Minister: We must have communities, especially people living with HIV tell us what is needed

ADDRESS BY THE MINISTER OF HEALTH DR ZWELI MKHIZE AT THE OPENING OF THE 9th SOUTH AFRICAN AIDS CONFERENCE

INKOSI ALBERT LUTHULI INTERNATIONAL CONVENTION CENTRE, DURBAN, KWAZULU-NATAL

11 JUNE 2019

Programme Director

The Conference Chair, Prof Refilwe Phaswana-Mafuya

Premier of the KwaZulu-Natal, Mr Sihle Zikalala,

Ministers, Deputy Ministers and MECs present

The Mayor of eThekwini, Ms Zandile Gumede and other leaders from the local government

The UNAIDS Deputy Executive Director, Dr Shannon Hader,

Representatives of Multilateral and Bilateral Development Partners

SANAC Trust Board members

The Deputy Chair of SANAC and Chair of the Civil Society Forum, Ms Steve Letsike and other Civil Society Leaders

Senior Officials

Scientists, Researchers and Activists

Distinguished guests

Ladies and Gentlemen,

We meet during Youth Month, a few days before June 16th – a historic day in history of our country when thousands of young people took on the might of the apartheid regime. We salute the youth of 1976 and all young people who fought against the evils of oppression and we thank those that paid the ultimate price that they paid for our freedom.
Unfortunately, since then too many young people have succumbed to a preventable disease – HIV and AIDS! Every year for the past 9 years, South Africans gather here in the ICC to discuss ways to prevent HIV transmission as well as how to ensure that we initiate and keep people who are living with HIV on treatment.
The theme of this year’s conference is: Unprecedented Innovations and Technologies: HIV and change. Lest we forget, we have an estimated 7.1 million South Africans who are HIV positive with 4.6 million on treatment. This means that we must move rapidly to ensure that everyone living with HIV is on treatment. Equally we must ensure that those of us who are HIV negative remain negative! This needs innovation and change as the theme of this conference suggests!
For such a conference to succeed in its objectives we must have communities, especially people living with HIV tell us what is needed, researchers and scientists tell us what works and what does not work and government and its implementing partners who are implement with a great sense of compassion, passion and urgency all working together to defeat this epidemic!
This conference epitomises collaborative excellence where science, activism, government, and medicine come together in our responses to the HIV/AIDS epidemic and its twin – tuberculosis. This community has again come together, during this week, to rise to the enormous challenges the response to the epidemic continues to require. These include:
• The eradication of stigma and discrimination around HIV and calling out the prejudice that has fuelled it;
• The hard work of research and of ensuring that the research is relevant, puts the rights of people first and community voices are heard when planning and implementing the research;
• And importantly to ensure that government and its partners are responsive to the epidemic and that programmes are implemented effectively, efficiently and with quality.
This conference is where we dedicate our energy to share innovative plans to end the HIV epidemic. Today, we also pay tribute to the researchers and activists who have devoted their lives to finding solutions to end AIDS as a public health threat. In addition, we are reminded of the bravery and courage of late activists like Gugu Dlamini, Nkosi Johnson, and Prudence Mabele, who fought from the front to ensure that this epidemic does not define our destiny as a country. This day also brings to memory our global icon and the first President of democratic South Africa, Tata Nelson Mandela – who fought against the discrimination of people infected with HIV and TB and rallied behind the campaign for expanding ARV treatment.

Such gatherings remind us that we need to understand the needs of the person who lacks access to information and services so that we can provide them with information and services, including key populations, the LGBTI community, rural communities and people living with disabilities. These gatherings also remind us to harness the huge potential of people living with HIV to guide the response and delivery of services and the campaign against stigma and discrimination. The day also reminds us to create platforms for young people to shape and direct the programmes that are meant to empower them to stay HIV free and for those that are infected to live longer and reach their full potential so as to contribute to the development of the country.

Although our country is applauded globally for having progressive legislation and policies that promotes access to health services, evidence has identified stigma and discrimination, including self-stigma, and the negative attitudes of healthcare workers, as key barriers to accessing HIV and TB services.

The 2014 People living with HIV Stigma Index Survey, conducted by SANAC in partnership with the National Association of People living with HIV and AIDS (NAPWA), the Treatment Action Campaign (TAC and Positive Women’s Network (PWN), found the following:

• Over one-third of respondents (36%) reported experiencing some form of stigma in either their personal or social environments, including being gossiped about, experiencing verbal and physical harassment and assault.
• That over one-third (36%) of respondents reported being teased, insulted or sworn at because of their TB status.
• 27% harboured feelings of uncleanliness or dirtiness in relation to their TB diagnosis.
It is not surprising that people are discriminated against because they have tuberculosis – even though TB is a very old disease and has been around for hundreds of years – because it is airborne and anyone can contract TB.

A more recent survey, in 2018, conducted by the University of KwaZulu-Natal also found that stigma and discrimination affected access to health care services, creating barriers to access to and adherence to ART and deterred individuals with TB from accessing services for fear of breaches of confidentiality.

Let me be clear as the newly appointed Minister of Health, stigma and discrimination has no place in the provision of health services. We will take action against any health professional that discriminates against anyone on the basis of their illness, gender orientation, social status or any other characteristic!

In addition, to address these issues and to give effect to the objectives of goal 5 of our National Strategic Plan for HIV, TB and STI 2017-2022, I am pleased to announce that we have just launched a 3-year Human Rights Plan for HIV and TB, which aims to set out a comprehensive response to human rights and gender-related barriers to HIV and TB services in South Africa for people living with HIV, people living with TB, and vulnerable and key populations. This plan will focus on the following:

1. Stigma and Discrimination reduction
2. Train health and other frontline workers to provide care that is non-discriminatory
3. Sensitize and train Law makers and law enforcement agencies
4. Campaigns that focus on legal literacy and rights
5. Strengthening legal support services
6. Monitoring, reviewing laws and policies
7. Reducing gender inequality and gender based violence

I would like to take this opportunity to thank the SANAC Human Rights and Legal Task team under the leadership of the Deputy Minister of Justice, Mr John Jeffrey for overseeing the development of this plan. In working with the Chairperson of SANAC, I will ensure that the implementation of this plan becomes a standing item in all SANAC InterMinisterial committee meetings and in SANAC plenary meetings.

The response to the HIV and TB epidemics needs resources. We are grateful that our government is the main funder of our responses. In addition, we wish to thank the Global Fund for their support which was recently announced ($369 million over the next three years) and the President’s Emergency Fund for AIDS Relief (PEPFAR) which will provide $730 million in funding in the 2019/20 financial year. I want to encourage everyone that benefits from these funds to ensure that the funds are used as effectively and efficiently as possible. We have to use these scarce resources to reach the target that President Ramaphosa announced in the 2018 State of the Nation Address of 6.1 million people living with HIV on treatment by December 2020! We dare not fail to achieve this target if we wish to reach epidemic control!

