Gilead to Donate More than Million Doses of its Experimental Anti-Coronavirus Drug

Global pharma major Gilead is to donate 1.5 million doses of its experimental anti-coronavirus drug remdesivir, which could treat 140,000 patients. Daniel O’Day , Chairman and Chief Executive Officer, Gilead Sciences Inc., said in an open letter that  the drug will be offered for compassionate use, expanded access and clinical trials, and will treat patients with severe symptoms.. He added that the company is also boosting its supply of remdesivir to more than 500,000 treatment courses by October, and to more than 1 million by the end the year. Further, production time has also been accelerated to six months from one year, Daniel said. World Health Organization (WHO) panel observed in January this year that Remdesivir was considered to be the most promising therapeutic candidate based on its broad antiviral spectrum, and existing data based on human and animal studies.

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Civil society and public health advocacy groups across the world recently came together to raise their concerns on the access to the drug for COVID-19. The statement from Gilead’s chairman and CEO is somehow a response to the call by civil society organisations (CSOs), which requested Gilead to take immediate actions to ensure rapid availability, affordability and accessibility of its experimental therapy remdesivir for the treatment of pandemic COVID-19. The pandemic has so far spread across all continents and more than 1.2 million cases, including 62,784 deaths, have been reported so far in 209 countries and territories since the first COVID-19 virus emerged in China’s Wuhan in December last year. As per the latest reports Italy has reported 15,362 deaths and 124,632 cases. While Spain has reported 12,418 deaths and 124,736 cases, the US has seen 8500 deaths and 312,245 cases, and India 83 deaths and 3577 cases. The total confirmed cases in the UK have gone up to 47,806, while 4934 deaths have been reported so far. There have been 68,605 cases and 7560 deaths in France, and 58,266 cases and 3603 deaths reported from Iran. Meanwhile, the number of cases is steadily increasing in India and Pakistan.  Considering the alarming nature of the pandemic, making effective therapeutics available and accessible rapidly for all people based on their medical needs is essential for all countries to combat COVID-19 and save thousands of lives.

Remdesivir, produced by Gilead, is one of the COVID-19 treatment candidates that are being investigated in clinical trials in different countries. The pharma giant has poor track record in ensuring universal access to lifesaving treatments.

According to CSOs, Gilead’s current approach to remdesivir may obscure access to this potentially critical treatment for COVID-19, as it holds primary patents of remdesivir in more than 70 countries that may block generic entry until 2031. Despite public health emergency declarations in multiple states and cities in the US since the end of February, Gilead still sought an orphan drug designation from the US Food and Drug Administration (FDA) on remdesivir with the aim to obtain further exclusive rights in the US, and only applied to annul this exclusivity after public criticism in late March. There are no production sites for the drug outside of the US, and faced with an overwhelming global demand for individual compassionate use of remdesivir, Gilead announced its inability to ensure timely supply and reduced the scale of the programme.

Gilead’s recent actions with remdesivir are against the public interest. According to CSOs and health professionals, it is unacceptable for Gilead’s remdesivir to be put under the company’s exclusive control, since the drug was developed with considerable public funding for both early stage research and clinical trials. Moreover, health care workers and patients have faced extraordinary efforts and personal risks in using the medicine in clinical trial settings, and all countries are facing an unprecedented disaster for their people, their healthcare systems, and also their economies.

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In this context, more than 140 CSOs together wrote an open letter to Gilead urging it to take immediate actions to ensure the availability, affordability, and accessibility of remdesivir. 

Some of the major signatories of the open letter included the Third World Network (TWN), Médecins Sans Frontières/Doctors Without Borders (MSF); All India Drug Action Network (AIDAN); Treatment Action Group (TAG); Oxfam, Sankalp Rehabilitation Trust, All India Agricultural Workers Union, Society for International Development (SID), Access to Medicines Research Group (China), AHF India, Swasthya Adhikar Manch, Voice of Patient (India), PHM Germany, Doctors for America, Health Action International (HAI), Global Coalition of TB Activists (New Delhi), Human Rights Research Documentation Centre, Uganda, Focus on the Global South, and public health professionals and policy experts. They wanted Gilead to take immediate action to commit to not enforcing or claiming patents and other exclusivities on remdesivir anywhere in the world, and to enable the production and supply of remdesivir by generic manufacturers worldwide to ensure its availability, accessibility, and affordability, should the drug’s efficacy be demonstrated by the ongoing clinical trials.