Is scaling up active case finding the missing piece in our TB response?

By Sean MacDonell 

South Africa has one of the highest burdens of tuberculosis (TB) in the world. The World Health Organization (WHO) estimates that 322 000 people in South Africa had active TB disease in 2017, meaning they were presenting symptoms and could spread the TB bacteria. Approximately 60% of these people were also living with HIV. TB is the leading reported cause of death among people living with HIV and in South Africa overall (although models indicate that HIV still causes slightly more deaths). 

Increased access to antiretroviral treatment (ART) has meant that fewer people with HIV have developed TB and died of TB. But what else can be done to reduce TB rates besides improving access to ART for people living with HIV?

Although TB rates are slowly decreasing globally, there appears to be consensus in the TB research community that more must be done in order to reduce TB rates more quickly. One area where more can be done is active case finding (ACF).

What is active case finding?

People with TB are often diagnosed through passive case finding (PCF) when they present to clinics (primary health care centers) with TB symptoms. ACF is generally considered to be any other method of reaching people with TB outside of the primary health care system. According to the WHO, ACF is “the systematic identification of people with suspected active TB, using tests, examinations or other procedures that can be applied rapidly.” 

Because ACF is often defined as anything that is not PCF, different definitions have been employed by different people in different studies. This creates difficulties when trying to compare ACF interventions, as people may be describing distinct interventions while calling both ACF. 

Regardless, the purpose of ACF is widely agreed upon: to find people with undiagnosed active TB and to link them with treatment in order to help them get healthy and to reduce the period of infectiousness. Once people with TB start taking treatment, they become non-infectious very quickly. By the time someone goes to a clinic for help, that person may have transmitted TB to as many as ten or fifteen other people–ACF can help prevent these onward transmissions by getting people onto treatment more quickly.

In this way it is thought that greater ACF efforts particularly among high-risk groups will greatly reduce the number of people with active TB. High-risk groups for TB are people living with HIV, children, the elderly, mine workers, inmates, military personnel, and healthcare workers – in addition to people in the same household as someone with active TB or other close contacts of someone with TB.

Currently, ACF has not been widely undertaken in South Africa due to the stress it would put on the already overburdened health care system. “It comes down to perceived resources and disease burden being attended to in primary health clinics,” explains Erika Mohr-Holland, a Khayelitsha-based epidemiologist for Doctors Without Borders whose focus is on drug-resistant tuberculosis (DR-TB). “If health care workers are attending to a lot of sick people it becomes a lesser priority to see those who are perceived as well.” Therefore, there has been little focus on ACF and prevention. “It’s all on treatment,” says Mohr-Holland.

Contact tracing

One form of ACF is contact tracing. It is defined by the WHO as “the identification and follow-up of persons who may have come into contact with a person with active TB.” The WHO assumes each person has at least three close contacts. Contact tracing is probably the most widely implemented form of ACF in South Africa. 

Contact tracing was one of the ACF interventions in the ZAMSTAR study, a cluster randomised control trial carried out in areas with high burdens of TB/HIV in South Africa and Zambia. Contact tracing was performed through frequent household visits and screenings for contacts of patients with active TB. This resulted in a relative reduction in TB prevalence (the percent of the population who has TB) of approximately 22% compared to matched communities where these interventions were not implemented. 

 Mobile clinics

The use of mobile clinics for TB screening is another form of ACF.  Mobile clinics are clinics operated out of specialized vehicles and  are typically located in areas that do not have immediate access to primary health clinics. Mobile clinics can be especially useful as they can reduce barriers to access, such as the cost and time of travelling to a clinic. They can also tailor the services they offer to the communities that they are in. 

Both mobile clinics and house-to-house visits were used to conduct TB screenings in the DetecTB study, a cluster randomised control trial in Zimbabwe. Both interventions used sputum smear-microscopy. However, the mobile clinic intervention detected more TB cases than house-to-house visits. This led to a relative reduction in TB prevalence of 40% in the mobile clinic community compared to before the intervention.

Mobile clinics may more readily provide access to chest radiography, or x-ray, (CXR) as a screening tool. CXR is cheaper than other screening methods, is shown to provide accurate results in high TB/HIV burden areas, and may detect TB prior to someone developing symptoms. 

What needs to be done

Cost is one of the main barriers to implementing ACF interventions in resource limited countries. However, mathematical models can help us predict the costs and benefits of different ACF interventions. One recent model found an aggressive scaling-up of ACF could reduce the incidence of TB in South Africa by 55% and reduce mortality by 72% by 2025 (compared to 2015 numbers). Another found that scaling-up of ACF could reduce total patient costs by 28 billion rand between 2016 and 2035. The further development of reliable mathematical models, particularly with a focus on the South African context,  should be prioritised. 

It is not always clear which intervention, or combination of interventions, may be best for a certain district, province, or segment of the population. Therefore, in addition to more modelling work, there is a need for more cluster randomised control trials to determine the effectiveness of these different interventions. Large studies such as ZAMSTAR, DetecTB, and Kharitode are giving important indications of what works and what does not, but we still need more evidence. 

