[Ip-health] New York Times: Will New Covid Treatments Be as Elusive for Poor Countries as Vaccines?

Thiru Balasubramaniam thiru at keionline.org
Sun Oct 17 21:43:07 PDT 2021


Will New Covid Treatments Be as Elusive for Poor Countries as Vaccines?

Merck has taken a step to make its antiviral pill available in poor
nations, but many obstacles remain for broad access to coronavirus drugs.

https://www.nytimes.com/2021/10/17/health/covid-treatment-access-molnupiravir.html
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By Stephanie Nolen

Oct. 17, 2021, 5:00 a.m. ET

Nearly a year after the first Covid-19 vaccination campaigns began, the
vast majority of the shots have gone to people in wealthy nations, with no
clear path toward resolving the disparity.

News this month that an antiviral medication had proved effective against
the coronavirus in a large clinical trial has brought new hope of a turning
point in the pandemic: a not-too-distant future when a simple pill could
keep infected people from dying or falling severely ill.

The drug, molnupiravir, made by Merck, is easy to distribute and can be
taken at home. The trial results showed it halved the risk of
hospitalization and death among high-risk people early in their infections.
The company has applied for emergency-use authorization from the Food and
Drug Administration; a decision could come in early December.

Unlike the vaccine manufacturers Pfizer and Moderna, which have resisted
calls for license agreements to let overseas manufacturers make their
shots, Merck will allow generic manufacturers in India to sell the pills at
a far lower price in more than 100 poorer countries. Most nations in
sub-Saharan Africa, where vaccination rates are as low as 3 percent, are
covered by the deal.

Drug-access advocates say the Merck licensing deal is an encouraging start
but only a small step toward equity. Merck has begun production of the
drug, but it is unclear how much of the generic product will be available
next year. The agreements leave out many undervaccinated nations, such as
Ukraine, that have been hit hard by Covid. And an antiviral must be
combined with reliable, affordable testing, which is also limited in many
places.

Several other drug makers, including Pfizer, are expected to announce
efficacy data from trials of similar medications; the companies said it was
too soon to comment on whether they would enter similar agreements.

All this means that treatments could remain largely with nations able to
pay for early access, as they have done with vaccines.

“A drug like this that is kept at room temperature, you could get it to
even the remotest parts of the world —- it’s fair to say that this drug
could prevent hundreds of thousands of hospitalizations and deaths,” said
John Amuasi, an infectious disease expert and global health at the Kumasi
Center for Collaborative Research in Tropical Medicine in Ghana. “But the
barrier is going to be price. Look at how long it has taken for vaccines to
reach Africa. My worry is that we are steadily on course to do the same
with the drugs.”

More than 18 months into the pandemic, Covid remains an illness largely to
be endured rather than treated. The few medicines that have shown some
benefit — such as monoclonal antibodies — are costly, complex to
administer, and, in poor nations, scarce or absent. Yet without widespread
vaccination, those populations remain vulnerable to Covid and need
affordable medicines.

The U.S. government bought much of the supply of the antiviral remdesivir
last year after early research showed it might speed recovery from Covid.
Now it is pursuing a similar strategy for molnupiravir: It has a $1.2
billion agreement to purchase 1.7 million courses of the drug if it
receives F.D.A. authorization. That is 20 percent of what the company says
it can produce this year. Other relatively well-off countries, including
Australia, South Korea and New Zealand, have signed deals as well.

Merck was criticized two decades ago for selling its H.I.V. drugs at prices
unaffordable in Africa. This time, the company recognized the imperative of
widening access early.

“We really did have a responsibility that, if this drug was found to be a
safe and effective oral drug that someone could take at home, we need to
make sure that, especially in low- and middle-income countries where they
don’t have the strongest health care systems, that this would have very
wide access,” said Jenelle Krishnamoorthy, Merck’s vice president for
global policy.

The voluntary licenses the company negotiated with the Indian drugmakers
offer the possibility that governments in the poorest nations could buy
molnupiravir for well under $20 per five-day course, compared with $712 in
the U.S. deal.

The eight Indian companies are in clinical trials with their versions of
the drug, and four confirmed to The Times that they expected to release
results soon; one industry executive who was not authorized to speak on the
record said he expected his firm to produce the drug for less than $10 per
course.

Suerie Moon, an expert on drug access issues, called Merck’s Indian generic
licenses a positive precedent for Covid treatments —- and a smart business
move for the company.

