The Biden administration made waves in May when U.S. Trade Representative Katherine Tai announcement that the United States would support an effort by developing countries to temporarily waive intellectual property rules prohibiting generic drug makers from mass-producing COVID-19 vaccines and treatments.
Soon after, however, it became clear that the European Union, led by Germany, could still block a waiver of the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights, or TRIPS. Global public health advocates argue that removing these intellectual property barriers is a prerequisite for making expensive, timely and affordable pandemic vaccines available in the developing world.
Since the waiver would require the unanimous approval of all 164 WTO members, objections from just one country would bring it to a halt.
Now, ahead of critical negotiations among WTO member countries, the EU is inviting some developing country negotiators to Brussels to discuss new EU text that reaffirms existing exceptions to the TRIPS agreement, but does not relinquish monopoly control over where and how much vaccine. made. Developing countries and their allies say this latest waiver is needed to speed up production and dissemination of the COVID-19 vaccine.
The HuffPost got a copy of draft text that the EU’s Directorate-General for Trade has shared with at least one WTO member country with which it is negotiating.
The heart of the proposal, which follows a framework defined by the EU in June, is to reiterate the WTO procedures agreed in 2001 to force companies to license patents on their drugs in the event of a public health emergency.
“Ensuring that all WTO members can make effective use of the TRIPS Agreement is crucial and, therefore, a waiver of certain requirements related to compulsory licensing for production and export of pharmaceutical products linked to COVID, allowing their rapid supply, could be considered ”, indicates the proposal. “The aim would be to lift or simplify key requirements related to the export of COVID-related pharmaceuticals under compulsory license to Members who need them.”
“The EU’s counter-proposal is a delaying tactic which is not designed to solve the problem but to stand in the way of any viable resolution.”
– Graham Dutfield, professor at the University of Leeds
Notably, although the EU text uses the word ‘waiver’, it does not explicitly derogate from the requirements of the TRIPS Agreement that countries provide extensive monopolies for pharmaceutical companies holding patents, copyrights. , trade secrets and other forms of intellectual property.
Rather, the draft text describes the procedures countries can use to issue compulsory licenses. These procedures were clarified in the 2001 Doha Declaration on the TRIPS Agreement and Public Health which would create exceptions to the ordinary TRIPS rules.
But two intellectual property experts who advocate for better access to affordable drugs 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 existing WTO rules, which already allow governments to issue compulsory licenses, would be unsuccessful without a much broader waiver of intellectual property protections, according to Tahir Amin, an intellectual property lawyer. who co-founded the affordable medicines group, I-MAK, and Graham Dutfield, professor of international law at the University of Leeds, specializing in intellectual property regimes.
“This clearly shows that either the EU does not understand how intellectual property systems work in the development of generic / biosimilar medicines and vaccines, or it is deliberately misleading its intentions with this proposal and wasting precious time blocking the full waiver. to intellectual property, “said Amin, who helped India develop its revolutionary patent law of 2005.” I believe it is the latter. “
Dutfield had an equally scathing assessment.
“The EU’s counter-proposal is a delaying tactic which is not designed to solve the problem but to hamper any viable resolution,” he said. “This will protect corporate profits without significantly undermining the artificial shortages that intellectual property rights are designed to maintain.”
This is because, as the vaccine developers like to boast, vaccines are complex. They are the product of a large number of inputs from around the world, many of which are subject to forms of intellectual property protection that grant owners of that intellectual property a monopoly over their use. These protections include dozens of patents, but also a plethora of trade secrets – from technological know-how to lipid recipes, to copyrighted manuals and clinical trial data needed to actually use the patented components of the vaccine. COVID-19.
Obtaining compulsory licenses on each element would take years and might not cover all the intellectual property rules restricting the replication of these elements which are not patented but still exclusive to the production of vaccines.
The EU’s counter-proposal is unveiled ahead of major negotiations at the WTO. Ambassador Tai met with South African Trade Minister Ebrahim Patel on Tuesday. She is due to hold unspecified meetings with other WTO counterparts at WTO headquarters in Geneva, Switzerland, on Wednesday. Supporters of the TRIPS waiver hope that WTO member countries will reach some sort of deal by the end of the year.
Disagreements over the TRIPS waiver, which pushed the United States into an unlikely alliance with developing countries, are at the heart of a debate among wealthy countries over the best approach to tackle the spread of COVID-19.
Recognizing the continued vulnerability of the world to the persistence of the COVID-19 pandemic in developing countries, the governments of the United States, the EU and other developed countries have sought to donate doses of the vaccine through through an international program called Covax.
Covax has failed to meet the demand for COVID-19 vaccines in developing countries. By the end of September, 56 low-income countries had vaccinated less than 10% of their population, according to the World Health Organization.
Predicting such a situation, a group of developing countries led by South Africa and India applied to 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 large manufacturers of generic drugs – argue that the rapid vaccination of the world’s population requires a significant increase in vaccine production that only a temporary exemption from intellectual property rules can allow.
Brand-name pharmaceutical companies, and their advocates in the wealthy countries they inhabit, argue that even if the waiver took effect, the developing world would not have the technological know-how and manufacturing capacity to mass-produce the vaccine. .
But developing countries – and advocates for affordable medicines in their corner – insist that a TRIPS waiver is a prerequisite for acquiring this know-how and capacity without fear of devastating legal consequences.
The waiver could also force brand name drug companies that have been reluctant to negotiate licensing deals with generic drugmakers at the negotiating table by increasing the prospect that companies in developing countries will end up reverse engineering. their products without legal repercussions.
In the absence of this threat, branded pharmaceutical manufacturers have been content to limit much of their sales to rich countries able to pay the full price, while forcing poorer countries into war. “Hunger Games” type auctions for the remaining doses.
If the EU gets what it wants, however, supporters of the waiver fear that the WTO will simply give brand name pharmaceutical companies extra time to increase their production capacity so that they can sell doses of vaccines to developing countries at exorbitant prices, on their own. schedule – without changing the global intellectual property regime that protects the profits of the pharmaceutical industry.
“By kicking the box, the Pfizer and Moderna can become more efficient and more scalable, and they’ll be like, ‘Oh look, the current supply is going to meet the demand,’” Amin suggested.