them being scientists – underscoring the company’s strong commitment to diversity and inclusion. Their lab is accredited by the Association for the Advancement of Blood and Biotherapies (AABB) and ISO 13485 standards, a testament to their excellence in stem cell banking, cord blood services and other biotechnological advancements.
From its beginnings with Netcare, Next Biosciences’ focus on research and development has enabled the company to expand beyond local borders, bringing its innovative healthcare solutions to a wider audience. They now lead initiatives that support regenerative medicine with products like OptiSerum, a revolutionary umbilical cord blood serum for ophthalmic use, and AmnioMatrix, used in a range of medical applications from ophthalmology and wound care to dentistry.
Next Biosciences’ state-of-the-art Netcells storage lab, ensuring the safe preservation of precious stem cells for future medical advancements.
“Biotechnology and regenerative medicine are advancing at an unprecedented pace, offering new possibilities for treating diseases that were once thought incurable. Our focus remains on harnessing these innovations responsibly, ensuring that the latest advancements in cellular therapies, genetic diagnostics and biologics translate into real, life-changing solutions for patients,” says Dr Holt.
The biotechnology landscape has evolved worldwide, and South Africa has not been left behind.
Credit: Global Biotech Indus
The global biotechnology industry is currently valued at $546 billion, growing at approximately 13% per annum. Remarkable advancements have been achieved in genetic research, stem cell therapies and personalised medicine. “The potential for biotechnology over the next decade is extraordinary,” says Hulett, CEO of Next Biosciences. Breakthroughs in regenerative medicine and longevity science are revolutionising healthcare as we know it.”
Next Biosciences’ path hasn’t been without challenges. From navigating regulatory hurdles to sourcing cutting-edge technologies, the company’s growth has been driven by passion, resilience and innovation. As a majority female-led team, the company exemplifies the power of women in science and business, and they have become a beacon for female entrepreneurs looking to make a mark in the science and technology sectors.
“Building a biotech company in SA, with all its complexities, required tenacity and a relentless commitment to our mission. Over the years, we have witnessed our industry evolve and we are proud to have been at the forefront of that change,” says Hulett. “The future holds great promise and we are excited to see what the next 20 years will bring.”
Looking ahead, Next Biosciences aims to expand its footprint in Africa, focusing on reproductive, regenerative and longevity health to empower individuals to invest in their health and live their best lives. With a strong commitment to innovation, accessibility, convenience and sustainability, Next Biosciences plans to integrate cutting-edge biotechnologies, while maintaining a patient-centric approach. By staying at the forefront of the biotech industry, the company is set to strengthen its position as a trusted leader in African healthcare.
By Kelly Widdop, Consumer Health Cluster Division Head for Bayer Sub-Saharan Africa
Healthcare innovation in Sub-Saharan Africa is rapidly evolving, driven by the need to address critical healthcare challenges such as limited access to healthcare services, high rates of infectious diseases, and growing non-communicable diseases (NCDs). With a population of over 1.1 billion people, many of whom live in rural and underserved areas, innovations are crucial to improving healthcare delivery, accessibility, and affordability.
What innovation in healthcare looks like
Healthcare innovation means more than introducing new medicines or medical devices; it involves creating integrated solutions that address both immediate health needs and systemic barriers to care. Globally, healthcare innovation is being driven by advances in digital technologies, personalised medicine, and artificial intelligence (AI) diagnostic tools. In developed regions, this includes the development of digital health, which provides remote consultation, diagnostic services, and treatment monitoring, helping to overcome geographical barriers for patients in underserved areas. In Sub-Saharan Africa, healthcare innovation is focused on overcoming infrastructure challenges and expanding access to self-care and wellness education. Both globally and locally, and in Sub-Saharan Africa, innovation is reshaping healthcare systems, making them more resilient, accessible, and responsive to the evolving needs of populations.
A decade of transformation – where we are as Sub-Saharan Africa
Sub-Saharan Africa presents a unique set of healthcare challenges, including limited infrastructure, a shortage of resources, and barriers related to affordability and access. Although not showing all at once, many changes are being achieved within the healthcare sector.
