Prisons and the New NSP: Nobody left behind?

by  Ariane Nevin[1] and Thulani Ndlovu[2]

Evidence has shown that prisons are a key battleground in the fight against HIV and TB. Prison populations are transient, and inmates are released back into their communities, taking with them all of the infections and unhealthy behaviours learned in prison. This means that any HIV and TB plan that doesn’t address the drivers of HIV and TB in prisons will fall woefully short of achieving its goals. And sadly, the latest draft of the NSP, with its inadequate prison-focused interventions, looks set to do just that.

The first draft of the NSP, released in November 2016, was cause for some jubilation for prisoners’ rights activists, for the first time including inmates as an HIV key population and incorporating important human rights language and interventions for prisons. However, we may have celebrated too soon, as two drafts later, following a far from transparent or inclusive political process, the prison-focused language has been markedly stripped down.

Although inmates remain a key population for both HIV and TB, and recipients of a core package of services targeting key populations, the NSP is missing interventions directed at addressing the causes of the TB and HIV epidemics in prisons: insufficient infection control, non-implementation of the Policy to Prevent Sexual Abuse of Inmates, dismal levels of overcrowding , inadequate ventilation, and insufficient re-integration support or linkage to care for ex-inmates upon release, to list but a few.

The latest draft includes as an objective, ‘Train correctional and detention centre staff regarding the prevention and health care needs and human rights of detainees and inmates living with or at risk of HIV and TB.’ However, sexual violence and overcrowding in prisons, which are key drivers of HIV and TB respectively, do not feature in any objectives. Surely any plan directed at training correctional centre staff on the prevention of HIV should look first to existing policies, of which the Policy to Prevent Sexual Abuse of Inmates is an excellent one. Why not include the implementation of this policy as an objective? Likewise, if we are to reduce TB infection rates, the plan should at the very least include amongst its objectives a strategy to reduce overcrowding.

The Departments of Correctional Services and Health receive plenty of money to fund their TB and HIV response, which they are using to test and screen inmates. However, they can counsel and screen as much as they like; until plans are developed and fully implemented to address the drivers of the epidemics, attempts to contain and beat them back will continue to have minimal impact.

International donors need to push DCS for a more comprehensive approach, greater transparency and better data. We cannot continue simply to roll out treatment blindly. If we are going to win this fight, we need to cut off these diseases at the knees.

Inmates and ex-inmates would have been the most qualified to suggest effective strategies for preventing TB and HIV in prisons, and effective support for reintegration of ex-inmates into their communities. However,  the inclusion of key populations in NSP consultations was made difficult, if not impossible by SANAC’s dismal organisation and planning that left important participants stranded and ultimately not consulted. Not only this, but the processes through which provisions are included or left out was entirely opaque, leaving stakeholders frustrated and in the dark, and SANAC, unaccountable.

So, what should the targets be?

  • Full implementation of the DCS Policy to Prevent Sexual Abuse of Inmates in DCS Facilities: Sexual abuse is prevalent in prisons, and is a recognised driver of the spread of HIV inside prisons. Unless urgent steps are taken to detect, prevent and respond to sexual violence in prison, transmission of HIV will continue.
  • Full implementation of a TB infection control policy: Prevention is better than cure and raising awareness among inmates that windows should be left open is not adequate. Steps need to be taken to decrease overcrowding, to ensure that cells have sufficient cross-ventilation and to allow inmates to spend more time spent outside of their cells. The NSP must set more concrete targets in this regard.
  • Urgent steps need to be taken to address extreme overcrowding in prisons: TB and HIV infection control policies will continue to have limited impact until overcrowding is decreased. Studies show that implementation of national cell occupancy recommendations could reduce TB transmission risk by 30%. The NSP must set concrete and measurable targets in this regard and map out a clear and workable strategy to eliminate overcrowding as soon as possible.
  • An effective prison oversight body with sufficient independence and powers to investigate and refer complaints needs to be established to replace the Judicial Inspectorate for Correctional Services: this will ensure that DCS policies are adhered to, and their obligations met. It will also provide a safe avenue through which inmates may submit complaints. Improved linkage to care between prisons and communities, and support groups for ex-inmates: Inmates need to receive counseling, a copy of their medical file and a referral to a clinic accessible to their community to enable adherence to treatment once they leave prison. They also need ongoing support to avoid re-offending. These services are currently lacking. In order for this to happen simple systems need to be put in place, and the DCS, DOH and DSD need to work together to ensure that there is no loss to care in the transition between incarceration and freedom.
  • An effective collaboration in real time between the DCS and NDOH to ensure that new NSP policies, like Universal Test and Treat and condom distribution are implemented with no delay.

We hope that the final NSP 2017-2022 will take heed of this advice, and look forward to an NSP that is actually strategic and truly leaves nobody behind.

[1] Sonke Gender Justice

[2] Zonk’izizwe Odds Development

Towards a workable plan

By Vuyokazi Gonyela, SECTION27

A key ingredient to ensuring our response to the AIDS and TB epidemics is effective, is having a workable plan. To that end, consultants and experts are working furiously to make sure South Africa has a new National Strategic Plan (NSP) to take us through to 2022.

But we know what is said about South Africa and our plans and policies: Full marks for great plans and policies; fail for implementation. The involvement of civil society is a critical component of a

The involvement of civil society is a critical component of a workable plan.

The involvement of civil society is a critical component of a workable plan.

workable plan. Established civil society structures already exist within the various AIDS councils at national, provincial and municipal (local or community) level but there is an unequal distribution of resources from the councils to these structures, which, in turn, means they struggle to get work done and to participate meaningfully in processes.

South Africa’s response to the HIV/AIDS, TB and Sexually Transmitted Infections (STI) epidemics requires coordination and leadership from various accountability structures, including the South African National AIDS Council (SANAC). This body hosts the National Civil Society Forum (CSF), which monitors progress on the implementation of the NSP and holds government accountable on behalf of the users and practitioners in the health-care system.

Theoretically, national structures that manage the HIV/AIDS TB and STI response should function in a manner that provides both leadership and support to provincial and local structures. But, provincial and local bodies need to be just as empowered to hold the government accountable – even more so – on behalf of the health-care users on the ground.

Despite this theoretical commitment to the development and strengthening of provincial structures, little has been done to provide these structures with the resources and authority that they need.

In provinces like the Eastern Cape, the struggles and difficulties are clearly visible. The province has struggled to implement strategies to respond to HIV/AIDS, which has left the community at a great disadvantage. Among the factors that impact negatively on the work to be done, is poor leadership. In the Eastern Cape, for example, the former elected CSF chairperson was last seen in 2015. This critical position was left unattended because the leader had other interests that compromised, not only the forum, but the entire provincial mandate.

The intervention campaign and strategies also need to adapt and respond to new data. Recent statistics indicate that the prevalence of HIV/AIDS has shifted from adolescents to young women and girls: the stats show about 2,363 new infections weekly in South Africa, with AYWG accounting for almost 1,750 of these infections.

The goal to end HIV/AIDS by 2030 is far from being realised, particularly because there is little investment in developing young leaders and creating more active citizens. They have a big role to pay and are central in our response to HIV if we truly want to deliver on the rhetoric of ending AIDS.

