DRAFT NOT FOR CIRCULATION OR CITATION
Chapter in forthcoming book by April Harding
Chapter 4: Private Sector and Tuberculosis Control
Chapter authors: April Harding and Mukund Uplekar
4.1 TB in developing countries and the role of the private sector
4.2 What is TB and how TB programmes operate?
4.2.1 The nature and burden of the problem
4.2.2 How TB programmes operate
4.3 Global TB control architecture and programme evolution
4.4 Harnessing private sector involvement in TB care provision
4.4.1 Building a case
4.4.2 Global assessment
4.4.3 The Public-Private Mix concept
4.4.4 Evidence base
4.4.5 Global support for PPM development
4.4.6 Insights from learning projects
4.4.7 Guidance on ground level implementation
4.4.8 Scaling up PPM
4.5. Conclusions and lessons learnt
4.5.1 General lessons for TB programmes
4.5.2 General lessons for other programmes
WE STILL NEED A STORY...TO GIVE A REAL EXAMPLE OF WHAT IT MEANS
TO ENGAGE PRIVATE PRACTITIONERS (OR NOT) IN TB CONTROL.....
1

DRAFT NOT FOR CIRCULATION OR CITATION
Tuberculosis (TB) causes much illness and death in developing countries, especially among poor people. Recently, donors increased their efforts to support developing countries combat this deadly disease. And the headlines about the spread of drugresistant TB have elevated attention even more. Initially these programs tried to reach TB patients solely through public sector programs, despite the fact that in many high burden countries, a large portion of people with TB seek care from private practitioners.
Fortunately, program monitoring and a clear focus on impact led to expanding engagement with practitioners in a number of countries where it was needed to ensure proper treatment of private patients. Much remains to be done: many countries have not yet brought private practitioners into control programs; nor has the capacity of private laboratories been tapped to expand coverage of critically needed diagnostic services for drug-resistant TB and TB as a co-infection with HIV/ AIDS. Nevertheless, donors and other funders can learn from the experience of TB about what it takes to engage private practitioners productively in a complex program, and also, critically, what it takes to generate such a change in the context of a global program.
4.1. TB in developing countries and the role of the private sector
TB is among the top killer diseases in the developing world, especially of poor people.
Like many donor-supported public health initiatives in developing countries, TB control efforts are usually planned and designed by the government and implemented through government facilities through a national program structure.
1
In reality, however, many people and patients with symptoms of TB, including the very poor, don’t use government facilities, choosing instead to seek and receive care from a wide variety of private health care providers (ref). The private health sector is particularly large in Asia. Studies in
India which has the world's greatest burden of TB, have shown that in urban and rural areas alike, 75% to 88% of TB patients' first contact was a private provider (ref).
Increasing evidence from Africa also shows a rapidly growing private sector and its use by the people. Patient perceptions and preferences, convenience, stigma, gender are some of the factors that contribute to a patient's decision to first visit a private provider (ref).
Inconvenient clinic timings, long waiting times, provider attitudes, direct and indirect costs and perceptions on quality of care at government health facilities drive people away from public facilities, even when the prices are very low or free (ref).
The magnitude and the role of the private sector in delivery of TB care vary greatly from country to country. In some Asian countries, as many as ??% of people with TB will first
1 Developed countries, in contrast, historically implemented their TB control activities through the entire primary care system – which in many cases, was private. (Ref Think TB, Do PHC)
2

DRAFT NOT FOR CIRCULATION OR CITATION seek care in the private sector; while in some former Soviet republics almost everyone will turn to the public system. Some countries have a large private medical sector that provides services to all segments of population, rich and poor. Private health sector in poor countries is an unorganized and heterogeneous mix commercial and noncommercial care providers. These may include informal and formal private practitioners, pharmacies, non-governmental organizations (NGOs), private hospitals and academic institutions. With a plethora of providers with no linkages among them, people tend to shop around for care. Regulations such as quality-assurance for laboratory services for
TB or for rational use of anti-TB drugs may exist but are rarely enforced. In spite of their increasing use by the poor and the perennial human resource crisis in most settings, traditionally, public sector and donor supported programmes have paid little attention to the private sector in TB care provision
This chapter describes the evolution of efforts to facilitate engagement of private service providers in TB control. The following section presents basic facts about TB and describes how national TB control programs typically operate. Section three examines the evolution of TB control worldwide especially after the revitalization of efforts in the early 1990s. The mobilization and role of the global Stop TB Partnership, the progress achieved in TB control over the last two decades and constraints to meeting the global
TB control targets are discussed. Section four describes the evolution of private sector engagement in TB control highlighting processes and outcomes of efforts at the global and country levels. Lessons learnt from numerous learning projects are discussed. The final section presents insights for TB programs going forward, and what other programs can learn from the experience of TB programs with respect to engaging the private sector.
4.2 What is TB and how TB programs operate
4.2.1 The nature and burden of the problem
TB is caused by the Mycobacterium tuberculosis bacteria. TB infection occurs when a person carries the bacteria inside the body, but the bacteria are normally few in numbers and dormant. Most people’s immune systems keep the bacteria dormant, so it doesn’t cause symptoms or disease. Tuberculosis disease, in contrast, is the state in which one or more organs of the body become diseased as shown by clinical symptoms and signs. This is because TB bacteria in the body have started to multiply and become numerous enough to overcome the body's defences.
The most important cause of TB infection is coughing by patients with lung TB.
Coughing produces tiny infectious droplets containing TB germs that spread into the air.
A person’s risk of TB infection depends on the extent of exposure to the tiny droplets and his or her susceptibility to infection. TB infection can occur at any age. Once infected with TB bacteria, a person can stay infected for many years, often for life.
2
The vast majority of people who are infected with TB bacteria do not develop TB – the illness.
2 The presence of a TB infection can be demonstrated by a skin test – the tuberculin test.
3

