Developing a Rights-Based Approach to Prevention and Treatment of Tuberculosis in India

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1 University of Chicago Center in Delhi Developing a Rights-Based Approach to Prevention and Treatment of Tuberculosis in India Organizers United States: Evan Lyon, MD Assistant Professor of Medicine, Department of Medicine, University of Chicago Brian Citro, JD - Clinical Lecturer in Law, International Human Rights Clinic, University of Chicago Law School Kiran Raj Pandey, MD - Physician and Health Services Research Fellow, Department of Medicine, University of Chicago Mihir Mankad, MA, JD - Health Policy Advisor, Save the Children UK Discussion of Aims To develop a rights-based approach to prevention and treatment of tuberculosis (TB) in India. The project aims to: Examine and articulate how human rights, and the right to health in particular, may be used as tools to increase access to testing and treatment for TB in India, including multidrug-resistant TB (MDR-TB) and extensively drug-resistant TB (XDR-TB). Articulate the human rights obligations of government and non-state actors toward regulating and financing public and private sector testing and treatment for TB in India. Examine and articulate the role that the rights of people living with and vulnerable to TB in India play in prevention and treatment of the illness, including the right to be free from discrimination, the right to participation, the right to access health information, and the right to informed consent. Formulate human rights benchmarks and indicators associated with the prevention and treatment of TB and the protection of the rights of people living with and vulnerable to TB. Develop methods through which a rights-based approach to TB can be implemented in India and other low and middle income countries, such as through pilot projects, litigation and advocacy. Each aim will be achieved through collaboration with partners in India. Ideas and questions will be shared at a conference convened in Delhi and cases studies will be conducted throughout India to study existing systems. Partnerships with organizations outside of India will be sought at the implementation stage, as discussed in the last aim. 1

2 Significance Statement The global TB crisis remains at epidemic proportions. In 2012, there were approximately 8.6 million new cases of TB and 1.3 million deaths from TB nearly 3,600 deaths a day. The burden of TB is disproportionately borne by low and middle income countries, which account for 95% of all deaths from TB globally. Within countries, differences in TB prevalence reflect the same alarming disparities between the wealthy and the poor. However, TB is a readily preventable and curable disease; in clinical trials, cure rates of over 90% have been documented for treatment of drug-susceptible TB based on combinations of anti-tb drugs. In 2012, an estimated 26% of all global incidences of TB occurred in India alone. The central truth about the TB crisis in India is that social and economic factors and structural barriers drive the epidemic. As in other parts of the world, individuals most vulnerable to TB infection in India are members of socially and economically disadvantaged groups, including the poor, persons living with HIV, prisoners and detainees, and people who use drugs. These groups face significant barriers to preventing and treating TB infections, including financial and physical inaccessibility of testing and treatment services; a lack of awareness about the modes of transmission and prevention techniques; stigma and discrimination in the health system and society generally; and poor sanitation and unhealthy living conditions. The prevalence of MDR- and XDR-TB reaffirm the socio-economic character of the disease. Drug-resistant strains of TB develop as a result of a lack of infection control, irrational first-line treatment, and interrupted first-line treatment, which occurs most often due to an inability to afford continued treatment and interrupted access to health facilities and treatment services. In contrast to traditional approaches to TB prevention and treatment, a rights-based approach will focus on the underlying social and economic determinants and establish the rights of people living with and vulnerable to TB. The approach will articulate the legal obligations of governments and non-state actors, such as private health providers and drug manufacturers, to ensure good quality TB testing and treatment are available and accessible. And it will focus on the state s obligation to effectively regulate the health sector and ensure adequate, equitable and sustainable funding for health. A similar rights-based approach has been applied successfully to HIV prevention and treatment throughout the world. The mobilization of affected communities in grassroots campaigns has spurred research and development of new medicines and lowered the prices of existing drugs. Litigation based on the right to health and related human rights has been successful in increasing access to HIV medicines in numerous countries, including Colombia, India, Kenya, and South Africa. People living with HIV have claimed their rights to information, participation, and informed consent, and won greater protections against discrimination through litigation and advocacy based on constitutionally derived human rights. In India, Namibia, South Africa, and the United States, people living with HIV have won protections against 2

