In a pivotal case for access to affordable medicines in South Africa, the Treatment Action Campaign (TAC) and Doctors Without Borders (MSF) Southern Africa – represented by SECTION27 – earlier this year came together to help champion access to lifesaving new cystic fibrosis treatments.
Cheri Nel, a South African woman living with cystic fibrosis, and the Cystic Fibrosis Association started legal action against Vertex Pharmaceuticals earlier this year, challenging Vertex’s monopoly on the treatments. The TAC and MSF approached the court to be joined as amici curiae. Vertex, an American pharmaceutical company, holds the patents for both Trikafta and Kalydeco – medicines that have the potential to significantly improve the lives of cystic fibrosis patients. However, at a price of US $311 000 per year per patient in the United States (over R5 million), it is out of reach for most people living with cystic fibrosis.
The court application is for a compulsory licence, which, if granted, will mean another manufacturer of generics for Trikafta and Kalydeco would be permitted to enter the South African market. In this case, it is likely that competition between manufacturers would affect the price of this medicine, thus making it more accessible. A compulsory licence allows the holder of the license to produce a patented product without the patent holder’s consent.
Johannesburg-based investment banker Cheri Nel is the driving force behind a court case that may result in dramatically expanded access to life-changing new cystic fibrosis (CF) medicines. PHOTO: Supplied
Spotlight previously reported that Nel’s lawyers argued that by failing to register or supply their CF medicines in South Africa, make them available in South Africa at reasonable prices, or license other companies to supply the medicines, Vertex is abusing its patents. They further argued that Vertex’s actions are violating the Constitutional rights of people with cystic fibrosis in South Africa, including the right to health care. (Spotlight previously reported on the issue here, here, and here.)
Cystic fibrosis is a devastating multi-system illness known for causing frequent and severe lung infections, liver and pancreatic damage, lung failure, and can result in the potential need for lung transplants even in children from as young as two years old.
This case will set an important precedent that can influence access to medicines not only in South Africa but around the world. The involvement of SECTION27, where I work, underscores the broader issue of affordable access to medicines and the impact of intellectual property on healthcare access.
At present, MSF and TAC are awaiting the court’s decision to be admitted as friends of the court, while in the main application, the respondent (Vertex) has filed answering affidavits.
And while the clock is ticking in the courts, many families in South Africa are waiting and holding on to the glimmer of hope access to this medicine represents. For many who live with cystic fibrosis, a successful outcome of Nel and the Cystic Fibrosis Association’s application will mean a life where they can breathe easier.
Among those waiting is 6-year-old Janco Koorts.
A journey of hope
His mother, Tanya Koorts, says living with cystic fibrosis is like fighting every day for every breath. She says Janco had been diagnosed with cystic fibrosis at the age of two. She has since been on a mission to raise awareness about this life-threatening disease. It is hope, her family, and the support from the cystic fibrosis community that has kept her going, she says.
Reflecting on the start of their journey in the Northern Cape, she says, “The knowledge about cystic fibrosis is very little. We were lucky that Dr Jooste at the Kimberly public hospital diagnosed him so early on. After that, he sent us to the Red Cross Hospital in Cape Town and so our long journey of hope started.”
Later in a new job in a new city, the Koorts began again in Pretoria. They started Janco’s treatment at the Steve Biko Academic Hospital and then moved to the Charlotte Maxeke Johannesburg Academic Hospital.
“They don’t have much, but they do everything they can there to help. They also don’t have a lot of support but the people at Charlotte Maxeke helped Janco on his journey to stay breathing,” Koorts says, applauding the public health system.
Janco now has comprehensive medical aid which covers his monthly R48 000 medication bill and Koorts says she can now “breathe easier”. That, however, is just a fraction of the cost of living with cystic fibrosis.
When the Koorts family heard about Trixacar, a generic version of Trikafta, it only strengthened their resolve to save Janco’s life. The patent rights registered by Vertex Pharmaceuticals in South Africa, however, do not allow for the import of Trixacar. Trixacar is produced by the pharmaceutical company Gador in Argentina. Koorts will thus have to travel to Argentina to buy the medicine. This will cost about R400 000 to cover the travel costs and six boxes of Trixacar that will last six months, she says. (You can help the family fund this by donating here.)
‘a thief of joy’
Apart from the financial burden, having a young child with cystic fibrosis has affected the Koorts family mentally and emotionally.
“Cystic fibrosis is a thief of joy. Nobody speaks about fighting to save someone’s life,” says Koorts.
She says her family had to adjust to some of the social changes in their surroundings as well.
“At school, he has to fight for himself to stay alive. If we go to a restaurant and there are people smoking, it affects him and we have to move. So, as much as we have tried to give Janco a normal childhood, these social aspects will always hinder progress, and he is always reminded that he is sick. But I live in hope and so does he.”
In terms of her family relationships, Tanya says that her other children are healthy and for them to see their baby brother suffering every day hurts them.
“It’s painful as parents. Janco needs all the attention. I can’t go to a parent’s evening for my other kids. It’s difficult,” Koorts says.
She says she is proud of Janco.
“My child doesn’t know that he is dying. We fight every day so that Janco can have just one more breath.”
And that is ultimately what it is all about. From one perspective the exchange of documents in the High Court may seem abstract and full of legal technicalities. But let there be no doubt, for kids like Janco it is literally their futures that are being decided.
*Adams is a communications officer at SECTION27.
NOTE: This opinion piece was written by a staff member of SECTION27. Spotlight is published by SECTION27 and the TAC, but is editorially independent – an independence that the editors guard jealously. The views expressed in this piece are not necessarily those of Spotlight.
The NHI Bill does not contain any clarity on how South Africa’s large and complex medical schemes and insurance industry will be affected.
Photo by Bill Oxford on Unsplash
By Lenee Green, Partner, Mateen Memon, Associate & Mariam Ismail, Trainee Attorney at Webber Wentzel
On 12 June 2023, the National Health Insurance Bill (the Bill) was passed by the National Assembly and is currently with the National Council of Provinces for consideration. Its laudable aim is to make primary healthcare widely accessible.
The Bill has been closely scrutinised by various stakeholders in the healthcare sector. Concerns have been raised by medical schemes and insurers about the effect the Bill will have on their current businesses.
The Bill, among other things, covers:
who will be able to access health care services;
how these services will be funded;
the establishment of a board and advisory committees to achieve the objectives of the Bill;
general provisions applicable to how the fund will operate;
complaints about and appeals of decisions made by the fund; and
the source of income of the Fund and transitional arrangements.
Clause 33 of the Bill states that once the National Health Insurance (NHI) is fully implemented, medical schemes can only offer complementary coverage for services not reimbursed by the NHI. Clause 6(o) of the Bill allows individuals to purchase services not covered by the NHI through voluntary medical insurance schemes. This means medical schemes cannot cover services already covered by the NHI, potentially jeopardising their existence. This approach may face constitutional challenges related to the right to access healthcare, property rights of medical schemes, and freedom of trade and profession.
