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Competing Interests: Competing interests: We have read and understood BMJ policy on declaration of interests and have the following interests to declare: ALG is currently a member of the South African National Essential Medicines List Committee and previously served on the WHO Expert Committee on the Selection and Use of Essential Medicines.

Background and Objectives: The World Health Organization Model List of Essential Medicines has led to at least 137 national lists. Essential medicines should be grounded in evidence-based guideline recommendations and explicit decision criteria. Essential medicines should be available, accessible, affordable, and the supporting evidence should be accompanied by a rating of the certainty one can place in it. Our objectives were to identify criteria and considerations that should be addressed in moving from a guideline recommendation regarding a medicine to the decision of whether to add, maintain, or remove a medicine from an essential medicines list. We also seek to explore opportunities to improve organizational processes to support evidence-based health decision-making more broadly., Methods: We conducted a qualitative study with semistructured interviews of key informant stakeholders in the development and use of guidelines and essential medicine lists (EMLs). We used an interpretive descriptive analysis approach and thematic analysis of interview transcripts in NVIVO v12., Results: We interviewed 16 key informants working at national and global levels across all WHO regions. We identified five themes: three descriptive/explanatory themes 1) EMLs and guidelines, the same, but different; 2) EMLs can drive price reductions and improve affordability and access; 3) Time lag and disconnect between guidelines and EMLs; and two prescriptive themes 4) An "evidence pipeline" could improve coordination between guidelines and EMLs; 5) Facilitating the link between the WHO Model List of Essential Medicines (WHO EML) and national EMLs could increase alignment., Conclusion: We found significant overlap and opportunities for alignment between guideline and essential medicine decision processes. This finding presents opportunities for guideline and EML developers to enhance strategies for collaboration. Future research should assess and evaluate these strategies in practice to support the shared goal of guidelines and EMLs: improvements in health., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Background: Access to cancer medicines is a core component of comprehensive cancer care; as such, it is included in Mexico's public health insurance: Seguro Popular de Salud (SPS). Learning about stakeholders' experiences on processes and barriers influencing access to essential cancer medicines within healthcare facilities allows identifying needed policies to improve access to cancer care., Objective: The aim of this study was to obtain the insights of health professionals in public hospitals in Mexico on how SPS influences access to cancer medicines regarding medicine selection, financing, and procurement and supply systems. The purpose is to identify policy areas that need strengthening to improve access to cancer medicines., Methods: Semi-structured interviews were conducted with 67 health professionals from 21 public hospitals accredited by SPS across Mexico. A framework analysis was used with categories of analysis derived from the World Health Organization's Access framework., Results: Most stakeholders reported that the availability of listed cancer medicines was sufficient. However, cancer specialists reported that medicines coverage by SPS was restrictive covering only basic cancer care. Public hospitals followed SPS treatment protocols in selecting and prescribing cancer medicines but used different procurement procedures. When essential cancer medicines were unavailable (not listed or stocked-out), hospitals reported several strategies such as prescribing alternative therapies, resorting to direct purchases, and assisting patients in obtaining medicines elsewhere. Other reported barriers to access to treatment were: distance to health facilities, poor insurance coverage, and financial restrictions., Conclusions: Health professionals have encountered benefits and challenges from the implementation of SPS influencing access to cancer medicines and care in Mexico, pointing to areas in which action is necessary. Finding the right balance between expanding the range and cost of cancer treatments covered by insurance and making basic cancer care available to all is a challenge faced by Mexico and other middle-income countries., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Background: More alternatives have become available for the diagnosis and treatment of cancer in low- and middle-income countries. Because of increasing demands, governments are now facing a problem of limited affordability and availability of essential cancer medicines. Yet, precise information about the access to these medicines is limited, and the methodology is not very well developed. We assessed the availability and affordability of essential cancer medicines in Mexico, and compared their prices against those in other countries of the region., Methods: We surveyed 21 public hospitals and 19 private pharmacies in 8 states of Mexico. Data were collected on the availability and prices of 49 essential cancer medicines. Prices were compared against those in Chile, Peru, Brazil, Colombia and PAHO's Strategic Fund., Results: Of the various medicines, mean availability in public and private sector outlets was 61.2 and 67.5%, respectively. In the public sector, medicines covered by the public health insurance "People's Health Insurance" were more available. Only seven (public sector) and five (private sector) out of the 49 medicines were considered affordable. Public sector procurement prices were 41% lower than in other countries of the region., Conclusions: The availability of essential cancer medicines, in the public and private sector, falls below World Health Organization's 80% target. The affordability remains suboptimal as well. A national health insurance scheme could serve as a mechanism to improve access to cancer medicines in the public sector. Comprehensive pricing policies are warranted to improve the affordability of cancer medicines in the private sector.