However, waiting until more trials are conducted and the evidence is even clearer is not an option given South Africa’s high TB incidence. We simply cannot afford to wait. Current evidence leaves little doubt that TB prevention through some form of ACF, probably both increased contact tracing and mobile CXR clinics, must be scaled up in order to accelerate the fight against TB. Whether or not the resources will be found to do this properly will be a good measure of the South African government’s commitment to fighting TB.

  • MacDonell is a Spotlight intern and a student at Carleton College in the United States.

Graphs that tell the story of HIV in South Africa’s provinces

By Marcus Low and Sean MacDonell

The most recent outputs of the Thembisa mathematical model (version 4.2) of HIV in South Africa not only allow us to see the burden of HIV at the country level, but also allow for provincial comparisons. Through several tables, graphs, and maps, we illustrate how the HIV epidemic differs in each of the country’s nine provinces.

1. Which provinces have the most people living with HIV?

The table below shows which provinces have the largest number of people living with HIV. The ongoing increases in these numbers are both positive and negative. On the negative side, it reflects the fact that the rate of new infections remains high; on the positive side, it reflects the reality that people with HIV are not dying at the rates they used to since antiretroviral therapy is keeping millions of people alive. 

ProvinceNumber of people living with HIVPrevalence
Eastern Cape85932913.04%
North West52459313.59%
Western Cape4522106.76%
Free State419631

Northern Cape817787.13%

KwaZulu-Natal is clearly at the centre of South Africa’s HIV epidemic. The province has more people living with HIV (over two million) than North West, Limpopo, Western Cape, Free State, and Northern Cape combined. In interpreting these numbers one should of course keep in mind that KwaZulu-Natal is South Africa’s second most populous province behind Gauteng – which partly explains the high absolute numbers, but not entirely.

2. What percentage of the population is living with HIV in each province?

To contextualise the number of people living with HIV in a province in terms of the size of provincial populations we can look at the percentage of a province’s population who are HIV positive (also known as prevalence). In the same table above we can see that KwaZulu-Natal still tops the list with an incredible 18.23% of the population living with HIV.  While Free State ranked eighth for the absolute number of people living with HIV in the province, it ranks third in terms of prevalence at 14.62%. Despite the large absolute number of people living with HIV in Gauteng (nearly two million), the province ranks only fifth in terms of prevalence at 13.05%. Here we can see how prevalence has changed over time in South Africa’s four most populous provinces: Eastern Cape (EC), Gauteng (GT), KwaZulu-Natal (KZ) and Western Cape (WC). While the prevalence of HIV continues to rise in the Eastern Cape, KwaZulu-Natal, and Western Cape, we can see that it has now begun to fall (albeit slightly) in Gauteng. Prevalence continues to rise in most provinces for the same reasons that the absolute number of people living with HIV is rising, although prevalence is also impacted by changes in the province’s population.We can also conceptualize prevalence using the map above. One interesting trend is that provinces in the east of the country tend to have higher HIV prevalence than provinces in the west. (See the column on prevalence in the table for exact numbers.)

3. How many new cases of HIV are there each year in each province?The graph above shows the number of people newly infected with HIV each year in the four most populous provinces. Here we can see that KwaZulu-Natal has dramatically reduced the number of new HIV infections, now having fewer people newly infected with HIV than in Gauteng. While the number of new HIV infections continues to come down in the Western Cape, a much flatter line suggests a slower rate of decline than in the other three most populous provinces. 

4. The 90-90-90 targets

The 90–90–90 targets are a set of global goals established by the United Nations Programme on AIDS and HIV. By 2020, the goal is that “90% of people living with HIV will know their HIV status, 90% of those who know their HIV-positive status will be accessing treatment, and 90% of people on treatment will have suppressed viral loads.”

These targets provide a good measure of how well different provinces are performing in key areas such as the provision and promotion of HIV testing and helping people who test positive to start treatment and to stay on treatment.

Province% of HIV-positive individuals diagnosed% of HIV-diagnosed individuals on ARTFraction of ART patients virologically suppressed (RNA count <1000 copies/ml)% of HIV-positive individuals on ART with VL <1000
Eastern Cape90.14%61.60%87.19%48.41%
Free State89.24%73.40%91.48%59.92%
Northern Cape90.81%83.02%84.42%63.66%
North West89.21%57.65%87.87%45.20%
Western Cape88.73%65.53%89.79%52.24%

The table above displays 90-90-90 targets for each province. This allows us to examine how each province is either achieving or falling behind each target of 90%. The fourth column is the product of the three target percentages; in other words, it is the percentage of all people living with HIV in the province who are both accessing antiretroviral treatment and have suppressed viral loads. As this fourth column represents 90% of 90% of 90%, a province achieving all three targets would have at least 72.9% in the fourth column. In other words, at least 72.9% of people living with HIV in a province would be accessing ART and would have viral loads below 1000 if they are meeting all targets. 

In the table above we can also see that the Northern Cape is closest to achieving this target percentage as 63.66% of people living with HIV are both accessing ART and have suppressed viral loads.

It is clear from the table that the greatest barrier to achieving the 90-90-90 targets is ensuring that people with diagnosed HIV are taking antiretroviral treatment. Only in the Northern Cape is the percentage of people with diagnosed HIV who are taking treatment over 80%. While North West comes close to achieving the first and third targets, only 57% of people with diagnosed HIV in that province are on treatment.

