For Consultation with the Member States, Civil Societies and Public

Consolidated Action Plan to Prevent and Combat Multidrug-Resistant and Extensively Drug Resistant Tuberculosis

(extensive version)

2011-2015

draft v.6 March 2011

For consultation with the Member States, Civil Societies and Public

World Health Organization

Regional Office for Europe

The Consolidated Action Plan to Prevent and Combat Multidrug and Extensively-drug tuberculosis (TB) in WHO European Region 2011-2015 is a roadmap to strengthen and intensify efforts to address the alarming problem of drug resistant TB in the Region.

The Plan is being prepared in region-wide consultation with experts, patients and communities suffering from the disease. The participatory process of developing the Plan is led under the initiative of Special Project of WHO/Europe Regional Director to Prevent and Combat M/XDR-TB and is overseen by an independent Steering Group composed of key technical and bilateral agencies, representatives of Member States and civil society organizations.

Following a detailed assessment of TB and MDR-TB interventions in WHO European Region, and considering the Member States’ response to Regional Director’s solicitation for inputs and feedback of the Eighteenth Standing Committee of the Regional Committee for Europe in Andorra, from 18 to 19 November 2010, the first draft of Consolidated Action Plan to Prevent and Combat M/XDR-TB 2011-2015 was drafted. WHO/Europe organized a three day workshop in Copenhagen from 6 to 8 December 2010 and finalized the second draft of the Plan with participation of country representatives and key experts in the field. The Plan is posted on the internet for public and civil society consultation and simultaneously sent to Member States for their review by 25 March 2011.

Targets and objectives of the Consolidated Action Plan to Prevent and Combat M/XDR-TB in WHO European Region are aligned with those of the MDR-TB section of the Global Plan to Stop TB 2011-2015 and World Health Assembly Resolution 62.15 urging all Member States to achieve Universal access to diagnosis and treatment of MDR-TB by 2015. The Consolidated Action Plan to Prevent and Combat M/XDR-TB 2011-2015 is built upon the core principles of Health 2020 Strategy with the vision of equitable access to health.

The Consolidated Action Plan to Prevent and Combat M/XDR-TB 2011-2015 will be submitted for endorsement by the WHO Regional Committee for Europe in Baku, Azerbaijan, in September 2011 along with an accompanying resolution.

1

Contents

Acronyms and abbreviations 2

Target Audiences 3

Executive Summary 4

Introduction 5

Outline 8

Goal 8

Targets 8

Strategic directions 8

Areas of intervention 9

Milestones 9

Expected Achievements 10

Regional SWOT analysis in relation to M/XDR-TB 11

Strengths 11

Weakness 11

Opportunities 13

Threats 13

Areas of Intervention (adapted from Objectives of Global Plan 2011-2015) 14

1. Prevent development of M/XDR-TB cases 14

2. Scale up access to testing for resistance to first-line and second line anti-TB drugs and HIV testing among TB patients 17

3. Scale up access to effective treatment for drug resistant TB 19

4. Scale up TB infection control 22

5. Strengthen surveillance, including recording and reporting, of drug-resistant TB 24

6. Expand country capacity to scale up the management of drug-resistant TB including advocacy, partnership and policy guidance 26

7. Address the needs of special populations 35

Annex I: References 37

Acronyms and abbreviations

ACSM Advocacy, Communication and Social Mobilization

AIDS Acquired Immuno-deficiency Syndrome

BCG Bacille Calmette Guérin (Tuberculosis vaccine)

CSO Civil Society Organization

DOT Directly Observed Treatment

DOTS First element of WHO-recommended StopTB strategy

EEA European Economic Area

EU European Union

EQA External Quality Assurance

GLC Green Light Committee

GFATM GFATM, Global Fund for AIDS, Tuberculosis and Malaria

GDF Global Drug Facility

HIV Human Immunodeficiency Virus

HPC High (TB) Priority Countries

HRD Human Resources Development

HRH Human Resources for Health

IUATLD International Union Against TB and Lung Diseases

MDR-TB Multi Drug Resistant Tuberculosis (resistance to at least isoniazid and Rifampicin, the two most effective drugs available)

MDR HBC MDR high burden country, incidence > 4000 cases or >10% of the new TB cases with MDR.

