How TRIPS Patent Rules Shape Global Access to Generic Medicines

When you need a life-saving drug like HIV antiretrovirals or cancer treatment, the price shouldn’t depend on where you live. But it does. Thanks to the TRIPS agreement, the cost of generic medicines in poor countries has been locked in by international patent rules that favor big drug companies over patients. This isn’t theoretical-it’s why millions in Africa, Asia, and Latin America still wait months or years to get affordable drugs that exist, but are blocked by legal barriers.

What the TRIPS Agreement Actually Does

The TRIPS agreement, created in 1994 under the World Trade Organization, forced every member country to adopt the same minimum rules for patenting drugs. Before TRIPS, many developing countries didn’t even allow product patents on medicines. They could copy how a drug was made (process patents) and produce their own versions. That’s how India became the pharmacy of the developing world-making cheap generics for HIV, malaria, and hepatitis C.

TRIPS changed that. It required all 164 WTO members to grant 20-year product patents on medicines, starting from the filing date. That meant countries like South Africa, Brazil, and Thailand could no longer legally make or import cheaper versions of patented drugs-even if people were dying without them. The idea was simple: protect innovation. But in practice, it protected profits.

How Patents Block Generic Drugs

Patents aren’t the only barrier. Even after a drug’s patent expires, companies use other tricks to delay generics. One is data exclusivity. When a company runs clinical trials to get a drug approved, they submit all that data to health regulators. TRIPS doesn’t require data exclusivity, but many countries added it anyway. That means generic makers can’t use that data to prove their version works. They have to run their own expensive trials. Result? A 5-10 year delay in generic entry, even after the patent ends.

Then there’s patent linkage. Some countries now require health agencies to check if a drug is still under patent before approving a generic. That gives patent holders a direct line to block generics without going to court. The Access to Medicine Foundation found that 65% of low-income countries now use this system-far beyond what TRIPS requires.

Compulsory Licensing: The Loophole That Almost Didn’t Work

TRIPS does allow governments to override patents in emergencies. This is called compulsory licensing. A country can say: “We need this drug now. We’re not waiting.” They can let a local company make it, even if the patent holder says no.

But here’s the catch: the original TRIPS rule said these licenses had to be used “predominantly for the domestic market.” So if you’re a small country like Rwanda or Botswana and don’t have a drug factory, you’re out of luck. You can’t import generics made in India under a compulsory license-even if India is willing to make them.

That changed in 2005, with a “Paragraph 6 Solution.” It let countries without manufacturing capacity import generics made under compulsory license from others. Sounds fair, right? But the paperwork was a nightmare. Countries had to prove they couldn’t make the drug themselves, issue a license, notify the patent holder, and track every pill. By 2016, only one shipment of malaria medicine had ever moved under this rule.

Real-World Consequences: When Laws Cost Lives

In 1998, South Africa passed a law to let public hospitals import or make cheaper HIV drugs. Forty pharmaceutical companies sued. They claimed it violated TRIPS. The world watched as a country fighting an AIDS epidemic was threatened with legal action for trying to save lives. Public pressure forced the companies to drop the case in 2001.

Brazil took a different path. In 2000, it started making its own generic antiretrovirals. The U.S. threatened trade sanctions under Section 301. Brazil didn’t back down. The U.S. eventually withdrew the threat. Brazil now provides free HIV treatment to over 400,000 people-mostly thanks to generics.

India’s transition to TRIPS-compliant patent laws in 2005 caused a 300-500% spike in cancer drug prices. A drug that cost $1,000 a month jumped to $5,000. Patients died waiting. Only later did Indian courts start rejecting weak patents-like one on the leukemia drug imatinib-allowing generics to return.

TRIPS Plus: The Hidden Rules That Make Things Worse

TRIPS is the floor, not the ceiling. Wealthy countries like the U.S. and EU push “TRIPS Plus” terms in free trade deals. These add extra protections beyond what TRIPS requires:

• Patent term extensions-adding years to the 20-year patent
• 8-10 years of data exclusivity (TRIPS allows none)
• Blocking generic approval even if the patent is invalid
• Restricting compulsory licensing to only extreme emergencies

The EU-Vietnam Free Trade Agreement (2020) included 8 years of data exclusivity. The U.S. has done the same in 85% of its bilateral trade deals. These aren’t accidents. They’re deliberate moves to extend monopolies.

The COVID-19 Waiver: A Glimmer of Change

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.

In June 2022, they agreed to a limited waiver-only for vaccines, only for low- and middle-income countries, only for a few years. It was a win, but a weak one. It didn’t cover treatments or diagnostics. It didn’t remove data exclusivity. And it didn’t apply to countries that still produce vaccines, like South Africa. Still, it was the first time the WTO had ever modified TRIPS for public health.

Who Benefits? Who Loses?

The pharmaceutical industry says strong patents are needed to fund innovation. They point out that 73% of new drugs since 2000 came from companies in strong IP countries. But here’s the truth: most breakthrough drugs are funded by public money. The NIH in the U.S. spent $40 billion on HIV research alone between 1980 and 2010. The vaccines for COVID-19 were built on decades of taxpayer-funded science.

Meanwhile, 80% of the world’s medicines are off-patent. But in low-income countries, most of them still aren’t available. Why? Because of patent barriers, weak health systems, and lack of local manufacturing. The WHO found that between 1975 and 1997, only 13 of 1,223 new drugs were for tropical diseases. That’s not innovation-it’s neglect.

The Path Forward

The Medicines Patent Pool, started in 2010, shows another way. It negotiates voluntary licenses with drug companies to let generic makers produce cheaper versions. So far, it’s helped 17.4 million people get HIV, hepatitis C, and TB drugs. It’s not perfect-but it’s working where legal battles fail.

Countries need to stop letting trade deals override health needs. They need to use the flexibilities TRIPS already allows: compulsory licensing, parallel imports, and rejecting weak patents. Brazil, Thailand, and India have shown it’s possible.

And they need to invest in local generic production. South Africa, Kenya, and Ethiopia are starting to build factories. If they get support, they won’t have to rely on imports or charity.

Final Reality Check

The cost of first-line HIV treatment dropped from $10,000 per patient per year in 2000 to $75 today-because of generic competition. That’s proof that when patents are broken, lives are saved.

But second-line drugs? Still $300-$600 a year. New cancer drugs? Often over $100,000. The system still works for the rich. For the rest? It’s a gamble.

TRIPS wasn’t designed to save lives. It was designed to protect corporate control. The question now is whether the world will finally choose health over profit.