A further concern is that women are grossly under-represented within provincial leadership sectors tackling HIV. Across the nine provinces, the leadership is mainly dominated by men. Provincial CSF chairpersons sit on the Provincial Councils on AIDS as co-chairpersons; seven of the nine provincial chairs are male. The Eastern Cape took a bold stand in September 2016 and elected the first woman as a CSF chairperson. No attention is paid to this.

The voices of many women are suppressed in their households, communities and in leadership structures. Provincial AIDS structures need to take the lead, transform themselves, and support capacity-building female leadership as a critical investment, not only for the provinces but for the country. Nothing less will do.

Communities in crisis

By Treatment Action Campaign

The Treatment Action Campaign has shared the following stories with Spotlight from their provincial operations in KwaZulu-Natal, Limpopo, Mpumalanga and the Free State. Elsewhere in this issue of Spotlight we take an in-depth look at Gauteng – which is therefore not included here.

France, KwaZulu-Natal

france-kzn1

Branch members go door to door in France to find out how people in the community cope without a clinic.

The community of France in KwaZulu-Natal does not have a clinic. A mobile clinic comes to the community just once a month. But most people don’t use it; some don’t even know about it. Instead they travel by taxi to other clinics – if they can find the money. Sometimes they must lie about where they live in order to see a nurse, or they simply go without medicines and health services altogether. Only certain community caregivers can deliver medicines to patients, if they have an ID, and if the patient is being treated at the mobile clinic. The rest, however ill, have to collect medicines themselves. It seems people are defaulting on ARVs, TB treatment and other chronic medicines as a result. We can never have #treatment4all – or #EndTB – when people can’t even get to the clinic. TAC members have asked the people of France how only having a mobile clinic affects them. The resounding response is that once a month is not enough. To resolve service deficiencies such as this one, which keep the dual epidemics burning, health system challenges must be addressed in the National Health Department’s test-and-treat plan and within the new National Strategic Plan on HIV, TB and STIs. Otherwise we are doomed.  #FranceNeedsAClinic.

Khujwana, Limpopo

Within a few hours of walking door to door through the streets of Khujwana it is clear there is a major problem. Every home has a story to tell – a story of frustration and suffering, a story of failure.

While the local clinic looks functional, even ‘pleasant’, from the outside with its solid infrastructure and garden, inside it s a totally different matter. Many patients report ongoing stockouts and shortages of their medicines. They wait for hours before being seen by anyone – there is a shortage of nurses and no doctors ever come. Some go to other clinics altogether. People report incidences of nurses treating them badly, being rude or, worse, negligent. Mothers report the indignity of having been mistreated, or unattended to, in the midst of labour. Khujwana Clinic is failing the people and the community it is meant to serve. Tired of this situation, the community is mobilising. Testimonies from community members who try to use the clinic are being gathered. Local stakeholders are coming together to draw attention to the major shortcomings. All they want is a clinic that can give them the health-care services they need. They are clear: They will continue to escalate this issue until they #FixKhujwanaClinic.

Boekenhouthoek, Mpumalanga

The local TAC branch in Boekenhouthoek receives ongoing complaints about the local clinic. People

In Boekhouthoek a TAC branch member takes testimony from a community member struggling to access health services.

In Boekhouthoek a TAC branch member takes testimony from a community member struggling to access health services.

report waiting for long periods of time, with or without being seen. There aren’t enough nurses stationed in the clinic exacerbating this issue. The clinic is too small, and people wait outside while waiting to be seen. The clinic is faced with regular stockouts and shortages of medicines meaning people are often sent home empty handed. Some community members choose to go to different clinics altogether. A luxury that many of those unemployed people who live in the area cannot afford. Traditional leaders confirm these conditions, from personal experience. One woman spoke of never receiving a TB diagnosis, months after taking a test. One man spoke of misdiagnosis. Another had never been told he had HIV, yet had been prescribed ARVs for more than four years with serious side effects. People reported of nurses being rude to them in moments of severe vulnerability. The TAC Boekenhouthoek branch is monitoring the clinic and gathering information from residents about the challenges they face. How can we reach #treatment4all if clinics run out of medicines? Or if people don’t want to use them because of the lengthy waits and poor service? The reality is that the dysfunction in our health-care system will stop the new HIV guidelines on test-and-treat from being a success. We need significant investment into stronger systems in order to respond to the HIV and TB epidemics. #BetterBoekenClinic

Phuthaditjhaba, Free State

Members of the TAC in Phuthaditjhaba have reported serious problems at Manapo Hospital that are putting people’s right to access health care in serious jeopardy. This report followed a strike by frustrated, overburdened staff members, including doctors, nurses, physiotherapists, porters, cleaners, and kitchen staff, who claimed to have not received pay for significant amounts of overtime since 2015. TAC members investigated the hospital and spoke to many patients entering and exiting the facility. Reports of long waiting times, a lack of nurses, doctors, and other staff being stretched beyond their capacity, and medicine shortages, were common.

After being stabbed in the forehead, one teenager reported not seeing a doctor after seven days of waiting. Another teenager had been stabbed in the upper chest four days earlier. He was also still waiting to see a doctor. A woman with a homemade sling and swollen wrist left the hospital in pain to return to the clinic. One man, falling in and out of consciousness, was told to return to casualty with a referral letter. Outside the hospital, visibly injured patients could be seen wandering the grounds in their pyjamas. After taking a rest on the grass, one young man with bandages across his face struggled to stand up and had to be assisted by two other patients to get onto his feet before limping back inside. Portable toilets remain outside the hospital after a water crisis the month before. It is unclear whether the water shortages continue. A TAC member helped a man with crutches who struggled to climb up the metal steps to enter the toilet. If urgent action is not taken to turn around this crisis, the TAC will be forced yet again to embark on a campaign of civil disobedience in order to save the lives of those reliant on the failing public health-care system. #FSHealthCrisis

 

 

 

 

Rich province, poor health care

By Ufrieda Ho

In money terms, Gauteng’s health budget looks plump and healthy at R37,4 billion for the 2016-2017 financial year – R2.07 billion more than the previous financial year. It represents a sizeable portion of the province’s overall budget. On the surface, this is money that could make a significant contribution to improving the health outcomes for the province’s patients.

But, even though it’s South Africa’s richest province, Gauteng is under pressure from a growing metropolis and is not future-proofing fast enough for its evolving needs. There are challenges of rapid urbanisation, with high migrant numbers and community members who are transient and difficult to track medically. The province also has to plan for accelerated environmental degradation, overcrowding, job shortages, limited resources and the yawning gap between the haves and have-nots.

The divisions are evident in data from Stats SA’s General Household Survey of 2015, which was released in June this year. For example, Gauteng is home to the highest percentage of medical aid members in the country at 27.7 percent, but this still leaves 70 percent of the population reliant on that R37,4 billion to be spend wisely and effectively.

The Gauteng Department of Health has its own hurdles to overcome, including proving that it is fit to govern. After being placed under administration in 2013, the department finally achieved an unqualified audit from the Auditor General for its financial management this year.

But the health issues continue to be a challenge in the province. On-going staff shortages, overworked staff, unreliable ambulance services, staff who don’t treat patients with dignity, and a disconnect between policy and plans and the reality on the ground. Increasingly, bureaucracy replaces communication, and there are more reference numbers and records of complaint than actual solutions or firm plans on how problems can be rectified.

