Essential Medicines in National Constitutions

A constitutional guarantee of access to essential medicines has been identified as an important indicator of government commitment to the progressive realization of the right to the highest attainable standard of health. The objective of this study was to evaluate provisions on access to essential medicines in national constitutions, to identify comprehensive examples of constitutional text on medicines that can be used as a model for other countries, and to evaluate the evolution of constitutional medicines-related rights since 2008. Relevant articles were selected from an inventory of constitutional texts from WHO member states. References to states’ legal obligations under international human rights law were evaluated. Twenty-two constitutions worldwide now oblige governments to protect and/or to fulfill accessibility of, availability of, and/or quality of medicines. Since 2008, state responsibilities to fulfill access to essential medicines have expanded in five constitutions, been maintained in four constitutions, and have regressed in one constitution. Government commitments to essential medicines are an important foundation of health system equity and are included increasingly in state constitutions. S. Katrina Perehudoff, MSc, LLM, is a doctoral candidate in the Global Health Unit, Department of Health Sciences in the University Medical Centre, University of Groningen, the Netherlands, and Research Fellow at the Global Health Law Groningen Research Centre. Brigit Toebes, LLM, PhD, is Associate Professor and Rosalind Franklin Fellow in the Department of International and Constitutional Law, University of Groningen, the Netherlands, and Director of the Global Health Law Groningen Research Centre. Hans V. Hogerzeil, MD, PhD, FRCP Edin, is Professor of Global Health and the Right to Health, Global Health Unit, Department of Health Sciences in the University Medical Centre, University of Groningen, the Netherlands, and member of the Global Health Law Groningen Research Centre. Please address correspondence to S. Katrina Perehudoff c/o Dr. Brigit Toebes, Faculty of Law, International Law, University of Groningen, PO Box 716, 9700 ES Groningen, the Netherlands. Email: [email protected]. Competing interests: None declared. Copyright © 2016 Perehudoff, Toebes, and Hogerzeil. This is an open access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0/), which permits unrestricted noncommercial use, distribution, and reproduction in any medium, provided the original author and source are credited. Health and Human Rights Journal HHr HHR_final_logo_alone.indd 1 10/19/15 10:53 AM S. K. Perehudoff, B. Toebes, and H. Hogerzeil / papers, 141-156 142 J U N E 2 0 1 6 V O L U M E 1 8 N U M B E R 1 Health and Human Rights Journal Introduction Essential medicines are an indispensable component of health systems and are recognized as part of the right to health under international law.1 One indicator of a government’s commitment to access to medicines and health system equity is the inclusion of medicines-related rights in national constitutions.2 Constitutional rights to health and medicines set priorities for national health policies and programs, while also creating the mechanisms necessary to enforce these rights before domestic courts.3 An initial scoping study conducted in 2008 of 186 constitutions identified only three constitutions worldwide that included provisions on medicines, and a fourth that provided for essential goods and services.4 Since then, many constitutions have been amended or redrafted, coinciding with recent economic, political, and social tensions linked to the 2008 financial crisis, the 2009 European debt crisis, and the 2011 Arab Spring.5 Every constitutional review is an opportunity for the state to include health and medicines rights in the constitution, in line with human rights standards. The time is ripe to evaluate whether state constitutions recognize that essential medicines are part of the right to health. The starting point is a survey of the current provisions on essential medicines in national constitutions against the backdrop of states’ legal obligations under international human rights law and the right to health framework. We identify model text for policy makers and advocates seeking to enshrine these rights in their national constitutions. This study also develops an inventory of constitutional provisions on essential medicines in order to track their evolution since 2008. Essential medicines in international law The right to the progressive realization of the highest attainable standard of health first emerged as a social right in the World Health Organization (WHO) Constitution.6 It was also included in Article 25.1 of the Universal Declaration of Human Rights (UDHR) and confirmed in numerous international and regional treaties since then.7 The most important treaty in this respect, the binding International Covenant on Economic, Social and Cultural Rights (ICESCR), details the realization of the right to health through four concrete and targeted steps, including access to health facilities, goods, and services.8 The non-binding but highly respected General Comment No. 14, drafted by the Committee on Economic, Social and Cultural Rights (CESCR), further specifies in paragraph 43(d) that access to essential medicines is part of the right to health. Paragraphs 34-37 of General Comment No. 14 clearly describe governments’ legal obligations to respect, protect, and