Burcu Kilic of Public Citizen, along with some of her colleagues, had an op-ed this week in The Guardian, in which they argued the following:
But who will get the coronavirus vaccines and when? There are two big problems: whether they will be affordable, and whether there will be enough of them to go around. The root of both these problems is not the science – it is the web of intellectual property monopolies that surround the vaccines, as well as almost all the diagnostics and medicines that are of use in the pandemic. And the root of all those monopolies is a rule embedded in the World Trade Organization called Trade-Related Aspects of Intellectual Property Rights (Trips) that was hustled in after aggressive lobbying from Pfizer and IBM, with the full support of rich country governments. Twenty-five years after its introduction, it has done its job – curtailing access to life-saving medicines and vaccines, boosting the profits of major pharmaceutical companies, hobbling public health and, finally, prolonging our exit from the coronavirus pandemic.
A solution is at hand. Earlier this month, India and South Africa, two of the countries hardest hit by the pandemic, formally petitioned the WTO to suspend Trips for all members, on the grounds that it created “barriers to the timely access to affordable medical products” around the world. “There are significant concerns,” the governments of both countries wrote, about “how these will be made available promptly, in sufficient quantities and at [an] affordable price to meet global demand”.
The India/South Africa proposal (along with draft decision text) is here. The core of the waiver request is this:
12. In these exceptional circumstances, we request that the Council for TRIPS recommends, as early as possible, to the General Council a waiver from the implementation, application and enforcement of Sections 1, 4, 5, and 7 of Part II of the TRIPS Agreement in relation to prevention, containment or treatment of COVID-19.
Burcu and her colleagues explained the value of the waiver as follows:
... a waiver from the WTO would remove intellectual property obstacles and allow more countries to locally manufacture diagnostics and treatments, thereby reducing prices as well. While the petition may not be a silver bullet for vaccines, since western pharmaceutical companies would voluntarily need to share their knowhow and technology in addition to giving up their intellectual property, it would certainly build up the moral pressure for them to do so.
A suspension of pharmaceutical monopolies, even temporary, is what the world needs. It would mark a crucial turn in the right direction, in a moment of exhaustion and panic. As the Covid-19 pandemic aggressively advances, the WTO has the opportunity to sway the planet away from monopoly medicine, and towards a new planetary health system. As members of the WTO prepare for the Trips council meeting this week, their choices could not be starker. People or profit; a people’s vaccine or a debilitating vaccine apartheid. The world is watching.
This can all seem a bit abstract, so I asked Burcu what this waiver might mean in practice. What are the specific domestic measures that the waiver would apply to? She pointed me to a Médecins Sans Frontières (MSF) report that offered this example:
Testing kit reagents
The majority of COVID-19 laboratories in the Netherlands work with equipment made by pharmaceutical corporation Roche and depend on the company for supplies of the testing reagents, the liquid buffer needed to run the tests. A shortage of this buffer is one of the reasons why the Netherlands was not able to carry out mass testing for COVID-19 during the early stages of the pandemic in late March.
Despite the shortage, Roche initially refused to provide the recipe for the buffer, blocking labs from quickly making their own solution and ramping up their testing capability. Following public pressure, and after the Dutch Health Minister suggested issuing a compulsory license on the buffer formula and the European Commission started to investigate Roche for possible abuse of its market position, Roche agreed to release the buffer recipe for others to make. IP can pose a barrier to produce testing kit reagents, including tests for COVID-19, which can negatively impact a lab or country’s ability to screen samples for COVID-19 –an essential part of controlling the pandemic. Companies must share the recipes for critical medical products, like test reagents, to ensure the scale-up of supply worldwide.
Basically, the TRIPS waiver would mean that when governments do things similar to what the Dutch government and European Commission did with Roche, other governments won't have a basis to complain at the WTO.
The WTO membership has now rejected the waiver proposal, at least for now. Politico reported the following:
World Trade Organization members on Friday rejected a proposal to temporarily waive intellectual property rights, patents and other protections for any medical technologies relating to Covid-19.
The 164-member council on Trade-Related Aspects of Intellectual Property Rights failed to reach consensus on the proposal. ...
During a three-hour discussion, 16 members, including Egypt, Indonesia and Argentina, argued, inter alia, that current flexibilities in the agreement won’t guarantee timely access to vital supplies — such as diagnostics, personal protective equipment, medicines and eventually vaccines — during the pandemic.
But other members — including the EU, U.S. and the U.K. — opposed the waiver. “There is no evidence that intellectual property rights are a genuine barrier for accessibility of COVID-19-related medicines and technologies,” a Commission spokesperson told POLITICO.
“A waiver to the IP rights set out in the TRIPS Agreement is an extreme measure to address an unproven problem,” added the U.K. representative.
...
With eight opposing members, and no consensus, the TRIPS Council is likely to revert the issue to the next meeting in early 2021, a Geneva trade official said. “In the meantime, delegations could hold meetings in order to find common ground.”
What to make of all this? As a general matter, I think that public policy has pushed too far in protecting IP in recent decades, so I am generally sympathetic to efforts to rebalance these protections. In this case, it seems to me that the waiver is narrowly targeted, so the prospects for abuse are limited. It specifically covers only measures related to "prevention, containment or treatment of COVID-19." COVID-19 is obviously quite a big deal, but the vast majority of IP falls outside the scope of the waiver.
Putting that aside, it's not clear to me that you could enforce the TRIPS Agreement against such measures anyway (even assuming the measures violate TRIPS rules, which they may or may not). Sure, you could file a WTO complaint, but the dispute settlement process takes a while (and is broken right now anyway), and responding governments can choose to ignore the ruling and accept retaliation (and such retaliation would be a political loser for the government imposing it, I would think). Practically speaking, then, I'm not sure there would be much chance of using WTO dispute settlement to stop these measures.
At the same time, even if that view is correct, I don't see any harm in adopting the waiver just to be sure. It would simply confirm the following political reality: In this once in a century (hopefully!) public health crisis, all governments can and will take certain measures to protect the public health of their citizens. The Dutch government and European Commission seem to have done this already in the test kit example above. The waiver would make it clear that other governments, ones with perhaps less power to push pharmaceutical companies around, could do the same.
Could the waiver be abused? I guess so. But as I watch all the previously unheard of policy measures being tried around the world in recent months, it seems to me that the existence of a WTO waiver isn't going to have much impact on domestic policy experimentation. Governments will try things when they think it's worth trying things. This waiver just affirms the actual state of affairs.
It sounds like this issue will be on the TRIPS Council agenda again next year. Proponents of the waiver might want to put forward examples of specific measures they are considering. Making these issues more concrete might be a good way to press the case for the waiver, and to reassure the opponents that the implementation will be narrow.