University of Groningen The right to health as the basis for universal access to essential medicines Perehudoff, Sammi-Jo Katrina

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University of Groningen

The right to health as the basis for universal access to essential medicines Perehudoff, Sammi-Jo Katrina

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Perehudoff, S-J. K. (2018). The right to health as the basis for universal access to essential medicines: A normative framework and practical examples for national law and policy. Rijksuniversiteit Groningen.

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Towards access to medicines through

policy and practice

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Access to medicines in 195 countries:

A human rights approach to

sustainable development

S. Katrina Perehudoff Nikita V. Alexandrov Hans V. Hogerzeil

A version of this chapter is accepted for publication

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Ac cess t o medicines in 195 c oun tr ies: A human r igh ts appr oach t o sustainable dev elopmen t Abstract

In 2008 the UN Special Rapporteur on the Right to Health published 72 right to health indicators in 194 health systems. We present a follow-up report of 8 indicators for access to medicines to serve as a reference point for progress towards the Sustainable Development Goals target 3.8 on essential medicines. Data for these eight indicators in 2015 was collected and compared with the 2008 report. Between 2008-2015 we observed increased numbers of constitutions recognising access to medicines (7 to 13 countries), countries with a national medicine policy (118 to 122) and with a national list of essential medicines (78 to 107). Public spending on pharmaceuticals decreased or rose modestly in most of the 44 countries. Median availability of a basket of lowest-priced generics increased in the public (63% to 70% n=9 countries) and private (84% to 92% n=10) sectors. Median child immunisation rates remained constant for measles (around 93%) and improved for 3 doses of diphtheria-tetanus-pertussis (79% to 86%). These eight indicators are useful and feasible, but should be further strengthened and expanded. Future monitoring exercises should use these indicators to screen progress and guide national governments’ action to ensure universal access to essential medicines as part of the right to health.

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Ac cess t o medicines in 195 c oun tr ies: A human r igh ts appr oach t o sustainable dev elopmen t Introduction

Access to essential medicines is part of the right to health and a target in successive global development agendas. Essential medicines are defined by the World Health Organization (WHO) as those medicines required to meet the priority health care needs of a population (1). Global targets for essential medicines in the Millennium Development Goals (MDGs) and the Sustainable Development Goals (SDGs) neither reflect the multiple facets of the right to health nor are they regularly reported. Right to health indicators use public health data to assess the realisation of human rights in a population (2). In 2008 the UN Special Rapporteur on the Right to Health published 72 indicators related to the right to health in 194 health systems (3). Since 2008, this baseline measurement has not been repeated. In this chapter we present a 2015 follow-up report of eight right to health indicators specifically related to access to medicines from the 2008 report, in 195 countries. We recommend how these eight right to health indicators can be used for a more robust monitoring of a human rights approach to sustainable development.

Tenuous monitoring of access to medicines

WHO’s standardised pharmaceutical country profiles periodically collect data a range of self-reported indicators from most low and middle income countries; however, these profiles were last updated in 2013 (4). MDGs 4 and 8 adopted as national indicators the rate of childhood measles immunisation and the availability and affordability of essential medicines, respectively (5). Although robust immunisation data was collected during the tenure of the MDGs, they were criticised for ‘giving up’ on medicines availability after reporting only 26 country surveys in 6 years (6).

Now, achieving universal access to essential medicines is part of SDG target 3.8 on universal health coverage (UHC) (7). Unfortunately, monitoring exercises for this SDG target continue to marginalise access to medicines. Between 2010 and 2017 fewer than 30 national surveys of medicines availability have been collected (8). The 2017 UHC Global Monitoring Report committed to report on medicines availability as one of the 16 tracer indicators in the UHC service coverage index once data become widely available (8).

A human rights approach to monitoring

The right to the highest attainable standard of health imparts important responsibilities on States to design equitable and efficient health systems (3). Most countries have ratified at least one international treaty that

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Ac cess t o medicines in 195 c oun tr ies: A human r igh ts appr oach t o sustainable dev elopmen t

recognises the right to health, and are therefore legally obliged to progressively realise this right (9). As part of the right to health, governments have the minimum ‘core obligation’ to provide essential medicines without discrimination (10). States must ‘progressively realise’ or continuously expand access to health services, including essential medicines, through deliberate, concrete, and targeted action with a maximum of available resources (10). A rights-based approach requires that health services are continuously available in sufficient quantity, and are financially and geographically accessible (i.e. affordable) on a non-discriminatory basis (10). More generally, States are required to establish legal obligations, to adopt a national health plan, ensure sufficient financing and measures for transparency and participation in health systems, and introduce monitoring and accountability mechanisms (10).

Right to health indicators can signal the State actions and outcomes that are considered important from a human rights perspective. The indicators selected by the new SDG monitoring system for UHC and access to medicines do not fully reflect a human rights perspective (8). Therefore, we turn to the 2008 health systems monitoring exercise by the UN Special Rapporteur on the Right to Health and his team. In 2008 Backman et al. identified 72 right to health indicators for 194 health systems, of which eight indicators refer to access to medicines (Table 1). (3) Since then, this baseline measurement has not been repeated. Regularly monitoring access to medicines can identify areas of advance to be sustained and replicated elsewhere, and areas of stagnation or regression where improvements are needed. Our objective is to update the global report of these eight access to medicines indicators, and to determine progress between the initial 2008 report and 2015, which can then also serve as a reference point for future achievements under the SDGs.

