Tuberculosis (TB)


Stop TB Strategy: implementation and planning (2005–2007)

For the first time in 2006, countries were asked specific questions related to the six components of the WHO Stop TB Strategy, which was formally launched early in the year (Table 2). All HBCs have embraced the strategy to some degree and have been implementing diverse activities to achieve full DOTS expansion, to consolidate the gains made in previous years and to begin addressing the remaining challenges. The progress made by countries, and especially by the 22 HBCs, in implementing the Stop TB Strategy was evident from their responses to the questionnaire. These are presented in detail in Annex 2, and summarized below under the various components and subcomponents of the Strategy. Component 1e, concerned with monitoring and evaluation, is covered under Monitoring progress in TB control.

1. Pursue high-quality DOTS expansion and enhancement

a. Political commitment

The development of NTP strategic plans in line with the Global Plan to Stop TB, 2006–2015 is one indicator of sustained political commitment. A total of 18 HBCs reported having such plans, mostly covering the period 2006–2010, with the exception of Brazil (2004–2007), India (2006–2011), Pakistan (2005–2010), the Russian Federation (2007–2011) and Thailand (2006–2015). While Ethiopia’s plan was still under development, South Africa, UR Tanzania and Zimbabwe did not have country plans in line with the Global Plan at the time of reporting. A more rigorous assessment of the quality and completeness of country plans is described under Financing TB control and in Annex 1.

Human resource development

HRD for comprehensive TB control was included in regional strategic plans for TB control 2006–2010 in the African, Americas, South-East Asia and Western Pacific regions, although the level of detail varies considerably. At the end of 2006, the plan for the European Region was under preparation. In the Eastern Mediterranean Region, HRD was included in the TB/HIV strategic plan for 2006–2010, with details for the TB control component to be finalized.

A total of 15 HBCs reported having a comprehensive HRD plan for TB control (Annex 2). Of the 7 HBCs with no plan, both China and Mozambique had plans under development. In the Russian Federation, HRD has been described briefly in both the World Bank loan and the GFATM grant, but has not been fully developed. Kenya had not developed an HRD plan by the end of 2006. In Uganda, HRD was not directly under the control of the NTP. In UR Tanzania and Zimbabwe, TB control has been integrated with the delivery of other health services and there was no separate HRD plan for TB. Twelve countries reported that their HRD plans were linked and coordinated with national human resources for health plans.

In the 15 HBCs with HRD plans, all have included training and staffing needs for DOTS enhancement and sustainability, together with collaborative TB/HIV activities. Ten have incorporated training and staffing needs for MDR-TB, and 13 included training and staffing needs for PPM (Annex 2).

A total of 17 countries had a staff member at the central level specifically for HRD work, and in 9 countries this person worked on HRD full-time (Bangladesh, Brazil, Ethiopia, India, Indonesia, Nigeria, Pakistan, South Africa, Viet Nam). Some 19 HBCs had job descriptions for HRD positions, which were distributed and known to all staff.

Six HBCs had at least one health-care professional trained on TB in all peripheral-level health care units; 10 countries reported less than one. Training on TB control, following NTP guidelines, was included in the basic training of doctors in 19 of the 22 HBCs (Ethiopia, Pakistan and Uganda excluded) and was a part of the nursing curricula in 17 HBCs.

b. Case detection through quality-assured bacteriology

Table 15 summarizes information on laboratory services in HBCs. Although there has been progressive improvement in geographical coverage of laboratory services, these services need to be strengthened in several countries. For example, only six HBCs reported having a fully functional national reference laboratory (Table 15).

In terms of coverage, there has also been an improvement in EQA for smear microscopy in recent years. However, these efforts still need to be intensified, especially in the Region of the Americas, and in the Eastern Mediterranean and European regions. The data reported to WHO were incomplete but, in each of these regions, less than half of the smear microscopy centres appear to have been included in the EQA programme. Only nine HBCs reported EQA coverage exceeding 50% of designated laboratories. Similarly, while all 22 HBCs had plans for laboratory supervision, only half of them implemented these plans during 2006. Laboratory supervision was uneven in the remaining half.

