On January 1, 1995, a legal rule quietly changed how billions of people access medicine. The TRIPS Agreement - the Agreement on Trade-Related Aspects of Intellectual Property Rights - became binding for all 159 members of the World Trade Organization. It forced every country to grant 20-year patents on pharmaceuticals. For the first time, countries like India, Brazil, and South Africa could no longer make cheap copies of life-saving drugs. The result? Millions couldn’t afford treatment for HIV, cancer, or hepatitis - not because the science didn’t exist, but because the law said they couldn’t make it themselves.
What TRIPS Actually Does to Medicine Prices
Before TRIPS, India didn’t patent drugs - only the process to make them. That meant local companies could reverse-engineer patented medicines and sell them for a fraction of the price. A year of HIV treatment that cost $10,000 in the U.S. cost just $87 in India. By 2001, India was supplying generic antiretrovirals to 127 countries. That changed overnight when TRIPS came into force. TRIPS requires every country to give patent protection for 20 years from the date of filing. That means even if a drug was invented in 1990, no generic version can legally be sold until 2010 - and sometimes longer, thanks to extensions. The agreement also sets strict rules on what counts as an invention. Natural substances like plant extracts can’t be patented, but synthetic molecules - even if they’re just slightly modified versions of older drugs - can be. This opened the door for pharmaceutical companies to file dozens of minor patents on the same drug, stretching monopoly control for decades.The Flexibility That Doesn’t Work
TRIPS wasn’t meant to be a death sentence for public health. Article 31 lets countries issue compulsory licenses - allowing local manufacturers to produce generics without the patent holder’s permission, as long as they pay royalties. The Doha Declaration in 2001 confirmed this right, saying public health emergencies override patent rules. But here’s the catch: Article 31f says those generics can only be made for the domestic market. That’s fine if you’re Brazil or India, with big factories. But what if you’re Rwanda, Uganda, or Malawi - countries with no drug manufacturing at all? You can’t make the medicine, and you can’t import it from someone else who made it under license. The system was broken by design. The 2005 amendment - called Article 31bis - tried to fix this. It created a legal pathway for countries without production capacity to import generics made under compulsory license. Sounds good, right? But it took four years for the first and only successful case: Rwanda importing HIV drugs from Canada’s Apotex in 2012. The process involved 78 steps, legal teams from three continents, and help from Médecins Sans Frontières. Even then, the final price was 30% higher than if Rwanda had been allowed to produce it locally.Why No One Uses the System
A 2019 study found that 92% of low- and middle-income countries have no dedicated team to handle compulsory licensing. The paperwork is overwhelming. You need to prove a public health emergency, notify the WTO 15 days before export, get approval from the patent holder’s home country, and ensure the imported drugs are clearly labeled as generics. Most governments don’t have lawyers who understand international trade law, let alone the political courage to stand up to Big Pharma. And the pressure doesn’t stop at bureaucracy. When Thailand issued compulsory licenses for HIV and cancer drugs in 2006, the U.S. removed its trade benefits, costing Thailand $57 million a year in lost exports. Brazil faced similar threats after licensing efavirenz in 2007. The U.S. Trade Representative put Brazil on its “Priority Watch List” for two years - a diplomatic black mark that scared off investors. Between 2001 and 2021, there were 62 attempts to use compulsory licensing. Only 30% worked. The rest failed because of legal threats, political pressure, or simply giving up after months of red tape. The UN High-Level Panel on Access to Medicines documented 423 cases of trade threats against countries trying to use TRIPS flexibilities between 2007 and 2015.
Voluntary Licenses: A Band-Aid on a Bullet Wound
Pharmaceutical companies sometimes offer voluntary licenses through groups like the Medicines Patent Pool (MPP). These allow generic makers to produce cheaper versions in specific countries - usually in sub-Saharan Africa. As of 2022, MPP covered 44 patented medicines, mostly for HIV. That sounds like progress - until you realize it’s just 1.2% of all patented drugs globally. And these licenses come with strings. They often exclude countries like Brazil or South Africa, even though they have the highest disease burdens. They don’t cover diagnostics, vaccines, or new cancer drugs. And they’re voluntary - meaning companies can pull them anytime. There’s no guarantee. No legal right. Just a favor. Meanwhile, the global pharmaceutical market hit $1.42 trillion in 2022. Patented drugs make up 68% of that revenue - even though they account for only 12% of prescriptions. In the U.S., 89% of prescriptions are generics. In low-income countries? Just 28%. The price gap for identical drugs can be 1,000 times higher.TRIPS-Plus: The Hidden Rules That Make Things Worse
The real problem isn’t just TRIPS. It’s what comes after it. Bilateral trade deals - like the U.S.-Jordan Free Trade Agreement or the EU-India talks - often include “TRIPS-plus” clauses. These go beyond what TRIPS requires: extending patent terms by 4-7 years, blocking generic approval until the patent expires (even if it’s invalid), and requiring data exclusivity - meaning regulators can’t even look at the safety data of the original drug for five to ten years. This delays generics even if the patent is expired. By 2021, 86% of WTO members had slipped in TRIPS-plus provisions through side deals. That’s 141 countries locked into stricter rules than the original treaty. The result? An estimated $2.3 billion in lost savings each year across 34 low- and middle-income countries.What’s Changed Since COVID-19?
