Category: Healthcare Politics and Regulations

Categories : General Interest Healthcare Politics and Regulations Medical IndustryTags :

OPINION: NHI Bill Must Still Clear Many Hurdles to Ensure Adequate Medicine Access

On By ModernMedia

By Yanga Nokhepheyi, Marlise Richter, and Fatima Hassan for Spotlight

A frightful piece of information came to light recently. The pharmaceutical giant Pfizer announced its 2022 revenue at $100 billion. This is more than the combined health spending of 108 countries in 2020 according to calculations of The People’s Vaccine Campaign. The Pfizer COVID vaccine, of course, helped the dollars roll in. In fact, some reports suggest that Pfizer charged some countries $130 per dose of vaccine, while it is estimated that it costs less than $2 per dose to make. That equated to a markup of a stupefying 10 000% but we don’t know the full pricing details because the contracts are marked ‘secret’.

Figures like these make one’s eyes water.

In this pandemic, tackling the pharmaceutical sector and the perversities of its pandemic profiteering has been the focus of an international movement of health activists united under the banner of the People Vaccine Campaign. Partly because of severe resistance by governments in the global north and inaction locally, access to timely supplies of affordable and essential COVID vaccines, medicines and diagnostics has not materialised. But the struggle continues not only to tackle these structural barriers to beat COVID and future pandemics but also to help ensure implementation of Universal Health Coverage (UHC) systems. UHC means that everyone would be able to get the quality health services they need and benefit from scientific progress – irrespective of their ability to pay and without having to face financial hardship.

A Herculean task

South Africa, too, has committed to attaining UHC by 2030 as part of a set of promises made on the United Nation’s Sustainable Development Goals. South Africa’s main strategy to attain UHC is to implement a National Health Insurance (NHI) system. Unfortunately, progress has been historically slow, but in the build-up to the 2024 elections, the African National Congress (ANC) Members of Parliament (MPs) are rushing the law reform process despite an acknowledgement even from the health ministry that progress and timelines are hampered by the socio and mainly economic impacts of the pandemic. This includes a fiscus crisis with additional pandemic-related debt, and according to Dr Nicholas Crisp, Deputy Director-General in the health department responsible for NHI, “the NHI could take decades to be implemented at full scale”.

It will require a Herculean task to unify our apartheid-era two-tiered healthcare system, with the right skills, funding base, and transparency in decision-making around health policy and medicine selection. The pandemic has highlighted why all these elements are critical for healthcare for everyone.

We provide a short overview of our research below.

Law reform

Last year, the Portfolio Committee on Health in Parliament deliberated on the ‘NHI Bill’, but there were no significant changes made to it. It needs major revision. Many serious concerns and recommendations from parliamentary submissions by multiple stakeholders have gone unaddressed. The Health Justice Initiative (HJI) has focused on medicine procurement provisions in the Bill and in 2022 raised at least 17 questions that require greater attention before the law is passed. Neglecting to address the public’s submissions is not surprising seeing that ANC MPs serving on the committee were resolute in having the National Assembly adopt the Bill before the ANC Conference in December 2022. However, time ran out before the adoption of the Bill by Parliament, and the Parliamentary process is seemingly going to resume this month.

Stakeholder submissions to Parliament on the Bill (of which there were 64 000 written submissions following Parliament’s call for comment in 2019) and various commentators have warned about the ‘looming disaster’ that the Bill in its current form poses, but they are often divided on the main reasons. A tiny minority resists the principle of unified health systems and Universal Health Care for all (meaning, also for the poor). Many more groups agree that NHI is an ethical necessity but are concerned about South Africa’s disintegrating public health system, energy crisis, high levels of state corruption involving health product procurement, and the in/ability of the Department of Health to actually implement NHI in its current proposed form.

Other groups have rightfully pointed out concerns over conferring too much power on the Minister of Health, inadequate financing models, the feasibility of NHI in SA post-COVID, and the exclusion of specific categories of people from NHI. (For a curated archive of critical submissions, please see here).

Risks to medicine access

Regrettably, the provisions in the Bill on Medicine Selection, Pricing, and Procurement are ambiguous at best, and as the HJI pointed out in 2022, the entire shift of our medicine selection, procurement, and reimbursement system to “NHI reimbursement” has not been adequately thought through, potentially posing a great risk for the future of medicine selection and access in the country for all people. This requires immediate attention at the highest levels of the executive and the legislature too – and likely needs a multi-department and stakeholder technical group to urgently determine the exact trajectory of this planned process.

The World Health Organization has emphasised that UHC programmes will only be successful if there is “affordable access to safe, effective, and quality medicines and health products”. In addition, the COVID pandemic has taught us that timely and fairly priced access to essential diagnostics, therapeutics, and vaccines is key to addressing any public health emergency and improving health outcomes. We cannot safeguard public health without access to medicines – procured fairly, delivered on time, and based on expert and transparent decision-making and approval.

The cost of medicine, as elsewhere in the world where there are national health systems, remains a key concern. The Minister of Health last November in the National Assembly said that the funds for the NHI would be collected through a combination of taxes, including the reallocation of medical scheme credits paid to medical schemes, provincial health budgets to the NHI Funds, and payroll tax.

The financial feasibility of implementing the NHI is still unclear and a huge risk to the fiscus in a post-COVID economy that is dealing with a recession, load shedding, and high unemployment rates.

In late 2022, HJI argued that the Bill does not adequately consider the complexities of medicines access and that our medicines system could be severely jeopardised if poorly drafted sections in the current Bill become law. We said that government should set up a task team to urgently determine the exact trajectory of this planned process.

The Health Department’s recent response to submissions and its own recommendations on amendments to the Bill sadly does not realise the gravity of the threat to the future of medicine selection and access.