The dynamics between the three 90s can be interesting. For example, when a province suddenly initiates a lot more people onto treatment, we may at first see a reduction in the percentage of those with suppressed viral loads since many of the new patients will still have unsuppressed viral loads. Either way, ensuring that those who know their status receive the treatment and care they need is a priority in order for South Africa to achieve the 90-90-90 targets. The graph above shows the percentages of people with HIV who are both on treatment and virally suppressed for the four most populous provinces from the year 2001 until 2018. KwaZulu-Natal and Gauteng have consistently high rates, while there has been a slight drop-off in the Western Cape and Eastern Cape during the last few years.

Note: The graphs in this article were produced using RStudio and the ggplot2 package. Graphs are exclusively based on publicly available Thembisa model outputs. Spotlight takes full responsibility for any errors or misrepresentations there may be in the graphs.





High price delays introduction of new TB prevention therapy

By Amy Green

Despite being an ancient disease, tuberculosis (TB) remains the world’s leading infectious disease killer from a single infectious agent. For decades effective preventive therapy has existed, but has not been widely used. Recent optimism about a shorter and safer form of prevention therapy has been dampened because of its high price. While price negotiations continue behind closed doors, Spotlight asks when this new therapy will become available in South Africa.

A quarter of humanity is infected with the TB bug, according to the World Health Organisation (WHO). If left untreated, TB infection can develop into active TB disease, the form of TB that makes people sick and is capable of being transmitted from one person to another.

Only a small percentage of infected people, up to an estimated 15%, ever progress from TB infection to active disease, but the rates are much higher in children as well as people living with HIV and other diseases affecting the immune system. South Africa’s high rates of HIV raise this risk tremendously.

Additionally, while the global levels for infection with the TB bug, known as latent TB infection, are high, they are much higher in South Africa. “More than half of the South African population has latent infection,” says Professor Harry Hausler, chief executive officer of TB HIV Care. “The idea is to treat this latent infection so that it doesn’t progress to TB, and the focus up until now has been on people living with HIV because of their higher risk.”

According to Lotti Rutter of Health GAP, an international HIV advocacy organisation with a presence in South Africa, despite the fact that “people living with HIV with latent TB infection are 21 times more likely to develop active TB than HIV negative people, and one third of all HIV-related deaths are due to TB, fewer than one million people with HIV were started on preventive TB therapy in 2017”.

A large proportion of these were in South Africa, mostly receiving the drug isoniazid. So-called isoniazid preventive therapy (IPT) has to be taken for anything from six to 36 months.

According to Deputy Director General at the National Department of Health (NDoH) Dr Yogan Pillay there was a slight increase in the number of newly diagnosed HIV patients started on isoniazid between 2017 and 2018: from 40 7602 to 48 4982.

A new TB prevention option

“Isoniazid preventive therapy is long in duration, carries a higher risk of liver toxicity and is less likely to be completed in full than novel therapies using the drug rifapentine,” says Rutter.

Rifapentine-based preventive therapy, commonly referred to as 3HP, only has to be taken for three months.

At a cost of $45 for the three-month course 3HP is widely considered to be unaffordable to most countries, including South Africa. The sole manufacturer, pharmaceutical giant Sanofi, has been in talks with global funders since 2017 to reduce the price.

The target price is $15 per course which has been deemed affordable to funders like Pepfar, a United States government funding mechanism, and Unitaid, a multilateral aid organisation. Earlier this year Pepfar indicated that they would be able to procure 3HP for their programmes at this, or a lower, price.

Citing University of Liverpool research, the New York-based health advocacy organisation Treatment Action Group (TAG) has argued the regimen could be sold for as little as $10 per course and still provide Sanofi with a reasonable return.

The negotiation process with Sanofi was kicked into action following a 2017 Unitaid grant for the IMPAACT4TB project which had a direct goal to lower the price of rifapentine and to foster generic competition to radically ramp up access to 3HP in high-burden countries.

Initial negotiations included Unitaid but after a generic manufacturer registered a 3HP product for WHO prequalification earlier this year, UNITAID decided it would make more sense to wait.

Spotlight has learned from two reliable anonymous sources that the manufacturer responsible for the generic, in the form of a fixed-dose-combination, is India’s Macleods Pharmaceuticals.

Macleods and other generic players will increase competition in the market and should in time bring down the cost significantly. Most countries, however, have to wait for the WHO prequalification process to conclude, with some like South Africa requiring registration with national medicines regulators, before they can begin procuring generic 3HP.

According to Professor Gavin Churchyard, chief executive officer of The Aurum Institute, South Africa will likely be one of the first countries in which generic manufacturers will register their 3HP options but “given how long it took for Sanofi to register 3HP locally – about two years – registration is not going to happen right away.”

The NDoH has placed rifapentine on tender and Sanofi has responded, according to Pillay, and currently the negotiations are happening between these two parties alone.