Materials & Methods

A detailed description of these methods is given in Web appendix 1. (11)

Indicators

We used the same eight right to health indicators of access to essential medicines that Backman et al. used in 2008 based on WHO’s health systems indicators at the time (Table 1). The Office of the High Commissioner of Human Rights advises that structural, process, and outcome indicators be used to compose a complete snapshot of State action. Structural indicators assess a State’s infrastructure and

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commitment to realising health rights (i.e. recognising the right to health in national constitutions or the adoption of a national medicines policy (NMP)) (2). Process indicators are intermediate indicators of State efforts to enact its right to health commitments in practice (i.e. the existence of a national essential medicines list (EML) or the amount of public spending on pharmaceuticals) (2). Outcome indicators capture the results of States’ commitments and efforts on individuals’ health. They reflect the degree to which the right to health is enjoyed by individuals (i.e. the availability of essential medicines in health centres or percentage of vaccinated children in a nation) (2). Moreover, each indicator should correspond to a specific State obligation under the right to health, which we indicate in Table 1.

Data collection

We collected data from 195 health systems for the period 2008-2015 and, where possible, data reported prior to 2007 in order to verify and update the original 2008 data set.

We collected national constitutions (12), NMPs EMLs, and national reimbursement lists (13), information on public spending on pharmaceuticals (see Web appendix 1 for method) (4,11), facility assessments of medicines availability (14), and national immunisation rates (15) from reliable online databases given in the references. We used the E-DRUG network and an online search to obtain additional NMPs, EMLs, and reimbursement lists.

Data were collected between January-October 2015 and exhausted all online leads. Data for NMPs, EMLs, and medicines availability were updated in December 2017 following the report by the Lancet Commission on Essential Medicine Policies (16).

Data analysis

Our final dataset included the original 2008 data, our revisions to the 2008 data, and the latest available data gathered in 2015. We reported achievements in 2015 for all available countries. We also evaluated historical trends by using paired observations within countries stratified by economic development (defined by the World Bank): low-income countries (LICs), lower-middle income countries (LMICs), upper-middle income countries (UMICs), and high-income countries (HICs). Countries were grouped by their economic level in 2015, except where stated otherwise. We compared the availability of identical baskets of lowest price generics surveyed before and after 2008 in the public and private sectors. Where relevant, the statistical significance between median values before and after 2008 was determined using the

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Wilcoxon signed rank test with a significance level of 0.05, using SPSS IBM statistics version 24.

Results

Country-level data from 2008 and 2015 are presented in Annex 3 to this thesis and in a Web appendix (17). The most relevant data are presented below.

The situation in 2015

13/192 (7%) national constitutions recognise medicines-related rights, mostly in middle-income countries. 123/157 countries (78%) have an official NMP, 14/157 (9%) have a policy of unclear status (i.e. draft or unpublished), and 20/157 (13%) have no NMP at all. 107/173 countries (62%) had an EML, 24/173 (14%) had a national reimbursement list, and 42/173 (24%) had no list. Most low and middle income countries had a national EML (n=103/133, 77%), whereas most HICs had a national reimbursement list (n=15/37, 41%) (three countries did not have an income classification).

Global median public spending on pharmaceuticals in 70 countries is US$25.01/capita (interquartile range (IQR) US$2.32-US$258.64) since 2008. Public spending in most LICs and LMICs is below the $12.90/ capita minimum level estimated by the Lancet Commission (16), with notable exceptions in Morocco (2010: US$14.35/capita), Tuvalu (2009: US$15.71/capita), Afghanistan (2011: $17.56/capita), and Iraq (2008: US$39.64/capita). Public spending on pharmaceuticals was above the $12.90/capita threshold in most UMICs and all HICs, except Gabon and the Seychelles.

Data on medicine availability are only available from about 30 countries. The median availability of a basket of lowest-price generic medicines is slightly higher in private facilities (66.6% IQR 53.3%-74.0% n=30 countries) than in public centres (54.7% IQR 41.0%-68.5% n=28). Median availability rarely meets the 80% global target, except in a republic of Russia (both sectors) and only in the private sector of Afghanistan, Tajikistan, Sudan, and Boston, USA.

Immunisation with a measles-containing vaccine (MCV) reaches 90.0% of children (IQR 78.5-96.0%) in 153 countries. Median vaccination rates in LICs (58.5% IQR 79.5-95.0% n=12 countries), LMICs (82.0% IQR 59.3-94.0% n=36), UMICs (93.0% IQR 81.0-97.5% n=53), and HIC (92.0% IQR 88.0-96.0% n=52) are below the 95% global target.

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Three doses of a vaccine against diphtheria, tetanus and pertussis (DTP3) reach 86.0% of children (IQR 71%-95%) in 98 countries. Median coverage in UMICs (91% IQR 83%-95% n=21 countries) meets the 90% global target whereas rates in LICs (84% IQR 63%-93% n=33) and LMICs (86% IQR 66%-95% n=44) miss the target. Data was only available for one HIC (Equatorial Guinea) with 41% coverage.

