The 2023 WHO Essential Medicines List & The Importance of Industry Engagement


Regular contributor Brendan Shaw* casts his eye over the recently announced 2023 WHO Essential Medicines List, how it reflects growing pharmaceutical innovation, and why maintaining a ‘seat at the table’ for the pharma industry in these discussions will be crucial to meeting global healthcare access goals.


Recently, the World Health Organization (WHO) released its updated Model List of Essential Medicines, its 23rd edition. This Essential Medicines List (EML) is updated every two years to provide advice to countries and international organisations on which medicines they should consider for inclusion in their formularies, funding and regulatory decisions. The WHO also prepares a Model List of Essential Medicines for Children (EMLc).

As well as providing guidance for individual countries on which medicines to have in their own health systems, the update of the EML often provides an opportunity to discuss important global health policy issues concerning the availability and access to medicines and gives a snapshot of the trends in global drug development.

While potentially presenting challenges for pharmaceutical companies, the EML also provides opportunities for companies to support improvements in global health and even potentially build more successful businesses by engaging in the process.

The EML has continued its evolution and development since its first iteration released in 1977. Initially, with just 204 medicines on the list, this year in 2023 the EML reached a new milestone with 502 medicines now on the adult EML, the largest number ever. A total of 36 items were added to the lists for adults and children, with the EMLc now reaching 361 medicines.

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The growth in the number and scope of medicines on the EML over the decades reflects the growth in technology and development in pharmaceuticals and the growing importance of medicines in health systems around the world. It is an indication of the growing arsenal of medical tools humanity has at its disposal to treat disease. There are more medicines today than ever before developed by the pharmaceutical industry that the WHO regards as ‘essential’ for health systems.


Developments in this year’s EML

The additions and other changes to the EML also provide a snapshot of some of the new treatments that become available and are accepted as standard care in a range of diseases.

For example, the new 23rd edition released late last month includes additions of medicines for multiple sclerosis and for Ebola – examples of treatment options available now for diseases where previously there were few, if any.

As with every year, the Executive Summary of the report of the Expert Committee who recommend medicines for listing on the EML makes for interesting reading. It provides an overview of the changes to the List, as well as discussion of some of the issues the Committee considered in its deliberations.

As well as its private, internal deliberations, the Committee also has a one day ‘Open Session’ where external experts and stakeholder groups have the opportunity to present to the Expert Committee and discuss key essential medicine policy issues. As in other years, this year’s Open Session was held in April during the Expert Committee’s formal review meeting.

The Committee reviewed a total of 85 applications, including 52 applications for new medicines or medicine classes, as well as 9 proposals for new indications for 22 currently listed medicines, and 9 proposals for the addition of new formulations of currently listed medicines. The Committee also received 6 proposals for the removal of 13 medicines, formulations or indications.

The Committee’s recommendations for the 23rd edition of the EML include a few highlights that reflect changing global health issues, including:

