[Ip-health] Canadian company pursues compulsory license to distribute Covid-19 vaccine to low-income countries

Ed Silverman pharmalot at gmail.com
Wed Mar 31 08:07:09 PDT 2021


Canadian company pursues compulsory license to distribute Covid-19 vaccine
to low-income countries
By Ed Silverman @pharmalot
March 29, 2021

Twice in recent months, a small Canadian company approached two large drug
makers to obtain licenses to manufacture Covid-19 vaccines so the shot
could be distributed in low and middle-income countries where supplies are

But a request made to AstraZeneca (AZN) was ignored, while Johnson &
Johnson (JNJ) denied the overture, according to executives at Biolyse. So
now, the privately held company is asking the Canadian government to
sidestep the vaccine patents in what could be a test of the willingness of
a wealthy country to help ensure Covid-19 vaccine supplies reach
impoverished corners of the globe.

“If we could manufacture a vaccine already approved, it would save a great
deal of time. And the transfer of know how would be the way to do it”
said Biolyse
president Brigitte Kiecken, who noted the company makes sterile injectables
and, last summer, offered to help placing finished vaccines made by others
in vials. “We have the facility, the equipment and we can expand and adapt
to the technology.”

For that to happen, though, the company has to pass through several hurdles
to obtain what is known as a compulsory license, which allows a public
agency or another drug maker to copy a patented medicine without the
consent of the brand-name company that owns the patent. This right was
memorialized in a section of a World Trade Organization agreement known as

Canadian law already permits the government to issue a license, but the
process is complicated. Last Friday, a spokeswoman for Innovation, Science
and Economic Development Canada, the agency that largely oversees the
process, told us Biolyse had not yet filed an application, although the
company argued there is no one obvious step for doing so, but is holding
talks with government officials.

The Canadian government, in any event, has rarely issued a compulsory
license. More than a decade ago, a generic manufacturer, Apotex, received a
license to make and distribute an AIDS drug to Rwanda. And Biolyse previously
sought a license for the Tamiflu influenza drug during the H1N1 scare, but
the process took several months and the flu had largely abated by the time
the government moved forward.

Compulsory licensing is increasingly at the center of a global debate about
widening access to Covid-19 vaccines as quickly as possible. Unlike wealthy
nations that signed deal with vaccine makers for hundreds of millions of
doses, countries lack the means to place such orders and global health
officials fear that inequitable access will cause further suffering and the
coronavirus will not be contained.

To remedy the situation, the World Health Organization has promoted a
program called COVAX, which is designed to provide enough vaccines to
inoculate 20% of the populations in each of the participating countries,
including 92 low and middle-income nations. But achieving that goal is
uncertain amid questions about production capacity and exports from
countries where vaccines are made.

Last week, for instance, India placed a hold on vaccine exports due to a
rise in Covid-19 cases. The country is home to the Serum Institute of
India, which has a deal to distribute the vaccine developed by AstraZeneca
(AZN) and Oxford University. And the European Union is considering tighter
restrictions on vaccine exports as the number of coronavirus cases in the
bloc continues to increase.

More than 12 billion doses of different Covid-19 vaccines are forecast to
be manufactured this year, according to the Duke Global Health Innovation
Center. Large drug makers are collaborating on manufacturing –
GlaxoSmithKline (GSK), for instance, just reached a deal with Novavax
(NVAX) to make 60 million doses. But such moves to expand capacity are not
evenly spread across vaccine makers.

“Whether or not these doses will be efficiently distributed may be decided
by governments in a few countries that are home to much of the
manufacturing capacity,” Duke researchers wrote in a blog. “…There may be a
negative feedback loop at work here: the perception of scarcity is driving
nationalism, which is in fact driving further scarcity. This is
inefficient, and we cannot afford inefficiency.”

Although more money is being slated for COVAX – the Biden administration
committed $4 billion, for instance – there is growing concern among
lesser-developed nations that production and supplies will still be
inadequate for large swaths of the globe. This is why South Africa and
India last fall asked the World Trade Organization to temporarily waive a
provision in the TRIPS agreement.

This proposal, which is still being debated at the WTO, would make it
easier for countries that permit compulsory licensing to allow a
manufacturer to export vaccines. But pharmaceutical industry trade groups
argue that intellectual property is not a barrier to increased production
and point to the growing number of deals among drug makers as evidence.

Even so, the Biden administration is reportedly debating the possibility of
sidestepping patents in order to ramp up vaccine production. Whether the
White House will authorize such a move is uncertain, but a growing number
of health experts are warning that the longer the global population is
vulnerable to Covid-19, the more it will mutate, and present new and
unknown risks around the world.

Meanwhile, one member of the European Parliament - Kathleen Van Brempt, a
Belgian social-democratic politician – is interested in exploring
compulsory licensing to determine the extent to which it would be possible
for Biolyse to manufacture and distribute a Covid-19 vaccine. In her view,
the opportunity is an “interesting case study” for using the rights in the
WTO trade agreement.

“The question that interests us is whether the current TRIPS flexibilities
are fit to react to pandemics. The fact that this exercise for obtaining a
compulsory license is taking place in Canada is also interesting, because
it is the only country who has experience with compulsory licensing for
exports under (a provision of the TRIPS agreement,” she wrote us.

“We, therefore, see the Biolyse case as an important test which can further
guide the international discussions on pharmaceutical patent rights and
access to life-saving health products, certainly in times of pandemics… There
are significant legislative differences between the different EU countries,
with different degrees of difficulty for obtaining a compulsory license.
The Canadian case can provide more insight in how we could improve our
systems in the EU. It might be necessary to implement a more harmonized
system in the future.”

A key question, she added, is what would be required for Biolyse to be able
to produce a vaccine. “Is it possible without a technological transfer? Can
the company find enough investors, suppliers and buyers? What are the
stumbling blocks? These are matters that are interesting to learn from as
policy makers, and it is for this learning process that we took interest in
the case.”

Although Biolyse noted in its letter to J&J that it seeks to sell a
Covid-19 vaccine in Canada as well, an attorney for Knowledge Ecology
International, an advocacy group that has been assisting the company with
its applications, explained that, as a practical matter, the company is
actually just seeking a license to make and export a vaccine. A Biolyse
spokesman confirmed this.

Either way, Kiecken acknowledged it would take six months for Biolyse to
ready its plant, including regulatory approvals. And while Biolyse has
never made a vaccine before, she maintained the company will be able to
produce about 20 million doses annually. She also argued that other
companies with no experience in new vaccine technology are retrofitting
equipment to hasten Covid-19 vaccine production.

“Filling vials is something we do every day,” said Kiecken. “This will
really be part of a war effort.”

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