Category: Healthcare Politics and Regulations

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Analysis: Where We Are with NIMART 13 Years Later

On By ModernMedia
Photo by Hush Naidoo Jade Photography on Unsplash

By Tiyese Jeranji for Spotlight

Like many countries, South Africa has a shortage of healthcare workers – particularly of doctors. One response to such shortages is task-shifting – in short, to let doctors focus on the things only they can do, and to shift some other less specialised tasks to other healthcare workers like nurses or pharmacists.

Task-shifting can take many forms. Earlier this year Spotlight reported on a court case that gave the green light to specially trained pharmacists to dispense antiretroviral treatment without a script (the judgement is being appealed). Similarly taking pressure off public sector clinics, the Department of Health has for several years now allowed some people to pick up their medicines at participating private sector pharmacies or other pickup points. Less well implemented, was the introduction of clinical associates in 2008 as a new type of mid-level healthcare worker that can take some of the pressure off of doctors and stand-in for them in some situations.

Probably the most impactful example of task-shifting in South Africa, however, was the introduction of Nurse Initiated and Managed Antiretroviral treatment (NIMART) in 2010.

What is NIMART?

Dr Silingene Ngcobo, a lecturer at the School of Nursing and Public Health at the University of KwaZulu-Natal and a Board Member of the Southern African HIV Clinicians Society, says NIMART is a clinical management program for people living with HIV which is driven by registered nurses. This means that registered nurses can independently manage a person living with HIV, starting from screening and diagnosis, all the way to treating, and monitoring throughout the HIV care continuum in the absence of a medical doctor.

As explained by Mmotsi Moloi, Training Programme Manager at the Aurum Institute (an NGO), prior to the introduction of NIMART in 2010 only doctors were authorised to prescribe antiretroviral therapy.

The rollout of antiretrovirals in South Africa technically started in 2004, but it only gathered momentum after the end of state-backed AIDS denialism in 2008. It soon after became clear that South Africa would not have enough doctors to handle the demand for HIV treatment and nurses would have to be roped in.

“The waiting lists became long, and the doctors could not meet the increasing demand of clients in need of antiretroviral treatment, this led to the death of clients while awaiting to be initiated,” says Moloi. “There was an urgent need to remedy the situation which was to decentralise management of HIV to Primary health care facilities and professional nurses to be trained and authorised to manage HIV infected clients.”

Ngcobo says nurses are often the only healthcare providers available to provide HIV prevention, care, and treatment services. She says the South African healthcare delivery system approach has changed from hospital-centred care to promotion of health and prevention of disease through primary healthcare and the introduction of NIMART fits this shift.

Hard to quantify

According to estimates from Thembisa, the leading mathematical model of HIV in the country, the number of people taking HIV treatment in South Africa increased from 1.2 million in 2010 to 5.7 million in 2022. How big a part NIMART played in this remarkable scale-up of treatment is hard to quantify, but that it played a pivotal role seems clear.

A review study published in 2021 that looked back at 10 years of NIMART in South Africa, found that adequate NIMART training “results in improved knowledge of HIV management, greater confidence and clinical competence, particularly if accompanied by mentoring”.

The review summarised results from several smaller studies conducted in different provinces on NIMART – which show, on a small scale at least, what potential impact NIMART has had. Among other things, the training of nurses to initiate and manage HIV treatment led to feelings of empowerment, and when coupled with appropriate training and support can “lead to increased quality of patient care, confidence and professional development”.

Studies conducted in Johannesburg cited by the review found that NIMART training increased access to HIV treatment, reduced workloads at referral facilities, and reduced referrals to tertiary hospitals. Nurses also saw an “improvement in the quality of life of their patients and the retention of patients in care, which they felt reflected the success of NIMART”.

When asked how many NIMART-qualified nurses we have in the country, Foster Mohale, spokesperson for the National Department of Health, says he can’t provide an exact number since they no longer collect data on NIMART since it has been incorporated in broader HIV training. He also says that provinces are the custodians of data for all trained healthcare workers and points out that the numbers change all the time due to attrition.

What NIMART nurses do

Ngcobo says NIMART nurses assess and screen people living with HIV for treatment eligibility, initiate antiretroviral therapy, provide adherence counselling and monitoring, screen for opportunistic infections, offer various preventative therapies, psychological support, as well as appropriate referrals to other members of the disciplinary team, and oversee repeat visits throughout the healthcare user’s life while managing any other health condition that the person might have.

Nurses also have to support people with tuberculosis and non-communicable diseases (such as diabetes and hypertension) to take treatment as prescribed.

“For effective management of other diseases, NIMART nurses should actually work with all other conditions because a person living with HIV still can gets various other conditions which still need to be managed. Therefore, the role of [the] NIMART nurse is to wholistically manage the patient and provide all the necessary healthcare services that the healthcare user in front of them will be requiring,” says Ngcobo.

Training requirements

The NIMART programme has changed somewhat since its launch back in 2010. Mohale says the programme now also covers the majority of healthcare professionals like medical doctors, pharmacists, registered or professional nurses, and other healthcare professionals who are authorised by their statutory bodies to assess, diagnose, prescribe, and dispense medications. He says in 2017 NIMART was changed to “Basic HIV for Health Care Professionals”, but the name NIMART is still in wide use.