17 questions

In HJI’s 2022 analysis of the Bill, we raised 17 key questions that we believe must be addressed by lawmakers in the next version of the Bill and before NHI comes into effect. These include:

  1. What specific measures are envisaged to enable and promote public transparency related to medicine selection, procurement, and contracting processes under the NHI?
  2. How will the price of medicines not included in or covered by the NHI be regulated? And what role will External Reference Pricing (ERP) methodology play in the NHI and beyond?
  3. How will the NHI Fund (e.g., the Office of Health Products Procurement, the NHI Board) negotiate with global pharmaceutical manufacturers and suppliers to procure for government and how will that process be transparent and accountable?
  4. How will the Minister determine that the NHI is ‘fully implemented’, and what will take place in terms of what medical schemes can and cannot offer members during the transition period, and after the (undefined) date?
  5. Has consideration been given to designing a competitive and different single medicine pricing system for SA?

(See the full list of questions here).

The need for safeguards

Drawing on our work on medicine access during the HIV and COVID pandemic, we appreciate that there are powerful vested interests located in the multi-trillion-dollar pharmaceutical industry – this is why there is a need for legal safeguards, sound legislation, and independent and transparent institutions to ensure access to affordable medicines for all of us living here.

The pandemic showed that a lack of transparency, autonomy, and information around expert advice can bedevil open government decision-making. Secret procurement contracts for essential vaccines could become the norm even under NHI as they did in COVID, something we are fighting in our courts to open up, later this year.

Figuring out a sound system for a unified medicine access system under NHI is a formidable undertaking that requires a multi-disciplinary task team with experts from various fields, experience, and technical know-how. It is not easy to simply merge two parallel medicine procurement and selection systems. The risk is that the status quo could continue – where the rich and insured access the best medicines at a higher price.

We believe that the principles underpinning NHI for our highly regressive, unequal two-tiered healthcare system are too important for our collective health, well-being, and our Constitutional democracy to have lacklustre legal provisions and worrying gaps on the essential issues of medicine procurement and selection.

As the Bill currently stands, it will strengthen the private healthcare sector’s stranglehold on us and our fiscus. It will leave us at the mercy of advisory committees that bear no duty to be transparent in deciding which medicines you and I will be able to access under NHI.

We can and need to do better.

* Nokhepheyi and Richter are researchers and Hassan the Director of the Health Justice Initiative.

Source: Spotlight

Categories : Healthcare Politics and Regulations Metabolic DisordersTags :

Budget: Decision Not to Raise the Sugar Tax ‘Puts Profits Ahead of People’ Say Activists

On By ModernMedia
The flash mob by HEALA featured a choreographed dance in which learners pretended to refuse sugary drinks. Photo: Ashraf Hendricks

By Daniel Steyn for GroundUp

Health activists demonstrating in Cape Town for a rise in the tax on sugary drinks were disappointed by Finance Minister Enoch Godongwana’s announcement in his Budget speech that the tax would be frozen for two years. Godongwana said this was “due to the difficult operating environment for the sugar industry from the impact of flooding and social unrest.”

The tax on sugary drinks was first introduced in 2018 to reduce consumption. The tax is imposed on drinks with more than 4g of sugar per 100ml. Research from the University of the Witwatersrand in 2021 showed that it has been effective in reducing the consumption of sugar-sweetened drinks.

HEALA, a coalition of organisations focused on nutrition, organised a flash mob in the Cape Town city centre ahead of the Finance Minister’s Budget Speech on Wednesday, advocating for an increase in the sugary drinks tax. They want the tax to be increased from 11% to 20%, following the guidance of the World Health Organisation.

The flash mob was part of HEALA’s “Less Sugar, More Life” campaign, and featured school pupils from Cape Town in a dance.

“We don’t even notice how much sugar we are drinking in sugary drinks and it’s harmful to our health. I want other young people to know that it’s dangerous,” said one of the dancers, Enkosi Stofile.

“The announcement by the Finance Minister, coupled with ineffective increases on other health taxes such as alcohol and tobacco, is a direct attack on the lives of millions of people at risk of serious health conditions such as diabetes, cardiovascular diseases and cancer,” said Nzama Mbalati, HEALA’s Programmes Manager.

Mbalati said there was no rationale for the decision to maintain the rate of tax on sugary drinks. “This decision is not in the interest of ordinary people. Instead, it puts profits ahead of people.”

About 10 000 new cases of diabetes are reported in South Africa each month, according to the International Diabetes Federation. Up to 70% of women and 39% of men are obese or overweight. Sugar is a cause of obesity and tooth decay, and is linked to a range of other non-communicable diseases. The national budget for 2023, tabled by Godongwana in parliament today, includes a R200-million reduction in health spending this year.

Before the budget speech, News24 reported that the South African Sugar Association said 6000 jobs could be lost if the tax was increased. SASA also said 9,000 jobs had already been lost since the levy was introduced.

However, in the aftermath of a fraud scandal at Tongaat Hulett, South Africa’s largest sugar producer, in 2018, 5,000 workers were served with retrenchment letters.

Disclosure: Community Media Trust does work for HEALA. GroundUp was once a project of Community Media Trust and still has a close relationship with Community Media Trust.

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

Source: GroundUp

Categories : Emergency Medicine Healthcare Politics and RegulationsTags :

R27m Needed to get Eastern Cape EMS Plan off the Ground

On By ModernMedia
In October last year, Eastern Cape Health MEC Nomakhosazana Meth announced a three-phase plan to address key challenges with the province’s emergency medical services. PHOTO: Black Star/Spotlight

By Siyabonga Kamnqa for Spotlight

Gogo Nothembile Fanti (76) says she suffers from a heart condition and every time her grandchildren call an ambulance, they are told to wait, but it never arrives. She is one of about 40 patients – mostly older persons – sleeping on the floor and in chairs at All Saints Hospital in Ngcobo in the Eastern Cape during Spotlight’s visit on 30 January. They are all waiting for an ambulance to take them to referral hospitals such as Nelson Mandela Academic Hospital and Bedford Hospital about 60 kilometres away in Mthatha. They come from various villages around Ngcobo.

