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WHO Model Formulary: International Standards for Essential Generics

WHO Model Formulary: International Standards for Essential Generics

The WHO Model List of Essential Medicines isn’t just a list. It’s the global blueprint for what medicines every health system - no matter how poor or remote - should have on hand. First published in 1977, this living document is updated every two years by the World Health Organization. As of 2023, it includes 591 medicines covering 369 conditions, and nearly half of them are generics. These aren’t just cheap alternatives. They’re the backbone of affordable, life-saving care for over 80% of the world’s population.

What Makes a Medicine ‘Essential’?

The WHO doesn’t pick medicines based on popularity or profit. Every drug on the list must meet strict, evidence-based criteria. It has to work. It has to be safe. And it has to be affordable. The selection process is rigorous. Each medicine is scored across four areas: public health need (30%), proven efficacy and safety (30%), cost-effectiveness (25%), and whether it can realistically be used in a low-resource setting (15%). To make the list, a medicine needs at least a 7.5 out of 10 overall score.

For example, a medicine must show clear results from high-quality clinical trials - usually randomized controlled studies. It must also be cost-effective, meaning the health benefit it delivers per dollar spent shouldn’t exceed three times the country’s GDP per capita. And it must treat a condition that affects at least 100 people per 100,000. That’s how the WHO filters out niche drugs and focuses on what actually moves the needle for public health.

Core vs. Complementary: Two Lists, One Goal

The WHO Model List isn’t one big pile of drugs. It’s split into two parts: the core list and the complementary list. The core list includes the minimum set of medicines needed for a basic health system - things like antibiotics for pneumonia, insulin for diabetes, and antiretrovirals for HIV. These are medicines that can be managed by community health workers, need no special equipment, and are safe for most patients.

The complementary list includes medicines that require more expertise or infrastructure. Think cancer drugs needing lab monitoring, or anticoagulants requiring regular blood tests. These aren’t less important - they’re just harder to deliver. Countries with stronger health systems use both lists. Low-income countries often start with the core list and build up over time.

Why Generics? The Power of Affordability

Of the 591 medicines on the 2023 list, 273 are generics. That’s 46%. And that’s by design. The WHO knows that branded drugs are often unaffordable in places where people live on less than $2 a day. Generics make treatment possible. For example, the price of generic HIV antiretrovirals dropped by 89% between 2008 and 2023 - from over $1,000 per patient per year to just $119. That’s what allowed treatment to scale from 800,000 people in 2003 to nearly 30 million in 2022.

But not all generics are created equal. The WHO insists on quality. Every generic on the list must meet WHO Prequalification standards or be approved by a stringent regulatory authority like the FDA or EMA. That means the medicine must be bioequivalent to the original - its absorption in the body must fall within 80-125% of the branded version. For drugs with narrow therapeutic windows, like warfarin or digoxin, that range tightens to 90-111%. This isn’t just bureaucracy. It’s what keeps people from getting sick because their medicine didn’t work.

Split scene showing core essential medicines versus complex drugs in a high-contrast poster style.

How Countries Use the List - And Where It Falls Short

Over 150 countries have built their own National Essential Medicines Lists based on the WHO Model List. In Ghana, adopting these standards cut out-of-pocket medicine costs by 29% between 2018 and 2022. In India, hospitals saw a 35% drop in antibiotic spending after switching to WHO-recommended generic alternatives.

But adoption doesn’t guarantee access. In Nigeria, a 2022 survey found that only 41% of essential medicines were consistently available. Stockouts averaged 58 days per drug - not because the list was wrong, but because supply chains broke down. Warehouses ran empty. Transport failed. No list can fix that if the system around it is broken.

Another gap? Pediatric doses. Many medicines on the list come in adult tablets. But 42% of the 2023 list now includes child-friendly formulations - a big jump from 29% in 2019. Still, many clinics in rural areas don’t have liquid forms or dispersible tablets. Parents crush pills, risking wrong doses. The WHO is working on it, but implementation lags.

How It Compares to National Formularies

In the U.S., insurance formularies like Medicare Part D divide drugs into tiers - each with different co-pays. The goal isn’t health impact. It’s cost control for insurers. They must offer at least two drugs in each of 57 therapeutic categories, regardless of whether one is clearly better.

The WHO doesn’t do tiers. It doesn’t care about insurance networks or pharmacy benefit managers. It picks the best drug for the job - even if there’s only one. For example, if one antibiotic is proven safer and cheaper than all others, the WHO lists just that one. No backup. No marketing push. Just science.

U.S. hospitals rarely use the WHO list for domestic decisions. Only 22% of pharmacy directors consult it regularly, according to a 2023 ASHP survey. They rely on Micromedex or Lexicomp instead. But when U.S. NGOs run clinics in Africa or Asia, they turn to the WHO list. It’s the only global standard that aligns with real-world need, not profit margins.

