Day: September 8, 2023

In-depth: What Two Major Bills Might Mean for Health Sector Procurement in SA

Groote Schuur Hospital, Cape Town

By Alicestine October for Spotlight

Recently, in a major feat for transparency and accountability, the North Gauteng High Court ordered that the public must have access to COVID-19 procurement contracts – details of which, until now, have been kept away from the public eye as the government cited confidentiality clauses.

The Health Justice Initiative’s – who brought the court application – victory is a crucial one given the staggering size of public procurement contracts in the health sector.

According to Zukiswa Kota, South African Programme Head at the Public Service Accountability Monitor (PSAM), this judgement deserves celebrating “as it deepens the case for transparency in public procurement and effectively challenges the many reasons often used to evade publication”. “Ultimately, what we need is proactive disclosure that is built into procurement legislation and – more importantly – is adhered to by government,” said Kota.

“It is inconceivable,” she said, “that in 2023 there continues to be limited transparency around fairly basic info – in this case COVID-19 vaccines. “The fact that there is no explicit transparency is an indictment and something we need to reflect on.”

The need for transparency has also been affirmed in the HJI judgement. “Non-disclosure of any of the records sought means that a shroud of secrecy is placed over the entire negotiation, procurement, and payment process – the very mischief our Constitution and legislation such as Paia seeks to address,” the judgement states. S217 of the Constitution states that public procurement by any state organ must be “in accordance with a system which is fair, equitable, transparent, competitive and cost-effective”. 

The case for transparency

The call for open contracting and to strengthen public procurement legislation is not a new one. It is also not confined to COVID-19 vaccines, but all public procurement, also in the health sector.

Dominic Brown, director at the Alternative Information & Development Centre (AIDC), also recently during a webinar on the launch of a report on pending legislative and regulatory changes in the healthcare sector made the case for transparent procurement. The Rural Health Advocacy Project compiled the report that also provides several recommendations for procurement reforms.

“The level of public procurement in the country is approximately 25% of GDP and the majority of government’s involvement in the economy is through this procurement, so it’s no small issue. It’s of extreme significance,” said Brown.

He said that in 2016, the former chief procurement officer in National Treasury estimated that between 30 to 40% of the country’s procurement budget is lost to inflated prices and fraud by the private sector. At the time, this amounted to R230 billion.

“At the moment, our procurement budget is about R1 trillion, which means that we are losing between R300 and R400 billion each year as a result of corruption linked to public procurement and this has major detrimental impacts on service delivery.”

Putting this impact into perspective, especially as it pertains to the health sector, RHAP’s director, Russel Rensburg during the same webinar said that provinces can spend up to 30% of their health budgets on the procurement of goods and services, which can run into billions. “Contrast this with the huge chunk spent on employee costs (often between 60 and 65% of health budgets), and growing inefficiencies and waste due to non-compliance to legislative prescripts – the pool of money remaining for health services is limited,” he said.

“Lack of compliance with financial management policies, particularly around supply chain monitoring policies, has resulted in the deterioration of several financial management indicators. We’ve seen an increase in qualified audit opinions of health departments and an increase in irregular and wasteful expenditure – amounting to R6 billion in the last financial year,” said Rensburg. “Competent financial management is essential to ensuring that maximum value is achieved from the resources deployed.”

The need for this “competent financial management” in the public sector was highlighted again last week when the Gauteng Department of Health’s Annual Report for 2022/23 was tabled in the provincial legislature. The report showed irregular expenditure to the value of over R2 billion, which means legislative prescripts were not followed in the procurement of goods and services, among others. In the Auditor-General’s (AG) report, she flagged the irregular expenditure stating that there were no effective and appropriate steps taken to prevent it. “The majority of this irregular expenditure,” the AG stated, “was caused by the department’s failure to invite competitive bids” when procuring goods and services.

Legislative reforms and procurement

Currently, in Parliament’s National Assembly, MPs are set to deliberate on the Public Procurement Bill. The bill provides for far-reaching reforms in public procurement. In Parliament’s National Council of Provinces, deliberations on the National Health Insurance Bill are underway. This bill also provides for far-reaching reforms to how health services will be structured and funded.

Both pieces of legislation have major implications for procurement in the health sector.

