A patient receives treatment at a hospital in Indonesia

Covid-19 patients get treatment in an emergency tent on July 18, 2021 in Bekasi, Indonesia. (Photo: Oscar Siagian/Getty Images)

'Therapeutics Nationalism'? Poor at Risk of Being Left Behind as Rich Buy Up New Covid Drug

"The U.S. government should challenge Merck to license molnupiravir more broadly."

Public health experts are voicing increased concern that poor countries--already denied adequate access to coronavirus vaccines--could be left behind once again as rich nations rush to buy up supplies of Merck's promising new Covid-19 drug before it has even won regulatory approval.

"Merck's intellectual property monopolies should not be permitted to obstruct global treatment access."

"Have we learned our lesson?" Rachel Cohen, North America regional executive director for the nonprofit group Drugs for Neglected Diseases Initiative, asked in an interview with Bloomberg on Tuesday. "The majority of people in low- and middle-income countries haven't been vaccinated and could potentially benefit tremendously from this treatment if they got it early enough."

The treatment in question is known as molnupiravir, an antiviral pill that--according to late-stage clinical trial results that have not yet been peer-reviewed--cut in half the risk of hospitalization or death in patients with mild to moderate cases of Covid-19. On Monday, Merck asked the U.S. Food and Drug Administration (FDA) to grant emergency use authorization for the treatment, which entails a five-day course of two pills every 24 hours.

The same day Merck announced the results of its trial last week, the New York Timesreported that the Biden administration had "placed advance orders for 1.7 million courses of treatment, at a price of about $700 per patient"--a 4,000% markup from the cost of production, which researchers have estimated to be around $17.74.

Amid rapidly growing demand, Merck said it plans to double its manufacturing capacity for the new drug, which was developed with the help of large infusions of U.S. government funds. The New Jersey-based company has also promised to make the treatment widely available, but experts fear that rich countries' early attempts to snag supplies of the drug could mean limited access or complete exclusion for poor nations.

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As Bloomberg reported Tuesday, "Some wealthy and middle-income nations, including Australia, Singapore, Malaysia, and Thailand, have followed the U.S. and already secured molnupiravir or started talks to obtain it."

"Nations that have struggled to vaccinate their populations," Bloomberg noted, "could end up in the back of the line for brand new therapies like Merck's pill."

"The molnupiravir case illustrates why the 'TRIPS waiver' is so urgently needed."

Brook Baker, a professor at Northeastern University and a senior policy analyst for Health GAP, has warned of the emergence of "therapeutics nationalism"--a repeat of the "vaccine nationalism" that led to the present inequities in vaccine distribution. Less than 3% of people in low-income countries have received at least one coronavirus vaccine dose, according to the latest figures from Our World in Data.

"We have every reason to believe that there will be shortages of supply, needlessly high prices, and inadequate, overly restrictive voluntary licenses that will exclude countless people in urgent need around the world, including fully 50% of people living in low-income and middle-income countries (L/MICs) alone," Baker argued in a blog post on molnupiravir earlier this month. "This will lead to avoidable disease progression, more long-Covid, and increased deaths."

In anticipation of gaining regulatory approval from governments around the world, Merck has entered into voluntary licensing agreements with several generic manufacturers in India. But Baker and other experts fear such deals will not be sufficient to guarantee equitable access to molnupiravir.

"Even if the eight Indian generics make it to market and can satisfy this demand in licensed territories, Merck will be unable to meet the remaining 70% of global need," Baker wrote. "Merck's intellectual property monopolies should not be permitted to obstruct global treatment access. Merck should be forced to allow generic competition. The U.S. government should challenge Merck to license molnupiravir more broadly."

"An even better solution," Baker added, "would involve the long-delayed adoption of the temporary waiver of intellectual property right obligation at the World Trade Organization (WTO), which would allow countries to export and import generic molnupiravir without fear of state-to-state dispute settlement or infringement claims."

Leena Menghaney, South Asia head for Doctors Without Borders' Access Campaign, echoed Baker, saying in a statement Monday that "the molnupiravir case illustrates why the 'TRIPS waiver' is so urgently needed."

Rich European countries, Canada, and a handful of other nations are currently stonewalling the proposed patent waiver, and the Biden administration is facing protests over its failure to take on a more active role in the ongoing negotiations at the WTO.

"Instead of offering broad open licenses widely to all able manufacturers in different countries, a narrow voluntary license agreed by Merck in April 2021 only includes Indian generic companies, and hinders countries like Brazil from being able to produce and import generic versions and raw materials," Menghaney said. "Middle-income countries excluded from the license had 30 million Covid-19 infections in the first half of 2021, 50% of all infections in low- and middle-income countries."

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