The recognition of the importance of essential medicine started in 1985 at Nairobi Conference on the Rational Use of Drugs. 30 years later, The Lancet’s Commission on Essential Medicines Policies convened to explore these questions: what progress has been achieved? What challenges remain to be addressed? Which lessons have been learned to inform future approaches? And how can essential medicines policies be harnessed to promote UHC and contribute to the global sustainable development agenda? This report addresses these questions, with the intent to reposition essential medicines policies on the global development agenda. > The Commission identified five areas that are crucial to essential medicines policies: paying for a basket of essential medicines, making essential medicines affordable, assuring the quality and safety of medicines, promoting quality use of medicines, and developing missing essential medicines. # Paying for a basket of essential medicines to promote sustainable access for all “Using two consumption scenarios, the Commission estimated that between US$77·4 and $151·9 billion (or $13 to $25 per capita) is required to fi nance a basic package of 201 essential medicines (378 dosage forms) in all LMICs. Yet in 2010, the majority of low-income countries (LICs) and 13 out of 47 middle-income countries, spent less than $13 per capita on pharmaceuticals. Thus, the Commission confirmed that many people worldwide do not have access to even a limited basket of essential medicines. Countries should adapt the Commission’s model to their national contexts to create a locally relevant estimate as a benchmark for measuring performance on essential medicines.” (Wirtz et al., 2017, p. 403) The Commission’s recommendations on financing of essential medicines are: 1. Governments and national health systems must provide adequate financing to ensure inclusion of essential medicines in the benefit packages provided by the public sector and all health insurance schemes. 2. Governments and national health systems must implement policies that reduce the amount of out-ofpocket spending on medicines. 3. The international community must fulfil its human rights obligations to support governments of LICs in financing a basic package of essential medicines for all, if they are unable to do so domestically. 4. Governments and national health systems must invest in the capacity to accurately track expenditure on medicines, especially essential medicines, in both the public and private sectors, disaggregated between prepaid and out-of-pocket expenditure, and among important key populations. # Making essential medicines affordable is necessary to achieve equity in access The complexity of the problem of affordability illustrates the urgent need for comprehensive policy solutions; no single policy alone can solve this problem. The lack of medicines pricing information makes it difficult for consumers—both individuals and health systems—to make informed decisions about purchasing medicines. Scarcity of data also impedes assessments of whether individuals and households face financial barriers when making out-of-pocket payments for medicines, and creates a barrier to cross-national comparisons that could inform the setting of benchmarks and the establishment of appropriate and effective pricing policies. Medicines benefit packages guide procurement and reimbursement for affordable essential medicines. Compiling these packages necessitates building capacity at national level to translate findings from evidence (including [[Health Technology Assessment (HTA)]]) to local contexts, and to use the findings as inputs in decision making (including when to intervene to influence pricing). Governments and other purchasers of medicines can expand their transparent sharing of information to increase efficiency and avoid duplication of efforts. The Commission’s recommendations on making essential medicines affordable are: 1. Governments and health systems must create and maintain information systems for routine monitoring of data on the affordability of essential medicines, as well as price and availability, in the public and private sectors. 2. Governments must implement a comprehensive set of policies to achieve affordable prices for essential medicines. 3. Governments and health systems must develop national capacity to create medicines benefit packages that guide procurement and reimbursement for affordable essential medicines. 4. Governments, national health systems, and the pharmaceutical industry must promote transparency by sharing health and medicines information. # Assuring the quality and safety of medicines is needed to prevent harm to patients A clear trend towards international regulatory collaboration and electronic communications has emerged. These trends can now be leveraged to ensure continued progress for the full array of essential medicines for all countries. The Commission’s recommendations on assuring the quality and safety of essential medicines are: 1. Global efforts must be made to promote the harmonisation of quality assurance efforts through the use of an international standard regulatory dossier that covers both format and content. 2. WHO should evolve the WHO/UN Prequalification Programme to maintain a moving focus on new essential medicines. 3. Payers and procurement agencies must adopt good procurement practices that incorporate effective and transparent quality assurance mechanisms. 