The WHO Model Formulary isn’t a formulary at all-not in the way hospitals or insurance companies use the term. It’s a global blueprint. A list of the medicines that every country, rich or poor, should have on hand to treat the most common and deadly diseases. And at its core? Generics. Not brand names. Not fancy packaging. Just proven, affordable, life-saving drugs that work.
First published in 1977, the WHO Model List of Essential Medicines has been updated every two years since. The latest version, released in July 2023, includes 591 medicines for 369 conditions. Nearly half of them-273-are generic versions. That’s not an accident. It’s the point.
Why Generics? Because Lives Depend on It
Imagine you’re a nurse in rural Ghana. A child comes in with pneumonia. The antibiotic you need costs $50 a dose in the private pharmacy. But if your clinic uses the WHO Model List, you can get the same drug, made to the same standard, for $1.50. That’s the power of generics.
The WHO doesn’t just recommend generics. It demands them. For a medicine to make the list, it must be cost-effective. That means it has to deliver the same clinical result as the brand-name version but at a fraction of the price. The WHO uses strict benchmarks: a medicine must cost less than three times the country’s GDP per capita per quality-adjusted life year gained. Most generics clear that bar easily.
And it works. Since 2008, the price of generic HIV antiretrovirals has dropped by 89%. In 2003, fewer than a million people worldwide were on treatment. Today, nearly 30 million are. That’s not because of new drugs. It’s because generics made them accessible.
How the WHO Picks What Makes the List
It’s not a vote. It’s not lobbying. It’s science.
Every two years, 25 independent experts from 18 countries meet to review hundreds of applications. Each medicine is scored across four areas: public health need (30%), proven safety and effectiveness (30%), cost-effectiveness (25%), and whether it can actually be used in real-world settings (15%). A medicine needs at least a 7.5 out of 10 overall to be included.
The evidence has to be solid. Randomized trials. Systematic reviews. Meta-analyses. No anecdotal data. No marketing claims. In 2023, 94% of inclusions were backed by high-quality research. That’s why the list is trusted-even by countries that don’t always follow it.
And quality? Non-negotiable. Every generic on the list must meet WHO Prequalification standards. That means it’s been tested for bioequivalence: it must deliver the same amount of active ingredient into the bloodstream as the original drug, within a tight range (80-125% for most drugs, even tighter for drugs like warfarin or levothyroxine). In 2023, 92% of the generics on the list had passed this test.
What’s on the List-and What’s Not
The 2023 list covers everything from antibiotics for sepsis to insulin for diabetes, from painkillers for childbirth to medicines for childhood malaria. Antibiotics and antivirals make up nearly half the list. Cardiovascular drugs come second. Cancer medicines are growing fast.
But it’s selective. Not every new drug gets in. Between 2018 and 2022, only 12% of newly approved novel therapies made the list. That’s not because they’re bad. It’s because they’re expensive. A new cancer drug costing $150,000 a year doesn’t meet the cost-effectiveness threshold for a low-income country. The WHO isn’t ignoring innovation-it’s prioritizing what works for the most people.
There’s also no “tiered pricing” like in U.S. insurance plans. No “preferred” or “non-preferred” list. No copays. The WHO doesn’t care how much you pay out of pocket. It only cares if the drug is effective, safe, and affordable enough to be available in every clinic, every pharmacy, every emergency room.
How Countries Use It (and Why They Struggle)
Over 150 countries have created their own national essential medicines lists based on the WHO’s. In Africa, 92% of countries do. In Ghana, using the WHO list cut out-of-pocket medicine spending by 29% between 2018 and 2022. In India, switching to WHO-recommended antibiotics lowered antimicrobial costs by 35%.
But adoption doesn’t mean availability. A 2022 survey in Nigeria found that only 41% of medicines on the national list were consistently in stock. Stockouts averaged 58 days per drug. Why? Not because the list was wrong. Because supply chains broke down. Because funding was unpredictable. Because logistics in remote areas are still a nightmare.
Even when the drugs are there, quality is a problem. WHO surveillance found that 10.5% of essential medicine samples in low- and middle-income countries were substandard or falsified-mostly antibiotics and antimalarials. The WHO’s Prequalification system helps, but it can’t catch everything.
Generics vs. Brand Names: The Real Difference
There’s a myth that generics are “weaker” or “less reliable.” They’re not. They contain the exact same active ingredient, in the same dose, with the same intended effect. The only differences? The name on the bottle. The color of the pill. The packaging. And the price-often 80-90% lower.