The essence of the programme however remains that a professional nurse, or other qualifying healthcare professional, must complete special training (see this online course for example) before they are authorised to prescribe HIV treatment and manage the treatment and care of people living with HIV. Training typically requires both an exam and some practical work, ideally with the support of a mentor.

All prescribing by nurses in the public sector relies on section 56(6) of the Nursing Act, which allows an exception to the Medicines Act and other health-related laws, explains Andy Gray, Senior Lecturer  in pharmaceutical sciences at the University of KwaZulu-Natal. “They therefore do not need section 22A(15) permits or section 22C(1)(a) dispensing licences in terms of the Medicines Act,” he says.

The legalities of how nurse prescribing works in South Africa is set out in a 2016 policy document issued by the National Department of Health. Amongst others, the document states that, “a nurse may only perform the functions authorised by Section 56(6) in public sector facilities in the district or municipality where the authorisation was granted to him/her”. In other words, nurses who move to jobs at other facilities or in other districts will often require new authorisation before they may prescribe medicines such as antiretrovirals.

Some concerns

But there are signs that training and mentorship is not functioning optimally across the board.

“There is non-standardised training and inadequate mentoring as the country doesn’t have enough trainers,” says Mohale. “There are human resource constraints for both trainers and nurses to be trained. Some districts rely on their district support partners to carry out trainings on their behalf.”

“Staff shortage from the facilities also leads to some nurses not being able to be trained due to demand for other health services at their service delivery points. Some challenges include failure to identify and manage drug-drug and drug-food interactions which are important in making sure that the patients are suppressing their viral loads,” he adds.

Mohale’s comments echo several barriers to the success of NIMART that were identified in the 2021 review study, including: “non-standardised training, inadequate mentoring, human resource constraints, health system challenges, lack of support and empowerment, and challenges with legislation, policy and guidelines”.

Republished from Spotlight under a Creative Commons licence.

Source: Spotlight

Categories : Healthcare Politics and Regulations Medical IndustryTags :

SAHPRA Recalls Lubri-A, Sterile Lubricating Gel

On By ModernMedia
Photo by Jan Kopřiva on Unsplash

The South African Health Products Regulatory Authority (SAHPRA) is aware of the product Lubri-A (Sterile Lubricating Jelly) manufactured by Electro-Spyres, classified as Class B medical device and currently being distributed across the country. 

SAHPRA has been informed of multiple complaints received from health institutions, both public and private across the country. The complaints are as a result of a number of patients who became ill due to developing a fungal infection, caused by exposure to the fungal species, Wickerhamomyces anomalus (previously Candida pelliculosa) associated with use of Lubri-A (Sterile Lubricating Jelly).

Lubri-A is available in two presentations, the 2.5 g sachets and 50 g tubes.

Considering the wide usage of the product for lubricating purposes in medical and surgical procedures, the Regulator has taken a decision to urgently recall this product from the market as there are multiple contaminated batches, with the potential to cause serious and widespread nosocomial infections. SAHPRA is alerting healthcare professionals and the public to discontinue the use of the product, remove it from their inventory and return it through their normal distribution channel(s) with immediate effect.

As the source of the contamination of the product is still under investigation and not confirmed, all batches of Lubri-A are being recalled. Future manufacture and distribution of the product will be subject to review and authorisation by SAHPRA.

Classification of the recalls

The recall is being classified as a Class 1, Type A recall, which is associated with a serious product quality concern that may have severe consequences. This is a countrywide recall. The product is being recalled from hospitals, retail outlets, health care professionals, authorised prescribers and individual customers or patients.

What the public should know

Healthcare professionals that have used this product should contact their patients to determine any symptoms of infection after use of product.

The recall is limited to the product called LUBRI-A (2.5g and 50g sachets) and does not affect other lubricating gel products authorised for sale in South Africa.

The contact telephone numbers for Electro-Spyres are:

Landline:         011-608-3998 or 011-402-7208

WhatApp:       +27-82-355-8862

“As a national regulatory authority, the recalling of medical products is a crucial measure to address safety concerns or quality issues so that we protect the health of the public. SAHPRA is recalling this product from the market as there are multiple suspected contaminated batches with the potential to cause serious and widespread nosocomial infections, ” indicates SAHPRA CEO, Dr Boitumelo Semete-Makokotlela.

Categories : Healthcare Politics and RegulationsTags :

NHI Bill Threatens All Citizens’ Constitutional Rights

On By ModernMedia

HFA outlines presidential petition to prevent decimation of the SA healthcare system

The NHI Bill presented to President Cyril Ramaphosa cannot be permitted, as in its current form, it will infringe the rights of all South Africans by destroying the South African healthcare system. The Health Funders Association (HFA) has petitioned the President to withhold assent of the Bill on constitutional and procedural grounds and intends to take the matter as far as necessary and to the Constitutional Court if need be.

“We have taken a strong stand by respectfully urging the President to withhold assent of the Bill, citing constitutional and procedural concerns that pose a significant threat to the integrity of the country’s healthcare system,” remarks HFA Chairperson Craig Comrie.

“Should the need arise, the HFA is prepared to escalate the matter to the courts. Our goal is to meticulously align the legislation with the authentic objectives of Universal Health Coverage and the principles enshrined in the South African Constitution.