It is contemplated that the Minister of Health will introduce regulations limiting benefits to services not reimbursable by the Fund. We have not yet seen any indication when these regulations will be published.
Current regime
Broadly, four main categories of business will be impacted by the Bill:
business of a medical scheme as defined in the Medical Schemes Act 131 of 1998 (MSA);
insurers licensed to conduct insurance business pursuant to the Insurance Act 18 of 2017 (the Insurance Act);
insurers who offer products pursuant to section 8(h) of the MSA (the Exemption Framework); and
insurers who offer products pursuant to the regulations published under each of the Long-Term Insurance Act 52 of 1998 and the Short-Term Insurance Act 53 of 1998 (the Demarcation Regulations).
Medical schemes
Presently, only medical schemes may carry on the “business of a medical scheme” as defined in the MSA. The “business of a medical scheme” involves undertaking liability for the provision of obtaining “relevant health services”, defraying expenditure for “relevant health services” or rendering health services by the medical scheme itself or by any supplier of a “relevant health service” in return for a premium or contribution.
A “relevant health service” under the MSA is very wide. It includes “any health care treatment of any person by any person registered in terms of any law, which treatment has as its object…” The objects include a broad range of medical services, including the physical or mental examination of a person, the diagnosis, treatment or prevention of any physical or mental defect, illness, or deficiency, ambulance services and hospital or similar accommodation.
Insurers
Medical schemes must be distinguished from medical insurance provided by insurers. Insurers may provide medical insurance under, among other dispensations, the Insurance Act. Schedule 2 to the Insurance Act provides for various classes and sub-classes of insurance business for which life insurance companies and non-life insurance companies may be licensed. Schedule 2 allows insurers to provide health and disability benefits under the risk class of business for life insurance and accident and health and travel insurance under the classes for non-life insurance.
Health insurance is provided upon the happening of a health event. A health event is defined in the Insurance Act as one that relates to the health, mind or body of a person or an unborn, other than a disability event. The disability event is defined and includes circumstances where a person loses a limb or becomes physically or mentally impaired. It is apparent that there is an overlap of products provided for in the Insurance Act and offered under the MSA.
The Demarcation Regulations provide for the demarcation between insurance business and medical schemes business. The regulations provide that a benefit that would otherwise have been a medical scheme benefit, but meets the exact requirements (definitions) set out in the tables in the Demarcation Regulations, is classified as an insurance product.
In March 2017, the Counsel for Medical Schemes (CMS) issued an exemption framework for insurers as a transitional arrangement while the development of a low-cost benefit option (LCBO) for medical schemes was developed (Exemption Framework). To the extent that an exemption was granted to an insurer in terms of section 8(h) of the MSA, and subject to the conditions of the exemption, the insurer was permitted to continue to underwrite those products until the expiry of the exemption. On 25 January 2022, the CMS granted insurers that had previously been granted an exemption in terms of the Exemption Framework an extension of a further two years.
The background to the LCBO is that a ministerial task team on social health insurance launched the low-income medical scheme consultative process in 2005. In 2015, the CMS issued a circular that considered introducing a guideline to allow medical schemes to introduce LCBOs in response to the growing number of working South Africans who did not have medical scheme coverage because they could not afford it. Following various engagement processes, the LCBO Framework Advisory Committee issued a Report in May 2022 (the Report). The Report states that LCBOs still have the potential to “alleviate pressure in the public healthcare system and allow resources to be redirected to the poor”. This process has progressed quite slowly, and it remains to be seen what comes of it if anything.
While the Bill is a piece of framework legislation, it does not provide clarity on what will become of insurance under the current regime. The fate of medical schemes is dealt with in a very cursory manner, without considering the nuances of the current regime.
The LCBO could have been a path to make healthcare more accessible, but the process has become stifled, and it may never come to fruition. What is left in the wake of the Bill is a great deal of uncertainty. Industry participants and stakeholders will have to keep abreast of the process and ensure that their comments are taken into account as the system evolves.
The Law Society of South Africa (LSSA) has urged members of the public and civic associations to formally object to proposed amendments to the Road Accident Fund Act which, if approved, will have “dire consequences” for all South African road users.
The draft amendment bill was gazetted earlier this month by the transport minister. It proposes major changes to how the fund operates and how it will pay claims.
According to the LSSA, it proposes significant changes to the existing law, including removing the rights of drivers, passengers and pedestrians to claim compensation for injuries they have suffered. Instead, it proposes that the fund will only provide significantly reduced “social benefits”.
And, says the LSSA, an innocent injured party would still be denied the common law claim against the guilty party for the balance of his or her loss.
Yet all road users contribute directly or indirectly to the fund through the fuel levy, estimated to be about R45-billion a year.
“The poor and disempowered, who make up the vast majority of claimants and who are compelled to use public transport, will bear the brunt of the consequences of these amendments. They will be forced into the public health system, as the prescribed tariffs will not cover the actual costs incurred at a private hospital. Under the present system, many receive treatment at dedicated private healthcare facilities,” the LSSA says in its statement.
Claimants will also not receive any lump sum payments and, if they are not able to produce a payslip, it was unlikely that they would receive compensation for loss of earnings.
The LSSA said those who can afford it will be compelled to take out private accident cover for medical and other expenses as well as accident benefits.
“This is likely to be very costly, as there will be no reimbursement of expenses covered from the fund. Medical aids will more than likely exclude cover or the cost thereof will have to materially increase to preserve the funds in the pool for all members.”
The LSSA said road accident victims will be uniquely discriminated against by the proposed legislation.
“Their rights to be compensated for harm suffered by the fault of another will be taken away. Persons who suffer harm from medical negligence or are injured in train or plane or boat accidents or in shopping centres, hotels, construction sites, holiday resorts, private homes or by electrocution or pollution and by a host of other causes, have unfettered rights to seek compensation from the person or entity who caused them harm.
“Innocent motor vehicle accident victims, alone, do not have this right, despite the fact that they pay premiums to the fund.”
At present, injuries sustained in a motor car accident anywhere in South Africa by any person are covered by the Fund.
The Bill now excludes injuries suffered in motor vehicle accidents in parking areas, sports fields, farm roads, driveways, private estates, game reserves or any other private road.
People who are not citizens or permanent residents are also not covered.
Persons crossing a highway are not covered. Persons injured in a hit and run are not covered. Pedestrians, drivers and cyclist who may test over the legal limit for alcohol and their dependents are not covered.
The Bill also proposes doing away with payments for pain and suffering, loss of amenities of life, disability, disfigurement or shock.
It also does away with lump sum payments for loss of earnings or support, replacing them with monthly payments, and giving the fund the right to continually reassess its liability to continue to pay.
While at present all medical and other expenses reasonably incurred that arise directly from the accident are covered, these will now be subject to a prescribed tariff. Any future medical expenses have to be pre-authorised.
The LSSA said the Bill also largely ousts the role of the courts in determining contested claims, establishing instead alternative dispute resolution procedures followed by referral to be a yet-to-be established Road Accident Fund Adjudicator.