“Unitaid is open to procuring Rifapentine from Sanofi to facilitate 3HP introduction in early adopter countries before generic formulations come to market at scale, provided a reasonable price is offered. Several countries want to move with 3HP now. For South Africa, even if the first generic product receives prequalification in 2020, the duration of the national Health Products Regulatory Authority process would mean that it is unlikely to be available in South Africa before 2021,” says Unitaid’s director of operations Robert Matiru.
“We are monitoring the outcome of South Africa’s negotiations with Sanofi for a lower rifapentine price and feel it’s important that the final price is extended to other low and middle-income countries,” he said.

Additionally, in March the results of the DOLPHIN study were announced providing evidence that 3HP is compatible with the antiretroviral dolutegravir which Pillay said would be introduced as the first-line HIV treatment in South Africa on 1 September (initially set for 1 August). Previously, a small study had raised questions as to whether 3HP and dolutegravir could safely be taken together.

IPT for the time being

Locally, says Hausler, 3HP is only available on a miniscule scale at three demonstration sites. Instead, isoniazid is given to people living with HIV for a minimum of six months to a maximum of 36 months.

According to Churchyard, most people living with HIV in South Africa are prescribed isoniazid for a year, after active TB disease has been ruled out. Those in which latent infection has been confirmed are meant to take the drug for 36 months and a six-month course is given to people who have not started taking antiretroviral treatment.

Hausler explains that studies have shown that people living with HIV who have taken the full course they have been prescribed have been protected against active TB for up to three years.

One of the biggest problems with this regimen is the long duration of treatment and that very few patients who are started on the drugs actually complete the course, says Hausler.

Pillay told Spotlight that the treatment completion rates are “very low” but he was not able to provide concrete figures because “we do not monitor this.”
However, according to Hausler, the government does attempt to record this data but it is problematic. “At every patient visit, clinicians are meant to write down whether they received isoniazid or not and below 40% actually do. But we know that completion rates are low and definitely not where we want them to be,” he says.

The only quality data is on how many newly diagnosed HIV patients given ART are also given isoniazid, even though the current guidelines state that TB prevention treatment should also be offered to any HIV positive person as well as children under the age of five living in the same household as someone with active TB.

Guidelines to be updated

The NDoH is in the process of finalising new guidelines on preventive TB treatment which will extend its offering of isoniazid, as well as 3HP when it becomes available, to all household contacts of persons with active TB. At the moment only children aged five or younger and contacts living with HIV are eligible.

Pillay says that the guidelines are not, however, on the agenda of the next meeting of the National Health Council’s technical committee set for the first week of August and will only likely be discussed at the following meeting. These meetings generally happen every six weeks.

Hausler says that this is where 3HP will have most of its benefit over isoniazid. People already on daily drugs for HIV might not mind an additional pill for a year in the form of isoniazid, but HIV negative people might rather choose to take 3HP which is given once a week for three months.

“Intuitively, it’s hard for people to grapple with the concept of prophylaxis: taking drugs when they are not sick, to prevent and not to treat. So, a shorter course for these groups is very important,” he says.

Currently 3HP comes in the form of 10 pills per week which is a high pill burden for anyone, according to Pillay, who said that South Africa is hoping for the WHO to approve (pre-qualify) a fixed-dose-combination version as soon as possible.

In the meantime, activists are hoping for a quick resolution to the high cost of Sanofi’s regimen.

“Sanofi is not the originator of rifapentine. It’s an old drug and its primary patents have expired long ago. It came into their portfolio through decades-long pharmaceutical mergers and acquisitions,” explains TAG’s TB Co-Director Mike Frick.

“It is true that they have advanced its development and it’s not as though they haven’t been good stewards but the majority of the research was funded by the United States (US) tax payer. And the citizens involved in the trials pivotal for the formation of 3HP, not only in the US, but in countries like South Africa, don’t necessarily have access to rifapentine,” he says. “Considering the millions in public investment and the fact that the drug is old and has many public benefactors, the continued high price is really unconscionable.”

Health DG welcomes new guide to National Health Act


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.  


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.


Tuberculosis in SA: Three graphs that tell the story

By Sean MacDonell and Marcus Low

According to World Health Organization (WHO) estimates, South Africa continues to have one of the highest burdens of tuberculosis (TB) in the world. The burden of a disease refers to the number of infections and deaths within a population and the associated costs of treatment of a specific disease. Here we attempt to tell the story of the burden of TB on human life using several graphs. As the story of TB cannot be separated from that of HIV, we use estimates from both the WHO TB data portal and the Thembisa mathematical model of HIV in South Africa to examine trends in the data from 2000 to 2017. 

You can find more of Spotlight’s graphical storytelling on HIV here.

          1. How many people in SA get TB? 

The graph above shows the estimated number of TB cases per year in South Africa from 2000 to 2017. The solid red line indicates the median WHO estimate of the number of TB cases – these are the figures that are most commonly quoted. As you can see, the number of TB cases in South Africa is estimated to have been relatively stable from 2006 to 2014, peaking at approximately 500 000 cases in 2008, yet has decreased substantially since 2015.

The dashed lines on the graph represent the high and low bounds of the estimates (in technical terms the 95% confidence interval). The fact that these lines are as far apart as they are tells us that there is very significant uncertainty about these figures and that we should take the estimates reflected by the red line with a grain of salt. As you can see from the dashed lines, the number of TB cases per year may well have peaked in 2007 at nearly 700 000 or in 2011 at only 370 000 – with the limited information at our disposal we can’t be sure. 

