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Trade experts have welcomed a preliminary agreement by four influential World Trade Organization (WTO) members that would allow companies to produce and export Covid-19 vaccines without falling foul of patent laws. 

An internal WTO document leaked last week revealed that the EU, India, South Africa and US had agreed to let countries waive intellectual property (IP) rights for vaccine production, nearly 18 months after the proposals were first tabled. Discussions have since taken place within the WTO’s Council for Trade-Related Aspects of Intellectual Property Rights, known as TRIPS. 

The document, seen by GTR, would allow eligible member countries to “authorise the use of patented subject matter with the right holder’s consent” – effectively letting domestic producers manufacture their own versions of vaccines rather than rely on the output of major producers such as Pfizer and Moderna. 

The compromise would also allow companies to export vaccines produced, either directly to fellow WTO members or as part of regional joint initiatives. 

WTO director-general Ngozi Okonjo-Iweala hails the agreement as “a major step forward”, though emphasises that all members are yet to agree to the proposals and that some details must still be ironed out. 

“My team and I have been working hard for the past three months and we are ready to roll up our sleeves again to work together… to bring about a full agreement as quickly as possible,” she adds. 

Trade experts have long called for increased production and export of Covid-19 vaccines. 

The UN Conference on Trade and Development warned in October that failure to widen vaccine access in the developing world could cost the global economy more than US$9tn, adding that supply chain chaos would likely continue for years to come if containment measures are still needed. 

There are also financing opportunities associated with vaccine production and distribution, such as facilitating the import or export of raw materials and equipment. 

“Manufacture of pharmaceuticals and vaccines requires access to vaccine IP, active drug substances, critical components such as active pharmaceutical ingredients, packaging and storage materials such as vials, cold chain and distribution,” Ken Osei, principal investment officer for manufacturing and consumer services at the International Finance Corporation (IFC), tells GTR. 

“IFC therefore supports the transfer of vaccine IP and technology by IP providers to manufacturers [in Africa], as it could help accelerate local or regional vaccine manufacturing, thus improving access to vaccines.” 

However, even if the preliminary agreement was adopted by the WTO as a whole, there are still limitations to what it would allow. 

Humanitarian organisation Médecins Sans Frontières (MSF) points out that the compromise “neglects Covid-19 treatments and diagnostics and fails to address intellectual property barriers beyond patents”. 

“Excluding treatments and diagnostics is a critical weakness, especially as access to Covid-19 treatments remains a significant problem in many low- and middle-income countries, particularly in Latin America, in part because of patent barriers and restrictive licensing deals controlled by pharmaceutical corporations,” says MSF’s EU policy advisor Dimitri Eynikel. 

MSF adds that laws on trade secrets should also be incorporated into any agreement, to ensure producers using the waiver have access to the necessary manufacturing information. 

Rachel Thrasher, a legal scholar and researcher at the Boston University Global Development Policy Center, agrees it would be essential to cover diagnostics and treatment in any final waiver text, but notes the agreement “leaves room for expanding the scope… beyond vaccines”. 

Thrasher also welcomes the introduction of a “peace clause”, which would prohibit WTO disputes related to waiver-related activity. 

However, she tells GTR that there are doubts over whether the agreement would be sufficient to allow vaccine production and export on the scale required. 

“One major concern of mine is that the de facto exclusion of China – with China not in the room to be part of the negotiations – runs the risk of alienating an important partner and potential collaborator in the global health sector,” she points out. 

“Moreover, the waiver would not apply to the US or the EU, so that the major firms with those trade secrets would still be protected under the US and EU intellectual property regimes.” 

The draft agreement extends only to eligible countries, defined as WTO members that were responsible for under 10% of the world’s Covid-19 vaccine exports last year. MSF says this would also exclude Brazil from participating. 

Thrasher adds that there should also be parallel pressure on pharmaceutical firms to share technology and know-how with other potential vaccine manufacturers, as well as relevant information such as data from clinical trials. 

Waiving intellectual property rules alone could leave alternative producers with “access to the ingredients, but not the recipe that tells you how to use them”, she says.