Fanti, like many other patients, says they are forced to sleep there overnight as the free transport provided by the hospital leaves at the crack of dawn.

“I had to call my neighbour to [bring] me here, otherwise I could have died waiting for the ambulance. They told me that I have to be taken to Mthatha to see a specialist, but having to sleep under these conditions at my age is a terrible experience,” she says.

An old problem

The challenges with patient transport, specifically emergency medical transport in the Eastern Cape, are not new. Spotlight has previously reported on the issue here, here, and here.

In October last year, Eastern Cape Health MEC Nomakosazana Meth in a response to a written question in the provincial legislature by DA MPL Jane Cowley said that there are 84 Emergency Medical Services (EMS) bases in the Eastern Cape – 16 of those are in the Chris Hani District where All Saints Hospital is situated.

Based on the numbers Meth provided, the district also has the highest vacancy rate – 65%. This means of the 796 posts available, there were 518 vacancies for EMS staff at the time of her response in October. Overall, for the whole province, the total posts were 3 269, but 1 202 were vacant at the time.

The province needs 671 ambulances based on its population but has 447 ambulances of which only 200 were rostered, meaning they were in service at the time. In Chris Hani District, they need at least 72 ambulances but only have 62 of which just 38 were rostered and on the road to provide a service.

Staff shortages and ambulances undergoing maintenance are among the reasons why there are not enough ambulances rostered in the province. Not one of the 84 EMS bases in the province complied with the national EMS regulations for personnel numbers.

According to the DA’s provincial health spokesperson, Jane Cowley, there are 150 ambulances at any given time in for repairs. “The average turnaround time for repairs is a shocking 100 days – this is because they use the Government Fleet Management Services, who are owed in excess of R300 million by the [provincial health department] so they really don’t prioritise ambulance repairs.” She says the DA has been calling for the decentralisation of ambulance repairs and the development of public-private partnerships, which the party believes would speed up repair turnaround times dramatically.

Shouldering the burden

Providing some perspective on the impact this has on services and patient lives, a doctor says there are some districts where, at times, there is only one paramedic on duty per shift (the doctor spoke to Spotlight on condition of anonymity given the risks of reprisals from the health department). “When there is a serious call from opposite ends of the district, then you have to wait for the paramedic to deal with the one case, then come to the second. Patients in hospitals are deemed ‘less serious’ than if they are on the roadside. So, patients can wait for hours in a district hospital before being referred to a tertiary hospital. We recently had an elderly man with wet gangrene on his foot who waited in a casualty for two days. Then he died,” the doctor says.

The doctor says they often have a full casualty unit on Saturday nights. At times there may be four patients waiting for a referral. They may have gunshot wounds, been stabbed in the neck, and assaulted with a head injury. The casualty fills up as time passes and the number of patients waiting for referrals now grew by three, while the other four are still waiting in casualty. The three may be all orthopaedic patients. The doctor will ask the nurse about the patients and is told EMS said “no ambulances available”. “Maybe you have the energy to paste this update on the EMS WhatsApp group. Maybe you try to phone someone yourself to escalate this issue. Maybe someone is able to contact the provincial office and request a private ambulance to assist. But by morning, there are still six patients waiting… then one dies. The oncoming team will now have to re-discuss these patients with the new team at the referral centre. The same thing happens day after day… patients miss appointments, have to be re-discussed, get a new date due to the perseverance of the doctors, then maybe miss another date due to EMS not being available… It is extremely exhausting for all concerned,” the doctor says.

According to two paramedics (who also spoke on condition of anonymity), they struggle with inadequate equipment in EMS vehicles. This, coupled with poor road infrastructure, often puts them under enormous pressure, they say. “Cellphone network also disappears during loadshedding and this makes it impossible for patients to reach our services,” says one of the paramedics. “When we eventually arrive at the accident scene or at a sick patient, we are often met with insults from frustrated patients who said they’ve been trying to get hold of an ambulance for hours. Often, they forget about the challenges we face in trying to get to them on time,” he said.

Three-phased plan – yet to be financed

Meth in her parliamentary response last year said, “The[se] frequent transfers of patients put a heavy burden on the emergency medical services as there are no ambulances to do inter-facility transfers and therefore the emergency ambulances are used to transfer patients from hospitals to other hospitals over long distances with no ambulances left for emergency response at community level.” She said this is why there are often poor ambulance response times or no response at all.

In an attempt to address this, the provincial health department is working on a three-phased EMS plan targeting 28 hospitals across districts – among them All Saints.

This plan, however, will need funding to get off the ground.

Explaining the department’s three-phased plan, provincial health spokesperson Yonela Dekeda last week said the department plans to recruit additional personnel as funding becomes available and so did not provide timeframes. She says phase one is aimed at providing a dedicated inter-hospital transfer ambulance on a day-shift basis at the 28 priority hospitals. They aim to appoint 120 new staff members for this.

In phase two, the department wants to appoint an additional 120 personnel to make the day service a twenty-four-hour service and phase three is to extend this to other hospitals and provide them with the personnel needed.

But, says Dekeda, the department will need R27 million and they expect funding only to be made available in the 2023/24 financial year.

Working to address EMS challenges

Meanwhile, she says, the department has been working to address the many challenges facing EMS in the province and there are some improvements. “These include the response rate to priority 1 calls (life-threatening calls). Over the past three quarters – ending December 2022 – the department has been meeting its targets for priority 1 calls by responding within 30 minutes (urban areas) and 60 minutes (rural areas).” She didn’t however specify what percentage of calls met these targets.