Kelly Widdop, Consumer Health Cluster Division Head for Bayer Sub-Saharan Africa
Over the past decade, the consumer health sector has undergone transformative growth, driven by a shift towards personalised wellness and a global demand for accessible and preventative care. Innovations in digital tools such as telemedicine and health-tracking apps, have empowered individuals to take charge of their health in real time, fostering a proactive approach to wellness. Alongside this, there has been a surge in personalised health products from targeted vitamins and mineral supplements, dry-to-sensitive skincare solutions, eco-friendly packaging and natural-based ingredients, which is gaining importance as consumers increasingly seek brands that align with their values. These changes have reshaped consumer health, making it more responsive, inclusive and environmentally conscious.
In the realm of nutritional vitamins and minerals, due to the rise in health awareness and lifestyle health management, many consumer health companies have tailored supplements to address common nutrient deficiencies such as bleeding gums, fatigue, joint pain, and delayed wound healing which are usually linked to, for example, a lack of calcium, vitamin b, vitamin c, vitamin d, and zinc. Consumer healthcare products, particularly vitamins and supplements, have empowered individuals to manage everyday health needs independently. With the availability of essential nutrients that support immunity, energy, mental clarity, and general well-being, consumers can now address minor ailments and manage everyday minor issues without needing to visit a doctor all the time, which can get expensive, especially for the low-income consumer. Instead of relying on medical help from a doctor for minor problems, consumers can now find over-the-counter solutions, saving both time and money.
The past decade has brought many changes in the dermatology space within the Sub-Saharan African market. With a focus on unique skin issues in the region, like sun damage and risks from unregulated skin-lightening products, there have been several public campaigns promoting safer skincare. Plus, with the expansion of telemedicine and digital health platforms, more and more people have access to dermatological consultations than ever before, without worrying about distance. The growing popularity of the use of natural ingredients has become super popular as consumers prefer these safer skincare options. In addition to the easily accessible dermatological products, there has been a significant increase in dermatological education and training across the region to build dermatological expertise in the region. Overall, these investments in both new product innovation and community engagement continuously empower consumers to manage their skin health.
In Sub-Saharan Africa, there have been some great advancements in allergy care, making it easier for people to find over-the-counter solutions for their allergy issues. With more people living in cities and changes in lifestyle and the environment, allergies like rhinitis, food allergies, and seasonal allergies are on the rise. To help with this, healthcare providers and companies have made antihistamines more accessible, allowing people to manage their symptoms without always needing to see a specialist. Plus, there is now a lot of useful information available on how to recognize, prevent, and treat allergic reactions, which helps consumers handle their allergies more effectively without frequent medical visits.
Capacitybuilding – a crucial aspect of the transformation
Capacity building has been a crucial aspect of this transformation. Investments in healthcare infrastructure, training programs, and community health initiatives have strengthened the overall healthcare system. For instance, healthcare providers have been trained to use digital health tools effectively, ensuring that they can offer remote consultations and monitor patients’ health from a distance. Community health workers have been equipped with the knowledge and resources to educate people about self-care practices, preventive measures, and the importance of regular health check-ups. These efforts have not only improved healthcare delivery but also empowered individuals to take control of their health.
Access to self-care has also expanded significantly. With the availability of over-the-counter products, individuals can now manage minor health issues on their own and educational campaigns have raised awareness about the importance of self-care, encouraging people to adopt healthier lifestyles and seek medical advice when necessary. This shift towards self-care has reduced the burden on healthcare facilities and allowed individuals to take a more active role in managing their health, and these changes have reshaped consumer health in Sub-Saharan Africa, making it more responsive, inclusive, and environmentally conscious.
What Sub-Saharan Africa can continuously adopt to succeed
Global relations and intercontinental trade have uniquely provided Sub-Saharan Africa an advantage in bringing successful healthcare innovations to the region.
The adoption of digital health platforms has the potential to change healthcare delivery in rural and underserved areas. Remote monitoring systems can help close the gap in access to health services, making it easier and more convenient for people to get care—just like what has been done successfully in places such as India and Latin America. Personalised health solutions, such as vitamin supplements and skincare products, can cater to local needs and encourage people to take charge of their health and health education initiatives delivered through social media and schools can empower individuals with health literacy, creating a culture of preventive self-care and informed consumer choices.
