Category: Healthcare Politics and Regulations

Categories : COVID Healthcare Politics and RegulationsTags : 1 Comment

Political Factors Drove Hydroxychloroquine and Ivermectin COVID Prescriptions

On By ModernMedia
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Hydroxychloroquine and ivermectin, two COVID treatments that have been shown to be ineffective for those purposes, were more heavily prescribed in the second half of 2020 in parts of the US that voted for the Republican party, according to a new research letter published in JAMA Internal Medicine.

“We’d all like to think of the health care system as basically non-partisan, but the COVID pandemic may have started to chip away at this assumption,” said lead author Michael Barnett, assistant professor of health policy and management.

The study compared prescription rates for hydroxychloroquine and ivermectin with rates for two control medications, methotrexate sodium and albendazole, which are similar drugs but have not been proposed as COVID treatments. Comparing different US counties, researchers looked at deidentified medical claims data from January 2019 through December 2020 from roughly 18.5 million adults as well as census and voting data.

Overall, hydroxychloroquine prescribing volume from June through December 2020 was roughly double what it had been in the previous year, while the volume of ivermectin prescriptions was seven-fold higher in December 2020 than the previous year. In 2019, prescribing of hydroxychloroquine and ivermectin did not differ according to county Republican vote share. However, that changed in 2020.

After June 2020 – coinciding with when the US Food and Drug Administration revoked emergency use authorisation for hydroxychloroquine – prescribing volume for the drug was significantly higher in counties with the highest Republican vote share as compared to counties with the lowest vote share.

As for ivermectin, prescribing volume was significantly higher in the highest versus lowest Republican vote share counties in December 2020 a 964% increase on the overall prescribing volume in 2019. The spike lined up with with a number of key events, such as the mid-November 2020 release of a now-retracted manuscript claiming that the drug was highly effective against COVID, and a widely publicised US Senate hearing in early December that included testimony from a doctor promoting ivermectin as a COVID treatment.

Neither of the control drugs had differences in overall prescribing volume or in prescribing by county Republican vote share.

The authors concluded that the prescribing of hydroxychloroquine and ivermectin may have been influenced by physician or patient political affiliation. “This is the first evidence, to our knowledge, of such a political divide for a basic clinical decision like infection treatment or prevention,” said Barnett.

Source: Harvard T.H. Chan School of Public Health

Categories : General Interest Healthcare Politics and RegulationsTags :

NHI Faces Healthcare Human Resource Emigration Challenges

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While the proposed National Health Insurance (NHI) could make use of existing private healthcare human resources, the necessary tax increases to fund it could drive more healthcare professionals from the country, the Professional Provident Society (PPS) has said.  Economic and other factors, such as the Durban unrest, have already caused a surge of emigrations of professionals since July last year. In addition, foreign students graduates who study critical skills in South Africa (such as nurses and GPs) will no longer have an easy route to permanent residency. 

The PPS, which counts about 30 000 healthcare professionals among its membership, pointed out the vulnerability of South Africa’s tax base – which has shrunk to only 6.9 million taxpayers, down from 7.6 million the year from the year before.

While it raised a number of concerns about the NHI, the group stated that it was broadly supportive of establishing universal healthcare in the country, and this goal could still be accomplished by using a dual public-private system. The PPS further noted that the government could benefit from the exceptional administrative capabilities and existing patient management systems.

However, NHI is dependent on strong, competitively remunerated human resources, with PPS pointing out that “South Africa has experienced a mass exodus of nurses in the 90s; we cannot risk that again. Both the government and private sector need to find a solution for South Africa and it cannot ‘import solutions’.”

“Professionals are a big proportion of healthcare delivery and the tax base. Their voices need to be considered.

“We urgently need to see the funding model, the implementation of the Health Market Inquiry (HMI) and details of how the system will work.”

The PPS said in a 2019 report that the highest risk to effective universal health cover in South Africa is losing highly skilled professionals to emigration. Healthcare professionals have a great deal of geographic freedom, and it is becoming easier to work in their trades the world over. COVID with its restrictions may have slowed emigrations by skilled professionals, but since July 2021, experts have seen a surge backed up by 18 months of pent-up demand. 

