- December 20, 2020
- Posted by: samdenis
“Gilead made it clear that production capacity was limited by a number of problems and outlined the steps they took to meet demand. www.gilead.com/purpose/advancing-global-health/covid-19/working-to-supply-remdesivir-for-covid-19. They did not comment on the current situation following the announcement by the U.S. Department of Health and Human Services (HHS), but they may be invited to do so. The agreements are officially referred to as non-exclusive voluntary licences, which is a similar approach Gilead has taken in the past in response to pressure to expand access to its hepatitis C drugs. In this case, the cases mainly concern low- and middle-income countries, but also some middle- and high-income countries, which Gilead said faced with significant barriers to access. Indeed, if prior negotiations with the patent holder do not reach a compromise, it is possible to obtain compulsory licenses under World Trade Organization rules. And compulsory licensing is entirely possible in the event of a national emergency and extreme emergency, as defined in the Agreement on Trade-Related Intellectual Property Rights (TRIPS). A generic version of Remdesivir has just been approved in India, at 64 USD (56 USD) per dose (100 mg bottle). This requirement for mandatory dual licences would certainly apply to existing licensees of Gilead, headquartered in India, where two Remdesivir patents have been issued, and egypt, where a Remdesivir patent is pending.
(Although I have not researched the problem, egypt may not have a provision authorizing mandatory licensing of a pending patent and, therefore, Eva Pharma is not entitled to become a compulsory license holder in derene.) For Ferozson Laboratories , the gilead licensee from Pakistan, where there appears to be no patent application on Remdesivir, a compulsory license should only be granted in the country of use/import. There is no doubt that Gilead Sciences has a strong interest in seizing the opportunity and selling as many re-communities as possible. The drug can potentially shorten the duration of the disease for people with a new coronavirus, but it has no influence on human survival chances. Peter Liese, de epp, requests the granting of a compulsory licence if Remdesivir is not available in sufficient quantities in the EU According to the agreements, companies can set their own prices, but must not pay royalties to Gilead until the World Health Organization has announced the health emergency of the new coronavirus or until another drug or vaccine for the treatment or prevention of Covid-19 has been approved.