How TRIPS Patent Rules Shape Global Access to Generic Medicines

When you take a generic version of a blood pressure pill or an HIV drug, you’re benefiting from a global battle over patents, power, and survival. The rules that determine whether these cheap, life-saving copies can even be made come from a 30-year-old international treaty called the TRIPS agreement. It’s not just a legal footnote-it’s the invisible hand behind the price of medicine in every country, rich or poor.

What TRIPS Actually Does

The Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement, signed in 1994 and enforced in 1995, forced every member of the World Trade Organization (WTO)-164 countries-to adopt the same basic patent rules. Before TRIPS, many developing countries didn’t even allow patents on drugs. They could copy medicines using different manufacturing methods and make them affordable. India, for example, was a global supplier of low-cost HIV drugs because it only protected the process of making a drug, not the drug itself.

TRIPS changed that. It required all countries to grant 20-year product patents on pharmaceuticals, starting from the date the patent was filed. That meant if a company patented a new cancer drug in the U.S. in 2010, no one else could legally make or sell a copy anywhere in the world until 2030-even if that drug was desperately needed in a country with no money to pay $100,000 per patient per year.

The result? A global spike in drug prices. A 2001 study in the Journal of the American Medical Association found that in developing countries, the price of patented drugs jumped by over 200% after TRIPS kicked in. In South Africa, generic versions of HIV drugs were priced at $1,000 per patient per year before TRIPS. Afterward, the branded version cost $10,000. The same drug, same chemical, same effect-just a different label and a vastly different price tag.

Compulsory Licensing: The Loophole That Was Hard to Use

TRIPS wasn’t completely rigid. Article 31 lets governments issue compulsory licenses-essentially, permission to make a generic version without the patent holder’s consent-if there’s a public health emergency. This was supposed to be the safety valve.

But there was a catch. Paragraph (f) said the generic version had to be made mostly for the domestic market. So if a country like Zambia didn’t have a drug factory, it couldn’t import generics made in India, even if India had the capacity and the willingness. Millions of people in need were stuck because the system didn’t allow cross-border trade of life-saving generics.

In 2001, countries in Africa and Latin America were dying from AIDS because they couldn’t afford the drugs. The world responded with the Doha Declaration, which affirmed that public health matters more than patents. But it didn’t fix the problem. It just said, “You can do this… if you can figure out how.”

The 2005 “Paragraph 6 Solution” was supposed to fix the cross-border issue. It allowed countries without manufacturing capacity to import generics made under compulsory license from another country. Sounds simple, right? In practice, it was a bureaucratic nightmare. Countries had to submit complex paperwork, get approvals from both the exporting and importing nations, and navigate legal loopholes. By 2016, only one shipment of malaria medicine had ever been sent under this rule. Rwanda and Canada were the only two countries that ever used it.

TRIPS Plus: The Hidden Rules That Make Things Worse

Even after TRIPS, the biggest threats to generic access aren’t from the WTO-they’re from bilateral trade deals. The U.S., EU, and other wealthy nations started slipping extra patent rules into free trade agreements with poorer countries. These are called “TRIPS Plus” provisions.

They include:

• Data exclusivity: Prevents generic makers from using the original company’s clinical trial data to prove their drug is safe and effective. Even after a patent expires, the generic can’t be approved for 5 to 10 more years.
• Patent term extensions: If a drug approval got delayed by regulators, the patent gets extended-sometimes by years.
• Patent linkage: Requires regulators to check patent status before approving a generic. This gives brand-name companies the power to block generics just by filing a lawsuit, even if the patent is weak or invalid.

By 2020, 85% of U.S. free trade agreements included these TRIPS Plus rules. The EU-Vietnam deal, signed in 2020, gave 8 years of data exclusivity-longer than TRIPS allows. These aren’t just technicalities. They delay generic entry by 10 to 15 years in some cases. That means a cancer drug that should be cheap by year 15 is still expensive at year 25.

Real Consequences: Who Pays the Price?

The numbers don’t lie. In 2000, the cost of first-line HIV treatment was $10,000 per person per year. By 2019, thanks to generic competition in countries that managed to bypass patent barriers, it dropped to $75. That’s a 99% drop. But that only happened because countries like Brazil, Thailand, and India used compulsory licenses, ignored TRIPS restrictions, or had strong domestic generic industries.

In countries without those tools? The price stayed high. A 2019 report from the Access to Medicine Foundation found that 65% of low-income countries had delays in approving generics because of patent linkage rules they didn’t even need to follow under TRIPS-they were forced into them by trade deals.

India’s transition to product patents in 2005 caused a 300-500% price jump for cancer drugs. One generic version of the leukemia drug imatinib dropped from $2,500 to $175 per patient per year after India allowed generic production. But when the patent holder sued, the government had to negotiate a compromise-still, millions got the drug at a price they could afford.

Meanwhile, in countries like Kenya or Uganda, where the government can’t afford to fight legal battles, the branded drug remains out of reach. The World Bank found that countries implementing TRIPS without strong public health safeguards saw a 15-20% drop in generic availability within five years.

The COVID-19 Test: Did the System Work?

When the pandemic hit in 2020, India and South Africa proposed a TRIPS waiver for vaccines, tests, and treatments. Over 100 countries supported it. The U.S., EU, and Switzerland refused. Their argument? Strong patents drive innovation.

But the data didn’t back them up. The mRNA vaccines were developed with over $20 billion in public funding. The technology was built on decades of publicly funded research. Yet, Pfizer and Moderna held exclusive rights and kept prices high.

In June 2022, the WTO agreed to a limited waiver for COVID-19 vaccines-but only for vaccines, not for treatments or tests. And it only applied to countries with low vaccine production capacity. It took two years of global pressure to get even this small change.

The lesson? The system only bends when the pressure is overwhelming. And even then, it bends just enough to look like it’s working.

Who Wins? Who Loses?

The pharmaceutical industry argues that without strong patents, no one would invest in new drugs. They point out that 73% of new medicines since 2000 came from companies in countries with strong IP laws. But here’s the flip side: 90% of drug R&D spending goes toward drugs for wealthy markets. Between 1975 and 1997, only 13 of 1,223 new drugs were for tropical diseases like malaria or sleeping sickness-diseases that kill millions but don’t make profits.

The Medicines Patent Pool, created in 2010, has helped negotiate licenses for 16 HIV drugs, 6 hepatitis C drugs, and 4 tuberculosis drugs. It’s reached 17.4 million people. But it’s a patchwork solution-relying on voluntary agreements, not legal rights.

Meanwhile, countries like Brazil and Thailand learned how to use the rules to their advantage. They built domestic generic industries, trained regulators, and didn’t back down from lawsuits. They didn’t wait for permission. They took action.

The Future: Will TRIPS Survive?

The global health community is split. Médecins Sans Frontières calls TRIPS “a system designed to prioritize profits over people.” The pharmaceutical industry says it’s essential for innovation.

But the reality is more complicated. TRIPS didn’t stop innovation-it just redirected it. New drugs are being developed, but mostly for conditions that affect rich people. The ones that kill the poor? Still waiting.

The only way forward is to reclaim the flexibilities TRIPS already allows. Compulsory licensing, parallel imports, and public funding for R&D need to be used more aggressively. Countries need to stop signing TRIPS Plus deals. And the global community needs to stop treating medicine as a commodity and start treating it as a human right.

The tools are there. The law allows it. What’s missing is the political will.