Co-chair of the KZN Personal Injury Lawyers Association Anthony De Sousa said the biggest issues around the Bill was what was not known, such as what “social benefits” were and what the treatment tariffs would be.
“We don’t know what we are signing up for”.
“What also worries me is the people it excludes, such as pedestrians crossing highways. They don’t do that for fun. They do it because they have no choice and are trying to get to work or home.
“They are poor people and if they are knocked down, they really need help. To exclude them is just weird.”
He said while there may be a case not to cover motorists who don’t have licences, or who are over the legal alcohol limit, the Bill also proposed that their dependents are not covered, such as a child who is injured.
“The kids are not at fault, but suddenly they have no claim.”
He said the approach seemed to be: “Let’s try and save some money”.
“We pay a lot of money to the fund in terms of the levy. If you were to take that money and take up an insurance policy, you would probably get better cover and better value for money.
“I don’t think, no matter how they change it, it won’t work until they sort out the dysfunctionality, the administrative inefficiencies in the fund. You can change it to whatever system. They cannot properly administer it and run it.
“If they did their jobs properly, the fund would be saving itself a bucket load of money.”
De Sousa said the association was presently putting together its formal response to the proposals.
Collen Msibi, spokesperson for the Department of Transport said, “The bill is out for comments. The department will welcome all views and suggestions for its consideration.”
The National Treasury’s Cost Containment Letter sent to government departments instructing, among others, the freezing of posts was one of the big themes underlying talks about building South Africa’s healthcare worker capacity during the Public Health Association of South Africa’s (PHASA) conference held recently in Gqeberha.
With Finance Minister Enoch Godongwana expected to deliver the medium-term budget policy statement on 1 November, the freezing of posts will further hamstrung already strained health services, some presenters at the conference warned.
An oversight visit to TB hospitals by members of the provincial legislature (MPLs) in the Eastern Cape in the first week of September (5 to 8 September) showed just how bad the staff shortages are. The only remaining hospital in Nelson Mandela Bay dedicated to TB services, Jose Pearson Hospital in Bethelsdorp, has had staff vacancies hovering around 20% since 2019. The hospital provides dedicated TB services to the western part of the province. MPLs heard that in some other hospitals, vacancy rates are even higher, and non-filling of critical posts in some cases results in further medico-legal claims against the department, as the current staff buckles under massive patient loads.
Last year, in response to a parliamentary question, figures the health department released showed that there were 3 892 vacant healthcare worker posts in the province. In the nursing categories, there was a vacancy rate of 15.3%. For paramedics (EMS) the vacancy rate was 10.7%, medical practitioners 8.4%, and pharmacists 13.7%. By June this year, in another response relating to specialist nurses, the vacancy rate in the province had dropped to 13%.
Dr Prudence Ditlopo Senior Researcher at the University of the Witwatersrand, was presenting her research on the impact of nurse workloads and professional support on healthcare outcomes at the PHASA conference. Ditlopo said nurses already have a huge workload and issues around budget cuts impact morale. “I am sure they are asking themselves what will happen to [them] when we [they’re] already understaffed.
“This is not the first time that this monotonous cycle has been happening. Yes, we understand the economic side of it, but at the very same time, what does it say about the well-being of the nurse practice environment, the patients, and the quality of patient care? If nurses see that they are overwhelmed by the workload, they will make sure to find ways that will enable them to cope.
“Enable them to cope” means nurses will find a way that works for them. If what works for them is only seeing ten patients per day, they will do that and they will be gatekeepers for other patients who are coming to the facility. That alone will influence the quality and standard of care in primary care in South Africa,” said Ditlopo.
‘Will create more problems’
Dr Busisiwe Matiwane of the University of The Witwatersrand’s School of Public Health also weighed in on the implications of the Treasury letter.
“In the current system, health professionals have to work for the government to fulfil their community service obligations. However, it can be challenging for them to be assigned to specific hospitals when it is time for their community service. Additionally, with the government announcing a freeze on posts, many individuals who are not government-funded may be compelled to seek employment outside of the government after completing their community service,” Matiwane told delegates.
“If these posts are indeed frozen, does that mean that the government will also halt the placement of individuals who are required to complete community service? The current structure dictates that if you fail to fulfil your community service, you will not be recognised by the statutory bodies as an independent practitioner.
“The implication of this proposal by the government will create more problems, as we already face the challenge of health professionals’ placement or their community services,” she said. “The main concern is whether the posts will be frozen and what will be done. I think this concern has raised questions for many people, who wonder what it means if they are unable to complete their community service or the internship. Does it mean they cannot work?” she asked.
‘protect what is already there’
Speaking on the sidelines of the three-day conference, director of the Rural Health Advocacy Project, Russell Rensburg, said the wage agreement on a 4.5% increase for the public sector had Treasury’s back against the wall since that was not budgeted for in their February budget.
“Treasury is playing hardball and the provinces must decide what they need. The national government must also decide what they need. If they follow through on this, they won’t be able to sustain the public health system. There is concern that doctors will leave as part of cost containment measures, and you can’t run a healthcare system without healthcare workers. But we will only know the true position of the Treasury when they publish the medium-term budget policy statement,” said Rensburg.
“I believe at the moment they are just testing the market. They are saying we must have one thing, but we can’t have both, so that is the game they are playing. Our position is clear on this issue. Before any salary cuts or job freezes, we need to protect what is already there. We need to retain this year’s cohort of community service doctors, pharmacists, and nurses because these people helped us during COVID-19. Some were interns during COVID-19 and they are the core that can build the health service in the post-COVID-19 era. So, the immediate priority is to retain those posts because we don’t know if there will still be community service going forward,” said Rensburg.
‘working with what we have’
Several speakers and presenters at the PHASA conference raised concerns about the existing scarcity of healthcare workers and urged the Department of Health to take action. The experts, academics, researchers, students, non-governmental organisations, and civil society members all agree that healthcare is a fundamental human right, but that right won’t be fulfilled without healthcare workers, as there cannot be health services without workers. The government’s key policy document on human resources for health warned as far back as 2020 that the country is facing a critical shortage of healthcare workers.
Dr Krish Vallabhjee, former Chief Director of Strategy and Health Support in the Western Cape Health Department, believes that management must use whatever resources are available to achieve good results.
Vallabhjee said, “Budget cuts are a reality, so whatever we talk about here and in many of these conference sessions, we can’t be talking about wanting more and more. We need to work with what we have. How can we repurpose the people we have? Can’t we use them more effectively to achieve the same effect?” he asked.
“Managers need to work with their staff instead of just sitting in some corner and making budget cut decisions. Managers need to engage with staff to address the problem of not having enough budget. How do we work together? What are our priorities? As managers, we must listen to what people are saying on the ground. What are the doctors, nurses, and local managers saying? We must be united. [It should not be a thing that one hospital, clinic, and the district [are] fighting for their own piece. We are one department and we have this problem of a budget. How do we unite and do the best we can?”
Government will clarify
In a cabinet statement issued on 14 September, Minister in the Presidency, Khumbudzo Ntshavheni said that Finance Minister Enoch Godongwana would clarify the cost-containment letter issued on August 31.