Additionally, telemedicine and remote care technologies can also be expanded across Africa to keep track of consumers’ health, ensuring they get continuous care even when healthcare facilities are hard to reach. Healthcare in Sub-Saharan Africa should go beyond just offering new products; it should be about creating lasting solutions that truly empower people, patients, and communities. Innovations that fit local needs can make a real difference and improve lives across the continent.
The government took its first steps towards the implementation of the recommendation of Health Market Inquiry into the private healthcare sector.
By Chris Bateman
Medical aid schemes will be given collective power to negotiate prices, according to draft regulations published last week. While some see the move as an important step toward reining in private healthcare prices, others argue that they do not go far enough and are legally unsound. We spoke to several leading experts about the proposed reforms.
Complaints about the high cost of private healthcare services in South Africa are nothing new. For the last two decades, above inflation increases to medical aid scheme premiums have been the norm. Added to this, many of the 16 or so percent of the population who are members of a scheme will have been asked to pay unexpected out-of-pocket co-payments at some point.
To understand why all this is happening, the Competition Commission launched a Health Market Inquiry (HMI) in 2014. The final HMI report, published in 2019, found that government had failed in its duty to regulate the private health sector, which it described as “neither efficient [nor] competitive”.
This failure in regulation has resulted in a private healthcare market that is “highly concentrated”, “characterised by high and rising costs of healthcare and medical scheme cover, and significant over utilisation without stakeholders being able to demonstrate associated improvements in health outcomes”, Justice Sandile Ngcobo, chairperson of the HMI panel, said at the time.
A key regulatory failure identified by the HMI was the absence of any effective mechanisms to keep prices under control. Medical aid schemes would set a price that they would cover – but there is nothing stopping healthcare providers from charging much higher prices. This is particularly a problem for prescribed minimum benefits (PMBs) – a set of healthcare services that schemes have to cover in full.
The HMI recommended the establishment of a supply side regulatory authority (SSRA) that would be independent from both government and the private sector. Among others, the SSRA would set maximum tariffs for PMBs as well as reference tariffs for all other health services.
In September 2020, around a year after the HMI report was released, the Competition Commission published a notice that seemed to set the ball rolling on establishing a new tariff negotiating framework along the lines of the HMI recommendation. Their proposed multilateral negotiating forum would have been governed by the Council for Medical Schemes until the SSRA could be established. But things then largely went silent, until earlier this month.
A new tariff-setting framework
On 14 February 2025, draft regulations published by the Minister of Trade Industry and Competition, Parks Tau, set out a new tariff determination framework for private healthcare in South Africa. At its core are two structures. The Tariffs Governing Body (TGB), consisting mainly of experts responsible for providing oversight in the tariff determination process, and the Multilateral Negotiating Forum (MLNF) made up of multiple stakeholders “which shall serve as the primary forum for collectively determining the maximum tariffs for prescribed and non-prescribed minimum benefits for healthcare services”.
In short, the work of negotiating and determining tariffs will be done by the MLNF, with the TGB providing some oversight and support. The TGB is also empowered to make a tariff determination when the MLNF fails to reach agreement.
The National Department of Health will have substantial control over both structures. Members of the MLNF will be appointed by the Director General of Health, and will include representatives of government, associations representing healthcare practitioners, healthcare funders, civil society, patient and consumer rights organisations, and any other regulatory body within the healthcare sector. The TGB will be located in the National Department of Health and will be chaired by an official of the department.
The regulations came in the form of a draft interim “block exemption” from certain provisions in the Competition Act. Such an exemption is required in order to enable the tariff governing body and the multilateral negotiating forum to function legally. The stated purpose of the exemption is to “contribute to the affordability of quality healthcare services…reduce costs and prevent the overutilization of healthcare services”.
In addition to the “collective determination of healthcare services tariffs”, the exemption also provides for “the collective determination of standardised diagnosis, procedure, medical device and treatment codes”, and “the collective determination of quality measurements/metrics, medicines formularies and treatment protocols/guidelines with the purpose of contributing to affordability of quality healthcare services across both PMBs and non-PMBs, contributing to reducing costs and contributing to the prevention of overutilization of healthcare services”.
The exemption doesn’t apply to everyone in the health sector. While healthcare providers like GPs and specialists are included, hospitals are not included.
Not an independent entity
While generally in favour of implementing the HMI recommendations, several experts Spotlight consulted are critical of how the government is going about it.
