The plan to revive medicines regulation in South Africa

By Catherine Tomlinson

The South African Health Products Regulatory Authority (SAHPRA) is responsible for the regulation of medicines in South Africa to ensure that medicines marketed in the country are safe, effective and of good quality. In addition, SAHPRA is responsible for the regulation of medical devices, clinical trials and radiation-emitting devices.

SAHPRA replaced South Africa’s previous medicine regulatory authority, the Medicines Control Council (MCC), in February 2018 with the objective of creating an effective regulator that is responsive and publicly accountable and able to make timeous regulatory decisions. However, SAHPRA inherited many historical challenges that plagued the MCC, including slow regulatory decision times, an extensive backlog of pending regulatory applications, and a culture of non-transparency and resistance to public accountability. Since its formation, SAHPRA has developed a range of plans to overcome these challenges, which were outlined in its recent 2019/2020 annual performance plan.

Inherited challenges

At its establishment, SAHPRA inherited a massive backlog of around 16 000 medicine regulatory applications from the MCC. These include applications for “new registrations, variations, duplicates, clones, multiple doses and different dosage forms”.

While 50% of backlogged applications were submitted in the past five years, the backlogged applications date all the way back to 1992 and include applications for high priority public health products, including medicines for HIV, tuberculosis, cancer and diabetes.

The University of Western Cape’s Henry Leng and colleagues have highlighted the adoption of policies to promote generic access as key drivers of the accumulated backlog. In the early 2000s, South Africa adopted policies to fast-track the registration of medicines of high public health priority and to promote generic access. The adoption of these policies led to a large influx of applications for the registration of multiple generic versions of high priority products.

In general, the registration and availability of multiple generic versions of individual medicines is critical to improving medicine access, because competition between generic suppliers drives down prices and improves affordability. Research conducted by the United States’ medicines regulatory authority, the Food and Drug Administration, has shown that it generally takes the introduction of multiple generic products to bring down prices, as the first generic companies to enter the market tend to price their products close to the prices offered by originator companies.

While broad generic competition plays an important role in enabling medicine access, the introduction of policies to promote generic access in South Africa contributed to a regulatory backlog, as they were not coupled with an expansion of capacity at the regulator to process the influx of applications. At the same time, South Africa has struggled with “frivolous” regulatory filings by companies that fail to market their products after receiving registration. In a review of eight priority medicines, Leng et al. found that only 54% of registered generic medicines were actually marketed in the country following registration. Leng et al. suggested that the comparatively low cost of filing for registration in South Africa may encourage filings by companies without serious intentions to market their products, and cautioned that time and resources spent by the regulatory authority on fast-track approval of unmarketed products for which there are already existing alternatives, delays the registration of new products for which there is no equivalent in the country, or existing competition.

Inadequate capacity

SAHPRA has indicated that even without the large inherited backlog, the regulatory authority does not currently have the capacity to timeously process new applications. Evidence shows that while SAHPRA receives an average of 4 700 new applications annually, it is only able to process around 2 550 applications per year. With inadequate capacity to process backlogged and new applications, timelines for registration of medicines in South Africa are typically extremely long.

Research conducted by Keyter et al. demonstrated that the median time for approval of new chemical entities by the MCC was 1 161, 1 678, and 1 422 calendar days in 2015, 2016 and 2017, respectively. Keyter et al. further demonstrated that the median time for approval of fast track applications was 1 218, 921, and 609 calendar days in 2015, 2016 and 2017, respectively – far slower than the regulatory authority’s target for approval of fast-track applications in 250 days.

Slow regulatory decision times in South Africa have serious public health consequences, as they impede access to important and life-saving medicines, as well as cheaper generic versions of medicines, long after they are available on the global market. Recognising this challenge, SAHPRA has set a target to reduce regulatory decision times to 275 working days for new chemical entities and 180 days for registration of generic products. SAHPRA has also set a target to clear the regulatory backlog in two years.

The recently released annual performance plan outlines SAHPRA’s plans to “re-engineer” the regulatory authority to achieve its targets. Its plans include (among other interventions) the strengthening of its human resource capacity, the introduction of a new fees model and the digitisation of key processes.

SAHPRA’s strategy to address the medicine regulatory backlog

SAHPRA has set a target to clear the regulatory backlog in two years – but notes that, at current capacity with no new applications, clearing the backlog will take up to eight years. SAHPRA’s annual performance plan clarifies that the regulator has developed a costed strategy to clear the backlog and has secured ring-fenced funding for the backlog clearance strategy from the government, development partners and donors.

SAHPRA’s strategy to reduce the backlog involves three key elements, including reducing the number of backlogged applications to remove applications that are no longer relevant, prioritising the remaining applications for review according to public health needs and risk, and implementing new regulatory pathways to reduce regulatory decision times.

Given that the regulatory backlog dates back to 1992, it is expected that some applications may no longer be of commercial interest to applicants or of public health relevance. SAHPRA will seek to remove applications that are no longer relevant through requiring applicants who submitted applications in 2013 or earlier to indicate that they would still like their applications to undergo review through a survey template and requiring all applicants to update their applications to meet current requirements. SAHPRA has already begun to implement this and noted in a May 2019 communication that 3 000 applications in the backlog have already been deemed to be withdrawn. Moving forward, SAHPRA has indicated that it will prioritise the remaining backlogged applications for review according to public health risk and need. Public health need will be based on the government’s priority therapeutic areas and unmet medical need, and public health risk will be based on the complexity and type of application and “level of prior scrutiny by recognised regulators”.

In addition to reducing the number of applications and prioritising applications for review according to public health need and risk, SAHPRA has committed to implementing “new evaluation models” to clear the backlog, as well as to facilitate timeous registration of new applications. This strategy will involve the implementation of so-called reliance pathways to facilitate greater collaboration and information sharing with other regulatory authorities.

Reliance pathways provide mechanisms for collaboration across global regulatory agencies, and with the World Health Organisation, by creating pathways that allow regulators to access and use data and reports, and rely on other evaluator decisions, in domestic regulatory decision making. Reliance pathways provide important mechanisms to reduce times to regulatory decision making when capacity challenges impede timeous local decision making. Medicine regulators in both developing and developed countries struggle to manage their workloads and make timeous regulatory decisions due to increasing application volumes, and the need to monitor the compliance of foreign producers to good manufacturing practices (GMP).

Historically, South Africa’s medicine regulators (the MCC and SAHPRA) have not utilised reliance pathways – despite arrangements and collaborations in place with other regulatory bodies to facilitate their use – and selected instead to conduct full scientific reviews of quality, efficacy and safety data for all regulatory applications. However, SAHPRA has now committed to operationalising these pathways to address the backlog and reduce regulatory decision times for new applications. SAHPRA has further indicated that it will formalise processes to facilitate the use of several different reliance pathway models, including full review, abridged review, verified review, recognition and notification – each requiring different levels of local review and evaluation.

Implementation of the “abridged review” model, for example, would allow SAHPRA to rely on regulatory data and evaluations from other agencies (such as the European Medicines Agency), while requiring local review and evaluation of domestic contextual issues – such as the interaction of the medicine under review with HIV treatment.

Building SAHPRA’s human capacity

A further challenge faced at SAHPRA is its limited human resource capacity to effectively fulfil its mandate. According to information provided to Spotlight by SAHPRA’s CEO Portia Nkambule in November 2018, SAHPRA then had 178 full-time employees and around a similar number of external evaluators supporting regulatory activities. SAHPRA is seeking to significantly increase its staff capacity to around 450 full-time staff over the next five years and has already initiated a hiring drive, advertising more than 100 new posts in May 2019. SAHPRA has further indicated that staff members were recently transferred from the National Department of Health’s Pharmaceutical Trade and Product Regulation programme to SAHPRA under a section 197 transfer agreement and, according to SAHPRA’s annual performance plan, the transferred staff will support core programmes responsible for medicines evaluation and registration and authorisation management.