Health system trends since 2008

Constitutional recognition of access to essential medicines as part of health or consumers rights increased from 7/185 national constitutions (2008) to 13/192 (2015). Mostly LMICs and UMICs (Bolivia, Ecuador, Egypt, the Dominican Republic) adopted new language.

Most countries studied (85/145, 59%) retained their original NMP (Figure 1). 93/170 (55%) countries revised an existing or adopted a first-ever EML (Figure 2).

Public spending on pharmaceuticals in LICs and LMICs decreased in 6 countries, rose modestly in another 6 countries, and achieved sizeable growth in Morocco (2007: $2.20/capita, 2010: $14.35/capita) and Iraq (2007: $19.71/capita, 2008:$ 39.64/capita) (Table 2). In UMICs public spending on pharmaceuticals rose in Peru (2004: $2.27/capita, 2009: $15.70/capita) and dropped in the Seychelles and Tunisia. 14 HICs studied increased spending and 13 decreased spending (usually by <$100/capita).

Global median availability of lowest-priced generic medicines in the public sector increased in 9 countries from 63.2% before 2008 to 70.0% in different years after 2008. Availability increased significantly in Lebanon, Sudan, and Tajikistan, and decreased significantly in Iran and Mongolia (Table 3 & Figure 3).

Global median availability in the private sector increased in 10 countries from 84.2% before and 91.5% in various years after 2008. Availability increased significantly in Mongolia, Tajikistan, and Sudan, and decreased significantly in Indonesia and Uganda (Table 3 & Figure 4).

Median MCV immunisation rates improved significantly in 47 UMICs (p=0.035) between 2008-2015 (Figure 5). Vietnam (18% estimated coverage to 92% coverage), Saint Lucia (33% to 95%), Uzbekistan (44% to 99%), Maldives (56% to 99%), Azerbaijan (75% to 98%), and Mauritius (80% to 96%) are the most improved.

Median DTP3 immunisation rates increased significantly in 65 LICs (p=0.000) and LMICs (p=0.012) over the study period (Figure 6).

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Kazakhstan (1994:51% coverage, 2009:97% coverage), Armenia (2004:71%, 2009:95%), Bolivia (2002:72%, 2012:93%), and Uganda (1999:55%, 2011:92%), Burkina Faso (2002:57%, 2009:90%) are the most improved.

In general, we found a mixed picture of progress and regression in health system performance between 2008-2015. Most progress was seen in LMICs and UMICs, such as Tajikistan (four indicators; Mongolia and Sudan (three indicators); and China, Egypt, and Fiji (two indicators). LICs Burkina Faso, Eritrea, Malawi, Tanzania, and Uganda also recorded gains on at least two indicators. Little change was seen in the HICs studied.

Discussion

We updated an earlier report by the UN Special Rapporteur on the Right to Health and his team on eight right to health indicators of access to essential medicines in 195 health systems. In general, LICs and LMICs demonstrated both the greatest need before 2008 and the best improvement on these eight indicators. Many countries progressed on most indicators between 2008 and 2015, although many fail still to meet the targets for each indicator. Data were more prevalent for all eight indicators and for most countries in 2015 than in 2008. Nevertheless, paired data was only available from 44 countries for government spending on medicines, and from 9 and 10 countries for medicines availability in the public and private sectors, respectively.

Monitoring medicines for sustainable development

Our 2015 study can serve as an updated and centralised reference point for the future advancement of health rights in health systems. In most cases, indicators reveal where large-scale government action is needed to achieve equitable outcomes, e.g. to legally recognise health rights, to commit funding for a basic package of essential medicines, to ensure their widespread availability, to address the root barriers to comprehensive immunisation coverage, and to establish monitoring mechanisms. Countries with substantial gains on these eight indicators can serve as policy laboratories to investigate the role of national factors (i.e. national laws, policies, litigation, and other initiatives) and external factors (i.e. donor financing and technical assistance) (18–21). Future research is needed to investigate these possible determinants and to understand how targeted action could help to replicate these successes in other countries.

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Ac cess t o medicines in 195 c oun tr ies: A human r igh ts appr oach t o sustainable dev elopmen t Comparison

More national constitutions with references to essential medicines in 2015 than 2018 may be a result of, among others, the desire to ensure access to medicines in the face of international trade agreements or neoliberal health reforms (22). Our inventory of recent and draft NMPs show that more countries have engaged in pharmaceutical policy making than previously reported by the Lancet Commission (16). WHO’s recommendation to revise a national essential medicines list every five years substantiates the high number of EMLs updated between 2008-2015 (23). More governments may now use the essential medicines concept to create a UHC benefits package that is more flexible than a national EML, which tends to be rather static even when updated once every two years. Reimbursement lists, and not EMLs, proliferated in UMICs and HICs over the study period. This may signal a renewed focus on a universal package of therapies that maximise health care at the lowest cost. Or it may be in response to the high prices of new essential medicines and cost-containment reforms during the global economic recession (24–26).

