Remdesivir Licensing Agreement

Under the licensing agreements, companies are entitled to transfer technology from Gilead`s manufacturing process to Remdesivir so that their production can be revived more quickly. Licensees also set their own prices for the generic drug they produce. Licenses are exempt from licence until the World Health Organization declares an end to the Covid-19 public health emergency, or until a drug other than remedivir or a vaccine for the treatment or prevention of COVID-19 is authorized, depending on the previous date. Gilead Sciences (GILD) has signed contracts with five generic drug manufacturers in India and Pakistan to manufacture experimental medicine and distribute it in 127 countries. However, the safety and efficacy of Remdesivir in the treatment of COVID-19 are still being evaluated in several ongoing Phase 3 clinical studies. Remdesivir is also part of the World Health Organization`s solidarity process, which is underway around the world, including at more than half a dozen sites in India. Gilead works with regulators to provide re-awareness to patients. To date, Gliead grants emergency access to Remdesivir to several hundred patients in the United States, Europe and Japan, as Gilead insists that a mandatory license is not even necessary for countries that cannot afford the cost of Remdesivir. It said it had entered into licensing agreements with nine generic drug manufacturers to ensure that the drug could be sold for less money in 127 countries. Public Citizen, the consumer group, found that nearly half of the world`s population, or about 3.7 billion people, are outside the licensing areas. The organization also argued that the licensing agreements „will discourage competition from generic drugs in large middle-income countries such as Brazil, China and Mexico, where treatment needs can be particularly serious.“ Instead, Public Citizen asked Gilead to give its patent and technology to the public.

This follows the publication of preliminary results of the study, suggesting that Remdesivir can successfully treat severe cases of Covid-19. The revelation led the Food and Drug Administration quickly approved emergency response for hospitals. For now, Gilead plans to finally give 1.5 million doses that could cover between 140,000 and 280,000 patients depending on the dosage. According to Peter Liese, this is not fast enough and he threatens to introduce the compulsory license, which means that the drug would be produced by others against the will of gilead.