Barriers to universal access

Most studies frame medicines as a single ‘input’ or commodity to be supplied in the health system. [3] This view leads to fragmented policies and interventions that fail to address the system-wide constraints (such as health care financing and medicine pricing) and consequently, have a limited effect on medicines access for vulnerable groups. [3] Moreover, public policy in many countries does not consistently recognise essential medicines as essential public goods, nor is medicines accessibility seen as part of the progressive realisation of the right to health. [10] This failure, among others, may be linked to stagnating public financing for medicines, insufficient financial protection for patients, high medicines prices, and a general indifference towards medicines inequities. [3,6,7,11,12] In response to these challenges, WHO promotes its policies for essential medicines and health systems as tools to design and assess comprehensive national strategies to achieve equitable and sustainable access to medicines. [2,4,13,14]

Public health policies and practices have changed since the turn of the century, which put much more emphasis on human rights and promoting universal health coverage (UHC). We therefore assert that greater coherence is now 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 also create a supportive environment for medicines affordability and financing for vulnerable groups.

The right to health emanates from international treaties, most notably the 1966 International Covenant on Economic, Social, and Cultural Rights (ICESCR), which is ratified by 165 States. [15] These governments therefore bear the irrevocable duty to protect and promote the right to health. 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. [16] Given that a NMP is a country-wide strategy for the pharmaceutical sector for the provision of essential medicines, State parties can be understood as having a legal obligation to establish and implement a NMP or similar policy. 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.

Gaps in existing evidence

Despite the breadth of WHO’s 2001 guidelines, little evidence exists about integrating essential medicines components and right to health commitments in existing NMPs. [4] The largest cross-national comparison of NMPs examines their effectiveness and uptake in 64 mostly LMICs, using national indicators for quality use of medicines. [8] Other analyses are single-country or regional studies comparing NMPs against WHO’s essential medicines policies without large-scale cross-national comparisons. [17–19] No earlier studies have assessed the presence of right to health principles in NMPs.

An updated online repository of NMPs has only recently been established. NMPs are generally published in English or the national language, and were only available in hard copy or on local websites. Earlier policy studies therefore mostly relied on governments’ self-reports in the WHO Pharmaceutical Sector questionnaire of having a NMP or of its contents with binary (yes/no) answers. [8,18] In 2016 the Lancet Commission on Essential Medicines Policies undertook a first global search for all NMPs and later made them available to the WHO Essential Medicines Portal, which now provides easy access to these primary sources. [6]

Our article presents a first cross-national content analysis of essential medicines and right to health principles for access to medicines in 71 NMPs. Our comparison of NMPs also identifies some examples of strong text in support of universal access to medicines. These examples can inform policy makers who are developing and revising NMPs in the era of UHC and a strengthened right to health.

Data collection

Between January to October 2015 we conducted a systematic search of all NMPs mentioned in academic literature, published in online repositories and on government websites, and further expanded through a global call through the E-DRUG online network and targeted individual approaches. We included one official NMP per country. We excluded draft, incomplete, and unclear medicine policy documents, policies addressing a specific component (i.e. intellectual property management), and documents in other languages besides English, Dutch, French, or Spanish. This method, previously reported in Wirtz et al., yielded 67 full text NMPs, which were deposited in WHO’s online Essential Medicines and Health Products Information Portal (publicly accessible here: http://apps.who.int/medicinedocs/en/). [5] Between January 2017 to March 2018 we were able to identify 13 additional full text NMPs that met the inclusion criteria.

We recorded the year of the country’s most recent official NMP and its World Bank income category in the year of publication.

Policy checklist

To analyse and assess the content of the NMPs, we developed a policy checklist by extracting the relevant principles for medicines affordability and financing from WHO’s policies for essential medicines, and from international human rights law. [2,4,13,16,20–22] These human rights documents were chosen because they list the provision of essential medicines as a core obligation or elaborate on the nature of State duties.