Although our data on government expenditure on pharmaceuticals are sparse, it suggests that most LICs and LMICs spend below the annual threshold established by the Lancet Commission of US$12.90/capita (required to purchase around 200 basic essential medicines for first and second line therapy) (16). In many countries, publicly purchased medicines are often the only source for those who are too poor to pay out-of-pocket. Consequently, impoverished patients in countries with meagre public financing may still forego even basic priority medicines. Public spending in countries advancing towards UHC (i.e. Morocco, Peru) increased over the study period. However, public spending on pharmaceuticals decreased in some other countries with UHC (i.e. Tunisia and HICs), which is consistent with reports of high out-of-pocket health spending in Tunisia and cost-saving measures in HIC triggered by the recession (25,27)

Our reports of medicines availability are congruous with other secondary analyses of the same data (28–30).

Other reports show that MCV immunisation in children has flat lined at 83-85% since 2010, which is consistent with the stable coverage rates we observed (5). The anti-vaccination movement may contribute to the slight decrease in coverage rates we observed in HICs where recent measles outbreaks occurred in populations thought to have achieved herd immunity. Despite using different methods, Hosseinpoor et al. also

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identified formidable improvements in child DTP3 vaccination rates in Armenia, Uganda, and Burkina Faso (31).

How useful and feasible are these eight indicators for monitoring progress towards universal access to essential medicines?

Overall, the eight indicators were clear, feasible and informative, but less than half the expected data points were available. Some indicators should be revised in the future, or expanded to include more detailed sub-indicators, as we explain below. The larger set of 24 indicators presented by the Lancet Commission on Essential Medicines Policies could then be used for further in-depth analysis and practical guidance for the implementation of national medicines policies (16).

Constitutional commitments (indicator 1) create a supportive environment for health rights promotion and enforcement, yet they are somewhat distant from national health laws and policies affecting individuals’ access to medicines (32). This indicator should be expanded to report whether countries have a legally-binding commitment in national health law for governments to control medicines prices and to adequately finance essential medicines for the poor and vulnerable. Official NMPs and EMLs (indicators 2 and 3) are important signals of government intention and action to implement a systems approach to access to medicines. We propose further investigation of possible qualitative measures that go beyond the binary yes/no indicators for NMPs and EMLs. These sub-indicators should capture how rights-compliant these documents are, for example by assessing whether a NMP covers all essential policy components.

Government spending on pharmaceuticals (indicator 4) is an important right to health indicator, epitomising the core obligation of States to provide essential medicines. Data for this indicator was scarce and, in some cases, of questionable quality. Nevertheless, this indicator should be retained in future research, and possibly complemented with a sub-indicator of equity that disaggregates government spending by wealth quintile.

The availability of a basket of essential medicines in the public and private sectors (indicators 5 and 6) are robust indicators that yield an accurate snapshot of patient-level access in the facilities surveyed. Although it is the primary indicator for access to medicines in MDG 8 and SDG 3, data collected using the standardised WHO/HAI facility survey methodology is meagre (5,8). In order to retain these indicators, coordinated efforts are needed to enhance their measurement and reporting in future research.

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National child immunisation rates (indicators 7 and 8) are clear and reliable measures of equitable access to the DTP3 and measles vaccines, which are widely reported by many governments. Further disaggregation by sex, gender, ethnicity, education, place of residence, and wealth quintile can help identify and target pockets of low coverage. Once most countries meet coverage threshold required to eradicate these diseases, future indicators should include immunisation rates for other priority diseases.

Strengths and limitations

Our online data sources are standardised and reliable, yet the quality and quantity of available data restrict the generalisability of our study. Limited country data was available for certain indicators (i.e. medicines availability) and for certain economic categories. We observed that the National Health Accounts (NHA) irregularly reports pharmaceutical spending and seldom at a level of specificity that enables cross-national comparison; therefore, we excluded NHA data from this report (33). Our other secondary data sources are susceptible to collection or reporting flaws, yet they remain the most authoritative in the field. We also report data from more countries than the 2008 report as a result of more online repositories and our deeper search strategy. Our methods (in Web appendix 1) are in as far as possible consistent with those of the 2008 report, to allow for a valid historical comparison and to facilitate follow-up monitoring.

Conclusion

Right to health indicators are an essential part of a human rights approach that holds governments accountable for designing equitable and efficient health systems in which individuals can enjoy the full range of their health rights. We conclude that these eight indicators have been useful and feasible, but also that they can be further strengthened and expanded. Inspired by the words of former WHO Director-General Dr. Margaret Chan, “What gets measured gets done”, future monitoring exercises should use these indicators not only as a screening tool but also as a guide for action for national governments to ensure universal access to essential medicines as part of the right to health. WHO should sustain its recent efforts to systematically collect and publish Member States’ NMPs, EMLs, and NHA, as well as regularly update the WHO Pharmaceutical Country Profiles and support national surveys of medicines availability. To aid routine reporting, WHO should establish an independent accountability mechanism based on these eight access to medicines indicators. These indicators could be complemented by the larger set of 24 indicators presented by the Lancet Commission on

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Essential Medicines Policies for a deeper analysis. Particularly in low and middle income countries data collection should be improved with the assistance of the international community to measure progress over time and ultimately hold governments accountable for delivering on their human rights obligations.

Acknowledgements: We thank Dr.