A pharmacist gives a child-friendly pill to a mother in a rural clinic, with a glowing WHO app and broken supply chains in the background.

Challenges and Controversies

Even with its success, the WHO Model List faces criticism. Some experts worry about industry influence. In 2023, 45% of the evidence used to approve new drugs came from industry-funded trials - up from 28% in 2015. The WHO says it now requires full financial disclosures from its expert committee, and compliance was 100% in the last review. But the concern remains.

Another issue? New drugs. Only 12% of medicines approved between 2018 and 2022 made it into the 2023 list. In high-income countries, 35-45% of new drugs get added to formularies within a year. The WHO moves slower. It waits for long-term data, real-world use, and cost comparisons. That’s good for safety. But it leaves patients waiting for breakthroughs like newer hepatitis C cures or targeted cancer drugs.

And then there’s the supply problem. 78% of generic medicine production is concentrated in just three countries: India, China, and the U.S. When the pandemic hit, 62% of low-income countries faced shortages of essential antibiotics. The system is efficient - until it isn’t.

What’s Changing Now?

The 2023 update brought big shifts. For the first time, it included biosimilars - cheaper versions of biologic drugs like monoclonal antibodies used in cancer and autoimmune diseases. Seven were added, with strict bioequivalence rules: 85-115% similarity to the original.

The WHO also launched a free app in September 2023. It’s been downloaded 127,000 times in 158 countries. Pharmacists in rural Kenya and clinics in Bolivia use it to check dosing, contraindications, and availability. It’s not fancy, but it works where internet is spotty and books are scarce.

Future updates will tie the list more closely to Universal Health Coverage goals. By 2030, the WHO wants to raise access to essential medicines in primary care from 65% to 80%. That means not just listing drugs - but ensuring they’re stocked, prescribed correctly, and paid for.

The Bottom Line

The WHO Model List of Essential Medicines isn’t perfect. It’s slow. It’s complex. It doesn’t solve supply chain chaos or underfunded health systems. But it’s the only global standard that puts health over profit. It’s why a child in Malawi can get antibiotics for pneumonia. Why a mother in Bangladesh can buy insulin for her son. Why millions aren’t dying because the medicine they needed was too expensive.

It’s not a formulary in the way U.S. insurers use the word. It’s a promise. A promise that no matter where you live, you deserve access to the medicines that save lives. And for the billions who rely on generics, that promise is kept - one low-cost pill at a time.

Is the WHO Model List the same as a national formulary?

No. The WHO Model List is a global recommendation that identifies which medicines should be available based on public health need, safety, and cost. National formularies are country-specific and include implementation rules like cost-sharing, prescribing limits, and pharmacy tiers. Many countries use the WHO list as a starting point, but they adapt it to local budgets, disease patterns, and supply chains.

Are all generics on the WHO list safe?

Only those that meet WHO Prequalification standards or are approved by stringent regulators like the FDA or EMA. These generics must prove they’re bioequivalent to the original drug - meaning they work the same way in the body. The WHO tests samples globally and has found that 10.5% of essential medicines in low-income countries are substandard or falsified. That’s why prequalification matters: it’s the best safeguard against fake or ineffective drugs.

Why doesn’t the WHO list more new drugs?

The WHO waits for strong, long-term evidence. New drugs often come with high prices and limited real-world data. The WHO prioritizes medicines that have proven benefits across diverse populations and can be used safely in low-resource settings. While high-income countries may add new drugs quickly based on early trials, the WHO waits for cost-effectiveness data and evidence of impact on mortality and morbidity. This slows down inclusion but protects patients from expensive, unproven treatments.

Can low-income countries afford to implement the WHO list?

It’s challenging. Only 31% of low-income countries spend more than 15% of their health budget on medicines - the level WHO recommends. Many rely on donor funding or global health programs like the Global Fund, which sources 85% of its medicines from WHO-prequalified suppliers. Without external support, implementing the full list is often impossible. The focus is on starting with the core list and expanding over time as funding and capacity grow.

How does the WHO ensure generics are produced at scale?

The WHO encourages generic manufacturers to seek Prequalification. Once approved, these companies can bid on large public tenders from UN agencies, governments, and NGOs. Between 2018 and 2023, the number of prequalified generic products rose by 47%. This creates competition, lowers prices, and builds supply chains. Countries like India and China dominate production, but the WHO is working with manufacturers in Africa and Southeast Asia to diversify sources and reduce dependency.

1 Comment

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    Tina Dinh

    November 30, 2025 AT 22:56
    This is literally the reason I believe in global health equity. 🌍💖 Generics saving lives? Yes please. No cap.

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