How TRIPS Patent Rules Shape Global Access to Generic Medicines
Nov, 25 2025
Before 1995, a country like South Africa could make its own version of a life-saving HIV drug using a different manufacturing process-even if the original formula was patented. That changed overnight when the TRIPS agreement came into force. Suddenly, every WTO member had to grant 20-year product patents on medicines. No more shortcuts. No more affordable generics. Just expensive branded drugs, locked behind legal barriers designed in Geneva and Washington, not in clinics in Durban or hospitals in Lilongwe.
What TRIPS Actually Did to Generic Drug Production
The TRIPS agreement didn’t just tweak patent laws. It rewrote the global rules for medicine access. Before TRIPS, only 23 of 102 developing countries gave product patents on pharmaceuticals. Most relied on process patents, which let local manufacturers make the same drug using a different chemical pathway. That’s how India became the pharmacy of the developing world-producing cheap antiretrovirals, antibiotics, and cancer drugs that saved millions. TRIPS changed that. Article 27 required all members to grant patents on pharmaceutical products, not just processes. That meant even if you could make the same drug more cheaply, you couldn’t legally sell it until the patent expired. And the patent clock started ticking from the day it was filed, not when it was approved. That’s why some drugs had 15 years of market exclusivity before they even hit shelves. Worse, TRIPS added data exclusivity. Even after a patent runs out, regulators can’t approve a generic version by referencing the original company’s clinical trial data. That creates a 5- to 10-year shadow monopoly. So even if the patent is dead, the generic can’t enter the market. In Brazil, this delayed generic HIV drugs by nearly a decade. In South Africa, it meant people kept dying while regulators waited for paperwork.Compulsory Licensing: The Loophole That Wasn’t
TRIPS wasn’t completely rigid. Article 31 lets governments issue compulsory licenses-allowing local companies to make patented drugs without the owner’s permission, if there’s a public health emergency. Sounds fair, right? But here’s the catch: Paragraph (f) says the output must be used predominantly for the domestic market. That rule killed cross-border access. If you’re a small African country with no drug factories, you can’t import generics made under license in India. You’re stuck. You can’t even buy the medicine your neighbor has access to. In 2001, Médecins Sans Frontières documented that 11 African countries couldn’t produce a single generic antiretroviral because they lacked manufacturing capacity. They had the right to license-but no way to use it. The Doha Declaration in 2001 tried to fix this. It said public health overrides patents. But words don’t change laws. So in 2005, the WTO created the "Paragraph 6 Solution"-a complex workaround allowing countries without manufacturing to import generics from others. Only two countries ever used it: Canada exported a small batch of antimalarial drugs to Rwanda. That’s it. The system was too bureaucratic. Too slow. Too expensive for countries already struggling with basic health infrastructure.Who Won? Who Lost?
The winners? Big pharmaceutical companies. Between 1995 and 2010, the number of developing countries granting pharmaceutical product patents jumped from 60 to 147. Drug prices soared. In South Africa, the price of the HIV drug efavirenz jumped 300% after TRIPS compliance. In India, cancer drugs like imatinib went from $200 a month to over $1,000-until local manufacturers found legal loopholes. The losers? Patients. The World Health Organization found that in the first decade after TRIPS, generic drug entry was delayed by 5 to 10 years in most low-income countries. For diseases like tuberculosis and hepatitis C, that meant thousands of preventable deaths. The Access to Medicine Foundation reported in 2019 that 65% of low-income countries had longer delays in approving generics because of patent linkage rules-rules even stricter than TRIPS required. And it wasn’t just about patents. Countries were pressured into "TRIPS Plus" deals through trade agreements. The EU-Vietnam Free Trade Agreement in 2020 added eight years of data exclusivity. The U.S. included similar terms in 85% of its bilateral deals. These weren’t negotiated in public health ministries. They were tucked into trade pacts, signed by officials who didn’t understand the human cost.