All of the graphs below use the relatively uncertain WHO TB estimates and should likewise be taken with a grain of salt. 

          2. TB cases and HIV status

The graph above shows the number of new cases of TB per year in South Africa. The coloured regions divide the number of new TB cases by HIV status. Well over half of all people who develop TB are living with HIV, as you’d expect in a country where the TB burden is fuelled largely by the HIV epidemic. The total number of new TB cases peaked in 2008 and has since been declining – a decline that is linked to the increase provision of antiretroviral therapy. Providing people living with HIV with antiretroviral therapy makes it much less likely that they will develop TB.

           3. How many people die of TB in SA?

The graph above displays the number of deaths from TB, with the different colours once again representing the breakdown by HIV status. The large swath of purple clearly indicates the majority of deaths from TB have been in people who were living with HIV. Deaths from TB among HIV positive individuals peaked in 2005 at approximately 130 000. It has decreased dramatically since then primarily due to increased access to antiretroviral therapy. 

The downward trend in TB mortality among HIV negative individuals, however, has not been as dramatic and has stagnated in recent years. Mortality peaked in 2005 at 30 000 deaths and was estimated at 22 000 in 2017. The plateau in TB mortality for HIV negative patients suggests that we are not doing a particularly good job at treating and preventing TB specifically – and supports the suggestion that most of the progress we have seen against TB in South Africa is fuelled by the country’s impressive HIV treatment programme.

Note: The above graphs can be downloaded here for use in presentations. The graphs were generated in RStudio using the ggplot2 package. All the data used in these graphs are freely available from the WHO TB portal and the Thembisa model outputs linked to at the top of this article.

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.


The TB in the air we breathe

Wedged between mountain and sea on a breathtaking stretch of Cape Peninsula coast, the township of Masiphumelele is home to 23 000 people on about 40 hectares of land.* Despite its name which means ‘we shall succeed’ in isiXhosa, living conditions here are dire. It is overcrowded, sanitation is not what it should be, and infectious diseases like HIV and tuberculosis (TB) are rife.

Professor Robin Wood in the new laboratory. Photo by Joyrene Kramer.

According to University of Cape Town Emeritus Professor Robin Wood, TB infections in the community are astronomically high, particularly amongst children and adolescents.

‘So at the moment, here in Masiphumelele,’ says Wood. ‘Kids of about five years old; 20% of them are infected with TB before they go to school. At the time they’re 14, about 50% are infected, and by the time they leave school, 65 to 70% of them are infected.’

These rates, he says, are applicable to other impoverished communities in the Western Cape, and across South Africa.

The question is ‘why?’

This is what Wood endeavours to learn at a new world class tuberculosis facility officially launched in the heart of Masiphumelele, at the Desmond Tutu HIV Foundation – of which Wood is CEO – on February 20. He says the new Aerobiology TB Research Facility will operationalise leading technology for studying TB transmission, by capturing and analysing exhaled breath from patients recruited at two local clinics: one in Masiphumelele and another in the nearby township of Ocean View.

The patients are brought to the laboratory, where, inside an airtight unit, their breath in captured for an hour. About 500 liters of expired air is collected, and then scanned for TB particles.

‘So what we do,’ says Wood. ‘We identify bugs in the air that people are breathing out. We use new techniques to show that the organisms are TB and that they are alive, without having to culture them (slowly grow them in the lab), which normally takes around six weeks or so. So we’re getting a measure of the infectivity, which I think is key.’

Not nearly enough being done to stop transmission

Photo by Joyrene Kramer

Referring to the fight against TB, Wood argues that prevention is just as important as cure. He says that while treatment of TB patients in South Africa is effective, not nearly enough is being done to stop transmission of the disease.

‘The philosophy behind the new centre,’ says Wood. ‘It is that we have a TB epidemic, which is now worse than anywhere else in the world. I think we need a new approach to this. For example, we know that infection is being acquired by children in schools, but again, we do nothing about it. So my feeling is, I’m trying to get people to refocus. This is an infectious disease. Why don’t we try and address people who are getting it, and try to stop them from getting it? Treatment is good; people used to die on average in two years after getting infected, treatment changed that around dramatically. But it hasn’t decreased the rate at which people are getting infected.’

Over the years, Wood’s research has taken innovative approaches to exploring TB transmission and the socio-environmental factors that drive it.

One such approach is to give people CO2 breath monitors that also tracked their location using GPS. This kind of research helps researchers to understand in which settings the most air is being swapped – with such settings presenting a higher risk of TB transmission if someone in that setting is coughing out or exhaling TB bacteria. One 2017 study co-authored by Wood found that the risk of TB transmission in Masiphumelele was particularly high in schools.

In 2011 he co-authored research published in the South African Medical Journal showing that the risk of becoming infected with TB in Pollsmoor Prison was around a staggering 90% a year. In a landmark judgement in 2012 the Constitutional Court found the state could be held liable for Dudley Lee contracting TB whilst being held in Pollsmoor. Wood wrote an expert affidavit in that case drawing on the 2011 study.