“Cabinet appreciates the current fiscal constraints which are not unique to South Africa but have resulted in budget shortfall. Cabinet has iterated that measures to address the budget shortfall must not impact negatively on service delivery. The Minister of Finance will shortly issue guidelines clarifying the unintended misunderstanding arising from the Cost Containment Letter issued on 31 August 2023. In addition, as part of the in-year performance review of progress in implementation priorities agreed to with Ministers, the President, and Deputy President will meet with individual Ministers to ensure that fiscal management does not derail the agreed to priorities.”
South Africa is not the only country faced with a flight of doctors over working conditions. According to a survey of UK medical students published by BMJ Open, one in three plan to leave the National Health Service (NHS) – either to practise abroad or to stop practising medicine entirely. Of those who plan to go abroad, nearly half plan on never returning.
The responses indicate that pay, work-life balance, and working conditions are the key drivers behind the decisions to leave.
The UK has 3.2 doctors for every 1000 people, ranking 25th among the Organisation for Economic Co-operation and Development (OECD) countries. This figure also represents the lowest number of doctors per head among European countries in the OECD, note the researchers.
In response to the shortage of doctors amid rising healthcare demand, the British government has opened new medical schools and expanded the student capacity of existing ones. But without addressing the issue of retention, increasing the number of medical students is unlikely to provide a sustainable long-term solution, they point out.
In a bid to understand current career intentions after graduation and on completion of the 2-year Foundation Programme, the researchers surveyed 10 486 medical students, around 25.5% of the total, from across 44 UK medical schools between January and March 2023.
The survey included sections on intended career immediately after graduation and after foundation training (if applicable), as well as the factors influencing decision-making.
Respondents’ average age was 22; around two thirds (66.5%) were women. All students were asked their career intentions after graduation with most (8806; 84%) saying they planned to complete both years of the UK’s foundation training after graduating.
But around 1 in 10 (10.5%;1101) intended to complete year 1 of foundation training and then emigrate to practise medicine: completion of the first year of foundation training provides doctors with full registration with the UK’s medical regulator (GMC), which is recognised internationally.
Another over 2% (220) planned to emigrate to practise medicine immediately after graduation while just over 1% (123) intended to take a break or undertake further study.
Just over 1% of respondents (132) planned to complete their first foundation year and then leave the profession, while just under 1% (104) intended to leave medicine permanently immediately after graduation.
Among the 8806 respondents intending to complete both foundation years, nearly half (49%;4294) planned to enter specialty training in the UK immediately afterwards.
Around a fifth (21%;1859) intended to enter a ‘non-training’ clinical job in the UK such as junior clinical fellowship or clinical teaching fellowship, or working as a locum doctor).
A further 23.5% (2071) intended to emigrate to practise medicine abroad, while around 6% (515) planned to take a break or undertake further study. Just 67 planned to leave medicine permanently after completion of year 2 of foundation training.
Around half (49.5%;1681) planned to return to UK medicine after a few years, while nearly 8% (267) intended to return after completion of their medical training abroad. But 42.5% (1444) indicated no intention to return.
Of those favouring emigration immediately after graduation, just under 81% didn’t intend to return to the UK. This fell to 60% (661) among those planning to emigrate after completing year 1 of foundation training and 29% (605) among those planning to emigrate after year 2.
Among the 2543 medical students expressing a preference for destination country, Australia was the most commonly mentioned (42.5%), followed by New Zealand (18%), the USA (10.4%) and Canada (10.3%).
In total, around a third of medical students (32.5%;3392) plan to leave the NHS within 2 years of graduating, either to practise abroad or to pursue other careers.
Remuneration at junior level, work-life balance, lack of autonomy over choice of training location, and the working conditions of doctors in the NHS were cited as the most important factors for those respondents intending to emigrate to continue their medical career.
These reasons were also given by those planning to abandon medicine altogether, with nearly 82% of them also listing burnout as an important or very important reason.
Only just over 17% of all respondents said they were satisfied or very satisfied with the overall prospect of working in the NHS.
Intention doesn’t necessarily translate into action, and minds may change, say the researchers. And while the 25% response rate is relatively large, that still means a substantial proportion of the medical student body weren’t surveyed.
But they highlight: “This study highlights that an alarming proportion of surveyed medical students intend to leave the profession or emigrate to practise medicine,” emphasise the researchers, “representing a potential loss of valuable medical talent.”
They continue: “The findings of this study emphasise the urgency of addressing the factors that are driving the exodus of doctors from the NHS and suggest that increased recruitment of medical students may not provide an adequate solution to staffing challenges.
“The causes of the problem are complex, and finding a solution will require a multifaceted approach. Steps could include improving work-life balance, increasing salaries, addressing the growing competition for specialty training posts and promoting greater flexibility in career pathways.”
They conclude: “Undoubtedly, the continued loss of skilled professionals from the NHS represents a significant concern, so it is critical to consider means of reversing this trend.”
Recently, in a major feat for transparency and accountability, the North Gauteng High Court ordered that the public must have access to COVID-19 procurement contracts – details of which, until now, have been kept away from the public eye as the government cited confidentiality clauses.
The Health Justice Initiative’s – who brought the court application – victory is a crucial one given the staggering size of public procurement contracts in the health sector.
According to Zukiswa Kota, South African Programme Head at the Public Service Accountability Monitor (PSAM), this judgement deserves celebrating “as it deepens the case for transparency in public procurement and effectively challenges the many reasons often used to evade publication”. “Ultimately, what we need is proactive disclosure that is built into procurement legislation and – more importantly – is adhered to by government,” said Kota.
“It is inconceivable,” she said, “that in 2023 there continues to be limited transparency around fairly basic info – in this case COVID-19 vaccines. “The fact that there is no explicit transparency is an indictment and something we need to reflect on.”
The need for transparency has also been affirmed in the HJI judgement. “Non-disclosure of any of the records sought means that a shroud of secrecy is placed over the entire negotiation, procurement, and payment process – the very mischief our Constitution and legislation such as Paia seeks to address,” the judgement states. S217 of the Constitution states that public procurement by any state organ must be “in accordance with a system which is fair, equitable, transparent, competitive and cost-effective”.
The case for transparency
The call for open contracting and to strengthen public procurement legislation is not a new one. It is also not confined to COVID-19 vaccines, but all public procurement, also in the health sector.
Dominic Brown, director at the Alternative Information & Development Centre (AIDC), also recently during a webinar on the launch of a report on pending legislative and regulatory changes in the healthcare sector made the case for transparent procurement. The Rural Health Advocacy Project compiled the report that also provides several recommendations for procurement reforms.
“The level of public procurement in the country is approximately 25% of GDP and the majority of government’s involvement in the economy is through this procurement, so it’s no small issue. It’s of extreme significance,” said Brown.
He said that in 2016, the former chief procurement officer in National Treasury estimated that between 30 to 40% of the country’s procurement budget is lost to inflated prices and fraud by the private sector. At the time, this amounted to R230 billion.
