[Ip-health] STAT (PHARMALOT): US pressures Colombia over plan to sidestep patent for a Novartis drug

Thiru Balasubramaniam thiru at keionline.org
Wed May 11 21:07:02 PDT 2016



US pressures Colombia over plan to sidestep patent for a Novartis drug

By ED SILVERMAN @Pharmalot

MAY 11, 2016

A Colombian Embassy official late last month warned his government that
United States backing for a peace initiative may suffer if the Colombian
health minister proceeds with plans to sidestep a patent for a Novartis
cancer drug.

The warning came just days after the health minister indicated he may issue
a so-called compulsory license, which would allow a generic company to make
a lower-cost version of the Gleevec leukemia treatment. The move, which
would save Colombia about $12 million annually, infuriated Novartis and
appears to have triggered concerns in the Obama administration and Congress.

The squabble over a license is only the latest example of the heated clash
between the global pharmaceutical industry and some governments over
intellectual property rights and access to affordable medicines. Drug
makers say patent rights are sometimes trampled, while consumer groups
argue such licenses are needed and, moreover, are memorialized in a World
Trade Agreement.

In an April 27 letter, Andres Florez, the deputy chief of mission at the
Colombia Embassy in Washington D.C., wrote to Colombian Foreign Minister
Maria Angela Holguin that a license for the Novartis drug “has become a
topic of interest for the US Trade Representative and the US Congress.” He
added that staffers from the US Senate Finance Committee and US Trade Rep
requested meetings with embassy officials.

“Given the direct link that exists between a significant group of members
of Congress and the pharmaceutical industry in the United States, the case
… is susceptible to escalate to the point that it could impair the approval
of the financing of the new initiative, Paz Colombia, as well as become an
issue in the framework of the free-trade treaty.”

This past February, the Obama administration offered to provide more than
$450 million to back peace initiatives in Colombia, which waged a
long-running battle with Marxist rebels. “We’re going to call it Peace
Colombia – Paz Colombia,” President Barack Obama said at a White House
ceremony alongside Colombian President Juan Manuel Santos.

A free-trade treaty between the two countries went into effect four years
ago, which obligates Colombia to comply with various international trade
laws. Florez also cautioned that issuing a compulsory license for the
Novartis drug may “weaken support” for bringing Colombia into the
Trans-Pacific Partnership, a trade pact between 12 countries in the Asia
and Pacific regions that must still be approved by Congress.

“Given these facts … we think that the national government should assess
the measures considered and respond at its best interest to the concerns
that have been expressed,” Florez advised the foreign minister. “Likewise,
we are of the opinion that it is necessary to take a correction of our
course in order to avoid claims against our country.”

Colombia moves to sidestep patent for Novartis cancer drug

A Senate Finance Committee spokeswoman wrote us that “committee staff
routinely meets with foreign governments to seek clarifications on actions
that may be inconsistent with international trade obligations.”

We asked the US Trade Rep’s office for comment about this latest
development and will update you accordingly. Colombia, by the way, is on
the US Trade’s watch list of countries that do an insufficient job of
enforcing intellectual property rights. As for Novartis, a spokesman writes
us to say that the company is “actively seeking a resolution to discussions
around our Gleevec patent in Colombia that benefits patients, innovation
and the healthcare system.”

One advocacy group criticized what it called US pressure on Colombia.

“It is shameful for anyone to link the outcome of a compulsory license,
based on a country’s health needs, to the outcome of a process of peace and
reconciliation in a country that has faced unspeakable violence, yet this
is raised in the memo,” said Andrew Goldman, legal affairs and policy
counsel at Knowledge Ecology International, which released the letter.

“Novartis has profited enough from Colombia, and Senator Orin Hatch (who
heads the Senate Finance Committee) and USTR have no business defending the
patent interests of a Swiss pharmaceutical company over the lives of cancer
patients in Colombia.”

Four years ago, the Colombian government tried to negotiate a lower price
for Gleevec, but failed. After patient groups urged the government to issue
a license, a committee recently decided that allowing other companies to
make Gleevec would be in the public interest by widening access and saving
health care dollars. Consumer groups note that Gleevec is on the World
Health Organization list of essential medicines.

As we wrote recently, Novartis objected and argued that a Declaration of
Public Interest “should never be used as a mechanism to force price
negotiations.” Doing so, the company maintained, “runs counter to the
spirit and intent of a compulsory license and its legal framework, and
would create a damaging precedent that could apply to all patent-covered
innovations — pharmaceutical or otherwise.”

A declaration is “inappropriate as there is no shortage of Gleevec or
evidence of other access issues, the price is already subject to government
controls, and there is no monopoly with multiple generics already on the

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

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