The policy checklist identifies 12 specific attributes of policy text for access to medicines and rates their strength on a 3-point scale (see Table 1). We (SKP, NVA) identified the 12 principles by first selecting a short list of concepts related to medicines affordability and financing from the above documents. We categorised the 12 principles into three domains (see Table 1 and the online S1 Appendix for a full description of the domains and principles): legal rights and obligations (i.e. government’s commitments and duties), good governance (i.e. governance principles and processes), and technical implementation (i.e. policy measures to achieve government objectives). The domains correspond to the structure-process-outcome framework for monitoring and evaluating the realisation of human rights. [23]

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Table 1. Policy checklist for access to medicines in NMPs.

https://doi.org/10.1371/journal.pone.0215577.t001

We calculated the reliability of NMP text selection by two coders using Cohen’s Kappa. SKP and NVA each independently coded six randomly selected countries (approx. 8% of the sample countries: Botswana, Ethiopia, Fiji, Malawi, Oman, Timor-Leste). We extracted the same NMP texts in 75.7% of cases with a Cohen’s K = 0.695, which indicates that 69.5% of similarities between coders were not due to chance (0.61<Cohen’s K<0.8 suggests ‘substantial’ agreement).

Data analysis

Given the substantial agreement between coders, we (SKP, NVA) worked with one half of the NMPs each to extract the relevant text (through keyword and manual search) and coded the strength of each principle in the NMPs on a three-point coding matrix (i.e. strong, weak, or absent text, defined in the online S1 Appendix). Generally, strong text includes a clear State commitment to a principle and an action (i.e. to adhere to the concept of essential medicines and introduce a national selection committee) and where possible related to medicines affordability and financing. Weak text includes vague commitments. All text selections and codes were independently reviewed (by both SKP and NVA) who discussed any inconsistencies and jointly agreed on the final codes. 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. Therefore we divided NMPs between those adopted in or before 2003 (n = 32) and those adopted in or after 2004 (n = 39). Associations were determined in SPSS version 25 using Pearson’s Chi-squared statistic with significance set at p<0.05.

12 principles for access to medicines in NMPs

Historical trends

Our findings suggest that some aspects of WHO’s 2001 guidelines were instructive and impactful on national pharmaceutical policy processes. Strong principles introduced in WHO’s 2001 guidelines are significantly more frequent in NMPs adopted in 2004 or later (i.e. an individual right to health, measures for cost-effective spending, and financial protection of vulnerable groups). Transparency is also significantly more common (although not always in relation to medicines affordability and financing) in NMPs adopted after 2003. Some important principles in WHO’s 2001 guidelines, such as measures to pool user contributions and to seek international cooperation, have rarely been taken up by any country. We cannot draw firm conclusions about the causal relation between WHO’s 2001 guidelines on NMP content, and subsequent national policies. We examined only the most recent NMP per country and cannot discount the possibility that certain countries already embraced the 12 principles in previous NMPs. Paired examples are rare: even our most up-to-date collection of all available NMPs only has the full text of NMPs before and after 2004 from four countries (Afghanistan, Colombia, Kenya, Uganda). The example of Kenya shows that legal rights or obligations appear in its 2008 NMP and not in its 1994 NMP. Conversely, both of Colombia’s 2003 and 2012 NMPs advocate for medicines as social goods, articulate health as a fundamental right, and promote measures to control medicines pricing.

Implications for national pharmaceutical policy

Our basic hypothesis is that a NMP that explicitly identifies our 12 policy measures has the potential to address inequitable access to essential medicines by refocusing government policy and programmes on the medicines needs of the most vulnerable populations. Evaluating this hypothesis is difficult because few studies have examined the impacts of NMP provisions on medicines financing and affordability impacts on vulnerable populations. It is important to keep in mind that measuring the impact of a national policy is methodologically difficult as a control group is never possible. The next best methods are longitudinal time-series analyses, and observational studies which are often only post-intervention; but these methods do not allow for a reliable assessment of policy impact or causality. [24] One cross-sectional study of 64 NMPs by Holloway et al. identified a significant association between having a NMP (regardless of its content) and the provision of free medicines, a supply-side measure. [8] In another example, Colombia’s 2012–2021 National Pharmaceutical Policy promotes efficient spending on medicines through external reference pricing (among other measures), which was indeed implemented in 2013. [25,26] An impact study of the best selling 90 medicines suggests that this external reference pricing policy achieved a decrease in prices between 2011–2015, although sales and spending increased in the same period. [26] It is very likely that the external reference pricing system had an impact on the government’s capacity to finance medicines for vulnerable groups, but the causal relation cannot be proven.