DRAFT NOT FOR CIRCULATION OR CITATION
Infected people can develop TB disease at any time. The disease can affect most parts of the body, but especially lungs. Any sustained stress that leads to lowering of immune defences can trigger progression from infection to disease. TB thrives in conditions of poverty and is rightly called a disease of poverty. HIV infection is an important trigger for weakening immune resistance, which is why there has been a surge in TB among populations with high prevalence of HIV. A large majority of patients with lung TB develop a cough soon after disease onset.
3
Globally, about a third of people are infected with TB. In 2007, there were 13.7 million cases of TB worldwide including 9.27 of these were new cases. An estimated 1.77 million people died of TB in 2007 including about 450000 due to TB associated with
HIV and about 500000 cases of multidrug-resistant TB - a from of the disease that is harder to diagnose and more difficult and expensive to treat (ref). The poor and marginalized in the developing world are the worst affected: 95% of all cases and 98% of deaths from TB occur in poor countries.
4.2.2 How TB programs operate
The aim of TB control programs is to decrease suffering and death due to TB and reduce its spread. The main strategies for pursuing these goals attempt to increase the proportion of TB cases which are identified among patients presenting to health facilities with cough of over 2 weeks duration and treating them appropriately ensuring that they are cured from the disease. Diagnosis of lung TB, the most infectious form of the disease, is done by microscopic examination of the sputum (spit) of patients. Chest X-rays can yield further information to aid diagnosis. Treatment of TB comprises a combination of medicines that need to be taken for a minimum of six months. Very often, patients feel better with a few weeks treatment and tend to stop treatment or take it irregularly. As a result, they continue spreading the disease around and may develop a drug-resistant form of the disease.
4
A TB program thus depends on a functioning network of facilities with sputum microscopy facilities capacity for diagnosis, constant availability of anti-TB medicines for treatment, and the necessary logistics and health work force to diagnose, treat and supervise each TB patient until the treatment is complete.
The internationally recommended DOTS strategy 5 for TB control launched in early 1990s specifies five components that are essential to run an effective national TB programme.
First, a sustained commitment from the government to mobilize necessary financial and human resources is required. Second, a widespread laboratory network for detecting cases through sputum microscopy is essential. Thirdly, an uninterrupted supply of medicines required to treat TB is a must. Fourth, a patient support and supervision system has to be in place to ensure that patients adhere to treatment until they are cured, and
3 However, not everyone with a cough has lung TB. The most common respiratory problems -- acute respiratory infections – usually resolve within 2-3 weeks. When a cough persists beyond 2 or 3 weeks – then lung TB becomes a more likely cause.
4 When patients stop taking their medicine, the still-present bacteria may have developed their defenses to the drugs taken. People infected with these drug resistant bacteria are even harder to diagnose and to treat.
5 DOTS was earlier used as an acronym of "Directly Observed Treatment, Short Course" but is subsequently used as brand name for the internationally recommended TB control strategy.
4

DRAFT NOT FOR CIRCULATION OR CITATION finally, a monitoring system for programme supervision and evaluation is required to monitor outcomes and measure progress.
4.3 Global program architecture and program evolution
Prior to 1990s, the problem of TB was forgotten in rich countries and neglected in poor countries. Increasing poverty, population growth and migration, and the HIV epidemic have contributed to a resurgence of TB – with cases increasing substantially in a number of developing countries. When TB cases reappeared in rich countries, their governments and the key multi-lateral organizations involved in health reinvigorated their attention and support for TB control. In 1991, a World Health Assembly (WHA) resolution recognized TB as a global public health emergency. The resolution also established two targets for TB control – to detect at least 70% of new infectious TB cases, and cure at least 85% of them globally, by the year 2000 (ref). In 1994, the internationally recommended control strategy, later named DOTS, was launched.
The DOTS strategy was developed with close coordination among WHO and its long standing partners in TB control, notably, among others, the International Union against
TB and Lung Disease (“the Union”) and the Netherlands TB Foundation (KNCV).
Advocates presented convincing evidence that TB control activities were among the most cost-effective public health interventions, and this helped mobilize resources from multiple financial partners including the World Bank and USAID. In order to achieve the global targets set for the year 2000, these core actors decided to focus their support and attention on the top 22 high TB-prevalence countries that accounted for over 80% of the global burden of TB.
During the 1990s, this group of organizations pressed developing countries to do more to control TB. And they provided more funding to build up the weakened or non-existent public sector TB programs, and promote the DOTS strategy. Program activities planned and implemented by the public sector received all the attention during this period. Much of the funding was coming via the World Bank and flowing to health ministries, 6 which made it hard to include the private sector in control program activities. As noted elsewhere in the volume (see especially child health chapter) government officials usually prefer to allocate funding to their own agencies and activities, seeing funds spent on private sector as “money lost”. The USAID was an exception in supporting a few small-scale initiatives with private sector engagement.
The WHO took steps to develop a global monitoring system for TB control. All highburden country government formally agreed to adopt the recommended recording and reporting systems, and the WHO started publishing a Global TB Report in 199?.
7
The progress focusing on the public sector services alone during 1990s however was not enough. By 1997, “it was clear that most countries with a high burden of tuberculosis would not meet their targets.” (ref. Stop TB Eval).
8
6 By statute, the World Bank can allocate funding only to national governments.
7 The report is issued yearly on World TB Day (March 24).
8 This would be confirmed in 1999. While 127 countries had adopted the DOTS strategy for TB control, only 23% of the global TB cases were treated under DOTS.
5