One line of criticism has been that the new framework is not sufficiently independent from the health department, as recommended in the HMI report.
Professor Alex van den Heever, Chair of Social Security Systems Administration and Management Studies at the University of the Witwatersrand (Wits), said the regulations deviate from the requirement for independence of any price regulator from political interference – which he points out is expressly addressed by the HMI.
In a media conference on Monday, Health Minister Dr Aaron Motsoaledi cited financial constraints for failing to set up an independent regulatory body. He also said that the department had a “mandate to manage healthcare systems”.
“We’re still looking at various options on an independent regulator, but National Treasury has severe constraints,” he said.
The exemption is for a period of three years and has been described as an interim measure.
Piecemeal implementation?
Another line of criticism is that only some HMI recommendations are being implemented, whereas the HMI stressed the need for an “inter-related” approach. While the tariff-determinations may bring down prices, it will not prevent doctors from, for example, sending people for medically unnecessary scans (a form of overutilisation).
Sharon Fonn, a professor in the School of Public Health at Wits and who was part of the HMI panel, said implementing aspects of the HMI piecemeal will neither foster competition nor protect the consumer.
“Controlling prices achieves little in the absence of the recommended holistic framework, which addresses the incentives of schemes to contract on cost, quality and demand,” she said.
Costs are influenced by both price and demand. The HMI did extensive work to show that supplier-induced demand was a problem – clearly indicating that price controls would achieve nothing in the absence of broader interventions, said Van den Heever.
“You’ll be hard pressed to find tariffs rising much faster than CPI (Consumer Price Index),” said Van den Heever. “Costs rise because of claims volumes, not the tariffs. This is because the frequency of patient consultations or in-patient days can rise in response to a fixing of prices. Providers are in a position to influence this demand. Annually you could have a 3% actual cost increase, with only a third of the increase (one percentage point) due to original price (tariff) changes. This is fully addressed in the HMI,” he added.
In response to criticism over the piecemeal implementation of HMI recommendations, Motsoaledi stressed that the HMI conceded that its recommendations would be implemented in phases.
Questions of scope
Elsabe Klink, an independent healthcare legal consultant and former advisor to the South African Medical Association, said government is mixing up the coding, protocols and Health Technology Assessments (HTA) which, on the HMI recommendations, are not up for negotiation in the MNLF.
“The HMI recommended that those functions be separate. How on earth can people negotiate on how a diabetic patient can be treated. That is a scientific question,” she said.
Klink said the HTA seems to be a veiled attempt at price control, directly for healthcare professionals and indirectly, to bar from the market devices and medications that did not make it onto the protocols or formularies.
“It [the draft regulations] purports to implement Health Market Inquiry recommendations but seems to stray into issues that are integral to NHI implementation as well, notably the HTA Committee,” said Dr Andy Gray, pharmaceutical sciences expert at the University of KwaZulu-Natal and Co-Director of the WHO Collaborating Centre on Pharmaceutical Policy and Evidence Based Practice.
Justifying the HTA measures, Motsoaledi said it was to prevent “the medical arms race” where healthcare practitioners prioritised patient volumes to enable them to beat their opponents in offering the latest technology. “This behaviour ruled by a medical arms race must end,” he said. He did not specifically explain why HTA was included in the exemption and not addressed through other regulations.
Questions of legality
Questions have also been raised over the legality of the regulations and whether or not they’d be vulnerable to litigation.
Van den Heever described the new regulations as “quite strange and extremely untidy, exposing the entire enterprise to legal challenge from the outset”. He said that the exemption bypasses normal legislative processes, that require evidence-based motivations and wide consultation.
He said the exemption went beyond competition concerns by establishing new governance structures that resembled a regulatory framework rather than a competition-related exemption.
“Furthermore, the structures and framework apply to a different minister (Health) – who has the legal authority to establish such a framework – not the Minister of Trade Industry and Competition. The Competition Act provides for exemptions, but only to facilitate competition-related objectives,” he said.
Dr Rajesh Patel, the Head of the Health System Strengthening Department at the Board of Healthcare Funders, had similar concerns. He said he finds it strange that “you need the Department of Trade Industry and Competition to tell the Department of Health to do their work”.
Could providers opt out?
