How TRIPS Patent Rules Shape Global Access to Generic Medicines

Before 1995, a country like South Africa could make its own version of a life-saving HIV drug using a different manufacturing process-even if the original formula was patented. That changed overnight when the TRIPS agreement came into force. Suddenly, every WTO member had to grant 20-year product patents on medicines. No more shortcuts. No more affordable generics. Just expensive branded drugs, locked behind legal barriers designed in Geneva and Washington, not in clinics in Durban or hospitals in Lilongwe.

What TRIPS Actually Did to Generic Drug Production

The TRIPS agreement didn’t just tweak patent laws. It rewrote the global rules for medicine access. Before TRIPS, only 23 of 102 developing countries gave product patents on pharmaceuticals. Most relied on process patents, which let local manufacturers make the same drug using a different chemical pathway. That’s how India became the pharmacy of the developing world-producing cheap antiretrovirals, antibiotics, and cancer drugs that saved millions.

TRIPS changed that. Article 27 required all members to grant patents on pharmaceutical products, not just processes. That meant even if you could make the same drug more cheaply, you couldn’t legally sell it until the patent expired. And the patent clock started ticking from the day it was filed, not when it was approved. That’s why some drugs had 15 years of market exclusivity before they even hit shelves.

Worse, TRIPS added data exclusivity. Even after a patent runs out, regulators can’t approve a generic version by referencing the original company’s clinical trial data. That creates a 5- to 10-year shadow monopoly. So even if the patent is dead, the generic can’t enter the market. In Brazil, this delayed generic HIV drugs by nearly a decade. In South Africa, it meant people kept dying while regulators waited for paperwork.

Compulsory Licensing: The Loophole That Wasn’t

TRIPS wasn’t completely rigid. Article 31 lets governments issue compulsory licenses-allowing local companies to make patented drugs without the owner’s permission, if there’s a public health emergency. Sounds fair, right? But here’s the catch: Paragraph (f) says the output must be used predominantly for the domestic market.

That rule killed cross-border access. If you’re a small African country with no drug factories, you can’t import generics made under license in India. You’re stuck. You can’t even buy the medicine your neighbor has access to. In 2001, Médecins Sans Frontières documented that 11 African countries couldn’t produce a single generic antiretroviral because they lacked manufacturing capacity. They had the right to license-but no way to use it.

The Doha Declaration in 2001 tried to fix this. It said public health overrides patents. But words don’t change laws. So in 2005, the WTO created the "Paragraph 6 Solution"-a complex workaround allowing countries without manufacturing to import generics from others. Only two countries ever used it: Canada exported a small batch of antimalarial drugs to Rwanda. That’s it. The system was too bureaucratic. Too slow. Too expensive for countries already struggling with basic health infrastructure.

Who Won? Who Lost?

The winners? Big pharmaceutical companies. Between 1995 and 2010, the number of developing countries granting pharmaceutical product patents jumped from 60 to 147. Drug prices soared. In South Africa, the price of the HIV drug efavirenz jumped 300% after TRIPS compliance. In India, cancer drugs like imatinib went from $200 a month to over $1,000-until local manufacturers found legal loopholes.

The losers? Patients. The World Health Organization found that in the first decade after TRIPS, generic drug entry was delayed by 5 to 10 years in most low-income countries. For diseases like tuberculosis and hepatitis C, that meant thousands of preventable deaths. The Access to Medicine Foundation reported in 2019 that 65% of low-income countries had longer delays in approving generics because of patent linkage rules-rules even stricter than TRIPS required.

And it wasn’t just about patents. Countries were pressured into "TRIPS Plus" deals through trade agreements. The EU-Vietnam Free Trade Agreement in 2020 added eight years of data exclusivity. The U.S. included similar terms in 85% of its bilateral deals. These weren’t negotiated in public health ministries. They were tucked into trade pacts, signed by officials who didn’t understand the human cost.

The Real Cost of Innovation

Pharmaceutical companies argue that strong patents are needed to fund innovation. They point out that 70% of new drugs since 2010 came from countries with strong IP systems. But here’s the flip side: 95% of new drugs developed between 1975 and 2000 targeted conditions in wealthy nations. Only 13 out of 1,223 new drugs were for tropical diseases like sleeping sickness or Chagas disease-diseases that kill millions but don’t pay well.

The market doesn’t reward cures for the poor. It rewards treatments for the rich. So patents don’t drive innovation for global health-they protect profits. The Medicines Patent Pool, created in 2010, is one of the few exceptions. It negotiates voluntary licenses with drugmakers so generics can be made for HIV, hepatitis C, and TB. So far, it’s reached 17.4 million people. But it’s voluntary. It’s not a right. It’s a favor.

COVID-19 and the TRIPS Waiver That Almost Wasn’t

In October 2020, India and South Africa proposed a temporary waiver of TRIPS protections for COVID-19 vaccines, tests, and treatments. Over 100 countries supported it. The U.S., EU, and Switzerland blocked it for over a year. Their argument? Waiving patents would hurt innovation.

But the reality? Pfizer and Moderna got billions in public funding. Their vaccines were developed with taxpayer money. The patents were just legal shields to keep competitors out. When the waiver finally passed in June 2022, it was watered down. It didn’t cover diagnostics or treatments. It didn’t force technology transfer. It didn’t lift data exclusivity. It was a symbolic win, but not a game-changer.

By then, the window had closed. Most high-income countries had already hoarded vaccines. Low-income countries were still waiting. The waiver didn’t help the people who needed it most.

What’s Left to Fix?

The TRIPS agreement still stands. The loopholes are too narrow. The enforcement is too one-sided. Countries still can’t import generics. Data exclusivity still blocks competition. And the global system still treats medicine like a commodity, not a human right.

There are three real fixes:

1. Remove the "domestic market" restriction on compulsory licensing. Let countries import generics freely.
2. Eliminate data exclusivity. Let regulators approve generics based on safety, not paperwork.
3. Stop TRIPS Plus clauses in trade deals. No more hidden patent extensions.

Some countries are trying. Brazil and Thailand issued compulsory licenses for HIV and cancer drugs. India still produces generics by exploiting legal gray areas. But they’re fighting a system designed to make them lose.

It’s Not About Patents. It’s About Power.

This isn’t a technical problem. It’s a political one. The TRIPS agreement didn’t happen by accident. It was written by pharmaceutical lobbyists, supported by powerful governments, and pushed through by trade leverage. Developing countries had no seat at the table.

The result? A global system where a child in Malawi can’t get a $300 cancer drug because a patent in Switzerland says no. Where a mother in Kenya pays 10 times more for insulin because the patent holder won’t license it. Where innovation is rewarded-but only if it serves the rich.

The next time you hear someone say "patents drive innovation," ask this: Innovation for whom? And at what cost?