In addition, a tangled web of social failings impact on the health-care challenges. There’s high unemployment and competition for scarce resources. Public works shortfalls mean infrastructure in hospitals and clinics is not upgraded or maintained. And the high cost of commuting, or lack of proper roads in new developments, represent very real barriers to accessing health care for many patients. The protracted drought in southern Africa has also made food security a great cause for concern among the most vulnerable people in the province.

It is a most distressing trend that already weak health-care standards are slipping further and that there are clear losses in areas where gains had previously been achieved. For Gauteng TAC leaders Portia Serote and Sibongile Tshabalala, these include noticeable deterioration in the way TB is being managed in many of the province’s clinics and hospitals.

Serote, who works mainly in the East Rand districts, says many basic good care and oversight practices are simply not adhered to.

‛We can walk into clinics and see people not using masks. Patients are all mixed up in the same small facilities – so you can see XDR and MDR patients with TB patients. There is no infection control, or the UV lights (that help limit the spread of infection) are not working,’ says Serote.

She says the TAC has had to step up its own outreach programmes after discovering in a spot sampling exercise recently, that out of 60 people, 10 had TB and three had MDR-TB.

Another growing concern, says Tshabalala, is the high number of ARV defaulters that they are noticing. Tshabalala says the target of getting patients to undetectable viral loads is slipping.

‛We did a workshop and survey in Orange Farm earlier this year and found that people default because they can’t afford the taxi fare to get to a clinic, and it’s too far to walk. They also have to wake up by 4 am to get to a clinic or hospital if they want to get help that day. There is a benchmark for waiting of 180 minutes, which is just too long,’ says Tshabalala.

The facilities that people rely on have no privacy, are often cramped and have not been properly maintained. Serote says she’s visited clinics where nurses have brought curtains from their homes so patients can have some privacy and dignity during their consultations.

And, Serote says, mental health patients are falling through the cracks in the province. The TAC has seen an increase in the number of patients who simply walk out of hospitals in hospital pyjamas, completely unnoticed, sometimes for days.

‛The nurses were just unaware in Pholosong in Tsakane, when a man who was mentally ill just got up from his hospital bed and left. He was living in really terrible conditions and that’s where we found him, still in his hospital clothes, but the nurses didn’t know anything,’ she says.

Both Serote and Tshabalala acknowledge the nurses are under immense pressure themselves. ‛Nurses are not just nurses; they are counsellors, they’re cleaners – they are expected to do everything. The Department of Health thinks that a benchmark of one nurse to every 40 patients is not being overworked, and very often the nurses see even more people than that,’ says Serote.

Even for a thriving economic hub like Gauteng, prosperity is shared by only a few. Money can buy many things, it seems, but clearly it can’t buy solutions that are inclusive, innovative or impactful for a health-care system that needs just these.

Editorial: Three months to get it right

By Anso Thom and Marcus Low

Delays at the South African National AIDS Council (SANAC) has meant that the new NSP (National Strategic Plan) will now only be ready in March 2017. While the delay itself is not of any great concern, the kind of plan that will be produced by an unsettled SANAC and a weakened, unrepresentative civil society is concerning and brings into question the very idea of SANAC and the NSP. Already we are hearing rumours of a back-track on various things contained in draft zero of the NSP – including a back-track on the recommendation to decriminalize sex work.

There is a risk that over the next three months an NSP will take shape that will lack many of the targets and deadlines it needs to make an impact. It is understandable that government doesn’t want what they see as an external plan to interfere with their internal plans. But civil society should not accept this. We need leaders who can stand up to government, when needed work with them, but ultimately demand we do better on key issues such as sex work, condoms in schools, active case-finding for TB and community healthcare workers. Unfortunately, from what we’re hearing, civil society is capitulating on these issues without much of a fight.

Even though many critical issues will be mentioned in the eventual NSP, mere mentions are not enough. We need plans, timelines and budgets. We need an NSP that is highly focused and concrete. The decriminalization of sex work, for example, has been on the agenda for years – but simply having it on the agenda is not enough. We need to have a roadmap from where we are now to an actual amendment in our laws. Without such a roadmap, we do not in fact have a plan.

Similarly, setting targets for providing more people with HIV treatment and helping people adhere to treatment is all good and well, but targets are not a plan. How do we improve treatment adherence? Do we need to employ more community healthcare workers to provide adherence support and to trace patients who default? We think we should. How do we provide differentiated care through adherence clubs, if we don’t pay people to run those adherence clubs? How do we ensure there are no drug stockouts which endanger trust in the health system. How do we build a Medicines Control Council that can cope with the workload or registering new drugs and investigation unlawful treatment and activities? These are the issues the NSP must map out in detail and force action on. It should make the case so clearly and convincingly that the Department of Health and treasury has no option but to fund it.

In the same way, we can say whatever nice things we wish about active case-finding for TB (possibly the most critical TB intervention we are not implementing), but if we don’t map out what that means in the real world then it will be just an another aspirational target. The NSP has to make it explicit that we can’t do active case-finding without people and that we need to train and pay people to start doing active case-finding. In two words Community Health Workers.

Another critical area on which the new NSP must move the dial is HIV and pregnancy prevention in schools. We need a programme that is explicit about the right to comprehensive sex education and the right to access condoms – the latter being a right in terms of the right to access healthcare services. But again there appears to be no clear plan on the table on how we get from here to there.

If the new NSP doesn’t deliver on these critical issues with detailed timelines and budgets then it will be hard for us to support it. As has become clear in recent issues of Spotlight (previously NSP Review), our HIV and TB response is at code red. Our public healthcare system is in crisis. We need a plan that deals with this emergency seriously and based on the best available evidence. Anything less is not good enough.

A difficult political environment

The development of the new NSP comes at a very difficult time in South Africa’s history. Amid the Public Protector’s State Capture Report, the various scandals relating to the Gupta family, spurious charges against Finance Minister Pravin Gordhan and widespread calls for President Jacob Zuma to stand down, Deputy President and SANAC chair Cyril Ramaphosa has had a lot on his plate. In this fraught political context the new NSP has hardly elicited the national conversation or leadership that is needed – that it is needed is clear from the fact that around seven million people in South Africa now live with HIV and tens of thousands still die of tuberculosis every year.

To some extent, our HIV and TB response is also falling victim to the wider crisis in our politics. It is thus very encouraging that Health Minister Dr Aaron Motsoaledi and deputy Minister Joe Phaahla took a public stand against corruption when late in October they publically declared their support for Minister Gordhan. The spurious charges against Minister Gordhan have since been withdrawn. We trust that these leaders will not lose their jobs or be victimised for having taken this correct and principled stance. We will watch closely.

While the fight against corruption and state capture in South Africa is urgent and critical, the development of the new NSP is also critical. We urge the Deputy President, the Minister of Health, the rest of the national cabinet and all provincial cabinets to engage with both these urgent issues. Just like corruption, HIV and TB impacts the lives of millions of people in this country.

While the big picture politics are deeply concerning, there are also some signs that all is not what it should be at SANAC. The position of SANAC CEO Dr Fareed Abdullah was recently advertised amid rumours of a campaign to replace him with a person more compliant to the whims of some in government. Whether there is any veracity to these rumours we do not know, but it has reached us from various sources.

What is clear though is that in the current political context we need SANAC to be stronger than ever. Abdullah has done well in steering SANAC over the last five years and much of what concerns us at SANAC is beyond his control. Removing him now will threaten operational continuity at SANAC – something we cannot afford.