Marg Ewen, Dr. Tialda Hoekstra, Prof. Brigit Toebes, and Mr. Aäron Blomme.

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Table 1.Eightrightto health indicators ofaccess to medicines. Type of

indicator Right indito catorhealth Human principlrightse WHO measurepolicy Globaltarget

St ru ct ur al 1.Constitutional commitmentto medicines

Legalobligation to realise health rights The recognition of access to medicines in constitutional law Medicines recognised in national constitutions (23) 2.National

medicines policy

Duty to adopta nationalhealth

plan Adopta national medicines policy National medicines policy

is adopted (34) Pr oc es s 3.National essential medicines list Duty to adopt appropriate administrative measures to a maximum ofits available resources. (Assured) quality ofhealth

services (ofthe AAAQ) Adopta national essential medicines list National essential medicines listis adopted (23) 4.Government spending on pharmaceuticals Financial accessibility of health services (ofthe AAAQ) Government per capita spending on medicines US$ 12.90-25.40 per capita per

year (16) O ut co m e 5.Essential medicines availability in the public sector 6.Essential medicines availability in the private sector Availability of health services (ofthe AAAQ) The availability of a basketof essential medicines in the public and private sectors 80% average national availability in both sectors (23)

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Ac cess t o medicines in 195 c oun tr ies: A human r igh ts appr oach t o sustainable dev elopmen t O ut co m e

7.Nationalchild immunisation rate for measles 8.Nationalchild immunisation rate for the third dose ofDTP Duty towards non-discrimination and attention to the vulnerable National childhood immunisation rates for measles and diphtheria, tetanus,and pertussis (DTP) 95% coverage with a measl es-containing vaccine to eradicate disease

(35) 90% coverage of

3 doses ofDTP vaccine to eradicate disease

(23,35) Abbreviations used in this table:AAAQ=Availability,Accessibility,Acceptability, and Quality as elements ofhealth services under the rightto health.

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Ac cess t o medicines in 195 c oun tr ies: A human r igh ts appr oach t o sustainable dev elopmen t O ut co m e

7.Nationalchild immunisation rate for measles 8.Nationalchild immunisation rate for the third dose ofDTP Duty towards non-discrimination and attention to the vulnerable National childhood immunisation rates for measles and diphtheria, tetanus,and pertussis (DTP) 95% coverage with a measl es-containing vaccine to eradicate disease

(35) 90% coverage of

3 doses ofDTP vaccine to eradicate disease

(23,35) Abbreviations used in this table:AAAQ=Availability,Accessibility,Acceptability, and Quality as elements ofhealth services under the rightto health.

Table 2.Public pharmaceuticalexpenditure by income economy.

Income

economy Number countriesof Mediin varian ous spendiyearsng before 2008 (IQR)

Median spending in various years after 2008 (IQR) p value Low 6 $0.40 ($0.13-3.01) ($0.$1.34-3.40 27) 0.345 Lower-middle 8 ($1.$4.89-7.01 49) ($2.$4.20-12.65 30) 0.674 Upper-middle 3 $44.(-)38* $15.(-)70* 0.285 High 27 $300.61 ($259.46-398.91) ($221.$316.09-437.64 43) 0.848 Data is for 44 paired countries with data before and after 2008.Allvalues are adj us-ted for inflation using 2015 as the reference year.

*Peru 2004:$2.27/capita,2009:$15.70/capita;Tunisia 2006:$51.81/capita, 2010:$30.78/capita;Seychelles 2006:$44.38/capita,2009:$2.92/capita

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Ac cess t o medicines in 195 c oun tr ies: A human r igh ts appr oach t o sustainable dev elopmen t Ta bl e 3. M ed ic in es a va ila bi lit y in 1 0 co un tr ie s in v ar io us y ea rs b ef or e an d af te r 2 00 8. Co un tr y Se ct or N me di ci ne s in su rv ey Da te o f fi rs t su rv ey Me di an av ai la bi lit y in fi rs t su rv ey (% ) IQ R (% ) Da te o f se co nd su rv ey Me di an av ai lab ili ty in se co nd su rv ey (% ) IQ R (% ) p va lu e Su da n pu bl ic 21 2006 63. 2 28. 3-78. 1 2013 80. 0 67. 15 -92. 9 0. 001 Su da n pr iv at e 19 2006 77. 2 72. 1-87. 7 2013 94. 4 80. 6-97. 2 0, 006 Ug an da pu bl ic 26 2004 45. 0 13. 8-71. 3 2015 65. 0 36. 3-75. 6 0, 077 Ug an da pr iv at e 25 2004 85. 0 78. 8-95. 0 2015 68. 2 59. 1-77. 3 0, 000 Ta nz an ia pu bl ic 28 2004 36. 0 16. 4-75. 8 2015 37. 8 29. 7-66. 3 0, 509 Ta nz an ia pr iv at e 28 2004 55. 3 44. 3-82. 8 2015 57. 0 45. 1-82. 6 0, 936 Le ba no n pu bl ic 15 2004 5. 0 0. 0-10. 0 2013 70. 0 53. 3-86. 7 0, 001 Le ba no n pr iv at e 16 2004 96. 3 82. 5-97. 5 2013 96, 7 87. 5-100. 0 0. 074 In do ne sia pu bl ic 25 2004 60. 0 33. 3-76. 7 2010 69. 0 18. 1-90. 5 0, 661 In do ne sia pr iv at e 24 2004 74. 1 44. 8-89. 3 2010 60. 2 11. 3-84. 4 0, 006 Mo ng ol ia pu bl ic 23 2004 100. 0 50. 0-100. 0 2012 58. 1 25. 8-71. 0 0, 002 Mo ng ol ia pr iv at e 23 2004 80. 0 32. 0-96. 0 2012 94. 3 60. 0-97. 1 0, 042 Ta jik ist an pu bl ic 29 2005 70. 0 27. 5-87. 5 2012 96. 6 79. 3-100. 0 0, 000