DRAFT NOT FOR CIRCULATION OR CITATION
In 1998, an influential report by an Ad-hoc Committee on the Tuberculosis Epidemic
9 expressed concerns about the slow progress of DOTS implementation in most high-TBburden countries (ref). Identifying the major constraints to DOTS implementation, including especially political commitment, the committee called for a Global Charter on tuberculosis. The Charter was intended to be a binding agreement between the key international agencies and donors involved in TB, and the governments of endemic countries. It outlined concrete steps to be taken in specified timeframes. The formal agreement among a core group of actors evolved into a partnership. In late 1998, a global partnership was formally launched in the fight against TB. The partnership, referred to as the "Stop TB Initiative", was hosted by the WHO. In the year 2000, a high level
Ministerial Conference of Ministers of Health and Finance of the top 20 high burden countries endorsed the "Stop TB Partnership" (ref). The first official Partners Forum and
Coordinating Board meetings were held in 2001. Global targets for TB control set in
1991 were reaffirmed and the date to achieve those targets was postponed to 2005.
The Partnership launched a new advocacy instrument in 2001 with the publication of the first Global Plan to Stop TB. It set out the priority actions that were needed in TB control over the period 2001–2005 (ref). It helped to steer global TB control efforts during that time.
The DOTS framework
10
was being implemented in 182 countries. By 2004, more than 20 million patients had been treated in DOTS programmes worldwide and more than
16 million of them had been cured. By 2005, the treatment success rate had reached 84%
(just short of the target of 85%), and the case detection rate (ref), was 60% (against the target of 70% by 2005).
Between 2001-2005 TB control efforts accelerated and improved, with the Stop TB
Partnership making a significant contribution. Nevertheless, the global targets were missed again in 2005, when WHA member states committed themselves to further strengthening efforts to achieve the TB-related targets included in the Millenium
Development Goals (MDGs) (ref).
11
To complement and accelerate implementation of the DOTS strategy, WHO and partners developed policies and strategies to address the major constraints to achievement of global TB control targets. These included expanding access to diagnosis and treatment through involving communities and the private sector in TB care and control. Innovative mechanisms such as the Global Drug Facility and the Green Light Committee were developed to improve access to quality-assured and affordable drugs in resource-poor settings.
12
The collaborative activities that needed to be implemented by TB and
HIV/AIDS programs were defined, and strategies for managing multidrug-resistant TB
(MDR-TB) were developed and tested (see Box: Complex diagnostics expensive drugs
9 The committee was convened by the WHO in London.
10 The DOTS framework was subsequently expanded ??? (ref).
11 This resolution built on the report of the Commission on Macroeconomics and Health (2001), the High-
Level Forum on the Health Millennium Development Goals (MDGs) in 2004, and the Second Ad-hoc
Committee on the Tuberculosis Epidemic (2005) (ref).
12 The GDF is….. The GLC is….
6

DRAFT NOT FOR CIRCULATION OR CITATION make it hard to control MDR-TB). New partnerships and academic research initiatives for development of new tools -- diagnostics, drugs and vaccines -- were also established and started developing their pipelines.
In addition to elevating resources and attention to TB control, through the Stop TB
Partnership the core actors were able to provide developing countries more, and more consistent, technical support in program design, and support to identifying constraints and new strategies to overcome them. The drugs supplied to countries via the GDF also provided leverage that could be used to nudge countries toward needed changes in their program, and private providers to engage in the TB control program.
Box XX: Complex diagnostics and expensive drugs make it hard to control MDR-TB
Explaining why MDR-TB is hard to deal with. What program activities to combat MDR-
TB usually consist of. Treatment; lab strengthening…
Spending on TB control increased dramatically since 2000 (Graph?). Countries mobilized more resources domestically, and the establishment of the Global Fund to Fight AIDS,
Tuberculosis and Malaria (The Global Fund) in 2001 and UNITAID
13
in ???? made more donor support available for TB programs. The advent of the Global Fund also made it easier to have private sector engagement components in TB programs, because GF rules, in contrast to the World Bank (the previous large funder) can channel their funds to private actors (refer to Box in malaria chapter on the GF vs the previous sources of funds in ability to use to engage private sector). Describe how UNITAID works.
After a thorough review of achievements of over a decade of DOTS implementation and taking into account the challenges ahead to meet the MDGs, WHO and partners launched two landmark documents in 2006: the "Second Global Plan to Stop TB 2006-2015"(ref) and the new "Stop TB Strategy" that underpinned the Global Plan (ref). The strategy and the global plan recognized the need to work with the private sector and made "engaging all care providers" through public-private mix (PPM) approaches an essential component for achieving TB control.
14
This was an outcome of systematic steps undertaken by WHO and partners to harness private sector engagement in TB care and control.
Countries themselves, driven by stagnating case detection rates, and elevated scrutiny both domestically and globally slowly became more open to new options to improve their programs. South Africa authorities, for example, facing constrained budgets and the need to increase case detection and treatment initiated collaboration with community based NGOs which could deliver TB services less expensively that public facilities.
15
4.4 Harnessing private sector involvement in TB care provision
4.4.1 Building a case
Stagnating case identification rates, the growing use of private practitioners, especially by poor people, made it clear the private sector was playing a significant role in TB. These
13 UNITAID is…..
14 The PPM concept is elaborated below in section XX.
15 Sinanovic and Kumaranayake 2009
7