Civil society leadership crisis

While operational continuity is critical at SANAC, we urgently need new energy and ideas on the political side. This political energy has to come from civil society leaders at SANAC. Many people we have spoken to have expressed their disappointment with the failure of the current civil society representatives to raise critical issues impacting on ordinary people living with HIV and/or TB over the last five years. There is a strong feeling that SANAC needs a civil society sector that is fully representative, that speaks with the voices of the marginalized, speaks with the voices of the poor and that the only way in which this can happen is if the current civil society is disbanded.

The new NSP provides an opportunity to make a clean start where we avoid the pit-falls of the past and ensure that people living with HIV and TB in South Africa feel they are properly represented. One way to avoid these pit-falls is to set some guidelines of what we expect from our civil society representatives.

To start with, we should insist that civil society leaders must represent constituencies and not just themselves (academics and other technical experts can of course contribute in their personal capacities to technical questions). Ideally, we want people who have been elected by affected people and who must account back to those people on what they have or have not done at SANAC.

Secondly, we should insist on transparency regarding the financial affairs of all civil society representatives. Where people represent NGOs, the finances of those NGOs should be open for public scrutiny – as is the case with all NGOs. If people do business with government, then that potential conflict of interest should be disclosed.

Looking back, there is much to be proud of, but what lies ahead is what matters now and what we do in the next three months will set the course of the next five years.

 

How do we get to zero TB?

By Salmaan Keshavjee MD, PhD, ScM
Department of Global Health and Social Medicine
Harvard Medical School

 

Tuberculosis (TB) has surpassed HIV/AIDS as the biggest infectious killer of adults worldwide.  In 2015, an estimated 10.4 million people became sick with the disease—one million of whom were children—and 1.8 million people died.  That’s one person dying every 18 seconds from a disease that has been largely treatable since 1948.

Why do so many people die from this treatable disease?  Mostly because they are not diagnosed in time or do not receive the correct care.  In 2015, more than 40 percent of the estimated number of people with TB were not diagnosed and received no treatment.  An estimated 580 thousand people became sick with multidrug-resistant TB (MDR-TB), disease caused by Mycobacterium tuberculosis resistant to the two main drugs of the first-line anti-TB treatment regimen; only 22 percent of those individuals received treatment and less than half were cured.  Because the disease is airborne, those who are not diagnosed or do not receive the correct treatment continue to spread the disease in their families, communities and places of work.

Until recently, many countries faithfully adhered to the World Health Organization’s (WHO) DOTS strategy to tackle TB.  Introduced in 1993, the DOTS strategy proposed a limited set of interventions for low- and middle-income settings, aimed at “controlling” the epidemic. For the most part, the approach ignored some of the pillars of TB epidemic control that had nearly eliminated TB in rich countries: active case finding (including the screening of close contacts); rapid treatment of people sick with any form of the disease, including drug-resistant strains; and prophylaxis for individuals with TB infection that has not yet progressed to disease (e.g. isoniazid prophylaxis therapy, or IPT).

Why was this the case?  Sadly, the reasons had little to do with science.  For example, as early as 1964, the WHO’s Expert Committee on Tuberculosis discouraged the use of IPT outside of rich countries, “arguing that cost, logistical difficulties, the likelihood of defaulting, and other concerns all made it unfeasible.” (Macmillan 2015: 195).  This decision was reaffirmed in 1974 by another WHO expert committee, which, despite overwhelming data showing the benefits of IPT from the work of George Comstock and others in the United States, deemed the use of IPT “irrational”.  It was again reaffirmed in 1982 because of fears that treating TB infection would divert resources away from tackling active disease.  The WHO and its partner, the International Union Against Tuberculosis and Lung Disease (IUATLD), argued then that “in practice [IPT] has virtually no role in developing countries.” (Ibid).  Similar arguments—based primarily on dogma about cost and the belief that countries outside the “global north” would not be able to deliver more than a rudimentary level of care to their populations—were made about active case-finding and about the treatment of MDR-TB.  Instead, the DOTS strategy relied on passive case-finding—waiting for the sick to make it to a clinic—as well as diagnosis with sputum smear microscopy, a low-sensitivity test ill-suited for the diagnosis of children, people co-infected with HIV, people with extra-pulmonary TB, and those with disease caused by drug-resistant bacteria.  While the policies of the WHO have changed in some of these areas, systems built around delivering the DOTS strategy have not.

The result of ignoring these important facets of TB epidemic control—both a moral and scientific failure—has been the death of millions and a largely unabated epidemic.  Over the last decade, the decline in TB has been paltry: roughly 1.5% per year. If this trend continues, this means that it will take approximately 200 years for the global TB rate to reach the level seen today in North America and Europe.  It does not have to take this long.  In order to change this trajectory, countries like South Africa, India, China, Russia, Brazil, Indonesia, Kenya, Peru, Pakistan and many others, must take the bold step of instituting a comprehensive package of tried and tested approaches to stopping the TB epidemic.

So what should be done?  This comprehensive approach, which has been outlined by scholars and practitioners from 11 countries in a series in The Lancet called How to Eliminate Tuberculosis, is conceptually simple, but requires that we rethink the way we are struggling against TB.  The series outlines how we should clearly know the TB epidemic, using data and deploying epidemic control strategies as needed to different hotspots.  It also outlines a strategy of three interlinked components: SEARCH, TREAT, and PREVENT.

search

SEARCH means to actively find people sick with TB, as well as those infected with TB but who are at high risk of becoming sick.  Finding those people who are already sick with TB is critical because they are infectious and continue to spread the disease in their families and communities.  Finding out who has been infected or exposed to TB—and who may later become sick—is also a critical part of searching.  Data have clearly shown that people infected with TB have at least a five percent chance of becoming sick with active disease within the first two years after infection.  That’s one in twenty people that will get the disease and continue to transmit the disease in families and communities, even after the original index patient has been treated.  Thus, stopping the epidemic means finding these people and offering them post-exposure treatment. Where does one find individuals at most risk of developing TB?  Again, the data are quite clear: people living in the household of a TB patient have a one to five percent chance of having active TB; those seeking care in general health care facilities have a five to ten percent chance of having active TB; and individuals receiving HIV-associated care have a one to 25 percent chance of having active TB.  There are other high-risk groups—such as people working in mines, garment factories, or spending considerable time in other over-crowded areas—but households and health care facilities are certainly an important place to start looking.

TREAT means ensuring that people sick with TB get the quickest correct treatment for their TB, regardless of whether they have a drug-sensitive or drug-resistant strain.  The correct treatment of the disease stops people from dying, from having long-term sequelae from the disease, and stops transmission.  Studies from the 1950s, 1960s, and even recently, have shown that if a sick person is started on the correct therapy—a therapy capable of killing the strain of TB with which he or she is infected—he or she is no longer infectious.  Part and parcel of this is ensuring rapid and ready access to new anti-TB drugs and fast-tracking research on shorter and more efficacious regimens.  One can never forget that TB leads to an almost certain death—like many cancers—so the risk of initiating treatment with new drugs or drugs with adverse events is far outweighed by the benefits.