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., (© The Author 2019. Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

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., Competing Interests: The authors have declared that no competing interests exist.

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 eight indicators for access to medicines to serve as a reference point for progress towards SDG Target 3.8 on essential medicines. Data for these eight indicators in 2015 were collected and compared with the 2008 report. Between 2008 and 2015 we observed increased numbers of constitutions recognising access to medicines (7-13 countries), countries with a national medicine policy (118-122) and with a national list of essential medicines (78-107). 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%-70% n  = 9 countries) and private (84%-92% n  = 10) sectors. Median child immunisation rates remained constant for measles (around 90%) and improved for three doses of diphtheria-tetanus-pertussis (79%-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.

Background: The World Health Organization recommends establishing and implementing a national pharmaceutical policy (NPP) to guarantee effective and equitable access to medicines. Mexico has implemented several policy approaches to regulate the pharmaceutical sector, but it has no formal NPP. This article describes the approach that the Mexican government has taken to improve availability and affordability of essential medicines., Methods: Descriptive policy analysis of public pharmaceutical policy proposals and health action plans on the basis of publicly available data and health progress reports, with a focus on availability and affordability of medicines., Results: The government has implemented pooled procurement, price negotiations, and an information platform in the public sector to improve affordability and availability. The government mainly reports on the savings that these strategies have generated in the public expenditure but their full impact on availability and affordability has not been assessed., Conclusions: To increase availability and affordability of medicines in the public sector, the Mexican government has resorted on isolated strategies. In addition to efficient procurement, price negotiations and price information, other policy components and pricing interventions are needed. All these strategies should be included in a comprehensive NPP.

About nine million children die every year before they reach the age of 5 years, of conditions largely amendable with existing medicines. Lack of medicines is not the single most important health problem of children, but work to provide children with better access to appropriate medicines is essential for achievement of the child health goals set. Taking into consideration the global aspect in the development of paediatric medicines the benefits of the regional paediatric initiatives can be spread worldwide. This chapter provides insights in the challenges and opportunities of developing paediatric medicines for health needs of children in the developing world. The Essential Medicines List for children first made available in 2008 serves as an example of the many tools available from WHO to improve children's access to the medicines they need.

Most countries have acceded to at least one global or regional covenant or treaty confirming the right to health. After years of international discussions on human rights, many governments are now moving towards practical implementation of their commitments. A practical example may be of help to those governments who aim to translate their international treaty obligations into practice. WHO's Essential Medicines Programme is an example of how this transition from legal principles to practical implementation may be achieved. This programme has been consistent with human rights principles since its inception in the early 1980s, through its focus on equitable access to essential medicines. This paper provides a brief overview of what the international human rights instruments mention about access to essential medicines, and proposes five assessment questions and practical recommendations for governments. These recommendations cover the selection of essential medicines, participation in programme development, mechanisms for transparency and accountability, equitable access by vulnerable groups, and redress mechanisms.

A national drug policy addressing the safe and appropriate use of injections is an important element to prevent overuse and unsafe use of injections. Because the World Health Organization World Health Organization Model List of Essential Medicines is a keystone of national drug policies, the authors examined the way it addresses injection practices. They reviewed the 11th World Health Organization Model List of Essential Medicines to collect information on (1) injectable medicines, (2) diluents, and (3) the recommendations regarding the procurement of injection devices. Of 306 active ingredients on the list, 135 (44%) are mentioned in injectable form. Of these, 41 (30%) need diluents for reconstitution. The list does not mention the need to procure appropriate diluents, injection devices, and safety boxes in quantities that match the quantities of injectable medicines. In addition, the list provides limited information that can be used to forecast the needs of injection devices to administer the injectable medicines that are included in the list. Future revisions of the World Health Organization Model List of Essential Medicines should attempt to reduce the number of injectable formulations on the basis of evidence. In addition, the list should specify that when injectable medicines are being supplied, diluents, single-use syringes, and safety boxes should be supplied. The volume of syringes needed for administration should be specified for each injectable medication on the list to facilitate the forecasting of the needs of injection devices., (Copyright 2004 American College of Clinical Pharmacology)