Poor countries are struggling to obtain new antiviral pills to treat covid, despite drugmakers’ promises to ensure wide access — in an uncomfortable echo of the global divide on covid vaccines.
Pfizer’s Paxlovid and Merck’s molnupiravir are the first covid treatments designed to be taken at home. Both drugmakers have entered into licensing deals with the Medicines Patent Pool (MPP), a U.N.-backed public health organization that works to make medicine accessible for low- and middle-income countries. Merck has also licensed its pill directly to several generic drug manufacturers in India.
But it will take several months for licensed factories to begin pumping out the pills. And the companies shut out many middle-income counties — including several small Latin American states as well as China, Russia and Brazil — from the licensing deals. That means they will be subject to prices set by the drugmakers unless they use legal maneuvers to allow domestic companies to produce the drugs before existing patents expire or import generic versions of the pills. But countries often do not resort to using these maneuvers out of fear of trade retaliation.
Rich countries have already placed large advance orders for Pfizer and Merck’s limited initial supply. Pfizer, meanwhile, is moving aggressively to patent Paxlovid in middle-income countries, according to the watchdog group Public Citizen. That could make it harder for these countries to reduce the cost of the pills by importing generic versions or instituting compulsory licensing.
“We are seeing the same pattern of hoarding, fighting, as we already saw with vaccines for the past three years,” said Yuanqiong Hu, a senior legal and policy adviser at Doctors Without Borders’ Access Campaign. “Limited supply has been pre-booked by who has money and who is quicker.”
Unequal access to vaccines has made it harder for low- and middle-income countries to prevent new covid cases. Any barriers to accessing the new antiviral pills could also put these countries at a disadvantage treating the sick. That’s not just a blow to people who live in these countries. As long as there are places where the virus is spreading rapidly, the world faces the risk that new and damaging variants will emerge.
Middle-income countries get creative
Pfizer has said it can produce 120 million treatment courses of Paxlovid by the end of this year; Merck plans to produce 30 million courses of molnupiravir. Because clinical trials have shown Pfizer’s drug to be 89 percent effective at preventing hospitalization or death in high-risk adults, compared with just 33 percent for Merck’s pill, rich and poor countries alike are setting their sights on Pfizer’s treatment.
The United States has purchased 20 million courses of the Pfizer drug this year, a point of pride for President Joe Biden. “We’ve ordered more of these pills than anyone in the world,” he boasted in his State of the Union address on Tuesday. “Pfizer is working overtime to get us 1 million pills this month and more than double that next month.”
Public health experts predict the European Union and rich countries will soon buy up the rest of Pfizer’s 2022 supply.
Licensing through the MPP could cover up to 53 percent of the world’s population. But that is little salve to the billions of people in middle-income countries that are not eligible for the plan.
“We let rich countries have preferential access through political power, economic power and willingness to pay higher prices,” said Brook Baker, a law professor at Northeastern University who studies access to medicine. “We’ve gotten exactly what you would predict. If a company has a monopoly, it can limit supply, it can set high prices.”
Efforts are underway in Chile and the Dominican Republic, two middle-income countries cut out of the MPP deal, to make a generic version of the Pfizer drug available through compulsory licensing. Innovarte, a nongovernmental organization that works on intellectual-property issues, is working in Chile with the Chilean Association of Pharmaceutical Chemists and Biochemists. In the Dominican Republic, the U.S. nonprofit Knowledge Ecology International (KEI) — which studies access to medical technology — is leading the charge.
Compulsory licensing has been successful in the past in expanding global access to treatments for other common diseases. Thailand and Brazil used compulsory licenses to import cheap generic versions of antiretroviral drugs to treat HIV, for instance.
But although most countries can issue compulsory licenses that allow third parties to produce a patented drug without the permission of the patent holder, they often try to avoid doing so out of fear of retaliation from trading partners.
If a government does not act on its own, outside entities can step in — depending on that country’s patent rules — and ask the government to take action.
“No company is going to be able to supply a global market to address the problems of covid-19, neither in the case of vaccines, nor in case of treatments,” said Luis Gil Abinader, a senior researcher at KEI who is leading the group’s licensing efforts in the Dominican Republic, his home country. “It is mandatory, if we want to end the pandemic as quickly as possible, to share the intellectual property and to share the know-how.”
KEI’s filing in the Dominican Republic was the first attempt in any country to establish a compulsory license for Paxlovid. If the group succeeds, Gil Abinader anticipates this will jump start such efforts in other nations. “If the Dominican Republic breaks the compulsory license taboo on licensing, we think other countries will do the same,” he said.
Prices will vary
If Pfizer opposes KEI’s request, the government of the Dominican Republic could make a decision on the license in court, Gil Abinader said. The drug company, which told Grid it does not believe compulsory licenses are necessary, has asked the government for more time to submit a reply. Once Pfizer files, KEI can request a hearing. That could happen as soon as April.
“We do not believe that granting compulsory licenses to PAXLOVID is an appropriate or constructive approach to improving access,” Pfizer spokesperson Sharon J. Castillo said in an email to Grid. “We are committed to working directly with governments and other stakeholders to ensure that our medicine is accessible and affordable for those who need it.”
Pfizer has said it will use a tiered pricing model with Paxlovid, adjusting its price based on a country’s income. Rich countries will pay higher prices than middle- or low-income nations. That does not guarantee that nations will be able to afford the drugs in sufficient quantity to treat their populations, however.
Panama reportedly paid $13.5 million for 54,000 courses of Paxlovid, which amounts to about $250 per course. That’s roughly half of the price the U.S. paid — but Panama’s gross domestic product per capita is just $12,510 per year, according to the World Bank, compared with $63,600 in the U.S.
“We’ve already been seeing this for 20 years in HIV, where you segment the market according to economic level and try to maximize the profit you can get out of any given country or region,” said Rachel Cohen, the North American regional executive director for the nonprofit Drugs for Neglected Diseases Initiative. “This is one of the limitations of the voluntary approach that allows [the] industry to call the shots and dictate the terms of these agreements rather than having the goal be maximizing production capacity to meet global needs.”
In the meantime, the world is closing in on 6 million recorded covid deaths, and the first generic versions of the covid antivirals are beginning to roll out. Beximco Pharmaceuticals in Bangladesh has begun making generic Paxlovid, while some of the 13 companies in India licensed to produce generic molnupiravir are already producing the drug. And the MPP said in January that it had signed agreements with more than two dozen drug manufacturers to make the Merck drug.