Background: As part of the development of practice guidelines, developers need to systematically engage relevant interest-holder groups. The Reporting Items for practice Guidelines in HealThcare (RIGHT) checklist for reporting practice guidelines lacks detailed guidance on how to report the engagement process. Objective: To develop a standardized checklist for reporting interest-holder engagement in practice guidelines, named the RIGHT-MuSE checklist. Design: The development process followed the methods recommended by the Enhancing the QUAlity and Transparency Of health Research (EQUATOR) Network, as well as lessons learned from the development of the RIGHT statement and its extensions. Key steps included developing the protocol, registering the project, establishing a working group, conducting background work, generating an initial list of items, conducting a consensus survey, holding panel discussions, and creating the final RIGHT-MuSE checklist and an accompanying explanation and elaboration document. Setting: International collaboration. Participants: 25 panelists from various guideline development interest-holder groups. Measurements: Consensus agreement on checklist items. Results: The final RIGHT-MuSE checklist consists of 11 items covering the guidance used, methods of engagement, characteristics of interest-holders, evaluation of engagement, and management of conflicts of interest. The checklist is supplemented with a glossary of key terms and detailed explanations for each item to facilitate its use. Limitation: The RIGHT-MuSE checklist has not been evaluated in a broader context or widely applied in real-world guideline development processes. Conclusion: Guideline developers can use the RIGHT-MuSE checklist to comprehensively report on interest-holder engagement. Primary Funding Source: The Vincent and Lily Woo Foundation.

Developing transparent, evidence-based allocation strategies for essential medicines is especially critical in low- and middle-income countries, where affordability and equity challenges are most acute.

Background and Objectives Health guidelines play a central role in informing clinical practice, public health measures and health policy. But their trustworthiness may be undermined by factors such as insufficient methodological rigor, lack of transparency, conflicts of interest, and inconsistent application of established standards. Existing appraisal tools address selected aspects of guideline quality but do not comprehensively assess the trustworthiness of individual recommendations, nor do they adequately reflect recent advances in guideline methodology, including living guidelines, Grading of Recommendations, Assessment, Development, and Evaluation, adaptation, and the use of artificial intelligence (AI). This study aims to develop and validate Transparent, Rigorous, Useable, Standardized, and Trustworthy Guide (TRUSTGUIDES), a globally applicable, flexible set of tools to assess the trustworthiness of health guideline recommendations. We define trustworthiness as distinct from methodological quality: it encompasses not only rigorous methods but also transparency, independence, and applicability, which together determine whether a recommendation merits user confidence. Methods TRUSTGUIDES will be developed through a multistep, mixed-methods process. First, a scoping review and expert consultation will identify existing guideline appraisal tools and inform domains and items generation. Using deductive and inductive approaches, domains and items will be generated and may be refined through focus groups and selected through iterative Delphi surveys involving an international, multidisciplinary working group. TRUSTGUIDES will be validated by assessing internal consistency, inter-rater reliability, content validity, and construct validity, including comparisons with established instruments such as the Grading of Recommendations, Assessment, Development, and Evaluation certainty domains, AGREE II, and PANELVIEW. Psychometric properties will be examined using factor analysis and, as necessary, item response theory models. AI will be integrated both as an object of assessment and as methodological support for tool application, with large language models evaluated against a human reference standard. Conclusion TRUSTGUIDES will be designed to evaluate the trustworthiness of individual guideline recommendations across key factors, including transparency and credibility, and to address relevant domains such as the certainty of evidence, strength of recommendations, conflicts of interest, applicability, adaptability, currency, certification, and the appropriate use of AI. TRUSTGUIDES addresses critical gaps in current guideline appraisal by offering a comprehensive, recommendation-level assessment of trustworthiness aligned with the World Health Organization guideline standard methodology. By integrating AI, our tools will support efficient, transparent, and future-ready guideline evaluation within an evolving health evidence ecosystem.