Another contentious, and not entirely clear, aspect of the new framework is whether healthcare providers will be able to charge higher prices than those agreed through the MLNF.
“Perhaps one of the most problematic elements is that to protect patients, there needs to be some system to prevent opting out. It is likely that providers will opt out of this system and pass on additional costs to patients,” warned Fonn.
But, when asked about healthcare providers potentially opting out, Motsoaledi said that if that happened, “we’d be back to square one where everybody can charge whatever they want. I don’t think the HMI wanted that.” He didn’t specifically clarify how the current reforms would prevent healthcare professionals from opting out.
According to the draft regulations, the tariffs determined by the MLNF are “binding on all parties to the agreement”. It does however leave the door open for bilateral negotiations outside of the MLNF, but “only for the purpose of concluding an agreement on reductions, but not increases, on the tariffs for PMBs and non-PMBs as determined by the MLNF process”. There appears to be nothing in the regulations that would prevent healthcare providers from opting out altogether and charging what they like – although it is unclear to what extent, if at all, schemes would reimburse in such instances.
Concerns over timing
On timing, there are both concerns over how long the process has taken so far, and how long it might take going forward. This month’s draft regulations were published roughly five and a half years after the publication of the HMI report. For most of this period, Motsoaledi was not health minister.
Motsoaledi blamed the COVID-19 pandemic and the national elections that followed shortly afterward for the delay.
Health Minister Dr Aaron Motsoaledi. (Photo: Kopano Tlape/GCIS)
Patel expressed serious reservations about the ability of the health department to implement the block exemption process. “If their history is anything to go by, we will see similar delays and consequently, rising healthcare costs,” he said.
Patel said that the quickest solution to render private healthcare more affordable would be if the Competition Commission granted exemptions to allow medical schemes to collectively negotiate tariffs with willing healthcare providers. The health department, he said, need not be involved at all.
“We have serious reservations about the Department of Trade, Industry and Competition putting the power in the Department of Health’s hands to manage the block exemption process. They have actively kept private healthcare expensive and inaccessible to justify the implementation of the NHI,” he claimed.
Spotlight sent written questions to the Department of Health last week and during Monday’s media conference. Though some of our questions were addressed in the media conference, others had not been responded to by the time of publication.
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.”
Dr Ali Hamdulay, Chief Executive Officer (CEO) of Metropolitan Health, a subsidiary of Momentum Health
As we commemorate Universal Health Coverage (UHC) Day on Thursday, 12 December 2024, it is essential to reflect on the progress made in advancing healthcare access and quality in South Africa. Universal health coverage means ensuring that all individuals and communities receive the health services they need without facing economic barriers. In the South African context, this involves addressing the disparities in our healthcare sectors and ensuring that every citizen, regardless of their financial or social status, has equitable access to quality care.
In South Africa, a large portion of the population lacks medical protection cover, underscoring the urgent need for affordable healthcare solutions. Employed and insured individuals seek comprehensive yet affordable healthcare, while the employed but uninsured (6 to 8 million) face financial strain accessing quality care. Workers in the informal sector and SMEs often lack medical cover too, exposing them to significant out-of-pocket expenses. Those unable to afford any medical funding rely heavily on overburdened public healthcare facilities, highlighting the necessity for accessible and inclusive universal healthcare across all economic groups.
For over 60 years, South Africa’s healthcare sector has been characterised by a dual system of providers. Government has invested heavily in healthcare infrastructure and services and has made notable strides in improving access to quality healthcare. However, there is a significant opportunity for greater collaboration and meaningful partnerships within South Africa’s healthcare sector, focused on developing solutions that cater to the diverse needs of the population.
The healthcare ecosystem relies on the interdependence of various role players, including healthcare professionals, facilities, funders, administrators and government entities. Each of these contributors play a crucial role in ensuring the health and wellbeing of every citizen.
For the system to be sustainable, we must understand, recognise and cater to the unique contributions and requirements of each role player. This approach is vital for maintaining service continuity, quality, and access to necessary healthcare services through collaboration. Effective partnerships across these functions are critical to the success of the healthcare ecosystem.