DRAFT NOT FOR CIRCULATION OR CITATION trends, combined with abundant evidence on mismanagement of TB in the private sector, finally spurred the global TB community led by the WHO to begin addressing the issue of private sector involvement in TB programs. In 1998, the Ad-hoc Committee on the TB
Epidemic made a specific mention of the need to engage the private sector -- private practitioners and voluntary organizations -- in TB control. However, the issue of private sector engagement did not find much consideration in the first Global Plan to Stop TB in
2001 (which outlined specific actions and timetables countries were committing to control TB). In 2002, WHO and partners expanded the DOTS framework through consensus stressing that "collaboration and synergy among the public, private, and voluntary sectors are essential to ensure accessible and quality-assured TB diagnosis and treatment" and added involving private health care providers as an additional key program component for expanding DOTS (ref).
4.4.2 Global assessment
For country officials and program managers to take private sector engagement in TB seriously, it was essential to demonstrate how the private sector mattered and if collaborating with private providers was feasible and beneficial. The WHO along with partners made systematic efforts and investments to tackle this issue. A global assessment in 23 countries was undertaken as a first step; it helped illuminate the role of private providers in TB care in diverse settings. It also presented examples of successful publicprivate collaborations, and presented a framework for national TB programs to begin addressing the problem (ref).
The assessment confirmed that a large proportion of TB suspects and cases are managed, partly or fully, in the private sector in many high-burden countries. It also collected evidence on widespread mismanagement of TB in the private sector not linked to public sector programs. It underscored the need to begin actively engaging the different types of providers in TB control activities. The assessment revealed that regardless of mixed perceptions and reservations, both sides - public and private - had indeed collaborated in some settings. Publication in the Lancet of a summary of the global assessment including a review of the literature on private sector roles in TB diagnosis and treatment and working examples of private sector involvement in TB control in low, medium and high income countries helped raise the profile of the issue and facilitated its incorporation in the "Expanded framework for effective tuberculosis control" endorsed by WHO and partners (ref). This review of experiences with engagement strategies led to the development of a template for engaging private practitioners in DOTS, which came to be referred to as the PPM concept.
4.4.3 Global support for private sector engagement development
It was clear that private practitioners would need to be engaged to reach DOTS coverage targets, especially in the many high-burden countries where people use the private sector in large numbers. Government officials and program managers were receiving such information in global forums; many signed formal commitments to private sector engagement as part of their TB control strategies. But it was to take more than this to bring about change in most national programs.
8

DRAFT NOT FOR CIRCULATION OR CITATION
Country pilots. In the following years, the WHO, and other Stop TB partners, supported several initiatives to engage private providers in TB control in diverse country settings. They started by supporting setting up and documenting what was called PPM initiatives at sites in India, Kenya and Vietnam. Documenting and sharing these experiences among Sub-group members in annual meetings and country review meetings helped to generate momentum and openness to private sector engagement in other countries. Since then, more than 50 such initiatives have been implemented in 14 countries and many of them have been formally evaluated, and these are discussed below in the evidence review section (4.4.6). For now we turn to how the global community was able to mobilize this important change in TB programs.
The mechanics. It was becoming more and more clear that in a number of highburden countries TB programs would not reach the coverage levels they were aiming for without engaging private providers. And the evidence of effectiveness of strategies to engage the private sector was accumulating. The global community was to work through the Stop TB Partnership apparatus to try to bring about the needed changes in program design at the country level. The Partnership operates through seven working groups, and a major one among them is the DOTS Expansion Working Group (DEWG).
16
In 2002, the Partnership set up a global Sub-group on Public-Private Mix for DOTS Expansion
(PPM Sub-group), as a part of the DEWG (ref-URL). Through its annual global meeting the PPM Subgroup provided a forum for country program managers, technical and financial partners, researchers and academicians as well as private sector representatives to share findings from the country based initiatives to engage private sector, discuss challenges and seek advice. Members of the Sub-group, supported by the WHO and
Partnership secretariat, help keep the issue of private sector engagement on the agenda and take a regular stock of the progress and problems related to private sector engagement implementation especially in high-TB-burden countries (ref).
Funding partners have also provided funding for staff positions in TB control programs at the country level (e.g. USAID in Pakistan); as well as for a position (s?) at the WHO to take forward this effort. These individuals have played a critical role in the progress that has been achieved.
Global level staff provide support to control programs to: assess the role of the private sector in TB in their country; to identify strategies to engage private practitioners; and to develop country appropriate guidelines for engagement.
The Partnership's second Global Plan to Stop TB set out the actions needed between 2006 and 2015, to achieve TB-related MDGs under all six components of the Stop TB Strategy, including, for the first time, scaling up implementation of private sector engagement for
TB care and control in countries where this would be needed to achieve program targets.
Two important documents helped establish and disseminate the case for engaging private practitioners in TB programs: one was titled "The International Standards for TB care"
16 The Stop TB Partnership implements much of its norm-setting, technical assistance, and program review through its Working Groups.
9

