The WHO Model Formulary isn’t a list you find on a hospital shelf or in a pharmacy’s computer system. It’s the global blueprint that tells countries what medicines every person should be able to get - no matter where they live, how much money they have, or whether their health system is broken or barely working. This isn’t about luxury drugs or cutting-edge treatments only available in wealthy clinics. It’s about the basics: antibiotics that cure pneumonia, insulin that keeps diabetics alive, antiretrovirals that turn HIV from a death sentence into a manageable condition. And nearly half of them? Generics. Cheap, proven, and life-saving.
What the WHO Model List Actually Does
The official name is the WHO Model List of Essential Medicines (EML). It’s been around since 1977, updated every two years, and now includes 591 medicines for 369 conditions. The list is split into two parts: the core list and the complementary list. The core list? That’s the bare minimum. These are the medicines any basic health center - even in a remote village - should have on hand. The complementary list? These are for more complex cases, needing special equipment or trained staff, like cancer drugs or advanced diabetes treatments.
It’s not a formulary in the way U.S. insurance plans are. Those divide drugs into tiers with different co-pays. The WHO doesn’t care about patient co-pays. It cares about whether a medicine works, is safe, and costs less than alternatives. If a generic version of a drug is just as effective as the brand-name one - and costs 90% less - the WHO puts the generic on the list. Every time.
Here’s the kicker: 46% of all medicines on the list are generics. That’s 273 life-saving drugs that are no longer under patent, made by manufacturers anywhere in the world. But here’s what makes the WHO list different from just any generic list: every single one must meet strict quality standards. They need to pass WHO Prequalification - meaning they’ve been tested to prove they’re as good as the original. That’s not just about being cheap. It’s about being reliable. A fake or substandard antibiotic can kill someone faster than the infection it’s meant to treat.
How Medicines Make the List
Getting on the WHO Model List isn’t easy. It’s not based on lobbying, marketing, or political pressure. It’s based on cold, hard science. Each application gets 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%). To get in, a medicine must score at least 7 out of 10 in each category, and an overall 7.5.
For effectiveness, they demand the highest level of evidence: randomized controlled trials. Not anecdotes. Not small studies. Real data. For cost-effectiveness, they look at whether the medicine gives you more healthy life years for your money. If it costs more than three times a country’s GDP per person per quality-adjusted life year saved, it’s unlikely to make the cut. That’s why expensive new cancer drugs rarely appear - they’re often too costly for low-income systems, even if they work.
The selection committee? Twenty-five independent experts from 18 countries. Doctors, pharmacists, public health specialists. No pharmaceutical reps. No lobbyists. In 2023, they reviewed 217 applications. Only a handful made it.
Why Generics Matter - And How the WHO Makes Them Work
Generics aren’t just cheaper. They’re the reason millions of people in Africa, South Asia, and Latin America can access treatment at all. Take HIV drugs. In 2008, a year’s supply cost over $1,000. Today? $119. That’s because the WHO pushed for generic versions and made sure they met quality standards. The result? From 800,000 people on treatment in 2003, we’re now at nearly 30 million. That’s not magic. That’s policy.
The WHO doesn’t just say “use generics.” It gives exact rules. For a generic to be approved, it must show bioequivalence: the amount of drug in your blood must be within 80-125% of the original. For drugs with a narrow therapeutic window - like warfarin or lithium - that range tightens to 90-111%. That’s not a suggestion. It’s a requirement for procurement by UN agencies, the Global Fund, and Gavi.
And it’s working. Countries that fully adopt the WHO list cut their pharmaceutical spending by 23-37%. In Ghana, out-of-pocket spending on medicines dropped 29% between 2018 and 2022. In India, hospitals saved 35% on antibiotics after switching to WHO-recommended generics. But here’s the problem: availability doesn’t always follow policy.
The Gap Between Policy and Reality
Just because a medicine is on the list doesn’t mean it’s in the pharmacy. In Nigeria, a 2022 survey found only 41% of essential medicines were consistently available. Stockouts lasted an average of 58 days per drug. Why? Not because the list was wrong. Because the supply chain broke. Poor roads, corrupt distributors, lack of cold storage for insulin, underfunded procurement systems - these are the real enemies.
Even when medicines arrive, quality is still a risk. WHO surveillance found 10.5% of essential medicine samples in low- and middle-income countries were substandard or falsified. Antibiotics and antimalarials were the worst offenders. Fake malaria pills? They don’t just waste money. They breed drug-resistant parasites.
And then there’s the issue of adaptation. The WHO list doesn’t tell you how to give a child the right dose. It doesn’t say what to do when your electricity fails and you can’t refrigerate vaccines. It doesn’t explain how to train community health workers to dispense medicines in villages without pharmacies. That’s where countries fail. 68% of low-income countries say they struggle to adapt the list to their local reality.
Global Influence and Industry Shifts
The WHO Model List doesn’t just guide countries - it moves markets. Around $15.8 billion in global medicine procurement follows its recommendations. The Global Fund buys 85% of its drugs based on the list. Generic manufacturers now chase WHO Prequalification like gold. Why? Because it’s the ticket to public tenders in dozens of countries. Between 2018 and 2023, the number of prequalified generic products jumped 47%.
