The WHO Model Formulary isn’t a formulary at all-not in the way hospitals or insurance companies use the term. It’s a living, evidence-based list of medicines that every country, rich or poor, should have on hand to treat the most common and deadly diseases. Think of it as the global baseline for what medicine should look like when lives are on the line. It’s not about luxury drugs or newest inventions. It’s about the pills, injections, and syrups that actually save lives in places with no electricity, no refrigeration, and no pharmacy down the street.
First published in 1977, the list has been updated every two years since. The latest version, released in July 2023, includes 591 medicines covering 369 health conditions. Nearly half of them-273-are generic versions of brand-name drugs. That’s not an accident. The World Health Organization deliberately prioritizes generics because they’re cheaper, equally effective, and can be produced at scale. A single generic HIV drug that cost $1,076 per patient per year in 2008 now costs just $119. That 89% drop didn’t happen by chance. It happened because countries started using the WHO list to negotiate better prices and avoid overpaying for branded versions.
How the WHO Picks What Makes the List
The WHO doesn’t just pick medicines based on what’s popular or profitable. Every drug on the list has to pass four strict tests:
- Public health relevance - Does it treat a disease that affects at least 100 people per 100,000? If it’s rare, it won’t make the cut.
- Efficacy and safety - It must have proof from high-quality clinical trials. No guesswork. No anecdotes.
- Cost-effectiveness - Does it give the most health benefit for the least money? If a drug costs more than three times a country’s GDP per capita per quality-adjusted life year saved, it’s unlikely to be included.
- Programmatic feasibility - Can it be stored without refrigeration? Can a nurse administer it? Can it be given in a single dose? If it needs a specialist, lab tests, or a complex dosing schedule, it goes on the complementary list-or gets left out entirely.
Each medicine scores between 0 and 10 in each category. To make the core list, it needs at least a 7.5 overall. The committee that makes these decisions includes 25 independent experts from 18 countries. They review over 200 applications every two years. No pharmaceutical company sits at the table. No lobbyists. Just science.
Core vs. Complementary: What’s the Difference?
The list is split into two parts. The core list includes the minimum medicines needed for a basic health system. These are the ones you’d expect to find in a village clinic: antibiotics for pneumonia, insulin for diabetes, antiretrovirals for HIV, painkillers, and basic vaccines. They’re chosen because they work reliably, are easy to use, and cost next to nothing.
The complementary list includes medicines that are just as important-but need more support to use safely. Think cancer drugs that require blood tests before each dose, or epilepsy medications that need careful monitoring. These aren’t excluded from access; they’re just flagged as needing more infrastructure. A rural health center might not stock them, but a regional hospital should.
This distinction matters because it keeps the list practical. If every medicine were dumped into one pile, no country could afford it. The WHO knows that. That’s why the list isn’t about having everything-it’s about having the right things, in the right places.
Why Generics Are the Heart of the List
Generics aren’t second-rate. They’re the backbone of global health equity. The WHO doesn’t just accept generics-it demands them. And not just any generics. Every generic on the list must meet one of two standards: WHO Prequalification or approval from a stringent regulatory authority like the U.S. FDA, the European EMA, or Japan’s PMDA.
What does that mean in practice? A generic insulin must prove it works exactly like the brand-name version. Bioequivalence studies show its absorption rate in the body falls within 80-125% of the original. For drugs with narrow therapeutic windows-like warfarin or lithium-that range tightens to 90-111%. No wiggle room. No shortcuts.
That’s why 92% of generic medicines on the list require WHO Prequalification. It’s not a stamp of approval-it’s a guarantee. Countries can trust that a prequalified generic won’t fail in storage, won’t break down in heat, and won’t contain toxic impurities. In 2022, WHO surveillance found that 10.5% of essential medicines in low-income countries were substandard or fake. Most were antibiotics and antimalarials. The WHO list fights that by forcing manufacturers to prove quality before they can even compete for public contracts.
How Countries Use the List (And Where They Struggle)
Over 150 countries have built their own national essential medicines lists based on the WHO Model List. In Ghana, adopting the WHO guidelines cut out-of-pocket medicine costs by 29% between 2018 and 2022. In India, hospitals using WHO-recommended antibiotic tiers reduced antimicrobial spending by 35%. In Kenya, the government now buys 85% of its HIV drugs through UN agencies that only source prequalified generics.
But not every country succeeds. In Nigeria, only 41% of essential medicines on the national list were consistently available in 2022. Stockouts lasted an average of 58 days per medicine. Why? Not because the list was wrong. Because the supply chain broke. No cold storage. No transport. No budget. The WHO list doesn’t fix logistics. It just tells you what to fix.