While SAHPRA is seeking to strengthen staff capacity in all of its programmes, the 100 recently advertised posts included 17 new posts for medicines regulation and 19 posts for the backlog clearance project. A key goal of SAHPRA is to build its internal capacity to fulfil its medicines regulatory functions, unlike the MCC which relied heavily on external evaluators. SAHPRA’s annual performance plan explains that its reliance on a “dwindling” number of external evaluators creates difficulties in managing and optimising regulatory decision times due to the lack of contractual performance agreements with external evaluators. The annual performance plan clarifies that while SAHPRA hopes to absorb some external evaluators as internal staff, it will also seek to build its internal capacity through upskilling existing staff and recruiting new staff – but notes challenges in attracting and recruiting new internal evaluators.

SAHPRA did not respond to requests for more information on the difficulties it is facing in recruiting new internal evaluators. However, recruiting challenges faced by SAHPRA may include challenges identified by regulatory authorities in other jurisdictions – such as shortages of required skills in the domestic labour market and difficulties in competing with higher salaries offered by the industry.

Opportunities and challenges for public engagement

SAHPRA has taken significant and commendable steps since its establishment in February 2018 in outlining reform plans and processes to improve its functioning to effectively fulfil its mandate. In addition to the adoption and initiation of a strategy to address the regulatory backlog and its efforts to build its staffing capacity, SAHPRA has developed plans to digitise key processes and implement a new fees model (among other interventions). These steps have been taken despite significant challenges faced by the new regulatory agency in its first year of operations, including staff protests and the closure of its offices in the Civitas building due to unsafe working conditions.

While SAHPRA should be commended for its important work to date, responsiveness to the public and accountability remains a challenge despite the regulators commitments to improving and demonstrating transparency and accountability. Health NGOs in South Africa continue to express frustration due to the non-responsiveness of the regulator following requests for information and engagement. Additionally, despite questions Spotlight sent SAHPRA for this article, no responses were received.

In December 2018, SAHPRA CEO Nkambule noted that the regulatory authority was seeking to create a culture of transparency and that in the current transitional phase it would prioritise the implementation of a formal communications strategy and systems. SAHPRA’s annual performance plan notes that a communications strategy has been drafted and has been approved to be implemented during 2019. The plan further adds that through implementing the communications strategy, SAHPRA will endeavour to (among other goals) “develop mechanisms to allow all stakeholders to communicate easily with the regulator including being able to lodge queries and complaints”.

Beyond the implementation of a communications strategy, the Minister of Health should introduce legislative reforms to require greater transparency and accountability from SAHPRA. Vawda and Gray recently undertook a review of secrecy provisions contained in section 34 of the Medicines and Related Substances Act No 101 of 1965 and concluded that section 34 “violates the right to access to information in section 32 of the Constitution of SA”. They added that section 34 “appears to grant the MCC/SAHPRA unfettered authority to refuse access to information, except on limited grounds, based on its sole discretion”. Vawda and Gray recommended the amendment of section 34 to accommodate the right to access to information and added that the regulatory reform processes underway “provides an opportunity to redress a serious anomaly in our regulatory framework, and to align it with our constitutional paradigm, in order to reflect greater openness, transparency and accountability in our public institutions”.

As SAHPRA moves forward with the development and implementation of plans to re-engineer the authority, there is significant scope for civil society to monitor developments to demand meaningful transparency and accountability from the regulator (including necessary regulatory reforms) and ensure that the development and implementation of reforms serve the public interest.

 

 

 

Health DG welcomes new guide to National Health Act

By MALEBONA PRECIOUS MATSOSO

SECTION27 recently published the third edition of its National Health Act Guide. South Africa’s Director General of Health MALEBONA PRECIOUS MATSOSO wrote a foreword for the guide – which we have reproduced below. The full guide can be downloaded here.  

Foreword

Government has a huge responsibility to provide health care services and to regulate the private sector, but it cannot operate alone. Civil society and individuals must speak up and government must listen, to ensure that we have a health care system that serves all the people of South Africa.

At a time of great policy shifts and a struggling health care system, which is both public and private, I welcome the publication of the third edition of The National Health Act Guide. I encourage everyone with an interest in health to use the Guide and to become an activist for positive change in our health care system. This publication must be on every policy maker’s table, on every manager’s desk, in every health worker’s pocket, and in every student’s bag. 

 MALEBONA PRECIOUS MATSOSO is the Director-General of the National Department of Health. This foreword was written in March 2019.

 

Assessing the Motsoaledi years

Dr Aaron Motsoaledi became South Africa’s Minister of Health 10 years ago, in

Former SA Minister of Health, Dr Aaron Motsoaledi.
Photo: David Harrison

May 2009. For most of the past decade, Motsoaledi and the Director-General of Health Malebona Precious Matsoso (appointed in 2010) have been tasked with ensuring people in South Africa have access to quality healthcare services. This week the Motsoaledi era came to an end with the appointment of Dr Zweli Mkhize as South Africa’s new Minister of Health. It is not known whether Matsoso will stay on.

The Motsoaledi years can broadly be judged on two fronts: The response to the HIV epidemic and the functioning of the public healthcare system and its related institutions. The verdicts in these two instances are quite different.

Turning the page on Aids denialism

Until September 2008 Thabo Mbeki was President of South Africa and Manto Tshabalala-Msimang Minister of Health. The Mbeki and Tshabalala-Msimang years were years of state-sponsored Aids denialism. The details of those terrible years will not be recounted here, except to say that South Africa needed to make a clean break from it. That clean break started with the appointment of Barbara Hogan as Minister of Health in September 2008.

Building on years of resistance and the hard work of many principled activists, lawyers, healthcare workers, and some politicians, Hogan spoke clearly about HIV and Aids and ended the policy madness of the Mbeki and Manto years. Hogan was in the position for only eight months before she was replaced by Motsoaledi.

Arguably the biggest job facing Motsoaledi when he took office in May 2009 was to accelerate the provision of antiretroviral treatment. Motsoaledi had some credibility owing to his time in the Limpopo provincial government and the fact that he is a medical doctor. He was also energetic, passionate and outspoken. All of this made him a great figurehead for the establishment of the world’s biggest antiretroviral treatment programme.

The numbers are worth looking at carefully. In 1994 an estimated 15,000 people died of Aids in South Africa. Deaths increased rapidly during the worst years of Aids denialism to a peak of around 273,000 in 2005. When Motsoaledi took office in 2009, Aids deaths had already dropped somewhat from the 2005 peak to around 195,000. By 2017 (eight years into Motsoaledi’s time in office) it had dropped much further to around 89,000. (In 2019 it is estimated at around 80,000 — but it is better to emphasise the 2017 figures given that they are more reliable.)

The decrease in Aids deaths over the past decade is particularly impressive given that the absolute number of people living with HIV has been increasing over the same time period. People are still contracting HIV, but antiretroviral treatment has clearly kept hundreds of thousands, or even a few million, people alive who would otherwise be dead by now. When Motsoaledi took office in 2009 about 792,000 people were receiving antiretroviral treatment. Today that number is estimated to be more than 4.7 million.

Important context to the Motsoaledi years is also to be found in changes in life expectancy. In 1994 life expectancy at birth was about 63.1. In 2017 it is estimated to have been about 65.2 (about 66 in 2019). The increase over the 1994 level is thus marginal and does not suggest massive improvements in public healthcare in the post-apartheid era. Between 1994 and now, however, things first got very bad and then better again.

Life expectancy declined to an incredibly low 53.8 in 2004, driven mostly by Aids deaths. As with Aids deaths, the recovery in life expectancy was already underway when Motsoaledi was appointed in 2009 (with life expectancy having risen to around 58.3 by then).

