After nearly 18 months of debate, World Trade Organization (WTO) members now appear likely to approve a limited waiver of patent rights on COVID-19 vaccines in their closing session on Wednesday. 

But if the current draft text is approved as it stands, it may be a pyrrhic victory for the medicines access groups that fought for months for a broad waiver of intellectual property (IP) rights on medicines, tests and vaccines, first proposed by India and South Africa in October 2020.  

Those civil society advocates are nervously eyeing the draft waiver’s provisions, which they fear could even set a bad precedent for future accords – a precedent worse than the limits currently contained in the WTO’s Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS). 

TRIPS sets out a global set of rules under which countries may break patent protections and issue “compulsory licenses” for urgently needed health products without risk of a formal complaint of trade violations being lodged at WTO.     

“I think we’d arguably rather walk away,” said Jamie Love, director of Knowledge Ecology International, at a press briefing on Tuesday.  “And I think there’s some in pharma that would prefer that too” he added, referring to the longstanding opposition by pharmaceutical groups to the waiver proposal. 

Scope: limited only to vaccines 

The biggest criticism from civil society about the decision likely to be adopted Wednesday is that the waiver is limited to COVID-19 vaccines, now in surplus, while omitting reference to tests and treatments where access is often more uneven.  

Potentially, the waiver’s provisions could be extended in the future to tests and treatments, but text explicitly stating that remained in brackets as negotiations over the final details continued Tuesday evening.   

Speaking at a WHO press briefing Tuesday, WHO’s Director-General Dr Tedros Adhanom Ghebreyesus echoed the civil society frustrations about the dramatically pared-down scope of the waiver text.

“As I have said many times, the TRIPS waiver was created for use in emergencies. So if not now, then when?  I hope countries will come to an agreement on a waiver not just for vaccines, but for diagnostics and therapeutics as well,” said Tedros. 

Worries about new legal precedents 

But other nuances in the near-final waiver text are even more of a concern for the civil society legal experts who follow WTO closely.  

Love and medicines access activist Ellen t’Hoen of Medicines, Law and Policy, described their concerns in a press briefing Tuesday. In particular they noted: 

• Contrary to existing WTO TRIPS exceptions, only  “developing countries”  can take advantage of the new COVID vaccine waiver formula to import vaccines, potentially excluding lower-middle or middle-income countries that don’t have that status at WTO.   
• The waiver formula is likely to limit, either explicitly or implicitly, those countries that can export vaccines under a compulsory license to producers with less than 10% of the world’s COVID vaccine export capacity.  In particular, that would exclude China, one of the world’s biggest exporters of medicines and vaccines.  

Those two provisions worry advocates for the precedents they could set. Even under the imperfect system of WTO’s existing TRIPS rules, any country – developed or developing – may opt to manufacture a health product under a compulsory license for urgent public health purposes. And any country may export their products – even if that export is sharply curtailed by a host of bureaucratic rules around packaging and notification to WTO, enshrined in a famous 2005 TRIPS amendment, known as 31 bis.    

What’s good about the waiver?

The one potential “improvement” in the waiver language, medicines access advocates say, is that reference to those “notification” requirements, as required under 31 bis have been streamlined somewhat.

Whereas under the existing rules, countries producing and exporting a health product under a compulsory license have to notify WTO officially of its moves ahead of time, the language in the IP waiver for COVID-19 vaccines states that such notification may take place “as soon as possible after the adoption of the measure.”

Since formal notifications of any kind to WTO typically take place at ministerial level, it can slow down exports immensely, Love noted.  “You can’t just talk to the Minister of Health, for example.

“You’re going to have to talk to the Minister of Trade. They’re going to go to the Foreign Affairs Minister if it’s  a WTO notification. 

“It may just be an email. But that email doesn’t just zip out the door. I mean, anytime that the WTO is invoked, it’s a high level of coordination within multiple government departments, including people with very different political views on things. 

“Often this involves four cabinet-level ministers in the exporting country and another four in the importing country.  So say you’re trying to run a business and you’re trying to get like maybe four Cabinet members in two different countries every time you change your order to sign off on something and notify the WTO. Not an easy process.

“And they [the trade and foreign affairs ministers] have counterparts in the United States, in Europe, for example, that they care about and they have relations with, and that just opens up and multiplies the areas for bilateral pressure, or maybe just inaction. 

Waiver doesn’t enable know-how sharing

Another oft-stated goal, at least indirectly, of the waiver measure, was to stimulate local manufacturing in countries that lacked means to buy vaccines abroad as well as the political or financial capacity to strike investment deals with major pharma companies on local production.  

Those gaps were most evident in African countries that were almost entirely shut out of the first months of vaccine roll-out after India banned exports of AstraZeneca’s COVID vaccines produced by Indian generic companies during the height of its pandemic, the sole supplier of vaccines for the global COVAX platform.

Perhaps it was partly as a result of political pressure around the waiver, that major pharma companies like Moderna and Pfizer eventually reached out voluntarily to strike a range of new deals with African manufacturers on COVID vaccine production. 

But pharma groups always maintained that the waiver could not compel vital sharing of know-how or even generate “one more dose” of vaccines.  

While Love and other access advocates still believe that the initial proposal for a broad-based waiver on all COVID health products, affecting not only patents but also trade secrets and know-how, could have triggered more transformational changes, they now are grudgingly in agreement with the idea that the WTO decision, as it stands now, will have little real impact. 

“If you want the vaccine, you need a certain level of collaboration, a sharing of that technology,” said t’Hoen. “WHO has tried to facilitate that through the technology access pool… But it’s much more important to have that know-how in the public domain at an earlier stage, so that it can be managed much earlier.”

The limited waiver process has snowballed, and will likely be carried forward Wednesday largely by ministers who need to show a political result out of the WTO, which critics have accused of being more and more irrelevant anyway. 

Meanwhile, Love and his allies are setting sights on new initiatives and formulas to shake up the trade body, one being a “public goods” platform where countries could commit under existing WTO rules to ensure that its public funding for new health-related R&D contains formulas for open-licensing of resulting medicines or vaccines innovations – or at the least, the open publication of trial results and research findings. 

A new WTO initiative on public goods

“I hope the WTO will walk away from the train wreck that this is and start working on the global good agreements,” said t’Hoen. 

“We hope that between now and the next ministerial..  more than one government will table a text on an agreement with the WTO on public goods,” added Love, noting that such an agreement could be modelled on the existing WTO “General Agreement on Trade and Services”. 

Trade-related “public goods” pledges made under the proposed mechanism would be binding, make use of the existing WTO dispute resolution processes, and could also be used to promote “public goods” well beyond medicines – from trade measures that advance climate mitigation or biodiversity to food security and refugee relief.  

“We think this would be a good project for the WTO… It would change the culture of the WTO and it would be a service to the public … It would get governments to sponsor and mobilize public goods, to put them on their agenda. 

At the same time he admits that, in terms of the IP waiver battle, he frames it as a chapter that may be closing for now, for better or worse: 

“I think that it has been overstated what the effect of the WTO rules are. The WTO doesn’t grant patents or enforce patents. If it disappeared tomorrow, it wouldn’t change any existing IP granted under national law, bilateral or regional agreements,” said Love.

Image Credits: Samy Rakotoniaina/MSH, Jay Louvion/ WTO, Tadeau Andre/MSF .