“Our action in opposing the NHI Bill being signed into law protects the interests of ALL South Africans who will require healthcare in future, including the people we are duty-bound to safeguard through the medical schemes and healthcare administrators we represent,” Comrie says.

While expressing unwavering support for achieving Universal Health Coverage (UHC) in South Africa, the HFA questions Parliament’s endorsement of a bill that raises significant constitutional and procedural concerns and fundamentally cannot achieve a sustainable system of UHC.

Some of the primary concerns outlined in the letter include:

  • Constitutional concerns: The NHI Bill’s clear infringement on constitutional rights, particularly the right to access healthcare and freedom of choice for South Africans, and by implication, the right to life. The Bill is seriously flawed in that regard, undermining the rule of law.
  • Procedural concerns: Questioning the extent and effectiveness of public consultation during the drafting and review of the NHI Bill, where thousands of submissions resulted in no meaningful changes to the Bill, the HFA advocates for a more inclusive and consultative approach.

The letter implores President Ramaphosa to exercise the powers granted by the Constitution to refer the NHI Bill back to Parliament for review.

“In addition to petitioning the President directly as guardian of the Constitution, the HFA will oppose the NHI Bill in its current form through every possible avenue, including approaching the courts to set aside the Bill on constitutional and procedural grounds.

“The HFA will also seek a High Court interdict against implementation of the NHI Act until the merits of our case have been heard and ruled upon by the High Court.

Craig Comrie concludes, “It is with a heavy heart that we make this plea, urging the President to secure the rights and wellbeing of our people. We will persist to ensure that what is right triumphs in our nation. South Africa deserves leadership that prioritises the welfare of all of its citizens, above all.”

Categories : Healthcare Politics and RegulationsTags :

Health in 2023: A Deceptively Busy Year in Fewer Than 1000 Words

On By ModernMedia
PHOTO: Ashraf Hendricks/GroundUp

By Marcus Low

2023 was a busy year for healthcare in South Africa. There were several policy developments, landmark court cases, important pieces of legislation, and some changes in leadership. Yet, take a step back and not much seems to have changed. Shortages of healthcare workers persist, corruption is still rife, budgets tight, and our health governance crisis remains as acute as ever.

Start with some positives. Following the release in 2022 of a non-communicable disease policy with important diabetes and hypertension targets, this year saw the release of South Africa’s overdue new mental health policy, an obesity policy, and a new strategic plan for HIV, TB and STIs. These policy documents were generally welcomed, although most experts we spoke to had questions over the state’s ability to implement them.

That ability to implement was dealt another blow this year with continued budget cuts in the public healthcare sector and the freezing of posts in some areas. As shown in several of the community healthcare monitoring group Ritshidze’s excellent provincial reports this year, staff shortages remain acute across much of the country – something that is unlikely to change given budget constraints. Though South Africa has a good healthcare worker strategy on paper, another year has passed with no clear indication that the state is committed to implementing it.

Instead, much of the political oxygen in 2023 was again consumed by National Health Insurance (NHI). As the year draws to an end, the NHI Bill has cleared parliament and chances are the President will sign it ahead of next year’s national and provincial elections – though actual implementation will take years.

Reforms to South Africa’s procurement legislation are also making its way through parliament, although critics have slammed the bill for not doing enough to clamp down on corruption. The State Liability Bill was delayed again because a report from the South African Law Reform Commission on medico-legal claims has still not been finalised.

In the courts, an important judgment in the Eastern Cape limited the extent to which the state can be held financially liable for medical negligence, although the law in this area remains somewhat unsettled. There were also major court victories for the right to transparency, with a court ordering the disclosure of COVID-19 contracts entered into by government, and for the ability of pharmacists to provide antiretrovirals without a script from a doctor – this latter judgment is being appealed. This year also saw the pieces put in place for what is set to be a landmark court case for access to medicines, as Cheri Nel and others challenge a monopoly on life-changing cystic fibrosis medicines.

Photo by National Cancer Institute on Unsplash

As for leadership changes, this year South Africa got a new health ombud (we interviewed the outgoing ombud here) and a new registrar of the Health Professions Council – the latter institution remains in urgent need of reform. Maybe the most important leadership change this year, however, was the controversial removal in September of Dr Rolene Wagner as head of the Eastern Cape Health Department. Wagner’s removal seems symptomatic of ongoing and excessive political interference in the running of provincial health departments.

Several of these departments again made the headlines for the wrong reasons. Current and former Officials in both the North West and Northern Cape Department of Health are facing serious charges, but maybe most dispiriting was the ongoing dysfunction in the Gauteng Department of Health. From botched food and security contracts to the lacklustre response to alleged corruption at Tembisa Hospital, those who hoped for a turnaround in the department were disappointed. The end of the inquest into the Life Esidimeni tragedy this year served as reminder that the department’s problems are entrenched and long-standing.

South Africa’s TB response was given a boost this year with the adoption of an ambitious new test-and-treat strategy, whereby people who test positive for TB are treated and at-risk people who test negative are offered preventive therapy. Some new TB treatment regimens have been rolled out, but we are unfortunately still waiting for others. A reduced price for the DR-TB drug bedaquline was secured, largely due to the work of South African and international TB activists, and two philanthropies put up the money for a critically important phase 3 TB vaccine trial.

