What Can We Learn About the Processes of Regulation of Tuberculosis Medicines From the Experiences of Health Policy and System Actors in India, Tanzania, and Zambia?

Background: The unregulated availability and irrational use of tuberculosis (TB) medicines is a major issue of public health concern globally. Governments of many low- and middle-income countries (LMICs) have committed to regulating the quality and availability of TB medicines, but with variable success. Regulation of TB medicines remains an intractable challenge in many settings, but the reasons for this are poorly understood. The objective of this paper is to elaborate processes of regulation of quality and availability of TB medicines in three LMICs – India, Tanzania, and Zambia – and to understand the factors that constrain and enable these processes. Methods: We adopted the action-centred approach of policy implementation analysis that draws on the experiences of relevant policy and health system actors in order to understand regulatory processes. We drew on data from three case studies commissioned by the World Health Organization (WHO), on the regulation of TB medicines in India, Tanzania, and Zambia. Qualitative research methods were used, including in-depth interviews with 89 policy and health system actors and document review. Data were organized thematically into accounts of regulators’ authority and capacity; extent of policy implementation; and efficiency, transparency, and accountability. Results: In India, findings included the absence of a comprehensive policy framework for regulation of TB medicines, constraints of authority and capacity of regulators, and poor implementation of prescribing and dispensing norms in the majority private sector. Tanzania had a policy that restricted import, prescribing and dispensing of TB medicines to government operators. Zambia procured and dispensed TB medicines mainly through government services, albeit in the absence of a single policy for restriction of medicines. Three cross-cutting factors emerged as crucially influencing regulatory processes - political and stakeholder support for regulation, technical and human resource capacity of regulatory bodies, and the manner of private actors’ influence on regulatory policy and implementation. Conclusion: Strengthening regulation to ensure the quality and availability of TB medicines in LMIC with emerging private markets may necessitate financial and technical inputs to upgrade regulatory bodies, as well as broader political and ethical actions to reorient and transform their current roles

Management of latent Mycobacterium tuberculosis infection:WHO guidelines for low tuberculosis burden countries

ABSTRACT Latent tuberculosis infection (LTBI) is characterised by the presence of immune responses to previously acquired Mycobacterium tuberculosis infection without clinical evidence of active tuberculosis (TB). Here we report evidence-based guidelines from the World Health Organization for a public health approach to the management of LTBI in high risk individuals in countries with high or middle upper income and TB incidence of <100 per 100000 per year. The guidelines strongly recommend systematic testing and treatment of LTBI in people living with HIV, adult and child contacts of pulmonary TB cases, patients initiating anti-tumour necrosis factor treatment, patients receiving dialysis, patients preparing for organ or haematological transplantation, and patients with silicosis. In prisoners, healthcare workers, immigrants from high TB burden countries, homeless persons and illicit drug users, systematic testing an

Private health care

During the last decade there has been considerable international mobilisation around shrinking the role of States in health care. The World Bank reports that, in many low and middle-income countries, private sources of finance comprise the largest share of total national health expenditures. Private sector health care is ubiquitous, reaches throughout the population, preferred by the people and is significant from both economic as well as health perspective. Resources are limited, governments are weak, and a new approach is needed. This paper provides a broad overview and raises key issues with regard to private health care. The focus is on provision of health care by private medical providers. On the background of the world's common health problems and interventions available to tackle them, the place of private health care in the overall context is first discussed. The concept of privatisation within the various forms of health care systems is then explained. The paper then describes the genesis and key elements of rapidly enhancing role of the private sector in health care and points to the paucity of literature from low and middle-income countries. Common concerns about private health care are outlined. Two illustrative examples -- tuberculosis, the top infectious killer among the poor and coronary heart disease, the top non-infectious killer among the rich -- are presented to understand the current and possible role of private sector in provision of health care. Highlighting the need to distinguish between health care as a public good or a market commodity, the paper leaves it to the reader to draw conclusions.Private sector Public health Health care Tuberculosis Heart disease

What Can We Learn About the Processes of Regulation of Tuberculosis Medicines From the Experiences of Health Policy and System Actors in India, Tanzania, and Zambia?

