TRIPS Agreement and Generic Medicine Access: How Patent Rules Shape Global Health

When you need a life-saving drug, the price shouldn’t depend on where you live. But for billions of people, it does. The TRIPS Agreement-a global rulebook for intellectual property-has made that reality worse, not better. Signed in 1994 and enforced since 1995, the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) forced every World Trade Organization (WTO) member to grant 20-year patents on pharmaceuticals. That sounds fair on paper. But in practice, it turned life-saving medicines into luxury goods in poor countries.

How TRIPS Changed the Game for Generic Drugs

Before TRIPS, countries like India, Brazil, and Thailand could make their own versions of patented drugs. They didn’t have to wait for a company to decide to sell them. They just copied the formula, made the pills, and sold them for 5% to 10% of the original price. In the 1990s, HIV medicines cost over $10,000 a year per patient in the U.S. In India, the same drugs cost $350. That difference saved millions of lives.

TRIPS changed that. It said: no more copying. Every country had to protect pharmaceutical patents like they protect a new iPhone design. The result? Generic drug makers in developing nations lost their legal right to produce affordable versions. The World Health Organization estimates that 2 billion people still can’t get the medicines they need-and patent rules are behind 80% of that gap.

The Flexibilities That Were Supposed to Help

TRIPS wasn’t meant to be cruel. It included escape hatches called “flexibilities.” The biggest one? Compulsory licensing. That’s when a government says, “We’re going to let someone else make this drug, even if the patent holder says no.” It’s legal under TRIPS. So why don’t more countries use it?

Because it’s almost impossible. The process is full of paperwork, legal threats, and political pressure. In 2006, Thailand used compulsory licensing for three key drugs-HIV, heart disease, and cancer-and slashed prices by 30% to 80%. The U.S. responded by pulling away trade benefits, costing Thailand $57 million a year in lost exports. That’s not a coincidence. It’s a warning: use your rights, and you’ll be punished.

The 2005 amendment to TRIPS tried to fix one big flaw: what if your country doesn’t make drugs at all? The new rule, called Article 31bis, lets countries import generics made under license in another country. Sounds perfect. But only one country has ever used it: Rwanda, in 2008. It took four years to get a shipment of HIV medicine from Canada. Médecins Sans Frontières called it “unworkable.” The system required 78 steps across two governments. Most low-income countries don’t even have a single full-time employee assigned to handle this.

Why Voluntary Licenses Don’t Solve the Problem

Pharmaceutical companies sometimes offer “voluntary licenses” to generic makers. The Medicines Patent Pool (MPP) is the main platform for this. It’s supposed to be a win-win: companies get paid, patients get cheaper drugs.

But here’s the catch: MPP covers only 44 patented medicines out of over 10,000. Most are for HIV. Cancer drugs? Rare. Diabetes? Almost never. And 73% of these licenses only apply to sub-Saharan Africa-even though diseases like hepatitis C and tuberculosis hit Asia and Latin America just as hard. The system doesn’t fix the root problem. It just lets companies pick who gets help.

Meanwhile, countries like Brazil and South Africa used to make and export their own generics. Brazil produced antiretrovirals for 127 countries before TRIPS locked them out. Now, they’re forced to pay inflated prices or do nothing.

TRIPS-Plus: The Hidden Rules That Make Things Worse

The real problem isn’t just TRIPS. It’s what comes after it: TRIPS-plus.

Bilateral trade deals-like the one between the U.S. and Jordan in 2011-add extra restrictions. They extend patent terms beyond 20 years. They delay generic approval until the patent expires, even if the drug is safe. They block parallel imports. These rules aren’t part of the WTO. They’re buried in trade agreements that developing countries are pressured to sign.

A 2021 WTO report found that 86% of WTO members have slipped in TRIPS-plus clauses. The result? An estimated $2.3 billion in lost savings every year across 34 low- and middle-income countries. That’s money that could buy millions of pills.

The Human Cost of Legal Barriers

Behind every statistic is a person who couldn’t afford treatment.

In 2001, 39 drug companies sued South Africa for trying to import cheap HIV drugs. The world protested. The lawsuit was dropped. But the message was clear: even trying to save lives could trigger legal war.

In 2017, a study of 105 developing countries found that 83% had never issued a single compulsory license-not because they didn’t need to, but because they were afraid. Fear of trade sanctions. Fear of losing aid. Fear of being labeled “uncooperative.”

The UN High-Level Panel on Access to Medicines called this “institutionalized inequity.” They documented 423 cases between 2007 and 2015 where countries were threatened with retaliation for using their legal rights. That’s not policy. That’s coercion.

What’s Changed Since COVID-19?

The pandemic exposed the system’s fragility. In 2020, India and South Africa asked the WTO to temporarily suspend TRIPS protections for COVID vaccines and treatments. After two years of delays and compromises, the WTO approved a partial waiver in June 2022. It only covers vaccines-not tests, not pills, not future treatments.

That’s a start. But it’s not enough. The UN’s 2024 Pandemic Meeting called for full TRIPS reform. The WHO now says digital health tools-like AI diagnostics and telemedicine software-should also be covered by access rules. The debate is expanding beyond pills to include the entire health technology ecosystem.

The Future: Will TRIPS Be Reformed?

Right now, 58 countries are negotiating new trade deals that include TRIPS-plus rules. The WTO has 12 active disputes over medicine access. The UN Development Programme predicts that without change, 3.2 billion people will lack access to essential medicines by 2030.

Some progress is happening. Seven of the top 10 drug companies now say they consider “human rights” in their pricing. But only 14% of their patented drugs actually have access programs attached. That’s not accountability. That’s PR.

The truth is simple: the TRIPS Agreement was designed to protect corporate profits, not public health. The flexibilities were never meant to be the main solution-they were a Band-Aid on a broken system.

Countries that want real change need to do three things: pass laws that make compulsory licensing easy, refuse to sign TRIPS-plus trade deals, and demand that the WTO remove barriers to generic production. The tools are there. The will is not.

What You Can Do

If you live in a wealthy country, your voice matters. Pressure your government to support global access. Demand that your country doesn’t pressure others to abandon their legal rights. Support organizations like Médecins Sans Frontières and Health Action International that track these issues.

If you live in a low-income country, know your rights. Compulsory licensing is legal. You’re not breaking the law-you’re enforcing it. The real enemy isn’t the patent holder. It’s the silence around the issue.

The system isn’t broken because it’s poorly designed. It’s broken because it was designed exactly as intended-to protect profits over people.