MOH Ministry of Health

MOJ Ministry of Justice

NGO Non-Governmental Organization

NTP National Tuberculosis Programme

PHC Primary health care

PMDT Programmatic Management of Drug-resistant Tuberculosis

PSM Procurement and supply management

SLD Second line anti-TB drugs

SRL Supra-national Tuberculosis Reference Laboratory

WHO World Health Organization

XDR-TB MDR-TB resistant also to a fluoroquinolone and a second line injectable agent

Target Audiences

The primary audience of this Action Plan is the national authorities in the Member States of the WHO European Region, responsible for tuberculosis control in the health Ministries as well as other government bodies responsible for health in penitentiary services, health financing, health education and social services.

The Plan urges intensified involvement of civil society, communities affected by the disease, professional societies and national and international technical agencies and donors.

The MDR-TB Action Plan calls for consolidated and coordinated action by the World Health Organization Regional Office for Europe and all stakeholders engaged in TB control in the Region.

Executive Summary

In response to the alarming problem of Multidrug resistant tuberculosis (MDR-TB) and Extensively drug resistant Tuberculosis (XDR-TB) in WHO European Region, the Regional Director has established a Special Project to Prevent and Combat M/XDR-TB in the region. In order to scale up comprehensive response and prevent and control M/XDR-TB, a Consolidated Action Plan has been developed for 2011 to 2015 to function as a road map for the Member States, WHO/Europe and partners. The Consolidated Action Plan to Prevent and Combat M/XDR-TB in WHO European Region 2011-2015 has six strategic directions and seven areas of intervention. The strategic directions are crosscutting and are to safeguard the values of Health2020 Strategy and highlight the priorities of the WHO European Region and the Member States. The areas of interventions are aligned with the Global Plan to StopTB 2011-2015 and follow the same targets as set by the Global Plan and World Health Assembly 62.15 to provide Universal Access to diagnosis and treatment of MDR-TB.

A more concise version of the Consolidated Action Plan to Prevent and Combat M/XDR-TB in WHO European Region 2011-2015 is developed for endorsement by the Member States along with a resolution.

WHO/Europe has assisted Member States with high MDR-TB burden countries in the WHO European Region to develop national MDR-TB response Plans based on the Beijing Commitment. The Consolidated Action Plan to Prevent and Combat M/XDR-TB in WHO European Region 2011-2015 will lead the Member States for further elaboration and integration of national MDR-TB response plans in the national TB and/or national health strategy plans.

With implementation of the Consolidated Action Plan to Prevent and Combat M/XDR-TB in WHO European Region 2011-2015, the emergence of 10,000 new MDR-TB patients and 1500 XDR-TB patients would be averted yearly and an estimated 60,000 MDR-TB patients would be diagnosed and at least 40,000 of them would successfully be treated and hence interrupting transmission of MDR-TB (a detailed modelling is being worked out along with the cost of implementation and savings by cutting transmission which will be ready in April 2011)

Introduction

Of 440000 estimated multidrug-resistant TB (MDR-TB) patients in the world, 81000 MDR-TB prevalent cases are estimated to be in WHO European region (20% of the global burden). The top nine countries in the world with MDR-TB exceeding 12% among new TB cases, and the top six exceeding 50% among previously-treated TB cases, are in the WHO European Region. A high correlation of MDR TB among HIV-positive patients and downstream and upstream determinants of health, such as imprisonment, migration and low socio-economic status have been documented in several Member States.

MDR-TB is the result of inadequate treatment of tuberculosis which can then be transmitted within the community and/or due to poor airborne infection control in health care facilities and congregate settings. While the WHO European Region comprises only 5.6% of newly detected and relapsed TB cases in the world, it reported 329,391 new episodes of TB and 46,241 deaths from TB in 2009, the majority of them in the 18 high priority countries (HPC) of the Region[1].

The trend in TB notifications has been decreasing since 2005. In spite of this encouraging trend, notification rates of the newly-detected and relapse TB cases in the 18 HPC remained almost eight times higher (73.0 per 10000 population) than in the rest of the Region (9.2 per 100000) and double the Regional average (36.8 per 100000 population).

The rates of MDR-TB throughout the Region remain very alarming. The proportion of MDR among new TB cases and previously treated TB patients in 2009 was 11.1% and 36.7% respectively. Many countries in the region have reported extensively drug-resistant TB (XDR-TB). In spite of still very low coverage of drug susceptibility testing on second-line drugs in non-European Union (EU)/ (European Economic Area (EEA)[2] countries the total number of such patients with extensively drug-resistant TB (XDR-TB) notified in the Region almost tripled from 132 in 2008 to 344 in 2009, the vast majority of them (80%) were notified in non-EU/EEA sub-region. In order to diagnose the extensively drug resistant TB (XDR-TB), there is a need to have access to second line drug susceptibility testing which is not readily available for all patients.