DRAFT NOT FOR CIRCULATION OR CITATION
(ref) and the other "Engaging all care providers in TB control: Guidance on implementing public-private mix approaches"(ref). Both the Standards and the guidance on private sector engagement approaches were based on the existing evidence from studies and interventions on the ground in diverse country-settings. Making private sector engagement an integral part of the Stop TB Strategy and providing necessary guidance and tools for implementation and scale up encouraged more countries to pursue private sector engagement options (ref: Stop TB evaluation).
Many country initiatives use the phrase public private mix (PPM) approach to characterize their private sector engagement activities – reflecting the phrasing from the
Sub-group, and WHO and Stop TB guidelines. The phrase encompasses the range of strategies used to collaborate with the private sector. The guidelines use the phrase to emphasize the partnership element of such collaborations, and the importance of the stewardship role played by the government and the TB control program. Such emphasis was undoubtedly appropriate, both technically, and politically – because many public officials and program managers would be more open to private sector engagement which was clearly structured leave them in the driver’s seat, and which would contribute to public health and program goals.
Indicators and reporting. The annual Stop TB meetings and the global TB control report monitoring process created a foundation for identifying countries whose progress in expanding coverage was stalled, and conducting discussions about how to increase coverage of the programs. This “feedback” process was an important mechanism for drawing attention to the need to, and strategies for, engaging the private sector to increase coverage of the control programs. Countries were required to report case identification figures (e.g. how many new cases of active malaria was their program “catching”), 17
and the proportion of people treated who were successfully treated with DOTS. In a number of these countries, high private sector utilization was clearly contributing to the stagnant coverage (case identification) figures.
An important distinction between TB and other programs is that a key program monitoring variable, cases detected – reflects demand (patient attendance) and not simply supply. That is, people with TB have to go to a provider participating in, and reporting to, the control program for the program to get “credit”. AIDS programs typically report on treatment figures (which also require demand/ attendance), but malaria and child health programs often report on outputs or supply figures (e.g. nets distributed; children living near facilities where staff has received training). When output figures are the focus of program monitoring – failures to expand use and meaningful coverage are much more likely to go unnoticed. TB program monitoring indicators were helpful in making expansion bottlenecks more obvious – and therefore signalling the need to engage the private sector when that is needed.
17 The official statistic that is supposed to be collected is the case identification rate – that is, the proportion of total active cases in the population which are identified by the control program. However, there are few countries with reliable estimates for this denominator. So, in essence, the programs are reporting on the numerator – the number of cases identified.
10

DRAFT NOT FOR CIRCULATION OR CITATION
In countries with stagnating case detection figures, the figures provided a solid foundation for discussions in the yearly sub-Group meetings, and provided an important source of leverage to motivate national TB programs to start applying private sector engagement strategies in countries where private sector utilization was significant. The
Stop TB Partnership activities clearly contributed to increased consideration and implementation of private sector engagement in countries where it was necessary to make progress on TB control (ref: Stop TB evaluation). NB: This was partly due to their actions, and partly due to the change in requirements to access external funding for TB control – which is discussed below in section 4.4.6.
4.4.4 Insights about implementation from learning projects
Documentation of the processes and outcomes of the learning projects and country experiences helped identify some key factors about the design of program activities that make private sector engagement work.
18
These were: a) Government commitment to private sector engagement is essential. The control program needs to develop clear stewardship (e.g. regulatory and oversight) functions for private sector engagement strategies. The government should finance or facilitate financing of private sector engagement strategies, including drug costs and cost for manpower for supervision, monitoring and evaluation activities. b) It is important to allot time for dialogue among all stakeholders in order to build trust and achieve consensus on common goals for the planned collaboration. When conflicts of interest exist, they need to be identified early and discussed openly. c) Using an NGO or a medical association as an intermediary or as a neutral ground may facilitate collaboration, especially when there is initial distrust between the control program and private providers. d) Training is crucial and it is as important to sensitize program staff to the philosophy and rationale for collaboration with the private sector, as it is to sensitize private providers to the DOTS strategy. e) An improved referral and information system through use of simple practical tools is essential both to secure effective operationalization of a public-private collaboration as well as to enable evaluation of engagement initiatives. f) Adequate supervision and monitoring of private providers are required, and this should ultimately be the responsibility of the national control program.
Private practitioners usually must be paid by patients directly, since few developing countries have extensive health insurance or contracted health services. Since TB drugs are costly, and treatment must continue for 6 months, adherence can be hard to achieve in the private sector where patients will be more and more tempted to discontinue treatment
– as they feel better and the drugs are costly. Two strategies emerged to deal with this: providing private providers free TB drugs and patient pre-payment. Providing TB medicine free of charge improves adherence and patient outcomes, promotes equity and is also a tool for motivating private practitioners to participate in control programs through formal or informal “drugs-for-performance” contracts.
19
Where there aren’t
18 These experiences also shed light on how the programs should be managed, and the PPM Sub-Group of the Stop TB Partnership developed guidelines for program managers based on this knowledge. The
Guidelines can be found at (URL)
19 The range of strategies used to engage private practitioners is discussed it the next section.
11

DRAFT NOT FOR CIRCULATION OR CITATION enough resources, or where political or ideological objections block giving free drugs to private practitioners, prepayment at the start of treatment by patients is an alternative to free drugs that can improve adherence (and outcomes), but it constitutes a barrier to treatment for poor people.
4.4.5
Evidence from engagement
In the past 10 years, a wide range of engagement strategies have been tried in a variety of country settings. Many are small in scale, but more recently larger initiatives have been put in place. This section reviews the evidence from impact and cost effectiveness assessments.
The examples outlined below highlight the considerable variation in country settings, the extent of engagement, the nature of engagement strategies and their contribution to improving TB program performance. Assessment finding are summarized in the table below.
These include diverse projects linking control programs to various care providers including untrained village doctors, informal and formal private practitioners, specialist chest physicians, public and private hospitals, and non-governmental organizations.
Engagement strategies used include “drugs for performance” agreements, verbal agreements, and franchising. Evaluations showed that treatment success rates in the projects that provided drugs free of charge to patients were between 75% and 90%. The initiatives where impact on case detection was evaluated showed an increase in case detection ranging from 10% to 60% (ref).
Bangladesh provides a working example of scaled up rural private sector engagement initiative. The control program is working through partner non-governmental organizations (NGOs) to engage the large for-profit private sector in the country. The
Damien Foundation Bangladesh has engaged (what mechanism?) "village doctors" in referral of TB suspects and treatment supervision since 1997. Village doctors are semiqualified or unqualified practitioners, including drug vendors, which live and practice within communities and provide care to a large portion of Bangladeshis with TB. They have been successfully engaged in provision of DOTS, and proper referral as well as in supporting MDR TB patients (ref).
Insight unqualified practitioners can be successfully engaged
Private sector engagement can significantly help reach the poor.
-
Since people with TB widely turn first to a pharmacy, the national program in Cambodia has been working with them through the Pharmacists Association of Cambodia.
Pharmacies are expected to refer TB suspects and supervise treatment of patients staying close by. PPM activities to engage informal practitioners, private clinics, small businesses and prisons are in their initial stages. The involvement of pharmacies has also helped promote rational use of anti-TB drugs in PPM areas by containing their unrestricted availability in private pharmacies (ref).
12