Regarding culture facilities, there were also large gaps in the information reported to WHO. Brazil, Cambodia, South Africa, Thailand and Viet Nam were exceptional in reporting good coverage of culture facilities, i.e. exceeding the minimum of one culture facility per five million population. On the larger scale, over half of the populations in the African, South-East Asia and Western Pacific regions had limited coverage of culture services. India had only five laboratories linked to the NTP that provided a culture service, and only these five were able to do DST. Most countries had neither national policies to expand culture and DST services nor the technical capacity to implement and support such services.

Lack of staff, problems of transportation and inadequate funding, including that for technical assistance, were reported to be the major barriers for HBCs to operate or strengthen quality-assured laboratory services.

c. Standardized treatment, with supervision and patient support

All 22 HBCs, and 171 of 176 responding countries, used standardized, short-course chemotherapy in DOTS units; 149 of 178 responding countries routinely used directly observed therapy (DOT) during the initial phase of treatment. In the Russian Federation, South Africa, Thailand, Uganda and Zimbabwe, some DOTS units were not using DOT during the initial phase of treatment.

A total of 159 countries, and all HBCs except China, provided anti-TB drugs free of charge to all patients treated with Category I regimens under DOTS; 129 countries responding to the questionnaire, and all HBCs except Brazil and Zimbabwe, reported that they used the WHO-recommended Category I regimen. Only 20 out of 37 responding NTPs in the European region said that they used the Category I regimen.

Treatment with Category I regimen for six months was reportedly used in 91 countries worldwide; 31 reported that they used an eight-month regimen; 21 of the countries that used an eight-month Category I regimen, notably those in the African Region, said that they had plans to change to the six-month regimen.

d. An effective drug supply and management system

Uninterrupted provision of quality-assured anti-TB drugs is central to effective TB control. All WHO regions reportedly had at least one country (16 countries in Africa) facing a stock-out of first line drugs at the central or peripheral levels (basic TB management units). Africa reported that 22% of countries suffered a peripheral-level anti-TB drug stock-out during 2005. Fourteen countries in Africa had a stock-out of first-line drugs at the central level (Annex 2). HBCs reporting a stock-out of any first-line drug at the peripheral level included China, DR Congo, India, Mozambique, Thailand, Uganda and Zimbabwe (Annex 2).

The Stop TB Strategy recommends the use of drugs in fixed-dose combinations (FDCs) in the treatment of TB. During 2006, only 44 countries were using four-drug FDCs in the initial phase and two-drug FDCs in the continuation phase of treatment. The South-East Asia Region had the highest proportion of countries (5/11) using FDCs (Annex 1). Nine HBCs (41%) were using patient kits for drugs, including seven with FDCs: Afghanistan, Brazil, Indonesia, Kenya, Nigeria, the Philippines and Viet Nam. A total of 17 HBCs had in place mechanisms for the quality control of anti-TB drugs.

2. Address TB/HIV, MDR-TB and other challenges

Implement collaborative TB/HIV activities

The association between HIV and TB has been known almost since the start of the HIV-epidemic, but programmes to implement collaborative TB/HIV activities have been developed only in the past five years. Now, with the increasing availability of antiretroviral drugs, and the support of international donors and technical agencies, the number of countries that have policies to implement collaborative TB/HIV activities is increasing rapidly, especially in the African Region (Figure 24).

Of the 63 TB/HIV focus countries, 59 provided data to WHO in 2005. Figure 24 shows that, of those that provided data, between 58% and 71% had appointed a TB/HIV focal point in the NTP, had developed a national plan for implementing collaborative TB/HIV activities, had a national policy of HIV counselling and testing to all TB patients, and had a national policy to provide CPT and ART to HIV-positive TB patients. However, fewer countries had policies and procedures for diagnosing (through screening), treating (CPT and ART) and preventing TB (IPT) in people infected with HIV. Only 34–41% had policies on intensified TB case-finding among HIV-positive people, on the provision of IPT to people who are HIV-positive but who do not have active TB, and on infection control to minimize the spread of TB among HIV-positive people. Figure 24 also shows that only 47% had a system for HIV surveillance among TB patients.