In 2009, from estimated 81,000 MDR-TB patients, only 27,760 cases (34.2%) were notified[3] due to low availability of bacteriological culture and drug susceptibility testing (Table 1). From this number of MDR-TB patients only 36.4% (10,107 patients) received adequate treatment with quality second-line drugs (SLD)[4].

Currently, treatment of MDR-TB patients is lengthy and takes up to 24 months with the use of SLD and/or surgery, often accompanied by adverse effects, which cause further burden to the patients and their families. The latest available data indicates that the treatment success rate of MDR-TB patients in WHO European Region receiving quality assured second line medicines is 62%. The other two third of notified MDR-TB patients have no access to quality treatment or are not reported so and may die after few years. Access to quality SLD and TLD medicines for treatment of M/XDR-TB is limited in many Member States. Some of the SLD and TLD are too expensive and/or not available for all the patients.

Despite good progress in several countries, in others the TB control network, especially regarding diagnosis and treatment of MDR has not yet included the prison system.

Currently, a recommended package of airborne infection control measures is missing in most of the hospital wards and outpatient clinics where patients with MDR-TB are treated. The latest available data from MDR-TB HBCs indicates that TB IC is still in a preliminary implementation phase in most of these countries. TB IC national situation assessment has been done so far in ten MDR-TB HBC. TB IC National action plan exists in four countries and six notified that there were preparing it.WHO/Europe in collaboration and coordination with other partners has provided guidance and technical assistance to Member States to improve TB, MDR-TB and TB/HIV prevention, control and care, including planning and programme management, airborne infection control, surveillance, monitoring and evaluation, human resources capacity-building, quality assured laboratory diagnosis, guidelines and policy development, provision of quality medicines through the Global Drug Facility (GDF) and Green Light Committee (GLC), advocacy, communication and social mobilization.

Concerning vaccination, the Bacille Calmette Guerin (BCG) is the only vaccine available against TB which was first used in 1921. BCGhas limited efficacy for protection against the disease and can’t be administered for people living with HIV, however it can to some extent protect against the severe form of TB in children. The most effective drugs against TB were discovered in 50s and since then other agents are being introduced with often more adverse effects. There is an urgent need for more effective medicines and vaccines and the European scientific institutes can play an important role in research and development for new medicines and vaccine.

Recently several molecular techniques including Gene Xpert was endorsed by World Health Organization (WHO) as a rapid method of diagnosing of tuberculosis and Rifampicin resistance; however the technology has not been introduced in most MDR-TB high burden countries of the Region.

The Berlin Declaration on Tuberculosis, endorsed in 2007, binds all Member States to fight against TB and properly address M/XDR TB. Adequate interventions addressing drug resistant TB require proper national planning and effective implementation, comprehensive approaches in and across countries as well as strong support from national and international partners. Ministers from the 27 M/XDR-TB high burden countries of the world met in Beijing, China, from 1 to 3 April 2009 to urgently address the alarming threat of MDR-TB. This was reflected in a Call for Action on M/XDR-TB to help strengthen health agendas and ensure that urgent and necessary commitments for action and funding are made to prevent this impending epidemic. In the same year, the World Health Assembly Resolution 62.15 urged all Member States to achieve universal access to diagnosis and treatment of MDR-TB. High MDR-TB burden countries in Europe have already developed their national M/XDR TB response plan 201l-2015. European high TB priority countries in Europe need to align their approved national TB plan with the new commitments in preventing and controlling M/XDR TB.

Based on the above, the WHO Regional Director for Europe confirmed the strong commitment of WHO to fight against TB and to develop an action plan to prevent and combat M/XDR TB in the Region.

The Consolidated Action Plan to Prevent and Combat M/XDR-TB 2011-2015 is developed under the leadership of WHO Regional Office for Europe and the guidance of an independent steering group[5] with inputs of the Member States, technical agencies and civil societies involved in TB control in Europe. The Consolidated Action plan follows the Beijing call for Action and Berlin Declaration.

Countries with high burden or high incidence of MDR-TB in the WHO European Region, 2009 in alphabetic order

·  Estimated annual incidence over 4000 MDR-TB cases and/or at least 10% newly registered cases with MDR-TB. Source: Multidrug and extensively drug-resistant TB (M/XDR-TB). 2010 global report on surveillance and resistance. WHO/HTM/TB/2010.3