Either way, the increases in life expectancy in the Motsoaledi years are better thought of as a recovery from the specific disaster of Aids denialism than a general improvement in the quality of healthcare services.

Ultimately, the HIV epidemic would probably have been bad no matter what, but government intransigence in the early 2000s undoubtedly made it much, much worse than it would have been otherwise. Similarly, while things had already started to turn by the time Motsoaledi was appointed in 2009, he used what positive momentum there was to accelerate the provision of treatment, saving many, many lives in the process. For this, he deserves immense credit.

But what happened to the healthcare system?

If Motsoaledi took the baton from Hogan regarding HIV, he seems to have dropped the baton when it came to the healthcare system. In her short stint as Health Minister Hogan commissioned a series of reports into the public healthcare system in various problems. These so-called Integrated Support Team reports still stand as some of the best diagnoses of the problems in our public healthcare system. Ten years later, it seems these reports are still gathering dust and most of the problems they identify remain or have become worse.

Generalising about the public healthcare system is not always fair. There is significant variation between provinces, between districts and between individual facilities. There are undoubtedly many qualified and committed people out there putting in the hours for the communities they serve. But there are also persistent reports of under-staffing, long waiting times, patients sleeping on the floor and worse.

While much information is anecdotal, and while the media tends to focus on some of the worst cases, there are objective reasons to be very worried. So, for example, it is hard to argue against the deeply depressing picture painted by the reports of the office of Health Standards Compliance.

It is also hard to look at tragedies such as Life Esidimeni in Gauteng, the oncology crisis in KwaZulu-Natal, and the persistent problems with emergency medical services in multiple provinces without concluding that these are symptoms of deep-seated dysfunction in provincial health departments. The president himself talks of a “crisis”.

There was a sense in the Motsoaledi years that there was always a new crisis, always a new fire to put out, and that there was just never enough capacity in the National Department to deal with it all. Often short-term interventions were found.

After our Death and Dying report exposed serious problems in the Eastern Cape healthcare system in 2014, the Minister moved swiftly to intervene. Emergency plans were made and announced at a press conference. But then the Minister and the media moved on and things slowly reverted to the way they were.

After the PharmaGate scandal of 2014, Motsoaledi made headlines by describing the pharmaceutical industry plot to derail law reform efforts in South Africa as “genocide”, but strident as his public statements were at the time, he never used his powers to issue a compulsory licence on an overpriced medicine, nor did he expend much political capital on reform of South Africa’s outdated patent laws.

Similarly, while Motsoaledi was an outspoken critic of the private healthcare sector in South Africa, the draft report of the Competition Commission’s Health Market Inquiry leaves little doubt that he failed to use the levers he had at his disposal to regulate the private sector.

How to make sense of all this?

One version of the past 10 years would see Motsoaledi as a victim of the politics of State Capture. As good as his intentions may have been, unruly provincial health departments, often beset with corruption, made it impossible for him to implement.

For example, various Free State MECs for Health and the head of the Provincial Health Department were essentially untouchable, given that they were protected by Ace Magashule, Free State Premier for much of the Motsoaledi years. It could be argued that if Motsoaledi stuck his head out too far, Zuma would have fired him, and that he was therefore justified in playing the long game, much like Ramaphosa. There is definitely something to this excuse, but it only takes you so far.

As an aside, while Motsoaledi, like Ramaphosa, could and should arguably have done more to arrest the institutionalisation of corruption in the state, it is important to recognise that he was one of a small number of ministers who stood up against former President Jacob Zuma when the political crunch came in 2017. He was brave and right to do this and, quite apart from what he may or may not have done in healthcare, deserves credit for it.

A second version of the last 10 years would hold Motsoaledi and those close to him at the National Department responsible for much of the systemic failures in the healthcare system. It could be argued that the National Health Act gives the Minister much greater powers to interfere in provinces than Motsoaledi was ever willing to use. It could also be argued that what influence he did have in provinces, was not always used particularly well.

For example, the National Department of Health has relative control over the HIV conditional grant (having to approve business plans submitted by provinces), yet the grant was grossly misused in the North West to pay a private ambulance company. In addition, rather than allowing dysfunction in provinces to be exposed, Motsoaledi’s instinct was often to spin his way out of it — take the specific problem seriously, deny that it is systemic, protect your ANC comrades in the provinces.

While unruly provinces are one thing, there are various national level processes and institutions that Motsoaledi had significant influence over in his decade in office. Today the Special Investigating Unit (SIU) is looking into alleged corruption at the Health Professions Council, the National Health Laboratory Service and the ongoing problem of fraudulent medico-legal claims against the state.

Motsoaledi both supported the appointment of persons now suspected of corruption and failed to intervene effectively when the extent of some of these problems became apparent. That the SIU has now been asked to mop up, does not reflect well on Motsoaledi’s leadership – although the politicised Hawks and National Prosecuting Authority did not make things easy for him.

Some critically important policies were allowed to expire, such as the Human Resources for Health Policy in 2017, which has not yet been replaced. The need for a single electronic health records system for the public healthcare system has been a priority for years, but progress has been painfully slow. National Health Insurance has been on the cards for ages, but when a draft bill was published in 2018 it was half-baked and lacked clarity in various key areas, such as the role of provinces.

State Capture or unruly provinces cannot be blamed for these policy and leadership failings. Something else has clearly gone wrong.

Even so, while the healthcare system and many of the institutions meant to support it have struggled in the Motsoaledi years, these failings are arguably outweighed by the tremendous growth of the HIV treatment programme and the many lives that have been saved through this programme. The numbers do not lie.

In the final analysis then, Motsoaledi is likely to be remembered primarily as the minister who definitively closed the book on Aids denialism and made sure that millions of people living with HIV received life-saving antiretroviral therapy.

Note: Figures quoted in this article are taken from the Thembisa model outputs version 4.1.

 

 

 

Our health system: Babies are the “canaries in the mine”

Nineteen years ago Dr Glenda Gray, a young paediatrician based at the Chris Hani Baragwanath hospital’s then Perinatal HIV Research Unit, joined a picket at the hospital gates organised by the Treatment Action Campaign (TAC). The demonstration was to call on the government to provide the drug AZT for pregnant women with HIV to protect their babies from infection. It was March 1999 and we were months before an election. Gray called on women to be at the forefront of TAC’s campaign and famously shouted out “No AZT, No Vote!”

The TAC’s campaign was eventually successful. Now, almost all pregnant women with HIV have access to ARVs and fewer than 1.2% of infants are born with HIV every year. That’s only 3,000 babies – down from 40,000 in 2005. As a result HIV is no longer the leading cause of under-5 mortality.

But while we may be protecting babies from HIV at birth, neonates face another risk: severe perinatal injury or death during the birthing process. It is a horrible fact that up to 8,000 neonates a year lose their lives, primarily as a result of avoidable medical or administrative errors. Although this is less than 2% of total births — it accounts for 27% of under-5 mortality — the personal cost to families and the financial cost to the health system is enormous.

Today, Glenda Gray is President of the Medical Research Council (MRC). In a speech on Steve Biko day she likened babies who die at birth to the canaries that were once carried into coal mines as a way of detecting fatal gases. If the canary died, miners did their best to get the hell out — in other words they knew something was very wrong. Babies, according to Gray, are like the canaries of our health system.

Babies die in unacceptably high numbers because they are born at the confluence of several of the major problems that blight our health system: Human resource shortages accompanied often by a lack of basic training, medicine and equipment stock-outs, poor infection control and the lack of emergency transport, especially in rural areas. The triennial Saving Babies report (2014-2016) (which is not online) catalogues the causes of their deaths. It makes sad reading. For example, among what it terms the “personnel associated avoidable factors” are listed:

  • Delay in referring patient for secondary/tertiary treatment (2,118 records);

  • Nosocomial infection (1,101 records); and

  • Neonatal care: Management plan inadequate (795 records).

