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Swiss Re Pandemic Risk Talk WHO guidance on ethical issues in TB care and control WHO guidance on ethical issues in TB care and control Andreas Reis Department of Ethics, Equity, Trade and Human Rights Ernesto Jaramillo Stop TB Department

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DOTS Expansion Working Group meeting 2009, 13 October 2009 What is Ethics? A discipline dealing with what is good, right, and fair, and with moral obligations and rights. A process to seek agreement when values are in conflict. "Fair processes to reach fair outcomes".

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DOTS Expansion Working Group meeting 2009, 13 October 2009 "Science and ethics tell us what we must do." Dr Margaret Chan to the World Health Assembly, 2006 Why address ethical issues in TB care and control? WHO's 11th General Programme of Work defines six core functions for the organization, one of them being: "Articulating ethical and evidence-based policy options"

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DOTS Expansion Working Group meeting 2009, 13 October 2009 THE ATLANTA JOURNAL- CONSTITUTION : TB DIAGNOSIS DOES NOT REPEAL A PERSON'S RIGHTS BYLINE: BOB BARR; For the Journal- Constitution When I was a young boy, growing up in the early 1950s before the Salk vaccine became widely available against polio, pictures of boys and girls lying in "iron lung" machines struck fear into our hearts. Having to spend one's life captive to a body- sized metal cylinder in order to breathe was terrifying, and the risk of contracting polio was real. Thanks to the miracles of post- WWII medicines, however, the risk of diseases like polio has been largely, if not quite entirely, eradicated from life in these United States. In the post-9/11 world, however, every incident involving a remotely serious possible problem becomes a headline story to be red- flagged and repeated endlessly, until it becomes all-consuming and takes on an aura of importance it may very well not deserve. Why address ethical issues in TB care and control? Drug-proof TB strain poses ethical bind Man locked up indefinitely, sparking civil liberties debate The Associated Press updated 6:01 p.m. ET April 2, 2007 PHOENIX - Behind the county hospital s tall cinderblock walls, a 27-year-old tuberculosis patient sits in a jail cell equipped with a ventilation system that keeps germs from escaping. Robert Daniels has been locked up indefinitely, perhaps for the rest of his life, since last July. But he has not been charged with a crime. Instead, he suffers from an extensively drug-resistant strain of tuberculosis, or XDR-TB. It is considered virtually untreatable. Is it ethical to provide TB treatment without quality counselling? March 20th, 2009 - 11:00 pm ICT by admin By Bobby Ramakant (CNS) How ethical is it to providing treatment for anti-TB drug resistance without quality counseling? The treatment literacy, infection control, toxicity and side-effects related to the treatment, adherence and a range of other issues need to be addressed in counseling sessions, believes the activist from the West Bengal Network of people living with HIV (BNP+) in India. This indeed provides a food for thought for delegates of the 3rd Stop TB Partners Forum (Brazil: 23-25 March 2009) and the high-level ministerial meeting on drug-resistant TB (Beijing, China: 1-3 April 2009). Detention and the Evolving Threat of Tuberculosis: Evidence, Ethics, and Law Richard Coker 1, Marianna Thomas 2, Karen Lock 3, and Robyn Martin 4 1 Reader in Public Health in the Department of Public Health & Policy at the London School of Hygiene and Tropical Medicine. 2 Honorary Research Fellow in the Department of Public Health & Policy at the London School of Hygiene and Tropical Medicine. 3 Lecturer in Public Health in the Department of Public Health & Policy at the London School of Hygiene and Tropical Medicine. 4 Professor of Public Health Law at the Centre for Research in Primary and Community Care at the University of Hertfordshire, U.K. Copyright 2007 American Society of Law, Medicine & Ethics, Inc.

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DOTS Expansion Working Group meeting 2009, 13 October 2009 Ethical guidance is needed to support countries to solve existing problems TB is primarily a disease of poverty and therefore raises issues of social and global justice Public health measures aimed at TB control can sometimes create challenges in terms of balancing the rights of different individuals Stigmatization and discrimination occur in the context of TB TB has received comparatively little attention by human rights and bioethics Ethical issues have been highlighted by the emergence and spread of MDR/XDR-TB Why address ethical issues in TB care and control?

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DOTS Expansion Working Group meeting 2009, 13 October 2009 Basis: Moral duty and ethical responsibility for all stakeholders: National TB programs, health care providers, patients, communities, donors, researchers, etc. "Added value" of respecting ethical norms: Maximize acceptability of TB programs among patients & communities Enhance adherence and improve program and patient outcomes Maintain public trust regarding research activities and TB programmes Why address ethical issues in TB care and control?

