WTO's COVID deal: more vaccine ‘enabler’ than IP waiver?
After several days and sleepless nights, members of the World Trade Organisation (WTO) finally agreed several key trade initiatives last week, including one that promises to suspend patent protection of the COVID-19 vaccines.
The agreement follows previous discussions between four key continents (the European Union, India, South Africa and the US) aimed at identifying “practical ways of clarifying, streamlining and simplifying how governments can override patent rights, under certain conditions, to enable diversification of production of COVID-19 vaccines”.
At 5am on June 17, a deal was reached between the 164 WTO members. The aims include tackling the inequality of resources seen earlier in the pandemic, due to countries’’ differing levels of infrastructure and finances.
It also promises a more stable and predictable trading environment; more equitable access to safe, affordable and effective COVID-19 vaccines; the encouragement of information sharing; and the removal of “unnecessary” barriers to trade or disruptions in the supply chain in emergency responses to COVID-19.
Ultimately, it intends to create a “strengthened, productive, scientific and technological capacity across the world” in relation to the global response to COVID-19.
But with case numbers seemingly under control, and an alleged glut of the vaccine, why now—and will it really make a difference to the countries it intends to help?
Vocal critics include the Chartered Institute of Patent Attorneys (CIPA), and the Pharmaceutical Research and Manufacturers of America (PhRMA), which both see the waiver as undermining the value of innovation and competition.
Inside the room
Antony Taubman is director of the WTO’s IP division, with responsibility for its programmes on intellectual property, competition policy and government procurement.
He was still recovering from the marathon WTO meeting when he spoke to LSIPR.
This agreement, says Taubman, “provides positive guidance, and indicates some positive tools that can and, in my view, should be used”.
There are two elements to the decision, he explains, most of which clarify existing rights that WTO member governments already have, such as Crown use in the UK, or government or public, non-commercial use in other countries.
“It's the essential principle that regardless of the legitimacy and the value of patent rights, there's always a reserve entitlement for governments to step in and say, effectively, there's an emergency, there's an overwhelming public need. And we are therefore authorising a third party to make use of the patented technology.”
This, he points out, is built into the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and patent law in general.
“But what became apparent in the course of the pandemic was uncertainty, unease and a lack of clarity about what the options really were, and it got caught up in a conversation about compulsory licensing', which in many patent systems is in a separate category,” he explains.
These two things became tangled, he says, with the effect of limiting the agency and ability of developing country members to undertake alternative approaches to vaccine production.
“For many governments, the lesson learned was that they needed to ensure, enforce or somehow leverage greater, more equitable geographical distribution of the production capacity because they saw rich countries finding their way to the front of the queue, and that's indelibly imprinted on their memories.”
Part of the outcome on Friday, he says, was to clarify a number of these available options.
“In the TRIPS Agreement, compulsory licensing is normally meant to be predominantly for servicing the domestic market or domestic need more generally. But if you are looking at building alternative vaccine production, people are naturally looking at this from a regional perspective.
“It doesn't make sense for every single country to have its own standalone production capacity—it just won't happen if it's not viable.
“And so, there is a waiver component in this decision, which lifts that part of the requirement, thereby enabling production to be exported to developing countries, and making it possible to have an alternative regional production and distribution supply chain.”
More enabler, than waiver
In fact, Taubman takes issue with the term ‘waiver’, thinking it to be misleading. Instead, he says, it is “a streamlined pandemic tool for governments to access vaccine technology, to address the public health need, without the agreement of the patent holders”. Or an enabler, for purposes of brevity (but we’ll stick with ‘waiver’).
And this waiver, he points out, differs greatly from the original waiver proposal, put forward by India and South Africa in October 2020, which was “simply a waiver of international obligations”.
Taubman explains that the waiver “zeroes in on a particular obstacle which has come up again and again as a potential problem. And it does that by creating a kind of streamlined mechanism, so that firms and countries can plan from the outset for regional distribution, with economies of scale and confronting the logistics of distributed production chains across the region, when, as you know, the production of the vaccines involves multiple inputs.
“The overarching concern was and is the high concentration in production capacity. And because of the political reality that so many have observed—that if there's any uncertainty, any shortage or any anxiety—vaccines will inevitably be reserved for the population in the country they're produced. And we saw a number of examples of that.”
He adds that the agreement provides for that framework, all without the consent of the patent holder, if that is an obstacle—an enabler, in other words.
“Like all of these agreements, it's up to individual countries and groups of countries to work out if and how they actually want to use it,” he adds. “Because, like the original waiver proposal, it's not self-activating in any way. It maps out options, additional possibilities, but then it's up to those planning for vaccine production and access to work out how best to make use of those opportunities.”
A question of relevance
Despite its intentions, the so-called waiver has not been welcomed by many in the patent community, with questions over its relevance and necessity often being raised.
