Medicines in Health Systems Advancing access, affordability and Edited by: appropriate use Maryam Bigdeli, David H. Peters, Anita K. Wagner Medicines in Health Systems: Advancing access, affordability and appropriate use Edited by: Maryam Bigdeli, David H. Peters, Anita K. Wagner WHO Library Cataloguing-in-Publication Data: Medicines in health systems: advancing access, affordability and appropriate use. 1.Drugs, Essential – supply and distribution. 2.Drugs, Essential – standards. 3.Universal Coverage. 4.Delivery of Health Care. 5.Drug Utilization. 6.Drug Costs. I.World Health Organization. ISBN 978 92 4 150762 2 (NLM classification: QV 736) © World Health Organization 2014 All rights reserved. Publications of the World Health Organization are available on the WHO website (www.who.int) or can be purchased from WHO Press, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel.: +41 22 791 3264; fax: +41 22 791 4857; e-mail: [email protected]). 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Printed in South Africa Designed by Corrales Creative This Report benefited from the contributions of Lydia Bendib and Stephanie Ngo who coordinated the design and printing. 5 – Contents CONTENTS Contributors ........................................................................................................................................................8 Acknowledgements ...........................................................................................................................................9 Preface ...............................................................................................................................................................10 Executive Summary .........................................................................................................................................11 Acronyms ...........................................................................................................................................................16 Chapter 1 Why a health systems approach? ..................................................................................................................18 1.1 Introduction to Essential Medicines ............................................................................................................19 1.2 Introduction to the Flagship Report ............................................................................................................20 1.3 Definitions and concepts ...........................................................................................................................21 1.3.1 Selection and availability of medicines ................................................................................................21 1.3.2 Affordability .......................................................................................................................................21 1.3.3 Appropriate use .................................................................................................................................22 1.4 Essential medicines and health systems .....................................................................................................22 1.5 Applying systems thinking to access to medicines .......................................................................................25 1.6 Overview of chapters .................................................................................................................................26 Chapter 2 Evolving concepts in essential medicines and health systems................................................................28 2.1 A historical perspective ..............................................................................................................................30 2.1.1 Essential medicines since the 1970’s...................................................................................................30 2.1.2 Health systems: from Alma Ata to UHC .............................................................................................. 31 2.1.3 The impact of HIV/AIDS on health systems and essential medicines .....................................................31 2.2 Current situations of medicines in LMICs ...................................................................................................32 2.2.1 Availability of medicines .....................................................................................................................32 2.2.2 Affordability for patients .....................................................................................................................32 2.2.3 Affordability for health systems .......................................................................................................... 33 2.2.4 Prescribing practices, dispensing and use ............................................................................................33 2.2.5 Health-seeking behaviour and reliance on the informal health sector ...................................................34 2.2.6 Traditional medicines ......................................................................................................................... 34 2.2.7 Quality control and regulation ........................................................................................................... 34 2.2.8 Investing in research and development ...............................................................................................35 2.3 The future of medicines in LMIC health systems ......................................................................................... 