Of patents and power: "Doses are charity. Knowledge is justice"

A conversation with advocates for global vaccine access about drug patents, activism, Big Pharma, and more

Recently the plague descended on my extended family back in India — and on my wife’s, too. We were not atypical. It began to be said that few Indian families were spared the Covid crisis. And the crisis has revived a subject that I’ve reported on in the past and care deeply about: that of drug patents and poor countries.

Patents are temporary monopolies granted to inventors, to reward invention and thus encourage more of it. But what happens when you invent a drug that people around the world require to stay alive? What happens when, furthermore, that drug was built in part on technology the public paid for? Are there limits to intellectual property?

For years, activists have pressured the United States government to break or suspend patents in particular cases, as with HIV/Aids. They have had little luck. Indeed, the United States has often fought developing countries when they try to break patents to do right by their citizens, choosing American drug companies over dying people.

So it was a dramatic swerve when, last week, the Biden administration announced that it supported a waiver of the patents for Covid vaccines.

Not long afterward, I reached out to several leading activists for vaccine access to understand the significance of the announcement and where we go from here.

Priti Krishtel and Tahir Amin are each cofounder and co-executive director of the Initiative for Medicines, Access, and Knowledge, also known as I-MAK. Zain Rizvi is a law and policy researcher at Public Citizen. Gregg Gonsalves is an expert on infectious disease at the Yale School of Public Health. And Fatima Hassan is founder of the Health Justice Initiative in South Africa.

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ANAND: In recent months, India, South Africa, and other developing countries have been pushing for Covid vaccine patents to be waived. And in a stunning reversal, the United States government just announced its support for their position and willingness to fight for patent waivers.

Can you explain to those of us who are not public health or patent law experts how drug patents work, for starters, and frame the debate about whether they should be broken in crises like this one?

PRITI KRISHTEL: The original intention behind the patent system was to motivate people to invent by rewarding them with a time-limited monopoly. But today that intention has been distorted beyond recognition. Corporations have teams of lawyers and lobbyists whose sole job is to leverage patent protection to block competition, prolong monopolies, and protect profits.

Today, in the middle of the worst pandemic we've seen in a century, we have to remember that innovation exists to serve people, not the other way around. Innovation exists to save lives — and if patents and other intellectual property are standing in the way of saving lives, these rights are not sacrosanct and must be waived to ensure we can get as many manufacturers as possible going to make life-saving vaccines and other medical products.

ANAND: In theory, poor countries could agree with Priti and make generic versions of these drugs, not honoring patents. How have they been prevented from doing so by the World Trade Organization?

TAHIR AMIN: The WTO placed intellectual property at the heart of the trading system in 1995 for the first time. It was essentially imposed on developing countries at the behest of the pharmaceutical and copyright industries, with the support of the U.S., E.U., and Japanese governments. Prior to the WTO, many countries did not have laws that required them to protect intellectual property, including patents.

The TRIPS agreement is one of the agreements within the WTO that specifically govern intellectual property, and it requires member-states to give a minimum level of protection for all types of IP.

What the WTO TRIPS agreement did was globalize the IP system to all member-states. As a result, it means generic manufacturers in the global South were restricted by IP laws and could not compete, lest they infringe the intellectual property and patents of the bigger pharmaceutical companies. It stalled their own technological development and economic development while maintaining the power and control of knowledge in the global North.

If the waiver does come through and suspends IP, including patents, it allows other vaccine manufacturers to re-invest and operate without risk. It all depends on what the final text of the waiver looks like.

ANAND: How has the United States government shown up in this debate in the past — on HIV/Aids and other questions — and how was it initially showing up on the question of the Covid vaccine patents? And what was the significance, therefore, of the recent shift?

FATIMA HASSAN: Well, former President Bill Clinton put South Africa on a trade watch list while people were dying, because our democratic government wanted to pass a law to make medicines more affordable for Black, poor people in my country. Pharma pressured him to do so. The same pharma making vaccines now, too. 

Pharma even sued Nelson Mandela at the time. International solidarity and local campaigning showed them to be profiteers of the worst kind, so they withdrew the case — but not their IP claims. So they made the struggle for affordable drugs even harder. Non-state actors had to engage in patent defiance, civil disobedience, and litigation and force Pharma to issue voluntary licenses to get multiple suppliers in the system. 

So the Biden administration’s announcement was significant, yes, but it’s late, limited to vaccines alone, and still subject to more politics and talk. Time is against us.

Also, Tahir, Priti, and I were all by chance in India for a meeting in 2005, and then India decided to pass a law to make it TRIPS-compliant. Now that is a story!

PRITI KRISHTEL: It was the passage of an amendment to Indian patent law, which attempted to balance public health needs with patent rights. Activists mobilized, ignited the global public to support us, and that law has lasted over time to ensure more affordable medicines for not only India but all the countries that it supplies.

While it is not without its own set of problems, this Indian law reform work is another example of how public pressure is critical in our current market-based system. Drugmakers have repeatedly failed to make their life-saving drugs accessible during global pandemics.

During the peak of HIV/Aids, Gilead’s drug Viread remained unavailable to most patients five years after its 2001 FDA approval. The reasons: Gilead dragged its feet in registering the product across high-burden countries and waited four years before licensing it to generic suppliers. During this period, millions of people died each year from AIDS. Given this track record, which we've seen play out over and over again, we need public scrutiny over drugmakers now more than ever.

This doesn’t mean vilifying drugmakers and their critical work. It means using the one tool we have — public pressure — to ensure everyone who needs vaccines, treatment, testing, etc., get them as fast as possible. The market just doesn't incentivize that!