BackgroundThe WHO Model List of Essential Medicines (EML) includes those medicines that offer the best health payback for individuals and health systems. It serves as a guide for countries to develop and update national EMLs. The implementation of essential medicines policies is therefore mostly oriented to medicines on the EML. However, medicines evaluated and not recommended for inclusion in the EML also have relevant implications for development of efficient medicine policies. This study analyzed the characteristics, frequencies, and reasons for applications for medicines proposed for inclusion in the WHO EML not being recommended.MethodsAssessment of the recommendations for all medicines proposed for inclusion in the WHO EML in reports of the Expert Committee on Selection and Use of Essential Medicines in the WHO Technical Reports Series from 2002 to 2023. We collected key information from EML applications including active substance, therapeutic indication, orphan status, applicant, and reasons for negative recommendations. Logistic univariate and multivariate regression analyses assessed predictive characteristics for applications with negative recommendations.ResultsA total of 359 applications for addition of new medicines to the EML were submitted: 211 (58.8%) received a positive recommendation. Among the 148 (41.2%) applications with a negative recommendation, the most prevalent reasons for not recommending were quality of clinical evidence (62.1%) and economic criteria (33.1%). Concerns about capacity to implement the new medicines in health care systems or requiring specialized expertise increased over time. Applications submitted by pharmaceutical companies, individuals not affiliated with scientific societies or non-governmental organizations, and academia were more prone to receiving a negative recommendation.DiscussionAn appreciable proportion of applications for addition of new medicines to the EML are not recommended. Over time, low or limited quality of clinical evidence was a consistent explanatory reason leading to non-recommending. Economic considerations and feasibility are emerging justifications for non-recommending.

Access to many cancer medicines on WHO's Essential Medicines List (EML) is restricted because of price, especially in low-income and middle-income countries (LMICs). Other cancer medicines that have been shown to improve survival, such as immune checkpoint inhibitors for lung cancer, are not included on the EML because approved doses and schedules exceed affordable prices in LMICs. Multiple strategies are therefore needed to reduce medicine costs or circumvent these problems, such as optimising doses and schedules. Cancer medicines are approved by regulatory agencies, such as the US Food and Drug Administration and the European Medicines Agency, following rigorous clinical trials. However, these approvals can involve dosing regimens and treatment schedules that, although effective in showing statistically significant benefits in trials, can be higher in intensity, frequency, or duration than is necessary to achieve meaningful improved survival. In clinical practice, these regimens can lead to concerns about balancing optimal therapeutic outcomes with the risk of side-effects, patient quality of life, and long-term health effects. Various types of evidence can, and should, be used to explore and show near-equivalence of beneficial outcomes from reduced-intensity treatments, including randomised clinical trials, dose-finding phase 1 and 2 studies, and pharmacokinetic and pharmacodynamic studies. The positive effects of proving that lower doses or less intensive schedules retain therapeutic activity include reduced toxicity and large price reductions, leading to better cost-effectiveness and greater access to treatments that improve survival. Beyond regulatory approvals, identification of regimens that have similar outcomes with reduced doses and less intense schedules should be a priority for clinicians and policy makers in the selection process to identify effective medicines at national and global levels.

Users of GRADE (Grading of Recommendations Assessment, Development and Evaluation) make judgments about the size of intervention effects on desirable and undesirable people-important health outcomes or on benefits and harms. Benchmarking effect sizes by using decision thresholds (DTs) can help to facilitate these judgments and the process. This article provides GRADE guidance for use of DTs for judgments about the magnitude of desirable and undesirable health effects, such as in a health guideline or health technology assessment. Through iterative discussions and refinement in in-person and online meetings of a GRADE project group and through e-mail communication, the authors developed guidance for using DTs in Evidence-to-Decision (EtD) frameworks. The authors applied the approach and used these examples from guidelines and the results of a randomized methodological study to develop official GRADE guidance. Several alternatives for determining and using DTs are presented. In the first main approach, outcome-specific DTs for trivial, small, moderate, and large effects are determined through a calculation using empirically derived generic coefficients and the outcome's utility value and are compared with the effect estimate obtained from an evidence synthesis. In the second main approach, outcome-specific DTs are also determined, but through direct surveying of decision makers to explicitly assign thresholds for the prioritized health outcomes. The article also describes how these approaches can be combined. The suggested approaches provide transparency for judgments in EtD frameworks that are based on findings from evidence syntheses.