The Real Cost of Innovation
Pharmaceutical companies argue that strong patents are needed to fund innovation. They point out that 70% of new drugs since 2010 came from countries with strong IP systems. But here’s the flip side: 95% of new drugs developed between 1975 and 2000 targeted conditions in wealthy nations. Only 13 out of 1,223 new drugs were for tropical diseases like sleeping sickness or Chagas disease-diseases that kill millions but don’t pay well. The market doesn’t reward cures for the poor. It rewards treatments for the rich. So patents don’t drive innovation for global health-they protect profits. The Medicines Patent Pool, created in 2010, is one of the few exceptions. It negotiates voluntary licenses with drugmakers so generics can be made for HIV, hepatitis C, and TB. So far, it’s reached 17.4 million people. But it’s voluntary. It’s not a right. It’s a favor.COVID-19 and the TRIPS Waiver That Almost Wasn’t
In October 2020, India and South Africa proposed a temporary waiver of TRIPS protections for COVID-19 vaccines, tests, and treatments. Over 100 countries supported it. The U.S., EU, and Switzerland blocked it for over a year. Their argument? Waiving patents would hurt innovation. But the reality? Pfizer and Moderna got billions in public funding. Their vaccines were developed with taxpayer money. The patents were just legal shields to keep competitors out. When the waiver finally passed in June 2022, it was watered down. It didn’t cover diagnostics or treatments. It didn’t force technology transfer. It didn’t lift data exclusivity. It was a symbolic win, but not a game-changer. By then, the window had closed. Most high-income countries had already hoarded vaccines. Low-income countries were still waiting. The waiver didn’t help the people who needed it most.
What’s Left to Fix?
The TRIPS agreement still stands. The loopholes are too narrow. The enforcement is too one-sided. Countries still can’t import generics. Data exclusivity still blocks competition. And the global system still treats medicine like a commodity, not a human right. There are three real fixes:- Remove the "domestic market" restriction on compulsory licensing. Let countries import generics freely.
- Eliminate data exclusivity. Let regulators approve generics based on safety, not paperwork.
- Stop TRIPS Plus clauses in trade deals. No more hidden patent extensions.
It’s Not About Patents. It’s About Power.
This isn’t a technical problem. It’s a political one. The TRIPS agreement didn’t happen by accident. It was written by pharmaceutical lobbyists, supported by powerful governments, and pushed through by trade leverage. Developing countries had no seat at the table. The result? A global system where a child in Malawi can’t get a $300 cancer drug because a patent in Switzerland says no. Where a mother in Kenya pays 10 times more for insulin because the patent holder won’t license it. Where innovation is rewarded-but only if it serves the rich. The next time you hear someone say "patents drive innovation," ask this: Innovation for whom? And at what cost?Can developing countries still make generic medicines under TRIPS?
Yes, but it’s extremely difficult. TRIPS allows compulsory licensing for public health emergencies, but only if the country has manufacturing capacity. Countries without factories can’t import generics from others unless they go through the complex and rarely used "Paragraph 6 Solution." Most lack the legal expertise, political will, or resources to even try. So while the right exists on paper, in practice, very few can use it.
Why do some countries still have cheap generics despite TRIPS?
India is the biggest example. Before TRIPS, India only granted process patents, not product patents. After 2005, it had to change, but loopholes remain. India still produces generics for drugs where patents are weak, expired, or challenged successfully. Many countries import these generics legally. Brazil and Thailand also use compulsory licensing aggressively. But these are exceptions-countries with strong legal systems, political will, and manufacturing capacity. Most can’t follow suit.
Does TRIPS stop all generic drug production?
No. TRIPS only stops generic production of drugs still under patent. Most medicines in use today are off-patent and widely available as generics. But the problem is with newer, life-saving drugs-like cancer treatments, hepatitis C cures, and HIV second-line therapies. These are often still patented, and generics can’t enter the market for years. So while generics exist, they’re not reaching the patients who need the newest treatments.
What’s the difference between a patent and data exclusivity?
A patent gives the drugmaker exclusive rights to make and sell the medicine for 20 years. Data exclusivity is separate: it prevents regulators from using the original company’s clinical trial data to approve a generic version, even after the patent expires. This adds 5-10 more years of monopoly. So a drug might be off-patent, but still unaffordable because no generic can get approved.
Why did the WTO approve a TRIPS waiver for COVID-19 vaccines but not for treatments?
The 2022 waiver was a political compromise. It only covers vaccines, not diagnostics or treatments, because wealthy countries refused to go further. The pharmaceutical industry lobbied hard to protect profits on treatments like Paxlovid and monoclonal antibodies. Even though these drugs were developed with public funding, companies argued that waiving patents would hurt innovation. The result? A partial waiver that helped little, and only after millions had already died.