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DOTS Expansion Working Group meeting 2009, 13 October 2009 Diagnosis and Treatment Obligations and Rights of Health Care Workers, Patients, and Communities Liberty-restricting Measures (e.g. isolation) TB Research Main areas where ethical issues need to be addressed

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DOTS Expansion Working Group meeting 2009, 13 October 2009 Do wealthy countries have an obligation to improve access to care in poorer countries and / or to promote the development of new drugs and diagnostics? Is it ever appropriate to deny treatment in case of apparent, or expected, treatment failure and/ or non- adherence? Should diagnosis of MDR-TB occur in contexts where second-line drugs are not available? How should privacy and informed consent in the context of directly observed therapy be managed? Ethical issues regarding diagnosis and treatment

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DOTS Expansion Working Group meeting 2009, 13 October 2009 Where are the limits of the "duty to care" for HCWs ? Can HIV-positive health care workers be expected to care for patients with suspected TB or MDR-TB? Do patients have the right to decline treatment? Obligations and rights of health care workers and patients Medical Institute, Beijing, Photographer: Pierre Virot

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DOTS Expansion Working Group meeting 2009, 13 October 2009 How should the goal to protect public health be balanced against the goal to protect individual rights and liberties in the context of TB? Is it ethically acceptable to isolate and treat MDR/XDR-TB patients against their will? Dilemmas in the context of liberty-restricting measures

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DOTS Expansion Working Group meeting 2009, 13 October 2009 Are there morally relevant differences between research and surveillance? What are the ethical requirements of surveillance programs? Should research, such as drug resistance surveys, be conducted if treatment is not available? Dilemmas in the context of TB research

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DOTS Expansion Working Group meeting 2009, 13 October 2009 Established in August 2008 by the Ethics and Health Unit and the Stop TB Department of WHO, following the recommendation of the WHO Task Force on XDR-TB at 2nd meeting (April 2008) Goals: - to identify key ethical questions that arise in TB programmes and potential solutions - to advise WHO on a broad range of ethical issues related to TB care and control, with the ultimate goal of developing guidance for national TB programs Task Force on Ethical Issues in TB Care and Control

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DOTS Expansion Working Group meeting 2009, 13 October 2009 Composition: 22 Members from NTP, Civil Society, Ethics, Human Rights, and Health Law Milestones: 08-10 December 2008:1 st Meeting of the Task Force (Toronto) 26-28 August 2009: 2 nd Meeting of the Task Force (Geneva) 15 October 2009:Consultation (Geneva) November 2009:Present draft guidance to STAG Meeting early 2010:Publish and disseminate final document 2010:Trainings and capacity-building Task Force on Ethical Issues in TB Care and Control

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DOTS Expansion Working Group meeting 2009, 13 October 2009 Consultation on Ethical Guidance for TB Control and Care Programs When: 15 th October, 9.00 17.30 Where: WHO HQ, Salle C.102 Who: National TB Program Managers, Civil Society Purpose: To discuss outline of WHO guidance document on Ethics & TB Informal invitation

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DOTS Expansion Working Group meeting 2009, 13 October 2009 Ethics & TB Task Force Paula Akugizibwe, ARASA, Namibia Ron Bayer, Columbia University, US Solomon Benatar, U. of Capetown, SA Jeff Blackmer, Can. Med. Assoc. Oscar Cabrera, Georgetown U., US Richard Coker, LSHTM, UK Angus Dawson, U. of Toronto, Canada Anne Fanning, U. of Alberta, Canada Michel Gasana, NTP Rwanda Case Gordon, World Care Council Larry Gostin, Georgetown U., US Acknowledgements Dirceu Greco, U. of Minas Gerais, Brasil Przemyslaw Musialkowski, Council of Europe, Poland Pr.R. Narayanan, TB Res. Center, India John Porter, LSHTM, UK Rajeswari Ramachandran, Tuberculosis Research Centre, India Lee Reichmann, New Jersey Med. School, US Michael Selgelid, Australian National U. Julia Seyer, World Medical Association Jerome Singh, U. of Kwa-Zulu Natal, SA Ross Upshur, Joint Center f. Bioethics, Toronto, Canada Lyn Vianzon, NTB Philippines Xie Xiu Wang, CDC China WHO: Marie-Charlotte Bousseau, Carl Coleman (consultant), Ernesto Jaramillo, Andreas Reis, Diana Weil, Matteo Zignol

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DOTS Expansion Working Group meeting 2009, 13 October 2009 Thank you very much! Contact: reisa@who.int

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DOTS Expansion Working Group meeting 2009, 13 October 2009 Should treatment be denied to patients in whom treatment is very likely to fail or adherence is virtually impossible (e.g. refugees, migrants)? What practice is ethically acceptable regarding patients who are still infectious, but have exhausted all treatment options? Should rapid diagnostic methods be deployed in the field when the capacity to properly manage MDR-TB, including quality-assured drugs, is not readily available? Should research, such as drug resistance surveys, be conducted if treatment is not available? Is it ethically acceptable to isolate and treat MDR/XDR-TB patients against their will? Can HIV positive health-care workers be expected to care for patients with suspected TB or MDR-TB? Some questions for the discussion