Efrem Lukatsky/AP Photo
Activists hold banners during a rally demanding support for patent waivers on COVID-19 vaccines in front of the European Union office during a Ukraine EU summit, in Kyiv, Ukraine, October 12, 2021.
More than a year after Joe Biden announced his support for a waiver of intellectual-property rules to supply cheap vaccines to most of the world’s people, the process remains blocked. The European Union is still siding with the drug companies, and the U.S. has not followed through on Biden’s pledge. The issue comes to a head next week in Geneva, at the Ministerial Conference of World Trade Organization member nations beginning Sunday, June 12.
Under the 1995 WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (known as TRIPS), countries that do not protect trademark, patent, and copyright rights of global corporations can face economically disabling sanctions. TRIPS, however, does allow countries to license local production of drugs in public-health emergencies. But in practice, this requires the support of the EU and the U.S.
It’s hard to think of a more defining global health emergency than a pandemic. According to the World Health Organization, 15 million people had died from COVID-19 as of the end of 2021. Vaccination rates in the Global South, averaging well under 20 percent, have lagged far behind those in rich countries.
In October 2020, South Africa and India formally proposed a waiver of some TRIPS rules to allow global production and thus broader access to affordable COVID vaccines, treatments, and tests. For more than a year, three WTO members, the EU, U.K., and Switzerland, blocked the start of any negotiations. In January 2022, WTO director-general Ngozi Okonjo-Iweala called together the EU, U.S., South Africa, and India to try to break the deadlock.
In March, a draft TRIPS waiver promoted by Okonjo-Iweala was leaked. It supposedly had the support of the four major negotiating parties—the EU, U.S., India, and South Africa. In fact, only the EU endorsed it.
When no country would submit it as their own, the rump text was offered on May 3 by Okonjo-Iweala as a substitute for the waiver proposal formally sponsored by 67 WTO member nations. After almost two years, negotiations finally started, but on a text that would not result in more vaccines being made or more access to the most effective mRNA shots. It does not cover treatments and tests at all. And it would roll back some existing if extremely limited WTO flexibilities that authorize countries to license generic production.
“The text represents the least common denominator of EU fealty to Big Pharma, in that it does not waive intellectual-property barriers,” according to Lori Wallach, director of Rethink Trade at the American Economic Liberties Project.
With less than a week to go before the key meeting, the WTO director-general is now pressuring countries to agree to what is a sweetheart deal with the drugmakers. Despite the WTO’s claims that the text represented a compromise, the U.S. has declined to support the EU version. But neither has it fought for a clear waiver, as Biden promised to do.
The right of nations to use compulsory licensing exists in principle, but without the backing of the U.S. and Europe, it is empty. There are two reasons why, one political and the other technical.
Global vaccine production is blocked by the interaction of intellectual-property rules and technical obstacles.
A U.S. trade law passed in 1988, heavily promoted by the drug industry, includes a provision known as a “Special 301.” Under this law, the U.S. government is required to monitor other nations for violations of intellectual-property laws. Most countries in the world undergo this evaluation by the Office of the U.S. Trade Representative annually.
If a country enacts drug price caps or makes it easy to make generic versions of medicines under compulsory licenses, it can be placed on a kind of blacklist. Countries on the list may have more difficulty selling bonds, raising private capital, and enlisting economic cooperation of the United States on other issues. If a country does not reverse the listed policy, it can be placed on what is known as the Priority Watch List, which automatically leads to a Section 301 investigation and possible trade sanctions.
Global vaccine production is blocked by the interaction of intellectual-property rules and technical obstacles. While scores of countries have the know-how and production capacity to produce treatments like the anti-COVID drug Paxlovid, the technology behind mRNA biologics such as the Pfizer and Moderna vaccines is far more complex.
Developing countries need not just a waiver of patents but the trade secrets and undisclosed technical information to produce the best vaccines at scale quickly without having to reverse- engineer production processes. But the WTO director-general’s text does not even waive patent barriers.
There is one important precedent for global action getting WTO obstacles out of the way: the HIV/AIDS epidemic. At the Seattle ministerial meetings of 1999, developing countries pressed for a waiver in order to gain affordable access to lifesaving treatments such as antiretroviral drugs like AZT, which had already begun to transform HIV/AIDS from a certain death sentence into a manageable chronic illness. But the Clinton administration, acting for the drug companies, blocked this.
By 2001, the nations of Global South had escalated their demands for a total rewrite of TRIPS, and some were threatening to defy the rules. It was President George W. Bush who brokered a compromise that faced down the drug companies and allowed global generic production of drugs like AZT.
A WTO declaration, formally agreed to at a WTO ministerial meeting in Doha on November 15, 2001, affirmed that “Each member has the right to grant compulsory licenses and the freedom to determine the grounds upon which such licenses are granted”; and specifically that “Each member has the right to determine what constitutes a national emergency or other circumstances of extreme urgency, it being understood that public health crises, including those relating to HIV/AIDS, tuberculosis, malaria and other epidemics, can represent a national emergency or other circumstances of extreme urgency.”
Bush complemented his diplomatic initiative with a program called PEPFAR, standing for the President’s Emergency Plan for AIDS Relief. With initial funding of $15 billion approved in 2003, PEPFAR ultimately spent about $90 billion on treatment, research, and capacity-building in poor countries. The combination of U.S. support for prioritizing saving lives over pharma monopolies and American financial assistance is estimated to have saved at least 18 million lives.
But even though the COVID pandemic is a public-health crisis at least on a scale with HIV/AIDS, the Biden administration has failed to act with the clarity and resolve of George W. Bush. Meanwhile, drug industry profits keep soaring. Big Pharma sees the global crisis as a worldwide market where billions of people can be made to pay sticker prices, as charities such as COVAX raise money to pay for grossly inadequate doses of less effective vaccines.
The WTO has revealed itself to be nothing more than the tool of Big Pharma and other industries, worse than useless to protect global public health. Understood politically, the WTO is not some autonomous bureaucracy; its policies are the revealed expression of the biases of its most powerful member nations and their corporate allies.
Biden has a matter of days to decide which side he’s on.