“It’s not a coincidence that Merck has experience from H.I.V. — internally,
with their leadership and culture, they know that if they don’t address the
access challenges, they will be slammed,” said Dr. Moon, co-director of the
Global Health Centre at the Graduate Institute of International and
Development Studies in Geneva.

Generic manufacturing it not in itself a guarantee of global access. Half
of all the coronavirus infections reported in low- and middle-income
nations in the first six months of 2021 occurred in 32 countries excluded
from the Merck license. Brazil, Malaysia, Mexico and Peru are not included.
Nor are China and Russia.

Generic production licenses for restricted territories can leave
middle-income countries that have frail public health systems paying prices
nearly as high as rich ones. Merck says it will use World Bank income data
from these countries to calculate what it charges for the drug in each.

Merck is also in negotiations with the Medicines Patent Pool, a United
Nations-backed nonprofit that works to make medical treatment and
technologies accessible. Charles Gore, director of the organization, said
he hopes Merck will agree to a licensing agreement that could permit
companies in an even wider range of places to make the drug, while Merck
sells its own product in rich nations. Such a deal, he said, would set an
important precedent for other companies.

If Merck, or Pfizer or other drug makers do not ensure widespread
availability of Covid treatments, they could face widespread use of
compulsory licensing, in which governments override intellectual property
restrictions to allow manufacture of medications, often in emergency
situations. While Merck will earn a royalty on the drugs sold by the
generic makers, and likely also on any deals reached through the patent
pool, under compulsory licensing the company has no say in the price of the
drug or the amount of the royalty.

Unitaid, the Geneva-based global health agency, said $3.5 billion in new
funding from rich nations was needed to make therapeutics accessible, the
bulk of it for antivirals in low-income countries.

“We need a global effort. We need donors to step up with funds to make sure
treatments reach everyone,” Janet Ginnard, the director of strategy, said.

Unitaid and partners are preparing to make a provisional purchase agreement
for a treatment such as molnupiravir, conditional on a recommendation by
the W.H.O.

But it is not clear what supply will be available, given the bilateral
deals that have been struck or are being negotiated by the U.S. and others.

“Countries will prefer to negotiate bilaterally or at a regional level
rather than wait and rely on a global mechanism,” Dr. Moon said.

She noted that as vaccine supply became a global crisis, lower-income
countries took out loans to strike bilateral deals, and treatment purchases
could be similar.

Merck’s voluntary licenses for molnupiravir are all with companies in
India, a concentration that could pose risks. Covax, the United
Nations-backed alliance of organizations working to deliver vaccines to
poorer nations, was relying on the Serum Institute of India to produce the
bulk of shots. But after the virus surged in March, the Indian government
banned vaccine exports, and those are only resuming now.

There is also a supply-chain question: Licenses with the United Nations’
Medicines Patent Pool could see companies all over the world making generic
treatments. But most medications’ raw materials are made in India and
China, and they have faced crunches throughout the pandemic.

Recent experience with vaccines suggests that if there is limited supply,
those who can pay will have first access, said Mariângela Simão, a senior
World Health Organization official. “The risk right now is that the rich
countries dominate the market and buy all of these medicines,” she said.

She said the W.H.O had been working on Covid treatment access with limited
success.

“We’ve had enormous difficulties. We talked to every company that has a
product that potentially could be good, we have been discussing voluntary
licensing through the Medicines Patent Pool, and there’s very little
interest,” she said. “If there is not an opening on the part of industry to
share technology now, when the world needs it most, when will it happen?”

Testing will be an additional challenge. The drugs work best if taken as
soon as symptoms appear, and patients must be sure they have the
coronavirus. But testing is scarce in many places: The W.H.O. estimates
that fewer than 15 percent of Covid infections are detected in Africa, for
example.

But if early antiviral treatment is made available globally, it could
reduce spread. “Then you have fewer health systems incapacitated and a
greater economic recovery for the benefit of everyone,” said Brook Baker, a
law professor at Northeastern University who is part of a therapeutics
access effort led by the W.H.O. “Even from a somewhat self-interested
perspective, it’s shortsighted and counterproductive not to ensure access
to these medicines.”




-- 
Thiru Balasubramaniam
Geneva Representative
Knowledge Ecology International
41 22 791 6727
thiru at keionline.org


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