Table 16, and Figure 26, show the number of TB patients tested for HIV, and the numbers testing HIV-positive, started on CPT, ART and IPT, how the numbers varied among regions, and how they changed between 2003 and 2005. For every 100 adult (15-49) HIV-positive TB cases in the world, estimated as described in the Methods, 59 TB patients were tested for HIV in 2005 (Figure 25; this index is expected to be greater than 100). The highest testing rates were in the European Region, which has the lowest incidence rate of HIV-positive TB cases; the lowest testing rates were in the African Region, where the incidence rate is highest. The Eastern Mediterranean, South-East Asia and Western Pacific regions had the lowest rates of HIV testing among notified TB patients in 2005 (T/N in Table 16). The European and Western Pacific regions had the lowest prevalence of HIV among those tested (P/T). In the African Region, where all TB patients should be tested for HIV, about 10% of notified TB cases were tested.

A better measure of the coverage of HIV testing is the number of TB cases that were found to be HIV-positive, expressed as a percentage of the expected number of incident HIV-positive TB cases (Figure 25; P/E in Table 16). In the Region of the Americas in 2005, 66% were detected. In the African Region 13% were detected, while only 4% were found in the Western Pacific Region. Globally, only 14% of all estimated HIV-positive TB cases were identified by testing in 2005 (Figure 25, Table 16). Among all TB patients tested, the proportion positive (P/T) remained fairly constant between 2003 and 2005 at about 51% in African Region, and about 23% worldwide (Table 16).

Table 16 also shows that the African Region led the world in the provision of CPT, at least in relation to TB patients who tested HIV-positive (C/P), while the Eastern Mediterranean Region lagged behind in the provision of ART (A/P). The uncertainties in the estimated proportion of HIV-positive TB patients that are given CPT or that start ART (ranges in Table 16) reflect fundamental problems in patient management as well as in reporting.

The Global Plan laid out objectives for TB/HIV control in 2006, and the targets to be reached by 2015 (Table 17). It proposed that 1.6 million TB patients would be tested for HIV in 2006. It also suggested that 220 000 patients should be started on ART, as compared with a total of 80 000 in country plans for 2006. In 2005, 25% and 11% of the expected numbers were reported to have been tested for HIV and started on ART, respectievly. In the African Region in 2005, where the burden of HIV-related TB is highest, 17% of 737 thousand, suggested in the Global Plan for 2006, were tested for HIV and 10% of the 197 thousand, suggested in the Global Plan for 2006, were started on ART. Furthermore, the number of HIV-positive people screened for TB in 2005 was only 1.7% of the 11 million targeted for 2006; the number started on IPT in 2005 was 2.2% of the 1.2 million targeted for 2006.

The proportion of all (estimated) adult (15-49) HIV-positive TB patients put on ART (A/E) was only 4% in 2005 Annex 2. Although screening is an efficient way of finding TB patients, just 0.2% of the estimated 24 million HIV-positive people in the African Region were screened in 2005, and approximately 0.1% of the estimated 21 million HIV-positive people without active TB were started on IPT.1

In sum, many more HIV-positive TB patients need to be diagnosed and treated in order to satisfy expectations of the Global Plan from 2006 onwards.

The time trends in these indicators are more encouraging because they do show rapid expansion of diagnosis and treatment, albeit from low levels (Figures 25 and 26). The numbers of TB patients tested for HIV, and found to be HIV-positive, increased more then 15-fold between 2002 and 2005 (Figure 26). The provision of CPT and ART to TB patients has also expanded globally (Figure 26), in the African Region (especially ART, Figure 25), and in some countries (see box [pdf 75kb]) Screening for TB among HIV-positive cases, followed by the provision of IPT, also increased quickly between 2002 and 2005 (Figure 26).

Recording and reporting of HIV testing in TB patients is improving but still weak. Of the 63 TB/HIV focus countries, 6 that account for 2.7% of all HIV-positive TB patients had modified their TB registers to capture HIV data routinely (Belize, Brazil, Estonia, Jamaica, the Russian Federation and Trinidad and Tobago), 19 that account for 57% of HIV-positive TB patients were planning to do so, and 32 that account for 37% of HIV-positive TB patients did not have plans to do so. Only 21 out of 37 focus countries in the African Region reported the number of TB cases tested for HIV.

Prevent and control MDR-TB
MDR-TB surveillance and control in high-burden countries

Among the 22 HBCs, 11 had carried out nationwide drug resistance surveys by 2006, including Ethiopia and the Philippines, with UR Tanzania finalizing its first nationwide survey. A further 6 HBCs are expanding regional coverage of DRS, among which China, India and the Russian Federation have all made substantial progress. Additionally, China is planning to undertake a nationwide survey in 2007. Indonesia has its first DRS under way. Afghanistan, Bangladesh, Nigeria and Pakistan have never reported drug resistance data, but all except Afghanistan have plans to carry out surveys.

