Ahead of the 50th anniversary of the World Health Organization’s Model List of Essential Medicines (EML) in 2027, Brendan Shaw explains how the EML has evolved from a basic guide for low-income countries to a global benchmark shaping universal health coverage. Looking at the recently-published 2025 update, Shaw examines the list’s shift towards innovative therapies, rising policy and access tensions, and how a broader coalition of stakeholders than ever before are now contributing to it.

 

There are some important emerging trends and issues for the pharmaceutical industry in the World Health Organization’s recent 2025 update of its Model List of Essential Medicines. The List, first developed in 1977, is updated every two years and provides guidance to various countries about what medicines should be considered in developing countries’ own essential medicines list or formularies. Every two years, the WHO forms an Expert Committee to review the List and advise on which medicines should be added, removed or amended. Typically, the Expert Committee will meet for several days in April or May in the year of the review, and includes a day of open dialogue, presentations and consultation with health system stakeholders.

 

Long-term trends

The number of medicines on the EML has grown from 204 back in 1977, to 523 today. This in and of itself is testament to the contribution of the pharmaceutical industry to global health in that the number of medicines considered ‘essential’ to health systems has more than doubled in the last half century. Mind you, in policy circles there is much to debate about whether what the WHO considers ‘essential’ is sufficient, and what that means in policy terms.

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One of the ongoing issues that has emerged over the years is what should be the purpose and scope of the EML. Once upon a time, the EML was largely a list of older cheap generic medicines and was largely targeted at poorer, lower-income countries. It was a tool principally designed to help countries with very limited resources work out which medicines they would need to establish a basic, rudimentary health system.

However, with the growth in the number of new medical technologies over the decades, together with the global aspiration to achieve universal health coverage, the EML has become more of a barometer on health care for a range of countries. Increasingly, newer, patented medicines for non-communicable diseases like cancer, cardiovascular diseases and diabetes are being added to the EML, something the Expert Committee observed in its 2025 review. The growing importance of newer, patented medicines on the List has sometimes caused tensions as countries have sought to utilise these medicines in their health systems, and arguments amongst health system stakeholders and the pharmaceutical industry about the role of medicines on the EML. It has also triggered conflicts about these medicines on issues like financing, pricing, intellectual property laws, and access to medicines.

 

What’s new in the 2025 WHO Model List of Essential Medicines?

This year’s update, the 2025 edition, provides some useful insights into global health priorities and the policy conundrums that often occur when health systems try to cope with the swathe of emerging new therapies the pharmaceutical industry is developing. The Executive Summary of the Expert Committee’s 2025 review is worth a read, given the insights into the Committee’s thinking and reasons for its recommendations.

The first thing that strikes you about the 2025 review process is how much stakeholder engagement occurred in the Expert Committee’s review meeting. The agenda for the open day of the Committee meeting reveals a plethora of participants from industry, patient groups, public health groups and academics. Issues covered in that open session include the role of the List, financing essential medicines, how countries use the List in their domestic policy decisions, how patient groups view the List and its issues, pharmaceutical industry views on the List, and access to medicines issues.

In terms of the actual medicines that were added to the list, there were several big classes of emerging therapies recommended, including in cancer and diabetes.

Cancer therapies took a big part of the review process, including PD-1/PDL-1s for multiple conditions. The WHO’s Cancer Medicines Working Group, which provides advice to the Expert Committee, was working overtime this year to review the range of cancer therapies. The Committee recommended several immunotherapy cancer medicines for the EML, including expanding pembrolzimab’s indication to first line for monotherapy for metastatic cervical cancer, colorectal cancer, and non-small cell lung cancer; atezolizumab and cemiplimab for NSCLC; panitumumab for metastatic colorectal cancer; and zanubrutinib for chronic lymphocytic leukaemia/small lymphocytic leukaemia. A range of cancer therapies were not recommended for EML listing for various reasons around what the Committee interpreted as uncertainty or immaturity in the data and place of therapy.

Several mental health medicines were reviewed by the Expert Committee for inclusion, including aripiprazole for schizophrenia, and brexpiprazole for major depressive disorder, where the former was recommended but the latter was not.

GLP1s were evaluated for both obesity and diabetes, with obesity being considered in the Model List of Essential Medicines context for the second time. The first review for an obesity indication was in 2023. The Committee recommended semaglutide and tirzepatide for type 2 diabetes patients with cardiovascular disease or chronic kidney disease and obesity but rejected listing GLP1s on the EML for obesity on its own.

Other medicines that were added in the 2025 review include:

  • elexacaftor + tezacaftor + ivacaftor for cystic fibrosis
  • the inclusion of rapid-acting insulin analogues for diabetes
  • the inclusion of adalimumab and ustekinumab for the treatment of adults and children with moderate-to-severe psoriasis, and
  • vaccines for Ebola, Mpox, RSV and hepatitis E.

The Executive Summary of the Committee’s report provides discussion of the outcomes recommendations and rejections.

Overall, the developments in the medicine listings on the List again reflect scientific advances and the growing suite of medical technologies available to treat disease around the world.

 

Review of the Model List of Essential Medicines proposed for its 50th anniversary

The next review of the Model List of Essential Medicines, due in 2027, will mark the 50th anniversary since the first issue of the List in 1977. Against this backdrop, the WHO has proposed that a review of the List’s role, function and processes be undertaken. This review could help ensure that the List is fit for purpose for the 21st century and perhaps help explore some of the longstanding policy and access to medicines issues that have hung in the background while medicines have been evaluated for the List over the last half-century.

Changes in medical technology, the number of treatments available today, the diseases that can be treated, the adoption of universal health coverage, and the opportunities to improve human health with medicines all support the idea of reviewing the function and role of the Model List of Essential Medicines. Ideally, the medicines industry – the industry that makes and supplies medicines to the world – should be part of this review. While some may baulk at this prospect, obtaining industry input into how the List can work in the 21st century would be a good idea. A better understanding of the scientific and commercial realities of bringing medicines to the global community in the modern age would help inform the review of the issues in access to medicines and how to overcome them in partnership with all stakeholders, including industry.

The Expert Committee discussed the impending 50th anniversary of the Model List of Essential Medicines and the WHO’s plans to use the 50th anniversary to revamp, celebrate and promote the List in global health circles. The WHO has flagged various suggestions for what may occur here, and the Committee discussed some of these. These include possible prioritisation of medicines, more investment in cost and pricing data in List evaluations, a focus on aligning countries’ national lists with the WHO List, and a greater focus on access strategies for medicines once they are added to the List. The revamp of the application and selection processes may involve greater use of electronic, digital and AI technologies.

 

Implications for the pharmaceutical industry

The role of the pharmaceutical industry in the process and operation of the Model List of Essential Medicines is, sadly, often controversial. The pharmaceutical companies that develop and supply medicines to the world should be encouraged to be part of the processes around the Model List of Essential Medicines.

In the 2025 update, the participation of pharmaceutical companies has continued to maintain its resemblance to a patchwork quilt. Some companies have proactively engaged in the process, others have stayed silent, and a few have run a mile and wanted to be nowhere near it. These different approaches each have their reasons and merits, depending on company strategy, circumstances and portfolio.

As the 50th anniversary review of the Model List of Essential Medicines gets started, and as the world reflects on its success in achieving universal health coverage as part of the United Nations Sustainable Development Goals in the lead-up to the 2030 deadline, stakeholders may want to consider how they best engage with industry in the review going forward.

While engaging in the process might be challenging, demonstrating that companies and the pharmaceutical industry are key to improving global health is a good reason for them to be more involved in the process.

 

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