Rush to Buy Merck’s Covid Pill Risks Leaving Poor Countries Behind
(Bloomberg) -- Moves by several countries to buy supplies of Merck & Co.’s promising Covid pill before it’s even approved are raising concerns that some poorer nations could be left behind, in a repeat of the slow and inequitable rollout of vaccines.
Merck has taken steps to ensure countries around the world can get its drug, including licensing its experimental medication to generic-drug firms and planning production increases. Yet in a worrisome echo of the global vaccine situation, some wealthy and middle-income nations like Australia, Singapore, Malaysia and Thailand have followed the U.S. and already secured molnupiravir or started talks to obtain it.
Countries that have struggled to vaccinate their populations could end up in the back of the line for brand new therapies. A global initiative to deploy treatments is at risk of running into the same problems the Covax vaccine distribution effort has faced, according to an independent report commissioned by the World Health Organization.
The therapies arm of the ACT-Accelerator, which is working to distribute Covid treatments, has expanded access to the steroid dexamethasone, analyzed more than 1,700 clinical trials to identify new treatments and funded large studies. Still, the program “does not yet have a clearly articulated procurement structure to supply countries or to negotiate contracts,” according to the report from consulting firm Dalberg Advisors that was based on interviews with government, company and health-group officials.
Without preemptive action, the WHO-backed effort “could face similar challenges to Covax in ensuring sufficient supply” for poor and middle-income countries, the review found, highlighting the advanced purchase of molnupiravir by the U.S. as a risk.
The Merck pill is a potential boon to poorer countries because of its low production cost and ease of use. The company signed licensing agreements with Indian generic manufacturers aimed at supplying more than 100 lower- and middle-income countries should the therapy get approved. Global health group Unitaid and its partners are in supply discussions.
“The concerns I think are understandable, but we’ve put in place a strategy with our voluntary license partners that will be able to meet the demand and really bring this medicine to patients worldwide who need it,” said Paul Schaper, executive director of global pharmaceutical public policy at Merck.
Officials are anxious not to replay the disappointments of Covax, the program coordinated by the WHO and other groups. The effort has been hobbled by a lack of supplies after rich nations rushed ahead to protect their own populations, with some already beginning to give booster doses.
“Have we learned our lesson?” said Rachel Cohen, North America regional executive director for the nonprofit Drugs for Neglected Diseases Initiative. “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.”
Testing also needs to be ramped up in order to detect cases in the first days of infection when the drugs may be most effective, Cohen said. How much the drugs will cost -- and who will receive them if supplies are limited -- remain key questions.
The U.S. agreed in June to pay Merck about $1.2 billion for 1.7 million treatment courses, or about $700 per course. Australia, Malaysia, Singapore and New Zealand have already secured supplies, while Thailand was finalizing its own pact last week. In all, about 10 countries have either signed deals or are in talks to do so, according to London-based Airfinity Ltd.
Hopes are running high that the drug will be widely available. In April, Merck licensed it to Indian companies including Cipla Ltd., Dr. Reddy’s Laboratories Ltd. and Hetero Labs Ltd. The company also has been in discussions with the Medicines Patent Pool to weigh additional licenses and said it plans to implement a tiered pricing approach based on World Bank income criteria.
Merck itself said it expects to produce 10 million courses by the end of the year as it seeks emergency use authorization in the U.S. “Substantially more” should become available next year, Schaper said.
The ACT-Accelerator, launched last year, has helped speed the development and delivery of tools to fight Covid. But it has grappled with external and internal challenges that have hampered progress, according to the Dalberg report Friday. The WHO said in an email that it’s pushing patent holders to share know-how and intellectual property, giving any qualified manufacturer the right to produce and expanding capacity to vulnerable regions.
Unitaid, one of the groups overseeing the therapies campaign, said it is working to ensure new treatments are ready once they’re approved, but more than $3 billion is needed to fund the effort next year. “With therapeutics, the pipeline is more complex and there are more entities involved than with vaccines,” it said.
Covid therapies are critical for many countries due to the risk of further variants and low immunization levels. More than 55 countries had yet to vaccinate 10% of their populations as of last week.
“The countries where we don’t have widespread access to vaccines are the exact same countries where treatment will be more urgently needed,” said Suerie Moon, co-director of the Global Health Centre at the Graduate Institute of International and Development Studies in Geneva.
Then there are the hard-hit, middle-income countries that could get left out if licensing agreements favor lower-income nations, said Brook Baker, a professor at Northeastern University who warned of a new wave of “therapeutics nationalism.”
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