WTO COVID text wouldn’t improve vaccine access and excludes treatments and tests
If this proposal were adopted, it would actually add some new burdens on countries relative to the limited flexibilities they now have in the existing WTO rules for making affordable medicines available.
Too bad there is no waiver of any Big Pharma intellectual property (IP) monopolies at all despite the March 15 afternoon tweet from a Politico reporter about a “TRIPS waiver compromise.”
People were ready to celebrate progress after a 17-month fight to remove World Trade Organization (WTO) intellectual property barriers that undermine access to COVID-19 vaccines, treatments and tests. Clearly the pressure from campaigners, legislators, and former heads of state worldwide, other major world luminaries and even the Pope have made unavoidable scandal of millions of avoidable COVID-19 deaths and economic devastation.
But the actual text that later leaked would not facilitate a timely boost in COVID-19 vaccine production, or maybe not any boost at all. It would not meet the righteous mission of saving lives that President Biden declared last May when the U.S. announced support for waiver.
And, it does not even cover COVID-19 treatments and tests despite these becoming frontline measures in the fight to save lives and limit the virus’ economic and social damage. Perversely, if this proposal were adopted, it would actually add some new burdens on countries relative to the limited flexibilities they now have in the existing WTO rules for making affordable medicines available.
So, it certainly is not a “compromise.” Instead of suspending provisions of the WTO’s Agreement on Trade-Related Aspects of Intellectual Property (TRIPS), the text reflects the opposition of pharmaceutical corporations and their allies in the European Union (EU) trade agency to the very notion of waiving IP monopolies. For months, EU officials — with only the support of Switzerland and the UK in the entire WTO — have blocked the more than 100 WTO countries, including the United States, that support waiving some WTO barriers.
The leaked text is the marginalized EU position. It’s another day-of-the-walking-dead moment for the EU’s tired efforts to resell the existing WTO rules on what is called “compulsory licensing.” (A compulsory license or “CL” is a mechanism for a government to grant someone other than a patent owner rights to produce or sell something under patent protection without the permission of but usually compensation to the patent holder.)
Article 31 of the WTO’s TRIPS agreement provides for use of patents without the authorization of the patent holder, including by use of compulsory licenses. A 2001 Declaration on the TRIPS Agreement and Public Health spelled out WTO countries’ flexibilities in using the Article 31 rules.
Some reporters covering the leaked text picked up the EU spin and celebrated as new the terms that are already in the existing WTO rules. Already TRIPS Article 31 provides for “other use without authorization of right holder.” Already the text of Article 31 does not specify whether that is via a compulsory license or some other mechanism so already countries do not need to have a CL law in place and can use executive orders and the like. Already countries can cover multiple patents with one authorization. Article 31 already provides the flexibility that the EU claims is new.
But most critically, many WTO countries support a waiver precisely because they recognize that the existing WTO “flexibilities” won’t do the job in the COVID context. What might work for small molecule HIV-AIDS drugs (ie. pills with fewer ingredients and fewer forms of IP) would not work for complex COVID-19 vaccines with hundreds of inputs subject to various forms of IP barrier.
Indeed, there is overwhelming evidence that product-by-product compulsory licensing for patents — the existing WTO approach that this text continues — simply will NOT facilitate the needed boost in production and supply of COVID vaccines in a timely manner, if at all.
The leaked text simply does not remove the limitations on “freedom to operate” that a prospective new manufacturer would need to be able to actually make the COVID vaccines in a timely manner. And it’s not only because it continues to require product-by-product authorizations of patent compulsory licenses by governments, in stark contrast to a waiver.
To maintain their monopoly control, pharmaceutical firms have created IP “thickets,” adding layers of additional trade secrets, copyright, industrial design and other exclusivities that extend beyond the patent barriers that were the focus of the 2001 WTO flexibilities. But the leaked text does not lift restrictions to access the undisclosed data and trade secrets that are the know-how needed to translate the right to “exercise” a patent into the ability to do so. (This would require a full waiver of TRIPS Article 39, not the leaked text’s reiteration of what is understood to already be permissible, namely governments’ ability to use previously filed test data to approve additional identical medicines.) As well, the leaked text also does nothing to deal with copyright protections on software and algorithms that would thwart production.
The one meaningful thing in the text is removal of impossible procedural requirements now in place for medicines made under a compulsory license to be exported. But that prospective gain is illusory. First, because of the failure to waive all of the other IP barriers needed to make more vaccines, the leaked text would not lead to more shots being produced that could be exported. And perversely, while CLs on patents only could facilitate speedy increases in supplies of COVID treatments like Paxlovid, including for export, the proposal does not cover treatments. Worse, the leaked text introduces unnecessary steps and reporting requirements that could undermine the effectiveness of this one theoretically useful term.
Indeed, the leaked text represents the lowest common denominator of EU fealty to Big Pharma by not actually waiving intellectual property monopolies and the U.S. insistence that only vaccines be covered.
I did not support the U.S. vaccine-only focus, even as I could imagine the politics behind why it happened. But now with the new lifesaving treatments that President Biden spotlighted in his State of the Union speech available and critical to dealing with COVID-19, it is unconscionable to exclude them. If access to such treatments is the best way forward for people in the United States, why should these medicines be unavailable to people elsewhere?
Yet, the only reference to treatments and tests in the leaked text is an unenforceable pledge to revisit those issues in six months. As someone who has observed the WTO for its entire existence, I suspect that if treatments and tests are not included in a meaningful waiver of WTO IP monopolies before the WTO’s mid-June Ministerial ends, and the pressure of that moment subsides, the chance they will be added later is slim.
The bottom line is that this text is more than disappointing. But it also is not the final word. For this text to go into effect, it needs support from all WTO member countries. And that means there is an opportunity to achieve the major improvements that would be necessary to make it a net positive, much less for it to deliver the urgently needed real gains in global access to COVID-19 vaccines, treatments and tests.
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