Photo by Sergey Mikheev on Unsplash

Pilot programmes testing HIV prevention injections and HIV prevention rings in South Africa were set to start at the beginning of the year, but the injection part of those pilots ended up being delayed. It is still not clear when the many young women in South Africa who could benefit from the prevention injection will be able to get it. A recently announced price for the injection is calculated to be far too high for our healthcare system.

There was some good news this year in that more people in South Africa are finally able to access breakthrough hepatitis C cures developed over the last decade. The picture looks less promising with new weight loss medicines – high prices, supply constraints, and monopolies are likely to keep these exciting medicines out of reach for most people in South Africa, despite the rising number of people with obesity who could benefit from them.

As for the numbers, the WHO this year estimated that in 2022 280 000 people fell ill with TB in South Africa and 54 000 people died of TB. According to the latest estimates from the Thembisa model, in 2022 around 13% of the population were living with HIV, 164 000 people were newly infected with HIV, and 48 000 died of HIV-related causes (there is substantial overlap since many people with HIV die of TB). The Human Sciences Research Council (HSRC) raised some eyebrows when it estimated that 91% of people diagnosed with HIV were on treatment in 2022, UNAIDS and the Thembisa model have this number at well under 80%. New UNAIDS and Thembisa estimates due in 2024 will be closely watched to see how they are impacted by the HSRC findings.

Republished from Spotlight under a Creative Commons Licence.

Source: Spotlight

Categories : Expert Opinion Healthcare Politics and RegulationsTags :

Opinion Piece: From Crisis to Cleanliness – CSI Initiatives Have the Power to Eliminate Pit Latrines in South African Schools

On By ModernMedia

By Robert Erasmus, Managing Director at Sanitech

The continued use of pit latrines presents grave risks in South Africa, particularly within school environments where the safety and well-being of children are compromised. Recent government statistics from March 2023 reveal a staggering reality: out of 23 000 public schools, over 3300 still rely on pit latrines, necessitating urgent action.

Private sector involvement through Corporate Social Investment (CSI) emerges as a critical player in tackling this pressing issue. In 2022, a substantial R10.9 billion was designated for CSI, with half of the funds directed to the education sector. By reallocating a portion of these resources towards sanitation initiatives, companies could act as a powerful force for meaningful change, especially if invested in innovative solutions like the Khusela dry sanitation unit. This advanced solution not only holds the potential to resolve the sanitation crisis in schools but also provides an avenue for businesses to elevate their Environmental, Social, and Governance (ESG) ratings simultaneously.

CSI can bypass burdensome bureaucracy

With approximately 14% of public schools still relying on hazardous facilities, urgent action is essential; but eradicating pit latrines from South African schools is no small feat. While close collaboration between the private and public sector will be required, government has been slow to address this health and safety crisis as promised, and their burdensome procurement and tender processes have only served to hinder progress, making it evident that relief will have to be sought elsewhere. This is where a beacon of hope emerges through the coordination of CSI and ESG initiatives in the private sector. One of the key advantages of leveraging CSI and ESG initiatives is their potential for rapid, impactful change. The private sector, with its focused CSI efforts, can target key areas for high-impact intervention. Schools, being the cornerstone of a child’s daily life, stand to benefit the most. Imagine the profound difference proper sanitation facilities could make in the lives of students who spend most of their day within these school premises. A rapid transformation in these facilities, facilitated by private sector involvement, can significantly improve the learning environment and overall, well-being of these young minds.

A swift and strategic approach to school sanitation

Measuring the success of CSI initiatives is crucial, and this is where a collaborative approach truly shines. Conducting nationwide surveys and prioritising schools most in need will allow for a strategic and targeted allocation of resources. Instead of waiting for bureaucratic processes to run their course, CSI initiatives can swiftly address the pressing issues of inadequate sanitation facilities. The results will be tangible, the impact immediate, and the benefits will reach those in need, without delay or diversion. Furthermore, ongoing collaboration with waste management providers will oversee these sanitation solutions to ensure initiatives remain purpose-fit, providing not just a one-time fix but a sustained relationship for ongoing positive change.

A safe, cost-effective sanitation solution

At the forefront of revolutionising sanitation in South African schools stands the Khusela dry sanitation unit. Unlike traditional pit latrines, the Khusela unit offers a safer and more hygienic alternative, eliminating the inherent health risks associated with dangerous, unsanitary facilities. Its design focuses on promoting a healthier environment by efficiently managing waste, mitigating contamination, and significantly reducing unpleasant odours. The introduction of Khusela units in schools will not only address a critical health concern but also empower students, especially girls, by providing a discreet and dignified space for personal hygiene, ensuring that the barriers to regular school attendance are diminished. Additionally, the ESG advantages of sanitation upgrade projects are significant, spanning environmental preservation, enhanced social well-being, and improved governance, aligning clearly with fundamental ESG principles that emphasise dedication to a sustainable future.