“At the moment, our procurement budget is about R1 trillion, which means that we are losing between R300 and R400 billion each year as a result of corruption linked to public procurement and this has major detrimental impacts on service delivery.”
Putting this impact into perspective, especially as it pertains to the health sector, RHAP’s director, Russel Rensburg during the same webinar said that provinces can spend up to 30% of their health budgets on the procurement of goods and services, which can run into billions. “Contrast this with the huge chunk spent on employee costs (often between 60 and 65% of health budgets), and growing inefficiencies and waste due to non-compliance to legislative prescripts – the pool of money remaining for health services is limited,” he said.
“Lack of compliance with financial management policies, particularly around supply chain monitoring policies, has resulted in the deterioration of several financial management indicators. We’ve seen an increase in qualified audit opinions of health departments and an increase in irregular and wasteful expenditure – amounting to R6 billion in the last financial year,” said Rensburg. “Competent financial management is essential to ensuring that maximum value is achieved from the resources deployed.”
The need for this “competent financial management” in the public sector was highlighted again last week when the Gauteng Department of Health’s Annual Report for 2022/23 was tabled in the provincial legislature. The report showed irregular expenditure to the value of over R2 billion, which means legislative prescripts were not followed in the procurement of goods and services, among others. In the Auditor-General’s (AG) report, she flagged the irregular expenditure stating that there were no effective and appropriate steps taken to prevent it. “The majority of this irregular expenditure,” the AG stated, “was caused by the department’s failure to invite competitive bids” when procuring goods and services.
Legislative reforms and procurement
Currently, in Parliament’s National Assembly, MPs are set to deliberate on the Public Procurement Bill. The bill provides for far-reaching reforms in public procurement. In Parliament’s National Council of Provinces, deliberations on the National Health Insurance Bill are underway. This bill also provides for far-reaching reforms to how health services will be structured and funded.
Both pieces of legislation have major implications for procurement in the health sector.
Yet, with these legislative reforms underway in Parliament, some stakeholders say that neither bill in its current form, will be a silver bullet to address all shortcomings in public procurement in the health sector. Questions also remain if these bills will ultimately result in real consequences for errant public officials in supply chain management or overreaching political office bearers.
Added to this is the overlap between provisions in the two bills, several provisions that lack clarity, and some areas of conflict between the bills that may lead to confusion down the line.
The case for alignment between the bills
The Public Procurement Bill aims to standardise and create a uniform regulatory framework for all procurement by government departments and entities. The NHI Bill, in turn, if passed will transform how publicly-funded health services are organised and delivered. The bill provides for a NHI Fund that will “strategically purchase healthcare services on behalf of users”.
Rensburg explains this fund must transfer funds directly to accredited and contracted central, provincial, regional, specialised and district hospitals based on a global budget or Diagnosis-related Groups. The bill also provides for an Office of Health Products Procurement (OHPP), he said, but the exact scope of this office’s mandate is not yet clear.
According to the bill, this office (OHPP) will be responsible for “the centralised facilitation and coordination of functions related to the public procurement of health-related products”.
According to Yana van Leeve, from the law firm ENSafrica, the NHI fund will be a S3A public entity so the procurement bill will apply to that entity. S3A public entities under the Public Finance Management Act can be defined as a public entity with the mandate to fulfil a specific economic or social responsibility of government and they depend on government funding and public money.
Van Leeve was also a panellist during the RHAP webinar.
She explained that section 217 of the Constitution will also apply to this process of acquiring services because the NHI Fund will be engaging in public procurement when it engages healthcare service providers and health establishments in both the public and private sectors. Van Leeve said that it is not clear in the NHI Bill, however, that “there is an appreciation that this dimension of the scheme will amount to formal procurement and will thus be subject to normal procurement law”. “The implication would then be that one of the prescribed forms of procurement, for example, quotations or open bidding must be used to secure the services of these health service providers.” According to her, the NHI Bill, however, creates the impression that there is a different type of arrangement to be considered for the acquiring of such services. In section 39 of the NHI Bill, for example, accreditation of health service providers is required.
The procurement bill, in turn, provides for a Public Procurement Office that must create and maintain a database of prospective suppliers. Departments or other public entities may only procure from suppliers listed in this database. This may result in some practical problems as the requirements to be added to the existing central supplier database of National Treasury may differ from what the NHI Bill requires from suppliers. For example, to get on the database, National Treasury may consider a legitimate entity as one with a valid tax certificate, but, said van Leeve, “If you are procuring health products, for example, you may need other things to accredit a potential supplier, which treasury does not necessarily look at when it builds its database”.
“So, immediately you can see there will be tension between what the NHI envisage for creating its services and products lists versus what the public procurement office will develop in terms of the national supplier database. So, on the one hand, NHI is creating a special procurement system for health and providing for units and committees that will be responsible for identifying health services and buying health products and it’s not clear how these two pieces of legislation are going to interact.”
Van Leeve did say, however, that it is possible that the Minister of Finance “can differentiate between institutions and categories of procurement, but nothing in the procurement bill currently requires the minister to do so and there is no guidance on the considerations relevant to differentiating between categories of public institutions”.
She said it is possible for the bill to still make clear provision for the minister to make exemptions from the procurement bill. Currently, section 56(b) of the bill, for example, only provides – “the Minister may, with or without conditions, by notice in the Gazette, exempt a procuring institution from any provision of this Act, if— (a) national security could reasonably be expected to be compromised, or (b) the procurement is to be funded partially or in full by donor or grant funding and such exemption will benefit the public in general or a section of the public”.
But van Leeve insists that one way or the other, “It will be important – certainly in the way in which the NHI and procurement bills become operationalised for there to be comity between the bills.”
The RHAP report also recommends that “the relationship between health authorities and the public procurement structures proposed in the draft Public Procurement Bill must be clarified. The Public Procurement Bill makes no specific reference to health procurement as a special type of public procurement. At the same time, the NHI Bill contemplates a very particular regime in respect of health procurement. These two draft Bills will have to be aligned.”
According to the report, “the tension between the decentralised nature of public finance management in South Africa under the PFMA and Municipal Finance Management Act on the one hand and the highly centralised nature of public health services spending under the proposed NHI on the other hand, will have to be addressed”.
The shadow of politics
There are also other considerations besides overlapping provisions in the two bills – the shadow of politics through the blurring of the administrative and political interface often becomes a problem.
Rensburg highlighted, among others, it is still not clear how compliance with procurement policies will be audited and how often, or what the different sanctions will be for those not complying. “We see, especially with emergency procurement, that managing procurement functions is open to a lot of different kinds of pressures, he said. “The procurement bill does create frameworks for public office bearers to not be involved in the procurement process and for subject matter experts to be involved in procurement decisions, but there are a lot of things happening in the shadow that you can’t explicitly link to involvement of political principles in administrative processes,” said Rensburg.
“There is an added complexity,” Brown said, “when you hear, for example, of ANC tender committees, or when there is a tender chairperson who then can determine who gets and doesn’t get various contracts. This is deeply rooted in the state – from local government all the way up to national level, and across state-owned enterprises.”