Among “administrative avoidable factors” are:

  • Inadequate facilities/equipment in neonatal unit/nursery (1,567 cases);

  • Lack of transport institution-to-institution (885 cases); and

  • No accessible neonatal ICU bed with ventilator (949 records).

Not listed are the “avoidable political factors” — MECs and former MECs who don’t care, among others Qedani Mahlangu, Brian Hlongwa, Peggy Nkonyeni, Benny Malakoane, Phophi Ramathuba and Sibongile Manana.

If our hospitals were mines they would be declared unsafe. Unfortunately, though, our canary-babies and their mothers can’t choose not to go into the mine.

From a health system that kills to a health system that heals

In the face of facts like these there is no longer any dispute that our public health system is haemorrhaging uncontrollably. Even President Cyril Ramaphosa admits it. The greatest tragedy, though, is that when it comes to the cause of the health’s system sickness we have the diagnosis, we have the knowledge, we even have the resources. We also have a mountain of barely considered expert reports suggesting solutions. But we don’t seem to have an algorithm between the problem and the solution.

Consequently, our health system is caught in a vicious circle, where each component of crisis has a knock-on effect on to another, and so on. The chain of disorder created by corruption is just one example:

  • Corruption in the health system robs us of billions of rand in resources which means we don’t fund critical posts.
  • At worst the shortage of nurses and doctors leads to high rates of peri-natal mortality and other harm; at best to poor health outcomes and pervasive inefficiency.

  • Then, death and disability at the hands of the health system leads to rising medico-legal costs which once more divert money from frontline health care. By 2017, according to the audited reports of provincial health departments, R51-billion was listed as contingent liabilities for medico-legal claims — that’s almost a third of the national health budget. And, to add insult to injury, in 2017 provinces spent nearly R1-billion on legal fees — more than the R820-million the government cut this year from hospital infrastructure maintenance and upgrades.

Medico-legal claims as at 31 March 2017

Total medico-legal claims (contingent liabilities)

% of annual budget

Amount spent on legal services

% of annual budget

Eastern Cape

R16,658,078,000

81.2%

R131,269,000

0.6%

Free State

R1,505,184,000

16.6%

R54,000

0.0%

Gauteng

R18,614,087,000

49.7%

R748,165,000

2.0%

KwaZulu-Natal

R9,230,309,000

24.9%

R34,843,000

0.1%

Limpopo

R2,115,529,000

12.3%

R20,168,000

0.1%

Mpumalanga

R547,469,852

5.2%

R0

0.0%

Northern Cape

R1,252,269,000

28.7%

R5,340,000

0.1%

North West

R1,285,126,000

13.2%

R31,886,000

0.3%

Western Cape

R32,040,000

0.2%

R22,168,000

0.1%

TOTAL RSA

R51,240,091,852

30.9%

R993,893,000

0.6%

  • Exacerbating this is extremely poor management and a high level of political interference in operations. This stifles initiative, causes a lack of accountability and demoralises health care providers.

  • Poor management and demoralisation causes us to lose lives and health workers and thus the cycle of corruption starts all over again.

It’s a perfect storm. We couldn’t have made a bigger mess even if we had held a health summit to try. Somehow we have to break this cycle. Where should we be starting?

Not another summit

Like other societal haemorrhages this weekend health will have its very own summit. I mean no disrespect to President Ramaphosa, but unfortunately, one has to doubt whether a summit will staunch anything (there will be a Presidential Health Summit on Friday and Saturday). It is bound to be another dither-fest.

As I have said, health workers have answers and interventions that will work. What they don’t have is leadership and permission to fix the system. They don’t have decisiveness. And it’s unlikely that another mass summit will provide that.

So where should we start?

Understandably we tend to fixate on what’s bad. My advice to President Ramaphosa would be: this time, start by identifying what’s good, what works and who works in our health system; affirm and consolidate it, and then build outwards. If you adopt this approach you may be surprised to discover, although it’s not often in the news, that there is a lot of residual capability and potential in public health.

Here are some pluses to work with:

  • We have a strong legislative and policy framework. Frankly, although Minister Motsoaledi presents the National Health Insurance Bill as a panacea, legislative change is not the place where we need to tinker at this point. Drop the Bill for now. It’s ill conceived, impossible to implement and will become a distraction.
  • Although our human resources base is severely overstretched and demoralised, we still have more health professionals than other developing countries have. We also have a small legion of community health workers and clinical associates who are desperate to be integrated properly into the system. If the policy logjam could be solved and there was more bravery and far-sightedness about budgeting for higher health returns, we could get better results — quickly.

  • The private health sector might be considered a bane to public health. But it’s also an asset. It has a precious infrastructure, resources and expertise. As recommended by Justice Sandile Ngcobo and the panel that conducted the private Health Market Inquiry (HMI), its services and management capability can be better integrated with public objectives to fill obvious holes in public services (like oncology) and with quick results.
  • We have the best research and surveillance capacity of any country in Africa, and in some respects the world; we have strong universities and teaching institutions; we have world-class institutions like the National Health Laboratory Services, whose ability to go to a massive scale in response to HIV and TB, has prepared them for almost any challenge.

  • Finally there’s a community of activist health professionals that wants to get it right and an active and engaged civil society that, as the response to AIDS has shown, is capable of mobilising behind a genuine plan to fix the health system.

But where’s the plan? Where’s the leadership?

Saving babies as a key to saving the health system

That question brings us back to our canary babies.

One of the first things we need is hope and self-belief. Our world-class ARV roll-out campaign has taught us that the best way to fix is by doing. Less talk and more mobilisation for targets and tangible outcomes.

There are nearly a million births a year in SA… a campaign that aims at saving babies and simultaneously improving the quality of care for their mothers would require us to zoom in on the health system at critical interfaces. It would focus us and we would be forced to target resources at a key place of delivery. Actually, saving babies would raise the morale of users and health workers.

If funding to implement such a plan is a problem, then we should rescue some the billions of rand that are siphoned out of the health system through theft.The money “saved” from corruption should be returned immediately to the coal face. And while we are at it could we please have an anti-corruption task force for health in the Hawks?

If expensive neo-natal ICU equipment is a problem, almost every doctor you talk to will tell you about the huge wastage in supply and procurement systems.

When it comes to human resources the problem is as much one of morale and scopes of practice as it is of staff shortages. If we fix the first two we buy time for the latter. For example, the Saving Babies report emphatically states:

“Evidence and experience amply demonstrate that community health workers in sufficient density can have a rapid and positive impact on neonatal and young child mortality, especially when allowed to treat common acute conditions.”

For God’s sake act on the evidence then!

Recently President Ramaphosa committed to “immediately fill 2,200 critical medical posts, including nurses and interns”. Please tell us which posts and when and where? This is a welcome stop-gap but it needs to be accompanied by a presidential instruction and time frame to the national departments of Health and Treasury to finalise the human resources for the health plan.

Human resource policy is one area where there is lots of unfinished business: If it was finished and properly implemented, it might quickly make a difference to service delivery. Take the issue of community health workers and clinical associates, where there has been policy stagnation for a decade. Community health workers, properly employed, trained and supervised as recommended by the World Health Organisation High Level Commission Health Employment and Economic Growth could make a huge difference to health outcomes.

Finally, as pointed out by the Health Market Inquiry, although our public hospitals are at bursting point, our private ones have space. Negotiate an agreement to use this space!

The measures suggested above are aimed at saving lives through treatment and care. However, as soon as possible we need to turn off the tap of non-communicable disease that is already overwhelming every level of the health system with preventable and costly disease.