In closing, I would like to thank the Conference Planning Committee under the leadership of Prof Refilwe Phaswana-Mafuya for all the hard work of planning such a big conference and wish everyone fruitful deliberation over the next 3 days.

I thank you.

A healthcare system in crisis: The long road ahead

A healthcare system in crisis: The long road ahead
A Speech by Sibongile Tshabalala, TAC National Chairperson, 11 June 2019, SA AIDS Conference Opening Plenary, Durban

Greetings comrades!

I would like to take this moment to acknowledge the Deputy President, DD Mabuza; the Health Minister, Dr. Zweli Mkhize; the Premier of KwaZulu Natal, Sihle Zikalala; MECs for health; the organisers of the SA AIDS Conference; the media; delegates; and importantly, people living with HIV who managed to make it to the conference. We also acknowledge those who could not make it as a result of many factors such as the high cost of conference fees and  the need to work in order to feed their families, amongst others.

Comrades, the ninth SA AIDS Conference occurs during a critical juncture in South Africa’s history.

We meet at a time when AIDS denialism is beginning to recede in the nation’s collective psyche.

A time where South Africa has the world’s largest HIV treatment programme.

And let me pause here to acknowledge the tremendous work of former Minister of Health Dr. Aaron Motsoaledi in building the HIV treatment programme.

But we also meet at a time where corruption is rampant.

While the disgraceful details of state capture are being exposed in commissions of inquiry – much corruption in our provincial departments of health goes unreported and unprosecuted.

Comrades, we are being trampled down into the dirt by the co-epidemics of corruption and mismanagement.

These are the co-epidemics behind the Life Esidimeni tragedy, behind the disgraceful cancer crisis here in KZN, and the looting of the HIV Conditional Grant to pay Buthelezi EMS in the NorthWest.

Honourable Deputy President and Minister of Health, if you have any doubts of the scale of the crisis, I urge you to study the reports of the Office of Health Standards Compliance.

Let me focus on one symptom of these co-epidemics. Stockouts.

Comrades and friends, as some of you know, the Treatment Action Campaign turned 20 in December last year. As one of the foremost social movements in the country, we have been monitoring drug availability in health facilities for much of those two decades.

According to PEPFAR data, in 2018, around 750 thousand people were initiated on treatment but only around 400 thousand additional patients were retained by the last quarter of the year.

What happened to the other 350 thousand people?

Through our ongoing monitoring campaign, which recently focused on the Free State and Gauteng provinces, PLHIV sector members found that many facilities still undergo drug shortages, or worse, stockouts.

As part of the Stop Stockouts Project, 673 facilities were monitored by members of the PLHIV sector and other comrades within the past two months. We found that of the health care facilities monitored, 109 facilities in the two provinces had drug stockouts of Dumiva, a key antiretroviral. 106 overall did not have injectable contraceptives. When our publication Spotlight travelled to the Northern Cape, they found many facilities with no stock of basic medical supplies such as bandages, plasters and intravenous drips.

It is heartbreaking that as we stand here today in 2019, some of the same issues from a decade ago still plague us.

We cannot run away from the fact that the health system that you are inheriting, Honorable Minister, is one that is in dire need of resuscitation.

Often we have stockouts simply because our healthcare system is in such a terrible state that medicines pile up in depots while clinic shelves are empty.

When the problem is with the supplier, it takes months for the news to filter through to clinics and for the department to provide advice on alternatives – as has just been the case.

Honourable Minister, patients are being turned away. Patients are being told to go pay R900 for Dumiva at private clinics.

Stockouts is one thing. But there are also long queues, often demoralized healthcare workers, a lack of confidentiality. These are all symptoms of the mediocrity and dysfunction in our healthcare system.

We do not accept this.

We do not accept that the price we have to pay for accessing healthcare services is to give up our dignity.

So what do we ask?

We as the Treatment Action Campaign, the PLHIV sector and public health care users call for the urgent prioritization of health care through an access to healthcare ‘bailout’ starting with the  during the October budget review.  In real terms our health budgets have been falling while the need for healthcare services has grown. In simple terms, we need money so that we can employ more healthcare workers.

We urge government to root out corruption in our provincial healthcare systems and to ensure only appropriately qualified persons are appointed in these departments. We will hold you responsible if the co-epidemics of corruption and mismanagement are not dealt with.

We urge the new national and provincial administrations to prioritise the welcome back campaign, in order to trace people who are missing and link them back to care and treatment.

Our HIV response is already beginning to unravel.

In order to get it back on track, we have to transform our healthcare system into a place that affirms human dignity rather that degrades it.

Comrades, Deputy President, Minister, Premier, MECs, we are not anti-government.

But please understand that we are a membership-based organizations andour responsibility is to our members and to the poor.

We are guided by this responsibility and by the Constitution of South Africa and the right to access healthcare and the right to dignity.

We will work with government in instances where it is in the best interest of our members and of the poor to do so.

But we will also hold you accountable to the highest standards.

Our lives, our dignity, is not negotiable.

Amandla!

I thank you!

Why SA’s medicines regulator should consider affordability

By Tendai Mafuma and Nomatter Ndebele

Before any medicine can be sold in South Africa, it has to be approved by the South African Health Products Regulatory Authority (SAHPRA), who certify that the medicine is safe, of good quality and is effective. Unless the medicine has gone through these processes, it cannot be on the shelves for sale. In exceptional circumstances, SAHPRA may permit access to unregistered medicines. This exception is permitted by section 21 of the Medicines and Related Substances Act, 101 of 1965 through a process that is commonly referred to as “a section 21 application”.

Section 21 applications are typically used to access an unregistered medicine in circumstances where there is no version of that medicine that has been registered in South Africa. An example of this could be where registration of the medicine is pending but there is a need to urgently access that medicine in order to save lives. This was the case during the height of the HIV/AIDS pandemic, when organisations such as the Treatment Action Campaign used section 21 applications to get access to fluconazole for the treatment of HIV-related opportunistic infections. This provision may also often be relied on where a patient has sufficiently justified why they cannot use the registered product, for example if a patient can show that the unregistered alternative is not only superior in terms of safety and quality standards but will also have superior therapeutic effect on their health.

One of the questions that comes up regularly is whether the fact that a registered medicine is excessively priced is sufficient justification for seeking section 21 access to an unregistered alternative. Over the past decade, individual patients have sought access to unregistered medicines on the basis that the alternatives registered in South Africa are excessively priced, and therefore inaccessible. SAHPRA has routinely declined authorisation of the applications on the basis that cost is not a factor to be considered. Put simply, according to SAHPRA, if there is a registered medicine in South Africa, that would be effective for the diagnosed condition, you cannot request access to an unregistered alternative solely on the basis that you cannot afford the registered medicine. This means that if patients cannot somehow find money for the registered treatment, they will not access any treatment.

People with chronic health conditions such as cancer are particularly affected by this. We use cancer as an example because due to the astronomical costs of cancer medicines, very few patients are able to gather the money required for new cancer medicines.