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Ac cess t o medicines in 195 c oun tr ies: A human r igh ts appr oach t o sustainable dev elopmen t Ta jik ist an pr iv at e 30 2005 85. 0 42. 5-91. 3 2012 96. 6 79. 3-100. 0 0, 000 Ir an pu bl ic 26 2007 100. 0 93. 3-100. 0 2014 86. 7 80. 0-90. 0 0, 000 Ir an pr iv at e 26 2007 96. 7 95. 8-100. 0 2014 96. 7 93. 3-100. 0 0, 979 Ky rg yz sta n pu bl ic -Ky rg yz sta n pr iv at e 20 2005 83. 4 53. 3-95. 9 2015 88. 6 58. 6-97. 1 0, 444 Et hi op ia pu bl ic 11 2004 79. 4 50. 0-91. 2 2013 76. 5 55. 9-82. 4 0, 919 Et hi op ia pr iv at e 11 2004 96. 0 80. 0-100. 0 2013 80. 0 63. 3-96. 7 0, 052 Da ta is p ai re d an d so ur ce d fro m n at io na l p ric e a nd av ai la bi lit y su rv ey s. Ab br ev ia tio ns u se d in th is ta bl e: IQ R, In te rq ua rt ile ra ng e.

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Ac cess t o medicines in 195 c oun tr ies: A human r igh ts appr oach t o sustainable dev elopmen t Figur e 1: A doption of na tional medicines p olicies , 2008-2015.

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Ac cess t o medicines in 195 c oun tr ies: A human r igh ts appr oach t o sustainable dev elopmen t Nu mb er of co un tri es w ith a n E ML Figur e 2: A doption of na tional essen

tial medicines lists and r

eimbursemen

t lists

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Ac cess t o medicines in 195 c oun tr ies: A human r igh ts appr oach t o sustainable dev elopmen t Lo w in co m e Lo w er -m id dl e in co m e U pp er -m id dl e in co m e Figur e 3: M edian na tional a vailabilit y of selec ted lo w est-pric

ed generics in the public sec

tor of 9 c oun tries in v arious y ears b ef or e and af ter 2008. Ab br ev ia tio ns u se d in t hi s fi gur e: E TH=E thio pi a. IND=I ndo nesi a. IRN=I ra n. LB N=L eb an on. M O N=M on go lia. S UD=S ud an. TJK=T aji ki sta n. TZ A=T anza ni a. UGA=U ga nd a

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Ac cess t o medicines in 195 c oun tr ies: A human r igh ts appr oach t o sustainable dev elopmen t Ab br ev ia tio ns u se d in t hi s fi gur e: E TH=E thio pi a. IND=I ndo nesi a. IRN=I ra n. K GZ=K yr gyzs ta n. LB N=L eb an on. M O N=M on go lia. SUD=S ud an. TJK=T aji ki sta n. TZ A=T anza ni a. UGA=U ga nd a. Figur e 4: M edian na tional a vailabilit y of selec ted lo w est-pric

ed generics in the priv

at e sec tor in 10 c oun -tries in v arious y ears b ef or e and af ter 2008.

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Ac cess t o medicines in 195 c oun tr ies: A human r igh ts appr oach t o sustainable dev elopmen t p = 0 .0 3 5 Figur e 5: M easles immunisa tion r at es in 114 c oun tries , 2008-2015.

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Ac cess t o medicines in 195 c oun tr ies: A human r igh ts appr oach t o sustainable dev elopmen t p = 0 .0 0 0 p = 0 .0 1 2 Figur e 6: D TP3 immunisa tion r at es r ep or ted in 82 na tional sur ve ys in v arious y ears b ef or e and af ter 2008.

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Ac cess t o medicines in 195 c oun tr ies: A human r igh ts appr oach t o sustainable dev elopmen t References

1. WHO Expert Committee on the Selection and Use of Essential Medicines. The selection and use of essential medicines [Internet]. WHO Technical Report Series No.: 914. Geneva: World Health Organization; 2003 [cited 2018 May 18]. Available from: http://apps.who.int/medicinedocs/en/d/Js4875e/ 2. Office of the High Commissioner for Human Rights. Human rights

indicators: a guide to measurement and implementation [Internet]. Geneva: United Nations; 2012 [cited 2018 May 18]. Document No.: HR/PUB/12/5. Available from: http://www.ohchr.org/Documents/Publications/Human_ rights_indicators_en.pdf

