“At long last, the first public health license for a covid-19 treatment or vaccine has been signed, allowing this medicine to be produced by all capable producers, which will increase supply and drive down prices,” said Mohga Kamal-Yanni, senior health policy adviser to the People’s Vaccine Alliance, a coalition advocating rapid production and equitable deployment of covid drugs.
Merck announced in October that a global clinical trial showed molnupiravir, an antiviral pill, reduced hospitalizations and deaths by half among higher-risk coronavirus patients diagnosed with mild to moderate illness.
The company agreed to share its license with the United Nations-backed Medicines Patent Pool, or MPP, which in turn can sub-license it to manufacturers. The deal is designed to expand the drug’s availability, widen its manufacturing base and potentially push down the price.
The U.S. government is paying about $700 per course of the molnupiravir treatment, the New York Times reported. But, according to Brook Baker, a professor of law at Northeastern University who has tracked the negotiations over the drug, the price of a course of treatment could fall below $10 as competition increases among manufacturers and production scale grows.
When Merck began working on the drug, along with partners Ridgeback Biotherapeutics and Emory University, and learned that it could be administered as a pill, “we right away understood that this could be a game-changer,” said Jenelle Krishnamoorthy, the company’s vice president of global public policy.
“We had a responsibility,” she added. “You could not have a capsule and not be able to find a way to get it across the world.”
Molnupiravir has yet to receive approval from either U.S. or European regulators. Merck applied to the U.S. Food and Drug Agency for emergency use authorization this month, and the European Medicines Agency recently began a rolling review of the drug.
But experts say that it has huge potential to fight the pandemic. Pills are generally easy to make, transport, store and administer, making them a particularly attractive option for lower- to middle-income countries with weaker infrastructure and limited vaccine supplies.
Earlier this year, Merck struck deals with eight Indian pharmaceutical manufacturers to produce a generic version of molnupiravir. Last week, the Bill and Melinda Gates Foundation announced what it said was an initial investment of up to $120 million to incentivize those drugmakers to begin producing the treatment now — even before it has been approved by regulatory bodies.
About two dozen manufacturers around the world have also expressed interest in producing molnupiravir through the MPP license. Drugmakers will be able to apply to MPP for permission to produce the drug starting Wednesday.
Geneva-based MPP was founded in 2010 to enable low- and middle-income nations access to essential patented medicines during the HIV/AIDS epidemic. This is the first covid-related drug for which it has received a license.
Merck’s sharing of its intellectual property stands out in the pandemic as many other companies have lobbied to maintain rights to therapeutics or vaccines. There’s something else unusual, too: The terms and conditions of the deal are being posted online, a marked change from the veil of secrecy surrounding negotiations for coronavirus vaccines.
“Unlike the grotesquely unequal distribution of covid-19 vaccines, the poorest countries will not have to wait at the back of the queue for molnupiravir,” Kamal-Yanni said.
As long as covid-19 is classified as a public health emergency by the World Health Organization, neither Merck nor its partners will receive royalties from drug sales under the agreement, according to a company statement.
But some experts say that there is far more that needs to be done, and advocacy organizations have called on Merck to provide greater access to the drug worldwide.
Baker, the law professor, said that he remains concerned about provisions in the license that could limit the sale of generic drugs outside of the 105 countries and that Merck would be unable to meet demand in these excluded countries. Countries such as Brazil, Russia and Turkey — upper-middle-income countries hit hard by the pandemic — would not be able to purchase generic versions under the new license, he says.
Paul Schaper, Merck’s director of global pharmaceutical public policy, said that the company looked at a “range of criteria” when deciding which countries to include on the list. Some countries, he said, didn’t make the cut because “they are more able to support their health system and their pandemic response.”
The license agreement could move the needle in ongoing negotiations over intellectual property during the pandemic. Member states at the World Trade Organization are still debating a proposal introduced by India, South Africa and others earlier this year to temporarily waive intellectual property rights on coronavirus vaccines and treatments.
Kamal-Yanni said that if Merck did not change its tack, excluded countries could issue compulsory licenses that would allow production of molnupiravir without the approval of the patent holder.
“This license will not solve everything, but it is a starting point and an example,” said Peter Maybarduk, director of Public Citizen, a consumer advocacy organization, and a member of the MPP board.
This report has been updated.