36 MEDICINES IN HEALTH SYSTEMS: ADVANCING ACCESS, AFFORDABILITY AND APPROPRIATE USE Contents – 6 Chapter 3 The role of medicines in achieving universal health coverage .............................................................42 3.1 Introduction ..............................................................................................................................................44 3.2 Why is an explicit focus on medicines needed to achieve UHC? ..................................................................44 3.2.1 The inappropriate use of medicines can threaten equity, quality, affordability, and efficiency .................45 3.2.2 Decision-makers must balance competing policy objectives .................................................................45 3.2.3 Decision-makers can use information and financial levers to balance competing objectives ..................46 3.3 Medicines management in China, Ghana, Indonesia and Mexico ................................................................47 3.3.1 Systems striving towards UHC face common policy implementation challenges ................................... 50 3.3.2 Using financial and information levers to increase quality and efficiency ..............................................50 3.3.3 A systems approach is important when implementing medicines policies .............................................52 3.4 Towards UHC: ethical considerations must guide policy decisions................................................................53 3.4.1 Striving towards equity-enhancing pharmaceutical policies ..................................................................54 3.5 Information about medicines is key to achieving UHC goals ....................................................................... 55 3.6 Conclusions and recommendations ............................................................................................................57 Chapter 4 Innovation to ensure better access to medicines ...................................................................................60 4.1 An inclusive definition of innovation ..........................................................................................................62 4.2 Towards innovative R&D models ............................................................................................................... 62 4.2.1 India’s Open Source Drug Discovery initiative (OSDD) ..........................................................................64 4.3 Innovation in expanding markets for high-quality generic products .............................................................66 4.3.1 The evolution of Brazil’s approach to generic medicines ...................................................................... 68 4.4 Innovation in expanding access to specialty medicines ...............................................................................69 4.4.1 The E2 Access programme for high-cost specialty medicines in Thailand .............................................. 71 4.5 Innovation and ethics in medicines decision-making .................................................................................. 72 4.6 Conclusions and recommendations ............................................................................................................72 Chapter 5 Making health market systems work for medicines ..............................................................................74 5.1 The growing role of health care markets in access to medicines ................................................................. 76 5.2 A systems approach to analysing health care markets .................................................................................77 5.3 Case-studies of interventions addressing market failures in LMICs ..............................................................79 5.3.1 The United Republic of Tanzania: Accredited Drug-Dispensing Outlets ..................................................79 5.3.2 Cambodia: task shifting to expert patients for diabetes care ................................................................81 5.3.3 Thailand: Antibiotic Smart Use initiative ..............................................................................................83 5.3.4 Kenya: Familia Nawiri social business initiative ................................................................................... 86 5.4 Conclusions and recommendations ............................................................................................................89 MEDICINES IN HEALTH SYSTEMS: ADVANCING ACCESS, AFFORDABILITY AND APPROPRIATE USE 7 – Contents Chapter 6 Using a systems approach to innovate in access to medicines ............................................................92 6.1 Introduction ............................................................................................................................................. 93 6.2 Essential cross-cutting elements: Engagement, information and adaptation ................................................94 6.2.1 Engaging diverse health system stakeholders ..................................................................................... 94 6.2.2 Generating and using information to facilitate dialogue and inform decisions ..................................... 97 6.2.3 Adapting to changing health systems..................................................................................................99 6.3 A framework for moving forward .............................................................................................................101 List of Figures Figure 1.1 Interconnectedness of health system components ............................................................................23 Figure 1.2 Access to medicines from a health system perspective ......................................................................24 Figure 2.1 Timeline of milestones in development of essential medicines and health systems concepts ............. 