  • The inclusion of sevoflurane as an anaesthetic on the List because it has less impact on global warming and climate change than other similar gases.
  • The decision not to include fentanyl as an opioid analgesic, in part due to the potential for misuse and addiction.
  • A few medicines for diseases where effective treatments have been difficult to find not being recommended due to what the Committee called uncertain clinical efficacy. Examples here include donepezil for Alzheimer’s Disease and risdiplam for spinal muscular atrophy.
  • The inclusion of three medicines for multiple sclerosis – cladribine, glatiramer acetate and rituximab. The Committee noted that this was the first time that any medicines to treat MS were included on the EML, a neurological disability that particularly affects young adults, with approximately 2.8 million people worldwide living with the condition. The recommendations around MS medications touched on several ongoing issues with EML medicines, including the recommendation of rituximab which is ‘off-label’ use, and the rejection of ocrelizumab for MS due to what the Committee said were its concerns about cost and impact on health budgets compared to the medicine’s benefits.
  • The inclusion of some – but not all – proposed antibiotics on to the ‘Reserve’ list for antibiotics. This list is designed to recommend some antibiotics be kept in reserve and used sparingly for particularly drug-resistant pathogens.
  • The addition of monoclonal antibodies ansuvimab and atoltivimab + maftivimab + odesivimab for the treatment of Ebola virus disease caused by Zaire ebolavirus. The Committee noted that the clinical evidence showed demonstrated important reductions in mortality against normal standard of care. Again, this an example of medicines being available to treat diseases where previously no treatments existed. Five years ago there were few, if any, effective treatments for Ebola.
  • Regarding COVID-19, the Committee decided not to recommend specific treatments for EML listing, given the speed of evolving treatments, disease profile and clinical need in the global community. However, in an innovation, the Committee recommended that a new section on COVID-19 treatments be added to the EML, but should reference the online WHO guidelines for COVID-19, rather than have the individual medicines on the List.
  • The Committee received 12 applications for new or expanded indication cancer treatments, making positive recommendations for several new medicines and expanded indications. Just as important, perhaps, are the cancer medicines that were rejected. These included several PD-1/PD-L1 immune checkpoint inhibitors – resubmissions of medicines rejected in 2021, as well as Cyclin-dependent kinase 4/6 inhibitors (abemaciclib, palbociclib and ribociclib) for the treatment of hormone receptor positive/HER2-negative advanced breast cancer, and Osimertinib for first-line treatment of EGFR-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC). As in 2021, the Committee’s reasons were what they saw as the balance between these treatments’ relative additional clinical benefit against their price and health system management problems present in low-resource settings in low- and middle-income countries. In several cases, the Committee recommended the WHO continue working on strategies to improve the affordability of these medicines and also suggested some for consideration for licensing under the Medicines Patent Pool.
  • In a reflection of rapidly changing technology in medicine, the Committee also considered the use of CAR-T cell therapy for relapsed or refractory large B-cell lymphoma for listing on the EML. While not yet recommending this therapy, the Committee recognised the emerging treatment options presented by CAR-T therapies. The Committee noted it is still early days in their clinical use and identified the health system resources required to administer these therapies – something that may be currently out of reach for many low- and middle-income countries. Notwithstanding these issues, the Committee recommended these be monitored in the future and “noted with interest that these therapies are becoming increasingly available in academic settings and closed/semi‑automated manufacturing process systems are now available which may substantially reduce prices and likely increase availability”.
  • Rejection of a first-time proposal to include glucagon-like peptide-1 receptor agonists for treatment for obesity and weight-loss on the EML. While another indication of the growing range of medicines available to treat disease, the Committee suggested that there was a lack of evidence on long-term clinical benefit and safety information.
  • A total of 16 applications for medicines for mental and behavioural disorders, many of which were recommended, including medicines for bipolar disorders, anxiety disorders, obsessive compulsive disorders and alcohol use disorders. In many cases, these medicines were older, cheaper, generic medicines that had established effectiveness and safety profiles. The fact that more medicines in these categories can now be added to the EML reflects the past product development work of science, research and the pharmaceutical industry.


The EML going forward

Finally, the Expert Committee also recommended that the WHO and member states consider a review of the whole process for evaluating medicines for the EML. Noting that there had been only one review of the process in 2001 since the list was first created in 1977, the Committee felt that given the changing landscape and complexity of medicines and medicine policy issues, it was time for a review to be done. The Committee recommended that a wide range of stakeholders should be included in this process, including representatives from the pharmaceutical industry.

Various stakeholders, including the pharmaceutical industry, have engaged in the development of the EML through the years. The pharmaceutical industry is involved both through its international representative body, the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), and individual companies themselves. In this year’s update there are examples where companies such as AstraZeneca, MSD and Roche have themselves engaged in the process, either making applications for listing medicines themselves, or providing letters of support for applications.

The growing attention of Expert Committee reviews on medicines for diseases like Alzheimer’s, obesity, multiple sclerosis, cancer and mental health reflect developments in medical technology and the growing global health focus on non-communicable diseases in addition to communicable diseases.

While not without its challenges, on balance it is important for the industry to engage in this EML process. As newer, patented medicines have been added and as health policy has become more globalised, each EML review has been a focus for debates on the price of medicines, health system funding and the role of the pharmaceutical industry. These issues are often discussed in the context of EML updates, as demonstrated by the most recent update this year.

In the drive for universal health coverage, the EML plays an important role in this. Having industry engaged and ‘at the table’ for these discussions is important to the success in providing universal health coverage for all people.


*Brendan Shaw is Principal of Shawview Consulting and an Adjunct Professor at the Pharmacy School, Faculty of Medicine and Health, at the University of Sydney.

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