Take for instance Hayley Stols who was diagnosed with stage 4 malignant metastatic myeloma. Her oncologist recommended treatment with Opdivo, a drug that was not registered in South Africa. At the time, there was a registered drug, Pembrolizumab which would have cost R1,8 million per year. Opdivo, on the other hand, would have cost R770 000 per year if purchased from the Netherlands. Whichever option Hayley chose, it would have had to be self-funded as neither medicine was covered by her medical aid scheme. It is difficult to imagine anyone in South Africa who has R1,8 million per year for one course of treatment. R770 000 is still a lot of money, but it is significantly less than R1,8 million.

Hayley made two section 21 applications to SAHPRA to request permission to access Opdivo. In both applications, she clearly stated that the reason for this request was that Opdivo was more affordable. Both applications were rejected.

There are a few exceptional cases where SAHPRA has approved section 21 applications on the basis of cost, for example applications by MSF for access to the TB medicine linezolid, but the fact is most of these applications are rejected. Patient advocacy groups have been trying to engage SAHPRA on this issue with little success.

In the past, SAHPRA has argued that the law does not empower it to make decisions based on cost and that its only mandate is to consider the “safety, quality, and therapeutic efficacy” of medications. This, in our view cannot be the only consideration.

Firstly, the Constitution doesn’t only guarantee the right to access to health care services, it also requires the State to take reasonable measures, within available resources, to achieve progressive realisation of the right. It also places an obligation on organs of state such as SAHPRA, to respect, protect, promote and fulfil fundamental rights. Moreover, the Constitution states that legislation must be given an interpretation that promotes the spirit, purport and objects of the Bill of Rights. This means that laws must be interpreted in a manner that will allow the enjoyment of rights to the fullest possible extent. As an organ of state responsible for ensuring that consumers have access to safe, quality and effective medicines, SAHPRA’s interpretation of the law should not be one that effectively hinders access to healthcare.

It also means that SAHPRA must develop and implement policies that do not undermine access to medicines. At the most basic level, access to medicines refers to the ability of all persons to receive the medicines necessary for the treatment of any condition affecting them. It entails physical, informational and economic access (i.e. affordability). This interpretation of access to medicines has been laid out by the courts. If SAHPRA does not concern itself with practical concerns about whether patients can afford medicines, that is tantamount to a failure of its duty to respect, protect, promote and fulfil the constitutional right to have access to medicines.

Considering affordability does not mean that SAHPRA must turn a blind eye to considerations of safety, quality and efficacy. Neither will it open the flood gates of section 21 applications as patients seek access to unregistered medicines even where the price difference is marginal. Rather, it requires an acknowledgement that there can be no access if the medicines are priced excessively and beyond the means of those who need them.

SAHPRA recently published a guideline aimed at ensuring that section 21 applications are received, processed effectively and consistently, and decided timeously. Despite SAHPRA already having dealt with several section 21 applications based solely on cost, the guideline makes no mention of how the entity intends to resolve such applications. Given the constitutional obligations, we think that it is about time SAHPRA begins to concern itself with matters of affordability of medicines. Failing to do so would be a failure to ensure access to medicines and a violation of the right to access health care services.

ARV stockouts putting lives at risk, says SSP

By Anso Thom and Marcus Low

LATEST NEWS! Updated circular on Lamivudine can be seen here

Stockouts of several critical medicines have been reported at healthcare facilities in five provinces, according to a statement from the Stop Stockouts Project (SSP). This includes stockouts of the antiretroviral (ARV) combination of Abacavir and Lamivudine and of various oral and injectable contraceptives. The Abacavir and Lamivudine combination is prescribed in the public sector to tens of thousands of patients who have become resistant to first line ARVs.

Following up on initial reports from users of the public healthcare system, Treatment Action Campaign (TAC) members are currently visiting healthcare facilities in the Free State and Gauteng to assess the situation. They are reporting stockouts of ARVs, paracetamol, flu medication, contraceptives, some antibiotics and HIV test kits. The TAC, together with various other civil society organisations, is a member of the SSP.

National Department of Health Director-General Precious Matsoso said they had sent technical teams to work with the TAC in an effort to identify affected facilities and patients. She said a circular was being prepared and will be sent to doctors with guidance on how to switch patients to alternative drugs.

The SSP says that several stockouts have been unresolved since the second half of 2018 and “the situation has now escalated into a crisis”.

They warned that scores of lives are at risk.

SSP’s Kopano Klaas said they had received stockout reports of second-line ARVs from the Free State, Gauteng, Mpumalanga, Limpopo and KwaZulu-Natal.

A list of stockouts supplied by the Treatment Action Campaign in the Free State reveals that since March there has been stockouts of the Abacavir/Lamivudine combination in at least 15 health facilities.

In the Mangaung Metro district it includes Mafane, Thaba-Nchu, Freedom Square, Bloemspruit and Gabriel Dichabe.

In the Lejweleputswa district the TAC reported stockouts at Rheederspark, Bophelong, Tshepong, Welkom, Leratong, Phomolong, Boithusong and Welkom.

In the Thabo Mofutsanyane districts stockouts were reported at Intabzwe and Qholaqhwe. The stockouts at Qholaghwe were understood to be mainly due to a break-in at the clinic.

Information from a TAC visit to Gabriel Dichabe Clinic in Bloemfontein suggests that there has been a breakdown between the provincial depot, the pharmacy, the clinic and patients. In cases where the clinic does not have stock, patients are given scripts so that they can purchase medicines at private pharmacies. The Medicines Price Registry lists a price of R921 for a month’s supply of the Abacavir and Lamivudine combination – likely out of reach for most public sector patients.

SSP also said that there had been repeated stockouts of injectables and oral contraceptives. Klaas said according to their information only one company was contracted to supply the oral contraceptive and because they were given very short notice they have been unable to keep up with the demand. Klaas also claimed that alternative companies were not interested in supplying the contraceptives as they were paid late or not at all.

The only alternative, an implantable device, is ineffective in women on ARV regimens containing Efavirenz, contained in most first line combinations provided in the public healthcare system.

“The SSP reports in to District, Provincial and National Departments of Health staff on a daily basis, but they seem to know as much or as little as we do. Surely someone needs to account to the scores of patients, who are travelling long distances to collect their medication, having to take a day off work to do so, only to be turned away when they get there?” Klaas said.

Deputy Director General in the NDOH Dr Anban Pillay said that there was a shortage of  Lamivudine globally and that the pharmaceutical company Mylan was unable to supply full order quantities.

He said they had secured a section 21 approval so that they can get stock from another source. Pillay advised facilities to manage the shortage by providing lesser quantities than usual for each patient.

On the contraceptives, Pillay said there should be no stockout but a shortage of the injectable nuristerate. “This is due to the only supplier Bayer being unable to produce sufficient quantities relative to demand. SA is one of a few countries using nuristerate,” he said.

