WHO Model Formulary: Global Standards for Essential Generic Medicines
Jonathan Neal
The WHO Model Formulary isn’t a list you’ll find on a hospital shelf or in an insurance plan. It’s something far more powerful: the world’s most trusted guide for which generic medicines every country, rich or poor, should have available to save lives. Created and updated every two years by the World Health Organization, this list isn’t about profit, marketing, or convenience. It’s about survival.
Think of it this way: if you’re a doctor in a rural clinic in Malawi or a pharmacist in a public hospital in Bangladesh, you don’t have access to hundreds of drug options. You need to know exactly which medicines work, are safe, and can actually be bought and stocked. That’s what the WHO Model List of Essential Medicines - often mistakenly called a formulary - gives you. The 2023 version includes 591 medicines for 369 conditions. Nearly half of them, 273, are generic versions of life-saving drugs. And that’s by design.
Why Generics Are the Core of Global Health
Brand-name drugs can cost 10 to 100 times more than their generic equivalents. In low-income countries, that difference is the difference between treatment and death. The WHO doesn’t just recommend generics - it insists on them. Why? Because generics with proven quality work just as well. And they make universal health coverage possible.
The list doesn’t just say “use generics.” It demands they meet strict standards. Every generic medicine on the list must pass WHO Prequalification. That means independent labs have tested it to prove it releases the same amount of active ingredient into the body as the original brand - within 80% to 125% of the reference drug. For drugs with narrow safety margins, like warfarin or digoxin, that range tightens to 90% to 111%. No guessing. No risky substitutes.
That’s why 92% of the generic medicines on the list require WHO Prequalification. It’s not a suggestion. It’s a requirement for any country or global agency - like the Global Fund or UNICEF - to buy them in bulk. In 2023, $15.8 billion in global medicine purchases followed this rule. That’s billions in savings, redirected from corporate profits to patient care.
How Medicines Make the List
Getting onto the WHO Model List isn’t easy. It’s not about popularity or lobbying. It’s about hard data. Each candidate medicine goes through a four-part scoring system reviewed by 25 independent experts from 18 countries.
- Public health relevance (30%): Does it treat a disease that affects at least 100 people per 100,000? Think malaria, HIV, hypertension, or postpartum hemorrhage.
- Efficacy and safety (30%): Must be backed by high-quality clinical trials - randomized, controlled, and replicated.
- Cost-effectiveness (25%): Is it worth the money? The medicine must offer value - ideally, costing less than three times the country’s GDP per capita per quality-adjusted life year gained.
- Programmatic feasibility (15%): Can it be stored, distributed, and used in low-resource settings? Does it need refrigeration? Special training? Lab tests?
A medicine needs at least a 7 out of 10 in each category and an overall score of 7.5 to be included. In 2023, 217 applications were reviewed. Only a fraction made the cut. This isn’t politics. It’s science.
What’s on the List - And What’s Missing
The 2023 list breaks down like this:
- 49%: Antibiotics, antivirals, antifungals
- 22%: Cardiovascular drugs
- 12%: Cancer treatments
- 17%: Everything else - diabetes, mental health, pain, vaccines
There are no trendy new drugs just because they’re flashy. Only 12% of medicines approved between 2018 and 2022 made it into the 2023 list. That’s a problem some experts point to. In high-income countries, new cancer drugs or rare disease treatments get added fast. But the WHO waits for proof they’re not just expensive - they must be better and accessible.
That’s why the list includes only one medicine for many conditions - even if multiple brands exist. If one generic does the job safely and cheaply, adding others wastes money and confuses supply chains. The goal isn’t choice. It’s effectiveness.
How Countries Use It - And Where It Falls Short
Over 150 countries have built their own national essential medicines lists using the WHO model as a foundation. In Ghana, after aligning their national list with the WHO, out-of-pocket medicine spending dropped by 29% between 2018 and 2022. In India, hospitals cut antimicrobial costs by 35% after switching to WHO-recommended generic tiers.
But adoption doesn’t mean availability. In Nigeria, a 2022 survey found that only 41% of essential medicines on the national list were consistently in stock. The problem wasn’t the list - it was broken supply chains, poor funding, and corruption. In many low-income countries, the WHO list is a great plan with no money to execute it. Only 31% of low-income countries spend more than 15% of their health budget on medicines - the minimum WHO says is needed.
Another gap? Pediatric dosing. Many medicines on the list come in adult tablets or injections. Children need syrups, chewables, or smaller doses. In 2023, only 42% of listed medicines had age-appropriate formulations - up from 29% in 2019, but still far from enough.
