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

On January 1, 1995, a new global rule took effect that changed how millions of people access life-saving medicines. The TRIPS Agreement - the Agreement on Trade-Related Aspects of Intellectual Property Rights - became binding for all 159 members of the World Trade Organization. Its goal was simple: make sure every country protected pharmaceutical patents the same way. But the result was anything but simple. For the first time, countries like India, Brazil, and South Africa were forced to stop making cheap generic versions of patented drugs. Overnight, medicines that cost $50 a year became $10,000. And the people who paid the price weren’t corporate executives - they were mothers in rural villages, children with HIV, and elderly patients with diabetes.

What TRIPS Actually Requires

The TRIPS Agreement doesn’t just say "patents are good." It spells out exact rules. Article 33 says every pharmaceutical patent must last 20 years from the date it’s filed. That’s not from when the drug hits the market - it’s from when the company first applies. Many drugs take 8-12 years just to get approved by regulators. That means companies often have only 8-12 years of real market exclusivity, but the clock starts ticking long before the drug is even sold.

Article 27 says patents must be granted for any invention, including synthetic drugs, as long as it’s new, involves an inventive step, and can be made or used. This blocked countries from using old, natural compounds - like the active ingredient in aspirin - as the basis for cheaper generics. Even if a medicine had been used for decades, if a company patented a new chemical form, no one else could copy it.

And then there’s Article 31. It says countries can ignore patents in emergencies - but only under strict conditions. A government can issue a compulsory license to let a local company make a generic version without the patent holder’s permission. But there’s a catch: the medicine can only be made for the domestic market. That meant countries without drug factories - like Rwanda, Uganda, or Malawi - couldn’t import generics made elsewhere. They were stuck.

The Doha Declaration: A Loophole That Wasn’t a Loophole

By 2001, the world was drowning in HIV deaths. In sub-Saharan Africa, 70% of people who needed antiretrovirals couldn’t get them. The cost of patented drugs was killing people faster than the virus. In response, WTO members met in Doha and issued a declaration. It said: public health emergencies matter more than patents. Countries could use TRIPS flexibilities to save lives.

It sounded like a win. But the fine print was brutal. The declaration didn’t change the law - it just said the law could be interpreted in favor of health. It didn’t fix Article 31f. It didn’t create a way for countries without factories to import generics. It just gave them hope.

So in 2005, the WTO passed a formal amendment: Article 31bis. For the first time, it allowed one country to export generic drugs made under compulsory license to another country that couldn’t make them. Sounds perfect, right? Except no one could make it work.

The Only Time It Worked - And Why It Failed Everyone Else

Between 2005 and 2017, only one country ever used the Article 31bis system: Rwanda. In 2007, Rwanda needed a fixed-dose combination of HIV drugs. It couldn’t make them. It asked Canada’s Apotex to produce them under a compulsory license. The process took four years. Why?

First, Rwanda had to prove to the WTO it had no manufacturing capacity. Then Canada had to issue a license that specifically allowed export. Rwanda had to notify the WTO 15 days before shipment. Canada had to label every pill with a special barcode. The medicines had to be shipped in separate containers, clearly marked as "for Rwanda only." And the patent holder - Merck - had to be paid a royalty. All of this required lawyers, bureaucrats, and diplomats from three countries.

Médecins Sans Frontières called it "unworkable." Apotex said the paperwork was worse than the science. The final cost? $1.3 million for 3 million pills - still 30% higher than if Rwanda had its own factory.

Since then? Zero other uses. Not one. Not even during the COVID-19 pandemic.

Why No One Uses Compulsory Licensing

You’d think if a country needed a drug, it would just issue a license. But it’s not that easy.

In 2017, a study of 105 low- and middle-income countries found that 83% had never issued a single compulsory license. Why? Fear.

Thailand tried in 2006. It issued licenses for three drugs: efavirenz (HIV), clopidogrel (heart disease), and imatinib (cancer). Prices dropped by 30% to 80%. Then the U.S. government punished Thailand. It removed its trade benefits. Lost exports? $57 million a year. Brazil did the same in 2007 with efavirenz. The U.S. put it on its "Priority Watch List" for two years. South Africa tried in 1997. Thirty-nine drug companies sued them - until global protests forced them to back down.

