How TRIPS Patent Rules Shape Global Access to Generic Medicines

When a life-saving drug costs $10,000 a year in one country and $75 in another, it’s not because one is richer than the other. It’s because of TRIPS-a global patent rule that decides who can make generic drugs and who can’t.

What TRIPS Actually Does

The TRIPS Agreement, created in 1995 under the World Trade Organization, forced every member country to give drug companies at least 20 years of patent protection. Before TRIPS, many developing countries didn’t even allow patents on medicines. They made their own versions using different manufacturing methods. That changed overnight. By 2010, 147 of 151 developing countries had to rewrite their laws to match TRIPS rules. The result? Prices for patented drugs jumped by 200% to 500% in places like India, Brazil, and South Africa.

TRIPS didn’t just protect patents-it added hidden barriers. Data exclusivity means regulators can’t approve a generic drug based on the original company’s clinical trial data for 5 to 10 years, even after the patent expires. That delays generics without a patent being in force. Patent linkage locks generic approval to patent status, so even if a patent is weak or disputed, the generic can’t enter the market. These aren’t in TRIPS. But rich countries slipped them into trade deals anyway. Today, 85% of U.S. free trade agreements include these extra restrictions.

Compulsory Licensing: The Loophole That Almost Didn’t Work

TRIPS does have a safety valve: compulsory licensing. If a country faces a health emergency, it can let a local company make a generic version without the patent holder’s permission. But here’s the catch: the license must be used mostly for the domestic market. That meant countries without drug factories-like Rwanda or Malawi-couldn’t import cheaper generics from India or Brazil, even if they had the legal right.

In 2001, the Doha Declaration said public health matters more than patents. But it didn’t fix the problem. In 2005, WTO members agreed to a workaround called the “Paragraph 6 Solution.” It allowed one country to export generics made under compulsory license to another country that couldn’t make them. Sounds simple, right? It wasn’t. The paperwork was so complex, and the rules so narrow, that only two shipments ever happened before 2016: one from Canada to Rwanda for HIV drugs, and one from Canada to Thailand for flu medicine.

Why? Because the exporting country had to prove the importer had no manufacturing capacity. The importer had to label every pill with a special code. The whole process took over a year. By the time the drugs arrived, the emergency was often over. Real-world access didn’t improve. The system was designed to look like it worked, not to actually work.

India’s Turnaround and the Global Generic Engine

India was the world’s pharmacy before TRIPS. It made cheap generics using process patents-making the same drug in a different way. When TRIPS forced India to switch to product patents by 2005, the world feared the worst. Would generics vanish? Would HIV drugs become unaffordable?

They didn’t. India’s courts and regulators pushed back. They rejected evergreening-small, meaningless patent tweaks meant to extend monopolies. They allowed generics to enter the market as soon as the real patent expired. They didn’t accept data exclusivity unless the law required it. And they kept making drugs for the rest of the world. Today, 80% of the antiretroviral drugs used in low-income countries come from India. Generic makers like Cipla and Natco don’t just save lives-they cut prices. One HIV drug dropped from $10,000 a year to $75 because of Indian generics.

But India’s success isn’t universal. Countries without strong legal systems, regulatory capacity, or political will couldn’t follow. Many African nations still struggle to approve generics because their health ministries lack staff, training, or funding. TRIPS didn’t just change laws-it demanded infrastructure. And most countries didn’t get the help they needed.

TRIPS Plus: The Hidden Rules No One Talks About

The real battle isn’t happening at the WTO. It’s happening in quiet trade talks between rich countries and smaller ones. The EU, U.S., and Switzerland push “TRIPS Plus” terms into bilateral deals. These go beyond what TRIPS requires: longer patent terms, stricter data exclusivity, patent linkage, and bans on compulsory licensing for certain diseases.

The EU-Vietnam Free Trade Agreement, signed in 2020, gives 8 years of data exclusivity-three years more than TRIPS allows. The U.S.-Morocco FTA bans compulsory licensing for all medicines, not just emergencies. These deals lock countries into stricter rules forever. Even if a country wants to use a TRIPS flex later, it’s already bound by the trade deal. And there are over 300 such agreements in force worldwide. Most developing countries signed them hoping for better market access. Instead, they traded public health for trade deals.

The Pandemic Test: Did TRIPS Change?

In 2020, India and South Africa asked the WTO to temporarily waive TRIPS protections for COVID-19 vaccines and treatments. Over 100 countries supported it. The U.S., EU, and Switzerland blocked it for over a year. They argued that patents were needed to drive innovation. But the data didn’t back them up. The mRNA vaccines were built on decades of publicly funded research. The companies didn’t invent them from scratch-they scaled what others had already built.

In June 2022, the WTO agreed to a limited waiver. It allowed countries to export generic versions of COVID-19 vaccines without patent permission. But only for vaccines. Not for treatments. And only for low- and middle-income countries. The waiver had so many conditions that only one company, the Serum Institute of India, ever used it. The rest didn’t bother. The system was still too slow, too complex, too risky.

By 2023, the waiver had done almost nothing. Meanwhile, the cost of a single course of Paxlovid, a patented antiviral, stayed above $500 in most places. Generic versions? Still blocked by patent thickets and data exclusivity. The pandemic proved one thing: TRIPS wasn’t broken. It was working exactly as designed-to protect profits, not people.

Who Wins? Who Loses?

The winners are clear: big pharmaceutical companies. Between 2010 and 2020, 70% of new drugs came from firms in countries with strong patent systems. Their profits soared. The losers? Patients in low-income countries. In 2019, 65% of them reported delays in getting generic medicines because of patent rules that went beyond TRIPS. For diseases like hepatitis C, tuberculosis, and cancer, generics exist-but they’re locked behind legal walls.

The Medicines Patent Pool, created in 2010, has helped. It negotiates voluntary licenses with drug companies to let generic makers produce cheaper versions. So far, it’s reached 17.4 million patients. But it’s a Band-Aid. It only works if companies agree to participate. And they don’t have to. They choose which drugs to license, which countries to serve, and when to stop.

Meanwhile, the global generic medicine market is worth $420 billion. But over 80% of that is in rich countries. In low-income regions, most medicines are off-patent-but still out of reach because of weak supply chains, corruption, or import bans tied to patent claims.

What Needs to Change

TRIPS isn’t evil. But it’s outdated. It was written in 1994, when HIV was a death sentence and no one imagined mRNA vaccines. The world has changed. The rules haven’t.

Three fixes would make a difference:

1. Remove the “domestic market” rule from compulsory licensing. Let countries import generics freely.
2. Ban TRIPS Plus provisions in trade deals. No country should be forced to give up public health rights to get a trade agreement.
3. End data exclusivity for medicines. If a drug is off-patent, regulators should be free to approve generics using existing data.

These aren’t radical ideas. They’re basic fairness. The same drugs that cost $10,000 in the U.S. cost $75 in India. The difference isn’t quality. It’s policy. And policy can be changed.

For now, the system still favors patents over people. But history shows it doesn’t have to.