More than 60 countries now accept WHO Prequalification as proof of quality - no need for duplicate testing. That’s huge. It cuts red tape and speeds up access. But the market is still lopsided. 78% of generic production happens in just three countries: India, China, and the U.S. That’s dangerous. During the pandemic, 62% of low-income countries faced shortages because supply chains snapped. One country’s lockdown = another country’s medicine crisis.
High-income countries don’t use the WHO list directly. U.S. hospitals rely on Micromedex or Lexicomp. Only 22% of U.S. pharmacy directors consult the WHO list regularly. But they use it indirectly - when funding global health programs, when supporting research, when deciding which generics to stock for international aid.
What’s New and What’s Next
The 2023 update brought big changes. For the first time, it included biosimilars - cheaper versions of complex biologic drugs like monoclonal antibodies used in cancer and autoimmune diseases. Seven were added, with stricter bioequivalence rules: 85-115%. That’s a win for patients who need these drugs but can’t afford the original $100,000-a-year price tag.
Pediatric formulations? Now 42% of listed medicines have child-friendly versions - syrups, dispersible tablets, smaller doses. That’s up from 29% in 2019. A child shouldn’t have to swallow a whole adult pill cut in half.
The WHO also launched a free app in September 2023. Over 127,000 downloads across 158 countries. Pharmacists in rural clinics use it to check dosing, interactions, and availability. It’s simple. No internet needed after download.
Looking ahead, the WHO is tying the list to Universal Health Coverage goals. By 2030, they want essential medicine availability in primary care to rise from 65% to 80%. That means fixing supply chains, training staff, and - critically - funding. Only 31% of low-income countries spend more than 15% of their health budget on medicines. WHO says that’s the minimum to make it work.
The Bigger Picture
The WHO Model Formulary isn’t perfect. It’s slow to add new drugs. Only 12% of novel therapeutics approved between 2018 and 2022 made it onto the 2023 list. Critics say it’s too cautious. Others say it’s too influenced by industry-funded studies - 45% of evidence now comes from pharma-sponsored trials, up from 28% in 2015. The WHO says it’s tightened conflict-of-interest rules. All committee members now disclose financial ties. Full compliance in 2023.
But here’s what’s undeniable: before the WHO Model List, many countries had no list at all. Medicine access was random, expensive, and often deadly. Now, over 150 countries have national lists based on it. Millions of people get life-saving drugs because of it. It’s not a cure-all. But it’s the closest thing we have to a global health safety net.
It’s not about which drug is flashiest. It’s about which one saves the most lives, for the least cost, with the least risk. That’s the standard. And it’s working.
Is the WHO Model Formulary legally binding?
No, it’s not legally binding. Countries aren’t forced to follow it. But nearly all of them do - because it’s the most trusted, evidence-based guide available. When donors like the Global Fund or UNICEF fund medicine purchases, they require WHO-listed drugs. That makes it a de facto standard.
Are all generics on the WHO list safe?
Only those that pass WHO Prequalification or equivalent approval from agencies like the FDA or EMA. The WHO doesn’t just accept any generic. Each must prove bioequivalence and quality through independent testing. But even then, supply chain problems mean fake or degraded medicines sometimes slip through - especially in places with weak regulation.
Why doesn’t the WHO include more new drugs?
The WHO prioritizes affordability and public health impact over novelty. Many new drugs are expensive, with limited evidence in low-resource settings. A $50,000 cancer drug that helps 10% of patients doesn’t make the list if a $10 generic antibiotic saves hundreds. The focus is on what works for the most people, not the latest science.
Can low-income countries afford to implement the WHO list?
They can - if they prioritize it. The list reduces spending by focusing on cost-effective generics. But many lack the systems to buy, store, and distribute medicines. The real barrier isn’t the cost of drugs - it’s weak health systems. Investment in supply chains, training, and procurement is just as important as the list itself.
How does the WHO Model List compare to U.S. insurance formularies?
They serve opposite purposes. U.S. formularies are designed to control costs for insurers - they limit choices, push patients toward cheaper options, and use tiered co-pays. The WHO list is designed to maximize access and health outcomes. It doesn’t care about co-pays. It only cares if a medicine saves lives and works for everyone - not just those who can pay.
caroline hernandez
February 3, 2026 AT 19:11The WHO Model Formulary is a foundational pillar in achieving Universal Health Coverage-period. By prioritizing cost-effectiveness and public health impact over commercial interests, it creates a scalable framework for low-resource settings. The emphasis on WHO Prequalification ensures that generics aren’t just cheap-they’re clinically reliable. This isn’t just policy; it’s a public health imperative. When you look at the 273 generic drugs on the list, you’re seeing the difference between life and death for millions who’d otherwise be priced out of care. The real win? The 47% increase in prequalified generics since 2018. That’s market transformation driven by evidence, not lobbying.