Case in point, in the public health sector, the Digital Vibes scandal epitomised this “complexity” when then-Minister of Health, Dr Zweli Mkhize was implicated in tender irregularities and subsequently resigned.
Another criticism of the Public Procurement Bill is that it leaves a lot, arguably too much, of the detail of how procurement will actually work up to regulation rather than setting it down in primary legislation. This, suggested Caroline James and Sam Sole in a recent Daily Maverick article, leaves the door open to political interference.
Corruption Watch’s executive director, Karam Singh, during a different webinar in August on the procurement bill by the Special Interest Group on Public Procurement Law, also flagged some gaps in the definitions in the procurement bill, especially around issues like conflicts of interest and politically exposed persons.
In terms of chapter three of the procurement bill that deals with procurement integrity and prohibition of certain practices and debarment, anybody who is involved in the procurement process – that is from the accounting officer, bid committee, or tribunal – must comply with the prescribed code of conduct, failing which will constitute misconduct. According to Singh, however, the bill falls short of stipulating who must issue the code of conduct, how it would be updated, and where it would work, as well as where or when it must be made available. “There is very little detail on how misconduct would be handled,” he said, “and so there is a gap between understanding what this code of conduct would be, how it would come about and if it will be presented for public participation and public comment.” He said it is also unclear what would be the enforcement mechanism which would stand behind the code of conduct to make it effective.
Responding to concerns over tender corruption risks
In June this year, during a briefing by Dr Nicholas Crisp, Deputy Director-General in the National Health Department on the NHI Bill to MPs in the NCOP, concerns were flagged over the risk of tender corruption in the NHI Fund. Later, in August during a briefing to MPLs in the Western Cape provincial legislature, the same concerns were raised.
At every point, Crisp insisted, “The NHI Fund will handle very little by way of tender. The accreditation is not a tender process. It’s voluntary registration by a service provider – public or private – as long as they meet the criteria. The prices will be fixed and the way services are delivered will be fixed when it comes to the procurement.”
According to Crisp, when it comes to the procurement processes for goods, particularly health products, the NHI Fund is only involved in the first stage. “The Fund would not go about the logistics of purchasing anything. The providers needed to purchase once those prices were set. There was far less vulnerability in the Fund than first thought when one looked at the Bill,” he said.
Spotlight followed up with Crisp for further clarification in lieu of the RHAP report and the implications of the procurement bill for the NHI Bill. Crisp said, that according to the NHI Bill, the Fund will determine the Formulary that it will pay for and will establish the prices of the items in the Formulary. “It is the intention that the NHI agency will not buy any ‘health products’ and will not have storerooms and warehouses since the agency (the NHI Fund) is not a provider of services. The providers will buy what they need to deliver the benefits that they are accredited to provide. Accredited providers (public and private) will buy at the approved NHI prices and this is how the health department works now,” he said. “The provincial health departments do the buying and storing, etc.”
He stressed that the Fund will not go on tender for healthcare providers. “The bill in s39 says that providers will be accredited and all accredited providers will be paid for the benefits that they deliver. So, it is intended to not be exclusionary.”
On the implications of the Public Procurement Bill for the NHI Bill, he told Spotlight the department is still studying the procurement bill and these issues (as raised in the RHAP report and through various stakeholders) are being considered. He also noted that according to the NHI Bill, “If any other law, except the Constitution or PFMA, conflicts with the NHI Bill then the NHI bill prevails. But we will want to engage with the intentions, merits, and any potential challenges with Treasury,” he said.
Have your say
Members of the public have until 15 September to make written submissions on the version of the NHI Bill currently before the NCOP. Meanwhile, National Treasury this week briefed MPs in the Standing Committee on Finance on the Public Procurement Bill. The deadline for written submissions is 11 September.
At a recent media briefing session hosted by the Board of Healthcare Funders (BHF), managing director, Dr Katlego Mothudi, together with a distinguished panel of healthcare leaders addressed critical concerns regarding the National Health Insurance (NHI) Bill proposed by the South African government. The panellists, including BHF’s Chairperson, Ms Neo Khauoe, Dr Stan Moloabi, Chairperson of the BHF’s Universal Health Coverage Committee (UHC), Dr Mvuyisi Mzukwa, Chairperson of the South African Medical Association (SAMA), Prof Alex van der Heever, an expert in Health Care Governance at University of Witwatersrand (WITS), and BHF’s Head of Health System Strengthening, Dr Rajesh Patel, jointly emphasised the critical importance of addressing the current shortcomings in the NHI Bill. The panel highlighted the urgent need for systematic amendments before the Bill’s implementation.
While the BHF supports the concept of universal health coverage, Neo Khauoe strongly disagrees with the approach of the NHI Bill that public healthcare funding must increase at the expense of medical schemes. “The private health funding sector in South Africa should not be sacrificed in favour of NHI. It is too valuable in terms of jobs, scarce skills, infrastructure, financial investment, the quality of the health care services its beneficiaries receive, the value it adds to the economy, and the support it has lent to the public health sector,’’ she said.
Rajesh Patel, highlighting concerns within Section 33 of the Bill, pointing out the need for clarity in the Minister’s decision-making processes regarding the inclusion of rules for thorough implementation and addressed ambiguity in NHI contracting with health service providers. He said, one of the bigger complications is that maternity care has been excluded from the medical scheme’s benefits.
“There are absolutely no indicators in Section 33 to guide the Minister as to when NHI is fully implemented. Section 33 is thus contrary to the constitutional principle of administrative justice and allows the Minister to act arbitrarily. The determination by the Minister is an administrative decision that is subject to Section 33 of the Constitution and the Promotion of Administrative Justice Act No. 3 of 2000. As such, it must be lawful, reasonable, and procedurally fair. How is the Minister to know what will make his decision lawful if Parliament gives him no guidance in the NHI Act? The minister is not the lawmaker. That is Parliament’s role,” said Patel.
He emphasised the complexity of the NHI fund contracting health service providers and proposed the simplification of the process to encourage the participation of private sector firms in this undertaking. The private health service providers are estimated to be between 65 000 and 70 000 individuals and entities. The issues raised include the capacity for the responsible party for certifying and accrediting these health service providers and facilities, which will thereafter determine their eligibility for contractual engagement. The slow pace of certification and accreditation may limit access to care for healthcare users, as the user must register with NHI via accredited health service providers. Should contractual arrangements fail the health citizens risk not being funded from the NHI.
Stan Moloabi, Chair of the UHC Committee at BHFs, emphasised that medical schemes are important in healthcare provision and this importance is beyond just financial aspects. Serving as an integral stakeholder in the ecosystem that allows the health citizen’ to access the necessary health services in a timely, effective, and efficient manner, ultimately ensuring the provision of high-quality care. Moloabi concluded by saying, “We are currently facing uncertainties regarding the specific details that will arise from the ongoing policy changes outlined in the NHI Bill. As private healthcare funders, our primary goal is to actively collaborate with policymakers, which is crucial to achieving our shared objective of achieving UHC.“
According to Alex van der Heever, the NHI Bill is designed in a manner that will further undermine the already precarious situation of the South African healthcare sector. The discourse surrounding the move towards the achievement of universal health coverage in the country necessitates a comprehensive examination of the underlying goals associated with the concept of universal health care. Medical schemes are currently an integral component of the health system providing cover to 9 million lives. The hybrid universal coverage model is widely employed across the globe. He expressed his concerns pertaining to the single funder in the NHI Bill and the pressure on the health care system should all citizens rely on a single scheme. Furthermore a single fund is an impractical approach for both rich and developing countries Given South Africa’s limited GDP strength, such a proposition appears particularly unreasonable.