Background: The unregulated availability and irrational use of tuberculosis (TB) medicines is a major issue of public health concern globally. Governments of many low- and middle-income countries (LMICs) have committed to regulating the quality and availability of TB medicines, but with variable success. Regulation of TB medicines remains an intractable challenge in many settings, but the reasons for this are poorly understood. The objective of this paper is to elaborate processes of regulation of quality and availability of TB medicines in three LMICs – India, Tanzania, and Zambia – and to understand the factors that constrain and enable these processes. Methods: We adopted the action-centred approach of policy implementation analysis that draws on the experiences of relevant policy and health system actors in order to understand regulatory processes. We drew on data from three case studies commissioned by the World Health Organization (WHO), on the regulation of TB medicines in India, Tanzania, and Zambia. Qualitative research methods were used, including in-depth interviews with 89 policy and health system actors and document review. Data were organized thematically into accounts of regulators’ authority and capacity; extent of policy implementation; and efficiency, transparency, and accountability. Results: In India, findings included the absence of a comprehensive policy framework for regulation of TB medicines, constraints of authority and capacity of regulators, and poor implementation of prescribing and dispensing norms in the majority private sector. Tanzania had a policy that restricted import, prescribing and dispensing of TB medicines to government operators. Zambia procured and dispensed TB medicines mainly through government services, albeit in the absence of a single policy for restriction of medicines. Three cross-cutting factors emerged as crucially influencing regulatory processes - political and stakeholder support for regulation, technical and human resource capacity of regulatory bodies, and the manner of private actors’ influence on regulatory policy and implementation. Conclusion: Strengthening regulation to ensure the quality and availability of TB medicines in LMIC with emerging private markets may necessitate financial and technical inputs to upgrade regulatory bodies, as well as broader political and ethical actions to reorient and transform their current roles

The “vertical–horizontal” debates: time for the pendulum to rest (in peace)?

This section looks back to some ground-breaking contributions to public health, reproducing them in their original form and adding a commentary on their significance from a modern perspective. To complement the theme of this month’s issue, Mukund Uplekar & Mario C Raviglione review a paper by Halfdan Mahler on tuberculosis programmes in developing countries that was published in the Bulletin of the International Union against Tuberculosis and Lung Disease (1966;37:77-82). The paper is reproduced here in full

Private practitioners and public health: weak links in tuberculosis control

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Hard gains through soft contracts: productive engagement of private providers in tuberculosis control.

Over the past decade, there has been a rapid increase in the number of initiatives involving "for-profit" private health care providers in national tuberculosis (TB) control efforts. We reviewed 15 such initiatives with respect to contractual arrangements, quality of care and success achieved in TB control. In seven initiatives, the National TB Programme (NTP) interacted directly with for-profit providers; while in the remaining eight, the NTP collaborated with for-profit providers through intermediary not-for-profit nongovernmental organizations. All but one of the initiatives used relational "drugs-for-performance contracts" to engage for-profit providers, i.e. drugs were provided free of charge by the NTP emphasizing that providers dispense them free of charge to patients and follow national guidelines for diagnosis and treatment. We found that 90% (range 61-96%) of new smear-positive pulmonary TB cases were successfully treated across all initiatives and TB case detection rates increased between 10% and 36%. We conclude that for-profit providers can be effectively involved in TB control through informal, but well defined drugs-for-performance contracts. The contracting party should be able to reach a common understanding concerning goals and role division with for-profit providers and monitor them for content and quality. Relational drugs-for-performance contracts minimize the need for handling the legal and financial aspects of classical contracting. We opine that further analysis is required to assess if such "soft" contracts are sufficient to scale up private for-profit provider involvement in TB control and other priority health interventions

Involving private practitioners in tuberculosis control: issues, interventions, and emerging policy framework

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