Pfizer’s and Merck’s rollouts of Covid-19 treatment pills threaten to exacerbate inequities in pandemic treatment access as the global community braces for the impact of the new omicron virus variant.
Licensing agreements with the UN-backed Medicines Patent Pool open the doors for multiple generic drug producers to put out their own versions of Pfizer Inc.'s and Merck & Co.'s pills to treat those infected with Covid-19 in overseas markets.
The moves throw lifelines to low-income countries across the globe, with Pfizer boasting coverage of over 50% of the world’s population and Merck creating access for over 100 low- and middle-income countries. But some policy experts say the deals are limiting in nature, cutting off swaths of the globe in dire need of treatment in the name of high prices.
“Both companies have introduced restrictive licensing agreements that deny affordable access to half of the world’s population. Most of the countries included in the licensing agreements do not have the testing and treatment infrastructure to ensure that people that contract COVID-19 get access to treatment,” said Rohit Malpani, board member for nongovernmental organizations at Unitaid, which sponsors the MPP.
Pfizer and Merck have “reserved territories” among wealthier countries that “allow the companies to maximize their profits in the near term,” he added. “Only systematic, government-led approaches can ensure that we have equitable access to medicines, vaccines, and diagnostics.”
The drugmakers’ pill rollout comes amid increasing calls for World Trade Organization countries to sign off on a pact to temporarily waive intellectual property protections on Covid-19 innovations that many argue are roadblocks to ramping up production and broadening access to pandemic treatments, vaccines, and tests.
Such a waiver would “certainly help to override Merck and Pfizer’s patent and data protection rights in one fell swoop, reducing the need for country-by-countries solutions, including compulsory licenses,” said Brook Baker, a professor at Northeastern University School of Law and a senior policy analyst at Health GAP, an advocacy group focusing on equity in access to HIV medications.
“The waiver is still a key liberator of IP monopolies,” he said.
The WTO was slated to meet Tuesday to discuss the waiver, but postponed talks due to concerns over the omicron variant. WTO director general Ngozi Okonjo-Iweala said work on an IP waiver would continue despite the postponement.
U.S. lawmakers and advocates have urged the Biden administration to take the lead in persuading other nations to push for an international waiver that has drawn criticism from drugmakers and IP advocates alike.
A U.S. Food and Drug Administration advisory committee on Tuesday is convening to vote on recommending whether the agency should authorize Merck’s Covid bill—dubbed molnupiravir —for emergency use within the U.S.
Treatments like the pills “will be pivotal for Covid-19 control,” said Monica Gandhi, University of California San Francisco professor of medicine, but it “does not negate the fact that Pfizer did not allow vaccine IP waivers to occur for their product to provide greater global vaccine access.”
“I am disappointed still that Moderna and Pfizer have not yet shared IP around vaccines and do not think this gets Pfizer ‘off the hook’ for that fail,” Gandhi said.
Companies ‘Scaling Up’
While some policy watchers accuse drugmakers of hoarding vaccine IP and unfairly distributing pandemic treatments, others consider the pill rollout a prime example of major companies acting in the interest of the public.
“We’ve led the way with COVID-19 vaccines, and now it is clear that innovative biopharmaceutical companies that have developed effective treatments—in particular the treatments for mild conditions which will be needed in large quantities worldwide—are following suit,” said Thomas Cueni, director general of the International Federation of Pharmaceutical Manufacturers and Associations.
“They are doing it voluntarily and because it’s the right thing to do,” he said.
According to Cueni, Pfizer’s and Merck’s announcements fit into a line of moves—such as Gilead’s attempt to make remdesivir more accessible in India—that demonstrate how “companies are working on scaling up manufacturing capacity.”
Licensing for Covid treatments “that lend themselves easily to technology transfer” is “proving to be a good solution to help scale up production while maintaining quality and therefore keeping patients safe,” Cueni said.
Opponents of a waiver—which would negate the need for licensing—caution that broader ability to manufacture Covid treatments doesn’t signal the ability to also increase vaccine production.
“Unlike vaccines that are extremely tricky to make, these treatment medicines can be made almost anywhere,” said James Pooley, a former World Intellectual Property Organization deputy director general.
In addition to safety, the wherewithal to produce a complex mRNA vaccine like those touted by Pfizer and Moderna and incentives for drugmakers to innovate are often voiced as reasons against waiving IP protections.
“We should be focusing on what can practically be done to address the pandemic, and enabling manufacture of treatment medicines is a good example. In contrast, waiving the IP protections we need to produce future vaccines is a bad idea,” Pooley said.
“We should support wider distribution, but keep in place the system that produced these amazingly effective vaccines,” he said. “Working hard now on broader and more equitable distribution of the vaccines we have would result in broader immunity for everyone and end this pandemic more quickly.”
Access to Pills
Yet inequity in access to vaccines has remained a problem throughout the pandemic.
While countries like the U.S. and Canada have given more than enough doses to go around—136.9 and 161.1 doses per 100 people, respectively—the picture is more bleak in poorer nations. Countries like Algeria and Egypt have yet to administer 50 doses per 100 people, while the Democratic Republic of the Congo and others have even lower numbers.
As for Covid treatment pills, Merck’s and Pfizer’s agreements will be accessible in lower and middle income countries. But “both licenses exclude almost all upper-middle income and high income countries where most Covid infections have occurred in the past year,” Baker said, leaving these locations with “constricted supplies and high prices.”
Baker said rich countries stand to face the highest prices, but costs could also be “potentially quite expensive in upper-middle-income countries as shown by the $300 a course of treatment price Merck is charging Thailand.”
“Because of the companies’ market segmentation strategy and continuing monopoly control, the risk of delayed and inequitable access may actually be higher in key countries,” including those in regions like Southeast Asia and Latin America, he said. “These licenses show that ‘voluntary’ company cooperation stops where commercial potential bangs up against access imperatives.”
What’s more, costs could prove “prohibitively expensive,” Malpani said, particularly important as “so many middle-income countries have faced a prolonged economic slump and cascading challenges that require government resources.
Nevertheless, Pfizer CEO Albert Bourla told CNBC that the company is expecting to up its own manufacturing of the pill from 50 million to 80 million and that he believes the treatment will be effective against the new omicron variant.
This increase “may help with the risk of inadequate supplies, but not the problem of needlessly high prices,” Baker said. But still, “even with respect to quantity, the new variant, omicron, could increase the number of infections and thus the need for treatment beyond previous estimates.”