3. Backman G, Hunt P, Khosla R, Jaramillo-Strouss C, Fikre BM, Rumble C, et al. Health systems and the right to health: an assessment of 194 countries [Internet]. Lancet. 2008 [cited 2018 May 23];372(9655):2047–85. Available from: https://doi.org/10.1016/S0140-6736(08)61781-X

4. World Health Organization. Development of country profiles and monitoring of the pharmaceutical situation in countries [Internet]. 2015 [cited 2018 May 18]. Available from: http://www.who.int/medicines/areas/ coordination/coordination_assessment/en/

5. United Nations. The Millennium Development Goals report 2015 [Internet]. New York: United Nations; 2015 [cited 2018 May 18]. Available from: http:// www.un.org/millenniumgoals/2015_MDG_Report/pdf/MDG 2015 rev (July 1).pdf

6. Gotham D, Onarheim KH, Barber MJ. How the MDGs gave up on

measuring access to medicines. Lancet Glob Heal [Internet]. 2016 May [cited 2018 May 18];4(5):e296–7. Available from: http://www.ncbi.nlm.nih.gov/ pubmed/27102189

7. UN General Assembly. Transforming our world: the 2030 Agenda for Sustainable Development [Internet]. 2015 [cited 2018 May 24]. Adopted in Resolution No.: A/RES/70/1. Available from: http://www.un.org/e

8. World Health Organization, World Bank. Tracking universal health coverage: 2017 global monitoring report [Internet]. Geneva: World Health Organization and the International Bank for Reconstruction and Development / The World Bank; 2017 [cited 2018 May 18]. 69 p. Available from: http://pubdocs.worldbank.org/en/193371513169798347/2017-global-monitoring-report.pdf

9. UN General Assembly. International Covenant on Economic, Social and Cultural Rights [Internet]. 1966 [cited 2018 May 23]. Adopted in Resolution No. 2200A (XXI). Available from: http://www.ohchr.org/EN/ ProfessionalInterest/Pages/CESCR.aspx

10. UN Committee on Economic, Social and Cultural Rights. General Comment No. 14 on the Right to the Highest Attainable Standard of Health [Internet]. 2000 [cited 2018 May 23]. Document No.: E/C.12/2000/4. Available from: http://tbinternet.ohchr.org/_layouts/treatybodyexternal/Download. aspx?symbolno=E%2fC.12%2f2000%2f4&Lang=en

(28)

4.1

11. Perehudoff K. Web appendix 1 for the project ‘Access to medicines in 195 countries’: description of the methods to retrieve, select, and calculate each indicator [Internet]. 2018 [cited 2018 May 18]. 12 p. Available from: https:// figshare.com/s/cdae072cb238b9ed4438

12. Constitute [Internet]. No date [cited 2018 May 18]. Available from: https:// www.constituteproject.org/content/about?lang=en

13. World Health Organization. Essential medicines and health products information portal [Internet]. No date [cited 2018 May 18]. Available from: http://apps.who.int/medicinedocs/en/

14. Health Action International. Medicine prices, availability, affordability & price components [online database] [Internet]. No date [cited 2018 May 18]. Available from: http://www.haiweb.org/medicine prices/

15. World Health Organization, UNICEF. WHO UNICEF coverage of DTP3 [online database] [Internet]. 2017 [cited 2018 May 18]. Available from: http://apps.who.int/immunization_monitoring/globalsummary/timeseries/ tswucoveragedtp3.html

16. Wirtz VJ, Hogerzeil H V, Gray AL, Bigdeli M, De Joncheere CP, Ewen MA, et al. Essential medicines for universal health coverage. Lancet [Internet]. 2016 Nov 7 [cited 2018 May 18];1-74. Available from: http://dx.doi.org/10.1016/ S0140-6736(16)31599-9

17. Perehudoff K. Web appendix 2 for the project ‘Access to medicines in 195 countries’: Meta data for 8 indicators of access to medicines in 195 health systems [Internet]. 2018 [cited 2018 May 22]. Available from: https://figshare. com/s/8cda5bd90602faa5ac9e

18. Kaplan WA, Ritz LS, Vitello M, Wirtz VJ. Policies to promote use of generic medicines in low and middle income countries: A review of published literature, 2000–2010. Health Policy (New York) [Internet]. 2012 Aug [cited 2018 May 18];106(3):211–24. Available from: http://www.ncbi.nlm.nih.gov/ pubmed/22694970

19. Gray AL, Suleman F. The relevance of systematic reviews on pharmaceutical policy to low- and middle-income countries. Int J Clin Pharm [Internet]. 2015 Oct 17 [cited 2018 May 18];37(5):717–25. Available from: http://www. ncbi.nlm.nih.gov/pubmed/26177819

20. Faden L, Vialle-Valentin C, Ross-Degnan D, Wagner A. The role of health insurance in the cost-effective use of medicines [Internet]. WHO/Health Action International Review series on pharmaceutical pricing policies and interventions, Report No.: 2. Amsterdam: Health Action International; 2011 [cited 2018 May 18]. Available from: http://haiweb.org/wp-content/ uploads/2015/08/Health-insurance-final-May2011a1.pdf