There is a road to health, but to get on to it we need to do things very differently. A summit may be a start. Hopefully it will forge a new consensus. Hopefully people will leave their egos and political and election agendas outside the room and instead focus on what the Constitution demands we do to realise everyone’s right of access to health care services.

But President Ramaphosa, this is a war, the dead and injured are piling up, your generals have failed miserably. Ultimately winning this war needs a plan, a budget and a war room answerable only to the Commander-in-Chief.

But hey, who cares?

(Names have been anonymised in this article to protect the doctor, not the officials. They know who they are.)

Once upon a time and not so long ago our politicians and senior public servants cared about the lives of other people. They cared about the loss of life. They took personal risks to prevent it. They went to prison. They went to exile. They risked their own security and comfort.

That was once-upon-a-time.

That was history.

The loss of ethics, urgency and empathy is at the heart of our national malaise. We no longer care about lives, other than our own. In that spirit let me tell you a story of something that happened in the week we all celebrated Nelson Mandela’s 100th birthday.

Thursday 19 July 2018. Out of the blue, at precisely 13.15 I received a message from a doctor I do not know at a hospital in XXX. It read:

“I am a XXXX at XXXX. I have that awful situation where I have a baby who needs ICU care and there are no beds in the state hospitals. That state does not buy out beds…”

Nine minutes later, fighting my own sense of resignation, I responded and quickly found out that the baby was critically ill and “looking worse by the minute”. The doctor said she was “trying to do a desperate call round to hospitals on my cell” but that none of them had pediatric ICU beds available.

SECTION27 is an organisation that uses the law to protect and advance human rights: this includes human life. The Constitution says “no one may be refused emergency medical treatment” and that we must always act in “the best interests of the child”. But faced with a premature baby with respiratory distress the law was useless. Even an urgent court application to compel the Provincial government to open up an ICU bed would have taken hours. That would have been too late for Baby A.

She would have been dead Baby A, like other neonates that die every year because of deficiencies in the public health system.

I have an advantage. I know many senior officials in the Department of Health and also have many of their phone numbers. So I started my own round of phone calls. In my head somewhere I could hear the promise politicians had made during the Life Esidimeni Arbitration about “never again” and being “always available” on their cellphones.

First I tried the MEC for Health in XXX Province. His phone was answered by his assistant. I explained the purpose of my call and begged him to put me through to the MEC. He declined. The MEC was, he said, “in a meeting for at least another hour”.

He said I should call the Head of Ministry, Mr XYZ and gave me his number. I called. No answer. Instead I got one of those phone-generated “Sorry, I can’t talk right now”. I replied:

“It’s very urgent. Mark Heywood from SECTION27. I was advised to call you. It concerns a critically ill baby at XXXX. No ICU bed. Please call me Mr XYZ.”

But Mr XYZ’s probably doubles up as an ANC office bearer. It was a weekend of high drama in that Province’s intra-ANC politics. His meeting too was far too important for that. He replied with a message:

“Please call Mrs ABC the district manager to assist arranging the bed, I will also send her an SMS now.”

The clock was ticking. I sent another message to the MEC’s phone:

“I am trying to call you about a life and death matter. Was referred to your head of Ministry. He is not answering the phone.”

But medical doctor MEC’s meeting was too important by far for matters of life and death. He didn’t respond. Meetings trump the Hippocratic Oath if you are a politician.

That was the last I didn’t hear from him.

So I called ABC fighting a strong sense of déjà vu about the type of response I would encounter. At least she answered the phone. But I was right. She was mostly concerned about following protocol.

“Had the doctor spoken to the medical manager?” she asked. “Had the doctor spoken to the CEO?”

I explained that I didn’t know; the minutes were passing by and the baby was critically ill. I promised Mrs ABC that I would call the doctor and ask her. That was the end of Mrs ABC. A little later I sent her an SMS answering her questions: “The doctor has spoken to the medical manager and CEO. Don’t have authority.” But that didn’t generate a response.

Maybe she too had a meeting.

Feeling the doctor’s desperation, having hit a literal soon-to-be really dead, dead end, I tried another strategy. I called one of the CEOs of a major medical aid scheme. It was 13.31. Initially his phone too generated a “Can I Call you later?”

I replied:

“It’s urgent. I’m trying to see if I can get help getting a bed for a prem baby in XXX. XXXX hospital has no ICU bed. Desperate doctor trying to get help.”

He called me back within a minute.

I had asked the doctor if there were any private hospitals nearby. She said there were. So I asked him if he would ask a CEO of a private hospital group whether he would arrange to transport the baby to a nearby hospital and admit the baby there. For free. He agreed to ask. A few minutes after that the private hospital group CEO called. I told him what little I knew about the baby and the doctor and gave him the doctor’s number.

The next I heard from him was at 2.13pm:

“Hi, we will accept the baby and are just finding a bed and a pediatrician and will organize ICU ambo transfer.”

Two hours later the baby had been transferred, incubated and was out of danger. A little life had been saved. Two parents had been spared an agony that I know from personal experience. It lasts a life time. The doctor was soon being asked questions by her higher ups and asked to explain why she had sought outside help. Now there was a sense of urgency! It seems the department’s lethargy doesn’t extend to paper-work and protecting your own skin.

This all took place a day after we celebrated Madiba’s 100th birthday. Doctor DoGood lived his legacy. But what of those party apparatchiks and deployees who claim to act in his name? The less said the better, for their inaction would disturb Madiba’s peaceful soul.

And what is the moral of the story?

It is that the weakest among us suffer from the “who cares?” attitude of the post-Mandela politician, and it is the vulnerable who need health care who seem most frequently to be their victims.

It was not long ago that Mosebenzi Zwane, before he became more infamous, needed a patient to be kicked out of an ICU bed at Dihlabeng hospital in the Free State so that his relative could be put in the same bed.

It was only six months ago that Justice Dikgang Moseneke called the Gauteng government “delinquent” for their treatment of the Life Esidimeni victims and found its officials guilty of “torture” as well as “cruel, inhuman and degrading treatment.”

But, who cares? Nobody has been punished. Zwane’s still an MP. Despite appearing before the ANC’s Integrity Commission former Health MEC, Qedani Mahlangu, continues to enjoy the high life of a senior member of her political party.

Who cares? Baby A lives because of the choice of one good doctor to go out of her way to save his life. But that is not the end of the story because many other children continue to be at risk. One of the last messages I received that day read:

“The baby is just the tip of the iceberg. Cubicle one. We have three ICU and three High Care babies with 2 nurses. Should be 5-6. Cubicle 2. 8 HC babies 2 nurses. Should be 4. A packed low care …”

But hey, who cares?

If you are a politician or public servant please ask yourself a question: do you?

 

Life Esidimeni: One year after the arbitration

One year ago, Shaniece Machpelah, whose mother Virgina had tragically passed away in the Life Esidimeni tragedy died of a broken heart. She was only 21. Ironically, on the same day the Life Esidimeni arbitration started, the first step towards the heartbroken families’ attempts to find answers and hopefully some closure. The powerful outcome of the arbitration and the progressive steps taken this year are as much a tribute to the mental health care users, Shaniece and the families’ tireless work. The state also deserves acknowledgement for all the work they have done. However, it would be remiss not to point out that much more still needs to be done.

