The Biden administration made waves in May when U.S. Trade Representative Katherine Tai announced that the U.S. would support an effort by developing countries to temporarily waive intellectual property rules forbidding generic drugmakers from mass-producing COVID-19 vaccines and treatments.
Shortly thereafter though, it became clear that the European Union, led by Germany, might still block a waiver of the World Trade Organization’s agreement on trade-related aspects of intellectual property rights, or TRIPS. Global public health advocates maintain that eliminating these intellectual property barriers is a prerequisite for making costly pandemic vaccines available in a timely and affordable fashion in the developing world.
Since the waiver would require unanimous approval from the 164 members of the WTO, the objections of even one country would stop it in its tracks.
Now, ahead of critical negotiations between WTO member nations, the EU is inviting some developing country negotiators to Brussels to discuss a new EU text that reaffirms existing exceptions to the TRIPS agreement, but does not waive the monopoly control over where and how much vaccine is made. Developing nations and their allies say that the latter waiver is needed to ramp up COVID-19 vaccine production and dissemination.
HuffPost has obtained a copy of the draft text that the EU’s directorate-general for trade has shared with at least one WTO member nation with whom it is negotiating.
The core of the proposal, which follows a framework outlined by the EU in June, is to reiterate WTO procedures agreed to in 2001 for compelling companies to license the patents on their drugs in a public health emergency.
“Ensuring that all WTO Members can make effective use of the TRIPS Agreement is crucial and consequently a waiver with respect to certain requirements related to granting compulsory licenses for the production and export of COVID-related pharmaceutical products, allowing for their rapid supplies, could be considered,” the proposal states. “The objective would be to lift or simplify the key requirements related to exporting COVID-related pharmaceutical products under a compulsory license to the Members in need.”
“The EU’s counter-proposal is a delaying tactic that is not designed to solve the problem but to obstruct any workable resolution.”
Notably, while the EU text uses the word “waiver,” it explicitly does not waive the TRIPS agreement’s requirements that countries provide extended monopolies for drug firms holding patents, copyrights, trade secrets and other forms of intellectual property.
Rather, the draft text outlines procedures countries may use to issue compulsory licenses. These procedures were clarified in the 2001 Doha Declaration on the TRIPS agreement and public health that would create exceptions to the ordinary TRIPS rules.
But two intellectual property experts who advocate for greater access to affordable medicines told HuffPost that the proposal would do little, if anything, to alleviate the shortage of COVID-19 vaccine doses in the developing world.
South Africa and India initially proposed to temporarily waive WTO intellectual property protections because the existing WTO rules, which already permit governments to issue compulsory licenses, would be unsuccessful without a much broader waiver of intellectual property protections, according to Tahir Amin, an intellectual property attorney who co-founded the affordable medicines group, I-MAK, and Graham Dutfield, a professor of international law at the University of Leeds, who specializes in intellectual property regimes.
“This clearly shows that either the E.U. does not understand how intellectual property systems work in developing generic/biosimilar drugs and vaccines or they are deliberately being deceptive about their intentions with this proposal and wasting valuable time to block the full intellectual property waiver,” said Amin, who helped India develop its groundbreaking 2005 patent law. “I believe it’s the latter.”
Dutfield had a similarly scathing assessment.
“The EU’s counter-proposal is a delaying tactic that is not designed to solve the problem but to obstruct any workable resolution,” he said. “It will protect corporate profits without significantly challenging the artificial scarcities that intellectual property rights are designed to sustain.”
That’s because, as the vaccine’s developers are fond of boasting, the vaccines are complex. They are the product of scores of inputs from around the world, many of which are subject to forms of intellectual property protections that grant the holders of that intellectual property a monopoly over their use. Those protections include dozens of patents, but also a host of trade secrets ― from technological know-how to lipid recipes, copyrighted manuals and clinical trial data ― needed to actually make use of the patented components of the COVID-19 vaccine.
Getting compulsory licenses on each element would take years and may not cover the thicket of intellectual property rules restricting replication of those nonpatented-but-still-proprietary elements of vaccine production.
The EU’s counter-proposal comes to light ahead of important WTO negotiations. Ambassador Tai met with South Africa’s trade minister, Ebrahim Patel, on Tuesday. She is due to conduct unspecified meetings with other WTO counterparts at the WTO’s headquarters in Geneva, Switzerland, on Wednesday. Supporters of the TRIPS waiver hope that the WTO member nations strike some kind of deal by the end of this year.
Disagreements over the TRIPS waiver, which have pushed the U.S. into an unlikely alliance with developing nations, cut to the heart of a debate among wealthy nations about the best approach for combating the spread of COVID-19.
Acknowledging the entire world’s continued vulnerability to the persistence of the COVID-19 pandemic in the developing world, the governments of the U.S., EU and other developed nations have sought to donate vaccine doses through an international program called Covax.
Covax has failed to accommodate demand for COVID-19 vaccines in the developing world. As of the end of September, 56 low-income countries had vaccinated less than 10% of their populations, according to the World Health Organization.
Foreseeing just such a situation, a group of developing countries led by South Africa and India petitioned the WTO in October 2020 for a TRIPS waiver for COVID-19 vaccines and treatments associated with the disease. The group of countries ― some of which are home to big generic drugmakers ― argues that rapid vaccination of the global population requires a significant increase in vaccine production that only temporarily waiving intellectual property rules can enable.
Brand name pharmaceutical companies, and their defenders in the wealthy countries they call home, argue that even if the waiver took effect, the developing world would lack the technological know-how and manufacturing capacity to mass-produce the vaccine.
But developing nations ― and the affordable medicine advocates in their corner ― insist that a TRIPS waiver is a prerequisite for acquisition of that know-how and capacity without fear of devastating legal consequences.
The waiver could also force brand name pharmaceutical companies that have been reluctant to broker licensing agreements with generic drug makers to the negotiating table by raising the prospect that companies in developing nations will eventually reverse-engineer their products without legal repercussions.
Absent that threat, the brand name pharmaceutical makers have been content to limit much of their sales to wealthy nations capable of paying top dollar, while forcing poorer countries into a “Hunger Games”-style bidding war for the remaining doses.
If the EU gets its way, however, waiver proponents fear that the WTO will simply buy additional time for brand name pharmaceutical companies to scale up their production capacity so they can sell vaccine doses to developing countries at sky-high prices, on their own prolonged timetable ― without changing the global intellectual property regime that protects pharmaceutical industry profits.
“By kicking the can down the road, the Pfizers and the Modernas can get more efficient and more to scale, and they’ll say, ‘Oh look, the current supply is going to meet demand,’” Amin suggested.