Shannon Amos
November 26, 2025 AT 03:59So let me get this straight - we spent 30 years forcing poor countries to play by rules written by Big Pharma lobbyists, then acted shocked when people died because they couldn’t afford medicine? Classic. I mean, if your kid needs insulin and the patent holder says ‘nope, $1,000/month or GTFO’… that’s not capitalism. That’s just cruelty with a business plan.
stephen riyo
November 27, 2025 AT 17:26Wait… so you’re saying… the system… is rigged? Like… on purpose? I mean, I knew patents were bad, but I didn’t realize they were designed to KILL people? Like… literally? I mean… wow… I just… I didn’t know… I’m… I’m kind of sick now…
Wendy Edwards
November 27, 2025 AT 19:26Y’all don’t get it - this isn’t about patents, it’s about WHO gets to live. I’m crying rn. My cousin in Nigeria couldn’t get her HIV meds for 18 months because of this crap. And now they’re acting like the waiver was a win? Bro. It was a funeral. We lost so many people while they argued over paperwork. But hey - at least the CEOs got bonuses. Keep fighting. We’re not giving up. We’ve got this.
Damon Stangherlin
November 29, 2025 AT 02:02Just to clarify - TRIPS didn’t create the problem, it just codified it. Before TRIPS, countries like India were already making generics, but it was messy. The real issue is that the global health system treats medicine like a luxury product instead of a public good. The good news? We’ve seen what works: compulsory licensing, tech transfer, and the Medicines Patent Pool. The bad news? We keep ignoring the evidence because profits matter more than lives. But change is possible - we just need the will.
Cynthia Boen
November 29, 2025 AT 07:57So you’re blaming pharma for being pharma? Shocking. Maybe if developing countries spent less time crying and more time building labs, they wouldn’t be begging for handouts. Innovation costs money. Someone’s gotta pay for it.
Amanda Meyer
December 1, 2025 AT 01:55While I agree with the moral urgency of this argument, I must emphasize the structural complexity of the issue. The TRIPS Agreement was negotiated under the auspices of multilateral consensus - and while power asymmetries are undeniable, the legal architecture remains binding. Any reform must therefore proceed through institutional channels, not moral outrage alone. Nevertheless, the human cost cannot be ignored.
Jesús Vásquez pino
December 2, 2025 AT 15:41Look - I get it. Pharma’s greedy. But you think Brazil and India are saints? They steal patents too. And now they’re selling generics to other poor countries? Who’s paying for R&D then? If you want cheap drugs, fund the research yourself. Stop blaming the people who built the system.
hannah mitchell
December 3, 2025 AT 18:30Interesting. I didn’t realize data exclusivity was even a thing. I always thought it was just about patents. So… even after the patent expires, the generic still can’t get approved? That’s… wild. I guess I never thought about how regulation can be used as a barrier too.
vikas kumar
December 5, 2025 AT 13:41As someone from India, I’ve seen this up close. Our generics saved millions - not because we’re heroes, but because we had the guts to say ‘no’ to the rules. But even here, it’s getting harder. Every new trade deal tries to lock us down. We’re not perfect - but we’re trying. And we’re not alone. There are doctors in Malawi, nurses in Uganda, patients in Peru - they’re all fighting the same fight. We need to stand together.
Vanessa Carpenter
December 5, 2025 AT 19:14I used to think patents were fair. Then I read about a mom in Zambia who had to choose between her daughter’s hepatitis C treatment and feeding her siblings. I haven’t slept right since. This isn’t about economics. It’s about dignity. We can fix this - but only if we stop pretending it’s complicated.
Bea Rose
December 6, 2025 AT 10:09TRIPS is a scam. End of story.
Michael Collier
December 6, 2025 AT 11:32It is imperative to acknowledge that the international intellectual property regime, as codified under the Agreement on Trade-Related Aspects of Intellectual Property Rights, constitutes a structural impediment to equitable access to essential medicines in low- and middle-income countries. The imposition of product patent requirements, coupled with data exclusivity provisions and restrictive interpretations of compulsory licensing, has resulted in demonstrable and preventable mortality. Reform must be pursued through multilateral renegotiation, with particular attention to the elimination of TRIPS-plus provisions in bilateral trade agreements.
Douglas Fisher
December 7, 2025 AT 02:18I just… I didn’t know… I mean, I’ve heard about generic drugs, but I never realized how many people were being blocked from them just because of… paperwork? And patents? I thought patents were for protecting inventions… not for making people die. I feel like I’ve been asleep. I’m gonna start sharing this. Someone needs to hear this.