In a culture that thrives on amnesia, moving from one tragedy to the next based on the latest media frenzy, forgetting past tragedies has become the norm. For most, they are remembered only briefly, brought up on special occasions such as anniversaries. Examples abound, with Marikana being a recent example. That said, however, it is worth reflecting when these days come around, remembering that today marks a year since the Life Esidimeni arbitration started, led with such dignity by retired Deputy Chief Justice Dikgang Moseneke. The arbitration showed the tragic and devastating consequences that come with shockingly and murderously bad leadership making unethical decisions that led to people dying. It is “leadership” that saw people being lined up and loaded onto open trucks like cattle. It is leadership that saw family members searching for their loved ones only to find their dead composing bodies in makeshift mortuaries. It is leadership that saw an elderly father searching for his son for months only to find him traumatized and starving. At least 144 people, also referred to as mental health care users (MCHU) perished, a further 1 418 surviving MCHUs were inimically affected and the hearts of countless families and friends were broken in the process. Under the chairing of Justice Moseneke, the arbitration saw 60 witnesses provide the arbitration with testimony. Included in those were twelve senior government officials, including the Gauteng Premier David Makhura, the Minister of Health Dr Aaron Motsoaledi, the Member of the Executive Council (MEC) for Finance Barbara Creecy, the Gauteng MEC for Health Gwen Ramokgopa and former MEC for Health Qedani Mahlangu.

The arbitration hearings were traumatic, but also illuminating in several ways. It illustrated the complex ways in which actors working for the state operate. It showed the heavy top-down approach employed in the Gauteng Department of Health (GDoH) through testimony on Mahlangu’s leadership in particular and the fear associated with it. This was juxtaposed by the testimony of Levy Mosenogi’s, the head of the Life Esidimeni Marathon Project, which showed remorse, while Barbara Creecy and Aaron Motsoaledi’s testimony showed how a caring and competent state ought to look.

What is clear about the Life Esidimeni arbitration is that it would not have taken place without the active participation of state employees who acknowledged the culpability of some of their colleagues. The state has also carried out Justice Moseneke’s Award timeously, paying settlements, drafting a recovery plan and providing families with access to trained mental health care professionals, among other things. They should be commended for that. The wheels of justice have certainly moved faster than in other needless and senseless tragedies, such as Marikana and the Aquarius K5 mine in Sondela. However, sadly, criminal prosecutions have not yet taken place.

Over 11 months since Dorothy Franks admitted during her testimony to receiving R1 500 in monthly SASSA grant payments for 29 patients assigned to her, which  amounted to R43, 500 each month, she continues to live her life as a free woman, unrestrained by criminal procedures against her. Franks also admitted that she continued to receive funds for former patients who had long since perished at Anchor House, the NGO she ran in Pretoria. Furthermore, Franks also admitted during her testimony to receiving R600 000 from the state after her NGO was forced to close, a princely sum she could have refused. History will judge her harshly for her role.

A year after the Life Esidimeni arbitration started, Mahlangu, one of the three people who Health Ombud Prof Makgoba argued had “their fingerprints peppered throughout the project” still has not been criminally prosecuted. To add salt to the festering wound, she stood and was re-elected into the Provincial Executive Council of the Gauteng African National Congress, to the chagrin of families of mental health care users. While she has appeared before the party’s integrity commission (we still await their ruling), much more needs to be done. This is not what justice looks like and does not measure up to what the Makhura and many others have tried to bring to the fore, namely an ethical political party that takes the concerns of its people seriously.

While the National Prosecuting Authority (NPA) is likely working around the clock on bringing this important national matter to a successful resolution, the problem is that in this beautiful land, with its complex dynamics, retraumatisation is a real possibility. Stories abound about those who suffered at the hands of powerful people, seeing them while out in the streets of one town or another. With other central figures such as Dr Makgabo Manamela and Dr Barney Selebano also having managed to evade the long arm of the law so far, the prospect of families bumping into them increases with each passing day.

A speedy resolution to complaints brought to the Health Professions Council and the South African Nursing Council would also go a long way in providing accountability and a greater sense of justice for families.

While families have had some form of justice through Justice Moseneke’s Award, a powerful document which places constitutional damages at its core, and through the work of a number of state officials, a lot more needs to be done. To date the reasons for the Marathon Project still have not yet been unearthed. Getting to the root cause of it would help families continue to heal from this tragedy. So would more accountability through fast tracking prosecutions and strengthening of oversight mechanisms such as the mental health review board.

Building public health system capacity for NHI: Learning from disease-specific successes for system development

We are reminded on a daily basis of failures in our public health system:  strikes, stock-outs, critical vacancies, vulnerable patients left to die, cancer patients without treatment,  dilapidated and poorly equipped facilities, rampant corruption and wholesale capture of provincial health departments. By Helen Schneider, Uta Lehmann, Lucy Gilson

Yet viewed from different starting points, South Africa’s much maligned public health  system has achieved remarkable successes in tackling particular disease burdens over the last ten years:

  • More than 4 million people are receiving anti-retroviral therapy, mostly through nurse-based primary health care, free at the point of use;
  • the risk of an HIV infected mother transmitting HIV to her infant declined from a high of 25-30% in the early 2000’s to 1.5% in 2015, through greatly improved detection and management of HIV in pregnancy;
  • Progressive realization of new entitlements to a range of maternal, neonatal and child health interventions; and new diagnostic capabilities and drug regimens for tuberculosis.

These measures are largely responsible for the improvements in life expectancy, reductions in maternal and child mortality, and a declining incidence of tuberculosis. They have been implemented through the same national, provincial, district and facility service infrastructure that is also associated with the public sector’s many failings.

As columnists have pointed out since the publication of the NHI Bill, South Africa’s public health system – as both funder and provider – will form the bedrock of a future NHI. Its problems have to be confronted.

What can we thus learn from the disease-specific successes for addressing the wider problems of the public health system? We offer two key lessons, both of which can inform the urgent task of (re)-building the public health system’s capacity and unlocking its latent capabilities:  firstly, an understanding of the processes which led to the programmatic successes described above; and secondly, a recognition that disease-specific responses do not in themselves solve underlying systems problems, which require a different and new kind of focus.

With respect to first lesson, the approaches to HIV and to some extent maternal and child health in South Africa over the last 10 years have been characterized by the following:

  • Relatively open systems of national programme leadership that enabled participation and coordinated the actions of clinicians, managers, activists and researchers;
  • The development of significant communities of practice, drawing extensively on national expertise, with opportunities to interact in regular conferences, programmatic reviews, and technical committees;
  • Service delivery cultures embracing innovation, transparency, information, new scientific evidence and technologies, consensus and learning by doing;
  • The development of significant research capacity in universities and statutory research councils;
  • The drive to efficiency through measures such as task shifting and strategic purchasing of anti-retrovirals;
  • Supportive implementation processes that have engaged directly with frontline providers and the mobilization of local/district level support processes and teams.

Crucially, underpinning these approaches has been scrutiny and holding to account by global health bodies (through the Millennium Development Goals, for instance), as well as a national civil society, able and willing to contest decisions at every turn.

The development of the NHI proposals – from green to white papers, pilot sites and interventions, and the more recent Bills – has followed a very different path. Decision making processes have appeared to many as centralised, opaque and closed. There has been little investment in the development of technical expertise or crucial support systems or well evaluated local experiments. Also absent is a nationally mobilised community of provincial and district managers, practitioners, researchers and civil society players in support of NHI.

The measures outlined in the NHI Bill appear to rest on the assumption that the health system can be fundamentally “re-engineered” from the top through legislative, financial or compliance levers. They ignore the abundant global evidence that health systems function as complex adaptive systems: namely, that they are social and political institutions, are unpredictable, produce unintended consequences, and contain a multiplicity of interacting norms and values.  It is difficult to see how front line health care provision, involving powerful interests and hundreds of thousands of individual, daily transactions, can be controlled, let alone reoriented into completely new and better performance by strings pulled at the top, however necessary or well designed.

Learning from the successes of HIV, MCH and TB programmes, a better starting point would be to recognise that South Africa’s public health system offers numerous instances of positive functioning, has a large number of experienced, public interested and skilled players, and has within it the seeds of renewal.  These are evident in nodes of system innovation and good performance in community-based services, clinics, hospitals, districts and support systems within provincial bureaucracies. Yet these pockets of effectiveness, which could be a source of bottom-up energy in support of system strengthening and NHI remain largely undocumented and uncoordinated. There are few opportunities for genuine national dialogue, and sharing of experiences and learning across institutions, districts and provinces in these areas. Research is also under-developed, and that which has been done, inadequately utilised.