To address the needs of low-income earners who are privately employed but uninsured, Momentum Health launched Health4Me, a healthcare insurance product that enables employer groups to provide affordable healthcare cover to those who might not otherwise be able to afford it. Our approach goes beyond merely paying claims; we focus on promoting health, wellbeing, and productivity, ultimately enhancing quality of life. This is achieved through primary healthcare facilities, technology, and incentivising wellbeing. The rapid growth of this healthcare insurance solution speaks to its success and its impact on offering more healthcare for more South Africans, for less. By expanding access to universal healthcare through primary healthcare, technological capabilities, and healthcare-strengthening initiatives, there are opportunities to collaborate and address the needs of additional population cohorts.
Through our vast experience in the design and management of healthcare solutions, we have learned valuable lessons that enable us to effectively collaborate across sectors. One of the critical lessons is the importance of clear communication and defined roles for all stakeholders involved in working towards establishing universal healthcare access. Successful partnerships have demonstrated that when goals are aligned across sectors to achieve a common objective, such as improving patient outcomes, success is possible.
As such, the success of creating a healthcare sector that ensures access for all hinges on flexibility and adaptability. The healthcare landscape is constantly evolving, and partnerships must be adaptable to address new challenges and opportunities. This includes being open to innovative solutions and technologies that can enhance service delivery and patient care.
Healthcare is essential not only for individuals and households, but also as a cornerstone of the economy. Without a healthy workforce, productivity declines, leading to far-reaching ripple effects on business sustainability. In this evolving landscape, preventative measures, therefore, become increasingly important. Providing wellness programmes that support both the mental and physical wellbeing of employees is crucial. Equally important is equipping healthcare consumers with the tools and knowledge to understand and improve their health status.
By investing in community health programmes and early interventions, we can address health issues before they escalate, easing the burden on healthcare systems. Collaboration across sectors can significantly increase access to preventative care by leveraging the resources and expertise of both sectors. Integrating preventative care into primary healthcare shifts the focus from reactive to proactive care.
It is advantageous to focus on co-creating platforms and mutually solving for the needs of our population through collaboration. This approach fosters consistency in service delivery and builds trust between entities. Metropolitan Health, a subsidiary of Momentum Health, has demonstrated its commitment to health strengthening by supporting leadership and professional development through its partnership with the National School of Government. By sharing and imparting knowledge, we are supporting the education and empowerment of future healthcare leaders through regular joint training and capacity-building programmes. This further improves collaboration by fostering a culture of continuous learning and development.
Building on these collaborative efforts, innovative models such as health hubs can further enhance healthcare delivery. These hubs combine offerings from both sectors, providing a range of services from primary care to specialised treatments under one roof. Telehealth is another innovative approach that has shown great promise. By utilising digital platforms, we can extend healthcare services to remote and underserved areas, ensuring that more people have access to quality care.
While effective collaboration is key to providing access to quality healthcare for more people, success cannot be achieved without fostering an environment that encourages innovation and supports conducive partnership development. By creating a more enabling environment, we can facilitate smoother collaboration and attract more private sector investment in healthcare.
Looking towards 2025, the vision for healthcare in South Africa is one of greater access, integration, and collaboration. By working together, we can create a more resilient and responsive healthcare system that meets the needs of all citizens. I envision the future of healthcare delivery as one that drives innovation and improves access to care. By leveraging partnerships and co-creation, I believe we can make significant strides towards achieving universal health coverage and ensure that no one is left behind.
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.
JOHANNESBURG, 26 November 2024 – Life Healthcare Group has delivered a robust operating performance for the year ended 30 September 2024, marked by a strong second-half (H2-2024) performance in its southern Africa operations and exceptional growth in its international Life Molecular Imaging (LMI) business. Group revenue grew by 12.7% year-on-year.
In southern Africa, Life Healthcare experienced a strong second half performance, particularly within its acute and complementary business. Acute-hospitals paid patient days (PPDs) grew 1.6% and occupancies reached 68.7% for the year with the second half delivering occupancies of 70.7%. This positive momentum resulted in a 7.7% increase in revenue, with H2-2024 revenue growth of 9.3%. Strategic partnerships with funder networks further cemented Life Healthcare’s position as the preferred hospital network for leading medical schemes.
Peter Wharton-Hood, Chief Executive of Life Healthcare Group, commented, “Our Group maintains a solid financial foundation, characterised by a fortress balance sheet and minimal gearing, which allows us to strategically invest in expansion opportunities across our diversified portfolio. We are particularly encouraged by our second-half results in southern Africa and the ongoing success of LMI as well as the extraordinary distribution to shareholders over the year. Our focus remains on delivering superior patient care and broadening access to essential and complementary healthcare services.”