BackgroundChildren need specialized medicine formulations for proper dosing, safety, and adherence. The World Health Organization developed a pediatric essential medicines list prioritising pediatric formulations. Given global commitment by countries to children's health, we expected national lists similarly prioritizing pediatric medicines and formulations. We assessed the extent to which national lists include medicines for children.MethodsWe used a global essential medicines database to collect data on national lists identifying pediatric lists, medicines, and formulations. Six key therapeutic areas were selected a priori to present granular data. Data were categorized by country characteristics and income levels.ResultsOur study found that most countries do not include pediatric formulations in their Essential Medicine Lists (EMLs), especially high-income European countries. Of the 22 countries that do, most list medicines for infections, antiretrovirals, and cancer, but gaps exist for antitrypanosomal, antileishmanial, and antihepatitis treatments. Paracetamol had the most diverse formulations. Additionally, differences were found between national and World Health Organization (WHO) EMLs, with some countries listing fewer medicines overall, though some countries included more treatments for HIV and hepatitis than the WHO Essential Medicines List for children (EMLc).ConclusionIn many countries, it is unclear which medicines for children are prioritized, if any. The problem is particularly acute in high-income countries. Misalignments between national lists and the World Health Organization are common. There is little evidence that countries are adequately implementing medicines policies for youth.

Users of GRADE (Grading of Recommendations Assessment, Development and Evaluation) make judgments about the size of intervention effects on desirable and undesirable people-important health outcomes or on benefits and harms. Benchmarking effect sizes by using decision thresholds (DTs) can help to facilitate these judgments and the process. This article provides GRADE guidance for use of DTs for judgments about the magnitude of desirable and undesirable health effects, such as in a health guideline or health technology assessment. Through iterative discussions and refinement in in-person and online meetings of a GRADE project group and through e-mail communication, the authors developed guidance for using DTs in Evidence-to-Decision (EtD) frameworks. The authors applied the approach and used these examples from guidelines and the results of a randomized methodological study to develop official GRADE guidance. Several alternatives for determining and using DTs are presented. In the first main approach, outcome-specific DTs for trivial, small, moderate, and large effects are determined through a calculation using empirically derived generic coefficients and the outcome's utility value and are compared with the effect estimate obtained from an evidence synthesis. In the second main approach, outcome-specific DTs are also determined, but through direct surveying of decision makers to explicitly assign thresholds for the prioritized health outcomes. The article also describes how these approaches can be combined. The suggested approaches provide transparency for judgments in EtD frameworks that are based on findings from evidence syntheses.

BACKGROUND:The World Health Organization (WHO) Essential Medicines List (EML) and resource-stratified guidelines both prioritize high-value medicines. We compared the 2023 EML cancer medicines list with global cancer statistics, examined the proportion of EML therapies recommended by resource-stratified guidelines, and identified gaps that merit evaluation by the WHO EML Committee. METHODS:We compared the 2023 EML medicines for adult cancers with cancer incidence and mortality data from GLOBOCAN 2022. We cross-referenced the EML with 2 resource-stratified guidelines (National Comprehensive Cancer Network [NCCN] and National Cancer Grid [NCG] of India) and evaluated preferred treatments in resource-stratified guidelines that were not recommended by the EML. RESULTS:The 2023 EML included 64 cancer medicines for 219 tumor-specific indications. The greatest number of medicines are listed for leukemia (37/219 [17%]) and lymphoma (33/219 [15%]). Although some common cancers (eg, hepatocellular carcinoma) have no EML-listed medicines because of the low clinical benefit, we identified some cancers (eg, esophageal, gastric) with effective therapies that the EML Committee should evaluate for inclusion. Cancers with no listed medicines make up 34% of cancer deaths globally. Among EML indications with an NCCN resource-stratified guideline, 42% (35/84) and 73% (62/84) were recommended by the NCCN Basic and Core Guidelines, respectively. Among EML indications with an NCG resource-stratified guideline, 163 of 196 (83%) and 175 of 196 (89%) were recommended by the NCG Essential and Optimal guidelines, respectively. CONCLUSIONS:We identified some effective medicines that should be evaluated for inclusion in the WHO EML. Prioritization of cancer medicines was similar between the EML and NCG India but discordant between with NCCN resource-stratified guideline.