A total of 13 NTPs have staff responsible at central level for drug-resistant TB, 9 of which have national guidelines on the programmatic management of MDR-TB. In seven HBCs (Brazil, DR Congo, Mozambique, Philippines, the Russian Federation, South Africa and Thailand), MDR-TB is managed by the NTP.

Prior to 2006, the NTPs of Kenya, the Philippines and the Russian Federation were approved by the GLC for management of MDR-TB. In addition, India was approved by the GLC in 2005 for a project in New Delhi. In Kenya, the MDR-TB management project has not yet been launched because of lack of human and financial resources. In 2006, three additional HBCs were approved by the GLC: Bangladesh and DR Congo as part of the NTPs, and Cambodia for an operational research project. A major geographical expansion of GLC-approved MDR-TB management occurred in 2006 in the Russian Federation, with eight additional regions approved and two regions under review. Before 2006, only four regions were approved. In 2006, China and India submitted applications from the NTPs, which are currently under review. In addition, Uganda has a GLC application under review submitted by a national university working with an international NGO. The NTPs in Myanmar and Viet Nam have started preparing applications to the GLC, which should be submitted at the beginning of 2007 (Table 18).

The GFATM has approved funding (up to round 5) for both DRS and MDR-TB control in seven HBCs (Bangladesh, China, DR Congo, India, Indonesia, Mozambique and the Russian Federation). In addition, Cambodia, Nigeria and Zimbabwe have been approved for DRS and Kenya and the Philippines for MDR-TB management.

MDR-TB surveillance and control globally

Out of 182 countries that filled in the standard data collection form, 125 (69%) reported that management of MDR-TB patients was an activity of the NTP (Figure 27); a further 31 stated that they planned to treat MDR-TB in the next two years. Globally in 2005, 98 723 drug susceptibility tests were done at the start of treatment, almost 40% were reported from the European Region (38 817); 103 countries reported 18 415 laboratory-confirmed MDR-TB cases (16 countries in the African Region, 20 in the Region of the Americas, 14 in the Eastern Mediterranean Region, 38 in the European Region, 3 in the South-East Asia Region and 12 in the Western Pacific Region). Out of all MDR-TB cases, 10 827 (59%) were reported from the European Region (Figure 28). The total number of laboratory-confirmed MDR-TB patients reported in 2005, and the number known to be treated by WHO-recommended procedures, are far lower than the numbers anticipated by the Global Plan for 2006 (Table 17).

Up to December 2006, the Global DRS Project had collected data from areas representing more than 40% of global smear-positive TB cases. The GLC had approved 53 projects for more than 25 000 MDR-TB patients in 42 countries.2 This is almost a doubling of MDR-TB patients since December 2005, by which time about 13 000 MDR-TB patients had been approved for treatment. The countries approved in 2006 were: Armenia, Bangladesh, Belize, Burkina Faso, Cambodia, DR Congo, Ecuador, Guinea, Kazakhstan, Paraguay and Rwanda. Most GLC-approved countries are in the European Region and the Region of the Americas (12 countries each), followed by the African Region (6 countries), the Eastern Mediterranean Region (5 countries), the South-East Asia Region (4 countries) and the Western Pacific Region (3 countries).

From the data provided in the standard data collection form, GLC-approved projects globally were reporting slightly better outcomes at the end of treatment than non-GLC approved projects, 61% (variation among WHO regions 50–80%) versus 54% (range 48–79%) (Figure 28). Countries reported that they were expecting to treat 16 987 MDR-TB cases in 2006 (6345 under the GLC and 10 642 outside of GLC programmes; cf 20 000 in the Global Plan, Table 17), and 16 710 MDR-TB cases in 2007 (7096 under the GLC and 9614 outside of GLC programmes).

Address prisoners, refugees, other high-risk groups and special situations

Prison inmates are among the high-risk groups that have received most attention in HBCs. Some 20 HBCs had a plan of action for TB control in prisons. Other high-risk groups for which HBCs had specific action plans included refugees (11 countries), ethnic minorities (9 countries) and other marginalized groups (6 countries).