Yet, with these legislative reforms underway in Parliament, some stakeholders say that neither bill in its current form, will be a silver bullet to address all shortcomings in public procurement in the health sector. Questions also remain if these bills will ultimately result in real consequences for errant public officials in supply chain management or overreaching political office bearers.

Added to this is the overlap between provisions in the two bills, several provisions that lack clarity, and some areas of conflict between the bills that may lead to confusion down the line.

The case for alignment between the bills

The Public Procurement Bill aims to standardise and create a uniform regulatory framework for all procurement by government departments and entities. The NHI Bill, in turn, if passed will transform how publicly-funded health services are organised and delivered. The bill provides for a NHI Fund that will “strategically purchase healthcare services on behalf of users”.

Rensburg explains this fund must transfer funds directly to accredited and contracted central, provincial, regional, specialised and district hospitals based on a global budget or Diagnosis-related Groups. The bill also provides for an Office of Health Products Procurement (OHPP), he said, but the exact scope of this office’s mandate is not yet clear.

According to the bill, this office (OHPP) will be responsible for “the centralised facilitation and coordination of functions related to the public procurement of health-related products”.

According to Yana van Leeve, from the law firm ENSafrica, the NHI fund will be a S3A public entity so the procurement bill will apply to that entity. S3A public entities under the Public Finance Management Act can be defined as a public entity with the mandate to fulfil a specific economic or social responsibility of government and they depend on government funding and public money.

Van Leeve was also a panellist during the RHAP webinar.

She explained that section 217 of the Constitution will also apply to this process of acquiring services because the NHI Fund will be engaging in public procurement when it engages healthcare service providers and health establishments in both the public and private sectors. Van Leeve said that it is not clear in the NHI Bill, however, that “there is an appreciation that this dimension of the scheme will amount to formal procurement and will thus be subject to normal procurement law”. “The implication would then be that one of the prescribed forms of procurement, for example, quotations or open bidding must be used to secure the services of these health service providers.” According to her, the NHI Bill, however, creates the impression that there is a different type of arrangement to be considered for the acquiring of such services. In section 39 of the NHI Bill, for example, accreditation of health service providers is required.

The procurement bill, in turn, provides for a Public Procurement Office that must create and maintain a database of prospective suppliers. Departments or other public entities may only procure from suppliers listed in this database. This may result in some practical problems as the requirements to be added to the existing central supplier database of National Treasury may differ from what the NHI Bill requires from suppliers. For example, to get on the database, National Treasury may consider a legitimate entity as one with a valid tax certificate, but, said van Leeve, “If you are procuring health products, for example, you may need other things to accredit a potential supplier, which treasury does not necessarily look at when it builds its database”.

“So, immediately you can see there will be tension between what the NHI envisage for creating its services and products lists versus what the public procurement office will develop in terms of the national supplier database. So, on the one hand, NHI is creating a special procurement system for health and providing for units and committees that will be responsible for identifying health services and buying health products and it’s not clear how these two pieces of legislation are going to interact.”

Van Leeve did say, however, that it is possible that the Minister of Finance “can differentiate between institutions and categories of procurement, but nothing in the procurement bill currently requires the minister to do so and there is no guidance on the considerations relevant to differentiating between categories of public institutions”.

She said it is possible for the bill to still make clear provision for the minister to make exemptions from the procurement bill. Currently, section 56(b) of the bill, for example, only provides – “the Minister may, with or without conditions, by notice in the Gazette, exempt a procuring institution from any provision of this Act, if— (a) national security could reasonably be expected to be compromised, or (b) the procurement is to be funded partially or in full by donor or grant funding and such exemption will benefit the public in general or a section of the public”.

But van Leeve insists that one way or the other, “It will be important – certainly in the way in which the NHI and procurement bills become operationalised for there to be comity between the bills.”

The RHAP report also recommends that “the relationship between health authorities and the public procurement structures proposed in the draft Public Procurement Bill must be clarified. The Public Procurement Bill makes no specific reference to health procurement as a special type of public procurement. At the same time, the NHI Bill contemplates a very particular regime in respect of health procurement. These two draft Bills will have to be aligned.”

According to the report, “the tension between the decentralised nature of public finance management in South Africa under the PFMA and Municipal Finance Management Act on the one hand and the highly centralised nature of public health services spending under the proposed NHI on the other hand, will have to be addressed”.