Not enough has materialised

There are around 322 000 TB infections in South Africa per year. South Africa’s National Strategic Plan on HIV, TB and STIs for 2017 – 2022 includes an objective to ‘promote TB infection control’. To this end it specifies: ‘infrastructural changes to improve ventilation; introducing appropriate legislation and building regulations; developing norms and standards for housing and congregate settings including schools and public transport; and developing guidelines for TB infection control in congregate settings and households.’

Yet, a frustrated Wood says not enough of this has materialised. Inside his office, adjacent to the new Aerobiology TB Research Facility, a rubber stress ball sits on his desk.

‘So one of my pet annoyances is that we know where TB spreads, particularly at high rates, for example prisons such as Pollsmoor,’ says Wood. ‘We lock people up for 23 hours a day in rooms with no ventilation and we’re surprised that an airborne disease takes place in such numbers. Why don’t we do something about that? So that’s all we have to do in prisons: we have to change the socio-environmental circumstances they’re in. It’s not rocket science. This is a disease that is spread airborne. So it’s the amount of air that people swap with each other. And that’s determined by indoor environments with crowding and not enough ventilation.’

A mural outside the laboratory. Photo by Joyrene Kramer.

At the Aerobiology TB Research Facility, Wood hopes to soon test adolescents, including pupils from the Masiphumelele High School, which is next door to the premises.

‘One of my arguments is that if we want to control TB, we have to stop infecting children. Where they’re getting infected and how they get infected is something we need to further explore,’ he says.

Also on the Desmond Tutu HIV Foundation’s premises, a youth centre has computers for pupils to work on, while a youth friendly clinic offers free sexual and reproductive health services. The buildings are bright and sunlit, built around a courtyard with trees and flower beds. After school, pupils stream across a dirt road from the school to the centre, where a homework club is hosted daily from 3 to 4:30pm.

‘So we’ve always tried to mix social activity with health,’ says Wood. ‘This new era biology TB unit, it’s just the latest addition to a spectrum of things we do here in Masi.’

*These figures are estimates. When contacted by Spotlight, City of Cape Town spokesperson Simon Maytham said the city’s last official Masiphumelele population figures were from the Stats SA 2011 census. ‘Masi is comprised of an informal settlement component, a temporary relocation area and a number of formal erven with backyard tenants, and we only have some of this info as it stands,’ he said.



AIDS2018: Humans in the Age of HIV- “There was no one who came to visit them at their homes”

By Ngqabutho Mpofu

Ronnie came out in the early 1980s, telling his friends and sister that he was homosexual. This was not an easy thing to do, given the traditional Xhosa culture that he is from. He credits his support network for helping him come through that period in his life. Today he works in Observatory in Cape Town as a youth programme coordinator at a child and human rights programme.

He has been closely involved in issues affecting Men who have Sex with Men (MSM) for a long time, including as a (now former) board member of the Triangle Project, which focused on health issues affecting the LGBTI community.

Over the years he has witnessed the deaths of many comrades and friends as a result of HIV/AIDS related causes. “Most of the people that were in my (age) group have passed on because there was no support from government, they had no health support, there was no one who came to visit them at their homes, so they died in isolation”, says Ronnie.

He acknowledges that much has changed in the over 30 years since he came out, including the formation of initiatives run by the State and non-governmental organisations such as the Ivan Toms clinic, with programmes specifically tailored for MSM, which have yielded great results in terms of help-seeking[1] and greater access to health care amongst MSM.

Yet, Ronnie says there is still a very long way to go. Most of these health facilities are very far from the people who need them, which is problematic given the high levels of unemployment and poverty in the country. “Government needs to bring the services closer to the people through creating satellite clinics tailored for MSM. Unfortunately, we are still struggling with stigmatization and prejudice in South Africa against the LGBTI community in public health facilities”. This critical problem, which is not only limited to health care practitioners, but includes the attitudes of front line staff such as security guards, receptionists and cleaners, continues to severely stymie the country’s fight to attain its overall goal of an AIDS free population.

Ronnie argues that the state should implement mass sensitization campaigns so that staff in health facilities can acknowledge the LGBTI community and ensure that health care spaces are not spaces that they feel they cannot enter.

Community sensitization is also important, says Ronnie, as he has been heavily involved in community dialogues, educating them about key populations. He cites the important work done by Anova Health, which rolled out workshops in shebeens, a South African colloquial term much like the American ‘speakeasy’, a place mainly frequented by men who want to drink alcohol. Anova Health has sought to increase help seeking and foster tolerance in a country where men have been notorious for their role as perpetrators of violence.

Ronnie argues that another possible way that the State could significantly broaden its reach in terms of access to healthcare is to employ MSM from within communities as community health care workers, as they have greater access to MSM specifically and the broader LGBTI community that other health care practitioners would not be afforded.

The critical right to food is also extremely important to Ronnie, having seen his comrades waste away in the past. In a country where poverty has led to about 12 million people going hungry, Ronnie harks back to the Black Consciousness strategies of community upliftment projects through the establishment of vegetable gardens in order to be able to take one’s pills with a full stomach.

Ronnie shows no signs of slowing down. He hopes to pass on his knowledge to younger activists to join the fight for access to quality, affordable and dignified health care for MSM and other key populations.

This article is part of a Spotlight special series on people who form part of so-called key populations.

