ESPE Yearbook of Paediatric Endocrinology

Brief summary: The WHO List of Essential Medicines now includes more than 400 medicines. The addition to the list of medicines considered effective, safe, and important for priority public health is made increasingly complicated by the high cost of new drugs. This commentary recommends a new approach whereby consideration would be given separately to economic aspects and to clinical benefits.

Every two years, the WHO publishes a revised List of Essential Medicines for adults (EML, since 1977) and children (EMLc, since 2007). This list is a voluntary guide that helps member states to design their own national EML with the (sadly often unfulfilled) goal of making these medicines available and affordable in the country. Major changes in the diabetes section of the 2021 EML have taken place with the inclusion of long-acting analogues of insulin and of sodium-glucose cotransporter 2 (SGLT-2) inhibitors. While these new drugs are becoming mainstream for the management of diabetes in high-income countries, their high cost keeps them out of reach for patients in many low- and middle-income countries (LMICs) that are still struggling to access human insulin.

The authors suggest that the WHO should separate their assessment of the quality of the medicine by the EML expert committee from the evaluation of the price of the medicines and their cost-effectiveness. This alone is however unlikely to solve the issue of equitable access and new approaches are needed. The WHO has recently implemented a prequalification process for human insulins and for insulin analogues with the aim of increasing the number of available products (there are more than 20 manufacturers of insulin in the world although > 95% of the market is held by Novo Nordisk, Eli Lilly and Sanofi) and, as a consequence, decreasing medicine cost. As of May 2023, only Novo Nordisk’s human insulin and Sanofi’s glargine have been prequalified. Pooled procurement is another option that is already offered for several medicines (including human insulin) by the Pan American Health Organisation (PAHO, https://www.paho.org/en/paho-strategic-fund) to make drugs more affordable. Finally, as proposed by the authors, the WHO could work with the Medicines Patent Pool (https://medicinespatentpool.org) to develop licensing agreements with the patent holders to allow generic manufacturing and supply in LMICs.