DRAFT NOT FOR CIRCULATION OR CITATION
Following demonstration of feasibility, effectiveness and cost-effectiveness of PPM through several small scale projects, the India program scaled up private sector engagement in a phased manner beginning with 14 large cities covering a population of
50 million. National “schemes” to suit engagement of different providers are the main instruments of engagement. Special national and state level initiatives have also been put in place to support engagement of public and private medical colleges and the Indian
Medical Association has been engaged to involve private practitioners. The diverse PPM provider categories in India include private practitioners and hospitals, NGO facilities, medical colleges, corporate sector facilities, and public sector health facilities outside the purview of ministry of health. The surveillance system put in place especially to measure contribution of different providers has generated useful data to plan and inform future scale up (ref).
A private sector engagement (public-private collaboration?) initiative was started by
Kenya Association for Prevention of Tuberculosis Lung Disease through engagement of private chest physicians in Nairobi with a collaborating pharmaceutical company providing anti-TB drugs at subsidized costs. PPM activities have now been expanded to other cities. Analysis showed that there is considerable scope for effective engagement of practicing nurses, clinical officers, pharmacies and private laboratories (ref).
A range of engagement models are in place in Pakistan, which enable productive collaboration with NGOs, formal and informal practitioners and hospitals (ref). Of particular significance is the Greenstar social franchising initiative operating in five large cities. A social franchise mobilizes existing providers to deliver more and better services
–according to guidelines established by the franchisor organization. The franchisor does this by promoting its brand, so that affiliation brings more customers to providers in the franchise. While social franchises are most often established to address problems with reproductive health services, these networks have turned out to work well for addressing service problems in other areas. That is, it has proven possible to add TB services to existing reproductive health social franchises. In Pakistan, the Greenstar franchise has networked more than 8000 private practitioners and pharmacies. And by adding TB services to those provided by participating practitioners, in Karachi alone, over half of the
TB cases detected in the city are contributed by private practitioners working in slum areas and linked to the franchisor NGO. A pre-existing reproductive health focused franchise was also used to expand access to DOTS in Myanmar (ref).
Table: Evidence from private sector engagement
Case Description (engagement Results strategy; private actors)
India (Pune) Drugs for performance agreement with rural medical practitioners (practitioners refer and then receive free drugs to supervise patient);
NGO intermediary.
Contributed to 30% of the cases detected in the TB Unit over a 5-month period.
Withdrawal of NGO intermediary, and turnover in public officials led partnership to fall apart.
20
20
Rangan, S.G. and S. K. Juvekar, S. B. Rasalpurkar, S. N. Morankar, A. N. Joshi, J. D. H. Porter. 2004. Tuberculosis control in rural India: lessons from public-private collaboration. International Journal of Tuberculosis and Lung Disease. 8(5):552–559.
13

DRAFT NOT FOR CIRCULATION OR CITATION
India
(Delhi)
Drugs for performance agreement, training, supplies and payment or administration provided;
NGO intermediary, and private practitioners
Increased case detection by 29% for new sputum-positive cases. Treatment success rate of 81% (close to that in the government program of 86%).
21 c/e: $33 per patient treated in private sector (public sector cost) compared to
$63 when delivered via public clinic.
22 c/e: $24 per patient treated in private sector (public sector cost) compared to
$63 when delivered via public clinic.
India
(Hyderabad)
Pakistan
Drugs for performance agreement, training, supplies and payment for administration provided;
NGO intermediary and private practitioners
Social franchise; various providers
Ho Chi
Minh City
(Vietnam)
Lalitpur
(Nepal)
Nairobi
(Kenya)
25
Training, job aids (protocols); financial incentives (but no subsidized drugs) for detection, treatment and referral; pharmacies, GPs and chest physicians.
Free drugs to NGOs; training and IEC to private practitioners to make referrals, accreditation signs;
NGOs, nursing home, private clinic
Chest physicians
A fifth of all cases detected (39 635) were contributed by private
(participating) providers.
Increased case detection by 18% in intervention districts
23
, but quality not adequate – achieving only a 60% treatment success rate.
24
An overall increase of case notification of sputum positive patients in the study area from
54/100,000 before implementation in
1998 to 102/100,000 following implementation.
Treatment success rates were over
90%, exceeding the international target of 85%, and less than 1% of patients defaulted.
26
About 10% TB cases in Nairobi and
2% of all cases nationally are
21
Arora,V. K. and R. Sarin, K. Lönnroth. Feasibility and effectiveness of a public-private mix project for improved TB control in
Delhi, India. 2003. International Journal of Tuberculosis and Lung Disease. 7(12):1131–1138
22
Floyd, K. and Arora, V. K., K.J. Murthy, K. Lonnroth, N. Singla, Y.Akbar, Y. Zignol, and M.Uplekar 2006. Cost and costeffectiveness of PPM-DOTS for tuberculosis control: evidence from India. Bull World Health Organ. 84 (6) 437-45
23
Quy, H.T., and N. T. N. Lan, K Lonnroth, T.N. Buu, T. T. N. Dieu, L. T. Hai. 2003. Public-private mix for improved TB control in
Ho Chi Minh City, Vietnam: an assessment of its impact on case detection. International Journal of Tuberculosis and Lung Disease.
7(5):464–471.
24
Quy, H.T., and K Lonnroth, N. T. N. Lan, T.N. Buu. 2003Treatment results among tuberculosis patients treated by private lung specialists involved in a public-private mix project in Vietnam. International Journal of Tuberculosis and Lung Disease. 7(12):1139–
1146.
25
Aimed to reduce TB treatment by private practitioners – to get them to go to NGO run DOTS centers
26
Hurtig AK, Pande SB, Baral SC, Newell JN, Porter JD, Bam DS. Linking private and public sectors in tuberculosis treatment in
Kathmandu Valley, Nepal. Health Policy Plan. 2002;17:78–89.
14