[1] Avert, “Men who have Sex with Men (MSM), HIV and AIDS”,, accessed 16 July 2018 and MSMGF (2013) ‘MSM in Sub-Saharan Africa: Health, Access & HIV’


A new normal where SheDecides: What needs to happen to get there?

By Robin Gorna

I want to live in a world where every girl and every woman can decide what to do with her body, her life, and with her future. Without question.

The SheDecides manifesto (below) outlines the vision of the world I want to live in: a world which respects, upholds and promotes my fundamental rights to decide what I do with my body, the choices I make, the pleasure I have, the people I share it with, the times I use it to bring more life into the world. And the times I do not.

As an old AIDS activist, with a passion for womens rights (my activism began in 1986 and I was one of the first to write about HIV and women; my first book was published nearly a decade later, after many articles etc), I am dazzled and frustrated to see how we can make progress in many areas, and walk backwards in others.

When I started my AIDS work we were all about convening workshops, writing brochures, designing sexy campaigns, extoling the delights of Safer Sex. We promoted to young women and men – and some older ones too –  the positive joys of sex, the ways in which we needed to modify what we do to avoid HIV and other STIs, as well as pregnancy. And that consent was Queen. We’d call it integrated programming now, or comprehensive SRHR.

These are not radical notions. The underpinnings are enshrined in the Universal Declaration of Human Rights, and – as Mark Heywood & Thuthu Mbatha rightly observe in their excellent article they are bolstered by repeated declarations at United Nations and regional levels. What’s more: South Africa’s constitution has been heralded as one of the most progressive in the world. South Africa should be more than capable of creating a society where she decides. Yet the translation of good laws into policies and programmes is tough and complex, especially when sex is involved.

Mbatha & Heywood provide a rounded picture of that simplistic acronym: SRHR (sexual and reproductive health and rights). It gets flung around by professionals with few of them ever stepping back to remember that sex includes so much, including pleasure. Kudos to Heywood & Mbatha for bringing pleasure to the front of their paper and argument! They also rehearse, with great pain, the distance that must be travelled in order for South Africans to realise their rights, and enjoy good health in their sexual and reproductive lives.

Yes, activists must shoulder some blame – we have all too easily and too often collapsed into our silos – and there is much more that has brought us to this place. As a non-South African, perhaps it is not for me to comment on Pumla Dineo Gqola’s lament against “the culture of rape” that is so deeply embedded in South African society. Yet her description and analysis of the war on women’s bodies and autonomy cannot be denied: it is urgent that society tackles this perversion of culture, this abuse of the inherent goodness of sex.

Culture is society. Without tackling these enormities, these complexities, without shifting social norms, the promise and hope of the impressive South African constitution – or any brave international declarations – can not be realised. The rights of all people to enjoy their sexual rights, reproductive justice, the health and economic benefits that flow from those rights – all will remain a distant dream.

SheDecides has taken shape as a movement because it hooks into an urgent need to shift social norms, to shape a new narrative, removing the sting of historic battles and jargon and re-focusing communities and individuals on the simple story of fundamental rights: the autonomy of the body. It is an initiative designed to do what Barbara Klugman notes has been lacking: to frame these issues in ways that [catch] the public and media imagination[1]. It espouses the vision expressed by Mbatha & Heywood: All of it is connected…. SRHR can[not] be realised separately from other rights[2].

They go on to outline a plan of action, priorities that South Africa needs to work on. They remind us that the constitution provides the framework, that action is lacking, and they define an agenda to get the country back on track. It is a good one. Without doubt, tackling the rape culture and the HIV crisis are hot priorities for South Africa. And I would add in the urgency (for the 2018 short term) of getting good quality, comprehensive sexuality education (CSE) in place in every school across the country; the importance of vigilance on abortion policy (and scaling up provision of medical abortion, including by non-specialists); and emphasising (over the medium term) action on SRHR as a means to achieve Universal Health Coverage (UHC) – clearly a top priority in South Africa, and one where evidence of the linkages is already emerging.

In their agenda, Heywood & Mbatha talk about action in schools this year. Yes, PrEP, and condoms and sanitary pads – but without the knowledge, skills and resilience to understand how all of these commodities relate to my body, the self respect and resilience to choose what I do with my body, making pills and products available to young people will never be enough.

In India, where SheDecides engages through many organisations, and especially our Champion Indira Jaising (a remarkable senior advocate who has driven legal and policy change for women over the decades) there are repeated stories of girls, as young as 10, raped by family members and then forced to give birth. Why? Laws and policies exist (not perfect, but so much better than most countries) but these girls and young women simply do not know that they have had sex or that they became pregnant. There is an abject failure of the state to provide education and information. Of course the law must step in and make sure that abortion is available and easy for girls in these dreadful situations, but education, culture, social norms must also shift for that to be possible.

Currently in South Africa there have been efforts to tighten up the abortion legislation making it tougher for women and girls who choose not to continue with their pregnancies, by reducing term limits and imposing a set of conditionalities (such as a requirement for ultrasounds). The National Department of Health (NDOH) argued against the amendments[3] pointing out that WHO guidance does not support the amendments, the costs are prohibitive – and, significantly, that the amendments will add further barriers to services, and to the ability of women and girls to decide for themselves. The NDoH leadership here is important. It occurs against a backdrop – highlighted by Mbatha & Heywood – of a situation where fewer than 20% of health facilities offer abortion, and in 2010 there were some 250,000 unsafe abortions in the country. Laws must not go backwards; services must reach those in need. The promise of the constitution is not being realised, indeed it is under threat.