CSI and ESG: win-win for public schools and the private sector

In short, effective CSI initiatives focused on sanitation offer a dual advantage: they align with corporate CSI objectives while directly addressing essential ESG aspects like environmental and social responsibility. This unique synergy creates a win-win scenario, where the private sector can fulfil its societal and environmental obligations and ultimately contribute to a sustainable and equitable future. The call to action is clear – businesses must recognise the power they possess to expedite change and must engage with organisations in the waste management, hygiene, and sanitation space for impactful partnerships. Together, we can replace pit latrines in South African schools with safer, more hygienic alternatives and create healthier environments that are conducive for the growth and development of our youth. 

Categories : General Interest Healthcare Politics and RegulationsTags :

Universal Healthcare is Possible in Our Lifetime

On By ModernMedia

Universal Health Coverage Day calls on us to reflect on the progress that we have achieved in providing healthcare for all. As the health and pharmaceutical industries, it is time to question if our strides in achieving healthcare for all are successful and identify areas for improvement. The theme “A Time for Action”, speaks to the urgency of healthcare access regardless of socioeconomic status, age, race or demographic. It is not an ambitious dream and can be attained in our lifetime, writes Bada Pharasi, CEO of the Innovative Pharmaceutical Association of South Africa (IPASA). 

Universal Health Coverage (UHC) means access to primary healthcare for everyone. In South Africa, this is referred to as  National Health Insurance (NHI). Regardless of its name, the objective remains the same – to ensure that all citizens, regardless of where they live or their socioeconomic status, have access to healthcare.

A 2021 report released at the Africa Health Agenda International Conference (AHAIC) revealed that 615 million, or 52%, of the people in Africa, did not have access to the healthcare that they needed¹. It was also estimated that 97 million Africans face catastrophic healthcare costs, which push 15 million people into poverty every year¹. 

The effective implementation of UHC would mean that no person would have to go without appropriate healthcare. It would also mean that no person would have to undergo financial strain to receive treatment for ill health.

UHC covers a spectrum of health needs from health promotion to prevention, treatment, rehabilitation, and palliative care across the life course². In 2015, 193 United Nations (UN) member states agreed on the 2030 Sustainable Development Goals (SDG). These goals are aimed at seeing an end to poverty and a sustainable future by 2030², and ensuring health coverage for all is an integral part of reaching these goals. 

The World Health Organization (WHO) believes that UHC can be achieved by using the primary healthcare approach as it remains the most accessible, inclusive and cost-effective method to reach the majority of the population². 

Globally, as many as 72 countries have included UHC in their national healthcare systems. The countries where UHC has been the most successful include Canada, Australia, and several European countries, such as Switzerland and Sweden. It is from these countries that we can glean valuable lessons on the importance of strong healthcare systems, well-trained healthcare professionals and a cohesive relationship between governments and the private sector³. 

Ensuring a healthier nation may seem like an exorbitant mission. However, when we consider that a healthier population will be beneficial to the economy, it makes for a worthwhile investment. The World Bank adds that UHC allows countries to make the most of their strongest asset: human capital. A nation in good health is one where children can go to school and adults can go to work⁴. 

There is a common perspective that for a country’s overall health to improve, its economy must improve first. This idea fuels the understanding of why low- to middle-income countries have such poor healthcare infrastructure. The World Bank offers an alternative perspective, suggesting that when a country’s overall health improves, so will its economy. This as more citizens will be able to contribute to its economic growth and the workplace⁵.  

Some of the reasons why the adoption of UHC in African countries has seemed to stall include inadequate financial and technology support, limited pharma manufacturing companies, and unclear policies and regulatory frameworks⁶. 

In South Africa, the greatest hindrance to people receiving the healthcare they require boils down to numbers. With a population of more than 60 million people, there is a greater need for healthcare than there is capacity to meet the demand⁷. 

At IPASA, we believe that healthcare is a basic right and that citizens in any given country should be given the necessary access to healthcare. We understand that working with key stakeholders, such as the government, is critical to the success of universal healthcare. Our ongoing work with patient advocacy groups ensures we understand what patients need from a treatment perspective.

We recently attended the Access Dialogue conference with patient advocacy groups including Rare Diseases South Africa and Campaigning for Cancer to gain an understanding of some of the concerns faced by patients and share insights on the proposed NHI Bill. 

IPASA believes that an adequate supply of medicines is a critical pillar of any healthcare scheme, and the NHI is no different. For the NHI to succeed, it must be backed by a sustainable healthcare sector to ensure the security of healthcare provision and medicine supply.

To this end, the NHI must allow for a flexible, responsive pricing model that includes alternative/innovative reimbursement models to cover the cost of medicines and health products. This allows responsiveness to the needs of geographical areas, quality and levels of care, and negotiations directly with healthcare providers.

Healthcare for all can only be achieved by the joint commitment of the health and pharmaceutical industries, government stakeholders and patient advocacy groups for the benefit of patients. No person should be faced with the obstacle of finance at a time when they need healthcare: providing healthcare for all results in a healthier society and healthier world for us all. 