Note: Spotlight is published by SECTION27 and the TAC – both of which are members of the SSP. Spotlight is editorially independent and a member of the Press Council.

How does the roles of MECs differ from those of heads of departments?

Last week we saw the appointment of the national cabinet and provincial executive councils following South Africa’s 2019 national and provincial elections. The people serving on these structures are entrusted with providing coherent strategic leadership and coordination in policy formulation and overseeing service delivery planning and implementation in support of national and provincial priorities and plans.

Each of the nine provincial executive councils has an MEC (member of the executive council) for health. Spotlight reported earlier this week that only two of the nine current MECs for health have served in their positions for more than two years. In addition to a MEC for health, each province also has a head of department (HoD) for the province’s health department.

Broadly speaking, the MEC has executive authority (political power) and the provincial HoD plays an administrative role. Unfortunately, through ignorance, over-reach, or in some cases in the service of corruption, these roles often get tangled up.

How are MECs and HoDs appointed?

MEC appointments are often described as political appointees. This is because the appointment is solely at the discretion of the Premier of the province and there is no legal obligation for the appointment to be based on merit or experience. So, for example, new KwaZulu-Natal Premier Sihle Zikalala was fully within his rights to appoint Nomagugu Simelane-Zulu as MEC for health, even though she lacks what many would consider the qualifications and experience required for the position.

Premiers typically appoint MECs from their own political parties and who are willing to associate with the political direction and agenda of the government.

By contrast, the appointment of HoDs must be based on merit as the appointee is required to have educational qualifications to justify their appointment to a specific provincial department. The vacancy of an HoD position must be advertised widely and the recruitment process must be transparent.  The same is not required when appointing an MEC.

Once appointed, HoDs are protected by stringent labour laws and public service regulations that shield from arbitrary dismissal. The same cannot be said for MECs who may be removed at the discretion of the Premier.

Powers and responsibilities

The general powers and responsibilities for MECs, regardless of the department for which they are responsible, are set out in section 125(2) of the Constitution. It states that MECs exercise their executive authority through a wide range of responsibilities that include implementing national and provincial laws; developing and implementing provincial policy, and co-ordinating the functions of provincial administration and its departments. Put simply, the role of the MEC is to the policy objectives and ensure that those objectives are implemented.

During the Life Esidimeni Arbitration, the then Gauteng MEC for health, Qedani Mahlangu, sought to distance herself from the tragedy by stating that she was not responsible for the implementation of the Gauteng Mental Health Marathon Project, a project that was supposedly carried out in pursuance of the National Mental Health Policy Framework and Strategic Plan 2013-2020 (NMHPFS). This defence was rejected by the Arbitrator, as he found that it was in fact her job to ensure the implementation of plans in the delivery of mental health services in Gauteng in line with the NMHPFS. The implementation obligation on the MEC does not mean she must herself take every step to implement; it means she must ensure that all steps are taken.

MECs are responsible for the four I’s of authority: identifying; initiating, integrating and interpreting.[1]

  • Identifying – the MEC must identify the challenges and opportunities within their provinces.
  • Initiating – the MEC for health is expected to take initiative in developing and implementing policies that are necessary for the realisation of the right to access health care.
  • Integrating – At any given time, there are thousands of programmes aimed at addressing different issues in health. An MEC must have the ability to integrate and coordinate those programmes and ensure that they do not work against each other.
  • Interpreting – policy objectives must be clearly interpreted to those who implement.

Specific responsibilities for MECs for health are set out in section 25 of the National Health Act. It provides that the MEC for health must ensure the implementation of national health policy and norms and standards in his or her province. MECs are also obligated to perform any other functions assigned to them in terms of the Constitution or any other Act of Parliament e.g. the Public Finance Management Act (PFMA).  An example of an Act that assigns specific functions to MECs for health is the Choice on Termination of Pregnancy Act which states that the MEC must approve facilities that offer termination of pregnancy services.

Whilst the task of the MEC for health is to ensure that the right policies are implemented to achieve the objectives of the National Health Act, the implementation itself is carried out by the public service – in this context headed by the HoD.

The general roles and functions of HoDs are not set out in the Constitution, but rather in the specific Acts relevant to the function allocated to them.

Section 25(2) of the National Health Act sets out the extensive powers and responsibilities of a provincial department of health HoD.  It is evident from the long list of responsibilities in section 25(2) – including “(I) Plan, manage and develop human resources for the rendering of health services” and “(n) Control the quality of all health services and facilities” – that HoDs bear far-reaching responsibility in the delivery of health care services.

According to the PFMA, as the accounting officer of a department, the HoD implements a department’s policies and delivers the outputs defined in the department’s budget.  They are responsible for the effective, efficient, economical and transparent use of the department’s resources – which would include the hiring and dismissal of staff – to produce policy output. The PFMA also places the awarding of contracts strictly in the purview of the accounting officers who are supposed to ensure that the department has, and maintains, an appropriate procurement and provisioning system which is fair, equitable, transparent, competitive and cost-effective.

This does not mean that MECs do not have financial responsibilities. Firstly, the HoD must report to the MEC on the financial, commercial and socio-economic strategic performance of the department. The PFMA clearly states that it is the responsibility of the executive authority (the MEC) to ensure that departments perform their functions within the limits of the allocated budget and in compliance with the PFMA and other relevant policies. In circumstances where a directive from a MEC has financial implications, this must be done in writing. The failure to do so will result in the HoD being accountable for any resulting unauthorised expenditure.

While MECs can and should raise questions about appointments and procurement processes where there are valid concerns, these areas are the responsibility of HoDs. Maintaining the separation between the executive role of the MEC and the administrative role of the HoD is critical to avoiding political interference in procurement and human resource processes. For example, MECs should not have any say in the outcome of tender processes, nor should MECs appoint or dismiss staff employed by the department, as appears to have happened when Limpopo MEC for health Dr Phophi Ramathuba reportedly removed the entire management team at Tshilidzini Hospital.

So what should we expect from the MECs for health and HoDs?

Although they have differing roles, MECs and HoDs are all bound by the Constitution. In section 195 of the Constitution, the values and principles within which public administration must take place are set out. Amongst others, it demands that public officials perform their duties to a high standard of professional ethics, responding to people’s needs and encouraging the public to participate in policy making.  It also requires that public administration be accountable[2] and transparent by providing the public with timely, accessible and accurate information. Accountability, transparency and responsiveness means that when the media or general citizenry seeks answers from public officials, public officials must take all reasonable steps to respond, and not simply ignore.

Prior to the 2019 national and provincial elections Spotlight sent questions to all nine MECs for health. Despite various attempts at follow up, only two of the nine answered the questions. This reflects a wider trend of non-responsive MECs and provincial departments of health. In a number of instances, Spotlight has been refused basic information on tenders and government spending and asked to request information by lodging an application in terms of the Protection of Access to Information Act (a slow and time-consuming process). This is unacceptable – no matter if you are an MEC or an HoD.