37 Figure 3.1 Approaches to balance competing medicines policy objectives .........................................................46 Figure 3.2 Stakeholders in Ghana’s pharmaceutical sector and potential impacts of excluding medicines from case-based provider payments ........................................................................................................................ 52 Figure 5.1 Framework for understanding health market systems .......................................................................78 Figure 5.2 Reinforcing feedback loop representing the Familia Nawiri social business model ............................87 Figure 5.3 Interventions to create a growth loop for the ongoing purchase of medicines in the Familia Nawiri social business model .....................................................................................................................................88 Figure 5.4 Expanded conceptual map of Familia Nawiri social business model ..................................................89 List of Tables Table 3.1 Overview of health-care financing schemes in China, Ghana, Indonesia and Mexico...........................48 Table 3.2 Policy and management approaches in country case-studies ..............................................................51 Table 6.1 Examples of objectives, roles and responsibilities of key stakeholders in advancing the access, affordability, and appropriate use of medicines ................................................................................................95 Table 6.2 Intervention Implementation Outcomes ...........................................................................................101 List of Boxes Box 1.1 Systems thinking for health systems strengthening ..............................................................................25 Box 3.1 Universal Health Coverage ..................................................................................................................44 Box 3.2 Equity .................................................................................................................................................54 Box 3.3 The Harvard Pilgrim Health Care ethics advisory group .........................................................................56 Box 4.1 Innovative push and pull R&D Strategies .............................................................................................63 Box 6.1 Four steps to systems-informed intervention design .............................................................................98 Box 6.2 Factors influencing the implementation of policy decisions or specific interventions ............................100 Box 6.3 Medicines in health systems - An agenda for action ...........................................................................104 The Web Annex presents all the case-studies that informed this report, along with other useful resources. It can be accessed at: www.who.int/alliance-hpsr/resources/flagshipreports/en/ MEDICINES IN HEALTH SYSTEMS: ADVANCING ACCESS, AFFORDABILITY AND APPROPRIATE USE Contributors – 8 CONTRIBUTORS Editors Maryam Bigdeli, David H. Peters, Anita K. Wagner. Advisory committee Irene Agyepong, Kees de Joncheere, Abdul Ghaffar, Vera Lucia Luiza, Malebona Precious Mat- soso, Zafar Mirza, Eva Ombaka, John-Arne Røttingen, Göran Tomson, Suwit Wibulpolprasaert. Authors Chapter 1 – Why a health systems approach? Authors: Maryam Bigdeli, Laura F. Garabedian, Dena Javadi, Sandy Campbell. Chapter 2 – Evolving concepts in essential medicines and health systems Authors: Laura F. Garabedian, Dennis Ross-Degnan, Maryam Bigdeli, Richard Laing, Anita K. Wagner. Chapter 3 – The role of medicines in achieving universal health coverage Authors: Anita K. Wagner, Veronika J. Wirtz, Maryam Bigdeli, Calvin WL Ho, Dennis Ross-Degnan. Box: Anita K. Wagner, James E. Sabin (3.3). Case studies: Warren A. Kaplan, Wen Chen, Veronika J. Wirtz (China); Paul Ashigbie, Daniel K. Arhinful, Veronika J. Wirtz (Ghana); Mohammad Ibrahim Brooks, Yusi Aggriani, Veronika J. Wirtz (Indonesia); Veronika J. Wirtz, Anahí Dreser (Mexico). Chapter 4 – Innovation to ensure better access to medicines Authors: Anita K. Wagner, Maryam Bigdeli, Anthony D. So, Andreas Seiter; Calvin WL Ho (co- author of section on ethics of decision-making). Case studies: Anthony D. So, Will Woodhouse (Open Source Drug Discovery in India); Isabel C. M. Emmerick, Andréa D. Bertoldi (Generic medicines in Brazil); Rosarin Sruamsiri, Netnapis Suchonwanich (E2 Access Programme in Thailand). Chapter 5 – Making health market systems work for medicines Authors: David H. Peters, Maryam Bigdeli. Case studies: Edmund Rutta (Accredited Drug Dispensing Outlets in the United Republic of Tan- zania); Natalie Eggermont, Josefien van Olmen, Maurits van Pelt, Wim Van Damme (Task-shifting to peer educators in Cambodia); Anthony D. So, Will Woodhouse (Antibiotic Smart Use Initiative in Thailand), Anita K. Wagner, James P. Thompson, Dennis Ross-Degnan (Familia Nawiri social business initiative in Kenya). Chapter 6 – Using a systems approach to innovate in access to medicines Authors: Maryam Bigdeli, David H. Peters, Sandy Campbell, Anita K. Wagner. MEDICINES IN HEALTH SYSTEMS: ADVANCING ACCESS, AFFORDABILITY AND APPROPRIATE USE 9 – Acknowledgements ACKNOWLEDGEMENTS This report was developed by the Alliance for Health Policy and Systems Research (AHPSR) in col- laboration with the World Health Organization (WHO) Department of Essential Medicines and Health Products. AHPSR and WHO acknowledge with thanks the authors, editors, reviewers/advisors and consul- tants whose dedication and expertise made this report possible. Special thanks are due to Richard Laing for his contribution to the editorial process, especially during the review meeting in October 2013 and to Ruediger Krech for his final review of the report. Thanks are also due to Sandy Camp- bell and Priya Shetty, who edited the final text. Funding for this report was made possible through a grant provided in 2012 by the UK Depart- ment for International Development (DFID) to