Fabrice Mattei, global patent head at Rouse—an international IP firm that advises pharma companies and is based in developing markets—believes the agreement is political.
He asserts that it doesn’t add much more than is already provided by TRIPS, which imposes compulsory licences in specific situations, and therefore questions why we need this decision.
“I believe it is very much politically driven, because member states of the WTO in the past issued compulsory licences, for instance, in Indonesia and Thailand, against pharmaceutical products.
“And as a result of that, they faced some very unhappy reactions from developed countries, which took the view that these compulsory licences were damaging IP protection in general.”
He continues: “I think those developing countries really wanted an endorsement via the WTO to basically say, ‘we are facing a unique situation, COVID-19 solutions need to be implemented quickly’. And therefore, we don't want any political retaliation or consequences if we decide to impose compulsory licences.”
But Taubman says the waiver responds to specific demands from developing countries: “The countries pushing for this have said, ‘we see this as a strategic need because we were burned so badly in the initial distribution of vaccines, that we need the capacity to have more geographically distributed production’.
“And more than that, it's more likely to have a regional element, particularly for the newer vaccine platforms in the mRNA in particular, where regional technology hubs are emerging.
“That's the impetus behind it. It's not simply to globally produce more vaccines, but to ensure that production is more evenly distributed if there's a new set of variants, and a need to switch to a new set of adapted vaccine technologies to respond to that.”
The regional hubs are being created by the World Health Organization (WHO), through the COVAX partnership—the global scheme to enable access to the vaccine by poorer nations—with the main hub currently in South Africa and plans to create hubs elsewhere.
Why RNA over AstraZeneca Oxford?
Sheena Linehan, a patent attorney at Potter Clarkson whose background is in immunology and microbiology, is also critical.
“I've never thought that RNA vaccines were the answer to global distribution. I think Oxford University and AstraZeneca in their collaboration set out to develop a scheme where they would license the technology under a sort of franchise scheme as widely as possible.
“So the AstraZeneca Oxford vaccine is the most likely candidate for the global vaccine, not the RNA vaccines, which require ultra-low temperature storage, and are also more complex and expensive to make.”
Having said that, Linehan acknowledges that the waiver may allow the regional hubs to use confidential regulatory data when they get to the point of seeking approval. “But I think they've got some way to go yet. I think they still need to manufacture at scale and do clinical trials.
“I think that's really the initiative that is most likely to benefit from the waiver, but whether it will do that in practice remains to be seen.”
Like other critics, Linehan questions the waiver’s relevance given the global oversupply of the authorised vaccines through COVAX.
“I feel the impact of the waiver may be greater on the next generation of COVID. The next generation of vaccines is more likely to address the distribution challenges in the developing world than the current vaccines.”
She believes that innovators are continuing to address the challenges faced by the pandemic, including the problems faced by developing countries, through new types of vaccines that are better able to provide long-lasting immunity against current and new variants.
Waiver’s limitations and risks
Mattei believes there are three main challenges presented by the agreement: economic, legal, and issues of patient trust.
He thinks only a limited number of countries will, in reality, impose compulsory licences because it's not easy to manufacture a drug or a vaccine.
“You need infrastructure. You need skills, local talent, if you decide to re-export you need to have in place FDA approvals in different countries. This is not something you can do overnight,” he says.
On the legal aspect, he argues that a dearth of vaccine-maker patents in developing countries raises the question: how can they waive a patent if there are no patents?
“Not every patent has been granted so once again, you can't really break the patent if it has not been granted,” he adds.
The third limitation is how the public will react to locally made vaccines. For example, Mattei points out that there has been resistance in southeast Asia to the Chinese vaccine. “They don't rank it very high. They're still very much in favour of Pfizer or other highly reputed companies,” he says.
Linehan agrees. “If a vaccine is updated for a new variant in a developing country at the same time as it might do in the West, then those vaccines may not be really fully understood anywhere. So side effects happening in one country could have an impact on public trust elsewhere.
“We saw that with the AstraZeneca vaccine-the rare blood clots were seen in Europe-but it had an impact on public perception in South Africa.”
She adds that the risk of substandard production runs and not-so-stringent quality control could also be a concern.
Leaky borders could also become a risk under the waiver, says Linehan.
“Could vaccines be re-exported, illegally, perhaps substandard batches, or could [the agreement] in any way increase the risk of counterfeit drugs?” she asks.
Overall, she concedes that enabling developing countries “has to be a good thing”. “I believe that Africa imports 99% of its vaccines currently, and the pandemic may be a sort of catapult for them to develop their own manufacturing."
But, warns Linehan, there may be pitfalls in trying to do that.
“There are risks in trying to manufacture something as complex as a vaccine-it's not as simple as making a small molecule drug, which can be more easily quality-controlled.”
This article was first published on LSIPR on June 23, 2022.
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