According to her, the department has taken a developmental approach to achieve compliance with the national EMS regulations. She says over the next three years there will be continued investments in infrastructure, equipment, staffing, and vehicles to promote compliance with the ideal promulgated in the regulations.

“We have purchased an additional 50 ECG monitors at a cost of R19 million to supplement the equipment in our ambulances as required by the regulations. About R15 million has been allocated to improving the infrastructure at selected EMS stations around the province and an additional allocation is expected in the next financial year to support the strategy,” she says.

In the current financial year, she says, the Engcobo Local Service Area where All Saints Hospital is located was allocated two intermediate life support practitioners.

Dekeda says the department’s priority remains emergency patient care, so the majority of the current resources are still allocated to this.

“We are using our staff interchangeably between planned patient transport and the emergency transport service. One will understand that the planned patient transport works on weekdays (Monday to Friday) while emergency ambulance services are a 7-day operation, 24 hours a day. We are committed to increasing the number of staff on the emergency transport and then developing a separate staff complement for the planned patient transport service.”

Dekeda also says recruiting more staff is coupled with interventions to have the district hospitals offer the appropriate package of services, which will reduce the number of trips transferring patients. She says by employing dedicated teams to manage transfers of patients at the 28 priority hospitals as part of the three-phased plan, the hope is to improve the overall responsiveness of the ambulance fleet.

“We will continue with this recruitment in the next financial year and also focus on the operational staff to assist with the transfers of critical patients. All Saints is one of the district hospitals that will benefit,” she stresses.

“A total mess”

But some Eastern Cape residents remain sceptical.

Responding to the new plans, activist and community leader from Xhora Mouth, Phumzile Msaro says they are tired of empty promises. “This EMS problem is going to be with us for a long time as long as there are still unreliable people at the top. Every day we are faced with challenges as rural dwellers. Just yesterday (09 February), I called an ambulance for an elderly villager from Xhora Mouth who had fits. The assistants at the call centre lied and said the ambulance was on its way but we waited all day, only for the ambulance to arrive at 7 pm after a number of frantic calls throughout the day. The elderly person only managed to arrive and get assistance at Madwaleni Hospital at 9 pm. We keep hearing about all these so-called plans but nothing gets implemented on the ground. It’s a total mess,” he says.

Cowley echoes these sentiments. She says due to ambulance shortages and the severe shortage of EMS personnel, especially advanced life support paramedics, ambulance turnaround times are very slow, particularly in rural areas. “People can wait up to a day for an ambulance and sometimes that is too late. They have many plans but cannot seem to implement them as there is no political will to do so. It’s just a talk shop. In all my extensive oversight visits, the constant and main complaint is the lack of or slow ambulance service.”

Republished from Spotlight under a Creative Commons 4.0 Licence.

Source: Spotlight

Categories : General Interest Healthcare Politics and RegulationsTags :

Healthcare Workers Strike over Salaries and Poor Working Conditions

On By ModernMedia

On Tuesday 22 November, healthcare workers were among the public sector employees who engaged in a strike action to protest a lack of pay increase. A number of hospitals and clinics across South Africa and particularly Gauteng were affected, the Daily Maverick reports.

Unions had been offered a 3% increase plus an additional R1000, which the negotiating unions refused. Union leaders rejected this, demanding a 10% increase. Inflation is running at 6%, and food prices have risen by 12% from the start of the year to September – largely driven up by the war in Ukraine.

Union leaders say the strikes and protests are driven by wages staying the same over the past few years. Healthcare workers had already been suffering high rates of burnout battling COVID waves. In addition, workers complained of being understaffed, and enduring dire working conditions from lack of equipment, medication and food.

On Tuesday morning, burning tires were placed on Chris Hani Road in Soweto. Striking workers wearing union colours were preventing many vehicles, including ambulances, from entering Chris Hani Baragwanath Hospital. Patients inside were being left unattended.

Sebokeng Hospital in Sedibeng meanwhile was running on a skeleton staff, with doctors and nurses prevented from entering. Emergency services were being diverted to nearby facilities.

Meanwhile, GroundUp reported that patients were being turned away from Mabandla Clinic in the Eastern Cape. In Gqeberha, Motherwell NU8 clinic and the Motherwell Healthcare Centre were both reported to be closed. 

On Tuesday afternoon, the Gauteng Department of Health received an interdict against the strikes, preventing striking workers from interfering with access to hospitals, EWN reports. The public healthcare systems in Gauteng and other provinces have already been strained, with recent high-profile protests and resignations over inadequate funding and allegations of corruption.

Categories : COVID Healthcare Politics and RegulationsTags :

Supreme Court of Appeal Reverses Controversial Ivermectin Ruling

On By ModernMedia
Gavel
Photo by Bill Oxford on Unsplash

The Supreme Court of Appeal (SCA) has set aside a controversial supervisory order, granted in April 2021, compelling the South African Health Products Regulatory Authority (SAHPRA) to report back to court every three months on access to ivermectin for use in the treatment of COVID patients.

The court has ruled that there was no evidence to justify the order made by Pretoria High Court Judge Cassim Sardiwalla, that affected parties had not asked for the order, and that they had not been heard before he made it.

The judge had also failed to provide his reasons for making it, the court said.

The issue has its genesis in four applications, one by the African Christian Democratic Party in 2021 against SAHPRA seeking access to ivermectin for the treatment of COVID.

At that time, SAHPRA, which was wary of its use saying there was no reliable research to prove its efficacy, had already put in place its “controlled compassionate use” programme in response to reports of illicit ivermectin-containing products entering the South African market. The programme was stopped in May this year.