the Alliance for Health Policy and Systems Research on Access to Medicines. MEDICINES IN HEALTH SYSTEMS: ADVANCING ACCESS, AFFORDABILITY AND APPROPRIATE USE Preface – 10 PREFACE There is now a much welcomed push by WHO Member States to implement the concept of uni- versal health coverage (UHC) and thus to ensure that all people obtain the health services they need without suffering financial hardship when paying for them. UHC requires strong, well-run health systems, sustainable and equitable methods to finance health services, sufficient capacities of well-trained and motivated health workers, and – last but not least – access to essential medicines and technologies. This Flagship Report deals with the latter – the challenges to achieve equitable access to essential medicines. With expenditures on medicines reaching extreme levels – with some low- and middle- income countries directing two thirds of their entire health spending on medicines – the need to rethink and redirect action in the field of medicines has never been more pressing. Only with new ways of understanding the scope of the problems can policies, regulations and health interven- tions be designed to ensure that, when it comes to accessing necessary medicines, no one is left behind, no matter where they live, no matter their age, or sex, or race. This Flagship Report calls for a “systems approach” to position medicines within the complexity of any health system. This approach moves beyond the idea that medicines are little more than a series of interactions between patients and public health services. A health systems approach to medicines may facilitate the understanding of the system’s integral relations and connections, allowing for innovative and contextual responses in developing and implementing new medicines and new medicines policies and regulations. As evidenced throughout this report, medicines access, affordability and appropriate use must be a core focus for any effort to strengthen health systems and to advance universal health cover- age. This Flagship Report calls for greater accountability of stakeholders, and stimulates some fresh thinking among decision-makers, researchers, civil society, and development partners. This Flagship Report will undoubtedly inspire important conceptual and practical on-the-ground work. Marie-Paule Kieny Assistant Director-General Health Systems and Innovation Cluster World Health Organization MEDICINES IN HEALTH SYSTEMS: ADVANCING ACCESS, AFFORDABILITY AND APPROPRIATE USE 11 – Executive Summary EXECUTIVE SUMMARY The World Health Organization (WHO) defines medicines. Through various country case-stud- essential medicines as those medicines that ies, the report illustrates major challenges and respond to the priority health needs of a spe- advances in the access, affordability and ap- cific population. They should be available at propriate use of medicines in low- and middle- all times in adequate amounts, be affordable, income countries (LMICs). and have a proven efficacy, quality and safety. Only through an appreciation of the When observing these criteria, essential medi- dynamic interplay – often unpredict- cines are one of the most cost-effective ele- able and always changing – among ments for any health system, with an immedi- health system components and actors ate and long-lasting health impact. can we arrive at a full understanding of a health system, and specifically WHO has deemed medicines and health tech- how medicines policies and medicines nologies one of six health system building interventions affect and are affected blocks. Yet as a fundamental element, medi- by the system’s constant adaptation cines and health technologies do not lie in iso- and complexity. lation from the other components of a health system. To appreciate the many interconnec- Following a description of how the access to tions and actors that influence and shape medicines field has evolved since the 1970s, medicines, a systems approach is required. we explore specific links between medicines and UHC, then move to the role of innovation A systems approach features prominently in in developing and delivering medicines, and this report. This allows us to situate medi- then to a focus on the pluralistic health sys- cines against the full complexity of a health tems around medicines, with particular atten- system, understanding how interventions in tion on health market systems. We conclude the pharmaceutical sector influence the rest of with some action-oriented guidance and rec- the health system and vice versa. In applying ommendations for decision-makers to inform, a systems approach, we come to understand monitor, and evaluate the inevitable reforms that improving access to medicines can pro- required to improve medicines access, afford- mote health equity, and contribute to both ability, and use in LMIC settings. stronger health systems and the goals of uni- versal health coverage (UHC). As demand-side barriers are of critical impor- tance in accessing medicines, it is essential to As health systems and the actors who move past the traditional conceptual confines shape them feature many core interac- of medicines as goods transacted in a series tions and connections, it is essential to of interactions between patients and public examine the ways in which the access health services. to, affordability, and use of medicines affect and are affected by decisions in This report argues that only with sound deci- other parts of the health system. sion-making – informed by the aspirations Drawing on the work of the Alliance for Health of universal health coverage, a fuller under- Policy and Systems Research (AHPSR) (11, standing of the interrelationships between ac- 12), this report applies a systems approach to tors in systems, and guided by health system strengthening efforts – will we make viable MEDICINES IN HEALTH SYSTEMS: ADVANCING ACCESS, AFFORDABILITY AND APPROPRIATE USE