The Generics Supply Chain: A Global Weak Point
Most generic medicines are made in just three countries: India, China, and the United States. That’s efficient - until it’s not. During the pandemic, 62% of low-income countries reported shortages of essential antibiotics because factories shut down or export rules changed.
And then there’s the problem of fake or substandard drugs. WHO surveillance found that 10.5% of essential medicine samples in low- and middle-income countries were poor quality - especially antibiotics and antimalarials. Even if the WHO approves a generic, if it’s smuggled, mislabeled, or diluted, it won’t work. That’s why WHO Prequalification matters - it’s the only global stamp of trust.
Since 2018, the number of prequalified generic products has jumped 47%. More manufacturers are seeking approval because public buyers - from UN agencies to African governments - only purchase prequalified drugs. That’s creating real market pressure for quality.
How It’s Changing - And What’s Next
The WHO isn’t stuck in the past. The 2023 update added seven biosimilars - cheaper versions of complex biologic drugs used for cancer and autoimmune diseases. That’s huge. These used to be too expensive for low-income countries. Now, they’re on the list, with strict bioequivalence rules: 85% to 115% similarity to the original.
They also launched the WHO Essential Medicines App in September 2023. It’s been downloaded over 127,000 times in 158 countries. Pharmacists can search by condition, check dosing, and see which generics are approved. No internet? The app works offline.
Future updates will tie the list even closer to fighting antimicrobial resistance. New guidelines, released in early 2024, ask countries to group antibiotics into tiers - like “first-line,” “reserve,” and “last-resort” - to prevent overuse. This isn’t just about access anymore. It’s about smart use.
By 2030, the WHO aims to get essential medicine availability in primary care clinics from 65% to 80%. That’s the goal. But it won’t happen without better funding, stronger supply chains, and more local training.
Why This Matters Everywhere
You might think this is just a global health issue. But it’s not. The same generics on the WHO list are the same ones used in U.S. public hospitals, Medicaid programs, and VA pharmacies. The FDA and EMA often rely on WHO data to evaluate new generics. When a generic from India gets WHO Prequalification, it’s easier for it to be approved in the U.S. or Europe too.
The WHO Model List is the quiet engine behind affordable medicine worldwide. It’s why a month’s supply of generic HIV drugs costs $119 today instead of over $1,000 in 2008. It’s why a child in Kenya can get antibiotics for pneumonia without her family selling their land. It’s why millions of people alive today have access to treatment because the world decided - based on evidence, not profit - that some medicines are too important to be left to the market.
This isn’t about idealism. It’s about survival. And the list keeps getting better - not because it’s perfect, but because it’s honest, transparent, and stubbornly focused on what works.
Is the WHO Model Formulary the same as a hospital formulary?
No. A hospital formulary is a local list of drugs approved for use in that facility, often with tiered pricing and prior authorization rules. The WHO Model List is a global recommendation focused on which medicines should be available in any health system - especially where resources are limited. It doesn’t dictate how hospitals use them, just which ones they should have.
Are all generics on the WHO list safe?
Only those with WHO Prequalification. The list includes only generics that have passed strict testing for quality, potency, and bioequivalence. But once a medicine leaves the approved supply chain, counterfeit or substandard versions can enter the market. That’s why procurement through trusted channels matters.
Why doesn’t the WHO include more new drugs?
The WHO waits for proof that a new drug is not just effective, but also affordable and practical in low-resource settings. Many new drugs are expensive, require complex storage, or need monitoring that isn’t available in rural clinics. The goal is to save the most lives with the fewest resources - not to follow pharmaceutical trends.
Can a country ignore the WHO Model List?
Yes, but it’s rare. Over 150 countries use it as a foundation for their own lists. Ignoring it usually means higher costs, inconsistent care, and difficulty accessing global funding. Countries that align with the list get priority support from UN agencies and global health funds.
How often is the WHO Model List updated?
Every two years. The most recent version is the 23rd edition, published in July 2023. The next update is expected in 2025. Changes are based on new evidence, public health needs, and feedback from countries.
What Comes Next?
If you’re a policymaker, the next step is simple: align your national list with the WHO Model List and fund it. If you’re a pharmacist, start using the WHO Essential Medicines App to verify generics. If you’re a student or advocate, push for transparency in medicine procurement in your country.
The WHO Model Formulary isn’t just a document. It’s a tool - one that’s saved millions of lives because it refuses to compromise on what matters: safety, affordability, and access. The question isn’t whether we need it. It’s whether we’ll use it well.
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