By Saeed Shah
A group of developing countries, backed by United Nations
agencies and activist groups, is pushing to limit patent
protections for Covid vaccines being tested by some of the world's
biggest pharmaceutical companies so that inexpensive copies can be
produced for poorer nations.
South Africa, Ghana, Senegal, Pakistan and others argue they
won't be able to afford to protect their people without lower-cost,
generic alternatives to the vaccines now being tested by companies
such as Pfizer Inc., AstraZeneca PLC and Moderna Inc.
That stance puts the countries squarely at odds with the
pharmaceutical industry, which says it supports wide distribution
of the vaccines but warns that allowing drugs to be copied would
undermine innovation and raise the risk of unsafe vaccines.
Albert Bourla, chief executive of Pfizer, has said calls to
sidestep patent protections for Covid-19 vaccine are "nonsense" and
The developing countries' campaign is part of an intense global
race to secure supplies of Covid-19 vaccines. Even before the drugs
are fully tested, richer countries have struck deals worth billions
of dollars to buy up much of the known manufacturing capacity.
It is an effort that echoes moves in the late 1990s to reduce
the price of drugs used to treat AIDS. After years of being
criticized, drugmakers allowed inexpensive generic copies of AIDS
drugs to be distributed in some countries.
International law permits countries to eliminate patent
restrictions in some emergency situations and issue "compulsory
licenses" to allow domestic industry to copy a medicine and even
export it to other nations in need.
South Africa has already called for the intellectual property
barriers for Covid vaccines to be lifted at the World Trade
At the United Nations General Assembly this month, the World
Health Organization plans to set out operational details of a
voluntary patents pool where Covid-19 technology can be shared.
Companies would be paid a royalty for the use of their vaccine, but
one well below what they could earn otherwise.
"We cannot afford to have a monopolistic approach to
intellectual property for treatments and vaccines, nor maintain a
system which puts profits before the lives of people," said Winnie
Byanyima, executive director of UNAIDS, a U.N. agency set up to
Pharmaceutical companies say they support another WHO-backed
initiative dubbed Covax, which aims to collectively buy the vaccine
for developing countries. Covax is trying to raise funds from rich
countries and aims to buy enough vaccine for 20% of the population
of developing countries in 2021.
By comparison, the U.S., Japan, U.K. and the European Union
already have placed orders for more vaccine doses than they have
Replicating a vaccine is much more difficult than producing a
generic version of drug like Tylenol. Jesse Goodman, a doctor and
infectious-disease expert at Georgetown University, said success
would likely require drug companies to share their expertise and
"Small variabilities in a protein or something like that could
affect its safety or effectiveness," said Dr. Goodman.
Jayasree Iyer, executive director of the Access to Medicine
Foundation, which campaigns for the pharmaceutical sector to do
more for poorer countries, said developing countries have untapped
manufacturing resources that could be used, especially with
technical help from the big drugmakers.
"There is some manufacturing capacity available in regional
manufacturers, especially if you pool that capacity it can be
pretty big, " said Ms. Iyer.
In the past, the U.S. and other richer nations with robust
pharmaceutical industries have generally sought to protect patents
strenuously. In April, the U.S. Trade Representative's annual
report urged countries "to consider ways to address their public
health challenges while also maintaining IP systems that promote
innovation." The report acknowledged that in extreme circumstances,
nations can override patent protections.
"If you don't protect IP, then essentially there's no incentive
for anybody to innovate," Pascal Soriot, chief executive of
AstraZeneca PLC, said at a press event earlier this year. Emma
Walmsley, chief executive of GlaxoSmithKline PLC, questioned
whether patent protections really hamper the ability of developing
countries to obtain vaccines.
Public funds haven't covered all of the developmental costs for
the vaccines, said Tom DiLenge, president of public policy at BIO,
a biotechnology trade association based in Washington, which
represents several companies developing Covid-19 vaccines
"If the government could do this on their own, they would," said
Mr. DiLenge. "This is a partnership. You cannot have private
entities engage in a partnership if you're going to take their
intellectual property and restrict how they can price and market
Bernstein Research, a finance firm based in New York, estimates
that Covid-19 vaccines now in the testing phase will bring sales of
over $21 billion to six companies in 2021 alone. Pfizer would lead
the pack taking in more than $6 billion, followed by the Sanofi SA
partnership with GlaxoSmithKline, Johnson & Johnson, Moderna,
AstraZeneca and Novavax Inc., according to the Bernstein tally.
AstraZeneca and Johnson & Johnson have said that they won't
make a profit from the vaccine while the pandemic lasts. Pfizer,
which expects to profit from the vaccine, has said it won't take
public money, though it has sold its vaccine to the U.S. and other
AstraZeneca and Novavax have licensed 1 billion doses each of
their vaccines produced for poorer countries by the Serum Institute
of India, a private company which is the world's biggest vaccine
"We're doing our part," said John Trizzino, senior vice
president at Novavax. "We're approaching this globally, we're not
approaching this as European-centric or U.S.-centric."
Serum Institute said it doesn't know who will pay for the
manufacture of the doses. No governments or other entities have
stepped forward so far, "so it is a matter of great concern," the
company said through a spokesman.
Serum plans to export half of its production to other developing
countries, with the rest slated for India, a country with one of
the world's largest populations least able to afford the
Some poorer countries are seeking a supply from China, which has
four Covid-19 vaccines in final phase testing. China is testing its
vaccine candidates in countries including Pakistan in return for
promising to supply significant doses to protect at least some of
the most vulnerable.
However, Chinese company Sinopharm has said its vaccine will
cost around $145 for a two-dose course. At that price, it would
likely be unaffordable for developing countries, and much higher
than prices quoted so far for Western vaccine candidates, which
have ranged from $4 to $37 per dose.
In 1997, drugmakers, with the support of the U.S. government,
sued South Africa for trying to use cheaper generic copies of their
drugs to treat its HIV epidemic. The tide eventually turned and the
lawsuit was dropped in 2001 by the industry, which conceded it had
"The AIDS situation didn't begin to get resolved until the
political pressures particularly in the United States became so
intense that the governments had to deal with it," said Frederick
Abbott, a professor of international law at Florida State
University, who advised South Africa in that case.
He predicts: "You're going to have a situation with the Covid
vaccine fairly soon where you are going to have these intense
political pressures and governments aren't going to be able to say
to their people that 'We're sorry, you can't get a vaccine because
AstraZeneca or Moderna isn't willing to supply the
Write to Saeed Shah at firstname.lastname@example.org
(END) Dow Jones Newswires
September 17, 2020 11:21 ET (15:21 GMT)
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