Guru Prasad Mohanta
A cure for COVID-19 is most important. Japan, among others, is the latest to approve Remdesivir for use in severely ill COVID-19 patients. This is still an investigational drug and has not received approval for general use in any country. Earlier, the US federal drug authority had approved this for emergency use for hospitalized patients with severe Covid-19 infection. This is based on a clinical trial called Adaptive COVID-19 treatment.
Trial of the National Institute of Health, which showed that whoever received Remdesivir recovered faster than those who were administered placebo. The US drug authority’s nod for emergency use came with a rider that the US government would be in charge of the drug’s distribution. The US may impose an “America first” principle on the supply of this medicine. Remdesivir is not a new molecule but originally developed to combat Ebola. It was tested against Ebola outbreak in the Democratic Republic of the Congo but showed no effect. The innovator American Biotech Company, Gilead Sciences, did not lose hope and pursued its research. Now, clinical trials are on globally.
Notably, it’s not Gilead alone that developed this drug and brought this molecule up to this stage. This was collaborative effort of a private company, the government and the academic staff. Public Citizen, a non-profit consumer advocacy organisation, estimates that US taxpayers contributed $70.5million to Remdesivir’s R&D overall. Having contributed significantly, there’s obvious perception that America would benefit from this. Will the American government intervene if the medicine becomes unaffordable, because of the monopoly privilege of the patent-holder?
While the US government has contributed to research towards Gilead’s Remdesivir, it received no credit. Gilead’s behaviour vis-a-vis acquiring patent for Remdesivir raises serious concerns. In September 2015, the company applied for US patent for a compound, GS- 5734, for any number of coronavirus infections. The patent was granted last year. This is the same molecule what we know today as Remdesivir. A month after the filing of the patent application, Gilead employees whose name appeared in the patent application are cited as co-authors for a scientific paper submitted to Nature, along with numerous government scientists. This paper confirms the molecule as a promising cure against Ebola and other corona virus strains. Testing was done in high risk security labs run by the US government. In spite of participation of the federal government, Gilead applied and was granted the unilateral patent for Remdesivir. Bowing to public pressure, Gilead had withdrawn its application for Orphan Drug Status from US FDA. There is every possibility the price could be unaffordable even to the American people!
In India, Gilead filed the patent application for Remdesivir in 2015 and patent was granted recently –18 February 2020. The prices of patented drugs are always a major barrier for access to such medicines. As the cancer patients are more vulnerable to COVID-19, out of fear of the unaffordable cure, the Cancer Patients Aid Association has expressed its anxiety.
Having granted patent, the government has limited option to act if Gilead does not come forward to offer the medicine to Indians at a price we can afford. Though compulsory licencing is the best option, this may not be feasible as it requires three years’ waiting period after granting patent.
On the other hand, Gilead will most likely explore giving voluntary licensing to some Indian companies for manufacture and sale of the drug. But this option is not acceptable at this hour of the pandemic. Here the price would be fixed by Gilead. Earlier, it has exploited a similar situation for Hepatitis C cure. India is capable of producing this molecule without Gilead’s help and Indian Institute of Chemical Technology developed the key molecule for synthesizing Remdesivir. The government should override the patent or directly negotiate for the price under voluntary licencing option.
Amid intense anticipation over the possible success of Remdesivir as a remedy to COVID-19, there are apprehensions about its availability and affordability. The government needs to be proactive and explore all avenues available for India including overriding the patent to make Remdesivir accessible to every COVID–19 patient. Let patients’ interest prevail over profit at this hour of crisis.
