Amid questions about access to remdesivir, its treatment for Covid-19, Gilead Sciences (GILD) says it is pursuing several steps, including licensing agreements with several unnamed companies, to ensure the medicine is supplied to countries beyond the U.S.
Although details were scant, the drug maker indicated there are plans to issue voluntary licenses with “leading chemical and pharmaceutical” manufacturers to produce remdesivir for Europe, Asia and the developing world through 2022. Similarly, negotiations are under way to issue licenses to several generic drug makers in India and Pakistan in order to supply the drug to developing countries.
The company is also holding talks with the Medicines Patent Pool, a United Nations-backed agency that licenses HIV, tuberculosis, and hepatitis C treatments from drug makers in order to provide access in lower-income countries. The agency, which recently expanded its mandate to include Covid-19 products, has previously worked with Gilead on HIV drugs. The company also said UNICEF may distribute the drug.
The move comes after preliminary trial results released last week indicated remdesivir can successfully treat serious cases of Covid-19. The disclosure triggered intense global interest in the drug and the Food and Drug Administration quickly authorized emergency use for hospitals. For the moment, Gilead plans to eventually donate 1.5 million doses, which could cover between 140,000 and 280,000 patients, depending on dosing.
Beyond the encouraging headlines about study results, the news ignited a new round of concern over access to Covid-19 treatments, especially since the U.S. will coordinate distribution. Although Gilead has noted its intent to scale-up manufacturing – and rely, in part, on other companies – there are numerous questions about meeting unprecedented demand for the treatment as well as the cost.
“Producing the drug requires scarce raw materials, with their own lengthy production time, and specialized manufacturing capabilities with limited global capacity,” the company said in a statement. “Any disruption to the supply chain impacting these scarce raw materials and other manufacturing inputs could reduce the amount of remdesivir produced and increase the time it takes to do so.”
Access to Covid-19 medical products has become a prominent issue on the world stage. Led by the World Health Organization, a long list of countries, industry groups, and nongovernmental organizations committed to joining a project for developing and producing new drugs, vaccines, and tests for Covid-19 — and ensure worldwide access to the products. The goal is to obtain $8 billion in funding.
The effort may contain a so-called voluntary pool to collect patent rights, regulatory test data, and other information that could be shared for developing drugs, vaccines, and diagnostics. The Medicines Patent Pool, for instance, expressed its support for the idea last month. By reaching out to the nonprofit, Gilead is signaling its willingness to get on board with such proposals in an attempt to deflect criticism.
These moves reflect mounting pressure on the pharmaceutical industry, which has faced increasingly blistering criticism from cash-strapped governments – as well as wealthy nations – over the cost of the prescription medicines. Gilead, in particular, has been in the crosshairs over the years for the prices of its HIV and hepatitis C medicines.
Although Gilead has previously issued voluntary licenses to generic companies to produce those medicines, the company has still encountered pushback over criticism that its efforts did not go far enough. But with a new executive team installed over the past year, the drug maker is trying to get ahead of critics by pursuing far-reaching deals with remdesivir.
Last week, though, two U.S. lawmakers asked the U.S. Department of Health and Human Services whether taxpayer dollars helped pay for any of the research and development that led to remdesivir. If so, they also asked what the federal government will do to ensure that Americans do not later encounter “price gouging.”