Rather than drawing on the available sources of grounded experience and expertise, wider system change is often reliant on piece-meal (and sometimes contradictory) initiatives from the top, whether on ward based primary health care outreach teams, district health systems, regional and tertiary hospitals, human resource planning and development, information and financial management systems, to name a few.

Changing this situation would require willingness to invest in the functions, building blocks and relationships of health systems with the same degree of leadership, attention and rigour in which HIV and TB were tackled over a decade; and to capitalise on the considerable know-how and know-to already available within the health system, by creating the opportunities for feedback and learning.  We need more consultative processes, reviews, tasks teams and summits which seek to rally, build consensus, chart visions and inform decision-making – not more expensive talk shops to ratify pre-set positions.

One commentator has proposed mirroring the recently completed and excellent Health Market Inquiry with a National Commission of Inquiry into NHI.

In the same way the AIDS social movement led the way on HIV in South Africa, Schools of Public Health, statutory research councils, the Public Health Association of South Africa and civil society organisations need to mobilise under the banner of NHI. Together these could form an important voice in support of a new focus and approach to systems development, and provide the much needed critical mirror on the future development of NHI.

Professor Lucy Gilson is the Head of the Health Policy and Systems Division, School of Public Health and Family Medicine, University of Cape Town. Professor Uta Lehmann is Director of the School of Public Health, University of the Western Cape. Professor Helen Schneider is the SARChI Chair in Health Systems Governance, University of the Western Cape.

 

 

Dear Mr President, we need to talk about our health system

Four of South Africa’s top public health systems academics last month sent a letter to President Cyril Ramaphosa as the country grapples with finding solutions for our struggling health services. By Lucy Gilson, Jane Goudge, Uta Lehmann and Helen Schneider.

The four professors, Lucy Gilson from the University of Cape Town, Jane Goudge of the University of the Witwatersrand, Uta Lehmann and Helen Schneider from the University of the Western Cape state upfront their commitment to supporting the development of a health system that promotes health and wider social benefits, and contributes to redressing the inequities in our society.

They believe the 2019 elections provide a window of opportunity to institute actions that could, over the longer term, develop the health system as such a mechanism of societal transformation.

They make important points that should serve as reference for the ongoing and critical needed debates taking place as government considers various pieces of legislation and recommendations to fix our health system.

Collectively, for over 20 years, the professors have been deeply engaged in research to understand what makes our health system tick, what its challenges are and what strategies of positive change may support its development.

As internationally acknowledged, the public sector, as a funder and provider of health care, has a vital role in ensuring that the broader health system offers benefits for all[1].

In the letter the four academics pay tribute to the incredible individuals they have been privileged to work with, people who are working within the South African public health system – serving the population at large, holding true to high professional and ethical standards, making sure health care is offered day in and day out. They state clearly that there are clear pockets of effective care within our health system today.

On the flipside they also state that they have seen the pressures these colleagues are under, resulting from the HIV/AIDS epidemic, the necessary, massive response to it, a complex and changing disease burden, and, more recently, austerity budgets. And they have also seen how these pressures have been made worse by the dysfunctionality of the system of which they are part.

“We are mindful of the key fault-lines facing our health system: the skewed distribution of resources and access between public and private sectors, and the governance crises in provincial health departments. The problems facing the health system have been widely acknowledged.”

The authors identify the recently released NHI Bill as a touchstone for debate about how to tackle these problems. “We are encouraged by the amount of energy that has been galvanized around it, and we fully support the principles of cross-subsidisation and financial risk protection that underpin the Bill. It offers a range of proposals that should stimulate debate about how to strengthen the health system in the interests of the most vulnerable – and it clearly envisages that some of details will be further developed over time.”

However, they have some very real concerns:

“However, we write now to alert you to our real concerns that, first, the provisions of the Bill simply do not address some of the most critical problems facing the public health system.  Second, we are concerned that hasty action now could only exacerbate its existing dysfunctionality. On both grounds, there is then a danger that we will lose sight of the overall goal, namely a comprehensive, integrated and equitable health system.

Global experience certainly suggests that reforms of this scale demand that careful attention is paid to the processes of implementing change[2].  Yet, in South Africa, the process of developing this significant reform agenda has so far neither engaged society at large nor the majority of those who have hands on experience of how the system currently works and are committed to serving society.

We urge you to support actions now that will provide time and space for greater learning about how to manage the process of change moving forward. How we support change in the health system is a necessary component of delivering that change.

Our concerns are twofold:

First, the NHI Bill says very little about some vital aspects of health system development required to serve the interests of the most vulnerable groups in society.

  • There is nothing in the Bill about community engagement, although such engagement is internationally recognised as a critical feature of pro-poor health systems[3],[4].
  • The Bill reflects a bio-medical model of health care, and does not consider the inter-sectoral actions necessary to support health promotion and address the social determinants of health[5].
  • Although the Bill touches briefly on patient referral pathways, there is no direction on how to develop a coherent and integrated health system overcoming the multiple organisational silos that already exist; indeed, the new lines of financial accountability alongside existing bureaucratic and health structures seem likely only to fragment the system further. As the World Health Organisation notes, fragmentation ‘undermines the ability of health systems to provide universal, equitable, high-quality and financially sustainable care’[6].
  • There is almost nothing in the Bill about human resource planning and management, although this is a central pillar of any well performing organisation – essential in maintaining the motivation of health staff and in building the inter-disciplinary clinical and managerial teams required in a robust health system. Both have direct bearing on the care offered and received.

Second, the Bill’s provisions may well exacerbate current problems and unintentionally undermine the public health system.

These provisions will be implemented within a system that continues to be influenced by apartheid-era bureaucratic norms of control and hierarchy. These norms have been compounded by a top-down approach to change since 1994, primarily bureaucratic and vertical lines of accountability, and weak leadership and management[7],[8]. Failures in inter-governmental relations, the politicisation of the civil service and corruption are additional dimensions of dysfunctionality. The prevailing ‘compliance culture’ has prevented the public health system from being responsive to local communities and from creatively responding to routine challenges[9].

We are concerned that without wider measures to tackle this existing environment, the restructuring arrangements proposed by the NHI Bill will only consolidate organisational norms and cultures that contradict the goals of Universal Health Coverage.

More specifically

  • the institution of a complex network of contracting relationships may not achieve the performance gains anticipated, and, together with the proposed new governance structures, is likely to exacerbate the existing weaknesses of governance and management capacity at all levels of the health system (facilities, districts, province and national);
  • the exercise of powerful financial incentives could crowd out the non-financial incentives that also matter to any organisation’s performance[10] – such as the values that shape the caring behaviours so vital to health systems; wider experience about the impact of financial incentives in health systems offers cautionary lessons[11];
  • the Bill clearly envisages a much weaker future role for provincial departments of health, premised on greater centralisation in the NHI Fund, on the one hand, and decentralisation to districts and primary health care contracting units, on the other hand. However, as recent difficulties with contracting private general practitioners from the national level have demonstrated, the solution to poor performance in a complex system is not greater centralisation. The geographical diversity of health needs and size of the public health system are such that the role of provinces cannot be wished away. Rather than seeking to work around provincial departments should we not ask critically  – have we sufficiently used the existing public planning and accountability levers to ensure performance at provincial level? What can we do to strengthen them to play an enabling role in the health system?

Finally, the current public health system crises are clearly one symptom of the broader governance crisis facing the country. The ‘state capture’ project did not only entail corruption, but was also associated with political rather than meritocratic appointments across the health system, with managerial instability, with loss of vision, and with environments of dis-trust. The NHI Bill simply cannot itself address these issues.”

