Pfizer and Merck’s deployments of the Covid-19 treatment pills threaten to exacerbate inequalities in access to pandemic treatment as the global community braces for the impact of the new variant of the omicron virus.
Licensing agreements with the UN-backed Medicines Patent Pool open the door for several generics producers to release their own versions of the pills from Pfizer Inc. and Merck & Co. to treat people infected with Covid-19 on the foreign markets.
These measures throw lifelines in low-income countries around the world, with Pfizer covering more than 50% of the world’s population and Merck creating access to more than 100 low- and middle-income countries. But some political experts say the deals are limiting in nature, cutting off swathes of the globe that are in desperate need of treatment in the name of high prices.
“The two 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 who contract COVID-19 have access to treatment, ”said Rohit Malpani, board member non-governmental organizations of Unitaid, which sponsors the MPP.
Pfizer and Merck have “reserved territories” among the richest countries that “allow companies to maximize their short-term profits,” he added. “Only systematic, government-led approaches can ensure equitable access to medicines, vaccines and diagnostics. ”
The rollout of the drugmakers’ pill comes as World Trade Organization countries are increasingly called upon to sign a pact to temporarily waive intellectual property protections over Covid-19 innovations which, according to many are obstacles to speeding up production and expanding access to treatments, vaccines and trials.
Such a waiver “would certainly help override the patent and data protection rights of Merck and Pfizer all at once, reducing the need for country-by-country solutions, including compulsory licenses,” said Brook Baker, professor. at Northeastern University School of Law. and a senior policy analyst at Health GAP, an advocacy group focused on equity in access to HIV drugs.
“Waiver is always a key liberator of intellectual property monopolies,” he said.
The WTO is
On the same day, a Food and Drug Administration advisory committee will meet to vote on whether the agency should allow Merck’s Covid bill – dubbed molnupiravir – for emergency use in the United States.
Treatments like the pills “will be essential for controlling Covid-19,” said Monica Gandhi, professor of medicine at the University of California, San Francisco, but that “does not deny the fact that Pfizer has not authorized relinquishing the intellectual property rights of vaccines so that their product offers better global access to vaccines.
“I am still disappointed that Moderna and Pfizer have not yet shared the intellectual property around the vaccines and I do not think this allows Pfizer to get away with this failure,” Gandhi said.
While some political observers accuse drugmakers of accumulating intellectual property in vaccines and unfairly distributing treatments for the pandemic, others see the rollout of the pill as a prime example of big business acting in the best interests of the world. public.
“We have led the way with COVID-19 vaccines, and it is now clear that innovative biopharmaceutical companies that have developed effective treatments – especially treatments for mild conditions that will be needed in large numbers around the world – are following suit. not, “said Thomas Cueni, executive director of the International Federation of Pharmaceutical Manufacturers and Associations.
“They do it on purpose and because it’s the right thing to do,” he said.
According to Cueni, the announcements from Pfizer and Merck are part of a series of measures, such as Gilead’s attempt to make remdesivir more accessible in India, which demonstrate how “companies are working to increase their manufacturing capacity.”
Licensing Covid treatments “which lend themselves easily to technology transfer” is proving to be “a good solution to help increase production while maintaining quality and therefore ensuring patient safety,” said Cueni.
Opponents of a waiver – which would nullify the need for a license – warn that a larger capacity to manufacture Covid treatments does not signal the ability to increase vaccine production as well.
“Unlike vaccines which are extremely difficult to manufacture, these treatment drugs can be made almost anywhere,” said James Pooley, former deputy director general of the World Intellectual Property Organization.
In addition to safety, the means to produce a complex mRNA vaccine like those touted by Pfizer and Moderna and the incentives for drug manufacturers to innovate are often cited as reasons for forgoing IP protections.
“We should focus on what can be done in practice to combat the pandemic, and enabling the manufacture of treatment drugs is a good example. In contrast, forgoing the IP protections we need to produce future vaccines is a bad idea, ”said Pooley.
“We need to support wider distribution, but keep in place the system that produced these incredibly effective vaccines,” he said. “Working hard now on a wider and more equitable distribution of the vaccines we have available would result in wider immunity for everyone and end this pandemic faster. “
Access to pills
Yet unequal access to vaccines remained a problem throughout the pandemic.
While countries like the United States and Canada have given more than enough doses for everyone – 136.9 and 161.1 doses per 100 people, respectively – the picture is bleaker in the lower countries. poorer. 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 figures.
As for the Covid treatment pills, the Merck and Pfizer agreements will be accessible in low- and middle-income countries. But “the two licenses exclude almost all upper-middle-income and high-income countries where most Covid infections have occurred in the past year,” Baker said, leaving those locations with “limited supplies and high prices ”.
Baker said rich countries would face the highest prices, but the costs could also be “potentially quite high in upper-middle-income countries, as shown by the price of $ 300 per treatment that Merck invoice to Thailand “.
“Due to the corporate market segmentation strategy and continued monopoly control, the risk of delayed and unfair access may actually be higher in key countries,” including those in regions like Southeast Asia. East and Latin America, he said. “These licenses show that the ‘voluntary’ cooperation of companies stops where the commercial potential comes up against the imperatives of access.
Further, the costs could prove to be “prohibitive,” Malpani said, especially since “so many middle-income countries have faced a protracted economic slump and cascading challenges that require government resources.
Nonetheless, Pfizer CEO Albert Bourla told CNBC that the company plans to increase 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 contribute to the risk of under-supply, but not to the problem of unnecessarily high prices,” Baker said. But still, “even in terms of quantity, the new variant, omicron, could increase the number of infections and therefore the need for treatment beyond previous estimates.”