How TRIPS Trade Agreements Shape Global Access to Generic Medicines

When you need a life-saving drug, price shouldn’t depend on where you live. But for millions in low-income countries, it does. The reason? A global trade rule called TRIPS - the Trade-Related Aspects of Intellectual Property Rights Agreement. It was meant to protect innovation, but in practice, it’s made essential medicines unaffordable for people who need them most.

What TRIPS Actually Does

TRIPS is a WTO treaty that forces all 164 member countries to follow the same patent rules. Before 1995, many developing nations didn’t even allow patents on drugs. India, for example, made generic versions of HIV meds by changing how they were made - not the drug itself. That was legal under old rules. TRIPS changed that. Now, every country must give drug companies at least 20 years of exclusive rights from the date the patent is filed. No exceptions.

This sounds fair on paper. But here’s the catch: the 20-year clock starts when the patent is filed, often years before the drug even hits the market. That means a drug might only have 10 years of real exclusivity left by the time it’s approved. Meanwhile, companies file dozens of secondary patents - on packaging, dosages, or minor chemical tweaks - to stretch their monopoly. This is called “evergreening,” and it’s legal under TRIPS.

How Generic Drugs Got Blocked

Generic drugs are cheaper because they don’t repeat expensive clinical trials. They just prove they work the same as the original. But TRIPS added a hidden barrier: data exclusivity. Even after a patent expires, regulators can’t use the original company’s trial data to approve a generic version. That creates a 5- to 10-year delay - no matter how urgent the need.

Take HIV treatment. In 2000, a first-line antiretroviral cocktail cost $10,000 per patient per year in Africa. By 2019, thanks to generic competition in countries that could bypass patent rules, it dropped to $75. But that only happened because some countries - like Brazil and South Africa - fought to use TRIPS flexibilities. Most didn’t. And newer drugs? Many still cost $300-$600 per year in low-income countries because patents and data exclusivity keep generics out.

Compulsory Licensing: The Loophole That Almost Wasn’t

TRIPS lets governments issue compulsory licenses - allowing someone else to make a patented drug without the company’s permission. But there’s a trap. Paragraph 6 says these licenses must be used “predominantly for the domestic market.” That meant countries without drug factories couldn’t import cheaper generics from others.

Imagine a small African nation with no manufacturing. A neighbor has the capacity to make generic HIV meds, but under TRIPS, they can’t legally export them. So the sick people in the first country stay untreated. This wasn’t an accident. It was written into the agreement to protect big pharma profits.

In 2003, the WTO tried to fix this with the “Paragraph 6 Solution.” It allowed exports under license - but only if both countries jumped through 12 bureaucratic hoops. By 2016, only one shipment of malaria medicine had ever been sent this way. It was too slow, too complicated, and too risky for any country to try.

TRIPS Plus: The Hidden Rules Behind the Rules

Even when countries follow TRIPS, they’re often forced to do more. The U.S., EU, and other rich nations push “TRIPS Plus” terms into trade deals. These add extra protections: longer patent terms, stricter data exclusivity, and bans on compulsory licensing for certain diseases.

The EU-Vietnam Free Trade Agreement (2020) gave drug companies 8 years of data exclusivity - three years longer than TRIPS allows. The U.S. has done the same in 85% of its free trade deals. These aren’t global rules. They’re private deals, signed quietly, that lock poorer countries into even tighter restrictions.

Who Won? Who Lost?

Big pharma says strong patents drive innovation. And yes, most new drugs come from companies in countries with strict IP laws. But here’s the twist: 70% of new drugs since 2000 treat conditions that affect rich countries. Only 13 out of 1,223 new drugs between 1975 and 1997 were for tropical diseases. That’s not innovation - that’s market-driven neglect.

Meanwhile, developing countries lost their freedom to make affordable medicines. Before TRIPS, 23 of 102 developing nations allowed pharmaceutical product patents. By 2010, it was 147. India, once the “pharmacy of the developing world,” had to scrap its process-patent system by 2005. Cancer drug prices jumped 300-500% overnight.

South Africa tried to pass a law letting it import generics in 1998. Forty pharmaceutical companies sued. The case was dropped only after global protests. Brazil made generic HIV drugs in 2000. The U.S. threatened trade sanctions. They backed down - but only after public pressure.

The Real Cost: Lives Delayed, Not Just Prices

This isn’t about abstract policy. It’s about who gets to live.

In 2001, Médecins Sans Frontières reported that 8 million people needed HIV treatment. Only 50,000 got it - because the drugs cost more than most countries’ entire health budgets. Today, 29 million people are on antiretrovirals. That’s progress. But it happened because activists forced governments to use TRIPS flexibilities - not because the system worked.

And what about newer diseases? Hepatitis C, tuberculosis, and cancer drugs still sit behind patent walls. The Medicines Patent Pool, a nonprofit that negotiates voluntary licenses, has reached 17.4 million patients since 2010. But that’s still a drop in the ocean. Most new drugs never get licensed for low-income countries at all.

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

In October 2020, India and South Africa asked the WTO to temporarily waive TRIPS rules for vaccines, tests, and treatments during the pandemic. Over 100 countries supported it. The U.S., EU, and Switzerland blocked it for over a year. When they finally agreed in June 2022, the waiver was so narrow it barely mattered. It didn’t cover diagnostics or treatments. It didn’t remove data exclusivity. It didn’t apply to most low-income countries.

The waiver was symbolic. A gesture. Not a solution. It proved that even in a global emergency, the system still protects profits over people.

What’s Next?

The fight isn’t over. The Medicines Patent Pool is expanding. Countries like Thailand and Brazil still use compulsory licensing. But without systemic change, the pattern will repeat: new drugs come out, patents lock them up, and the poorest wait years - if they wait at all.

Some experts say the answer is reforming TRIPS. Others say it’s time to build alternatives: public funding for drug R&D, open-source drug development, and global pooling of knowledge. The World Health Organization has pushed for a treaty on pandemic preparedness that would require sharing technology and IP - but rich nations are resisting.

Until then, the gap stays wide. A child in Malawi still can’t get the same cancer drug as a child in Germany - not because the science is different, but because the rules are stacked.