The PPS noted that research has shown “that the decision to emigrate is a complex one that is driven by various personal and societal pull and push factors.”  The NHI could be yet another push factor adding to the list of healthcare professionals’ sore points. “Healthcare worker migration from South Africa in the past has been driven by policy decisions and socio-economic and political considerations.

“In 2001, the number of nurse emigrants was roughly 20% of the total number working within the public sector in South Africa. That, together with being ranked as having the eighth-highest global number of emigrating physicians in the year 2000, created a dire situation for the sustainability of healthcare in South Africa at the time.”

Among general professionals, PPS’s research has indicated that many are considering emigration. A majority of respondents surveyed (73%) cited NHI as a potential reason for emigration, with 15% unsure and only 12% not considering leaving at all.

In addition to losses from emigration, the Department of Home Affairs has ended a 2014 waiver which allowed a quicker path to a residency permit for foreign students who acquire critical skills in South African higher learning institutions. Going forward, foreign students will no longer be able to apply for permanent residency visas without complying with the usual requirements such as providing proof of five years’ work experience. This is seen as detrimental to South Africa’s ability to attract and retain skilled professionals. This may further impact NHI implementation as the necessary skilled human resources are squeezed further as fewer foreign students may choose to study and then work in South Africa.

Source: BusinessTech

Categories : Healthcare Politics and RegulationsTags :

National Treasury Proposes e-Cigarette Tax

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The National Treasury is proposing to impose a tax on both the non-nicotine and nicotine solutions in e-cigarettes (EC), and is asking for public comment by 7 February 2022.

The National Treasury published a draft discussion paper in December 2021 on the proposed taxation of e-cigarettes (ECs). The National Treasury defines e-cigarettes as battery powered devices that do not burn or use tobacco leaves but vaporise e-liquid solutions for inhalation.

In its discussion paper, the Treasury notes the uncertainty of e-cigarettes’ health risks, so it seeks stakeholder engagement on its proposal for the taxation of ECs.

The National Treasury proposes to introduce a specific excise tax on both the non-nicotine and nicotine solutions used in ECs and intends to use its existing policy guidelines applicable to other excisable products to do so. For example, traditional tobacco products are subject to excise duties at a rate of 40% of the price of the most popular brand in each tobacco category. 

For EC users, that would mean paying R2.03 per mL of EC solution nicotine-containing nicotine and R0.87 per mL of nicotine-free EC solution, if the draft proposals are accepted and become legislation. It is also proposed that EC products with a higher nicotine content will attract a higher duty rate.
Certain stakeholders may question that the Treasury’s proposed EC tax extends to nicotine-free liquids, as it does not necessarily support the government’s stated policy intention of reducing the consumption of tobacco products. The use of ECs as a means of quitting tobacco products is well established, with a Cochrane review showing that nicotine-containing ECs resulted in increased odds of quitting than nicotine-free ECs. 
It could also generate a knock-on illicit trade in e-cigarettes, as has  already happened in the tobacco sector.

Manufacturers and importers who would be taxed on ECs will need stringent certifications by accredited laboratories, which use either South African National Accreditation or International Laboratory Accreditation Cooperation (ILAC) approved methodologies.  Where such certifications are not available, a penalty rate of duty is being proposed.

Comments on the draft discussion document are due by 7 February 2022.

Source: Webber Wentzel

Categories : Healthcare Politics and RegulationsTags :

Mediclinic and Discovery Sound Warnings over NHI Bill

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Private hospital group Mediclinic has warned that the government’s proposed National Health Insurance (NHI) system will threaten public health in South Africa, and bring about the destruction of private healthcare and medical aid cover.

The NHI Bill is currently undergoing a public consultation process, with a number of healthcare, civil society and political groups presenting on why the new system should or should not be introduced.

The Bill as it stands will have a direct impact on access to healthcare services in South Africa. Mediclinic notes that there are insufficient resources to implement it; private-sector hospitals will be curtailed; and medical aids will be eroded.