Group revenue from continuing operations reached R25.5 billion (2023: R22.6 billion), with southern African revenue contributing R23.7 billion (2023: R22.0 billion), and international operations R1.8 billion (2023: R656 million).
Life Healthcare’s net debt to normalised EBITDA is at a healthy 0.45 times. Cash generated from continuing operations was R4.3 billion and available undrawn bank facilities amounted to R2.3 billion.
The Group’s total EPS increased by more than 1000% to 328.8 cents per share but this does include the profit on the disposal of Alliance Medical Group (AMG) (a profit of R2.8 billion). Excluding this profit and some small impairments the HEPS increased by 73.4% to 152.9 cents (2023: 88.2 cents). The best measure to reflect the Group’s strong financial performance for the year is normalised EPS excluding the benefit from the RM2 transaction, this reflected an increase of 14.5% to 132.3 cents per share.
The Group received R10.2 billion in net cash proceeds from the disposal of AMG, after the settlement of all offshore debt and transaction costs. A special dividend of R6 per share (R8.8 billion) was paid on 8 April 2024 from these proceeds.
The Life Healthcare Group board declared a final cash dividend of 31 cents per share, an increase of 14.8% over the prior year, and a special dividend of 70 cents per share. Total distributions for the year, including special dividends, amount to R10.6 billion.
“We are delighted with our progress in the acute, complementary, and pharmaceutical sectors,” remarked Wharton-Hood. “Our strategic funder network partnerships position us as the preferred choice among leading medical schemes. Our robust financial assets and prudent cost management will continue to support our capital expansion initiatives across all business areas. Exciting times lie ahead for Life Healthcare Group, and these results reflect that promise.”
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.
Photos supplied by Bayer showing the affected blister (left) and the normal blister (right).
On November 21, Bayer (Pty) Ltd issued a medicine recall for a specific batch (WEW96J) of YAZ PLUS tablets. In a press release, they explain the reason for the recall: it has been discovered that the active and inactive tablets in this batch are swapped. This mix-up has resulted in some packs containing only four hormone tablets instead of the required 24, and 24 hormone-free tablets instead of four, compromising the product’s contraceptive efficacy.
The company advises that healthcare professionals, wholesalers, hospitals, retail pharmacy outlets, doctors, nurses, pharmacists, authorised prescribers, dispensers, and individual customers or patients in possession of the affected batch can return product to their healthcare facility from which it was dispensed, for credit.
Bayer urges that if you are in possession of YAZ PLUS tablets from the affected batch, to do the following:
Stop Use Immediately: If you have been taking the tablets from a batch that is affected with the mix- up, stop taking them immediately and contact your healthcare professional. While only a limited number of packs from the respective batch is affected, as a precautionary measure, no tablets from these packs shall be used until you have consulted your Healthcare Practitioner, as they may potentially not provide the contraceptive protection you expect.
Return the Product: Please return any affected packs to the pharmacy or retailer where you purchased them for a replacement or refund.
Check Your Packs: If you have multiple packs of YAZ PLUS, please check each one of them, to ensure they are not from the affected batch.
Consult Healthcare Provider: If you have consumed tablets from the affected batch, or if you have concerns about your contraceptive coverage, please consult your healthcare provider as soon as possible for advice.
In the press release, Bayer says that it “takes the safety and efficacy of its products seriously and is committed to ensuring that all YAZ PLUS tablets in the market meet the highest quality standards.” It further advises that the root cause for the mix-up of tablets in the packaging has been identified and corrective measures taken. Only this one batch – and no others – was affected.
“The company is working diligently with SAHPRA and healthcare providers to facilitate the recall process and minimise any inconvenience to our customers. We are dedicated to addressing this issue promptly and ensuring the continued health and safety of all our customers.”