DRAFT NOT FOR CIRCULATION OR CITATION
Cambodia
Bangladesh
South
Africa (1)
South
Africa (2) clinics
Cambodia pharmacies
Myanmar Social franchise (subsidized); practitioners, labs
Training, drugs for performance; NGO intermediary - supervision,
“village doctors” – semi and unqualified practitioners.
Payment or drugs for performance agreement
(complying with program guidelines); occupational health clinics
30
Per patient payment; community NGO providers contributed by participating private chest physicians 27
488 private clinics referred 3136 TB suspects of which 18% diagnosed with smear positive TB.
21% of total new (smear positive) cases notified in intervention townships; 84% treatment success rate, compared to 81% of Myanmar national program. 68% of franchise
TB patients were from lower-income groups.
28
At large scale.15% (over 28 376) new smear positive TB cases detected in
2006 were referred by and over half of them, were supervised by village doctors achieving treatment success rate of over 90%
29
.
Treatment completion rates in the occupational clinics higher (87%) compared to public (79% and 62% in two sites).
31 c/e – provider costs per new smear patient cured
$788 and $978 (priv) vs $823 and 583
(pub) in 2001 $US c/e – total (provider plus patient) costs
$788 and $978 (priv) vs $1000 and
$700 (pub) in 2001 $US
Treatment completion rates of 73% and 69% in two sites compared to public (79% and 62% in two sites) c/e – provider costs per new smear patient cured
27
Personal Communication.Dr J Sitienei . NTP Director,Kenya.
28
Lonnroth, K and Tin Aung, Win Maung, Mukund Uplekar. 2007. Social franchising of TB care through private GPs in Myanmar: an assessment of treatment results, access, equity and financial protection.
29
Hamid, S.M., and M. Uplekar,P. Daru, M. Aung, M.,E. Declercq,K. Lonnroth. 2006. Turning liabilities into resources: informal village doctors and tuberculosis control in Bangladesh. WHO Bulletin, 84(6).
30 The mining companies are required by regulation to provide TB treatment to their workers – which adds to their motivation/ incentives.
31
Sinanovic, E. and L. Kumaranayake. 2006. Quality of tuberculosis care provided in different models of public-private partnerships in South Africa . International Journal of Tuberculosis and Lung Disease. 10(7):795–801
15

DRAFT NOT FOR CIRCULATION OR CITATION
$386 and $308 (priv) vs $823 and 583
(pub) in 2001 $US c/e/ - total (provider plus patient) costs per new smear patient cured
$446 and $354 (priv) vs $1000 and
$700 (pub) in 2001 $US
Philippines Insurance coverage and accreditation; physicians
About 18% of all new smear positive
TB cases treated under DOTS in the areas where PPM was in place.
Treatment success rates in private
PPM Units well above 85%
32
Another novel instrument successfully applied to expand DOTS coverage via private providers was the addition of a TB treatment package to an existing social insurance package. In the Philippines, the government health insurance organization, PhilHealth, will now reimburse any certified private provider for providing TB care to PhilHealth enrolees. Individual practitioners have to get trained and certified to be eligible for reimbursement by PhilHealth for providing TB services. Private as well as public sector institutions certified jointly by PhilHealth and the TB program are also eligible to receive the reimbursement for the services specified in the insurance package. The initiative is certainly expanding the coverage of DOTS, and on average, treatment success rates are higher than in the national programs (ref- trip report). However, problems with the reimbursement process and the exclusion of private providers from accessing NTP procured (free) drugs, is causing private providers to reduce their participation and referrals (pers. Communication – Christy Hanson, USAID).
Philippines has also advanced significantly in implementing PPM for programmatic management of MDR-TB (ref) involving the private sector.
The evidence clearly indicates that a range of practitioners can be engaged to increase, often substantially, case detection, and improve treatment outcomes. And this can be done in a variety of country settings. Available information indicates that engagement has helped improve program performance by increasing case detection from about 10% to 60% while maintaining the treatment success rates over 85% (ref).
Private practitioners are often fragmented and not well-organized. It’s important to know they can be successfully engaged to practice DOTS and report and refer patients as needed. But, to make decisions about programs, and how best to reach coverage (case detection) goals – we also need to be able to compare the cost of reaching those goals using different strategies. Two studies have been done comparing the costs and cost effectiveness of reaching patients via public delivery compared with private – one in
India, and one in South Africa. The study found that, in the city of Hyderabad the
32
Lonnroth K. 2008 Measuring the contribution of Public-Private Mix for TB Care and control - lessons from The Philippines,
Philippines. Mission Report December 2008. World Health Organization.
16