Finally, in the interest of good governance, all MECs and HoDs should serve the public within the bounds of the their legally-defined roles. This is critically important for both the smooth and correct functioning of the state and for the fight against corruption. MECs or HoDs who act outside of their roles or who underperform in other ways should be held accountable. After all, in the exercise of their powers and the discharge of their duties, MECs are individually and collectively accountable to the legislature, and by extension to the public.

[1] Adapted from “the role of local government” https://repository.up.ac.za/bitstream/handle/2263/25724/03chapter3.pdf?sequence=4&isAllowed=y Visisted 27 May 2019.

[2] In the exercise of their powers and the discharge of their duties, MECs are individually and collectively accountable to the legislature. Section 133 of the Constitution.

  • Mafuma is a senior researcher at SECTION27

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.

 

 

 

Only 2 of 9 Health MECs in job for more than 2 years

Following South Africa’s 2019 national and provincial elections, new members of provincial legislatures have been sworn in and new provincial executives appointed.

Four new MECs (provincial ministers) for health have been newly appointed and five were reappointed. MECs have substantial power in South Africa since most of the day-to-day running of the public healthcare system is devolved to provinces.

The latest set of changes follow a busy 2018 in which five new MECs for Health were appointed – two of those five have now been replaced.

Of the nine current MECs for health, four were appointed in 2019, three in 2018, and two in 2015.

Of the nine MECs seven are women and two are men.

Below is a province-by-province breakdown of the changes. Spotlight will provide more detailed analysis of some of the new appointments at a later stage.

Eastern Cape

Ms Helen Sauls-August is replaced by Ms Sindiswa Gomba. Sauls-August was appointed MEC for Health in 2018 and was only in the position for a year. Gomba was charged in relation to the Mandela Funeral scandal. The case was withdrawn earlier this month, but National director of public prosecutions Shamila Batohi has expressed serious concern over the withdrawal of the case.

Free State

Ms Montseng Tsiu remains MEC for Health. Tsiu was appointed MEC for health in 2018.

Gauteng

Dr Gwen Ramokgopa is replaced by Dr Bandile Masuku. Ramokgopa was Gauteng MEC for health from 1999 to 2006 and again from 2017 to 2019. Masuku is a medical doctor and a board member of the Office of Health Standards Compliance and chair of the Tswane University of Technology council.

KwaZulu-Natal

Dr Sibongiseni Dhlomo is replaced by Ms Nomagugu Simelane-Zulu. Dhlomo was KwaZulu-Natal MEC for Health from 2009 to 2019. Simelane-Zulu was previously the ANC’s spokesperson in the province. Both the DA and IFP have expressed concern over her appointment given her lack of health qualifications and experience.

Limpopo

Dr Phophi Ramathuba remains the MEC for Health. She was first appointed to this position in 2015. She is currently the joint longest serving Health MEC together with Nomafrench Mbombo of the Western Cape.

Mpumalanga

Ms Sasekani Manzini remains MEC for Health. Manzini was appointed as MEC for Health in 2018.

Northern Cape

Ms Fufe Makatong is replaced by Ms Mase Manopole. Makatong was appointed as MEC for Health in 2018. Manopole was previously a member of the National Council of Provinces.

North West

Mr Madoda Sambatha remains MEC for Health. Sambatha was appointed as MEC for Health late in 2018.

Western Cape

Dr Nomafrench Mbombo remains the MEC for Health. Mbombo was appointed MEC for Health in 2015. She is currently the joint longest serving Health MEC together with Phophi Ramathuba of Limpopo.

 

Five health policy priorities for the new administration

Under Health Minister Dr Aaron Motsoaledi’s watch government has made generally good HIV policy over the last decade. Treatment guidelines kept up with international best practice, newer medicines with fewer side effects have been introduced, and the malicious compliance of the last years of the Mbeki presidency was replaced with real political will and commitment to ensure people get the treatment they need, at least at national level.

But, while HIV and some aspects of TB policy has been good, there have been important failures in other areas. Below we highlight five important government policies or plans that have been stalled, are out of date, or simply never got off the ground. We recognise that National Health Insurance constitutes a major area of policy uncertainty, but we will not discuss that in this article.

These five health-related policy areas are not only areas that we hope will receive higher priority in the new administration, they are also areas in which we urge government to communicate its plans more clearly and more timeously.

  1. Human Resources for Health Strategy

People, or human resources if you will, are critical to the functioning of the public healthcare system. We need to have enough nurses, doctors, pharmacy assistants, managers and so on where they are needed most. This involves ensuring that enough people are being trained, but also ensuring that there are jobs and careers for these people in which they receive enough support. To make all this happen we need an over-arching plan or strategy.

Government’s key human resources strategy document for healthcare in South Africa is the HRH strategy for the Healthcare Sector 2012/2013-2016/2017 – in other words, it expired around two years ago. When we recently contacted the Department of Health to ask for the HRH plan, this outdated plan is what they sent us. They did point out that work is underway on a new plan, but did not say when it would be finished.

  1. Community Healthcare Worker policy

Community healthcare workers play an important part in the provision of primary healthcare services. Particularly in South Africa, where people with HIV or tuberculosis often only go to clinics or hospitals when they are very sick, CHWs can help get people into care earlier. This benefits both the individuals who are linked to care, but also helps prevent further transmission of HIV or TB.

Over the last decade provinces have gone about the employment of CHWs in very different ways. Salaries or stipends differ widely, required qualifications have differed, many provinces essentially outsourced the employment of CHWs to NGOs, training and job functions were not standardised across provinces, in one instance over 3 000 CHWs were dismissed without warning.

The need for a single, coherent national policy was recognised as far back as 2010 when the Health Minister and MECs went to Brazil and returned with a vision of a wide-reaching CHW cadre integrated into the health care system. Between 2011 and 2018, policy development and implementation moved at a glacial pace until the Policy Framework and Strategy for Ward Based Primary Healthcare Outreach Team 2018/19 – 2023/24 was published.

We now finally have the policy but adaptation to local needs and implementation is up to provinces. It should be made a top priority as new provincial administrations come into power. While having the right policies in place is essential, implementing policies is often another matter altogether.

  1. Policy on Occupational Health for Health Workers in Respect of TB and HIV

Healthcare workers are at a much greater risk of contracting tuberculosis than the general public. It goes without saying that we need to have good policies in place to ensure that as many healthcare workers as possible stay healthy.

By the end of 2016 a policy on “Occupational Health for Health Workers in Respect of TB and HIV” was completed. According to sources involved in the drafting of the policy, the policy was to be released on World TB Day (24 March) 2017. However, more than two years later the policy has still not been published.

  1. The National Drug Master Plan

The National Drug Master Plan is supposed to guide South Africa’s response to addiction and drug use – everything from tik to injecting heroin. A progressive, evidence-based plan is particularly important given that HIV and hepatitis rates are much higher among injecting drug users.