The shadow of politics

There are also other considerations besides overlapping provisions in the two bills – the shadow of politics through the blurring of the administrative and political interface often becomes a problem.

Rensburg highlighted, among others, it is still not clear how compliance with procurement policies will be audited and how often, or what the different sanctions will be for those not complying. “We see, especially with emergency procurement, that managing procurement functions is open to a lot of different kinds of pressures, he said. “The procurement bill does create frameworks for public office bearers to not be involved in the procurement process and for subject matter experts to be involved in procurement decisions, but there are a lot of things happening in the shadow that you can’t explicitly link to involvement of political principles in administrative processes,” said Rensburg.

“There is an added complexity,” Brown said, “when you hear, for example, of ANC tender committees, or when there is a tender chairperson who then can determine who gets and doesn’t get various contracts. This is deeply rooted in the state – from local government all the way up to national level, and across state-owned enterprises.”

Case in point, in the public health sector, the Digital Vibes scandal epitomised this “complexity” when then-Minister of Health, Dr Zweli Mkhize was implicated in tender irregularities and subsequently resigned.

Another criticism of the Public Procurement Bill is that it leaves a lot, arguably too much,  of the detail of how procurement will actually work up to regulation rather than setting it down in primary legislation. This, suggested Caroline James and Sam Sole in a recent Daily Maverick article, leaves the door open to political interference.

Corruption Watch’s executive director, Karam Singh, during a different webinar in August on the procurement bill by the Special Interest Group on Public Procurement Law, also flagged some gaps in the definitions in the procurement bill, especially around issues like conflicts of interest and politically exposed persons.

In terms of chapter three of the procurement bill that deals with procurement integrity and prohibition of certain practices and debarment, anybody who is involved in the procurement process – that is from the accounting officer, bid committee, or tribunal – must comply with the prescribed code of conduct, failing which will constitute misconduct. According to Singh, however, the bill falls short of stipulating who must issue the code of conduct, how it would be updated, and where it would work, as well as where or when it must be made available. “There is very little detail on how misconduct would be handled,” he said, “and so there is a gap between understanding what this code of conduct would be, how it would come about and if it will be presented for public participation and public comment.” He said it is also unclear what would be the enforcement mechanism which would stand behind the code of conduct to make it effective.

Responding to concerns over tender corruption risks

In June this year, during a briefing by Dr Nicholas Crisp, Deputy Director-General in the National Health Department on the NHI Bill to MPs in the NCOP, concerns were flagged over the risk of tender corruption in the NHI Fund. Later, in August during a briefing to MPLs in the Western Cape provincial legislature, the same concerns were raised.

At every point, Crisp insisted, “The NHI Fund will handle very little by way of tender. The accreditation is not a tender process. It’s voluntary registration by a service provider – public or private – as long as they meet the criteria. The prices will be fixed and the way services are delivered will be fixed when it comes to the procurement.”

According to Crisp, when it comes to the procurement processes for goods, particularly health products, the NHI Fund is only involved in the first stage. “The Fund would not go about the logistics of purchasing anything. The providers needed to purchase once those prices were set. There was far less vulnerability in the Fund than first thought when one looked at the Bill,” he said.

Spotlight followed up with Crisp for further clarification in lieu of the RHAP report and the implications of the procurement bill for the NHI Bill. Crisp said, that according to the NHI Bill, the Fund will determine the Formulary that it will pay for and will establish the prices of the items in the Formulary. “It is the intention that the NHI agency will not buy any ‘health products’ and will not have storerooms and warehouses since the agency (the NHI Fund) is not a provider of services. The providers will buy what they need to deliver the benefits that they are accredited to provide. Accredited providers (public and private) will buy at the approved NHI prices and this is how the health department works now,” he said. “The provincial health departments do the buying and storing, etc.”

He stressed that the Fund will not go on tender for healthcare providers. “The bill in s39 says that providers will be accredited and all accredited providers will be paid for the benefits that they deliver. So, it is intended to not be exclusionary.”

