Abstract

Persistent barriers to universal access to medicines are limited social protection in the event of illness, inadequate financing for essential medicines, frequent stock-outs in the public sector, and high prices in the private sector. We argue that greater coherence between human rights law, national medicines policies, and universal health coverage schemes can address these barriers. We present a cross-national content analysis of national medicines policies from 71 countries published between 1990–2016. The World Health Organization’s (WHO) 2001 guidelines for developing and implementing a national medicines policy and all 71 national medicines policies were assessed on 12 principles, linking a health systems approach to essential medicines with international human rights law for medicines affordability and financing for vulnerable groups. National medicines policies most frequently contain measures for medicines selection and efficient spending/cost-effectiveness. Four principles (legal right to health; government financing; efficient spending; and financial protection of vulnerable populations) are significantly stronger in national medicines policies published after 2004 than before. Six principles have remained weak or absent: pooling user contributions, international cooperation, and four principles for good governance. Overall, South Africa (1996), Indonesia and South Sudan (2006), Philippines (2011–2016), Malaysia (2012), Somalia (2013), Afghanistan (2014), and Uganda (2015) include the most relevant texts and can be used as models for other settings. We conclude that WHO’s 2001 guidelines have guided the content and language of many subsequent national medicines policies. WHO and national policy makers can use these principles and the practical examples identified in our study to further align national medicines policies with human rights law and with Target 3.8 for universal access to essential medicines in the Sustainable Development Goals.

Highlights

  • Universal access to essential medicines is an important component of the right to health and the Sustainable Development Goals (SDGs). [1] Essential medicines are those required to meet the priority health care needs of a population. [2] Realising universal access to medicines requires a coherent approach to medicines as essential public goods. [3]The World Health Organization (WHO) advocates for the adoption of a national medicines policy (NMP) as a commitment to a goal and a guide to action

  • WHO’s 2001 guidelines to Develop and implement a national drug policy elucidate the key components of a NMP. [4] NMPs should be based on universal principles, involve a range of national stakeholders, and be tailored to the local context. [4,5] The first NMPs were predominantly adopted by low- and lower-middle income countries, and only since 2007 have many higher income countries followed. [5,6] By 2015, over 90% of low and middle-income countries (LMICs) had published a NMP. [6,7] Adopting a NMP has been associated with the provision of a basic range of essential medicines free at the point of care, and better quality use of medicines, in LMICs

  • We report the frequency of each principle in NMPs and describe the different approaches towards each principle in different countries.We hypothesised that the content of WHO’s 2001 NMP guidelines would inform the content of subsequent NMPs

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Summary

Introduction

Universal access to essential medicines is an important component of the right to health and the Sustainable Development Goals (SDGs). [1] Essential medicines are those required to meet the priority health care needs of a population. [2] Realising universal access to medicines requires a coherent approach to medicines as essential public goods. [3]The World Health Organization (WHO) advocates for the adoption of a national medicines policy (NMP) as a commitment to a goal and a guide to action. We assert that greater coherence is needed between NMPs’ goals and strategies, the wider health system including UHC, and human rights; and that incorporating human rights principles and the wider health systems perspective in NMPs can create a supportive environment for medicines affordability and financing for vulnerable groups. General Comment No 14 (2000), an authoritative interpretation of the right to health by the UN Committee on Economic, Social, and Cultural Rights, establishes that governments have the ‘core obligation’ to provide essential medicines and to establish a national health strategy and plan of action. The right to health establishes universal minimum entitlements to essential medicines for all, a set of State duties and guiding principles for government action (i.e. transparency and participation), and mechanisms for rights enforcement and redress

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