Date Published: June 28, 2019
Publisher: Public Library of Science
Author(s): S. Katrina Perehudoff, Nikita V. Alexandrov, Hans V. Hogerzeil, Rosella Levaggi.
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.
Universal access to essential medicines is an important component of the right to health and the Sustainable Development Goals (SDGs).  Essential medicines are those required to meet the priority health care needs of a population.  Realising universal access to medicines requires a coherent approach to medicines as essential public goods. 
A detailed description of the methodology is in the online S1 Appendix.
Of the 80 full text NMPs we intitally retrieved, nine were excluded due to language restrictions or incompleteness. We included 71 NMPs published between 1990 and 2016. Our sample has a higher proportion of NMPs published before 2004 (≤2003 n = 32/47, 68% vs. ≥2004 n = 39/88, 44%) and by low income countries (n = 35/46, 76%) than middle and high income nations (n = 35/132, 27%).
This paper presents a first cross-national comparison of the most recent NMPs from 71 countries, published between 1990–2016, using a 12-point checklist for universal access to medicines based on human rights and health system principles. The selection of essential medicines and their cost-effectiveness are the most frequent policy measures in our sample of NMPs. Good governance (transparency, participation, monitoring, or accountability for medicines affordability and financing), and measures to pool user contributions and to seek international cooperation remain weak or absent. An individual right to health, and measures for government financing of essential medicines, cost-effective spending, and financial protection of vulnerable groups are significantly stronger in NMPs published after 2004 than in those published before. NMPs with the clearest and strongest commitments to essential medicines and human rights principles are from South Africa (1996), Indonesia and South Sudan (2006), Malaysia (2012), Somalia (2013), Afghanistan (2014), Uganda (2015), and the Philippines (2011–2016); these texts may serve as models for others.
Our study demonstrates to which extent a human rights-based approach to access to essential medicines within UHC schemes is integrated into 71 most recent NMPs, using a 12-point checklist focusing on medicines affordability and financing for vulnerable groups. Specific examples of how essential medicines and human rights principles are phrased in NMPs can be used by WHO and national policy makers to further align the goals and strategies of the national pharmaceutical sector with human rights law and the SDG targets for universal access to essential medicines.