The authors then turn to making a range of concrete proposals:

“We urge that the political and health debate is widened – to address a broader set of issues and to release bottom-up creativity within the health system itself. Strengthening any health system takes a combination of bottom up innovation and top down direction. Even with its challenges, the South African system has a huge reservoir of dedicated health staff and managers with commitment to public service. Their passion and professionalism needs to be harnessed, alongside that of the public at large, to support sustained and long-term health system change in the interests of the most vulnerable groups. We need to shift the narrative around NHI so that it can become the catalyst of energy and action towards that goal.

We suggest four starting points:

  • A central focus on the people of the public health system

‘People centred health services’ and ‘people centred health systems’ are international slogans intended to reinforce the message that health systems are, ultimately, human systems. They are slogans entirely in alignment with universal health coverage, as acknowledged in the World Health Organisation’s 2016 Framework on Integrated People Centred Health Services and the 2017 Lancet Commission on the future of health in sub-Saharan Africa.

People-centred health systems focus attention on prevention, primary care, and public health, on the values of respect, dignity, and compassion, and, as the World Health Organisation has argued, recognize ‘the importance of people, processes, systems, power relations, and values in the foundation and pillars of any effort to improve health and wellbeing’[12].

  • New thinking about health system governance

International experience clearly shows that governance is a critical leverage point of health system development[13],[14].  Strengthening health system governance requires concern not only for structures and legislation, the frameworks of accountability, but also – and vitally – for strengthening the responsible exercise of power by all health system stakeholders. Relationships of trust and accountability have to be established across the system as whole. Values and principles that shape those relationships must be affirmed. The capacities of all health system organisations and actors must be developed[15].

The existing ‘pockets of effective care’ within the South African public health system demonstrate the importance of new forms of governance. Such pockets include numerous instances of well-functioning clinics and hospitals as well as programmatic strengths (such as the widespread access to antiretroviral therapy and vaccines delivered through our primary health care system)[16]. The new forms of governance are illustrated by novel approaches to strengthening district health systems in the Eastern Cape, Limpopo and Mpumalanga, founded on collaborative relationships and reciprocal accountability, with positive health consequences[17]. As a province that has been able to sustain efforts towards an improved and functional public health system over more than 20 years, the Western Cape experience highlights, meanwhile, the importance of stable and purposeful leadership, clear demarcation of, and respect for, the boundaries of political and administrative power, decentralised and distributed leadership, clearly stated values driving health system change and the development of public health expertise and wider learning processes[18].

Whilst there have been health system initiatives since 1994 to address some of the governance processes highlighted here, others have simply been ignored and none have received adequate backing and resources to be effective. Policy requirements for clinic committees and hospital boards have, for example, not been translated into effective community accountability structures[19]. Meanwhile, the more recently proposed National Academy for Health Care Leadership and Management remains just an idea. Yet community engagement and system-wide leadership development are both vital in strengthening health system governance.

Moving forward, energy, technical, political and financial resources must be invested in strengthening the full range of necessary governance processes.

  • New thinking about human resource development and management

Without adequate numbers, and equitable distribution, of appropriately trained and motivated staff, health systems cannot serve the most vulnerable groups even if they have funding.

To take effective action to redress existing inequities, the lessons from past human resource initiatives, such as community service and the occupation specific dispensation, as well as international evidence, should be carefully considered to inform a rethinking of human resource development for the health sector. Action must be taken to allow for the better integration of community-based cadres, targeted recruitment of health professional students from under-served areas (something which has been done very successfully in small pockets[20]), and a rethinking of the teaching platform (as envisaged by the National Health Act) to give much more emphasis to primary health care and community-based training[21].  Valuable lessons in this regard can be learned from other middle-income countries such as Brazil and Thailand[22].

In addition, human resource management, presently oriented towards generic civil service rules and personnel administration, needs to be completely reconfigured. Human resource management staff must also be appropriately trained to play a more strategic and enabling role in supporting health care provision.

  • New thinking about how to implement health system change

Since 1994, South Africans have criticised themselves for their inability to implement what are generally regarded as good policies. Yet we continue to develop policies and legislation, and debate design details, whilst barely paying attention to the processes of their implementation – leading to unanticipated consequences[23],[24]. There is little recognition that new policies are implemented into settings of pre-existing policies and organisational cultures that influence how any new policy is understood and supported, and if and how it takes effect[25].

The lessons of international experience show clearly that organisational and system change cannot be prescribed from the top but must be developed with and through the experience of those within the system[26]. Indeed, the details of policy design often have to be developed during implementation, through processes of learning and engagement with those at the front line of change, such as the public and health staff[27].

The NHI pilot sites, from the first phase of NHI implementation, were intended to serve this purpose. A formal evaluation of their experience is now being conducted, and managers from the sites will have their own insights and experiences to share. However, will there be opportunities for these experiences to inform further implementation or indeed, as has happened previously, will this evaluation be ignored?

In addition, as there are health system challenges that NHI cannot address, how will they be tackled in parallel to the NHI reforms? How can implementation of the NHI proposals avoid undermining the pockets of effective care that do exist? And how can implementing the NHI Bill proposals itself help to develop the organisational capacities needed to sustain health system development?”

The authors then make specific proposals:

“With these four starting points in mind, and given the concerns we have raised, we propose the following as critical steps in public health system reform towards a comprehensive, integrated and equitable universal health system:

  • Immediate action to hold to account those politicians and health managers responsible for corruption and mal-administration – sending strong signals across the system;
  • The clear separation of political and administrative powers across every level of the public health system;
  • An immediate national health consultation process focussed on local level pockets of effective care and aimed both at engaging local level actors in generating ideas for future reforms as well as harvesting ideas about the system-wide actions needed to support local level health system development;
  • Dedicated action to strengthen the human resource development and management function across the entire health system – including engagement with the Department of Public Service and Administration;
  • Completion of the evaluation of the NHI pilot site evaluation currently under way, and consideration of its results;
  • Review of the NHI Bill’s implications for public health system governance, including consideration of the relative roles and responsibilities of the national and provincial departments of health, DHMOs and primary health care contracting units, and paying particular attention to issues of human resource management, clinical supervision and support, and community engagement in decision-making;
  • The development of NHI implementation processes aimed at supporting organisational capacity development at DHMO, hospital and primary care levels – possibly through the introduction of district support teams (as a governance and management equivalent to the District Clinical Specialist Teams introduced in the NHI pilot sites);
  • A process of trialling aspects of the current NHI Bill proposals (such as the role of PHC contracting units, or payment mechanisms) – to learn through implementation how they might impact on and take effect in the public health system, and so, to further develop the proposals;
  • Implementation of a coordinated process of health leadership and management development as a nation-wide and sustained public health system intervention, targeting teams and organisations, not only individual competencies;
  • A continuing and sustained nation-wide learning initiative to support the sharing of experience about reform implementation within the health system – considering the lessons of other countries, and engaging with the national department of health, provincial departments of health as well as concerned NGOs and research and education groups;
  • Dedicated capacity and resourcing to support these new initiatives;
  • Public commitment from the national Department of Health and Presidency for these processes, through supporting and engaging with them.

As academics deeply committed to the development of South Africa’s health system towards the goals enshrined in our constitution, we stand ready to be engaged in these proposed activities.”

Professor Lucy Gilson is the Head of the Health Policy and Systems Division, School of Public Health and Family Medicine, University of Cape Town. Professor Jane Goudge is Director of the Centre for Health Policy, School of Public Health, University of the Witwatersrand. Professor Uta Lehmann is Director of the School of Public Health, University of the Western Cape. Professor Helen Schneider is the SARChI Chair in Health Systems Governance, University of the Western Cape.

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