CSIC offers serological test to C-TAP

Geneva – WHO’s COVID-19 Technology Access Pool (C-TAP) and the Medicines Patent Pool (MPP) today finalized a licensing agreement with the Spanish National Research Council (CSIC) for a COVID-19 serological antibody technology. The test effectively checks for the presence of anti-SARS-CoV-2 antibodies developed either in response to a COVID-19 infection or to a vaccine.  This represents the first transparent, global, non-exclusive licence for a COVID-19 health tool, and the first test licence signed by MPP and included in the WHO Pool.

The aim of the licence is to facilitate the rapid manufacture and commercialization of CSIC’s COVID-19 serological test worldwide. The agreement covers all related patents and the biological material necessary for manufacture of the test. CSIC will provide all know-how to MPP and/or to prospective licensees as well as training. The licence will be royalty-free for low- and middle-income countries and will remain valid until the date the last patent expires.

“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. Costa Rica welcomes the signing of this licence and is convinced, today more than ever, that mechanisms such as C-TAP can help us overcome the current situation, while being beneficial for future health crises. I thank the Spanish Government and CSIC, for taking a step forward in solidarity and prioritizing health as a global public good.”

“I highly commend CSIC, a public research institute, for its commitment to solidarity and for offering worldwide access to their technology and know-how,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General. “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.”

“Our strong partnership with WHO and C-TAP partners has been essential in negotiating this licence, and I look forward to our continued collaboration, drawing on WHO’s expertise and guidance going forward,” said Charles Gore, Executive Director of MPP. “What is clear is that MPP’s model can work across different health technologies, and we are thrilled to be signing our first C-TAP/MPP test licence with CSIC.”

Dr. Rosa Menéndez, president of CSIC, emphasized how important it is to seek solutions so that technologies related to the COVID-19 pandemic in particular, and health in general, reach all countries, including those most in need. “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.”

The technology to date has resulted in four different tests, one of which has the potential to distinguish the immune response of COVID-19 infected individuals from vaccinated individuals. This should aid further research into the level and length of immunity and the efficacy of the tools at our disposal.

The tests are simple to use and suitable for all settings with a basic laboratory infrastructure, such as those found in rural areas in low- and middle-income countries. The reading can theoretically be done manually (with naked eye comparing the colour of the wells against the colour chart), but an ELISA reader is recommended for greater accuracy of results.

Promising performance data in the European population will need to be supplemented by the companies that will produce this technology if they plan to sell the test in low- and middle-income countries.

Access the licence agreement

The press release is available in French on our website, and Arabic, Mandarin, Spanish and Russian on the WHO website (translations by WHO).

MPP invites interested manufacturers based anywhere in the world to express their interest in obtaining a sublicence by submitting a single email to CTAPDiagnostics@medicinespatentpool.org with complete, detailed responses to the questionnaire provided here.

About C-TAP 

Launched in 2020 by the WHO Director-General and the President of Costa Rica, and supported by 44 Member States, C-TAP aims to facilitate timely, equitable and affordable access to COVID-19 health products by boosting their production and supply through open, non-exclusive licensing agreements. The C-TAP platform provides a global one-stop-shop for developers of COVID-19 therapeutics, diagnostics, vaccines and other priority health technologies to share knowledge and data and license their intellectual property to additional manufacturers through public health-driven, voluntary, non-exclusive and transparent licences. By pooling technologies, developers of COVID-19 health products can boost manufacturing capacity in all regions and expand access to life-saving tools.

About CSIC

The Spanish National Research Council (CSIC) is the largest public research organization in Spain, the fourth largest in Europe and the seventh largest in the world. The mission of the Spanish National Research Council is to promote, coordinate, develop and disseminate scientific and technological multidisciplinary research, in order to contribute to the progress of knowledge and economic, social and cultural development. Research at CSIC is structured into three Global Areas, Society, Life and Materia, covering all disciplines of human knowledge, and is carried out in its 123 research centres distributed throughout Spain. With a workforce of 13,000, the CSIC files more than 60 international (PCT) and average of 120 priority patent applications and signs more than 60 technology licenses each year.

About MPP

The Medicines Patent Pool (MPP) is a United Nations-backed public health organisation working to increase access to, and facilitate the development of, life-saving medicines for low- and middle-income countries. Through its innovative business model, MPP partners with civil society, governments, international organisations, industry, patient groups, and other stakeholders to prioritise and license needed medicines and pool intellectual property to encourage generic manufacture and the development of new formulations. To date, MPP has signed agreements with twelve patent holders for thirteen HIV antiretrovirals, one HIV technology platform, three hepatitis C direct-acting antivirals, a tuberculosis treatment, a long-acting technology, two experimental oral antiviral treatments for COVID-19 and a COVID-19 serological antibody technology. MPP was founded by Unitaid, which continues to be MPP’s main funder. MPP’s work on access to essential medicines is also funded by the Swiss Agency for Development and Cooperation (SDC). MPP’s activities in COVID-19 are undertaken with the financial support of the Japanese Government and the Swiss Agency for Development and Cooperation.