Further Information and Support: For more information about this recall, or if you have any questions or concerns, please contact Bayer +27 (0) 11 921 5000. Our team is available to provide the support and information you need. Report a side effect: Patient Safety Reporting – Introduction Report a product quality complaint for Pharmaceutical Products: afptc@bayer.com
The groundbreaking mRNA Technology Transfer Programme, launched in 2021, has achieved what was once unthinkable: from zero mRNA manufacturing capabilities in low- and middle-income countries (LMICs) in 2020, the initiative is positioned towards establishing 11 state-of-the-art good manufacturing practices (GMP) certified mRNA manufacturing facilities across 10 countries by 2030 and a further five facilities following later.
With all manufacturers in the Programme working on R&D across various diseases, this network is designed to meet the Global South’s R&D and mRNA vaccine needs. It stands ready to respond to any future pandemic to secure mRNA vaccine access across continents.
The transformative Programme, established by the World Health Organization (WHO) and the Medicines Patent Pool (MPP), works with the South African Consortium, Afrigen, Biovac, the South African Medical Research Council (SAMRC), and the Department of Science and Innovation and programme partners in Kenya, Brazil, Indonesia, India, Egypt, Nigeria, Ukraine, Bangladesh, Senegal, Tunisia, Serbia, Pakistan, Vietnam, and Argentina.
The Programme, support by South Africa, France, Belgium, Canada, the European Union, Germany, Norway, and the ELMA Foundation, has propelled LMICs to the forefront of pandemic preparedness. It represents an unprecedented global effort to ensure equitable health solutions, enabling LMICs to respond rapidly and independently to global health crises.
Charles Gore, Executive Director of the Medicines Patent Pool, stated, “From a standing start in 2020, the Programme’s growth has been nothing short of remarkable. After successfully developing a COVID-19 vaccine as proof of concept, the Programme is now expanding to address many other diseases relevant to LMICs. We are now poised to establish a sustainable mRNA vaccine production capacity that will benefit millions across the Global South, truly redefining what health equity can look like on a global scale.”
In a significant step forward, Sinergium Biotech is researching a human avian influenza (H5N1) mRNA vaccine candidate, and four R&D consortia have been formed in Southeast Asia, with more expected across other regions. The vaccines developed through this initiative will be shared across participating LMICs.
Unprecedented Capacity for Pandemic Preparedness and Resilience
With the manufacturing companies across four continents all based in LMICs, the Programme has fundamentally altered the mRNA vaccine production landscape. The initiative is projected to yield at least 60 million doses annually by 2030, with the potential to scale up to larger volumes that could supply up to two billion doses in the event of a declared pandemic. Leveraging future dose-reduction technologies, the Programme would have the capacity to cover all the mRNA vaccine requirements of the Global South.
As of December 2024, the mRNA Technology Transfer Programme has made significant progress, with nearly all site assessments completed. Half of the participating manufacturers have finalised their technology plans, with the remaining plans scheduled for completion by December 2025. Over a quarter of these manufacturers will have successfully received the technology platform transfer from Afrigen by the end of 2024, with the rest to be completed in 2025, marking an important milestone in the Programme. By December 2026, all manufacturing partners are expected to have demonstrated the technology at their respective sites, culminating in the full transfer of mRNA technology across all participants.
Prof. Petro Terblanche, CEO of Afrigen, highlighted, “The mRNA Programme has not only achieved our initial goals but exceeded them in every way. Afrigen’s work with our global partners has shown that LMICs can lead in R&D and manufacturing, transforming healthcare outcomes from diseases that affect the Global South. This Programme yet again demonstrates the power of partnerships and global collaborations.”
Dr Martin Friede, Coordinator at WHO, emphasised, “This mRNA Technology Transfer Programme exemplifies the power of collaboration in global health. We are delighted that WHO and the partners have signed an MOU with Prof Drew Weissman of the University of Pennsylvania to promote R&D of mRNA products for public health. We hope other institutions will also follow and share knowhow. We are committed to securing the necessary support to see these efforts through so that LMICs have the scientific and material resources to maintain this unprecedented level of pandemic preparedness.”
The Critical Role of Funding
Despite remarkable progress, additional funding is required to fully achieve the Programme’s ambition. An estimated US$200 million is needed to advance all manufacturers to GMP standards and continue to strengthen the R&D pipeline in support of at least 12 mRNA products currently in development. Encouragingly, Programme success has already attracted substantial catalytic co-investments. For example, for every dollar contributed by the Programme in the AFRO region, an estimated US$17 has been invested by regional stakeholders and other public health organisations.