Neo Khaoue provided an in-depth analysis of the prospective financial consequences that enterprises may encounter because of the implementation of the NHI programme. Khaoue specifically emphasised the expected discrepancy in healthcare accessibility rates among employees under the NHI Bill in comparison to the existing system. The discrepancy is anticipated to extend the duration of employees’ recuperation, resulting in supplementary expenses for employers because of the postponed resumption of employees’ work duties. Considering the democratic nature of South Africa, it is crucial to prioritise the provision of opportunities for South African citizens to exercise their autonomy in shaping the course of their own future. Khauoe questioned the means through which discrepancies between private and public healthcare systems can be mitigated, particularly considering the existing difficulty of lengthy waiting times for various medical treatments. She said, “What strategies could be used to help the NHI Bill to simplify some of its processes, for example, if one is prepared for a certain operation but there is no anaesthesia available and the procedure is not performed on the specified day, what then? Furthermore, it is imperative to establish a reliable mechanism to guarantee that those who have been scheduled for operations or procedures will indeed undergo them on the designated days without any rescheduling. This demonstrates the necessity of both public and private sector involvement in addressing and resolving existing imbalances as a primary concern.”
According to Mvuyisi Mzukwa, the Chairman of SAMA, the NHI Bill has the potential to impose financial consequences on healthcare practitioners. Although healthcare providers may qualify for payment for services provided to beneficiaries of the NHI, it is important to note that the rates for these services may be standardised. This standardisation could potentially lead to a decrease in their revenue compared to the fees charged in private practice. Therefore, it may be necessary for practitioners to adjust their financial expectations and business strategies. He affirmed that the potential consequences of NHI could vary significantly depending on the legislative and regulatory framework in place. He went on to say, “Nevertheless, it is crucial to consider the financial implications for healthcare professionals when finalising the NHI Bill. The most important thing is that as the private health care practitioners we want to participate via collaboration with the policy makers in ensuring that we achieve those ideas they have.”
“As BHF, we are resolute that we provide the health citizen with a comprehensive understanding of the potential implications, challenges, and shortcomings of the NHI Bill before the upcoming provincial briefing sessions to be convened by the government. This is essential for fostering transparency, informed public discourse, and evidence-based policymaking in healthcare reforms and for giving South Africans a clear understanding of how the Bill will affect the lives of every citizen. I urge all South Africans to participate as it will impact all of us,” Katlego Mothudi said.
Mothudi highlighted that BHF firmly supports the freedom of the people of South Africa to spend their disposable income as they see fit, including insuring any of their health needs through medical schemes. This right is derived from the constitutional value of personal freedom in a democratic society and the rights to human dignity, privacy, freedom of association, freedom of thought, belief, and opinion, and the right to have access to health care services and emergency medical treatment.
“The NHI Bill is anticipated to have a cascading impact on the already declining state of the public health system in South Africa,” concluded Mothudi.
The South African Health Products Regulatory Authority (SAHPRA) has been designated as a Regional Centre of Regulatory Excellence (RCORE) for Vaccines Regulatory Oversight for a period of four (4) years in the following functions:
Overarching Regulatory Systems
Marketing Authorisation and Registration
Vigilance
Market Surveillance and Control
Licensing of Premises
Regulatory Inspections
Laboratory Access and Testing
Clinical Trials
Lot Release
The rationale behind the African Union Development Agency, New Partnership for Africa’s Development (AUDA-NEPAD) designating RCOREs is to support continent-wide regulatory systems strengthening through leveraging capacity in better resourced regulators. The reality of medicine regulatory capacity limitation on the continent continues to hinder access to essential medicines as well as limit progress in regulatory harmonisation efforts. The intention is to address this regulatory gap and ensure the acceleration and strengthening of regional medicines regulatory harmonisation initiatives. RCOREs are required to support regulatory workforce strengthening through training in regulatory functions and enhance skills through hands-on training and exchange programmes amongst National Medicines Regulatory Authorities.
About RCOREs
The Regional Centres of Regulatory Excellence (RCOREs) is an initiative of the AUDA-NEPAD. As part of its mandate to strengthen regulatory capacity development in Africa, AUDA-NEPAD through its AMRH programme has designated 11 RCOREs in eight different regulatory functions which include:
Pharmacovigilance
Training in core regulatory functions
Quality assurance and quality control of medicines
Medicine registration and evaluation, quality assurance/quality control and clinical trials oversight
Licensing of the manufacture, import, export, distribution and inspection and surveillance of manufacturers, importers, wholesalers and dispensers of medicine
Clinical trials oversight
Registration and evaluation and clinical trials oversight
Various stakeholders within the medical schemes value chain have sharply raised concerns over the unending court challenges brought by the Board of Healthcare Funders (BHF) against CMS. As an agile regulator, the CMS endeavours to clarify any misconception and confusion over BHF’s court challenges.
Chronology of Events
Initially, the main issue brought by BHF in this case was to request the court to grant them a general exemption for medical schemes to offer low-cost benefit options and to declare an alleged moratorium unlawful by the CMS and Ministry of Health in order to prevent medical schemes from offering low-cost benefit options.
In response, the CMS vehemently opposed the application on the basis that there was no moratorium as alleged by BHF and it would be thus unlawful to grant BHF a general exemption for medical schemes to offer low costs benefit options.
“It must be noted that while the main case/dispute was still ongoing (even after CMS submitted an extensive record of documents that were compliant with relevant information and documents having been exchanged between CMS and BHF), surprisingly BHF brought an interlocutory application alleging that CMS and the Minister were hiding certain information.”
Accordingly, the interlocutory application requested CMS and the NDOH to release an exhaustive list of documents which the CMS believed were irrelevant and had no bearing on the main application.
Despite CMS’s vehement contestation to the court on the additional requested documents by BHF, Judge Botha granted the BHF the order they sought, and the CMS, as well as the Minister of Health were ordered to produce the documents listed in Notice in terms of Rule 30A within 10 (ten) days of the Court Order, being 24 July 2023.
Before the expiration of rule 18 of the superior court, CMS filed leave to appeal the court order of Judge Botha as CMS believed that the order was flawed in law and that the judge had no reasons for ordering CMS and the Minister to produce those documents.
While the CMS legal team was studying the order, BHF concurrently lodged a contempt of court on an urgent basis.
CMS, through its attorneys, moved swiftly and wrote to BHF urging them to withdraw the contempt application as the CMS had already lodged its leave to appeal the court order of Judge Botha and this meant that the court order by Judge Botha would been suspended.