On the implications of the Public Procurement Bill for the NHI Bill, he told Spotlight the department is still studying the procurement bill and these issues (as raised in the RHAP report and through various stakeholders) are being considered. He also noted that according to the NHI Bill, “If any other law, except the Constitution or PFMA, conflicts with the NHI Bill then the NHI bill prevails. But we will want to engage with the intentions, merits, and any potential challenges with Treasury,” he said.

Have your say

Members of the public have until 15 September to make written submissions on the version of the NHI Bill currently before the NCOP. Meanwhile, National Treasury this week briefed MPs in the Standing Committee on Finance on the Public Procurement Bill. The deadline for written submissions is 11 September.

Republished from Spotlight under a Creative Commons Licence.

Source: Spotlight

Semaglutide Eliminates Insulin Injections in Some Newly-diagnosed Type 1 Diabetes Patients

Novolog insulin pen. Photo by Dennis Klicker on Unsplash

Treating newly diagnosed Type 1 diabetes patients with semaglutide may drastically reduce or even eliminate their need for injected insulin, according to the remarkable findings of a small University at Buffalo study reported in the New England Journal of Medicine.

“Our findings from this admittedly small study are, nevertheless, so promising for newly diagnosed Type 1 diabetes patients that we are now absolutely focused on pursuing a larger study for a longer period of time,” says Paresh Dandona, MD, PhD, professor and senior author on the paper.

A total of 10 patients at UB’s Clinical Research Center in the Division of Endocrinology were studied from 2020 to 2022, all of whom had been diagnosed in the past three to six months with Type 1 diabetes. The mean HbA1c level over 90 days at diagnosis was 11.7, far above the American Diabetes Association’s HbA1c recommendation of 7 or below.

The patients were treated first with a low dose of semaglutide while also taking meal-time (bolus) insulin and basal (background) insulin. As the study continued, semaglutide dosing was increased while mealtime insulin was reduced in order to avoid hypoglycaemia.

“Within three months, we were able to eliminate all of the mealtime insulin doses for all of the patients,” says Dandona, “and within six months we were able to eliminate basal insulin in 7 of the 10 patients. This was maintained until the end of the 12-month follow-up period.”

During that time, the patients’ mean HbA1c fell to 5.9 at six months and 5.7 at 12 months.

Applying Type 2 diabetes drugs to treat Type 1 diabetes

For more than a decade, Dandona has been interested in how drugs developed for Type 2 diabetes might be utilized in treating Type 1 diabetes as well.

He and his colleagues were the first to study how liraglutide, another drug for Type 2 diabetes, might work in patients with Type 1 diabetes in a study he published in 2011.

“As we extended this work, we found that a significant proportion of such diabetics still have some insulin reserve in the beta cells of their pancreas,” Dandona explains. “This reserve is most impressive at the time of diagnosis, when 50% of the capacity is still present. This allowed us to hypothesise that semaglutide, which works through stimulation of insulin secretion from the beta cell, could potentially replace mealtime insulin administration.”

From the outset, the goal of the current study was to see if semaglutide treatment could be used to replace mealtime insulin, thereby reducing the insulin dosage, improving glycaemic control, reducing the HbA1c and eliminating potentially dangerous swings in blood sugar and hypoglycaemia.

The most common side effects for patients were nausea and vomiting as well as appetite suppression, which led a number of patients to experience weight loss, an outcome that Dandona says is generally an advantage since 50% of patients with Type 1 diabetes in the US are overweight or obese.

“As we proceeded with the study, we found that even the dose of basal insulin could be reduced or eliminated altogether in a majority of these patients,” he says. “We were definitely surprised by our findings and also quite excited. If these findings are borne out in larger studies over extended follow-up periods, it could possibly be the most dramatic change in treating Type 1 diabetes since the discovery of insulin in 1921.”

Source: University at Buffalo

Studies Point to New, Better Ways to Monitor Head and Neck Cancer Recurrence

Photo by National Cancer Institute on Unsplash

Early findings of a pair of studies from the University of Michigan Rogel Cancer Center shed light on new ways to anticipate recurrence in HPV-positive head and neck cancer sooner. The papers, published in Cancer and Oral Oncology, offer clinical and technological perspectives on how to measure if recurrence is happening earlier than current blood tests allow, and provide a framework for a new, more sensitive blood test that could help in this monitoring.

