Open letter asking 37 WTO Members to declare themselves eligible to import medicines manufactured under compulsory license in another country, under 31bis of TRIPS Agreement

Background In 2001, the World Trade Organization (WTO) began negotiations on the rules regarding patents and access to medicine. While several issues were clarified and resolved in the November 2001 “Doha Declaration on TRIPS and Public Health”, the negotiations took… Continue Reading

WHO Director-General Remarks in support of global pooling of rights in COVID-19 Technologies and data, in open science and open data

On April 6, 2020, the Director-General of the World Health Organization (WHO), Dr. Tedros Ghebreyesus, gave a media briefing on COVID-19 and the WHO’s efforts to combat the pandemic. In his remarks, Dr. Tedros specifically highlighted the proposal by the… Continue Reading

Open letter to the World Health Organization (WHO) and its Member States on the proposal by Costa Rica to create a global pool for rights in the data, knowledge and technologies useful in the prevention, detection and treatment of the coronavirus/COVID-19 pandemic

March 27, 2020. We are writing to ask the WHO and its Member States to support the proposal by Costa Rica for the creation of a global pooling mechanism for rights in the data, knowledge and technologies useful in the… Continue Reading

FDA States Submission Date of Gilead’s Coronavirus Treatment Orphan Status Application is ‘Confidential’

On Monday March 23, 2020, Gilead Sciences’ remdesivir received orphan designation from the US Food and Drug Administration (FDA) for the treatment of COVID-19. Remdesivir has been reported to be one of the candidates to potentially treat COVID-19, which the… Continue Reading

House Coronavirus Bill Provision Could be Used for COVID-19/Coronavirus-Related R&D without Public-Interest Safeguards

A House coronavirus stimulus bill contains a provision concerning the use of Other Transactions Authority to fund COVID-19 diagnostics. The provision appears to authorize the Department of Homeland Security (DHS) to award $2.2 billion to private sector companies to develop… Continue Reading

President and Minister of Health of Costa Rica ask WHO to create global pool for rights in COVID-19 related technologies

(KEI blogs and other work on COVID-19 are here: https://www.keionline.org/coronavirus) A letter from Costa Rica, signed by Carlos Alarado Quesada, the President, and Dr. Daniel Salas Peraza, the Minister of Health, to Dr. Tedros Adhanom Ghebreyesus, was sent this evening… Continue Reading

FDA gives Gilead a seven year regulatory monopoly for remdesivir to treat COVID-19, on grounds it is an “Orphan” treating a rare disease

Today the FDA granted Gilead Orphan Drug status for remdesivir for the treatment of COVID-19, on grounds this is a rare disease. The morning of the designation, the U.S. had confirmed, through testing, more than 35 thousand cases, including 8,477… Continue Reading

KEI Letter to Speaker Pelosi Regarding Use of “Other Transaction Authority” (OTA) in Coronavirus Bill to Escape Bayh-Dole Public Interest Safeguards

For more on KEI’s work on COVID-19, see keionline.org/coronavirus. On March 23, 2020, Knowledge Ecology International (KEI) sent a letter to Speaker Nancy Pelosi regarding a provision in the current draft of the Senate version of the coronavirus funding bill… Continue Reading