In terms of that programme, permission was granted to five importers of unregistered oral solid dosage forms of ivermectin. Health facilities were permitted to hold bulk stock but individual applications were still required. SAPHRA said it would monitor its use.

The ACDP and others approached the court for orders directing SAHPRA to remove restrictions and do “all things necessary to regulate and ensure the manufacture” of ivermectin until such time as clinical evidence demonstrated that it was not effective in the treatment of COVID.

The matter was settled along the same lines as SAHPRA’s programme.

But Judge Sardiwalla, in making the settlement agreement an order of court, also granted a “supervisory order”, putting SAHPRA under his judicial authority in respect of ivermectin.

SAHPRA and the Minister of Health applied for and were granted leave to appeal the order to the SCA.

Read the full judgment here

In heads of argument before the SCA, SAHPRA said its appeal concerned the propriety of the order directing an organ of state to report back to court and be subject to judicial supervision where the dispute had been settled and there was no evidence at all that SAHPRA and the minister would not comply with the settlement agreement.

“It was simply imposed without justification. The order constitutes a grave violation of the Constitution … it violates the rule of law, the right to a fair hearing and the principle of separation of powers,” it argued.

The judge, SAHPRA said, had improperly made findings on matters not in dispute and his written reasons for the supervisory order “do not constitute reasons at all”.

In the SCA ruling, Judge Clive Plaskett said Judge Sardiwalla had suggested to the parties that he “regarded himself as seized of all matters involving ivermectin” and had proposed the supervisory order.

Both SAHPRA and the minister indicated they would oppose this and filed further papers.

While the judge had indicated that he would hear the parties on 6 April 2021, his registrar had informed SAHPRA’s attorney that morning that he had made a decision, he would not hear arguments, and he would send his order to the parties shortly.

No reasons accompanied the order.

SAHPRA and the minister asked for reasons but when these were furnished, they made no mention of the supervisory order or why he granted it.

Judge Plaskett said the first difficulty with the order was that Judge Sardiwalla had not given SAHPRA and the minister a hearing despite knowing that they did not agree to it.

“He agreed to a hearing but inexplicably changed his mind. In these circumstances, an oral hearing was, without doubt, essential.

“Courts decide matters, particularly opposed matters, in open court and the exceptions to this rule are limited.”

Judge Plaskett said the fact that the order had not been applied for by any party required that it be set aside.

He said, further, there was a complete absence of evidence to justify it.

“Important as supervisory orders may be in appropriate cases, the granting of this type of relief must be carefully considered – and justified on the facts – particularly because of its separation of powers implications.

“In this case, not only was there no evidence as to the necessity of a supervisory order but the fact that SAHPRA and the minister had settled the matter and agreed to an order suggests that there was probably no necessity for one.

“Had he allowed the parties to argue the matter, he would have been informed of the separation of powers problem …

“Finally, it strikes me as telling that the reasons he furnished made no mention of the supervisory order – and this despite being pertinently asked to furnish reasons on this very issue,” Judge Plaskett said, upholding the appeal, and setting aside the order.

The ACDP originally opposed SAHPRA’s appeal but shortly before the SCA hearing, it withdrew its opposition on the basis that no cost order would be made against it. The SCA therefore did not order costs.

The ivermectin programme was stopped in May this year.

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

Source: GroundUp

Categories : Healthcare Politics and Regulations HIVTags :

Health Department Secures Lower Antiretroviral Prices

On By ModernMedia
Image by Cottonbro on Pexels

By Liezl Human

The national Department of Health (DOH) has managed to secure a significant reduction in prices for antiretroviral medicines that treat HIV, with the price of the regimen that is prescribed to most new patients (tenofovir/lamivudine/dolutegravir – TLD) dropping over 30%, from R99 to R68. By comparison the regimen costs well over R250 in the private sector.

TLD is recommended by the World Health Organisation as the preferred first-line regimen for adults living with HIV.

Currently over 4 million South Africans are using this regimen, according to statistics from the DOH. There are about over 5.5 million people receiving treatment for HIV, and 8 million people living with the virus in this country. 

Prices of ABC/3TC, commonly used to treat children with HIV, also fell with the DOH’s new contract.

Khadija Jamaloodien, director of the Affordable Medicines Directorate in the DOH, told GroundUp that South Africa is the biggest buyer of ARVs in the world. She said because of the sheer number of people needing ARVs, the department was able to bring the price down.

“Our volumes are just so huge that it makes it more efficient for manufacturers to be able to supply at reasonable prices,” said Jamaloodien.

She said another reason the department was able to reduce the price was that the manufacturers were applying for a three-year contract with “a certainty of demand”. She said constant communication with manufacturers about changes in demand also helped. If demand is likely to be reduced, the department would inform manufacturers who then would not “sit with stock that they are going to have to write off”.

The contract, which is already being executed, was awarded from July 2022 and ends in June 2025.

Jamaloodien said lower prices meant that the department could serve more patients and provide more medicines within the same budget envelope. (ARVs are provided free to public sector patients.)

Juliet Houghton, CEO of the Southern African HIV Clinicians Society (SAHCS), praised the DOH’s efforts to secure the ARVs so cheaply. She said a “healthy” degree of competition between manufacturers also helped drive prices down.

Houghton added that the reduction in prices “offers an opportunity to reinvest some of the savings into more expensive, particularly prevention drugs, that are coming”.

See DOH presentation

“As a country, we don’t want to just keep treating more and more people with HIV, we actually want to prevent it,” said Houghton. She said that the remaining budget could also be invested in prevention injectables, which might be more expensive.