“When metastatic head and neck cancer returns, it impacts their quality of life and can be disfiguring, interfering with the ability to talk, swallow, and even breathe,” said Paul Swiecicki, MD, associate medical director for the Oncology Clinical Trials Support Unit at Rogel. “As of now, there’s no test to monitor for its recurrence except watching for symptoms or potentially using a blood test which may not detect cancer until shortly before it clinically recurs.”

The paper in Cancer aims to identify different clinical ways that providers can more strategically track for recurrence. To do this, Swiecicki and his team needed to first understand what patient population was at the highest risk to then figure out an appropriate monitoring pattern.

The team examined 450 patients with metastatic head and neck cancer, including people with HPV-positive and HPV-negative cancer. HPV-positive cancer is caused by the human papillomavirus and is increasingly more common in head and neck cancer patients. The team identified some predictors of when recurrences would happen, and to what organs the recurrent cancer would most commonly spread. Patients with HPV-positive cancers were found to develop recurrent disease significantly later than those that were HPV-negative, and also were more likely to spread to the lungs. Taken together, these characteristics may help create a “surveillance” method in the future that combines routine blood testing and imaging to hopefully catch these recurrences and intervene before it’s incurable.

Swiecicki is quick to mention that, at this point, the results of this study are largely theoretical and provide a helpful framework to direct further research. That’s where the newly developed blood test, highlighted in Oral Oncology, comes into play.

Current blood biomarker tests which test for pieces of tumour-shed DNA, may not be sensitive enough to detect a recurrence significantly earlier than clinical surveillance, though several studies with multiple types of tests are ongoing. A research team, led by Muneesh Tewari, MD, PhD, Swiecicki and Chad Brenner, PhD, aimed to create a highly sensitive blood test to detect cancer even when a smaller number of DNA fragments were present, with the intention of providing a better option for detecting cancer earlier in patients.

Not only is this test more sensitive and able to detect a smaller number of DNA fragments in blood, but it’s innovative in other ways too, says first author Chandan Bhambhani, PhD: “We achieved this level of sensitivity by looking for nine different pieces of the HPV genome DNA all at once,” Bhambhani says.

Tewari says this is a step towards a more proactive approach to tackling recurrence in head and neck cancer. “As of now, we only have the tools to react to symptoms when they recur. We want to find a way to be able to detect what’s causing the symptoms much, much sooner, even before the symptoms appear.”

As a clinician, Swiecicki agrees. “It’s exciting to have the ability to potentially detect cancer before it’s incurable and offer us a window for clinical trials to see if we could intervene on cancer to help give people both a better quality of life and perhaps longer quality of life, and even convert their disease from incurable to curable. We don’t know if that’s the case yet, but this is the first tool needed for that to develop.”

Source: Michigan Medicine – University of Michigan

Microvascular Implants may Enable Faster Healing of Chronic Wounds

Photo by cottonbro studio

Researchers in South Korea have achieved a ground-breaking milestone in tissue regeneration with a technology that utilises autologous blood to produce three-dimensional microvascular implants. These implants hold immense potential for various applications requiring vascular regeneration, including the treatment of chronic wounds in conditions such as diabetes, as well as the potential for scarless healing.

Led by Professor Joo H. Kang from the Department of Biomedical Engineering at UNIST, the team successfully developed a microfluidic system capable of processing blood into an artificial tissue scaffold. Unlike previous methods based on cell-laden hydrogel patches using fat tissues or platelet-rich plasma, this innovative approach enables the creation of robust microcapillary vessel networks within skin wounds. The utilisation of autologous whole blood ensures compatibility and promotes effective wound healing.

Creating optimal stiffness

The technology, described in Advanced Materials, leverages microfluidic shear stresses to align bundled fibrin fibres along the direction of blood flow streamlines while activating platelets. This alignment and activation process results in moderate stiffness within the microenvironment – optimal conditions for facilitating endothelial cell maturation and vascularisation. When applied as patches to rodent dorsal skin wounds, these implantable vascularided engineered thrombi (IVETs) demonstrated superior wound closure rates (96.08 ± 1.58%), increased epidermis thickness, enhanced collagen deposition, hair follicle regeneration, reduced neutrophil infiltration, and accelerated wound healing through improved microvascular circulation.