PREVENT means engaging in a set of activities that will help stop the transmission of TB.  First, it is critical to ensure that infection control measures are taken in health care facilities so that TB does not spread.  Second, it means ensuring that individuals infected with the TB bacillus, but who are not yet sick with TB disease, receive post-exposure treatment that will prevent their infection from progressing.  Pathbreaking studies from the 1960s showed that prophylaxis after infection—coupled, of course, with active case finding and treatment of people sick with TB—not only helped bring down the rates of TB dramatically, but reduced TB deaths for at least 20 years after the intervention.

As we know, TB is a disease that moves preferentially among the poor, the malnourished, and the immunocompromised.  People with HIV coinfected with TB have a 5 to 10 percent chance each year of becoming sick with TB; malnourished people with a low body mass index (BMI) have a ten-fold risk of getting TB.  This means that treatment and prevention will require ensuring that people sick with TB and those receiving post-exposure treatment have enough food to eat, that they have access to appropriate housing, and that their co-morbid conditions (e.g. HIV, diabetes, malnutrition) are cared for.  Because TB is itself a driver of poverty, prevention also requires health systems to engage in a multi-sectoral approach, including linking people and families sick with TB to innovative poverty-alleviation mechanisms.

The interventions that are part of the SEARCH, TREAT, and PREVENT (S-T-P) strategy will take a major push, and many will be tempted to implement them piecemeal.  This would be a mistake.  Both global experience and mathematical models suggest that deploying these interventions in combination will rapidly lower both TB cases and deaths.  Creating systems capable of implementing the S-T-P strategy will require resources, and in many cases, reorganization and integration of activities with other programs.  If done properly this will not only move us rapidly towards eliminating the scourge of TB, but the systems developed can be used to give care to people with asthma, diabetes, hepatitis C, and a number of other diseases.  Taking the correct steps to end the TB epidemic is vital to building our collective capacity to provide high quality universal health care.

References:

Cavalcante SC, Durovni B, Barnes GL, et al. Community-randomised trial of enhanced DOTS for tuberculosis control in Rio de Janeiro, Brazil. International Journal of Tuberculosis and Lung Disease 2010; 14: 203–09.

Cegielski JP, Arab L, Cornoni-Huntley J.  Nutritional risk factors for tuberculosis among adults in the United States, 1971-1992, American Journal of Epidemiology 2012; 176(5):409-22.

De Cock KM, Chaisson RE. Will DOTS do it? A reappraisal of tuberculosis control in countries with high rates of HIV infection. International Journal of Tuberculosis and Lung Disease 1999; 3: 457–65.

Dye C, Glaziou P, Floyd K, Raviglione M. Prospects for tuberculosis elimination.  Annual Review of Public Health 2013; 34: 271–86.

McMillen, CW.  Discovering Tuberculosis: A global history 1900 to the present.  New Haven: Yale University Press, 2015.

Obermeyer Z, Abbott-Klafter J, Murray CJL. Has the DOTS strategy improved case finding or treatment success? An empirical assessment. PLoS One 2008; 3: e1721.

Ortblad KF, Salomon JA, Bärnighausen T, Atun R. Tuberculosis control for sustainable development. Lancet 2015; 386(10010): 2354-2362.

Rangaka MX, Cavalcante SC, Marais BJ, et al.  Controlling the seedbeds of tuberculosis: diagnosis and treatment of tuberculosis infection. Lancet 2015; 386(10010): 2344-53.

Theron G, Jenkins HE, Cobelens F, et al. Data for action: collecting and using local data to more effectively fight tuberculosis. Lancet 2015; 386(10010): 2324-33.

Yuen C, Amanullah F, Dharmadhikari A, et al. Turning off the tap: Stopping tuberculosis transmission through active case-finding and prompt effective treatment. Lancet 2015; 386(10010):2334-43.

 

 

TB: What the numbers tell us about political will

By Marcus Low

Last month the annual Union World Conference on Lung Health was held in Liverpool, United Kingdom. As always at this conferences, much was said about how the world needs to step up the fight against tuberculosis (TB) – about how we need new agendas and paradigm shifts.

Unfortunately, new data released at the conference and in the preceding weeks paint a very bleak picture of the global TB response. The severity of the crisis is unquestionable. Per the World Health Organisation’s Global Tuberculosis Report 2016, 1.8 million people died of TB in 2015, there were 10.4 million new TB infections in the same year and over half a million (580 000) of those cases were drug resistant forms of TB.

How is the world responding to this crisis? Well, according to Treatment Action Groups (TAG) annual report into TB R&D, not good. Their report reveals that the already low investment in TB research has declined even further in 2015. The entire global investment in that year was $621 million. This is less than a third of the $2 billion that the WHO estimates is needed per year. That the entire world together can’t even come up with this comparatively small amount (given the size of national budgets) is mind-boggling.

As Mike Frick of TAG recently pointed out in Spotlight, the situation is even bleaker when looking at high burden countries. The BRICS (Brazil, Russia, India, China, South Africa) have roughly half of the world’s TB cases and TB deaths, but only contribute 4.3% of public funding for TB research. South African universities received more TB research funding from the US National Institutes of Health (NIH) and the Bill & Melinda Gates Foundation than from the South African Medical Research Council or other domestic agencies. With a Trump presidency in the United States, it is unclear whether even these NIH funds will be there in future. (For those who are interested, there is a petition calling for BRICS to triple investment in TB R&D.)

The inescapable conclusion is that, even though TB is killing their citizens, BRICS nations do not see TB research as a priority. This is fundamentally a political problem. Most people who die of TB are poor and not politically well-enough organised to advocate for a better TB response. And, unfortunately, with a lack of grassroots political pressure most politicians remain indifferent to TB – the one notable exception being South Africa’s Minister of Health Dr Aaron Motsoaledi.

India has more TB cases and TB deaths than any other country. It is the epicentre of the TB epidemic much like South Africa is the epicentre of the HIV epidemic. Yet, while the Indian government has made several encouraging announcements regarding its TB response, almost two years after making these announcements they have failed to implement many of the things they have promised. These include absolute no-brainers like daily fixed-dose combination TB treatment for people with HIV and the provision of appropriately dosed pediatric FDC treatment for children. When activists interrupted Jagdish Prasad, Director General of Health Services of the Government of India, he responded by telling media that the activists are “unstable” and “mentally unwell”.

But one wonders why it was left mostly to activists to call out India’s broken TB promises. For all the talk of paradigm shifts and new agendas, most of the TB establishment seems more committed to politeness and quiet diplomacy than to doing what it takes to bring about a paradigm shift.

This inertia may in part be explained by the fact that many in the TB establishment are from and live in countries where there is very little TB. Incidentally, as pointed out in a recent civil society letter, of the 10 Union World Conferences on Lung Health from 2007 to 2016, six were held in Europe (none of which were in Eastern Europe), two in Africa (both in Cape Town), one in North America and one in Asia. Mostly, the conferences are where the TB is not.

There is nevertheless some limited reasons for hope. Firstly, there are a number of good researchers and healthcare professionals dedicating themselves to TB research under often very difficult conditions. As with the very encouraging early results from a trial of a new XDR TB treatment, these efforts are already resulting in life-saving advances. We must urgently do more to support these researchers and to encourage more medical researchers to work in TB a big part of that will be finding more money for TB research.