The financial and human resources necessary to effectively implement the NHI scheme is a legitimate concern, Mediclinic said. It pointed out South Africa’s low doctor- and nurse-to-population ratios are low compared to peer countries.

“Everyone’s right of access to health care services would be threatened if the existing health care delivery system is uprooted and the NHI scheme envisaged in the Bill cannot be effectively implemented,” it said.

Private healthcare is an integral part of the healthcare system with everything from hospital beds to staff at risk if replaced by the NHI.

The Bill’s key components threaten the private hospital sector, with the contracting and reimbursement frameworks proposed in it unable to accommodate private hospital participation.

Additionally, the NHI Fund will create a monopoly by acting as the single purchaser of health care services in South Africa, capable of harming the competition and eroding private sector resources.

Medical scheme provider Discovery said that current private health care funding amounts to R212 billion, some 44% of the total healthcare spend. If the government were to finance this through direct taxation, this would equate to 4.1% of GDP, an unfeasible amount.

Mediclinic also warned that medical aid in South Africa would be significantly eroded under the NHI, meaning only the bare basics for South Africans needing medical care, and expensive treatments being unavailable. It gave the example of a patient with chronic renal failure receiving haemodialysis treatment currently covered by a medical scheme, and showed that the patient would be placed on a long waiting list for this life-saving treatment since it was covered (but not properly funded) by the NHI.

Source: BusinessTech

Categories : COVID Healthcare Politics and RegulationsTags :

SA’s Top 10 Health Topics to Watch in 2022

On By ModernMedia
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Spotlight highlights the country’s top 10 health topics to keep an eye on in 2022.

1. COVID prosecutions
Former health minister Dr Zweli Mkhize resigned amid allegations of wrongdoing in the Digital Vibes scandal, and hit back at the findings of the Special Investigations Unit, which had also implicated a number of top health department officials. Whether Health Minister Dr Joe Phaahla  will take decisive action against those found guilty will be an important litmus test. Last year, Dr Phaahla assured the public that the department “is going to thoroughly and decisively act to ensure nothing is swept under the carpet”.

2. The NHI Bill
Public hearings on the National Health Insurance Bill will be done by the end of January, with feedback in February and final report by April 1. It then goes to the National Council of Provinces for a similar stakeholder process, and before the end of 2022 it could be signed into law.
To date, public inputs on the Bill were mostly on governance issues. A critical point this year is whether MPs will take these inputs on board and make significant changes to the bill, or whether they will simply force through the bill largely unchanged.

3. Medico-legal claims
With R74 billion in medico-legal claims against the state, the State Liability Bill is back on Parliament’s agenda. Instead of government departments paying a lump sum for successful medical negligence claims, the Bill proposes a new settlement structure of separate payments to relieve budgetary pressure on hospitals. Since the necessary final report from the South African Law Reform Commission is months away, Spotlight does not think the Bill will be passed this year – and first prize would be to prevent medico-legal claims from happening.

4. Healthcare budget cuts
Unfortunately, there is still no end in sight to continued budget cuts to healthcare. Employing more nurses could reduce medico-legal claims, but in fact there is a growing shortage of nurses. Even th Office of Health Standards Compliance is also hamstrung by inadequate funding, with only 61 inspectors to cover more than 5000 public healthcare facilities, putting off private sector inspections until next year.

5. HIV prophylaxis
With the extremely promising results of injectable pre-exposure prophylaxis (PrEP) for HIV, there is still a process to go through before it will be made available in South Africa this year. COVID has shown that processes can be sped up if there is the will, but whether there is the same drive to treat HIV remains to be seen. As such, PrEP will most likely only be available in public healthcare facilities by the end of 2023.

6. An end to the COVID pandemic
While South Africa is heading towards living with COVID as an endemic disease, it is impossible to predict what surprises the coronavirus will have in store for the world this year in the form of new variants. However, according to Director of the Medical Research Council, Professor Glenda Gray, the winter months will give us an idea of the direction the pandemic will take with a fifth wave. Vaccination will remain key to reducing its severity.