Jamaloodien said that the injectable pre-exposure prophylaxis (PrEP) medicines are not yet registered with South African Health Products Regulatory Authority (SAHPRA). These help prevent sexually active people from contracting HIV. She said after the medicines are registered, they will have to look at whether they are affordable.

Francois Venter, executive director of Ezintsha at Wits, also praised the DOH’s “excellent work in securing these price reductions”.

“We also need the department to start using these processes better to secure similar world-class treatments for other common diseases – including diabetes, cancer, obesity, and TB,” he said.

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

Source: GroundUp

Categories : Healthcare Politics and RegulationsTags :

European Medicines Agency Moves to Minimise JAK Inhibitor Risks

On By ModernMedia
Photo by Myriam Zilles on Unsplash

The European Medicines Agency’s safety committee (PRAC) has recommended measures to minimise the risk of serious side effects associated with Janus kinase (JAK) inhibitors used to treat several chronic inflammatory disorders. These side effects include cardiovascular conditions, blood clots, cancer and serious infections.

The Committee recommended that these medicines should be used in the following patients only if no suitable treatment alternatives are available: those aged 65 years or above, those at increased risk of major cardiovascular problems (such as heart attack or stroke), those who smoke or have done so for a long time in the past and those at increased risk of cancer.

The Committee also recommended using JAK inhibitors with caution in patients with risk factors for blood clots in the lungs and in deep veins (venous thromboembolism, VTE) other than those listed above. Further, the doses should be reduced in some patient groups who may be at risk of VTE, cancer or major cardiovascular problems.

The recommendations follow a review of available data, including the final results from a clinical trial of the JAK inhibitor tofacitinib and preliminary findings from an observational study involving baricitinib, another JAK inhibitor. During the review, the PRAC sought advice from an expert group of rheumatologists, dermatologists, gastroenterologists and patient representatives.

The review confirmed tofacitinib increases the risk of major cardiovascular problems, cancer, VTE, serious infections and death due to any cause when compared with TNF-alpha inhibitors. The PRAC has now concluded that these safety findings apply to all approved uses of JAK inhibitors in chronic inflammatory disorders (rheumatoid arthritis, psoriatic arthritis, juvenile idiopathic arthritis, axial spondyloarthritis, ulcerative colitis, atopic dermatitis and alopecia areata).

The product information for JAK inhibitors used to treat chronic inflammatory disorders will be updated with the new recommendations and warnings. In addition, the educational material for patients and healthcare professionals will be revised accordingly. Patients who have questions about their treatment or their risk of serious side effects should contact their doctor.

More about the medicines

The Janus kinase inhibitors subject to this review are abrocitinib, filgotinib, baricitinib, upadacitinib and tofacitinib. These medicines are used to treat several chronic inflammatory disorders (rheumatoid arthritis, psoriatic arthritis, juvenile idiopathic arthritis, axial spondyloarthritis, ulcerative colitis, atopic dermatitis and alopecia areata). The active substances in these medicines work by blocking the action of enzymes known as Janus kinases. These enzymes play an important role in the process of inflammation that occurs in these disorders. By blocking the enzymes’ action, the medicines help reduce the inflammation and other symptoms of these disorders.

Some JAK inhibitors are used to treat myeloproliferative disorders; the review did not include these medicines. The review also did not cover the use of baricitinib in the short-term treatment of COVID, which is under assessment by EMA.

Source: European Medicines Agency

Categories : Healthcare Politics and RegulationsTags : 1 Comment

In the Hot Seat: New Gauteng Health MEC Responds to 10 Questions from Spotlight

On By ModernMedia
Nomantu Nkomo-Ralehoko, MEC for Health in Gauteng. Photo: GP Health and Wellness/Twitter

By Spotlight Editors

On 7 October, Gauteng Premier Panyaza Lesufi appointed Nomantu Nkomo-Ralehoko to the position of MEC for Health in the province. Nkomo-Ralehoko replaced Nomathemba Mokgethi, who had been in the job for less than two years.

The position of MEC for Health in Gauteng is one of the most important, and probably one of the toughest public sector health jobs in South Africa. Spotlight sent Nkomo-Ralehoko ten questions about her plans and on the chronic problems plaguing health in Gauteng. We received the below responses via Tshepo Shawa, the MEC’s spokesperson.

1. After the murder of Babita Deokaran, the Gauteng Health Department was very slow to follow up on the alleged corruption that Deokaran had exposed at Tembisa Hospital. What steps will you take as MEC to ensure that the alleged corruption at Tembisa Hospital is fully investigated and that justice is done?

Nkomo-Ralehoko: The Gauteng Provincial Government has already, through the Office of the Premier, taken action to ensure that the Special Investigating Unit (SIU) conducts a forensic investigation into the transactions at Tembisa Hospital. I am also aware that the Hawks are probing the matter.

I have made a commitment that as soon as the SIU concludes the forensic investigation, we will definitely not hesitate to act on the recommendations.

Sometimes, justice might seem delayed, but it is important that we allow law enforcement agencies to complete their work so that firm action can be taken where there is wrongdoing.

2. From PPE-related corruption to alleged corruption at Tembisa Hospital, the Gauteng Department of Health appears to have a chronic and systemic problem with corruption. What steps will you take as MEC to:

i) root out corruption in the department at a systemic level;

ii) and ensure there are consequences for those implicated?

Nkomo-Ralehoko: One of my immediate focus areas is to ensure that the department’s systems across delivery areas such as Finance, Human Resources, Monitoring and Evaluation, Risk Management, etc. are strengthened so that processes are not dependent on human vulnerability but there are clear checks and balances.

An environment that has no consequence management breeds ill-discipline and a culture of ignoring processes and procedures as prescribed in our legislative framework. Our environment is highly regulated through various prescripts and it is important for oversight purposes and for good governance that the distinctive roles in terms of the role of Executive Authority and the role of Accounting Officer are appreciated.