3 discrimination in employment, access to healthcare, and the armed services. In many countries, including Kenya, Mozambique, and the United Kingdom, the rightsbased approach has led to the explicit prohibition of discrimination based on HIV status through legislation. At the same time, people living with and vulnerable to HIV have worked through the rights-based approach to reduce stigmatization and increase their participation in policy decisions affecting their health. For example, people living with HIV have secured meaningful levels of participation in state institutions, such as the National AIDS Control Organization of India, and international funding mechanisms, such as the Global Fund to Fight AIDS, TB and Malaria. The rights-based approach to HIV offers a model from which to develop a similar approach to prevention and treatment of TB. Rationale The right to health, understood broadly, will be at the center of a rights-based approach to TB in India. The right to health is articulated in a number of international instruments, most importantly article 12 of the International Covenant on Economic, Social and Cultural Rights (ICESCR). The right to health is judicially recognized as a constitutional right in India, associated with the right to life and human dignity. The broad conceptual scope of the right to health makes it an ideal tool with which to build a rights-based approach to prevention and treatment of TB. The right to health comprises multiple interrelated and interdependent components. At its core is the right to available, accessible and acceptable good quality health facilities, goods and services. This includes the right to access good quality, affordable medicines and testing services. TB drugs in India are often inaccessible due to financial and physical barriers faced by people living with TB. When medicines are available, they are often ineffective due to inappropriate and interrupted treatment schedules, which often results in development of drugresistant strains. Drugs for MDR- and XDR-TB are significantly more expensive than first-line medicines, require longer treatment schedules, cause more severe side effects, and have significantly lower cure rates. Advanced diagnostic services, particularly those needed to detect drug-resistant TB, are often too costly or unavailable, especially in rural or remote areas. Moreover, over the last several decades there has been little to no innovation with respect to TB medicines. Only one novel drug has been approved for TB in the last forty years. And while a number of more high profile diseases, such as HIV, have benefited from sustained advocacy and substantial medical innovation, TB, which results in higher rates of morbidity and comparable rates of mortality, has not. A rights-based approach will directly address factors influencing the cost and availability of medicines and diagnostics, including patent and intellectual property laws, pricing and regulation, and funding for research and development. The right to health encompasses the individual rights and liberties of people living with and vulnerable to TB. These include the right to be free from discrimination, 3

4 the right to participate in health-related decision making processes, the right to health information, and the right to informed consent and to be free from nonconsensual testing and treatment. Protecting these rights fulfills the normative imperative to respect human dignity, empowers affected individuals and communities, and is necessary to ensure effective and sustainable health interventions. Successful prevention and treatment of TB requires the full and informed participation of people living with and vulnerable to TB. This is only possible if adequate protections are in place for their rights and liberties. The right to health also establishes duties on governments to implement effective regulations and adequately finance health, including through budget prioritization and equitable resource allocation. The obligation to protect individuals from violations of their rights by non-state actors, including private healthcare providers and pharmaceutical manufacturers, requires comprehensive, evidence-based regulation of both the public and private health sectors. Inadequate and inequitable financing for TB prevention and treatment results in reduced testing and treatment levels and an increase in drug-resistant strains. The right to health provides a conceptual framework through which to develop the obligation of government to ensure adequate, equitable and sustainable funding for health, and TB in particular. Moreover, the rights-based approach will prioritize the needs of vulnerable and marginalized groups and focus on the underlying determinants of health, such as basic sanitation and adequate housing and living conditions. Individuals most vulnerable to TB infection in India are members of socially and economically disadvantaged groups, including the poor, persons living with HIV, prisoners and detainees, and people who use drugs. The right to health requires that special attention be paid to the needs of these groups in the design and implementation of health policies. Underlying health determinants, such as sanitation, hygiene and living conditions, play a major role in the spread of TB. A rights-based approach to TB prevention and treatment will require a holistic, comprehensive approach that prioritizes these social and economic components. A rights-based approach to TB will utilize litigation, legislative and policy advocacy, and grassroots activism to improve prevention and treatment outcomes and protect the rights of people living with and vulnerable to TB. Methodology Human rights and international law research and analysis, including treaties, case law, reports of UN Special Rapporteurs, and other secondary sources. Case studies on people living with and vulnerable to TB, medical professionals, policy makers, and lawyers in India. Analysis of the existing matrix of laws and policies related to TB in India, in light of a rights-based approach, toward identifying gaps and areas for improvement. 4

5 Relevant Experience of Organizers Evan Lyon has worked on public health and clinical programs for TB and HIV for 15 years in Haiti, including consultation and support for TB programs more broadly in Latin American and the Caribbean. He has extensive experience in treatment and policy concerns surrounding MDR-TB in resource poor settings. Dr. Lyon is on the board of the Human Rights Program at the University of Chicago and teaches at the College in the Department of Medicine. He has collaborated on numerous health and human rights studies, reports, and advocacy campaigns. Brian Citro worked in New Delhi, India for two years as a Senior Research Officer to the UN Special Rapporteur on the Right to Health and Project Manager of the Global Health and Human Rights Database at the Lawyers Collective, HIV/AIDS Unit. He conducted three UN Country Missions on the right to health, two of which examined prevention and treatment of TB in Azerbaijan and Tajikistan. And he co-authored three UN reports with the UN Special Rapporteur that developed a right to health framework for sexual and reproductive health, occupational health, and health financing. Mihir Mankad worked in New Delhi, India for three years as a Senior Research Officer to the UN Special Rapporteur on the Right to Health and as a Project Associate of the Global Health and Human Rights Database at the Lawyers Collective, HIV/AIDS Unit. He conducted four UN Country Missions on the right to health examining a variety of topics, including access to medicines, HIV/AIDS, and health systems and financing. And he co-authored seven UN reports with the UN Special Rapporteur that developed a right to health framework for, among other issues, development, sexual and reproductive health, and health financing. Kiran Raj Pandey worked as a Medical Officer at a rural District Hospital in Doti, Nepal from 2007 and He managed a DOTS TB clinic as well as an Anti- Retroviral Therapy HIV center, apart from providing regular clinical care at the hospital. He was born and raised in Nepal, where he also attended medical school. He has been in the United States since

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