[Ip-health] Stat News (Pharmalot): Colombia plans to unilaterally lower the cost of a Novartis cancer drug

Thiru Balasubramaniam thiru at keionline.org
Fri Jun 10 05:43:14 PDT 2016


Colombia plans to unilaterally lower the cost of a Novartis cancer drug

By ED SILVERMAN @Pharmalot

JUNE 9, 2016

In a dramatic move, the Colombian health minister plans to unilaterally
force Novartis to lower the price for its Gleevec cancer medicine after
more than two weeks of talks over a price cut went nowhere, according to
reports and sources in Colombia.

In public comments today, Health Minister Alejandro Gaviria said he will
declare a lower price for the widely used cancer medicine as being in the
public interest because it would save the country needed health dollars.
Under this scenario, Novartis would be obligated to sell Gleevec at the new
price, although he did not specify what that might be.

However, Gaviria stopped short of pursuing a compulsory license, which
would have allowed the government to sidestep the Novartis patent for the
drug so that generic companies could make lower-cost versions. Such a move
is permitted under World Trade Organization rules. The current patent for
the Novartis drug expires in 2018.

The battle over Gleevec has been closely watched as the latest
manifestation of a global skirmish over the cost of medicines. Patient
groups see it as a test case for using legal rights to ensure needed
medicines are accessible, while companies see it as a potentially
precedent-setting case in which a middle-income country use trade rules to
lower its drug costs.

For the past four years, Novartis and the Colombian government have been
sparring over the cost of the medicine. But even as price controls worked
to lower the price, the drug remained about 172 percent higher than
comparable medicines. With prodding from patient advocates, Gaviria
eventually threatened to pursue a compulsory license.

Patient advocates note that the annual cost of Gleevec is roughly $15,000,
which patient advocacy groups say is excessive in a country where the
nation’s per capita gross national income is about $8,000. And they note
that some efforts by drug makers to enforce intellectual property rights
may come at the expense of patients who cannot afford medicines.

As the squabble intensified in recent weeks, staffers from both the US
Senate Finance Committee and the US Trade Representative’s office met with
Colombian embassy officials in Washington DC, and suggested that Washington
might withdraw support for a free trade agreement and $450 million in
backing for a peace initiative between the Colombian government and Marxist
rebels. The threat prompted a rebuke from Democratic lawmakers.

A Novartis spokesman sent us this: “Throughout this dialogue we have
remained fully committed to finding a resolution that benefits patients,
innovators and the Colombian health care system. We have received no
official confirmation from the Colombian authorities regarding the
conclusion of these talks. Until we do, it is not appropriate to make
further comment.

“We have consistently said that Declarations of Public Interest can be
important and legitimate tools to be used only in exceptional
circumstances. This is simply not the case in Colombia. There are no
shortages of Gleevec or other access issues. Colombia’s universal
healthcare system means all patients who need Gleevec receive it. Novartis
does not have a monopoly. There are already noninfringing generic versions
on the market, which the government could purchase instead of Gleevec in
order to reduce its costs.”

Ed Silverman can be reached at ed.silverman at statnews.com
Follow Ed on Twitter @Pharmalot

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