Chronic wounds pose significant challenges as they often fail to heal properly over time and can lead to complications associated with diabetes and vascular diseases. In severe cases, they may result in sepsis due to insufficient oxygen supply and nutrients caused by loss of blood vessels.

By harnessing the power of microfluidic technology, Professor Kang’s team transformed autologous blood into IVETs suitable for transplantation. These IVETs were implanted into full-thickness skin wounds in experimental mice, resulting in rapid and scarless recovery of the entire damaged area. The study demonstrated successful regeneration of blood vessels within the wound site, facilitated movement of immune cells crucial for wound healing, and accelerated overall recovery.

Furthermore, the team evaluated the efficacy of IVET transplantation by infecting the skin damage area with methicillin-resistant Staphylococcus aureus (MRSA). When artificial blood clots made from autologous blood were implanted into infected mice, quick vascular recovery was observed alongside enhanced migration of proteins and immune cells to combat bacterial infection. Additionally, collagen formation and hair follicle regeneration occurred without scarring.

These ground-breaking findings pave the way for advanced techniques in tissue engineering and wound healing using autologous blood-based implants. With further development and refinement, this technology holds tremendous potential to revolutionise treatment strategies for chronic wounds while contributing to advancements in regenerative medicine.

Source: Ulsan National Institute of Science and Technology (UNIST)

Many Old People may be Unaware that They Have Glaucoma

Photo by Mari Lezhava on Unsplash

Research on 70-year-olds carried out at the University of Gothenburg, found that nearly 5% had glaucoma – with half of whom were unaware that they had the disease. The study also confirmed hereditary factors were involved in the disease and that intraocular pressure was normal in two-thirds of those newly diagnosed.

Glaucoma is a common eye disease that damages the optic nerve and thereby the field of vision and can lead to blindness. One of the most common risk factors for it is raised intraocular pressure, exceeding the normal range of 11–21mmHg.

The research, published in Acta Ophthalmologica, was carried out by Lena Havstam Johansson, a PhD student at the University of Gothenburg and a specialist nurse at Sahlgrenska University Hospital. The study shows that 4.8% of the 560 study participants examined by eye specialists had glaucoma.

“Of those who were diagnosed with glaucoma via the study, 15 people – or 2.7% of all participants – were unaware that they had the disease before being examined,” says Lena Havstam Johansson. “So half of those who turned out to have glaucoma were diagnosed because they took part in the study.”

For those who were newly diagnosed, the discovery of the disease meant they could start treatment with daily eye drops to reduce intraocular pressure, slowing the progression of optic nerve damage.

Glaucoma impacts some areas of life – but not others

People with glaucoma had similar levels of physical activity to those without the disease and did not smoke more, or drink more alcohol. They rated their overall quality of life as being just as good as others, they were not more tired or more depressed.

“This was a positive surprise, and was a finding that I hope can bring comfort to many people who have been diagnosed with glaucoma. It’s hard to live with a disease that gradually impairs vision, but life can still be good in many ways.”

By contrast, people with glaucoma reported that their vision-related quality of life was poorer.

“It’s harder to climb stairs, see curbs in the evening, and notice things in your peripheral vision. This means that people with glaucoma may avoid visiting others, or going to restaurants or parties, and instead stay at home. They lose their independence, and may feel frustrated about it.”

Ongoing study of 70-year-olds

The research was carried out as part of the H70 study, examining the health of older people, which has been conducted at the University of Gothenburg for fifty years. The H70 study continuously invites all 70-year-olds born in a certain year in Gothenburg to attend several comprehensive physical and cognitive examinations. The 1203 70-year-olds included in the glaucoma study were born in 1944. For these studies, 1182 participants answered written questions about their eye health and the presence of glaucoma in their family. Eye specialists at Sahlgrenska University Hospital also examined 560 of the participants.

The findings confirm that there are hereditary factors behind the disease, as those diagnosed with glaucoma were more likely to have a close relative with the same diagnosis. The results also confirm that glaucoma involves higher intraocular pressure, although they also show that the majority of those who were newly diagnosed (67%) still had normal eye pressure.

During the early stages of the disease, the healthy eye can compensate for the loss of vision, meaning that many people believe their vision is as good as before. These studies confirm that glaucoma often does not initially involve a loss of visual acuity, which may make it harder to detect the disease.

Source: University of Gothenburg