Behind the Essential Medicines List

March 2013

WHO’s Model Essential Medicines List provides an internationally recognizable set of selected medicines to help countries choose how to treat their priority health needs.

Scaling up the use of zinc sulfate could dramatically reduce the number of the
760 000 children under 5 who die from diarrhoea worldwide, every year. Used with oral rehydration salts, zinc can reduce the severity of childhood diarrhoea episodes, and reduce mortality. This is why the World Health Organization added a 20mg zinc tablet to its 2011 Model Essential Medicines List (EML).

Zinc is now one of the more than 350 medicines on the current Model EML – those that WHO recommends as the best medicines for priority conditions worldwide. Each medicine is selected, through an evidence-based process, for its safety, effectiveness and value for money.

Uses of WHO’s Model Essential Medicines List

WHO

The Model List aims to serve as a cornerstone for countries to develop their own national Essential Medicines Lists. It can assist national decision-makers in reducing costs by helping them identify priority medicines to meet their country’s health needs. It also plays an important advocacy role: inclusion in the EML highlights the potential impact of products; removal from the list can send a clear signal that a product is no longer appropriate.

The EML is also useful to nongovernmental organizations and the private sector: “The EML is one of WHO’s most important projects from the past 35 years,” says Dr Manica Balasegaram, Executive Director of Medécins Sans Frontiers’ Access Campaign. “We use it as a tool to flag drugs for priority use. I would like to see it become an even stronger tool to serve developing countries, a tool for innovation and change.”

In high-income settings, the list helps to provide insurance companies with a neutral, gold-standard list for reimbursement in countries that have their own National Reimbursement Medicines List.

Background to the Essential Medicines List

The World Health Organization created the first Essential Drugs List in 1977, containing 220 drugs (the name was later modified). Since then the EML Expert Committee has met every two years to update the Model List, using a transparent process. Any entity may propose an addition – individuals, governments, pharmaceutical companies, or medical associations. But they must provide evidence of the proposed drug’s safety, efficacy and cost-effectiveness. They also need to show that the medicine is both essential to meeting priority health care needs and is available in adequate amounts.

“The EML is one of WHO’s most important projects from the past 35 years.”

Dr Manica Balasegaram, Executive Director of Medécins Sans Frontiers’ Access Campaign

Each application is reviewed by two members of the Committee’s dozen or so experts, drawn from a larger expert advisory panel. Their reviews are posted on the WHO web site (the reviewer is not identified to avoid any possible attempts to influence) and are open to comments. Finally, the whole Committee meets for five days to compile the revised Model List, before submitting it for final approval from the Director-General, WHO.

Adapting the Model list to current needs

Over the past decades, changes to the list have reflected evolving public health challenges – adding in, for example, antiretroviral medicines for HIV and formulations to treat noncommunicable diseases.

In 2007, growing awareness among regulatory authorities that children were not being specifically catered to in medicines led to a World Health Assembly resolution calling on Member States to improve access to essential medicines for children. Later that year, WHO launched the ‘make medicines child size’ initiative and published the first WHO Model List of Essential Medicines for Children (EMLc).

Margaretha Helling-Borda, one of four members of the WHO secretariat supporting the first Expert Committee in 1977, says one of the key benefits for countries has been the setting of criteria for selecting medicines: “This is very important, as is the fact that these criteria and the process are set by WHO and that these are drugs that are scientifically proven. Every country can do what they like but they have to have an example of the criteria and the process to select the best medicines for their people’s needs.”

The List’s next update

The Expert Committee is reviewing the 17th Model Essential Medicines List from 8–12 April 2013. The updated List is expected to be available in the third quarter of 2013.

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