The first non-exclusive license for a COVID-19 health tool – a serological antibody test that checks for the presence of anti-SARS-CoV-2 antibodies – has been finalised by the World Health Organization’s (WHO) COVID-19 Technology Access Pool (C-TAP) and the Medicines Patent Pool (MPP).  

The license, announced on Tuesday in partnership with the Spanish National Research Council (CSIC), will facilitate the rapid manufacture and commercialization of CSIC’s COVID-19 serological test worldwide. 

WHO Director-General Dr Tedros Adhanom Ghebreyesus commended the CSIC, a public research institute, for “offering worldwide access to their technology and know-how.” 

“This is the kind of open and transparent licence we need to move the needle on access during and after the pandemic. I urge developers of COVID-19 vaccines, treatments and diagnostics to follow this example and turn the tide on the pandemic and on the devastating global inequity this pandemic has spotlighted.”

MPP Executive Director Charles Gore hailed CSIC for sharing its test, noting that there has been “too much selfish behaviour” during the pandemic.

Gore added that, as MPP had recently concluded a deal to licence and distribute two anti-viral treatments for COVID-19 with Merck and Pfizer, “the importance of diagnostic testing has increased ten-fold”.

Launched in 2020 by the WHO Director-General and the President of Costa Rica, C-TAP aims to pool technologies to boost manufacturing capacity and expand access to COVID-19 health products.   

Test is easy to use and royalty-free for LMICs 

The test is relatively simple and suitable for basic laboratory infrastructure, and if being offered royalty-free to low- and middle-income countries to promote equitable access to COVID-19 tools.

“This licence is a testament to what we can achieve when putting people at the centre of our global and multilateral efforts,” said Carlos Alvarado Quesada, President of Costa Rica, the founding country of C-TAP.  

“It shows that solidarity and equitable access can be achieved and that it is worthwhile continuing to support the principles of transparency, inclusiveness and non-exclusivity that the C-TAP defends.”

In July, WHO called on pharma companies developing therapeutic options for those with severe COVID-19 to waive exclusivity rights or issue transparent, non-exclusive licensing agreements, such as the one finalized with CSIC, in an effort to address ongoing global vaccine inequity. 

In order to sell the tests in low- and middle-income countries, companies producing the technology will need to supplement this manufacturing with performance data in the European population. 

CSIC president Rosa Menendez noted how this type of technology, and all COVID-19 technologies in particular, need solutions that reach all countries, especially those most vulnerable. 

“In this sense, we would like this action by CSIC, of taking part in the international initiatives of MPP and WHO, to become an example and a reference for other research organizations in the world,” she said.

The technology currently has four different serological tests, of which one has the potential to distinguish the immune response of COVID-19 infected individuals from vaccinated individuals. 

Health Action International (HAI) Senior Policy Adviser, Jaume Vidal, described the agreement as “a milestone for global health and a major step toward achieving more equitable access to health technologies”.

“The first product ever to be licensed to C-TAP is an example of public return on public investment in action. It is also evidence of the political will necessary to address protracted issues currently affecting the global response to the pandemic, such as limited manufacturing capabilities or obstacles to technology transfer,” said Vidal.

“The Spanish government is leading by example,” added Vidal. “Not only are they pushing for non-exclusive licensing through the Medicines Patent Pool (MPP) of a critical health technology and committing funding to C-TAP, but have also come out in support of the TRIPS waiver proposal currently under discussion at World Trade Organisation (WTO).”