South Africa’s last National Drug Master Plan covered the period from 2013 to 2017 – in other words, it is now out of date by about two years. In April 2019 cabinet approved an evaluation report of this plan.

When a new plan will be published is not known – although we understand that drafts have been around for well over a year.

  1. Guidelines for Sexual and Reproductive Health Rights, Contraceptives, Abortion, PrEP and Cervical Cancer

Everyone has a right to reproductive health care services. Exercising that right is beset by difficulties, however, including health workers who refuse to provide abortions, contraception stock outs, the non-availability of pre-exposure prophylaxis outside of a limited number of donor-funded pilot sites, and oncology crises across the country.

A Guideline on Abortion is in its sixth or seventh draft currently and, we understand, has been approved by the technical sub-committee of the National Health Council. When it will be passed by the National Health Council itself and whether it will be implemented is not known. We are also aware of pending draft guidelines relating to SRHR, Contraceptives, PrEP and Cervical Cancer but are uncertain as to the status of these guidelines.

Setting priorities

Apart from finalising all the above guidelines and policies, making those guidelines and policies that have been finalised easily accessible online should be a priority.

In addition to all of the above, there are areas in which clear national policies are needed, but where we are not aware of any sufficiently far-reaching policy processes that are underway. So, for example, emergency medical services and planned patient transport services in many provinces appear to be in a constant state of crisis. New EMS regulations came into effect late in 2018 and EMS is often mentioned as a key element of NHI, but beyond that there appears to be very little planning, leadership and public consultation on how to fix our chronic EMS and planned patient transport problems. If NHI is to be part of the solution, then maybe the EMS element of NHI should be fast-tracked and prioritised. Either way, we need publicly available and consultative plans and policies to address urgent crises such as those in EMS.

 

Regulatory barriers to life-saving and affordable HCV medicines can be overcome

Hepatitis C (HCV) is a viral infection of the liver that is transmitted through blood. HCV can be spread through blood transfusions, organ donations, needle stick injuries, injecting drug use and other blood exposures. The vast majority of people with untreated HCV will develop chronic hepatitis C infection, which can lead to serious and life-threatening liver conditions including liver damage, cirrhosis and cancer. The prevalence of HCV in South Africa is unknown due to inadequate screening. While prevalence in the overall population is believed to be low (under 1%), screening initiatives have indicated higher prevalence in certain populations. For example, a recent screening initiative in Cape Town showed an HCV prevalence of 3.4% in HIV-positive men and 5.6% in HIV-positive men who have sex with men. This was confirmed in another study. In addition, a viraemic prevalence of 50% has been demonstrated in people who inject drugs (PWID).

Until relatively recently, the gold standard of HCV treatment globally consisted of the medicines pegylated interferon and ribavirin. This regimen required patients to withstand lengthy treatment with difficult side effects and inadequate cure rates. The introduction of a new generation of direct-acting antivirals (DAAs) from 2013 onwards has been heralded as a “game-changer” for HCV. The new drugs which can be taken orally, have significantly shorter treatment lengths (generally 12 weeks), fewer side effects and cure rates of over 95%.

While new generation DAAs provide significant and game-changing benefits to patients, the high costs charged for patented DAAs has been a considerable barrier to their use and scale-up globally. However, patents should not be a barrier to use in South Africa, where voluntary licenses allow for generic versions of key DAAs to be marketed. Bilateral licenses between the pharmaceutical company Gilead and generic companies allow for the use of generic sofosbuvir on its own and in combination with ledipasvir or velpatasvir. Medicine Patent Pool (MPP) licenses also allow for use of generic daclatasvir and glecaprevir/pibrentasvir. (All of these are considered important DAAs for the treatment of HCV – which typically requires two or more DAAs).

Yet, despite the fact that there are licenses in place allowing for generic sale and use in the country, no generic versions of these new generation DAAs have so far been registered in South Africa. The lack of registered products has required patients and doctors to use alternative pathways to access these life-saving treatments in the country.

Groote Schuur hepatologists Professor Mark Sonderup and Professor Wendy Spearman have previously described the difficult journey faced by one of their patients in accessing affordable DAAs in South Africa. The patient described as a businessman in the import and export business learnt about the life-saving benefits of HCV DAAs sofosbuvir and daclatasvir and started exploring options to import the unregistered medicines in South Africa. However, he soon learnt that the pharmaceutical companies holding patents on sofosbuvir and daclatasvir were charging astronomical prices for the drugs. Unable to afford the cost of patented drugs, the South African businessman flew to China and bought sofosbuvir and daclatasvir’s active pharmaceutical ingredients, which he dispersed into empty capsules for his personal use. He later contacted Sonderup and Spearman to inform them of what he had done in the hope that it could help other patients. Sonderup and his colleagues advised the patient that they could not engage in any activities that contravened South Africa’s laws to bring unregistered products into the country and highlighted the potential dangers of developing one’s own drugs from active pharmaceutical ingredients, including the inability of the patient to ensure that what he bought was not mixed with toxic chemicals, or that it was properly formulated to ensure that it is safe and effective.

On testing the patient, Sonderup and Spearman found that while the patient’s attempt at self-treatment initially lowered his HCV viral load, it did not cure his disease. Together the clinicians and patient explored ways to legally import quality approved sofosbuvir and daclatasvir into the country. Their efforts opened up an important pathway for people living in South Africa to access new, life-saving HCV drugs. The clinicians found that while patented medicines remained unaffordable to the vast majority of people living in the country, generic HCV medicines had started entering the global market at substantially reduced prices – due to a combination of strategies to overcome patent barriers in the global South, including patent oppositions and challenges, voluntary and compulsory licensing.

Using Section 21 authorisations granted by the South African Health Products Regulatory Authority (SAHPRA), Sonderup and his colleagues began legally importing unregistered generic DAAs to South Africa for HCV treatment in patients. Section 21 authorisations refers to section 21 of South Africa’s Medicines Act, a section that contains provisions that provide for the importation of medicines that are not registered in South Africa. To date, more than 200 patients have been treated with DAAs imported with Section 21 authorisations.

Generic products that have been imported into the country using this regulatory pathway include generic sofosbuvir, sofosbuvir/ledipasvir, sofosbuvir/velpatasvir and daclatasvir. However, the pending registrations of Gilead’s patented sofosbuvir, sofosbuvir/ledipasvir and sofosbuvir/velpatasvir threatens to extinguish this important access pathway for sofosbuvir and sofosbuvir combination products. This is because Section 21 importation is often not allowed once there is a registered product on the market in South Africa, even if the product is unaffordable.

Something similar to this recently happened in South Africa following the registration of the patented cancer medicine lenalidomide, which is used to treat multiple myeloma. Prior to the 2016 registration of the pharmaceutical company Celgene’s patented lenalidomide in South Africa, multiple myeloma patients were able to access generic lenalidomide from India at around R4,000 per month (including importation costs) through Section 21 authorisations. After the registration of the patented product these authorisations were refused, leaving patients to pay over R70,000 per month for the same treatment they previously imported for a fraction of the price. With pro-bono legal support, the Cancer Alliance has been able to assist previously treated patients in challenging the refusal of their Section 21 re-authorisations to access further generic lenalidomide treatment. However no new patients have been authorised, so all new patients must now pay the exorbitant prices for the registered patented product – or forgo this treatment.