TAHIR: When I-MAK challenged Gilead's patents on the new hepatitis C drugs in 2013 in India and got a successful decision in 2015, former President Obama made a visit to India around the same time and the decision was soon reversed. We are still in court six years later trying to reverse that decision, and Gilead maintains its patent. 

The U.S. has never supported any attempt by the global South countries to relax IP rules so generic drugs can be more readily available at cheaper prices. Instead, they have pursued bilateral free trade agreements to further strengthen IP rights for pharma and their other industries. 

Also, remember, the U.S. uses Section 301 of its Trade Act to regularly pressure developing countries that are not "complying" with IP laws in the way the U.S. wants. 

So the Biden administration’s decision marks a significant shift from the usual line. 

ZAIN RIZVI: Everyone understands that countries are hoarding doses, but fewer pick up that the global vaccine access fight is also about knowledge. A dose of vaccine can be used by only one person, but all of humanity can benefit from the underlying knowledge about how to make the vaccine. It doesn’t get used up. Like a candle lighting another candle, as Jefferson would say.

But lifesaving knowledge is not available for everyone to use. In a pandemic where thousands are dying daily from a shortage of vaccines, this system is clearly immoral. What makes it even more egregious is that the corporations are getting monopolies on vaccines developed with huge infusions of taxpayer funding. The theoretical justification for a patent falls apart when we the people just paid the corporations for the research and development.

Consider Moderna, which not only received billions in funding, but also invented the vaccine in partnership with federal scientists (i.e., Tony Fauci’s staff). It’s literally the people’s vaccine. But Moderna gets monopoly control over pricing and production.

The Biden administration is saying the international rules that contribute to artificial scarcity for vaccines should be waived temporarily. It’s a big deal. But also a lot more needs to be done.

Yes, waive those barriers ASAP. And let’s affirmatively share the vaccine recipe with qualified developing country manufacturers, and make the investments needed to quickly ramp up production. Public Citizen estimates it would take $25 billion to help produce eight billion doses of the vaccine in regional hubs around the world. Let’s light the candles and end the pandemic.

Doses are charity. Knowledge is justice.

PRITI KRISHTEL: President Biden deserves credit for backing the waiver. It is a big, potentially precedent-setting deal — and, to be completely frank, it was not something most of us who've been raising the alarm on global vaccine access expected to happen. Of course you fight for it even though you expect politicians to stick to the status quo, but I was shocked when the announcement was made. It really signals a break with the market-driven, neoliberal approach the U.S. has taken to foreign and domestic policy over the past several decades.

But it's also only words at this point. It needs to be followed up with tangible action — in the case of vaccines, from ensuring that negotiations are swift and transparent to getting the recipes and related technology into the hands of manufacturers around the globe so they can begin production and stem the tragic, and preventable, loss of life we're seeing in places like India.

The other side of this is fundamentally changing our patent system here in the U.S., which is the wall these companies were hiding behind in the first place. The president must pick a Patent and Trademark Office director who will prioritize equity — from supporting the IP waiver to ensure access for lower-income countries in the midst of a global health crisis to ending the patent gaming by pharmaceutical companies that enables extended monopolies that drive up prescription drug costs for all Americans and disproportionately harm people of color.

ANAND: For now, the waiver proposed by the U.S. is just a proposal. What concerns do you have about its implementation?

GREGG GONSALVES: I have some fears.

  1. It could take months to negotiate the text of the waiver, and the opportunities for the companies and their allies to narrow and water down any final agreement are a real risk.

  2. The next step is driving originator companies to get busy on tech transfer. Some are saying, Can’t do, not enough experts to go around, sorry. The TRIPS waiver gives you the recipe and other cooking tips you might need that otherwise would remain trade secrets, but meaningful tech transfer is like getting a dozen Julia Childs in your kitchen to help you make that very complicated dish. Julia is busy. Julia may not want to come to your house. Julia may say, What’s in it for me?

  3. We need a massive infusion of resources to scale up manufacturing, building or retrofitting factories, coordinating global supply chains on every component of the vaccine from production to delivery (some of which are patented!). This needs leadership. The U.S. government or some other actor has to step in and say, We’ll do this. It’s a hefty political and operational task, and no one has stepped up yet.

  4. Meanwhile, a massive number of doses of vaccines are sitting in the freezers of the global North.

  5. For all the surprise and joy of this past week, these pharmaceutical companies are still getting away with murder.

ANAND: Covid is just one disease. Should this emergency exemption be just that? Or should this be the beginning of a broader public conversation about patents and drugs? What would the system look like if we were to do drug discovery another way?

FATIMA HASSAN: Maybe this negotiation is actually the first step in a long journey, where, over the next few decades, we’ll finally be able to have a real reckoning around the impact of intellectual property on access to healthcare services, in particular medicines.

The fact that medicines are still commodified, that they are subject to a trade regime and subject to the excessive and protectionist rules of the World Trade Organization, is a key concern for many organizations and many health advocates and activists.

Medicines (and here we include diagnostics and vaccines) must be treated as a public good. Otherwise, solidarity will just be a word, and press statements will be worthless.

PRITI: You know, in some traditions of healing, there's a way to think about the human body where you can apply pressure to just one point and then the whole system begins to relax and heal. For us, it's kind of like that. Rather than thinking about how to address the economy, healthcare — all the different systems that are unjust and not working for people — we start with reimagining how we do medicines.

Because when you do that, you are literally figuring out how people who are the most marginalized can access the lifesaving medical products that keep them alive. And that's where the patent system comes in: when you reimagine it, you are actually applying pressure on that root source of power in drug development, and allowing it to heal to actually work for people.

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Photo: Anindito Mukherjee/Getty