Pfizer Greed + WTO = Dying for Paxlovid

It’s relatively easy to get game-changing Paxlovid in the United States. But Pfizer’s greed means it’s not available in half the world.

We may be over COVID, but it’s not done with us…

That’s because ongoing outbreaks means a more deadly global variant is just a few mutations away.

And, globally billions of people still have no access to COVID vaccines. They suffer life-changing health and economic consequences needlessly from severe COVID while many vaccinated people in rich nations experience COVID as an annoyance.

Plus, some here choose not to get vaccinated or boosted. And with variants like Omicron that have “immune escape” from vaccines, breakthrough infections are up for those who are vaccinated.

This all makes global access to COVID treatments and tests essential.

Remember that in clinical trials, Pfizer’s COVID treatment Paxlovid reduced COVID mortality by 90% among high-risk groups that had no vaccines. (Almost 80% of people in low-income countries have not had even a fist shot, much less access to the most effective mRNA vaccines under monopoly control of BioNTech/Pfizer and Moderna.)

Treatments also mean shorter illnesses and that translates into less lost income, supply chain chaos and shortages.

It’s relatively easy to get game-changing Paxlovid here. But Pfizer’s greed means it’s not available in half the world.

Pfizer has monopoly patents on Paxlovid, which are enforced in numerous countries around the world as required by the World Trade Organization (WTO) Agreement on Trade Related Aspects of Intellectual Property (TRIPS.)

You may have heard about Pfizer’s deal with the UN Medicines Patent Pool (MPP) for generic Paxlovid production in 35 countries. The glowing press coverage largely skipped the details: Pfizer insisted that generic Paxlovid can only be sold in 95 of the world’s poorest countriesSo the licensing terms exclude 100 countries with 47% of the world’s population that also happen to have had the highest COVID infection rates.

A generic manufacturer in the Dominican Republic (DR) got one of the licenses. But it cannot sell generic Paxlovid in the DR. Next door in Haiti, sales are allowed. Perhaps Pfizer thinks there are no for-profit sales to be made there. Pfizer excluded sales in almost every nation in the Americas and most African, Middle Eastern and Asian nations that are not considered Least Developing Countries.

So, it’s not surprising that a big bloc of labor, health, faith, human rights and other organizations groups just called on President Joe Biden to increase access to Paxlovid and other COVID treatments and the tests needed to identify infections.

The groups’ letter calls on Biden to declare a trade ceasefire on COVID access-to-meds policies and to extend a June 2022 WTO Ministerial COVID Decision to cover treatments and tests. That June WTO deal is now limited to vaccines, and thus of little use. This is the next step after the long and painful global campaign to try to waive Big Pharma’s WTO intellectual property (IP) barriers undermining access to COVID vaccines.

Organization including the American Federation of Teachers, the Association of Flight Attendants-CWA, Doctors Without Borders, Health GAP, Oxfam, Amnesty International, Human Rights Watch, MoveOn, Indivisible, Public Citizen, Network Catholic Social Justice Lobby, Citizen Trade Campaign, Rethink Trade and dozens of other labor, faith, consumer and other groups wrote:

“We were deeply disappointed that a comprehensive [intellectual property] waiver, which could have enabled greater access to affordable COVID-19 medical tools for all who need them, was not agreed at the mid-June WTO Ministerial. Instead, the June 17, 2022 WTO Decision on the TRIPS largely restates the WTO’s existing flexibilities that allow countries to issue compulsory licenses on medical tools while adding some new limitations. While the June 17 Decision could make it easier for countries to export vaccines made under compulsory licenses, it does not apply to the COVID-19 treatments and tests that would be easiest to produce under such licensing.”

That June 2022 WTO text requires countries to decide whether to extend it to treatments and tests “no later than six months from the date of the Decision.” Immediate U.S. support will make the difference in the WTO decision being extended to diagnostics and therapeutics, the letter notes.

The June WTO COVID TRIPS outcome was a shocking loss for global vaccine access. Cynically, its ONLY actual gain over the status quo is to make it easier to export medicines made under a compulsory license or “CL”. (A CL is a license for a patented product that the government issues without permission of the patent holder. The holder gets compensated, but cannot block expanded production by denying licenses to more manufacturers.)

But COVID vaccines have too many IP barriers to be made in a timely fashion using CLs. They are walled off behind dozens of patents, copyrights, industrial design and trade secrets IP monopoly rights, each of which would require a CL. That’s why the full TRIPS waiver was so key. Yes, the June WTO deal makes it much easier to export generic vaccines you cannot make without the waiver that was not agreed.

BUT, if that June 17 WTO COVID TRIPS decision were expanded to cover treatments and tests, it WOULD make a real difference.

First there are fewer IP barriers and making these drugs does not require technology transfer. Plus, these medicines are simpler to make and thus hundreds of generic pill manufacturers not just dozens of vaccine manufacturers can help expand the volume of affordable pills.

SO, it IS entirely possible for numerous firms to produce Paxlovid under compulsory licensing. But while existing WTO rules allow that, it is for mainly domestic use not export. Enter the June WTO deal!

If that WTO Decision were extended to tests and treatments, then the companies in countries that could make Paxlovid and tests could export these products for sale to people all over the world.

BUT, BUT, BUT it is also critical that powerful countries stop threatening other countries that try to use the existing WTO “flexibilities” to issue compulsory licenses.

Ironically, the U.S. has probably issued the most medicine-related compulsory licenses during the COVID crisis, new research reveals. But, historically, the U.S. government has constantly threatened companies that try to use this WTO-permissible tool.

The recent letter to Biden demands that the U.S. government declare a trade ceasefire. That means no threatening “countries who do adopt or use WTO flexibilities, file trade enforcement cases against them at the WTO or under U.S. free trade agreements (FTA), list such actions in annual U.S. Big Pharma-favoring “Special 301” report, or otherwise threaten trade sanctions, withdrawal of trade preferences, or any other diplomatic or trade pressure to deter countries from adopting or using such TRIPS-compliant measures…”

This is not a hypothetical problem. Right now there are battles over compulsory licenses for Paxlovid in four countries that have Free Trade Agreements with the United States — the DR, Chile, Colombia and Peru. Pfizer is fighting back ferociously to preserve its monopoly and high prices, including by saying CLs would violate the requirements of the U.S. FTAs.

To date, Knowledge Ecology International, which filed for the Paxlovid CL in the DR, has been unable to get the Office of U.S. Trade Representative to clarify that the United States would not enforce FTA obligations against a Paxlovid compulsory license.

This may all sound a bit technical. But to cut to the chase: Until the rest of the world has access to vaccines, treatments and tests, the whole world is at risk for a more deadly variant emerging. A variant that combines lethality with the extreme infectiousness of the recent Omicron variants would be a horror we need to take action now to avoid. At a minimum absent global access to the medical tools needed to fight COVID, we will all face ongoing waves of illness and restrictions on our lives, needless deaths and economic disruption.

No one wants to think about COVID, I know. But either we take action now, or regret not doing so when the consequences hit us later.