Some countries resist generics because of pressure from brand-name manufacturers. In Latin America, generic substitution rates are 32% lower than in Africa, largely due to lobbying and misinformation. In the U.S., hospital pharmacists rarely consult the WHO list-only 22% do. Instead, they rely on domestic databases like Micromedex. Why? Because the U.S. system is built around profit, not public health. The WHO list doesn’t fit that model.
But in places where health is a right, not a privilege, the WHO list is gospel. It’s why a child in Malawi can get an asthma inhaler. Why a mother in Bangladesh can get oxytocin to stop bleeding after birth. Why a man in Uganda can get antiretrovirals and live to see his grandchildren.
What’s New in 2023-and What’s Coming
The 2023 update made big changes. For the first time, it included seven biosimilars-generic versions of complex biologic drugs used in cancer and autoimmune diseases. These require even stricter testing: bioequivalence must fall within 85-115%, not just 80-125%.
It also added more pediatric formulations. In 2019, only 29% of listed medicines had child-friendly versions. Now it’s 42%. That matters. A child can’t swallow a 500mg tablet meant for an adult. The WHO now insists on syrups, dispersible tablets, and age-appropriate dosing.
In September 2023, the WHO launched a free app that lets health workers search the list by disease, age group, or drug class. It’s been downloaded over 127,000 times in 158 countries. That’s real-world impact.
Looking ahead, the WHO is pushing to link the list directly to Universal Health Coverage goals. The target? Get essential medicine availability in primary care from 65% to 80% by 2030. But that won’t happen without money. Only 31% of low-income countries spend more than 15% of their health budget on medicines-the level WHO says is needed to make the list work.
The Bigger Picture
The WHO Model Formulary isn’t just about drugs. It’s about equity. It’s about saying: no one should die because they can’t afford a pill. That’s why it’s the most influential health policy document in the world.
It’s not perfect. It’s slow. It’s underfunded. It can’t fix broken supply chains or corrupt distributors. But it sets the standard. It gives countries a roadmap. And it gives manufacturers a target: make quality generics, get WHO Prequalified, and you’ll be in demand across the globe.
For every $1 spent on essential medicines through WHO-backed programs, $10 is saved in hospital costs, lost productivity, and preventable deaths. That’s the return on investment. And it’s all built on the simple idea that medicine should be a right-not a luxury.
Is the WHO Model Formulary legally binding?
No, it’s not legally binding. Countries choose whether to adopt it. But over 150 have, because it’s the most trusted, evidence-based guide for selecting affordable, effective medicines. It’s not law-it’s a recommendation that’s been proven to save lives and money.
Are all generics on the WHO list safe?
Yes-if they’ve passed WHO Prequalification. Every generic on the list must meet strict standards for bioequivalence, purity, and manufacturing quality. But the list doesn’t control what’s sold in local markets. Substandard or fake medicines still exist, especially where regulation is weak. That’s why WHO Prequalification is critical: it’s the gold standard for quality.
Why doesn’t the WHO include more new drugs?
Because most new drugs are too expensive for low-income countries. The WHO prioritizes medicines that treat the biggest health problems-like malaria, TB, HIV, and hypertension-and that can be made affordably. A $200,000 cancer drug might be life-saving, but if no clinic can afford it, it doesn’t belong on a global essential medicines list.
Can high-income countries use the WHO list?
Absolutely. Many U.S. hospitals and global health programs use it as a reference for international work. But domestic formularies often focus on profit-driven models, not public health. The WHO list doesn’t replace local guidelines-it complements them, especially when treating patients from low-resource settings.
How do generics get WHO Prequalification?
Manufacturers submit detailed data on manufacturing processes, bioequivalence studies, and quality control. WHO tests samples independently and inspects factories. It takes 12-24 months. Only about 1 in 3 applicants pass. But once approved, the drug can be bought by UN agencies, global health funds, and governments worldwide.
What’s the biggest challenge to the WHO Model Formulary today?
Supply chain fragility. Over 78% of generic medicine production is concentrated in just three countries: India, China, and the U.S. When one of them faces a disruption-like a pandemic, trade ban, or factory shutdown-hundreds of countries face shortages. The WHO is pushing for more diversified manufacturing, but progress is slow.