fulfill the right to health. The duty to respect is a negative obligation to refrain from interfering with the enjoyment of health rights. The duties to protect and to fulfill impose positive obligations on states to take measures to safeguard (to protect) and to take measures to ensure that health rights can be enjoyed (to fulfill).9 This tripartite typology helps to identify the specific legal obligations of states to realize the right to health. Moreover, the right to health framework in General Comment No. 14 (known as the AAAQ framework) enumerates the elements of the right to health as accessibility, availability, acceptability, and (assured) quality of goods and services, including essential medicines “as defined by the WHO Action Programme on Essential Drugs.”10 WHO defines essential medicines as “those that satisfy the priority healthcare needs of the population. Essential medicines are chosen with due regard to disease prevalence, efficacy, safety and comparative cost-effectiveness.”11 According to WHO, essential medicines are used for disease prevention, treatment, and control, and are applicable to most chronic and acute diseases.12 It is, therefore, of great concern that an estimated one-third of the population in developing countries is unable to access essential medicines on a regular basis.13 One way to address this unmet need is through national legislation that promotes a human rights approach to essential medicines. The constitutional right to health and essential medicines Most countries have ratified at least one of the international or regional treaties that include the S. K. Perehudoff, B. Toebes, and H. Hogerzeil / papers, 141-156 J U N E 2 0 1 6 V O L U M E 1 8 N U M B E R 1 Health and Human Rights Journal 143 right to health, including 163 state parties to the International Covenant on Economic, Social and Cultural Rights (ICESCR).14 Access to essential medicines as part of the progressive realization of the right to health is well founded in international law and binding on many states. But do these laws mean anything in practice? Hogerzeil et al. identified 59 court cases from 12 lowand middle-income countries in which access to essential medicines was claimed under the right to health. Half of these cases related to life-saving treatment of HIV/ AIDS. The study showed that international treaties, if enforced through constitutional provisions, could indeed promote the realization of individual rights at the national level. The examples identified by Hogerzeil et al., most of which are from Latin America, show that individual court cases can generate entitlements across a population group, that the right to health is not restricted by limitations in social security coverage, that government policies have successfully been challenged in court, and that states have special obligations towards the poor and disadvantaged. In the countries studied, other factors in successfully generating entitlements are a link between the right to health and the right to life (in case of life-threatening disease) and support by public interest NGOs.15 There is much variation in de jure constitutional recognition of human rights and de facto application of these rights in practice.16 One example can be found in high-income countries, over half of which lack a constitutional right to health or medical care.17 At the same time, many high-income economies do have functioning health systems providing services and medicines on a regular basis. Despite this phenomenon, constitutional health rights are valuable tools to promote access to medicines. Hogerzeil et al. showed that one of the most important success factors for the practical implementation of access to essential medicines was the fact that the right to health principles of the international human right treaties had been incorporated into national constitutions.18 For this reason, the constitutional recognition of access to essential medicines is an indicator of government commitment to the right to health and health system equity.19 Given that national constitutions have proven so important in realizing the right to health, the next question is: which countries have incorporated access to essential medicines in their national constitution? Our baseline study in 2008 identified provisions on essential medicines, goods, and services in only four national constitutions worldwide: Mexico, Panama, the Philippines, and the Syrian Arab Republic.20 Since 2008, many governments have revised and amended existing constitutions or created new constitutions, sometimes in reaction to the changing political, social, and economic circumstances caused in part by the global financial crisis, the European debt crisis, and the Arab Spring.21 The purpose of this study was to track the evolution of national constitutions and identify those that now include a specific reference to the legal obligations to respect, protect, and fulfill access to essential medicines as part of the right to health. We identified examples of constitutional texts that include the AAAQ elements of the right to health. These constitutional texts may serve as a model for other countries interested in updating or strengthening their own constitutions. Model constitutional provisions could assist domestic legislators in formulating an inclusive constitutional health clause suited to national needs and resources. Patient and advocacy groups can also use the model texts in their efforts to advance universal access to essential medicines.