Universal access to essential medicines as part of the right to health : a cross-national comparison of national laws, medicines policies, and health system indicators

Background: Access to essential medicines for the world's poor and vulnerable has made little progress since 2000, except for a few specific medicines such as antiretrovirals for HIV/AIDS. Human rights principles written into national law can create a supportive environment for universal access to medicines; however, systematic research and policy guidance on this topic is lacking. Objective: To examine how international human rights law and WHO's essential medicines policies are embedded in national law for medicines affordability and financing, and interpreted and implemented in practice to promote universal access to essential medicines. Methods: This thesis consists of (1) a cross-national content analysis of 192 national constitutions, 71 national medicines policies, and legislation for universal health coverage (UHC) from 16 mostly low- and middle-income countries; (2) a case study of medicines litigation in Uruguay, and (3) a follow-up report of eight right to health indicators for access to medicines from 195 countries. Results: Some, but not all, of the 12 principles from human rights law and WHO's policy are embedded in national UHC law and medicines policies (part 1). Even the most rights-compliant legislation for access to medicines is subject to the unique and inconsistent interpretation of domestic courts, which may be inconsistent with the right to health in international law (part 2). Many national health systems for which data were available still fail to meet the official targets for eight indicators of access to medicines (part 3). Conclusions: International human rights law and WHO policy are embedded in national law for essential medicines and practically implemented in national health systems. Law makers can use these findings and the example texts in this thesis as a starting point for writing and monitoring governments' rights-based legal commitments for access to medicines. Future research should study the effect of national law on access to medicines and population health

The right to health as the basis for universal health coverage : a cross-national analysis of national medicines policies of 71 countries

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

Legislating for universal access to medicines : a rights-based cross-national comparison of UHC laws in 16 countries

Universal health coverage (UHC) aims to ensure that all people have access to health services including essential medicines without risking financial hardship. Yet, in many low- and middle-income countries (LMICs) inadequate UHC fails to ensure universal access to medicines and protect the poor and vulnerable against catastrophic spending in the event of illness. A human rights approach to essential medicines in national UHC legislation could remedy these inequities. This study identifies and compares legal texts from national UHC legislation that promote universal access to medicines in the legislation of 16 mostly LMICs: Algeria, Chile, Colombia, Ghana, Indonesia, Jordan, Mexico, Morocco, Nigeria, Philippines, Rwanda, South Africa, Tanzania, Turkey, Tunisia and Uruguay. The assessment tool was developed based on WHO's policy guidelines for essential medicines and international human rights law; it consists of 12 principles in three domains: legal rights and obligations, good governance, and technical implementation. Relevant legislation was identified, mapped, collected and independently assessed by multi-disciplinary, multi-lingual teams. Legal rights and State obligations toward medicines are frequently codified in UHC law, while most good governance principles are less common. Some technical implementation principles are frequently embedded in national UHC law (i.e. pooled user contributions and financial coverage for the vulnerable), while others are infrequent (i.e. sufficient government financing) to almost absent (i.e. seeking international assistance and cooperation). Generally, upper-middle and high-income countries tended to embed explicit rights and obligations with clear boundaries, and universal mechanisms for accountability and redress in domestic law while less affluent countries took different approaches. This research presents national law makers with both a checklist and a wish list for legal reform for access to medicines, as well as examples of legal texts. It may support goal 7 of the WHO Medicines & Health Products Strategic Programme 2016-30 to develop model legislation for medicines reimbursement

Human rights & intellectual property for universal access to new essential medicines

This chapter illustrates how human rights principles can help governments, even those with the most modest budgets, scale-up universal access to expensive essential medicines. The key message is that governments have legally binding human rights obligations to immediately take steps to provide essential medicines. These steps include making a maximum of public resources available to finance essential medicines, particularly for vulnerable and marginalized groups, and using those resources efficiently. Crucially, using mechanisms to control medicines prices and, in the case of high priced patented medicines, the use of TRIPS flexibilities, is aligned with governments’ duties under human rights law to ensure access to essential medicines. Moreover, the right to health imposes duties on the international community of States and the pharmaceutical industry to respect and protect access to essential medicines