While Afghanistan, DR Congo and Nigeria have been addressing TB control among refugees following political unrest, India, Indonesia and Pakistan were attempting to manage TB among people forced to move by natural disasters. Efforts to improve TB control in Afghanistan, DR Congo and Uganda have been hampered by outbreaks of war.

3. Contribute to health system strengthening

The diagnosis and treatment of TB are fully integrated into the public health systems of most countries. Although HBCs normally have staff fully dedicated to TB control in central and provincial planning and supervision units, as well as dedicated TB control supervisors at the district level, a few also have dedicated staff at facility level (Figure 30). Some TB control functions were typically managed by NTPs, such as quality control of sputum smear microscopy and monitoring and evaluation. By contrast, anti-TB drug management was fully integrated into general drug management systems in nine HBCs. It was partly integrated in a further nine HBCs, while four managed the supply of anti-TB drugs separately.

Because TB services are normally delivered in general health facilities by multi-purpose staff, NTPs rely on a well-functioning health-care infrastructure, including committed and well-trained general health staff. Any challenge to the general health system is thus a challenge for TB control. Optimal planning of TB control therefore requires collaboration with relevant stakeholders involved in general health-care planning. It also requires coordination among the various health development frameworks at central, provincial and district levels, such as poverty reduction strategy papers (PRSP), sector-wide approaches (SWAPs) and medium-term expenditure frameworks (MTEF).

The extent to which this was being done in 2005 varied among HBCs. Most of the HBCs had developed their TB control plans with the involvement of a broad range of stakeholders (Figure 31). Eighteen had aligned their plans for TB control with a national health development plan. With respect to HRD, only 13 had coordinated the plan for TB with a national plan.3 Of the 19 HBCs with a PRSP, 14 had aligned their TB control plans accordingly. The TB control plans of nine HBCs were aligned with SWAPs.

Practical Approach to Lung Health

Worldwide, 70 countries reported that the Practical Approach to Lung Health (PAL) was a part of the national plan for TB control (10 HBCs). In 2005, PAL was operational in some form in 20 countries. Among them, Chile, El Salvador, Kyrgyzstan, Morocco and South Africa have been scaling up PAL activities, while Algeria, Bolivia, Guinea, Jordan, the Syrian Arab Republic and Tunisia have developed and tested their PAL guidelines and have begun the process of implementation. The remaining nine countries were at a preliminary phases of PAL development. Among the 22 HBCs, Uganda had adapted and was field-testing PAL guidelines. South Africa had progressed further in PAL development and implementation, with guidelines and training materials developed for primary health-care workers, emphasizing HIV-infected TB patients. Five additional Latin American countries, including Brazil, were to begin implementing PAL early in 2007.

4. Engage all care providers

Public–Public and Public–Private mix approaches

By September 2006, 11 HBCs (Bangladesh, China, DR Congo, India, Indonesia, Kenya, Mozambique, Myanmar, Philippines, UR Tanzania and Viet Nam) had started scaling up public–private mix for TB care and control (PPM), 5 were preparing to scale up and had developed PPM guidelines (Cambodia, Nigeria, Pakistan, Thailand and Zimbabwe), while the remaining had either initiated or prepared for PPM pilot proejcts. Specific training for non-NTP providers was organized in 18 HBCs, and 16 HBCs were providing anti-TB drugs free of charge to such providers. A focal person for PPM in the central NTP office was appointed in 14 HBCs, of which 4 were working full-time and 10 part-time.

Several HBCs had involved all health institutions belonging to public sector health-care networks, such as public hospitals, medical college hospitals, army health facilities and prison health facilities (Figures 32 and 33). However, many such providers continued to operate without formal links to the NTP and did not follow NTP or ISTC guidelines. Facilities governed by health insurance agencies were partly or fully engaged with the NTP in 8 of the 16 countries where such agencies were of relevance for TB control.

All but one HBC (Russian Federation) had begun to involve at least some private practitioners, private hospitals and NGO health facilities in referral to the NTP (Figure 32), in diagnosis following programme guidelines and/or in treatment with recommended drugs (Figure 33). However, in most HBCs, only a small fraction of all eligible private providers have so far been involved.