7. SA’s TB programme
COVID severely set back SA’s TB programme, but 2022 should see the arrival of a number of delayed initiatives. These include rollout of the relatively new 3HP prevention pills, the results of new X-ray detection technology and  consequent possible changes to screening and testing, and an update to the Thembisa HIV model which will now include TB.

8. The National Mental Health Policy Framework
The new National Mental Health Policy Framework and Strategic Plan are expected to be finalised this year. However, as with the NHI, funding remains a problem. Only 5% of the current health budget goes to mental health services, and it only provides for one in 10 of those in need.

9. Improved procurement legislation
As illustrated by the government’s COVID procurement debacle, an overhaul is needed. Draft Public Procurement Bill proposes a single regulatory framework for all goods and services procured by government departments and has the potential to strengthen and streamline procurement processes. However, Spotlight notes that critically important pieces of legislation can simply vanish, as did the Medical Schemes Amendment Bill of 2018.

10. No-fault compensation fund
The COVID vaccine injury no-fault compensation fund has quietly fallen off the radar, with no payouts made to date. However, the NICD again urged people to report adverse events with the vaccine.

Source: Spotlight

Categories : COVID Healthcare Politics and RegulationsTags :

Vaccine Patent Waivers are No Silver Bullet, Experts Argue

On By ModernMedia
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Rather than a World Trade Organization (WTO) patent waiver, COVID vaccine equity requires improvements to manufacturing and distribution of vaccines in the Global South and compulsory licensing mechanisms, according to a statement by ALLEA, the European Federation of Academies of Sciences and Humanities. 

They state that the low level of COVID vaccination in the Global South is ethically unacceptable and risks prolonging the pandemic. At the end of 2021, access to Covid-19 vaccines is still a priority. Only 5.9 % of people in low-income countries have received at least one dose (on 29 November 2021, compared with 0.3% on 14 April), with numbers in Africa remaining very low, save for Morocco. The patent waiver being discussed within the WTO since 2020 will not solve these vaccination bottlenecks in the short-term. For instance, the waiver as proposed by South Africa and India would in practice require unanimity between the 164 WTO Members to be adopted – to achieve this in practice would simply delay the waiver until after the pandemic.

Rather, measures should be undertaken to accelerate local manufacturing and distribution of vaccines in low- and middle-income countries (LMICs), ramp up investment in vaccination campaigns, and facilitate the compulsory licensing of patents and knowledge transfer.

In particular, the statement advocates for (i) practical measures that could accelerate the production, export, distribution, and administration of vaccines worldwide and ii) an international mechanism affording additional scrutiny of the manufacturing bottlenecks combined with new measures in the intellectual property (IP) framework such as flexibility for the compulsory licensing of patents.

According to the experts, the current co-sponsored waiver proposal at the WTO is “not well-tailored to the urgent vaccine problem” and needs additional national legislation to have any practical effect. A WTO waiver would only remove the obligation for WTO Member States to grant IP protection, but would not ensure that stakeholders can effectively benefit from the invention and related know-how.

“A waiver (in the sense of the co-sponsored proposal at the WTO) of IP protection, including of trade secrets, would never make this know how publicly accessible, but only remove the possibility for companies enjoying confidentiality protection to sue for trade secret infringement”, the experts argued.

Other IPR measures need to be considered instead, with the WTO waiver debate raising other IP fixes that are needed in the field of health. The WTO rules on compulsory licensing of health-related patents should be amended. Important adjustments to patents and trade secret protections should also be adopted by the EU, its Member States, and other countries. In particular, improved procedures and institutional design should help to streamline the process for compulsory licensing on pharmaceutical products, including vaccines.

Source: ALLEA

Categories : Healthcare Politics and RegulationsTags :

A Trend of Amalgamations is Underway for Medical Schemes

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A trend of amalgamations is underway in the South African private healthcare industry, in the face of growing challenges and the impending introduction of National Health Insurance (NHI).