Similarly to the lenalidomide case, the pending local registration of patented sofosbuvir products threatens to end Section 21 authorisation for use of generic sofosbuvir products in the country. The exorbitant prices likely to be charged by patent holders will block treatment access for most new patients that could benefit from this treatment. Yet, unlike for lenalidomide, there are voluntary licenses in place that allow for the sale and use of generic sofosbuvir products in South Africa as soon as they receive registration by SAHPRA. Unfortunately, experience shows that SAHPRA registrations are often extremely slow – and regulatory delays could thus interrupt access to generic sofosbuvir products in the country for years after the registration of patented products.

SAHPRA has however committed to clearing the backlog of applications that contributes to regulatory delays. In order to do this, the regulatory body will need to employ new strategies to speed up medicine regulation including through use of so-called “reliance pathways” that allow for SAHPRA to better utilise and rely on resources and decision making of other stringent regulatory authorities (such as the US Food and Drug Administration and European Medicines Agency) and the World Health Organization (WHO) in informing domestic decisions.

One of these reliance pathways is the WHO’s collaborative procedures for accelerated registration of medicines that have undergone regulatory review and received prequalification by the WHO. Through the collaborative procedures national medicine regulatory authorities can access regulatory evaluations and related information for medicines that have been prequalified as safe and effective by the WHO. Countries that use this process must commit to reaching national decisions within 90 days of receiving regulatory data from the WHO. This procedure has already been used to register generic sofosbuvir in Botswana, Zambia, Malawi, Zimbabwe, Ukraine and Thailand.

While South Africa has agreed to participate with the WHO’s collaborative procedures for accelerated medicine registration, to date it has not used these procedures to register a single medicine locally. Sofosbuvir offers an important ‘test case’ that South Africa can use to test these procedures as a reliance mechanism to speed up domestic registration of medicines – while simultaneously securing access to life-saving generic sofosbuvir.

Health advocates and the Department of Health should encourage generic companies whose sofosbuvir products have WHO prequalification (Mylan, Hetero and Cipla) to file for domestic registration as soon as Gilead’s sofosbuvir is registered and call on SAHPRA to use WHO collaborative procedures to accelerate rapid domestic registration. This procedure can also be used to secure access to generic sofosbuvir/velpatasvir and sofosbuvir/ledipasvir as soon as generic products under review by the WHO receive prequalification.

In addition to using WHO registration pathways, SAHPRA must develop new pathways for registering generic products when originator products are not yet registered in the country. Originator products may not be registered due to a lack of interest of originator companies in registering and marketing their products in South Africa – or delays by SAHPRA in registering originator applications.

Generic companies that have filed for registration of generic products that do not have a domestically registered originator have previously been told by SAHPRA that they need to provide their own clinical data. SAHPRA’s requirement for generic companies to submit their own clinical data effectively blocks generic companies from entering the market – as it is generally not financially feasible or ethically possible for generic companies to repeat clinical trials for their products. When originator products are registered, generic producers are able to rely on originator’s clinical trial data and must simply demonstrate bioequivalence with the originator product for registration – meaning that the two products are the same for all intents and purposes.

Previous experiences with SAHPRA have disincentivised generic producers of HCV DAAs from seeking registration in the country when originator products are not registered. To overcome this challenge, SAHPRA must create regulatory pathways for generic companies to enter the market when originator products are unregistered. Again, SAHPRA could utilise “reliance pathways” to access unredacted regulatory data and assessments from other stringent regulatory authorities with which it is aligned and has confidentiality agreements that have already registered relevant originators. Registration of generic daclatasvir could provide an important test case for use of this reliance pathway – despite licenses in place allowing for generic daclatasvir sale in South Africa since 2015, the originator producer Bristol-Myers Squibb has not filed for registration or indicated that it will seek domestic registration in South Africa.

While Section 21 authorisations currently provide an important access pathway to generic daclatasvir and sofosbuvir products in South Africa, the cumbersome nature of these procedures prevents broad access for all patients that could benefit from these medicines. However, despite their limitations, Section 21 procedures (which are currently under review) remain vital to securing access to unregistered products and should be expanded to explicitly allow for importation of unregistered generic products when the costs of registered originator products are prohibitive. There is precedent for this reform, as SAHPRA (when under the banner of the MCC) has previously authorised the importation of unregistered generic fluconazole and linezolid, used to treat HIV and TB respectively, on affordability grounds when patented products registered in the country were unaffordable. Section 21 approvals may also be used to allow for bulk importation of stock on other public health grounds, such as to address shortages of registered products.

As South Africa moves to adopt a viral hepatitis treatment policy, the registration of generic versions of key medicines (including sofosbuvir, sofosbuvir combination products and daclatasvir) will be critical to enabling an effective HCV response in the country. Regulatory barriers and delays have prevented the registration of affordable generic versions of key HCV medicines to date – and important access pathways secured through Section 21 authorisations are under threat. Through employing new reliance pathways, SAHPRA can begin to register key generic products. Health advocates and the Department of Health have an important role to play in highlighting the need for and encouraging SAHPRA to urgently use these pathways.

 

 

Hepatitis C in South Africa: A primer for civil society on the need for action

By Maria Stacey, Tim Lane, Anton Ofield-Kerr and Carlos Orte

OPINION: When the topic of Hepatitis comes up in conversation amongst people involved in the HIV response, people often confess they know very little about the illness. And yet, globally, viral hepatitis currently causes more deaths than HIV; and while the number of HIV-related deaths are falling, those associated with hepatitis are increasing yearly. Our National Strategic Plan for HIV, TB and STIs 2017-2022 recommends integrating viral hepatitis vaccination, screening and treatment into our comprehensive HIV response. Yet, there are significant barriers to making this a reality, including lack of awareness amongst health professionals, lack of public education, a lack of registration of life-saving medicines, and stigma and discrimination towards people at high risk for viral hepatitis, including people who inject drugs (PWID).

 Viral Hepatitis basics

The most common forms of viral hepatitis are Hepatitis B (HBV) and Hepatitis C (HCV). There are an estimated four million people with Hepatitis B and 400,000 with Hepatitis C in South Africa. Hepatitis C, in particular, affects key populations, especially people who inject drugs (PWID). Like HIV, Hepatitis C is a blood-borne virus, but is able to survive and remain infectious outside of the body longer than the HIV-virus. Although it can be sexually transmitted, the most efficient, and common, mode of transmission, is through re-used or shared needles and razor blades, or direct contact with infected blood.

