When you need a life-saving drug like HIV antiretrovirals, cancer treatments, or insulin, the price shouldn’t depend on which country you live in. But for billions of people, it does. The reason? A 30-year-old international trade deal called TRIPS - the Agreement on Trade-Related Aspects of Intellectual Property Rights - that made it harder for poor countries to make or buy cheap generic medicines.
What TRIPS Actually Does
TRIPS, which came into force in 1995 under the World Trade Organization (WTO), forces all 164 member countries to give pharmaceutical companies 20 years of exclusive patent rights. Before TRIPS, countries like India, Brazil, and Thailand could legally copy patented drugs and sell them as generics. That meant a year’s supply of HIV medicine cost $10,000 in the U.S. but just $87 in India. After TRIPS, those countries had to stop. Patents became non-negotiable.
The goal wasn’t to hurt patients. It was to create a global standard for innovation. But the outcome was predictable: drug prices skyrocketed in low- and middle-income countries. The World Health Organization estimates that 2 billion people still can’t get essential medicines - and patent rules are behind 80% of that gap.
The Flexibility That Doesn’t Work
TRIPS wasn’t completely rigid. It had escape hatches - called flexibilities - meant for emergencies. One was compulsory licensing: a government can override a patent and let someone else make the drug if there’s a public health crisis. Another was allowing countries without drug factories to import generics made elsewhere under license.
That second one - Article 31bis - was supposed to be the game-changer. It let countries like Rwanda import HIV drugs from Canada or India without having to make them themselves. Sounds simple, right?
It took four years for Rwanda to get its first shipment. Four years. And it was the only time it’s ever worked. Why? Because the paperwork was a nightmare. You needed 78 steps across two governments. You had to notify the WTO 15 days before export. You had to prove your country couldn’t make the drug. You had to pay the patent holder a fee. And you had to do it all while facing threats from the U.S. and big pharma.
That’s why, out of 105 low-income countries surveyed, 83% had never issued a single compulsory license - not because they didn’t need to, but because they were scared. Scared of trade sanctions. Scared of lawsuits. Scared of losing aid.
What Happened When Countries Tried
Thailand tried in 2006. It issued licenses for three key drugs: HIV medicine efavirenz, heart drug clopidogrel, and cancer drug imatinib. Prices dropped by 30% to 80%. Then the U.S. pulled Thailand’s trade benefits. The cost? $57 million a year in lost exports.
South Africa tried in 1997. Thirty-nine drug companies sued them. The case was dropped only after global protests. But the message was clear: challenge the system, and you’ll get punished.
Brazil issued a compulsory license for efavirenz in 2007. Prices fell 60%. The U.S. put Brazil on its “Priority Watch List” for two years. That’s a diplomatic slap - a warning that you’re not playing nice with patent rules.
Each time, the message from powerful countries and pharmaceutical companies was the same: stick to the rules. Don’t use the flexibilities. Even though those flexibilities are written into the treaty.
The One Success Story - And Why It’s Not Enough
The only time Article 31bis worked was Rwanda in 2008. With help from Médecins Sans Frontières and the UN, they imported $1.3 million worth of HIV drugs from Canada. But even then, the final price was 30% higher than if Rwanda had its own factory. The process took four years. It required dozens of lawyers, diplomats, and NGOs just to get one shipment.
That’s not a system. That’s a miracle.
And it’s still the only one.
Voluntary Licenses Aren’t the Answer
Big pharma says, “We don’t need compulsory licenses - we have voluntary ones.” The Medicines Patent Pool, backed by the UN, lets companies voluntarily license their patents to generic makers. So far, it’s covered 44 drugs - mostly for HIV.
But here’s the catch: only 1.2% of all patented medicines are covered. And 73% of those licenses only apply to sub-Saharan Africa, even though diseases like hepatitis C or diabetes affect people everywhere. Companies pick which drugs to license - usually the ones that are already losing money or have weak patents. They don’t give up the big ones.
Meanwhile, in the U.S., generics make up 89% of prescriptions. In low-income countries? Just 28%. The same pill, made in the same factory, costs 1,000 times more in a poor country because of patent rules.
TRIPS-Plus: The Hidden Rules That Make Things Worse
TRIPS is bad enough. But many countries have been forced into even stricter rules through trade deals - called TRIPS-plus provisions.
The U.S.-Jordan Free Trade Agreement, signed in 2011, extended patent terms beyond 20 years. It blocked generic approval even after the patent expired. Other deals require data exclusivity - meaning generic makers can’t even use the clinical trial data to prove their drug works. That adds five to ten extra years of monopoly.