Escalating healthcare inflation and costs, a declining and ageing membership, the impact of the COVID pandemic and a growing burden of disease are all impacting the not-for-profit Medical Scheme industry, which is highly regulated.

Medical scheme consolidation is one of the prominent trends, particularly given the prospect of NHI on the horizon, where smaller schemes will not compete, said Lee Callakoppen, principal officer of Bonitas Medical Fund.

The Council for Medical Schemes (CMS) advises that schemes that cannot compete sustainably on price should consider amalgamation partners, Callakoppen said.

“The trend towards amalgamations is not only for the sustainability of the medical scheme but for the benefit of members who ‘own’ the fund’.

“It is not only the call from CMS for schemes to join forces but also strict regulations around minimum solvency ratios and reserves which are more difficult for smaller schemes to maintain.”

It is a requirement of the Medical Schemes Act that medical schemes shall at all times maintain their business in a financially sound condition. They need to have sufficient assets for conducting business, providing for liabilities and having the prescribed solvency requirements of 25%, said Callakoppen.

“It’s a big ask for small schemes in this volatile and uncertain healthcare market,” he said.

A trend of amalgamation for small schemesThe CMS provides regulatory supervision of more than 80 medical schemes registered in the country and oversees amalgamation prospects.

One proviso for amalgamation is that schemes should complement each other and provide a more comprehensive offering to members.

“One clear indicator of risk is the size of the pool of lives being covered,” said Callakoppen. “Schemes with smaller risk pools are struggling to survive and experience more volatile claims”.

“Amalgamation into a bigger scheme means cross-subsidisation of costs. It is a trend I believe will continue, if not accelerate. In fact, in the past decade, we have seen 28 amalgamations approved by the CMS and the Competition Commission.”

The NHI has been criticised for potentially stifling innovation in healthcare, as well as not actually being able to fix the country’s flawed and unequal healthcare system.

Source: BusinessTech

Categories : General Interest Healthcare Politics and RegulationsTags :

Meet the Two Women in the Running for SA’s Top Medical Job

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Health Minister Dr Zweli Mkhize is in hot water over alleged procurement fraud for a R150 million COVID contract, and is widely expected to step down shortly.

President Cyril Ramaphosa is reportedly weighing up two candidates to replace Dr Mkhize as health minister.

The candidates are the former Gauteng health MEC Dr Gwen Ramokgopa, (who took over following the Life Esidimeni tragedy) and Dr Nkosazana Dlamini-Zuma, who, as Health Minister saw the overhaul of the country’s apartheid-era healthcare systems.

As an anti-Apartheid activist, Dr Ramokgopa held various leadership positions. She qualified as a medical doctor (MBChB) in 1989 and obtained her Master’s in Public Health (MPH) in 2007. She worked as a Medical Officer at the Dr George Mukhari (then Ga-Rankuwa) Hospital until 1992.

Having served once as the Gauteng health MEC in 1999,  Dr Ramokgopa took on the role deputy health minister from 2010 to 2014. She succeeded Qedani Mahlangu as Gauteng health MEC following the shameful Life Esidimeni tragedy involving the deaths of at least 94 mental health patients released from private mental healthcare facilities to 27 unlicensed facilities. In a  statement, she vowed to tackle waste and corruption.

Dr Nkosazana Dlamini-Zuma completed her MBChB at the University of Bristol in 1978, and took part in underground ANC activities. During Mandela’s presidency, she was appointed Minister of Health, and courted controversy by voicing support for Virodene, an ‘HIV cure’ which attracted heavy criticism and which was never approved.

She then served as Minister of Foreign Affairs from 1999 to 2009, and then Minister of Home Affairs to 2012, where she turned around a department mired by mismanagement. Despite stubborn resistance from French-speaking nations, she was elected the African Union’s (AU) Chairperson from 2012 to 2017 and was praised for focusing on gender issues. After this, she began vying for the ANC presidency as an MP. In 2019, she was appointed Minister of Cooperative Governance and Traditional Affairs.

During South Africa’s lockdown, she memorably rose to internet fame for using “zol” to refer to cannabis when giving reasons for the tobacco ban.