Public financing and affordability of essential medicines for vulnerable groups has only been framed as a right in WHO’s NMP guidelines of 2001. Framing in health policy is gaining increasing attention as a means to reorient public health debates, the perception of problems, and their plausible solutions. [27] In our study, framing medicines as part of the right to health moves the debate away from which patients can afford health commodities, towards the question of how governments can provide basic essential goods to everyone, based on the common respect for the human dignity of all people. Human rights framing also implies certain obligations, such as the minimum core obligation of governments to provide essential medicines to those who can not provide for themselves. [16] Finally, a rights-based lens implies a certain set of principles towards achieving universal access to essential medicines, such as non-discrimination in medicines provision, maximising available government resources, seeking international assistance and cooperation, and selecting low-cost/most efficient policy options. [28] An example of human rights framing is found in the Philippines’ constitution, its 2011–2016 NMP, and national legislation for medicines. These documents all affirm the government’s duty to “make essential goods, health, and other social services available to all people at an affordable cost,” and guide national health insurance programmes for access to medicines. [29–31] Indeed, the 2011–2016 Philippine NMP and related national legislation for universal health coverage promotes government financing for essential medicines, efficient spending on medicines through cost-effectiveness measures, and guaranteed financial protection for vulnerable groups to access medicines. [10] Unfortunately, little data is available to concretely assess the ultimate impact of these measures on patient affordability and access.

The debate around indication-based pricing (i.e. different prices for different indications of the same medicine) is ongoing. From the human rights perspective, it is important that governments ensure medicines prices do not preclude access to essential medicines for patients. As with all governmental pricing policies, States should regularly monitor, evaluate, and report on the level of patient access, and remedy barriers when they occur.

We suggest that the innovative ideas and example texts identified in this article (Table 3 and online S2 Appendix) may form the basis of a balanced commitment to medicines affordability and financing in NMPs. We recommend that NMPs should address each of the 12 principles to find the right balance between the government’s duties as the primary funder of public sector pharmaceuticals, as the coordinator of all revenues (including user contributions and international funding), and as the steward of medicines selection, procurement and pricing.

Implications for WHO policy

Updating WHO’s 2001 guidelines on NMPs and aligning them with WHO’s latest policies on essential medicines and human rights law will raise Member States’ awareness of the importance of human rights, their legal obligations, and the available policy measures to implement these duties in practice. Moreover, official WHO guidance on how to address UHC and embed the right to health in NMP text, with specific examples, can support ongoing national reforms or trigger other initiatives for universal access to essential medicines. Ultimately, enhanced legal commitments and political can catalyse inclusive progress towards universal access to essential medicines and the SDG for health.

How should WHO’s guidelines be revised? We recommend that WHO’s updated NMP guidelines should address critical gaps by explicitly referencing the State duty to provide essential medicines to those who need them, the participation of beneficiaries in medicines policy, and the creation of (non-judicial) accountability and redress mechanisms. If appropriately implemented, enhanced accountability and redress mechanisms, such as easy-to-access complaint and grievance procedures for patients, have the potential to swiftly remove access barriers. [32]

These mechanisms could also help stem the wave of spurious human-rights based litigation rising in some Latin American countries where many court cases claim access to publicly-funded, high-priced medicines using the misguided argument that the right to health entails immediate access to any treatment regardless of its price. [33–36] In previous work the authors have identified trends in UHC legislation for access to medicines. [10] We suggest that these same strategies could be embedded in NMPs to avoid deleterious medicine litigation; these trends are: articulating clear patient rights to access medicines proven to be cost-effective, and ensuring efficient and effective complaints procedures.

Implications for research

Future research should investigate whether and how the commitments in NMPs are implemented in government practice. More investigation is also needed to determine the effectiveness of rights-based medicines policies at improving medicines affordability and equitable access for patients, and what the practical facilitators and barriers to implementation are.

Strengths and limitations

Although our NMPs are sourced from the most comprehensive collection to date, our sample has more NMPs published before 2004, and from low-income countries. Retrieving few full-text NMPs from higher-income countries may be caused by governments self-reporting ‘yes’ in the WHO Pharmaceutical Sector questionnaire despite not having an official NMP (i.e. Mexico) or having a medicine law which functions as a NMP (i.e. Morocco). In some cases the full text of an official NMP was neither retrievable online nor through crowdsourcing in the E-drug network or targeted individual approaches.

We mitigated the risk of overlooking relevant policy content in our analysis by working with researchers fluent in the original language of the NMP and trained on the structure, standard terminology, and definitions used in the WHO guidelines and our checklist.