BHF refused to withdraw the contempt application and the application was heard on 8th August 2023 and the court dismissed BHF’s application on 10 August 2023 with costs in favour of CMS and Minister.
Citing Judge E van der Schyff who emphasised that “in the Practice Manual of the Gauteng High Court Division that while an application maybe urgent, it may not be sufficiently urgent to be heard at the time selected by an applicant” and also strongly highlighted that it does “not mean that applicants can indiscriminately approach the urgent court on the basis of extreme urgency without having regard to the context and facts of each individual application.”
Based on this order, the contempt application is now in our view moot or rather has been overtaken by the leave to appeal lodged by CMS and the Minister and CMS/NDOH. The leave to appeal will be heard somewhere September 2023.
The main application brought by BHF is likely to be heard in later parts of 2024.
Specially trained and accredited pharmacists in South Africa will now be allowed to provide people with medicines to prevent HIV and tuberculosis (TB) and to treat uncomplicated HIV without a doctor’s script. This is because the North Gauteng High Court this week ruled against an application by the IPA Foundation (an association of private doctors) attempting to block the implementation of Pharmacist-Initiated Management of Antiretroviral Therapy (PIMART).
PIMART involves the introduction of a legislative framework, a specialised training course, and an accreditation process to allow pharmacists to supply HIV and TB medicines to people visiting pharmacies, under certain conditions, without a doctor’s script.
While PIMART has been delayed for two years by the IPA Foundation’s legal challenge, Judge van der Schyff’s ruling now clears the way for the SAPC to proceed with its implementation.
Steve Letsike, Chair of the SAPC’s Health Committee and PIMART Task Team, said in a media conference on Thursday that the IPA Foundation has until 8 September to appeal the High Court’s decision. Speaking at the same media conference, Mogologolo Phasha, President of the SAPC, indicated that if the IPA Foundation appeals the ruling, the SAPC will continue to fight to preserve the initiative in higher courts.
Spotlight asked the IPA Foundation whether they plan to appeal the decision, but no response was received by time of publication.
The background
The introduction of PIMART was proposed by the SAPC in 2018 in response to a request from the National Department of Health for the SAPC to develop an intervention to enable pharmacists to help get HIV prevention treatment to more people quicker.
Pharmacists trained and accredited under the PIMART initiative will be able to provide preventative therapy for HIV (both post-exposure and pre-exposure prophylaxis – PEP and PrEP), TB preventive therapy, and first-line antiretroviral treatment for uncomplicated HIV.
According to Phasha, around 900 pharmacists, or 5% of pharmacists on the register have already undertaken specialised, supplementary training to enable them to provide PIMART services. He noted, however, that before trained pharmacists would be able to start providing PIMART services they would need to receive accreditation in the form of a permit granted by the National Department of Health under Section 22(A)15 of the Medicines and Related Substances Act.
The court’s response to the IPA Foundation’s arguments
In February 2022, the IPA Foundation filed an affidavit with the North Gauteng High Court seeking review and dismissal of the SAPC’s decision to implement PIMART and related legislation.
In its affidavit, the IPA Foundation argued that the provision of PIMART services falls within the domain of medical doctors and that pharmacists do not have the required training and competencies to provide these services. The IPA Foundation further argued that the SAPC does not have the legislative mandate to introduce PIMART, that the SAPC’s reasons for implementing PIMART were not adequately explained, and that the SAPC’s procedures for implementing PIMART were not procedurally fair and did not provide adequate opportunity for interested parties to comment.
The IPA Foundation warned of a “slippery slope” resulting from PIMART’s introduction, adding “this objection essentially warns of the opening of the floodgates or perhaps an anticipated negative precedent setting occurrence relevant to the provision of medication… without prescription”.
In her ruling, Judge van der Schyff noted that while tension between healthcare cadres regarding their scopes of practice is common, the World Health Organization calls for “a collaborative approach to primary healthcare issues and the embracing of task-shifting”.
She added that “competition, per se, does not limit or curtail the rights of medical practitioners to continue providing the services that they currently provide,” further stating that “even if the assumed competition is regarded to affect family practitioner’s rights adversely, the alleged adverse effect it holds for medical practitioners has to be considered against the need to expand primary healthcare services aimed at preventing and treating HIV”.
Judge van der Schyff dismissed the IPA Foundation’s argument that the SAPC is not mandated to introduce PIMART, stating that “the SAPC is empowered to prescribe the scope of practice of the various categories of persons registered in terms of the Pharmacy Act”. She added, “The development and implementation of PIMART, does not expand the existing scope of practice of pharmacists that generically provides for PIT [pharmacist-initiated therapy] and PCDT [primary care drug therapy]. It introduced a specialised category of PIT and PCDT focused on preventing and treating HIV.”
Judge van der Schyff also rejected the IPA Foundation’s arguments that PIMART’s introduction was procedurally unfair and the decision for its implementation was not properly explained, arbitrary, or capricious. She says that “through its collaboration with the Southern African HIV Clinicians Society, whose members include numerous medical doctors, the development of PIMART was given great exposure”.
“The need to widen access to first-line ART [antiretroviral therapy] and TPT [TB preventative therapy] on a community level is not a figment of SAPC’s imagination, but a dire need that is also evinced in other countries,” held van der Schyff.
Finally, Judge van der Schyff rejected the argument that pharmacists are not adequately trained to provide PIMART services, stating, “The PIMART training course was developed to ensure that pharmacists who successfully completed the training would be ‘suitably qualified to safely and effectively assist in providing ART’.” She adds that the PIMART training course was “developed by suitably qualified experts in the field, which experts include medical practitioners”.
The ruling was welcomed by the SAPC and several HIV groups.
“The superior court yesterday (Wednesday) confirmed what has been our long-held view that PIMART is a necessary and competently designed intervention programme to support South Africa’s efforts in providing access to patients diagnosed with HIV and AIDS,” said Phasha. “The programme may also arrest and lower the ballooning HIV budget, which is nearly half the national health budget, by reducing the rate of new infections.”
Nelson Dlamini, Head of Communications at the South African National AIDS Council (SANAC), told Spotlight that SANAC welcomes the court ruling.
“The magnitude of South Africa’s HIV burden requires innovative ways of accessing HIV treatment, care, and support. PIMART is one such approach that will improve access to antiretroviral therapy for people living with HIV and those requiring PEP & PrEP,” said Dlamini.
Sibongile Tshabalala, Chairperson of the Treatment Action Campaign (TAC), said the organisation also welcomes the ruling. “The challenges that we are facing in the country include one of people queuing for a long time in facilities… and also the attitude of nurses in facilities which chases away so many people from facilities. We also have the issue of key populations that are not comfortable to go in public health facilities to access medication… so if a pharmacist is able to issue and prescribe ARVs and TB medication it will mean that we will be able to cover a lot of people.”
*NOTE:A representative of the TAC is quoted in this article. Spotlight is published by SECTION27 and the TAC, but is editorially independent – an independence that the editors guard jealously. Spotlight is a member of the South African Press Council.