OBJECTIVES:Better engagement of diverse groups of interest-holders in the development of health guidelines has been proposed to improve their usefulness, implementability, and acceptability. Guidelines shape clinical or public health practice decision-making. Trustworthy guidelines are systematically developed documents that include actionable statements based on evidence and a formal, structured and transparent decision process. This paper describes the Guidelines International Network (GIN)-McMaster Guideline Development Checklist (GDC) Extension for Engagement to assist developers with engaging multiple interest-holders throughout all topics of guideline development. STUDY DESIGN AND SETTING:To produce this checklist extension, we conducted a 3-phase mixed methods study. First, we identified 10 groups of interest-holders to be engaged in health guideline development: patients, the public, providers, program managers, principal investigators, payers/purchasers of health services, payers/funders of health research, policymakers, peer-reviewed journal editors, and product makers identified in previous work and recruited coleads to represent these groups (n = 26 total). RESULTS:We conducted a series of reviews to identify existing methods and barriers/facilitators for engagement, approaches to managing conflicts of interest, and describe the impacts of engagement on the guideline development process. The results of these reviews informed the development of an online survey for which we received 195 responses. We clarified these results through 43 key informant interviews with interest-holders. The final GDC extension checklist was determined based on consensus methods with our coleads. CONCLUSION:This paper presents the GIN-McMaster GDC Extension for Engagement. This checklist provides interest-holder-informed recommendations for providing advice/feedback or participating in decision-making in guideline development. PLAIN LANGUAGE SUMMARY:Health-care guidelines are formal recommendations for diagnosing and managing medical conditions or public health concerns. The steps involved in developing guidelines include from planning the process, defining the focus of the guideline and the questions it should answer, and summarizing the evidence. The Guidelines International Network-McMaster Guideline Development checklist includes 146 steps of guideline development grouped into 18 topics. Our work extends this checklist to provide guidance on how to engage with people from different groups of 'interest-holders' throughout guideline development. These interest-holders include (1) patients, (2) members of the public, (3) health-care providers, (4) people who manage and operate health programs, (5) researchers, (6) people who pay for or purchase health services, (7) policymakers, (8) people who pay for health research, (9) people who publish research and guidelines, and (10) people who develop and sell health-care devices or products. We engaged with people from each of the groups to develop this guidance. Twenty-six people coled our interest-holder groups. We conducted a series or systematic reviews on (a) how to engage people in guidelines, (b) identifying the barriers and facilitators to engagement, (c) assessing the impacts of engagement, and (d) describing how to manage conflicts of interest related to engagement. These reviews were used to create a first draft of guidance. Then we conducted an online survey and gathered the opinions from 195 people from each of our interest-holder groups. We interviewed 43 interest-holders for additional information to revise the guidance and then finalized the guidance with our interest-holder coleads. This checklist provides guidance for engaging interest-holder groups throughout guideline development.

New antibiotics active against multidrug resistant bacteria (MDR-B) are licensed by regulatory agencies based on pivotal trials that serve the primary purpose of obtaining marketing-authorization. There is increasing concern that they do not offer guidance on how to best use new antibiotics, in which population, and to what extent they overcome existing resistance. We reviewed the literature for pre-approval studies (phase 2 and 3 randomized controlled trials) and post-approval studies (randomized and non-randomized controlled trials) evaluating efficacy and safety of new antibiotics, classified by WHO as Reserve, approved in the European Union and the US from January 2010 to May 2023. Substantial failures occur in generating evidence to guide routine clinical use: preapproval studies lack representativeness, select outcomes and comparators to chase statistical significance, and often avoid using prespecified analytical methods. Three recommendations are key to enhance the quality and relevance of clinical data underpinning use of last resort molecules on the WHO AWaRe Reserve list active against carbapenem-resistant MDR-B i). separation of pivotal trials from post-approval studies, which should be funded by public programs and de-linked from commercial purposes, ii). development and maintenance of a global infrastructure to conduct post-approval public health focused studies, and iii). development of trial platforms that use efficient, adaptive designs to inform clinical decision making and country level technology appraisal. These solutions will allow clinicians to determine whether recently approved Reserve antibiotics are not only “newer” but also “better” for vulnerable patient populations at particular risk for infections by MDR-B.