References:

  1. https://healthpolicy-watch.news/only-half-of-africans-have-access-to-health-care/ 
  2. https://www.who.int/news-room/fact-sheets/detail/universal-health-coverage-(uhc) 
  3. https://wisevoter.com/country-rankings/countries-with-universal-healthcare/#:~:text=The%20countries%20with%20the%20highest,comprehensive%20coverage%20of%20healthcare%20services.
  4. https://www.worldbank.org/en/topic/universalhealthcoverage 
  5. https://widgets.weforum.org/outlook15/10.html 
  6. https://www.iqvia.com/locations/middle-east-and-africa/blogs/2023/01/getting-quality-medicines-to-patients-faster-in-africa-how-to-solve-for-access-issues 
  7. https://www.wits.ac.za/covid19/covid19-news/latest/healthcare-in-south-africa-how-inequity-is-contributing-to-inefficiency.html
Categories : Healthcare Politics and Regulations Medical IndustryTags :

The EU Protects its Companies from Big Pharma. South Africa Needs to do the Same

On By ModernMedia
Photo by National Cancer Institute on Unsplash

By Fatima Hassan

Critical work done by South African scientists on mRNA vaccines for several diseases is at risk from patent claims from the pharmaceutical giant Moderna. Yet the government could easily protect this and other programmes by speeding up the passage of amendments to patent laws.

Every year, industry’s biggest players spend a combined US$4-billion on legal action. Even then, there was an audible gasp from the world’s media when Moderna, which developed a Covid vaccine with the US government, announced it was suing rivals Pfizer and BioNTech for “patent infringement”.

All three companies have made a fortune from selling Covid vaccines, and are now at war over the rights to the publicly-funded mRNA technology behind it.

After a year of suing and counter-suing in multiple jurisdictions, the European Patent Office stepped in two weeks ago and revoked one of Moderna’s patents covering “respiratory virus vaccines”. In doing so, the European Patent Office was seemingly defending BioNTech, a German company, from a ‘’threat’’.

This is not unusual. In most countries, governments can intervene to protect companies viewed as important to their national interest and can review, revoke, or withdraw patents. Most countries, but not South Africa.

Under Nelson Mandela, South Africa fought Big Pharma to secure affordable generic HIV medicines, and in the pandemic, the government made a valiant attempt to do the same for Covid vaccines by seeking a global waiver of intellectual property rules. But arcane apartheid-era laws still accept patent requests from companies – without substantive examination of the merits of the patent application and without the due process right to challenge it before it is granted. And, once a patent is granted, patient advocacy groups cannot easily revoke it.

There is legislation drafted which could give us the ability to challenge patents before they are granted, among other much needed mechanisms such as compulsory and government-use licensing.

In 2018, Cabinet approved a new Intellectual Property Framework which would give us this most basic right. It is compliant with international trade rules and should not be controversial. But, despite the fact the government has said it wants this legislation, has drafted it, and has even trained examiners on it, the law has sat languishing on the desk of the Minister of Trade, Industry and Competition Ebrahim Patel for several years. This has enabled Moderna to be granted far-reaching mRNA related patents in South Africa.

These patents put our widely-acclaimed mRNA vaccine manufacturing project, backed by the World Health Organisation (WHO) and others, at risk.

While the world quickly developed effective vaccines to combat Covid, intellectual property rules prevented us from making shots for ourselves. Western governments blocked our government’s efforts to suspend these global rules, leaving South Africa to wait at the back of the global queue, eventually paying unreasonably high prices for vaccines. Then at the height of our third wave of Covid infections, Johnson & Johnson exported vaccines which had been completed at a factory in the Eastern Cape to Europe, prioritising European customers over South Africa and the continent.

It was a dark time for South Africa. But amid the devastation, some hope came in the form of a small biotech company in Cape Town, Afrigen, when the WHO announced it would be at the centre of a new Global South programme to deliver vaccines.

Sharing technology

Moderna, Pfizer, and BioNTech have all refused to share their technology with the programme. But scientists from Afrigen and universities in South Africa as well as the South African Medical Research Council developed an mRNA vaccine of their own, using the publicly available information from the vaccine which Moderna developed with the US government. They have now begun sharing the technology with partners across the Global South – and are exploring vaccines for diseases such as TB too.

In a future pandemic, the programme could be used to rapidly share vaccine technology between low and middle-income countries, so that we don’t repeat the global inequality of the Covid vaccine rollout.

Except that Moderna filed far-reaching patents in South Africa which could be interpreted as covering any mRNA technology. And, under our faulty, unchanged intellectual property regulation system, the patents were granted.

Dozens of health and legal organisations have warned that the mRNA programme is vulnerable to patent claims from Moderna. While the company has given assurances that it will not enforce patents on its Covid vaccine in some lower-income countries, including South Africa, the work of the programme on other diseases remains under threat.

The Medicines Patent Pool, which is implementing the project for the WHO, wants each programme partner (in the Global South) to resolve the issue of patents itself. But, by suing Pfizer and BioNTech, Moderna has signalled that it wants a total monopoly on mRNA technology. What, then, is Plan B if Moderna turns on the WHO-backed programme next?

When earlier this year, the Health Justice Initiative took legal action to force the Department of Health to disclose secret contracts with Covid-19 vaccine manufacturers, we won – and the documents revealed that vaccine procurement negotiations were one-sided, with pharmaceutical companies pressuring our government into unfair prices, terms and conditions.

Back to court

Now we are once again preparing to take the government to court to pass key provisions of the Patent Amendment Act. At the very least, we need proper patent examination, ways to oppose patents before and after they have been granted, and easy-to-use compulsory and government-use procedures in place. And we need this quickly.