Secondly, and getting back to TB’s bigger picture political problem, there appears to be a growing awareness among at least a small group of committed people that we need to politicise TB outside of these annual conferences. Two things stand out in this regard: the push for a UN High Level Meeting (HLM) on TB and the growth of the Global TB Caucus of parliamentarians. In both the HLM and in the work of the TB Caucus, it will be difficult to find the correct balance between staying politically correct and saying what needs to be said – for example in relation to India. As was the case with HIV, we will need bureaucrats, diplomats and researchers to step out of their comfort zones and to become activists.

As always, most governments and government officials will attempt to underplay the TB crisis in their countries and the short-comings in their own responses. We should not stand for such short-sightedness. The numbers make it clear that TB is an urgent crisis in the lives of millions. We should allow it to become a political crisis as well. Only then will we see the paradigm shift people keep talking about.

 

Less money for TB research

By Mike Frick

Treatment Action Group

The world spent less on tuberculosis (TB) research in 2015 than it did in 2009. This decrease in spending does not track a similar decline in TB incidence or mortality.

The World Health Organisation (WHO) recently announced that the TB epidemic is larger than previously estimated, a grim truth uncovered by improved surveillance data from India. More than 10 million people fell ill with TB in 2015 and 1.8 million died from the disease, making TB the leading cause of death from a single infectious agent globally. Yet research by the Treatment Action Group (TAG) shows that funding for research to develop the diagnostic tests, preventive interventions, and combination drug treatments needed to eliminate TB fell for the second year in a row, landing at US$620,600,596 – the lowest level of funding since 2008.

The TAG’s 2016 Report on Tuberculosis Research Funding Trends: No Time to Lose is the 11th in a series of reports that track annual spending on TB research and measure actual spending against the targeted funding called for by the Stop TB Partnership’s Global Plan to Stop TB, 2011-2015.

Only one third of needed investment

The Stop TB Partnership estimated that the world needed to spend $9.84 billion on TB R&D between 2011 and 2015 to end TB as a public health threat. Instead, actual funding for TB R&D amounted to $3.29 billion, just one-third of this target. Most alarming, funding for TB R&D fell in three of the last five years – by $36.5 million in 2012, $12.3 million in 2014, and $53.4 million in 2015. This downward trend belies the upward revisions to the extent of the TB epidemic over the same time period and points to an acute anemia of political will to address TB. The fact that spending on TB research is falling as estimates of TB mortality rise is a damning illustration of how governments have failed to mobilise against TB.

All sectors – including the pharmaceutical industry – have an obligation to fight TB by investing in the science required to end this epidemic, but the heavy lift will need to come from governments. (In 2015, the private sector spent $86.8 million on TB R&D, 40 percent less than the $145 million industry invested in 2011.) Over 60 percent of TB research funding comes from the public sector, and over half of all public money for TB R&D from 2011 to 2015 came from a single country: the United States. This degree of concentration has produced a precarious reliance on the political commitment of a single country.

BRICS: Half of TB, 4.3 percent of TB R&D

Countries that shoulder the heaviest burdens of TB are conspicuously absent from the list of leading TB R&D funders. Together, the BRICS countries (Brazil, Russia, India, China, and South Africa) accounted for nearly half of all TB cases and deaths in 2015, but only contributed 4.3 percent of public financing for TB R&D. In absolute terms, India led the BRICS countries with $11.1 million, followed by South Africa with $3.9 million and Brazil with $1.9 million. (Despite repeated requests, the governments of China and Russia did not return TAG’s survey.)

South African universities – which conduct some of the world’s most cutting-edge TB research – received more funding from the US National Institutes of Health (NIH) and the Bill & Melinda Gates Foundation (Gates Foundation) than from the South African Medical Research Council or other domestic agencies.

In 2015, the South African Medical Research Council disbursed $3.1 million in support of TB research (some of these funds came from budgetary allocations by the Department of Science and Technology and the Department of Health). By comparison, the Gates Foundation gave $17.5 million to South African research organisations, and the NIH gave $3.9 million.

A crisis of political will

The growing recognition that the deficit of TB R&D funding is a crisis of political will owes a lot to the unflinching analysis of South African TB and HIV activists. After reviewing TAG’s 2015 TB R&D funding data, Lynette Mabote of the AIDS and Rights Alliance of Southern Africa offered this frank diagnosis: ‛There can be no end to TB without an end to political indifference in this R&D agenda.’

Mabote’s words echoed a point Anele Yawa, General Secretary of the Treatment Action Campaign, made in his closing speech at the 46th Union World Conference on Lung Health in Cape Town: ‛The lack of investment in TB is a political problem. It is political, because at its essence it is about governments not being held accountable for failing to respond to TB. We are not going to change it if we accept business as usual. We can’t win this battle if we don’t make it a political battle.’

Key UN processes

The tools, frameworks, and platforms for making TB R&D a political battle are starting to coalesce. In particular, two UN-led processes that culminated in September 2016 have created unprecedented opportunities for TB research activists to engage political leaders on the global stage.

The first is the final report of the UN Secretary-General’s High-Level Panel on Access to Medicines, which issued a formidable set of recommendations to address the market failures that have resulted in meager research funding for diseases like TB.

The second is a political declaration adopted at the first-ever UN High-Level Meeting on Antimicrobial Resistance in which UN member states expressed a broad intention to tackle the threat of antimicrobial resistance through joint action, including fixing the ‛lack of investment in research and development’.

The TB field should not let this flurry of ‛high-level’ activity dislodge its grounding in the organising and mobilisation work that must take place at the country level and in the communities hit hardest by TB. In the words of Mabote, there is a need for ‛actionable strategies which support R&D resource mobilisation’, both within countries and regionally.

Previous attempts to harness more support from the BRICS countries for TB R&D – for example, the 2012 Delhi Communiqué of the 4th BRICS Ministers of Health Summit – have resulted in mellifluous statements about the need to collaborate without any actual commitments of funding. Future statements of intent must come with all the ingredients of accountability – clear targets, action plans, and timelines – that have previously been missing, and empowered civil societies in the BRICS countries and elsewhere must ensure that promises to support TB research are followed by a real increase in funding.

 

Notes on our next NSP

By Marcus Low, Spotlight Editor

At the end of this year South Africa’s big plan to fight HIV and tuberculosis (TB) comes to an end. The National Strategic Plan (NSP) for HIV, TB and STIs 2012 – 2016 will be replaced by the 2017 – 2021 NSP. It is vital that the new NSP avoids the mistakes of the past and fully incorporates new scientific evidence. It is also critical that it sets an ambitious and realistic course that all of South Africa can get behind, not just people working in healthcare.

What went wrong with the previous NSP?

While there was a lot that was good in the previous NSP, we need to be honest about the problems with the NSP and how we use it. A great plan on paper is of little use if we do not have the systems or political will to use it. Two problems stand out over the last five years.

Firstly, there was so little effective tracking of our progress against NSP targets, that we only now and again got an idea of how we were performing against the targets. The NSP would have been of much more value if every single district or provincial AIDS council meeting had up-to-date data on a series of key indicators for their area. In the absence of such data, much of the work relating to the current NSP was done in a vacuum. This contributed to a lack of focus and direction.