OBJECTIVES:To compare the efficacy of influenza vaccines of any valency for adults 60 years and older. DESIGN AND SETTING:Systematic review with network meta-analysis (NMA) of randomised controlled trials (RCTs). MEDLINE, EMBASE, JBI Evidence-Based Practice (EBP) Database, PsycINFO, and Cochrane Evidence -Based Medicine database were searched from inception to 20 June 20, 2022. Two reviewers screened, abstracted, and appraised articles (Cochrane Risk of Bias (ROB) 2.0 tool) independently. We assessed certainty of findings using Confidence in Network Meta-Analysis and Grading of Recommendations, Assessment, Development and Evaluations approaches. We performed random-effects meta-analysis and network meta-analysis (NMA), and estimated odds ratios (ORs) for dichotomous outcomes and incidence rate ratios (IRRs) for count outcomes along with their corresponding 95% confidence intervals (CIs) and prediction intervals. PARTICIPANTS:Older adults (≥60 years old) receiving an influenza vaccine licensed in Canada or the USA (vs placebo, no vaccine, or any other licensed vaccine), at any dose. MAIN OUTCOME MEASURES:Laboratory-confirmed influenza (LCI) and influenza-like illness (ILI). Secondary outcomes were the number of vascular adverse events, hospitalisation for acute respiratory infection (ARI) and ILI, inpatient hospitalisation, emergency room (ER) visit for ILI, outpatient visit, and mortality, among others. RESULTS:We included 41 RCTs and 15 companion reports comprising 8 vaccine types and 206 032 participants. Vaccines may prevent LCI compared with placebo, with high-dose trivalent inactivated influenza vaccine (IIV3-HD) (NMA: 9 RCTs, 52 202 participants, OR 0.23, 95% confidence interval (CI) (0.11 to 0.51), low certainty of evidence) and recombinant influenza vaccine (RIV) (OR 0.25, 95%CI (0.08 to 0.73), low certainty of evidence) among the most efficacious vaccines. Standard dose trivalent IIV3 (IIV3-SD) may prevent ILI compared with placebo, but the result was imprecise (meta-analysis: 2 RCTs, 854 participants, OR 0.39, 95%CI (0.15 to 1.02), low certainty of evidence). Any HD was associated with prevention of ILI compared with placebo (NMA: 9 RCTs, 65 658 participants, OR 0.38, 95%CI (0.15 to 0.93)). Adjuvanted quadrivalent IIV (IIV4-Adj) may be associated with the least vascular adverse events, but the results were very uncertain (NMA: eight 8 RCTs, 57 677 participants, IRR 0.18, 95%CI (0.07 to 0.43), very low certainty of evidence). RIV on all-cause mortality may be comparable to placebo (NMA: 20 RCTs, 140 577 participants, OR 1.01, 95%CI (0.23 to 4.49), low certainty of evidence). CONCLUSIONS:This systematic review demonstrated efficacy associated with IIV3-HD and RIV vaccines in protecting older persons against LCI. RIV vaccine may reduce all-cause mortality when compared with other vaccines, but the evidence is uncertain. Differences in efficacy between influenza vaccines remain uncertain with very low to moderate certainty of evidence. PROSPERO REGISTRATION NUMBER:CRD42020177357.

Strongyloidiasis is a soil-transmitted helminthiasis that is estimated to affect 300–600 million people across Asia, Africa, South and central America, and the Pacific. This neglected parasitic disease is most known for its ability to persist as a lifelong infection due to autoinfection and its risk of hyperinfection and disseminated disease during immunosuppression, which has a more than 60% case fatality. Despite the large global burden of strongyloidiasis, there have been no large-scale public health programmes or WHO guidelines directed towards its control and elimination. However, over the past decade, key scientific and policy changes along with requests from endemic countries have led to WHO incorporating strongyloidiasis into its 2021–30 roadmap and public health targets for control and elimination of neglected tropical diseases. In 2024, WHO published its first guideline on public health control of strongyloidiasis with a single recommendation: in endemic settings with a Strongyloides stercoralis infection prevalence of 5% or higher (measured either with Baermann or agar plate culture from stool specimens), WHO conditionally recommends mass drug administration with single-dose ivermectin (200 μg/kg; oral therapy) in all age groups from 5 years and older to reduce strongyloidiasis. This Review, written by the 2023–24 strongyloidiasis guidelines development group along with WHO colleagues and international experts, presents a summary of the recently published WHO guideline recommendation for strongyloidiasis, and the supporting evidence, considerations for public health implementation, and future research needs.