We have seen how big pharmaceutical companies including Johnson & Johnson use our patent provisions to evergreen patents and then charge the state and sick patients more than they should by holding on to their patent monopolies.

We want to ensure that:

  • monopolies are not granted without examining their merits;
  • the public can exercise its right to oppose a patent before it is granted; and
  • the government can override patents and allow generic production where needed, as do the governments of many other countries.

It is our right in a constitutional democracy.

Hassan is founder and director of the Health Justice Initiative.

Views expressed are not necessarily those of GroundUp.

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

Source: GroundUp

Categories : Healthcare Politics and RegulationsTags :

BHF Responds to the Imminent Approval of the NHI Bill

On By ModernMedia

The National Health Insurance (NHI) Bill was approved by the National Council of Provinces today and is due to be signed into law by the president shortly after. The Board of Healthcare Funders (BHF) is deeply disappointed. We are not happy with the various sections of the Bill. Despite submissions to government in this regard, the recommendations of the BHF and other stakeholders have largely been ignored and the bill is being passed virtually unchanged from its originally drafted form.

While the BHF fully supports the concept of universal health coverage (UHC) as defined by the World Health Organization (WHO) and believes that it must be a strategic imperative for all those directly or indirectly involved in healthcare, it does not support the NHI Bill in its current form. The bill restricts medical schemes to the provision of complementary cover potentially rendering them unsustainable, further to which the enormous economic value that medical schemes currently add to the health sector would be lost to South Africa if the bill goes ahead unchanged, BHF strongly believes this section should be removed as well as all references to complementary cover contained in the bill.

Additionally, a number of the Bill’s provisions are unconstitutional. These were detailed in the BHF’s submission to government. South Africa needs a strong, vibrant private health sector because government resources will never be unlimited. . The incredibly wide powers it bestows on the Minister of Health grossly undermine the board of the NHI fund and its accountability. The power of the Benefit Advisory Committee to determine health benefits under NHI similarly undermines this accountability. In addition, the BHF is perturbed by the demonstrated inability of the state to adequately operate national public entities and state-owned enterprises, as well as the endless levels of relentless corruption in the public sector.

Other concerns

The Bill allows the Minister of Health and the NHI fund to issue directives that override all other legislation, except the PFMA and the Constitution, including legislation specifically mandated by the Constitution.

There are proposed amendments to the Medical Schemes Act that unfairly discriminate against pregnant women. 

In many instances, the language of the bill creates significant legal uncertainty, which is itself unconstitutional due to the principle of the rule of law upheld by the Constitution. The BHF provided specific examples of this in the body of its submission.

The NHI Bill allows the national sphere of government to encroach on the geographical, functional and institutional integrity of provincial governments. This is not permitted by Section 41 of the Constitution.

The bill tries to dictate to the President in Cabinet (the National Executive) what new legislation must be made or how to amend existing legislation. This is also unconstitutional, as the Constitution itself grants the National Executive its powers. Nothing can change this except an amendment to the Constitution.

The registration system proposed by the bill creates unconstitutional barriers to access to health care that do not currently exist. The certification, accreditation and contracting system proposed by the bill is unwieldy, and it too will create unconstitutional barriers to access to health care that currently do not exist. Both these points are explained further in the body of the BHF’s submission.

Dr Katlego Mothudi, BHF CEO, underscores these serious implications of the bill’s being passed unchanged. “We have consistently given input into this proposed law and are disappointed that our concerns and those of other stakeholders appear not to have been considered or even tested. The bill in its current form will have a negative impact on healthcare access for everyone. There are many areas of uncertainty that have not been clarified, not least with regard to funding and affordability. We are also concerned specifically that the bill may prejudice the rights of women,” he says. “The proposed amendments to the Medical Schemes Act exclude access to pregnancy-related healthcare services for women who are medical scheme members. This means that these women would have to access reproductive health care from the public sector at their own cost, which is in conflict with the provisions of the National Health Act.

“The bill also has the potential for a wider negative economic impact. There is still uncertainty around how the NHI will be funded, but it will very likely be through additional taxation, something that will unavoidably have a detrimental effect on the economy at large – companies, individual employees and the general public – in the form of job losses. This phenomenon has already been discussed in various papers, including one published by the World Bank in 2001. It cited Colombia’s experience in this regard. A 10% increase in payroll taxes resulted in a 4.9% reduction in employment. Those who remained employed experienced a reduction in their disposable income, while the decrease in the overall number of employees saw a reduction in revenue from personal tax. Should the bill pass in its current form, South Africa will almost certainly experience something very similar.

“More specifically, this phenomenon will also impact the health sector. With medical schemes reduced to providing only complementary cover, not only will the schemes industry itself shrink, but all the other private entities it does business with, including hospitals, pharmaceutical companies and health practitioners,” he concludes.

Provided by the Board of Healthcare Funders

Categories : Healthcare Politics and RegulationsTags :

Glaring Voids Threaten SA’s Path to Equitable Healthcare

On By ModernMedia

A coherent, achievable path to universal health coverage now imperative

Glaring voids highlighted in submissions on the National Health Insurance (NHI) Bill threaten South Africa’s path to equitable healthcare access for all, cautions the Health Funders Association (HFA). The organisation has voiced its profound concern, emphasising the disconcerting sway of politics over the bedrock mission of prioritising the well-being of our nation within this critical healthcare deliberation.