Secondly, the lack of coordination between government and AIDS councils meant that the NSP often ended up feeling irrelevant when it came to the actual implementation of TB and HIV programmes. Few people seem to understand that at all levels, the NSP and the work of AIDS councils are supposed to set the course for our collective AIDS response. Instead, government, from local level all the way up to national, appear to do what it wishes irrespective of the work done in AIDS councils – Kwazulu-Natal at times being a notable exception. This tendency of government to forge ahead with little regard to AIDS councils undermined the vision of a wider societal AIDS response drawn together by the NSP and AIDS councils.

 Top six priorities in the next NSP

In order to deal with these problems and to provide for a more focused and effective NSP the following should be considered for the NSP 2017 – 2021:

  1. We need real-time monitoring of the healthcare system

Rather than setting long lists of targets, the NSP must set fewer targets that we know we can track. It is essential that these indicators must regularly be shared with AIDS councils at all levels. When a district AIDS council meets, it must have fresh stats for the entire district as well as for each facility in the district. This will help focus our response in the areas where it is most needed. Often this data is already available to the Department of Health or the National Health Laboratory System, but not being shared timeously with AIDS councils or the wider public. If the new NSP is to revitalise society’s response to TB and HIV, the Department of Health will have to start sharing more data with society.

  1. We need a roadmap to treatment for all

The landmark START trial showed us that all people living with HIV should be offered antiretroviral treatment. In line with those findings and with World Health Organisation guidelines all people living with HIV in South Africa will be eligible for treatment from September this year. But merely making more people eligible is not enough. As shown by the recent TasP trial, much of the challenge will be to test people and then to get people who test positive to start treatment. Making a success of such a campaign will require a very ambitious new test and treat campaign – as well as the thousands upon thousands of community health workers and lay counsellors required to make such a campaign work. All this must be carefully planned, budgeted and coordinated through SANAC. The document that must bring all that planning together in one place is the new NSP.

  1. We need an ambitious plan for TB

While the new NSP will no doubt have good and aspirational targets for TB, it should also give clear guidance as to how those targets could be reached. For example, it should set South Africa on a course for dramatically scaled up contact tracing and active case-finding. Since these are human resource intensive activities, government has shied away from it. The NSP has to break this impasse. Similarly, the NSP should show the way toward addressing infection control both in the public and private sector – so that we can reduce TB transmission in schools, correctional facilities, taxis, hostels, shops, the mines, and all other places where TB is transmitted. As with HIV testing and linking to care, the TB response will not succeed if we can’t grow it outside of the healthcare system.

  1. We need to implement an ambitious and evidence-based HIV prevention plan

All indications are that the rate of new HIV infections in South Africa is still very high (over 300 000 per year). Rightly, much of the talk at the recent International AIDS Conference in Durban focused on prevention, especially prevention in women and girls aged 15 to 24. It is clear that we urgently need to ensure that all young people in this age group have easy access to condoms and comprehensive sex education. Yet, between the Department of Health and the Department of Basic Education government seems incapable of getting its act together in any meaningful way. The new NSP must help break this deadlock. It must launch a serious, focused, sustained, presidentially driven and endorsed HIV prevention campaign targeting schools and children of school-going age.

The NSP must also ensure that proven HIV prevention interventions like condom provision and voluntary medical male circumcision are scaled up aggressively. Promising initiatives such as the provision of pre-exposure prophylaxis to sex workers must be continued and expanded to other groups of people who are at high risk of HIV infection.

  1. We need concrete plans to bring in business and labour

Ensuring more people test and are then started on treatment will require taking our AIDS response beyond the healthcare system. Many people, especially men, simply never go near a clinic and we have to find other ways of reaching them. The solution is however not to have business and labour talk shops in Sandton every six months. Instead, the NSP must outline concrete ways in which business and labour can play a part in the HIV and TB response through for example facilitating HIV testing in the workplace. It must be a key part of the work of district AIDS councils to invite and involve local business and labour in our TB and HIV response in concrete ways. There are already good examples out there. We must learn from them and replicate them.

  1. We need to fundamentally reform SANAC

One of the elephants in the room is the severe dysfunction in many SANAC sectors. Unfortunately, these sectors are often little more than talk shops. Where it matters, for example in relation to medicines stockouts and the ongoing crisis in the Free State public healthcare system, SANAC leadership is often nowhere to be found. Rather than keeping government on its toes and pushing a progressive agenda, some leaders have become the lapdogs of government. This must change if SANAC is to have any relevance going forward and if SANAC is to help mobilise wider civil society in our collective TB and HIV response.

Part of the change will have to be in leadership, but a large part of it will have to be in the way SANAC is structured. Unpopular as such a move might be, all SANAC sectors should be disbanded. It is deeply disappointing, but for various reasons they simply haven’t delivered as many of us hoped they would. Instead, a single SANAC task force of no more than 15 people, including the Minister of Health and the Deputy President, should be established and should meet at least once a quarter. Business, labour, healthcare worker groups and membership-based civil society organisations must all be represented in this task force. Critically, no individuals who are not accountable to substantial constituencies should be on this task force. In addition to the task force SANAC should also convene a technical task team made up of appropriately qualified experts to consider technical scientific issues and to provide advice to the SANAC task force and the Minister and the Presidency.

Top eight indicators for the new NSP

It is critical that we monitor our TB and HIV response in as close to real-time as we can. It is also critical that we get data sliced up by district and facility so that we can see where the trouble spots are and respond to them effectively. Ideally all of the below indicators will be available to every ward, district, and provincial AIDS council in the country. This data should also be available to all members of the public. (Note that these suggested indicators include monitoring against the UNAIDS 90-90-90 targets – By 2020, 90% of all people living with HIV will know their HIV status, 90% of all people with diagnosed HIV will receive sustained antiretroviral therapy, 90% of all people receiving antiretroviral therapy will have viral suppression.)

  1. Number of people tested for HIV in the last three months by facility, district, province, and nationally. In as far as possible, this statistic should also be expressed as the percentage of HIV positive people who know their status (the first 90).
  2. Number of people on antiretroviral treatment by facility, district, province, and nationally. In as far as possible, this statistic should also be expressed as the percentage of people who know their status that are on treatment (the second 90).
  3. Viral load coverage by facility, district, province, and nationally. Viral load coverage must be expressed as the percentage of people on treatment who have received at least one viral load test in the last 12 months.
  4. Viral load suppression rate by facility, district, province, and nationally. This should be expressed as the percentage of people on antiretroviral treatment who are virally suppressed (the third 90).
  5. Number of people with a confirmed diagnosis of Drug-Sensitive-TB and Drug-resistant TB by facility, district, province, and nationally.
  6. Percentage of people with DS-TB or DR-TB who have started TB treatment by facility, district, province, and nationally.
  7. DS-TB and DR-TB cure rate by facility, district, province, and nationally.
  8. HIV vertical (Mother-To-Child) transmission rate at six weeks and 18 months by facility, district, province, and nationally.

In an upcoming article, we will compile a wish list for our response to paediatric TB and HIV.

Note: This article is written in Low’s personal capacity and does not necessarily reflect the views of the Treatment Action Campaign or SECTION27. Low is the co-editor of Spotlight. He is a former head of policy at the Treatment Action Campaign.

 

Won the battle, lost the war

By Marcus Low & Lotti Rutter

In the early days of the AIDS epidemic, the high price of antiretroviral medicines meant many lives were unnecessarily lost. While the global AIDS movement managed to force lower prices for key ARVs, the wider battle has not yet been won. Today, many people with hepatitis C, various cancers, drug-resistant tuberculosis and other conditions still cannot get the medicines they need to survive. This article explains the how inequality extends to drug development.