WTO data shows 141 countries - 86% of members - now have TRIPS-plus clauses in bilateral deals. These aren’t accidental. They’re negotiated under pressure. A 2019 study found that 67 of 48 least-developed countries still didn’t have the legal tools to issue compulsory licenses - even though they’re allowed until 2033 to catch up.
Why This Still Matters Today
The COVID-19 pandemic exposed the system’s failure. In 2020, India and South Africa proposed a TRIPS waiver for vaccines and treatments. It took 18 months of global protests, media campaigns, and political pressure just to get a partial waiver - and it only covered vaccines, not tests or treatments.
Even now, vaccine doses sit in warehouses in rich countries while children in Malawi or Haiti wait. The same companies that made billions from mRNA vaccines still control the formulas. No one else can make them without permission.
The UN’s 2024 Pandemic Agreement called for “reform of the TRIPS Agreement” - but reform doesn’t mean change. It means tinkering. The core problem remains: patents are treated as absolute rights, not as tools that should serve human life.
What’s Next?
The numbers are grim. By 2030, without real reform, 3.2 billion people will still lack access to essential medicines. That’s almost half the world.
Some say the answer is more voluntary deals. Others say we need to scrap TRIPS altogether. But the truth is simpler: the system was never designed to put health before profit. And until that changes, generic access will remain a legal loophole - not a right.
For now, the only real hope lies in pressure - from civil society, from public health advocates, from governments willing to risk trade sanctions. Because when your child needs medicine, the law shouldn’t be the barrier. It should be the bridge.
What is the TRIPS Agreement?
The TRIPS Agreement is a 1995 international treaty under the World Trade Organization that sets minimum standards for intellectual property protection, including 20-year patents for pharmaceuticals. It requires all member countries to enforce these rules, which has limited the ability of low-income nations to produce or import affordable generic medicines.
Can countries ignore TRIPS to make generic drugs?
Yes - but only under strict conditions. TRIPS allows compulsory licensing for public health emergencies, and least-developed countries had until 2033 to implement pharmaceutical patents. However, using these flexibilities often triggers political pressure, trade threats, or legal challenges from wealthy nations and drug companies, making it risky and rarely used.
Why hasn’t the Article 31bis system worked better?
The Article 31bis system lets countries without drug manufacturing capacity import generics under license. But it requires 78 procedural steps, detailed notifications to the WTO, and approval from both exporting and importing nations. It took four years for Rwanda to get its first shipment - the only time it’s ever succeeded. Most countries lack the legal expertise or political will to navigate it.
Are voluntary licenses from drug companies enough?
No. Voluntary licenses, like those through the Medicines Patent Pool, cover only 44 of over 1,000 patented medicines - mostly for HIV. They exclude most cancer, diabetes, and heart drugs. Companies choose which drugs to license, often ones with low profit potential. They retain control over pricing and geography, leaving millions without access.
What are TRIPS-plus provisions?
TRIPS-plus provisions are stricter patent rules added to bilateral trade deals - like extending patent terms beyond 20 years or blocking generic approval even after patents expire. Over 140 countries have them, often under pressure from the U.S. or EU. These rules reduce access to generics even further than TRIPS alone.
Did the COVID-19 vaccine waiver fix anything?
Not really. The 2022 WTO waiver only applied to vaccines, not tests, treatments, or future technologies. It also required complex legal steps and didn’t force technology sharing. Few countries used it because the process was slow and the rules too narrow. The real solution - open licensing and local production - was never included.
How does TRIPS affect everyday people in poor countries?
For millions, it means choosing between medicine and food. A single dose of insulin or cancer drug can cost months of wages. In countries where generics used to be available, patients now wait, die, or go without. TRIPS didn’t stop innovation - it made access a privilege, not a right.
What You Can Do
Most people don’t realize that a treaty signed in 1994 still controls whether their neighbor in Kenya or Laos can get a life-saving drug. But awareness is growing. Organizations like Médecins Sans Frontières, Health Action International, and the People’s Vaccine Alliance keep pushing for change.
If you care about global health, you can support campaigns that demand TRIPS reform. You can ask your representatives to oppose TRIPS-plus trade deals. You can push for policies that fund local generic production in low-income countries. You can refuse to accept that profit should come before life.
The law isn’t sacred. It’s made by people. And it can be changed - if enough of us demand it.