“The practical barriers to successfully executing NHI as it is laid out in the Bill are hard to ignore, and yet the numerous concerns and suggestions raised in the consultation process have not been considered or implemented,” says Craig Comrie, chairperson of the National Health Funders Association (HFA).

“The clear shortcomings of the NHI Bill in terms of practical funding mechanisms and lack of collaboration with experienced health funders, among other aspects, have been overlooked for the most part, with only the Western Cape so far rejecting the Bill in its current form.”

The National Council of Provinces (NCOP) Committee on Health’s approval of the NHI Bill with insignificant edits does not address the numerous concerns raised in submissions made by the public and informed stakeholders, including the HFA, on behalf of its members.

The HFA is a professional body representing medical schemes and half of South Africa’s medical aid membership.

“There are constructive solutions to address the problems identified in the NHI Bill effectively, and it is not too late to fix the legislation. While the Bill is rushing towards the President’s pen to be enacted, the HFA respectfully appeals to the President to reconsider the wisdom of signing into law a Bill that has no workable funding mechanism while disregarding solutions proposed by private health funders, leading organisations, businesses and other key constituents,” Comrie says.

“We anticipate considerable resistance to the NHI Bill on Constitutional grounds, and as the HFA, we will continue to advocate for a more achievable approach to fulfilling universal health coverage aims.

“The timing of the recent flurry of activity in moving the Bill through the necessary hoops ahead of next year’s election invites the notion of a blunt instrument, an unrealistic election promise rather than a pragmatic solution for the highly complex health challenges South Africa faces,” he says.

Health Funders Association members, including leading lights in the industry such as Bankmed, CAMAF Medical Scheme, Discovery Health Medical Scheme, Fedhealth, Glencore Medical Scheme, Momentum Medical Scheme, Profmed and PPS Healthcare Administrators, to mention but a few, are ready to work with government to develop evidence-based solutions that will help secure access to quality healthcare for all South Africans.

“There is so much opportunity to make the NHI work. Private public partnerships and collaboration have achieved so much good for the benefit of South Africans in other sectors, and there is much our industry can contribute to help make quality healthcare more accessible and sustainable for all,” Comrie concludes.

Categories : Healthcare Politics and Regulations Respiratory DiseasesTags :

WHO Requests Information on Respiratory Illness Cluster in Northern China

On By ModernMedia

The World Health Organization (WHO) noted an upsurge of unidentified pneumonia-like respiratory illnesses among children in Northern China, and asked China for more information. This is significant as previous outbreaks of severe respiratory illnesses have started out in this fashion, but such WHO requests for more information on disease clusters are routine as part of its monitoring. No “unusual or novel pathogens” have been found, according to China, which attributed it to an increase in multiple pathogens and the lifting of COVID restrictions.

Earlier this month, China’s National Health Commission reported a nationwide increase in respiratory disease incidence, mostly among children. This increase was attributed to lifting of COVID restrictions and the arrival of the cold season, and due to circulating known pathogens including Mycoplasma pneumonia and RSV, which are known to affect children more than adults.

On 22 November 2023, the WHO identified media and ProMED reports about clusters of undiagnosed pneumonia in children’s hospitals in Beijing, Liaoning and other places in China. The WHO requested from China additional epidemiologic and clinical information, as well as lab results from these cases and data about recent trends in circulating respiratory pathogens.

The WHO held a teleconference with Chinese health authorities and received data indicating an increase in outpatient consultations and hospital admissions of children due to Mycoplasma pneumoniae pneumonia since May, and RSV, adenovirus and influenza virus since October. Some of these increases are earlier in the season than usual, but not unexpected given the lifting of COVID restrictions, as similarly experienced in other countries. No changes in the disease presentation were reported by the Chinese health authorities, who said no unusual or novel pathogens or unusual clinical presentations had been detected, but only the general increase in respiratory illnesses by known pathogens. Local hospitals had not been overloaded by new cases.

Risk assessment

In the current outbreak of respiratory illness, the reported symptoms are common to several respiratory diseases and, as of now, at the present time, Chinese surveillance and hospital systems report that the clinical manifestations are caused by known pathogens in circulation. M. pneumoniae is a common respiratory pathogen and a common cause of paediatric pneumonia, and is readily treated with antibiotics.

China has stepped up its influenza-like illness (ILI) and severe acute respiratory infections (SARI) sentinel surveillance system since mid-October, including for M. pneumoniae.

There is limited detailed information available to fully characterize the overall risk of these reported cases of respiratory illness in children. However, due to the arrival of the winter season, the increasing trend in respiratory illnesses is expected; co-circulation of respiratory viruses may increase burden on health care facilities.

According to surveillance data reported to WHO’s FluNet and published by the National Influenza Centre in China, ILI was above usual levels for this time of year and increasing in the northern provinces. Influenza detections were predominantly A(H3N2) and B/Victoria lineage viruses.

WHO advice

The WHO advice was for people in China to take measures against respiratory illnesses, including vaccines, masking and social distancing. It also does not recommend any specific measures for travellers to China.

Source: WHO