There are two broad problems with the way society currently pays for medicines.

The first, the innovation problem, is that we are not investing enough money and energy into finding treatments for diseases mostly affecting poor people. This is why most of our tuberculosis (TB) treatments today are more than fifty years old and not very good.

The second, the price problem, is that many of the medicines that are developed are sold at such high prices that people cannot afford them. This is why many people with hepatitis C cannot afford the highly effective new hepatitis C cures on the market. For these people the new cures might as well not exist.

The innovation problem

Last year, tuberculosis killed more people than any other infectious disease on the planet, including HIV. At 1.5 million deaths, it far outstripped headline-making outbreaks like Ebola (11,315 deaths in 21 months). Yet, in 2014 humanity invested less than US$700 million in TB research – only about a third of the two billion a year that the World Health Organisation estimates is required to bring an end to TB. Of this US$700 million, less than US$100 million was invested by the pharmaceutical industry. In fact, a number of large pharmaceutical companies have stopped doing TB research altogether.

The first part of this problem is simple. Since most people needing TB treatment are poor, pharmaceutical companies see little potential profit in developing new TB treatments. Companies choose rather to invest in researching medicines that will sell in rich countries – medicines for diabetes, heart disease, or erectile dysfunction.

The second part of the problem is more puzzling: given that industry does not invest, one would expect governments to step in to fill the gap. However, with the exception of the United States, governments do not. While the BRICS countries (Brazil, Russia, India, China and South Africa) have over 40% of the global TB burden, they contribute less than 4% of global investment in TB research.

The price problem

When the patent system does deliver important new medicines, as it sometimes does, those medicines are often priced out of reach for many of the people who need it. So, for example, the breakthrough hepatitis C drug sofosbuvir is priced at US$84 000 for an 84-day course. Similarly, high prices mean that women in South Africa who need the breast cancer drug trastuzumab often can’t afford its R500 000 price tag.

Companies argue that they have to ask these high prices to recoup their investment in developing the drugs and to fund their investment in developing new medicines. In recent years this argument has begun to wear very thin.

Companies argue that they have to ask these high prices to recoup their investment in developing the drugs and to fund their investment in developing new medicines

Companies argue that they have to ask these high prices to recoup their investment in developing the drugs and to fund their investment in developing new medicines

A United States senate investigation in 2014 found that the pricing of sofosbuvir had nothing to do with how much it costs to develop the drug. Rather than basing prices on the investments made into a drug, companies are typically setting prices at levels that maximise profits – even if that means many people can’t access the drug in question.

At a more fundamental level, high prices charged by pharmaceutical companies have brought into question the basic social contract between the public and the pharmaceutical industry.

The thinking is that the people, through our governments, grant patent monopolies to companies in return for investment in new medicines. However, enforcement of this social contract is very one-sided. While companies almost always get and maintain their patent monopolies, there is no enforcement of the expectation on companies to invest in research. Typically, companies invest only between 8 and 18% of revenue in research and development (R&D), while they typically spend double on marketing and advertising. In addition, the way in which companies spend their R&D funds is completely non-transparent.

All the available evidence suggests that we are not getting much bang for our buck in the current system where there is no obligation on industry to reciprocate high prices with high investment in R&D.

We have other options

Various solutions to these problems have been under discussion at the World Health Organisation (WHO) over the last decade – with very little progress to show for it. In addition, in 2015 the Secretary General of the United Nations, Ban Ki-moon, convened a High Level Panel to look at exactly these problems. Even if the HLP comes up with strong recommendations, it will be up to governments to make those recommendations a reality.

Some possible solutions include:

An R&D agreement or treaty

Given that industry is failing to invest in diseases that have an impact on poor people, governments have a responsibility to step in and fill that investment gap. One solution is an R&D treaty or agreement. Countries would all contribute to a central fund. Money in this fund would then be used to fund research in neglected areas like TB. This is a simple and workable solution. The only thing that is lacking is political will. Even if rich countries like the United States and Germany oppose such a treaty or agreement, there is nothing preventing other countries from going ahead without them.

Delinkage

When governments invest in research, they often do so in a way that allows companies to patent the products of that research. In this way, governments end up paying twice – once through research grants and again when paying high prices for patented medicines. If governments invest in a delinked way, they will not allow this double-payment to happen. In such a case, governments will fund research through grants and prizes and then ensure that all the research is paid for up front and that the research cost is “delinked” from the sale price of the eventual product. The so-called 3P Project (see our previous issue) is an example of a delinked model.

Bring balance to the system

International law allows for steps to be taken to balance the worst excesses or exploitation of patent monopolies. These balancing measures are commonly referred to as TRIPS flexibilities (Trade-Related Aspects of Intellectual Property Rights) and they include allowances for: compulsory licenses (overriding patents); only granting patents for truly innovative products and not for reformulations or new uses of old drugs; and for the public to file oppositions to the granting of specific patents.

The problem is that due to trade pressure from the United States Trade Representative, many countries have not written these TRIPS flexibilities into their national law – and if they have, they are often afraid to use them.

Doing away with pharmaceutical patents altogether

One of the remarkable things about the history of patents and medicines is that there is no evidence that providing increased patent protection around the world has led to greater medical advances. In fact, in the golden age of medical discovery from the 1940s to 1970s, much of the world did not offer any patent protection on medicines. There was also no increase in innovation following the TRIPS agreement in 1995, which compelled all World Trade Organisation member countries to provide for at least 20 years of patent protection.

It would of course not make sense to simply remove the patent system and not replace it with anything else. The world, after all, is in desperate need of new medicines. Governments would have to redirect the money they would have spent on purchasing patented medicines to providing research grants and sponsoring prize funds for the development of new medicines. All indications are that such a transition would in fact see R&D spending increase dramatically – given how little industry currently spends on R&D as a percentage of revenue.

Lotti Rutter is a Senior Researcher for Treatment Action Campaign

Marcus Low is an editor of Spotlight

 

QUOTES:

You are aware of the exploding prevalence of cancer around the world and in our own country. We have just moved in a circle. Just as the price of ARVs were unaffordable then, cancer drugs are devilishly unaffordable today. If no drastic action is taken today, we are going to be counting body bags like we are at war.”

Dr Aaron Motsoaledi, Health Minister of South Africa, 2016 budget vote speech.
“Rationing is the ultimate consequence of high drug prices. Unsurprisingly, this is unpopular and is causing a backlash. In a number of US states, politicians are seeking to pass legislation forcing drug companies to disclose more information about the cost of producing their high-priced remedies. There is even talk of capping prices. The industry argues that such caps would drive capital out of the industry, cutting innovation and ultimately harming patients. But that is a hard argument to sustain when companies such as Gilead and Vertex are earning gross margins of 90 per cent and share prices are sky high. Pharmaceutical innovation has been one of the great successes of the past century, improving the lives of people immeasurably round the globe. But if the current dispensation is to continue, the industry must learn to price with greater restraint.”

Financial Times, August 16, 2016.

 

The patent system is expensive. A decade-old study reckons that in 2005, without the temporary monopoly patents bestow, America might have saved three-quarters of its $210-billion bill for prescription drugs. The expense would be worth it if patents brought innovation and prosperity. They don’t.”

The Economist, August 8, 2015.