Even high-income countries use it-just differently. In the U.S., only 22% of hospital pharmacists consult the WHO list regularly. Most rely on domestic databases like Micromedex. But when U.S. hospitals run global health programs-say, in Rwanda or Haiti-they turn to the WHO list. It’s the only common language they have.
The Hidden Problem: Who Makes the Generics?
There’s a quiet vulnerability built into the system. Nearly 78% of all generic medicines are made in just three countries: India, China, and the United States. That worked fine until the pandemic. When borders closed and shipping slowed, 62% of low-income countries reported shortages of essential antibiotics. No one had backup suppliers. No one had stockpiles.
The WHO knows this. That’s why the 2023 update included new guidance on diversifying production. It’s also why more countries are now recognizing WHO Prequalification as equivalent to their own approval. In 2018, 41 countries did. By 2023, it was 63. That means a generic made in India can be approved faster in Kenya, Senegal, or Peru-without repeating expensive tests.
What’s Changing Now?
The WHO is adapting. The 2023 list added 7 biosimilars-complex biologic drugs that mimic expensive cancer treatments like rituximab and trastuzumab. For the first time, it included detailed criteria for pediatric formulations. Now, 42% of listed medicines have child-friendly versions: dispersible tablets, flavored syrups, or smaller doses. That’s up from 29% in 2019.
They’ve also launched the WHO Essential Medicines App. Downloaded over 127,000 times in 158 countries, it lets pharmacists and nurses check dosing, storage, and alternatives-even offline. In remote areas with no internet, that’s a game-changer.
And the focus is shifting. In 2015, only 5% of the Expert Committee’s time was spent on implementation challenges. In 2023, it was 20%. That’s a big signal. The WHO isn’t just listing medicines anymore. It’s helping countries actually get them.
What’s Still Missing?
For all its strengths, the list has gaps. Only 12% of new drugs approved between 2018 and 2022 made it onto the 2023 list. That’s far lower than the 35-45% adoption rate in high-income countries. Critics say the process is too slow. The WHO argues it’s too careful. New drugs often lack long-term safety data. The WHO won’t risk including something that might cause harm years later.
Another concern: 45% of the clinical trial data used to support inclusions now comes from industry-funded studies-up from 28% in 2015. Some experts worry this could bias decisions. The WHO says it now requires full financial disclosures from all committee members-and has 100% compliance. But trust isn’t just about rules. It’s about perception.
And then there’s money. Only 31% of low-income countries spend more than 15% of their health budget on medicines-the minimum WHO says is needed to keep the system running. Without funding, even the best list is just a document on a shelf.
Why This Matters to Everyone
You might think the WHO Model Formulary has nothing to do with you. But it does. When a child in Malawi gets the right antibiotic for pneumonia, it’s because of this list. When a mother in Bangladesh gets insulin for her diabetic child, it’s because of this list. When a person in Peru gets affordable HIV treatment, it’s because of this list.
It’s not glamorous. No ads. No celebrity endorsements. No stock market buzz. But it’s the quiet engine behind global health equity. It keeps medicines affordable. It keeps them safe. It keeps them available.
And as climate change, conflict, and pandemics threaten health systems everywhere, that’s more important than ever.
Is the WHO Model Formulary legally binding for countries?
No, it’s not legally binding. Countries choose whether to adopt it. But over 150 have done so because it’s the most reliable, evidence-based guide available. It’s not enforced-it’s trusted.
Can a country add medicines to the WHO list?
Not directly. Countries can submit applications for new medicines during the two-year review cycle, but only the WHO Expert Committee decides what gets included. The process is transparent, and all submissions are publicly reviewed.
Are all generics on the WHO list the same quality?
Yes-if they’re on the list. Every generic must meet WHO Prequalification standards or approval from a stringent regulator like the FDA or EMA. That means proven bioequivalence, stable manufacturing, and no harmful impurities. But generics not on the list? Those can vary wildly in quality.
Why doesn’t the WHO list include more new drugs?
The WHO prioritizes safety and long-term data over speed. New drugs often lack real-world evidence of safety, especially in vulnerable populations. The list avoids hype. It waits for proof. That’s why only 12% of new drugs approved since 2018 made it into the 2023 list.
How does the WHO Model Formulary affect drug prices?
It drives prices down. When countries use the list to negotiate bulk purchases, manufacturers compete on price. For example, the cost of generic HIV drugs dropped 89% between 2008 and 2022. Countries that follow the list spend 23-37% less on medicines without losing health outcomes.
Can private hospitals ignore the WHO list?
Yes, they can. But most public health systems, UN agencies, and global health programs use it as their standard. Private hospitals in high-income countries often use local formularies, but when they work internationally, they align with the WHO list to ensure consistency and safety.