International Standards for Tuberculosis Care

The International Standards for Tuberculosis Care were familiar to 17 HBCs, of which 11 had developed plans for their wide dissemination and use as an advocacy and training tool so as to engage all health-care providers. Among HBCs, Indonesia, India, Kenya and UR Tanzania are pilot sites for implementing ISTC, and have adopted diverse approaches to make best use of the published standards. The ISTC have been particularly useful in engaging the national professional societies and academic institutions in TB control.

5. Empower people with TB, and communities

Advocacy, communication and social mobilization

The implementation of advocacy, communication and social mobilization (ACSM) at country level has been uneven. Some countries already have extensive experience carrying out communication programmes aimed at increasing case detection rates while, for other countries, ACSM is an entirely new field. The quality of ACSM depended largely on resources available. Some large programmes made liberal use of partners including NGOs, media and advertising agencies, multi-disease ACSM resources in governments, community groups, and others, who helped to develop materials and to disseminate key messages from national level down to community level. The two major barriers reportedly faced by HBCs to implement successful ACSM plans were limited resources and staff capacity. With the GFATM (round 5) approving substantial grants for ACSM for 18 countries (US$ 36 million over 5 years), a lack of skilled staff at the central and peripheral levels, rather than the availability of money, is likely to be the main problem. Monitoring and evaluation of ACSM is a major challenge for all HBCs: only seven HBCs currently claim to have data sources in place to measure and assess ACSM results. The Stop TB Partnership is in the process of developing guidelines on ACSM indicators to help countries develop a robust monitoring and evaluation system, and to develop strategies through identification of the most important gaps in knowledge and attitudes among their key target groups.

Community participation in TB care

Community-based approaches to TB control were implemented in all regions. All (expect for one) countries in the South-East Asia Region reported interventions for community involvement in TB control to a varying extent. About half of the countries in Africa, the Americas and in the Eastern Mediterranean and Western Pacific regions (65 countries), and only a quarter of countries in Europe (10 countries), reportedly engaged communities in TB care and prevention (Annex 1).

Most HBCs have been engaging communities in activities other than treatment support, with the exception of Afghanistan, India and Thailand. Other areas of involvement included case detection, defaulter tracing and raising awareness about TB. Future plans to involve communities included expansion of ongoing activities and new ACSM activities related mostly to raising awareness.

More than half of the HBCs have GFATM funding for community involvement (14 and 20 countries had grants approved in rounds 5 and 6, respectively). Among GFATM TB grants approved in round 6, 20 countries (including two HBCs, India and UR Tanzania) included community involvement as a part of their application, worth a total of US$ 25.7 million for up to 5 years (6.4% of overall budgets).

Patients’ Charter for Tuberculosis Care

The Patients' Charter for Tuberculosis Care was being promoted in all regions, although few countries reported any specific promotional activities. In the Indian state of Kerala, the state health minister launched the charter, presenting it to a TB patient and distributing copies translated into the local language. The minister also launched the ISTC, directed at health-care providers in the state.

6. Enable and promote research

Globally, no specific mechanism yet exists to promote or oversee TB research activities. Few, if any, NTPs monitor the TB research under way in their countries. NTPs were therefore expected to report mainly on research with which they were associated in 2005.

All HBCs did report having operational research (OR) in their respective NTP strategic plans, but only India and Pakistan provided details. TB/HIV and prevalence surveys were the most common OR activities undertaken across the HBCs. Mozambique and Zimbabwe reported only drug resistance surveys under OR. Kenya, Mozambique and Thailand reported no OR activities for 2005.


1 2006 Report on the Global AIDS Epidemic (UNAIDS/WHO) May 2006.

2 Armenia, Azerbaijan, Bangladesh, Belize, Bolivia, Burkina Faso, Cambodia, Costa Rica, Democratic Republic of the Congo, Dominican Republic, Ecuador, El Salvador, Egypt, Estonia, Georgia, Guinea, Haiti, Honduras, India, Jordan, Kazakhstan, Kenya, Kyrgyzstan, Latvia, Lebanon, Lithuania, Malawi, Mexico, Mongolia, Nepal, Nicaragua, Paraguay, Peru, Philippines, Republic of Moldova, Romania, Russian Federation, Rwanda, Syrian Arab Republic, Timor-Leste, Tunisia and Uzbekistan.

3 It is not known how many of the HBCs have formal sector-wide human resource development plans in the health sector, so further integration may be hindered by the lack of such a plan.