4. Governments must redirect the activities of national regulatory agencies towards those that add value and reduce duplication of effort, and engage with a system for independent and public assessment of the performance of NMRAs. 5. Regulatory agencies must encourage the involvement of other stakeholders and the general public in promoting the quality and safety of essential medicines. 6. WHO and national governments must establish concrete targets and a public accountability mechanism for the performance of national regulatory authorities. # Promoting quality use of essential medicines leads to better health outcomes and can achieve considerable efficiencies The problems with medicine include overuse (as with opioids in some settings), underuse (as in many countries with poor access to opioids for the management of severe pain), misuse (as when antibiotics are taken for a viral disease), and unnecessarily expensive use (as when brand-name medicines are used despite the existence of a lower-priced, quality-assured generic alternative). As UHC enables more people to have access to medicines, problems with the use of medicines threaten to undermine the potential benefits by harming individuals, reducing the efficacy of medicines (if antimicrobial resistance develops), and jeopardising the fi nancial stability of health systems. The Commission’s recommendations focus on strategies that enable collaboration among patients, health-care providers, insurers, supply chain managers, and others (including the pharmaceutical industry), to incentivise and support quality medicines use. Strong institutions with the capacity to generate evidence and implement evidenceinformed policies are crucial. The benefits of these eff orts will include improving clinical, public health, economic, and ethical outcomes. The Commission’s recommendations on improving the use of essential medicines are: 1. Governments and the main public or private payers should establish independent pharmaceutical analytics units (or equivalent) to focus on generating information for action to promote quality use, in conjunction with other objectives. 2. Pharmaceutical analytics units must collaborate with multiple stakeholders in all relevant systems to increase their engagement in and accountability for quality use of medicines, and to intervene jointly on medicines use problems. 3. Engaged stakeholder groups, led by data produced by the pharmaceutical analytics unit, should identify and prioritise local medicines use problems, identify contributing factors across the system, and develop and implement sustainable, long-term, multi-faceted interventions. # A global research and development (R&D) policy framework is needed to develop missing essential medicines and make them accessible to all > Pharmaceutical companies and their shareholders are typically reluctant to invest in marketing medicines for patient populations that do not represent a profitable market. These two problems are related, and disproportionately affect people in LMICs. With the current patent-based innovation system, the feasibility of achieving or maintaining UHC is seriously at risk. Several not-for-profit initiatives, often in collaboration with the pharmaceutical industry, have compensated for some problems with the current system, but they do not represent a long-term solution. A new global policy framework is needed to drastically adapt the current model and to reduce its reliance on market exclusivity as the main driver of innovation. Governments need to define a list of missing essential medicines to be provided under UHC schemes, and governments, non-governmental organisations, and the industry need to make the necessary R&D financing mechanisms available for these identified needs. The price of new essential medicines can then be delinked from development costs and the products can be made widely available and affordable through non-exclusive licensing agreements. The Commission’s recommendations on developing missing essential medicines are: 1. Governments and WHO must take international public leadership for priority setting for essential R&D, with due regard for the public health needs of LMICs. 2. Governments must lead the process towards a global research and development policy framework and agreements, which include new financing mechanisms to ensure that missing essential medicines are developed and made affordable. 3. The international community must create a general Essential Medicines Patent Pool. 4. Governments and national stakeholders must develop and implement comprehensive national action plans to guarantee equitable access to new essential medicines. 5. The pharmaceutical industry must better align its R&D priority setting with global health needs, and develop access strategies to make medically important innovations available to all in need. # Measuring progress holds all stakeholders accountable To transform these recommendations into reality will require commitments on the part of governments, policy makers, implementers, the pharmaceutical industry, donors, health-care providers, citizens, and patients, as well as international agencies and civil society organisations. This commitment can be created in part through deliberate steps to document efforts and demonstrate progress. ==Thus, the Commission proposes a set of 24 core indicators to measure progress in the implementation of comprehensive essential medicines policies.==