Government may not press Gilead on potential Covid-19 drug3 min read . Updated: 28 Apr 2020, 12:11 AM IST
Gilead’s remdesivir is a promising candidate for treating covid and, in terms of safety, is considered better than HCQ
NEW DELHI : India is counting on California-based Gilead Sciences Inc. to voluntarily issue generic licences for the antiviral drug remdesivir, said to be one of the more promising drugs being tested to treat covid-19.
Having burnt its fingers with Gilead’s hepatitis C drug back in 2015—a move that saw the US retaliate—the Indian government is not keen on asking Gilead to compulsorily issue the generic licence of its novel drug, two senior Indian government officials said.
Instead, the government is hoping Gilead will voluntarily issue licences for its patented drug, like it did for the hepatitis C drug, Sovaldi, in 2015, the first official said, on condition of anonymity.
Compulsory licensing allows generic drugmakers to produce a patented product without having to take permission from the patent holder. Such moves, though rare, give governments the firepower to confront emergency health challenges.
“We do not plan to get the drug under compulsory licensing. If you look at Gilead’s history, they have gone for voluntary licensing before with their hepatitis C drug, Sovaldi. They may give voluntary licence for this product also," the official said.
To be sure, the drug has to first clear clinical trials, which are underway. Gilead is doing about half-a-dozen clinical trials globally for the drug. The drug is also being tested under the Solidarity Trial by the World Health Organization. Another major trial is jointly supported by the Bill & Melinda Gates Foundation, the Wellcome Trust and Mastercard.
“We will wait until it is found to be effective and production continues before we take a final decision on how to procure it," the second government official said.
Banking on Gilead to voluntarily licence the drug could however be risky, potentially creating uncertainty over its supply, especially if the trials are successful.
Experts said remdesivir is one of the most promising candidates for treating covid-19 and, in terms of safety, considered better than hydroxychloroquine, although a large-scale clinical trial is yet to be completed on either.
Gilead is supplying remdesivir free of charge to all clinical trials. The medicine is only available to patients who are part of a clinical trial or for compassionate use, an official at the drugmaker said on condition of anonymity.
In a statement last week, Gilead said it expects to share results this week of its open-label study of remdesivir in patients with severe covid-19. It has also enrolled patients for a randomized clinical trial and will compare treatment and safety outcomes after 5 or 10 days of treatment with the drug. In addition, data from the company’s open-label study in patients with moderate covid-19 is expected by May end, along with the National Institute of Allergy and Infectious Diseases’ (NIAID) double-blind, placebo-controlled study of remdesivir in patients across a range of disease severity.
The non-governmental Médecins Sans Frontières, or Doctors Without Borders, on Monday cautioned against attempts by Gilead or any other drugmaker to profiteer from the pandemic. “Gilead is setting itself up to charge whatever it wants for remdesivir during this global health crisis, and for years to come. This is even more outrageous when you consider the tremendous amount of taxpayer dollars and public resources that have already contributed to the research and development of remdesivir," Dana Gill, US Policy Advisor for MSF’s Access Campaign, said in a statement.
An issue over patents for Gilead’s novel drug Sovaldi led to tensions between India and the US in 2015. The Indian patent office in 2015 rejected the company’s patent application filed in July 2014 for the hepatitis C drug on the grounds that it was not a significant improvement over an earlier compound developed by another firm.
The move became a flashpoint in India-US relations.
However, between its patent application and rejection, in September 2014, Gilead issued authorised licences to 11 Indian generic drugmakers to make and sell a low-cost version of Sovaldi in 91 developing countries amid criticism over the medicine’s pricing..