In October 2020, India and South Africa asked the WTO to waive TRIPS protections for COVID-19 vaccines, tests, and treatments. They argued that during a global emergency, patent rights shouldn’t block access. After two years of debate, the WTO agreed - but only for vaccines. Therapeutics and diagnostics were left out. And the waiver only applies to countries with low vaccine production. High-income countries like the U.S. and EU still blocked broader access. The 2024 UN High-Level Meeting on Pandemic Preparedness called for “reform of the TRIPS Agreement to ensure timely access to health technologies.” That’s a start. But without binding rules, it’s just words.
Who Pays the Price?
Two billion people still lack regular access to essential medicines. Eighty percent of that gap is due to patent barriers. In places like Malawi or Nepal, a child with leukemia has a 90% chance of dying - not because treatment doesn’t exist, but because the patent holder won’t let anyone make it cheaply. The system isn’t broken because it was poorly designed. It was designed exactly this way: to protect corporate profits over human lives. The legal framework says countries can use flexibilities - but the political and economic pressure makes it impossible.What Needs to Change
There are three clear paths forward:- Fix Article 31bis. Remove the 78-step nightmare. Let countries import generics without bureaucratic delays.
- End TRIPS-plus clauses. Ban bilateral trade deals from adding extra patent extensions.
- Expand compulsory licensing. Allow countries to produce and export generics for global emergencies - not just for their own borders.
Can We Fix This?
Yes - but only if public pressure forces governments to act. When South Africa tried to pass a law allowing generic HIV drugs in 1997, 39 pharmaceutical companies sued. Global protests forced them to drop the case. When Thailand issued licenses, the world watched. When Rwanda finally got its drugs, it took civil society, lawyers, and doctors to fight through the system. The law gives us the tools. But power decides who gets to use them.Can any country issue a compulsory license under TRIPS?
Yes - every WTO member has the legal right to issue a compulsory license for pharmaceuticals under Article 31 of TRIPS, even without the patent holder’s consent. This includes countries with no drug manufacturing capacity, as long as they follow the rules. But in practice, most don’t due to political pressure, legal threats from pharmaceutical companies, or lack of technical expertise. Only 30% of attempts to use this right have succeeded since 2001.
Why was the Rwanda-Canada case the only success under Article 31bis?
The Rwanda-Canada case in 2012 succeeded because it had unprecedented support: Médecins Sans Frontières provided legal and logistical help, Apotex agreed to produce the drug, and the UN Development Programme helped navigate the complex WTO notification system. Even then, it took four years and cost 30% more than if Rwanda could have made the drugs locally. The system is so slow and complicated that most countries give up before starting.
Do generic medicines have the same quality as branded ones?
Yes. Generic medicines contain the same active ingredients, are subject to the same safety standards, and are tested for bioequivalence. The World Health Organization certifies many generic producers in India and Brazil. The only difference is price - generics cost 5-95% less. In many cases, the same factory that makes the branded drug also makes the generic version under a different label.
Why don’t pharmaceutical companies just lower prices voluntarily?
They do - but only in limited cases and under pressure. Voluntary licenses from companies like Gilead or Merck cover only a small fraction of drugs, mostly for HIV in sub-Saharan Africa. Most companies refuse to lower prices in countries that can afford to pay, even slightly, because their profit model relies on high prices in all markets. The average cost to develop a new drug is $2.6 billion - but most of that is marketing, not research. The real barrier isn’t cost - it’s control.
Is the TRIPS waiver for COVID-19 vaccines enough?
No. The 2022 WTO waiver only applies to vaccines and excludes diagnostics, treatments, and future pandemics. It also has narrow eligibility rules - only low-income countries can use it, and they must prove they can’t produce the vaccine themselves. Many countries with production capacity, like South Africa and Brazil, were excluded. It’s a partial fix for a systemic problem. Without a broader waiver covering all health technologies, similar gaps will reappear in the next outbreak.