Vigilance on abortion services and laws is key. Globally we see a well orchestrated campaign aiming to influence the rights of girls and women to decide for ourselves. The “Opposition” failed in Ireland (by a hefty margin!) but their tactics are smart. And that is why the solidarity of global movements like SheDecides is important. It is not simply a “Pro Choice” movement – although you cannot be a Friend of SheDecides without sharing a belief in the rights of girls and women to end pregnancies that are not right for them. Nor is the movement focused solely on ending the Global Gag Rule: the pernicious re-introduction and expansion of that nasty piece of US policy sparked the creation of SheDecides. It was an immediate reaction by (mostly Northern European) politicians who turned around in January 2017 and said No: She – not He! – should decide.

The movement goes much further than that, and also stretches far beyond the ambitions of Northern donors (as an aside, I’m not convinced (m)any of those governments see SRHR as “soft” or easy rights[4]). Rather SheDecides believes, quite simply, that every woman, every girl, everywhere should have the skills, knowledge, and quality services, laws and policies in place so that she can decide for herself what happens to her body – especially in respect of her sexual and reproductive life. That means amplifying the campaigns and work of hundreds of others, all over the world. The intention is to work across silos, to bring issues, people and organisations together: to add an extra push to what is already happening, not re-invent an initiative or organisation to add to the confusion of efforts.

The movement is little over a year old. Like any infant and toddler we have stumbled and taken a few wrong steps. Yet the vision and actions needed to achieve that vision are clear. With growing numbers of Friends – now almost 50,000 around the world, with 300+ organisations and some 40 Champions driving it forward – the call is to Stand Up and Speak Out; Change the Rules and Unlock Resources. Three simple actions, which combined can lead to the new normal expressed in the manifesto. Anyone who shares the vision of the manifesto is invited to sign it, and to take action in whatever way makes sense in their community. There are already many examples, and with national movements taking off in India, Uganda, Tanzania, Kenya and beyond. National movements reflect the global shape of a Political movement with Community Support.

Why Political? Politicians have power to allocate resources and change laws and policies – and some act even before they are asked to by civil society. Indeed the first words and pledge by (then) Dutch Minster Lilianne Ploumen took many community groups my surprise.

SheDecides is political – and it is also driven by young people: the leaders of today and tomorrow. It is no accident that the extraordinary changes in Ireland – overturning long standing abortion laws – occurred under a new leader who is under 40 (and also brown and queer). He understood the power of young people’s vision for progress, of the youth vote. Our best estimate is that over two thirds of the Friends of SheDecides are young people (under 30) – also no accident. The biggest push on the first ever SheDecides Day (2 March 2018) was from young activists, organising over 50 events around the world. At the Flagship Event (in Pretoria) more than half of the 300 participants were young people, debating and co-creating future actions with their Parliamentarians and Ministers from across the East and Southern African region.

In every country there will be different priorities, different groups and leaders who are best placed to drive change. Heywood & Mbatha argue passionately that the time is now, and that other efforts will fail if these fundamental rights are not protected and promoted. I agree. There is a long tradition of South Africans drawing on the global community for solidarity, whether it has been to end apartheid or to end thousands of deaths caused by bad AIDS policy. The global SheDecides movement stands ready to participate, to stand in solidarity – as and when South Africans decide “how and when”.


The world is better, stronger, safer.
She decides whether, when, and with whom.
To have sex.
To fall in love.
To marry.
To have children.
She has the right. 
To information, to health care, to choose.
She is free.
To feel pleasure.

To use contraception.
To access abortion safely. To decide.

Free from pressure. 
Free from harm.
Free from judgement and fear.

Because when others decide for her, she faces  violence, forced marriage, oppression.
She faces risks to her health, to her dignity, to her dreams, to her life.

When she does not decide, she cannot create the life she deserves, the family she wants, a prosperous future to call her own.
We – and you, and he, and they – are uniting. Standing together with her so she can make the decisions only she should make.

Political leadership and social momentum are coming together like never before.
But we can go further, and we can do more. From today, we fight against the fear.
We right the wrongs.
We mobilise political and financial support.
We work to make laws and policies just.
We stand up for what is right.
Together, we create the world that is better, stronger, safer.  But only if. And only when.

She. Decides. [5]


Robin Gorna is an AIDS activist who lived in Pretoria, working for the UK Department for International Development, from 2007. She retains strong ties to South Africa. In the early 90s she wrote “Vamps, Virgins and Victims: How can women fight AIDS”, was ED of the International AIDS Society (IAS), the Partnership for Maternal, Newborn and Child Health (PMNCH) and now co-leads the global SheDecides Support Unit.

[1] see footnote 5 in orginal paper

[2] page 6 of orginal paper

[3] Yogan Pillay, personal communication. Power Point presented, 2 May 2018

[4] page 7 of orginal paper

[5] The SheDecides Manifesto, July 2017