Essential medicine lists (EMLs) are important medicine prioritization tools used by the World Health Organization (WHO) EML and over 130 countries. The criteria used by WHO's Expert Committee on the Selection and Use of Essential Medicines has parallels to the GRADE Evidence-to-Decision (EtD) frameworks. In this study, we explored the EtD frameworks and a visual abstract as adjunctive tools to strengthen the integrate evidence and improve the transparency of decisions of EML applications. We conducted user-experience testing interviews of key EML stakeholders using Morville's honeycomb model. Interviews explored multifaceted dimensions (e.g., usability) on two EML applications for the 2021 WHO EML-long-acting insulin analogues for diabetes and immune checkpoint inhibitors for lung cancer. Using a pre-determined coding framework and thematic analysis we iteratively improved both the EtD framework and the visual abstract. We coded the transcripts of 17 interviews with 13 respondents in 103 locations of the interview texts across all dimensions of the user-experience honeycomb. Respondents felt the EtD framework and visual abstract presented complementary useful and findable adjuncts to the traditional EML application. They felt this would increase transparency and efficiency in evidence assessed by EML committees. As EtD frameworks are also used in health practice guidelines, including those by the WHO, respondents articulated that the adoption of the EtD by EML applications represents a tangible mechanism to align EMLs and guidelines, decrease duplication of work and improve coordination. Improvements were made to clarify instructions for the EtD and visual abstract, and to refine the design and content included. 'Availability' was added as an additional criterion for EML applications to highlight this criterion in alignment with WHO EML criteria. EtD frameworks and visual abstracts present additional important tools to communicate evidence and support decision-criteria in EML applications, which have global health impact. Access to essential medicines is important for achieving universal health coverage, and the development of essential medicine lists should be as evidence-based and trustworthy as possible.

Objectives: Guidelines and essential medicine lists (EMLs) bear similarities and differences in the process that lead to decisions. Access to essential medicines is central to achieve universal health coverage. The World Health Organization (WHO) EML has guided prioritization of essential medicines globally for nearly 50 years, and national EMLs (NEMLs) exist in over 130 countries. Guideline and EML decisions, at WHO or national levels, are not always coordinated and aligned. We sought to explore challenges, and potential solutions, for decision-making to support trustworthy medicine selection for EMLs from a Grading of Recommendations, Assessment, Development and Evaluations (GRADE) Working Group perspective. We primarily focus on the WHO EML; however, our findings may be applicable to NEML decisions as well. Study Design and Setting: We identified key challenges in connecting the EML to health guidelines by involving a broad group of stakeholders and assessing case studies including real applications to the WHO EML, South Africa NEML, and a multiple sclerosis guideline connected to a WHO EML application for multiple sclerosis treatments. To address challenges, we utilized the results of a survey and feedback from the stakeholders, and iteratively met as a project group. We drafted a conceptual framework of challenges and potential solutions. We presented a summary of the results for feedback to all attendees of the GRADE Working Group meetings in November 2022 (approximately 120 people) and in May 2023 (approximately 100 people) before finalizing the framework. Results: We prioritized issues and insights/solutions that addressed the connections between the EML and health guidelines. Our suggested solutions include early planning alignment of guideline groups and EMLs, considering shared participation to strengthen linkage, further clarity on price/cost considerations, and using explicit shared criteria to make guideline and EML decisions. We also provide recommendations to strengthen the connection between WHO EML and NEMLs including through contextualization methods. Conclusion: This GRADE concept article, jointly developed by key stakeholders from the guidelines and EMLs field, identified key conceptual issues and potential solutions to support the continued advancement of trustworthy EMLs. Adopting structured decision criteria that can be linked to guideline recommendations bears the potential to advance health equity and gaps in availability of essential medicines within and between countries. (c) 2024 Published by Elsevier Inc. This is an open access article under the CC BY IGO license (http://creati vecommons.org/licenses/by/3.0/igo/).

The first version of the World Health Organization Model list of essential medicines contained 186 medicines in 1977 and has evolved to include 502 medicines in 2023. Over time, different articles criticized the methods and process for decisions; however, the list holds global relevance as a model list to over 150 national lists. Given the global use of the model list, reflecting on its future role is imperative to understand how the list should evolve and respond to the needs of Member States. In 2023, the model list Expert Committee recommended the World Health Organization (WHO) to initiate a process to revise the procedures for updating the model list and the criteria guiding decisions. Here, we offer an agenda outlining priority areas and a vision for an authoritative model list. The main areas include improving transparency and trustworthiness of the recommendations; strengthening connection to national lists; and continuing the debate on the principles that should guide the model list, in particular the role of cost and price of essential medicines. These reflections are intended to support efforts ensuring the continued impact of this policy tool.