I have already made an undertaking to work with stakeholders internally and externally to ensure that there is accountability and consequence management. Equally so, it will be important to also recognise people that go beyond the call of duty. We need to encourage an environment where we get back to the Batho Pele principles by ensuring that our work is geared towards improving patient experience of care and improving our service offering. We also need to make sure that employees work in an environment that appreciates the service they are rendering to communities and allows them to thrive.

3. The work of restoring Charlotte Maxeke Johannesburg Academic Hospital was handed over to the National Department of Health after the Gauteng government botched the job. What steps will you take as MEC to ensure that Charlotte Maxeke is fully functional again as soon as possible?

(Here, the MEC referred us to a response provided to the provincial legislature regarding the rebuilding of Charlotte Maxeke)

4. There have in recent years been chronic management-level vacancies in the Gauteng Department of Health. What steps will you take as MEC to ensure that all vacancies in the department are filled with suitably qualified people?

Nkomo-Ralehoko: Part of the intervention programme for the remainder of the 6th Administration term of office will be to review the age-old organisational structure which was last updated in 2006 to ensure that it is relevant and fit-for-purpose and takes into consideration the size of the Gauteng healthcare system and the kind of skills that are needed to provide adequate and effective care to the over 16 million people of the province, majority of whom rely on the public healthcare system.

We have put in place an ambitious plan called Turning The Tide: Reclaiming the Jewel of Public Health in Gauteng, which looks at a number of intervention areas. Key amongst these is the Human Resource component.

This is to ensure that we have a structure that responds adequately to clinical, administrative, social, and economic challenges faced by the province. This will enable the department to be able to deliver on the workforce that positively impacts its strategy execution efforts and acceptable levels of organisational performance.

5. Are you in favour of cadre deployment in the provincial health department?

Nkomo-Ralehoko: If by cadre deployment you mean a situation where highly trained and qualified personnel who understand the delivery imperatives of the developmental state and are committed to a high ethical standard embracing a culture and ethos of service, then indeed I am for cadre development.

However, if by cadre development you are referring to bringing incapable and unqualified people into the public service at the expense of delivery, then I can’t support such.

6. Healthcare workers often work under very difficult conditions and surveys have shown that many healthcare facilities are understaffed. What steps will you take as MEC to ensure sufficient numbers of healthcare workers are employed in Gauteng and work under decent working conditions?

Nkomo-Ralehoko: Kindly refer to the response to question 4 above. Additional to that response is that the Turning the Tide plan has also prioritised health infrastructure to ensure that healthcare workers work in a safe environment.

Our Department is now called the Department of Health and Wellness that on its own is a clear indication that issues of wellness will also receive special focus. We can’t preach a message of wellness while our employees are unwell and unhappy. In my first address to the staff at head office on 10 October 2022, I made a commitment to the team that charity will begin at home. For this reason, we will soon be rolling out Wellness Wednesdays, the aim of which is to bring the spotlight on employee wellness and to ensure that we pay more attention to the softer but critical issues that make the workplace a more conducive environment.

7. In your view, what is the key difference between the role of the MEC for health and the HoD of the province’s health department?

Nkomo-Ralehoko: The roles of the Executive Authority (MEC) and Accounting Officer (HoD) are clearly defined by various laws and regulations, such as the Public Service Act, Public Service Regulations, and Public Finance Management Act. The executive authority is the political head and is responsible for policy direction and oversight. The executive authority delegates certain functions to the accounting officer to ensure effective public management and administration.

The accounting officer is the administrative head of the department and is responsible for the day-to-day operations of the department.

8. As MEC, will you listen to and support healthcare workers like Dr Tim de Maayer who blow the whistle when the situation at health facilities becomes untenable, or will you take steps against such people?

Nkomo-Ralehoko: I have made a commitment to staff to work with them to turn the health system around. This means that performance systems and tools will have to be strengthened while we also create a conducive environment that allows employees to be heard. Everyone’s voice matters if it is a voice that seeks to move us forward. We all have a role to play to restore the tarnished image of the Gauteng public health system.

9. As the province’s new MEC for Health, what lessons do you take from the Life Esidemeni tragedy?

Nkomo-Ralehoko: You will appreciate that I am just a few days in office and I am obviously getting appraised with the myriad of issues confronting the healthcare system in the province. One of the commitments made by this 6th Administration was to be a patient-centred, clinician-led, and stakeholder-driven healthcare system. This is a commitment we intend to see through in the remaining period of the term of office. My job is to ensure that patients are at the centre of our work by giving clinicians space to do what they are trained to do while at the same time listening to the voice of the many stakeholders who want to see public health live up to its promise.

10. As we understand, you are not a medical doctor and in a SABC interview you said you are “a politician by accident”. What in your background and experience would you say makes you the right candidate for the role of MEC for Health?

Nkomo-Ralehoko: Yes I said I am a politician by accident given that I was drawn by many lived experiences which harnesses the activist in me that was driven to change things for the better. I am an administrator at heart, but I am also an experienced leader, having led across various structures in society.

I understand the plight of the people of Gauteng and I am committed to putting my skills and knowledge to change things for the better. I may not be a clinician or a nurse, but I do know that the healthcare system is nothing without healthcare workers.

Republished from Spotlight under a Creative Commons 4.0 Licence.

Source: Spotlight

Categories : Healthcare Politics and Regulations Substance UseTags :

Liquor Amendment Bill Might be Further Toughened up

On By ModernMedia
Source: Pixabay CC0

By Marecia Damons

Information about alcohol abuse gathered during the COVID lockdown may prompt further changes to the Liquor Amendment Bill, says the Department of Trade, Industry and Competition. The Bill has been on hold since 2018.