DRAFT NOT FOR CIRCULATION OR CITATION private practitioners engaged in the control program could deliver successful DOTS treatment for approximately $118 (US 2002 dollars) while the public sector cost approximately $144 to do the same (ref: Floyd, Uplekar et al).
In South Africa…
There is enough evidence to indicate that PPM helps increase case detection, improve treatment outcomes, reach the poor and save costs of care (ref).
4.4.6
Support for TB programs and how it influences engagement
The Stop TB Partnership and secretariat have contributed to overcoming the inertia, and tendency to overlook or exclude the private sector from TB control programs. The fact that the TB program reporting process and targets were taken seriously – helped make it clear when omitting the private sector from programs was going to be needed to achieve program goals. Encouraged by the outcomes of the small scale experiments mentioned above, and the support and pressure from the Stop TB Partnership reporting process and the PPM Subgroup, many countries are now embarking on scaling up PPM.
Increasing resources are also becoming available for scaling up private sector engagement. The establishment of the Global Fund was an important contributor to this increased availability of resources for private sector engagement strategies in control programs. Previously, the World Bank was a primary funder, and their funds, by statute, can go only to government. Governments may decide to use the money to establish collaborations with private providers, NGOs or others. Nevertheless, this requirement tends to make Bank support very focused on public sector activities and resources. A review of World Bank health projects between 1996 and 2007 found 9 projects with components supporting TB control. Only 2 of these projects, both in India, included private sector engagement activities (see Annex: World Bank TB control support projects or project components).
In 2002, the Global Fund was established. And the Global Fund model for allocating funding permits the allocation of funds to private actors. And it appears that, combined with the guidelines, support, and pressure to achieve coverage (case detection) targets – private sector inclusion in control programs is becoming more common. Currently, around 64% of countries and multi-country entities that have TB Global Fund grants include a PPM component (ref).
33
The USAID supported TB Control Assistance Program established in 2005 has facilitated several USAID country missions to invest in developing public-private collaborative initiatives in TB programs including in Ghana, Indonesia, Malawi, Nigeria,
Pakistan and Philippines.
4.5 Conclusions and insights for Funders
33 As noted above, GF statutes allow funding to be allocated to private actors, which makes it easier for them to support PPM in TB programs relative to the World Bank the previous largest funder.
17

DRAFT NOT FOR CIRCULATION OR CITATION
4.5.1 General lessons for TB programs: The long journey of the global TB community from completely ignoring private providers to making collaboration with them an integral part of the global TB control strategy has not been a smooth ride. The achievements so far, reflected more in the changing the mindset rather than making a huge difference on the ground, have been possible due to the increased willingness of technical and financial partners in recognizing reality on the ground, especially with respect to utilization of nonpublic providers, and acting on them. Now, all high-TB- burden countries have a national policy on engaging private sector providers in TB control; all have PPM related activities in place; and over a dozen have scaled up PPM program supported by the Global Fund and other multilateral and bilateral agencies.
While progress has been made, many programs still don’t engage, or engage private practitioners only on a small scale relative to their significance in healthcare provision overall. Donor-supported programs will increase their impact if they are more systematic about analyzing current utilization patterns – especially in countries where coverage of
DOTS has stagnated at too-low levels. Many of these countries will increase coverage only through expanded engagement with the private sector. The formal policies are in place – donors can support improved program effectiveness by supporting broader implementation of PPM. To engage effectively all relevant care providers -- public, private, corporate, voluntary -- in TB care and control on a sustainable basis, more must be invested in building capacities of both sides . Donor-supported programs need to include activities to strengthen the public sector’s capacity to engage non-program care providers. And programs must include proven strategies to mobilize the private sector to take on public health tasks over and above the clinical tasks they are used to undertake, such as those outlined in this chapter: drugs for performance agreements; social franchising; and, insurance coverage which includes TB treatment.
Learning projects and ways to expand PPM beyond routine DOTS implementation should now be encouraged. This may be undertaken to scale up collaborative TB/HIV activities, laboratory capacity strengthening, and MDR-TB management. Private sector providers engaged by TB programs may be willing to undertake HIV related activities and vice versa, as they were for DOTS. Involvement of private laboratories, for instance, to provide the much needed rapid increase in not only basic microscopy but also culture and drug sensitivity testing required for MDR-TB management should be explored. For this purpose, TB programs will first need to assess existing private laboratory capacity and assess their willingness to collaborate giving sufficient work, suitable incentives and support for training and quality assurance. In instances where substantial capacity exists in the private sector, it will often be much cheaper to enter into agreements which would allow them to ramp up production to provide diagnostic services for the TB program. The cost effectiveness of building a large number of new public labs, should be benchmarked against buying needed services from private labs in donor-supported programs.
Over 90% of MDR-TB patients are currently managed in the private sector, most likely inappropriately. The typical response of national TB programs has been to make massive investments in building new structures and capacity in the public sector to enable programmatic management of MDR-TB. It would be advisable to consider private sector
18

DRAFT NOT FOR CIRCULATION OR CITATION engagement even from the planning stage. It is possible that some TB program may take a conscious decision to exclude the private sector but it should be based on an assessment of field realities and justifiable reasons, and the ability to reach these patients through alternative strategies.
4.5.2 General lessons for other programs
The move from exclusion to engagement of private practitioners in TB programs provides insight for other programs. The important among them include: a) Progress is accelerated when both the technical partners are supporting progress and the funders have rules and processes that enable funding to flow to private actors (e.g.
The Global Fund). b) If utilization of private providers is high, programs that rely on reaching people through public facilities alone will not meet their coverage objectives. They will miss many people. c) Progress on private sector engagement (if engagement is needed) will require explicit recognition at the global and national levels of the need to address it to achieve program goals and objectives d) Technical assistance and capacity building – sharing evidence of outcomes of fieldbased interventions are required to help public officials play their new roles. e) In many setting, programs will be more successful if they promote public sector driven and supported private sector engagement rather than initiatives owned, operated and sustained by the private sector. f) Global mechanism(s) to help share experiences, measure impact, promote tools and instruments of collaboration, and offer advice and support. g) Availability of a menu of options and diverse approaches to engage the private sector rather than one recommended approach h) Express willingness on part of funding agencies and mechanisms to support private sector engagement for a public good i) Investments in terms of human and financial resources to support focal points at the global and national levels
------------------
19