21. Yamin AE, Parra-Vera O. How do courts set health policy? The case of the Colombian Constitutional Court. PLoS Med [Internet]. 2009 Feb 17 [cited 2018 May 18];6(2):e1000032. Available from: http://dx.plos.org/10.1371/ journal.pmed.1000032

22. Flood C, Gross A. Litigating the right to health: what can we learn from a comparative law and health care systems approach. Health Hum Rights [Internet]. 2014 Dec [cited 2018 May 18];16(2):E62-72. Available from:

(29)

4.1

Ac cess t o medicines in 195 c oun tr ies: A human r igh ts appr oach t o sustainable dev elopmen t https://cdn2.sph.harvard.edu/wp-content/uploads/sites/125/2014/12/Flood-final.pdf

23. World Health Organization. Medium Term Strategic Plan 2008-2013 [Internet]. Geneva: World Health Organization; 2008 [cited 2018 May 18]. 113 p. Available from: http://apps.who.int/gb/ebwha/pdf_files/MTSP-08-13-PPB-10-11/mtsp-3en.pdf

24. Gray AL, Wirtz VJ, ’t Hoen EFM, Reich MR, Hogerzeil HV. Essential medicines are still essential. Lancet [Internet]. 2015 Oct 24 [cited 2018 May 18];386(10004):1601–3. Available from: http://linkinghub.elsevier.com/ retrieve/pii/S0140673615005140

25. Leopold C, Mantel-Teeuwisse AK, Vogler S, Valkova S, de Joncheere K, Leufkens HG, et al. Effect of the economic recession on pharmaceutical policy and medicine sales in eight European countries. Bull World Health Organ [Internet]. 2014 Aug 1 [cited 2018 May 18];92(9):630–640D. Available from: http://www.ncbi.nlm.nih.gov/pubmed/25378754

26. Vogler S, Zimmermann N, Leopold C, de Joncheere K. Pharmaceutical policies in European countries in response to the global financial crisis [Internet]. South Med Rev. 2011 [cited 2018 June 8];4(2):69-79. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3471176/pdf/smr-04-069.pdf

27. Chahed MK, Arfa C. Monitoring and evaluating progress towards universal health coverage in Tunisia. PLoS Med [Internet]. 2014 Sep 22 [cited 2018 May 18];11(9):e1001729. Available from: http://dx.plos.org/10.1371/journal. pmed.1001729

28. Ewen M, Zweekhorst M, Regeer B, Laing R. Baseline assessment of WHO’s target for both availability and affordability of essential medicines to treat non-communicable diseases. PLoS One [Internet]. 2017 Feb 7 [cited 2018 May 18];12(2):e0171284. Available from: http://dx.plos.org/10.1371/journal. pone.0171284

29. Ghiasi G, Rashidian A, Kebriaeezadeh A, Salamzadeh J. The impact of the sanctions made against Iran on availability to asthma medicines in Tehran. Iran J Pharm Res [Internet]. 2016 [cited 2018 May 18];15(3):567–71. Available from: http://www.ncbi.nlm.nih.gov/pubmed/27980593

30. Kheirandish M, Rashidian A, Bigdeli M. A news media analysis of economic sanction effects on access to medicine in Iran. J Res Pharm Pract [Internet]. 2015 [cited 2018 May 18];4(4):199–205. Available from: http://www.ncbi. nlm.nih.gov/pubmed/26645026

31. Hosseinpoor AR, Bergen N, Schlotheuber A, Gacic-Dobo M, Hansen PM, Senouci K, et al. State of inequality in diphtheria-tetanus-pertussis immunisation coverage in low-income and middle-income countries: a multi country study of household health surveys. Lancet Glob Heal [Internet]. 2016 Sep [cited 2018 May 18];4(9):e617–26. Available from: http://www.ncbi. nlm.nih.gov/pubmed/27497954

32. Perehudoff SK, Toebes B, Hogerzeil HV. A human rights-based approach to the reimbursement of expensive medicines. Bull World Health Organ [Internet]. 2016 Dec 1 [cited 2018 May 18];94(12):935–6. Available from:

(30)

4.1

Ac cess t o medicines in 195 c oun tr ies: A human r igh ts appr oach t o sustainable dev elopmen t http://www.ncbi.nlm.nih.gov/pubmed/27994287

33. Bui AL, Lavado RF, Johnson EK, Brooks BP, Freeman MK, Graves CM, et al. National health accounts data from 1996 to 2010: a systematic review. Bull World Health Organ [Internet]. 2015 Aug 1 [cited 2018 May 18];93(8):566–576D. Available from: http://www.who.int/entity/bulletin/ volumes/93/8/14-145235.pdf

34. Hodgkin C, Carandang ED, Fresle DA, Hogerzeil HV, editors. How to develop and implement a national drug policy [Internet]. Second edition. Geneva: World Health Organization; 2001 [cited 2018 May 18]. Available from: http://apps.who.int/iris/bitstream/handle/10665/42423/924154547X. pdf?sequence=1

35. Strategic Advisory Group of Experts on Immunization. Assessment report of the global vaccine action plan [Internet]. Geneva: World Health Organization; 2014 [cited 2018 May 18]. 34 p. Available from: http://www. who.int/immunization/global_vaccine_action_plan/SAGE_DoV_GVAP_ Assessment_report_2014_English.pdf?ua=1

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