The message was clear: use your rights, and you’ll be punished.

A 2021 report by Médecins Sans Frontières tracked 62 attempts at compulsory licensing since 2001. Only 30% succeeded. 29% were abandoned because of political pressure. 41% were blocked by legal threats from pharmaceutical companies.

What About Voluntary Licenses? The Medicines Patent Pool

Pharmaceutical companies say they’re not the problem - they’re just protecting their patents. So they created the Medicines Patent Pool (MPP). It’s a nonprofit that negotiates voluntary licenses with drugmakers. So far, it’s licensed 44 patented medicines for use in 118 low-income countries.

Sounds good? Here’s the catch: it covers only 1.2% of all patented medicines. And 73% of those licenses are only valid in sub-Saharan Africa - even though HIV, TB, and hepatitis are global problems. The MPP doesn’t cover cancer drugs, diabetes medicines, or mental health treatments. It doesn’t cover new drugs like Paxlovid. And it’s entirely dependent on drug companies choosing to cooperate.

In 2022, the MPP had 118 licensees producing generics. But only 28% of prescriptions in low-income countries are for generics - compared to 89% in the U.S. Why? Because the system only works if companies decide to play nice.

The Real Cost of TRIPS

Before TRIPS, India made 90% of the world’s generic HIV drugs. Prices were 5-10% of branded versions. After TRIPS, that changed. By 2005, India had to start granting patents. Generic production dropped. Prices rose.

Today, the global pharmaceutical market is worth $1.42 trillion. Patented drugs make up 68% of that revenue - but only 12% of prescriptions. The rest? Generics. Yet in low-income countries, generics are rare. Why? Because patent laws block them.

The WHO estimates 2 billion people lack regular access to essential medicines. In low-income countries, 80% of that gap is because of patent barriers. For the same drug - say, the HIV treatment tenofovir - the price in the U.S. is $1,500 a year. In South Africa, it’s $87. But that’s only because South Africa fought for its rights. Most countries don’t even get that chance.

TRIPS-Plus: The Hidden Rules That Make Things Worse

Here’s the worst part: TRIPS isn’t even the full story. Many countries have signed bilateral trade deals with the U.S., EU, or Japan that add even stricter rules - called "TRIPS-plus."

The U.S.-Jordan Free Trade Agreement, signed in 2011, extended patent terms beyond 20 years. It blocked generic approval until the patent expired - even if the drug was never sold in Jordan. That meant no one could import cheaper versions, even if they were legal elsewhere.

A 2019 study found that 141 of 164 WTO members have added TRIPS-plus rules through trade deals. On average, these extend patent terms by 4.7 years. That’s 4.7 more years of monopoly pricing. For a cancer drug that costs $120,000 a year, that’s $570,000 more per patient - and billions lost globally.

What’s Changing Now?

In October 2020, India and South Africa asked the WTO to temporarily waive TRIPS protections for COVID-19 vaccines and treatments. After two years of debate, the WTO agreed - but only for vaccines. No diagnostics. No therapeutics. No future pandemics.

In September 2024, the UN held its first High-Level Meeting on Pandemic Prevention. The final declaration said: "We must reform the TRIPS Agreement to ensure timely access to health technologies during health emergencies." That’s the first time a global body has said TRIPS needs to change - not just be interpreted, but reformed.

The WHO’s 2023 Digital Health Strategy now says TRIPS flexibilities should apply to digital health tools too - like AI diagnostics and telemedicine platforms. That’s a new frontier. If a company patents an algorithm that detects TB from a smartphone photo, can a low-income country use it without paying?

Where Do We Go From Here?

The truth is, TRIPS wasn’t designed to save lives. It was designed to protect profits. And it worked - for drug companies. But for the 2 billion people without medicine, it’s a death sentence.

Countries like India and Brazil showed that generics work. They saved millions. But they were punished for it.

The solution isn’t to abolish patents. It’s to make sure they don’t override human rights. We need:

• A global compulsory licensing system that’s fast, simple, and doesn’t require 78 steps.
• A ban on TRIPS-plus clauses in trade deals.
• Public funding for drug research - so no one owns the rights to cures.
• Support for local manufacturing in low-income countries - so they don’t have to beg for pills.

The law says we can do better. But the will to change it? That’s still missing.