The Bill seeks to amend the National Liquor Act of 2003, by tightening alcohol restrictions and advertising and regulating where alcohol is sold.

Spokesperson Bongani Lukhele said the Bill was under review by the department.

“During the Covid-19 pandemic, it became more apparent that the problem of liquor abuse is quite huge in South Africa and requires more concerted measures, and that the Bill may not address the scale of the problem as the problem requires a concerted effort in government,” said Lukhele.

He said the department would reintroduce the bill to Parliament. Lukhele said as well as legislation to address liquor use, there was a need for health, education and behaviour issues to be addressed as well.

“Provincial laws must also be reviewed as it impacts directly on the retail trade,” Lukhele added.

Meanwhile, lobby groups are growing impatient with delays in the implementation of the bill.

Maurice Smithers, director of the Southern African Alcohol Policy Alliance in South Africa, said the Liquor Act had been reviewed in 2015 and found to be inadequate and inconsistent with the World Health Organisation’s Global Strategy to reduce the harmful use of alcohol. The Global Strategy suggests three priorities: reducing the availability of alcohol, increasing its cost, and limiting or banning marketing.

As a result, changes were proposed in the Liquor Bill, drafted in 2016, including:

  • restricting advertising of alcohol on public platforms;
  • increasing the legal drinking age from 18 to 21 years;
  • regulating specific trading days and hours for alcohol to be distributed and manufactured; and
  • placing liability on alcohol retailers and manufacturers for harm related to the contravention of regulations.

The amendments also propose banning alcohol advertising on radio and television at certain times and on billboards less than 100 metres away from junctions, street corners and traffic circles.

The bill was approved by Cabinet for public comment in 2016.

Smithers told GroundUp that the socio-economic and health problems associated with alcohol would worsen over time if the Bill and other legislation was not passed.

“The overall cost to society of such harm will continue to burden the state and divert resources from other delivery areas. Some specific consequences are that petrol stations are now applying for licences, something they would not be able to do if the bill were passed.”

“The current proposals in the Basic Education Laws Amendment Bill which will allow schools to have alcohol at schools and at school functions off school premises for fund-raising purposes would also not be allowed if the bill were passed,” said Smithers.

Basic Education Minister Angie Motshekga has said the department supports zero tolerance of alcohol at schools, but schools do sell alcohol during fund-raising and do hire out halls for functions where alcohol is consumed. She said the clauses in the Basic Education Laws Amendment Act are intended only to regulate this.

Onesisa Mtwa, innovation manager at the DG Murray Trust, told GroundUp that stronger regulations were necessary to address and reduce harmful patterns of consumption such as heavy and binge drinking.

In its 2018 Global Survey on Alcohol and Health, the WHO indicated that in 2016, South African drinkers over the age of 15 years consumed, on average, 64.6 grams of pure alcohol per day.

The data further showed that South African drinkers over 15 years old consumed 29.9 litres of pure alcohol in a year —the third highest consumption in Africa.

Citing a 2017  by economics-based consulting firm Genesis Analytics, Mtwa said the Bill could reduce alcohol consumption by between 3.2% and 7.4% which would, in turn, reduce public health costs by R1.9 billion per year.

“Despite the industry’s claims that this Bill will destroy the industry,” Mtwa said, the impact assessment suggested that South Africa’s gross domestic product would drop by less than 1%.

A study by the University of Cape Town and the Medical Research Council found that alcohol bans during COVID were strongly associated with a large drop in unnatural deaths (murders, vehicle collisions, suicides and accidents).

Researchers looked at death data during alcohol restrictions and curfews under the national lockdown from the end of December 2019 to late April 2021. The drop in unnatural deaths associated with a full alcohol ban ranged from 42 deaths per day under a curfew of 4 to 7 hours to 74 per day under hard lockdown.

Mtwa said implementing the bill would need “extensive” national and provincial cooperation.

“Some areas of regulation such as retail sales and liquor licences lie with provinces, while liability issues, manufacturers and the drinking age would be regulated by the national government. This highlights the need for a whole-of-government approach to reducing alcohol-related harm,” she adds.

Smithers said although the bill is not a silver bullet, it would send a signal to society that the government is serious about addressing the issue of alcohol-related harm.

“It’s not a perfect bill and it won’t result in a perfect act, but it is a step in the right direction,” he said.

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

Source: GroundUp

Categories : Healthcare Politics and RegulationsTags :

New Laws Set to Turn the Screws on Smoking in South Africa

On By ModernMedia
Cigarette butts
Source: Pawel Czerwinski on Unsplash

New legislation will soon place further curbs on tobacco smoking in South Africa – and these laws will also now extend to e-cigarettes. In South Africa, lung cancer is the third most common cancer among men and seventh for women. More than two-thirds of lung cancer patients are diagnosed at an advanced stage, resulting in poorer outcomes for treatment.

Read the smoking laws notice [PDF]Download

The proposed laws impose harsher penalties against smoking in smoke-free zones, being punishable with a fine or up to three months imprisonment. More areas would be designated smoke-free zones, essentially ending the smoking sections currently set aside for restaurants and bars. This would also extend to the homes of people who employ domestic workers – the employers would not be able to smoke while those workers are present.

Smoking would also be banned in homes used for teaching, tutoring and commercial childcare. Shared residences would also have smoking banned in common areas, as would smoking in vehicles with occupants under the age of 18.

Cigarette packaging will also be targeted, with a move to plain packaging with graphic health warnings. It will no longer be legal to sell cigarettes through vending machines, nor display cigarettes at the point of sale. Sweets and toys resembling cigarettes would also be banned – however, the sugar ‘cigarettes’ that many may remember from their youth are already banned.

Vaping and e-cigarette products will also be liable to the same legislation, and are also soon to have an excise tax levied upon them.