Prior to the 1990s, most HCV transmission occurred iatrogencially, that is, unintentional transmission through medical procedures, including medical injections using unsterile needles, and blood transfusions before the blood supply was screened for HCV. Most of the up to 400,000 South Africans with chronic HCV infection acquired HCV through these means. Most of these are likely unaware of their HCV infection unless it has caused liver disease (see “Symptoms of Hepatitis C” below). Thankfully, iatrogenic infection is now extremely uncommon and preventable through many of the same precautions through which health care professionals prevent HIV transmission in medical settings, including the use of gloves, sterile needles, and safe disposal of medical waste products.

Nevertheless, South Africa is currently facing a significant viral hepatitis epidemic challenge. Recent epidemiological studies reveal rapidly growing hepatitis outbreaks among South African PWID populations. HCV prevalence estimates among PWID range between 45% and 94%; as many as half of all PWID may be co-infected with HIV and HCV; and around 5% of PWID have chronic HBV infection. PWID in the national capital of Tshwane appear to carry the highest burden of viral hepatitis: two separate, independent studies by the national NGO TB HIV Care and the University of California San Francisco in 2018 found three-quarters or more of PWID with an untreated viral hepatitis infection.

The structural and human rights challenges which make PWID a key population for HIV apply to Hepatitis C as well: high levels of stigma, discrimination, violence, criminalization of drug using behaviour and police harassment, low access to health services, high rates of homelessness, and high rates of incarceration.

 Symptoms of Hepatitis C

Like HIV, people who are infected with Hepatitis C may be unaware of the infection, as they can be symptom-free for years. Infection has an acute phase – the first six months after becoming infected – during which as many as 20% of infected people may naturally clear the virus. For the remaining 80%, infection will become chronic.

Some people with chronic Hepatitis C will progress to develop fibrosis and cirrhosis (scarring) of the liver, liver cancer or end stage liver disease, while others experience very little liver damage, even after many years. In cases where there is an absence of symptoms many people do not discover that they have HCV until some time after they have been infected. Heavy alcohol use and co-infections, including HIV and HBV, can exacerbate and accelerate progression of chronic HCV infection to cirrhosis or liver cancer.

Another reason that Hepatitis C goes undiagnosed for many years is that its symptoms are often non-specific and are frequently attributed to other illnesses. These include depression, fatigue, difficulty concentrating, skin problems, insomnia, pain and digestive disorders. In fact, often hepatitis C infection is picked up by doctors when they do a liver function test while monitoring for another medical condition; hepatitis C infection is then confirmed with HCV antibody and viral RNA testing. For these reasons Hepatitis C is often referred to as the ‘Silent Epidemic’.

New drugs bring eradication within our reach

In the past, the only HCV treatment option available was weekly injections of interferon, combined with daily oral ribavirin, for up to one year. Interferon-ribavirin treatment was associated with high rates of unpleasant chemotherapy-like side effects, including anaemia, flu-like symptoms including severe fatigue after interferon injections, and psychological side effects including irritability, severe depression, and suicidal thoughts. Even for those who could endure the full course of treatment, cure rates were only around 50%.

However, now, finally, new solutions exist to treat Hepatitis C. New direct acting antiviral drugs (DAAs) provide a safer, more effective, orally administered cure over a shorter time period (either an 8 or a 12-week course) that is well-tolerated with none of the severe side effects associated with interferon-ribavirin treatment. South Africa has recently approved National Hepatitis Guidelines, in line with the latest WHO recommendations for DAA treatment. A National Hepatitis Action Plan (NHAP) is being finalised, for launch in mid-2019. As many as 96% of chronic HCV infections in South Africa can be cured by DAA therapies. It may even be possible to eradicate HCV in South Africa by 2030.

Yet, South Africa faces significant barriers to scaling up Hepatitis C screening and treatment for all. These include lack of awareness amongst both healthcare providers and the general population who may have been exposed through medical procedures before the 1990’s, as well as high-risk groups such as PWID; the current lack of availability of DAAs except through a special Section 21 named patient procedure; failure by the South African Health Products Regulatory Authority (SAHPRA) to register any of the new medications; lack of treatment activist engagement in the silent epidemic; overwhelmed public health infrastructure; and a lack of ambition to plan and implement an eradication strategy based on mass case-finding, screening, treatment and cure.

What are the barriers and what needs to happen?

For South Africa’s NHAP strategy to be effective, a few things need to happen:

  • Increased awareness among healthcare providers. At the moment, awareness of Hepatitis C amongst health professionals is very low, and expertise is highly centralised within tertiary hospitals. There is a dire need to increase expertise amongst health professionals at primary and secondary level, so that they become alert to the symptoms of Hepatitis C, and are competent in the diagnosis and treatment of the condition.
  • Multi-sectoral cooperation to reach key populations. Partnerships between public health facilities and NGOs, especially those working with key populations, will create synergies. NGOs can engage with key population communities, raise awareness, conduct social mobilisation, refer for treatment, and provide sensitisation training for health facility staff.
  • Registration of DAAs. Direct acting antiviral drugs have been awaiting registration by the SAHPRA for up to five years. These drugs will address a large unmet public health need and must be processed and approved by SAHPRA urgently.
  • Human-rights affirming HCV prevention, care, and treatment for PWID. Punitive law and drug enforcement policies and programmes targeting PWID drive people away from health services, contribute to the growing HCV epidemic outbreak, and ultimately, cost lives. Programmes and policies to assist PWID should all be guided by WHO-recommended harm reduction best practices, including access to sterile needles, and opioid substitution therapies (OST) to treat heroin addiction.
  • Needle and Syringe Programmes (NSP). PWID often do not have access to clean and sterile needles despite peer-based NSP outreach to PWID. For example, in eThekwini, the municipality shut down a civil society NSP. PWID need a continuous supply of adequate quantities of needles and syringes, otherwise even if people are treated for HCV, they can become re-infected.
  • Cost-effective Opioid Substitution Therapy (OST) access and scale up. OST is currently out of reach for most PWID due to its high retail cost. For example, the OST drug Methadone is currently approximately 30-40 times more expensive in South Africa than in other countries. Public health emergency strategies must be invoked to decrease the cost, including encouraging introducing competition into the market through new applications to SAHPRA.

Civil society advocacy has the power to unlock the hepatitis response in South Africa and save hundreds of thousands of lives, as it did with HIV. It is time for civil society to educate ourselves, talk openly about hepatitis, advocate for integration of hepatitis screening into primary health care and sexual and reproductive health services, and to reduce barriers to care and treatment, especially among PWID and other key populations. It is also time for government to lead the hepatitis response, with an ambitious strategy aimed to eradicate hepatitis through mass screening, treatment and cure.

  • The authors are Directors of Equal International, a niche consultancy group focused on supporting multi sectoral partnerships to ensure marginalised groups are not ‘left behind’, and would like to thank the PITCH programme (a strategic partnership a strategic partnership between Aidsfonds, Frontline AIDS and the Dutch Ministry of Foreign Affairs) for supporting multi-stakeholder engagement around Hepatitis C and PWID in South Africa.