[Ip-health] Stat: WHO launches ambitious global project to develop Covid-19 medical products

Thiru Balasubramaniam thiru at keionline.org
Sun Apr 26 23:21:51 PDT 2020


https://www.statnews.com/pharmalot/2020/04/24/covid19-coronavirus-who-vaccines-medicines-access/


WHO launches ambitious global project to develop Covid-19 medical products

By ED SILVERMAN @Pharmalot


APRIL 24, 2020

Led by the World Health Organization, a long list of countries, industry
groups, and nongovernmental organizations committed to joining a project
for developing and producing new drugs, vaccines, and tests for Covid-19 —
and ensure worldwide access to the products.

The orchestrated move, which is being called the Access to COVID-19 Tools
Accelerator, comes as the pandemic has infected more than 2.7 million
people and claimed approximately 191,000 lives, sparking urgent calls for
global cooperation in devising a medical response.

As part of the effort, a key goal is to level the global playing field so
that any products will be available to rich and poor populations alike, a
contentious issue that for many years has often pitted low-income countries
against the pharmaceutical industry, in particular.

“The world needs these tools, and it needs them fast,” remarked WHO
Director-General Tedros Adhanom Ghebreyesus during a 90-minute
presentation. “Past experience has taught us that even when tools are
available, they have been not been equally available to all. We cannot
allow that to happen. … Our shared commitment is to ensure all people have
access to all the tools to defeat Covid-19.”

The project, however, is still in the early stages. On May 4, countries and
organizations are encouraged to start pledging contributions with an eye
toward commitments worth about $8 billion in initial funding, according to
the European Commission President Ursula von der Leyen. At that point,
additional milestones will be announced as part of an ongoing “rolling
replenishment.”

Among those involved are France; Germany; the U.K.; Saudi Arabia; South
Africa; Italy; Norway; Spain; Malaysia; the World Bank; the United Nations;
the Bill and Melinda Gates Foundation; Unitaid; Wellcome Trust; the Global
Fund to Fight AIDS, Tuberculosis and Malaria; Gavi, the Vaccine Alliance;
Coalition for Epidemic Preparedness Innovations; and the International
Federation of Pharmaceutical Manufacturers (here is a list of those who
spoke at the launch).

Two economic powers, however, were notably absent from the proceedings: the
U.S. and China. The Trump administration recently announced plans to end
its funding to the WHO over allegations that the global health agency was
too close to China. Nonetheless, the WHO hopes to persuade as many
governments as possible to join the accelerator.

A U.S. Department of State spokesperson wrote us that, “America’s
world-leading scientists are working hard on a Covid-19 vaccine. We welcome
serious efforts to assist in that endeavor, and look forward to learning
more about the World Health Organization’s proposal. We remain deeply
concerned about the WHO’s effectiveness, given that its gross failures
helped fuel the current pandemic.”

For now, though, details were not discussed. Instead, the announcement
amounted to a high-level statement of intent rather than a primer on how
things will get done.

For instance, it remains unclear about the extent to which the project will
include a so-called voluntary pool to collect patent rights, regulatory
test data, and other information that could be shared for developing drugs,
vaccines, and diagnostics. The European Union drafted a resolution asking
the World Health Assembly to adopt the idea, which was proposed by Costa
Rica.

Costa Rica President Carlos Quesada Alvarado referenced the pool in his
remarks, and Tedros, as he is known, did indicate the pool would be
included in the initiative, but the scope remains unclear. Such a pool is
likely to be regarded warily by the pharmaceutical industry, given
questions that are may arise about the structure of the pool.

This is not the only effort to attempt to harness the abilities of the
pharmaceutical industry to come to the rescue. Last week, the National
Institutes of Health on Friday announced it would launch a sweeping
public-private partnership between federal researchers and 16 drug makers,
aimed at coordinating and accelerating the development of Covid-19
treatments and vaccines.

To be sure, the pharmaceutical industry is facing increased pressure. More
than three dozen asset managers, pension funds, and insurers are urging the
pharmaceutical industry to cooperate in the fight against Covid-19 by
sharing research data and providing affordable worldwide access to
medicines, diagnostics, and vaccines.

Some companies have already taken steps. Johnson & Johnson (JNJ) is getting
$456 million from the U.S. government to develop a Covid-19 vaccine and has
promised the project will be a not-for-profit endeavor. Gilead Sciences
(GILD) committed to donating 1.5 million doses of its experimental
remdesivir treatment after any regulatory approvals. And AbbVie (ABBV)
relinquished global intellectual property rights for an HIV drug after
Israel issued a license that would allow generic companies to manufacture
copies.

In a statement, Thomas Cueni, who heads the IFPMA industry group, said the
“biopharmaceutical industry is acutely aware of the enormous responsibility
we have to patients and society to engage in unprecedented levels of
collaboration to find a solution to Covid-19. We stand ready to bring to
this partnership our unique knowledge and expertise in the discovery and
development of medicines and vaccines, as well as our experience building
manufacturing capacity and distribution networks.”

Although reactions to the accelerator project were largely positive,
skepticism remains. For instance, Frederick Abbott, a professor of
international law at Florida State University and a WHO consultant,
believes the effort holds potential, but questions over patent rights,
marketing exclusivity, and compensation for innovative work need to be
addressed for the concept to succeed.

“Innovators should be well compensated for working to develop new technical
solutions, but the pandemic cannot be viewed as an event whose impact is to
bolster corporate profits. Innovations must be made available at prices
that will make them accessible to everyone,” he wrote us. “Some of the
institutions involved have long experience in designing push and pull
mechanisms for accelerating innovation while making the resulting products
affordable.”

Even if billions of dollars are pledged, many questions and barriers
persist, according to Brook Baker, a professor at Northeastern University
School of Law and a senior policy analyst for the Health GAP advocacy group.

What are those hurdles? As he sees it, drug, device and vaccines makers
should provide all of the technology transfer rights to needed for
sufficient worldwide manufacturing while eschewing monopoly rights that can
lead to excessive prices. And if the private sector does not cooperate,
governments may have to exercise emergency powers, he explained.

He also maintained that wealthy nations will have to disavow any interest
in gaining preferential access to products. Baker also pointed to the 80
countries, including the entire European Union, that have imposed export
controls on Covid-19 medical supplies and argued they need to open trade in
ingredients, components, and finished products.

“A high-level framework is important,” he wrote us, “but the call for
global solidarity must actually trump commercial prerogatives, nationalism,
and demagogic egos.”

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


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