[Ip-health] Stat: Colombia plans to proceed with price cut on Novartis cancer drug

Jamie Love james.love at keionline.org
Wed Sep 21 07:39:48 PDT 2016

We have asked USTR and the White House for a copy of the petition.  I
assume USTR has shared it with Swiss and US drug companies already.

On Wed, Sep 21, 2016 at 10:30 AM, Andrew S. Goldman <
andrew.goldman at keionline.org> wrote:

> This article updates about the ongoings in Colombia with regard to the
> imatinib case, and mentions that USTR has just recently submitted a
> petition to Colombia MOH on this.
> https://www.statnews.com/pharmalot/2016/09/16/colombia-
> cutting-price-novartis-gleevec/
> Colombia plans to proceed with price cut on Novartis cancer drug
> By ED SILVERMAN @Pharmalot
> SEPTEMBER 16, 2016
> After weeks of deliberations, the Colombia health minister is proceeding
> with plans to unilaterally lower the price of a Novartis cancer drug that
> has become the latest symbol of the battle between access to medicines and
> intellectual property rights.
> The amount of the reduction has not been announced, but Colombia media
> reported Health Minister Alejandro Gaviria may drop the price for Gleevec
> by up to 45 percent. Patient advocacy groups note that the annual cost of
> the drug is roughly $15,000, compared with per capita gross national income
> of about $8,000. This would amount to “significant savings for the whole
> health system,” the patient groups said.
> [UPDATE: Gaviria tells us that the health ministry planned to set the new
> price this month, but has just received a formal petition from the US Trade
> Representative seeking 30 days to submit. “We are studying the petition. In
> any case, we don’t want to put this off much more,” he tells us.]
> In explaining his actions, Gaviria has argued that issuing a so-called
> Declaration of Public Interest, which allows the government to take various
> steps to reduce the price of a medicine, would be justified since the cost
> for Gleevec is out of reach for some citizens. The government began
> exploring this step after talks with Novartis failed to yield a lower
> price.
> His decision, which came after the government rejected appeals by the drug
> maker, is the latest development in a closely watched struggle. Patient
> groups see it as a test case for using legal rights to ensure needed
> medicines are accessible, while the pharmaceutical industry views it as a
> potentially precedent-setting case in which a middle-income country uses
> trade rules to lower its drug costs.
> The episode drew particular notice, though, after Gaviria initially earlier
> this yearconsidered pursuing a compulsory license. This would allow the
> Colombian government to sidestep the Novartis patent on Gleevec so that a
> lower-cost version could be produced. Countries can issue such licenses
> under the terms of a World Trade Organization agreement.
> Novartis, Colombia face off over cancer drug cost
> For its part, the pharmaceutical industry has argued that compulsory
> licenses should be reserved for public health emergencies and as a measure
> of last resort. Fearing that the moves by the Colombian government might
> embolden other countries to quickly take similar steps, the industry turned
> to Washington for backing.
> Last spring, staffers from both the US Senate Finance Committee and the US
> Trade Representative’s office met with Colombian embassy officials in
> Washington D.C., 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 move, however, created a mini-backlash among some Democratic lawmakers
> and appeared to have hardened the resolve of Gaviria and his health
> ministry. In June, he signaled he would move ahead with a unilateral price
> reduction, although he has not ruled out the possibility of issuing a
> compulsory license, either.
> “We condemn the behavior of Big Pharma, their gremial representatives, and
> their supporters’ governments (effort) to press the government of Colombia
> in order to stop a sovereign power from …  protect(ing) the fundamental
> right of (its) people and the financial sustainability of the health
> system,” three patient groups — Mision Salud, Fundacion Ifarma, and Cimun —
> said in a statement.
> A Novartis spokesman sent us a note saying the company believes the
> declaration “was issued improperly and creates an unwarranted and damaging
> precedent that could apply to any patent-covered innovations, not just
> pharmaceuticals. Declarations can be important and legitimate tools in
> exceptional circumstances, such as when public health is at immediate risk
> and cannot be addressed by any other means. This is not the case with
> Gleevec.
> “Currently all patients in Colombia who need Glivec have access to it.
> There is no public health crisis, no shortages, and no evidence of other
> access issues. The government exerts price controls … and has reduced the
> price twice in the last three years,” he continued. He added generic
> versions that do not infringe the patent are available. However, government
> officials previously noted that Novartis has indicated any trace of its own
> drug appearing in a generic would be considered a patent violation,
> suggesting litigation might ensue.
> In a statement, Brian Toohey, a senior vice president for international
> issues at the Pharmaceutical Research and Manufacturers of America trade
> group said “the Colombian Government’s actions are without merit … Ad hoc
> price cuts are not effective or sustainable ways to improve access or
> achieve other critical public health goals. Pricing systems should be based
> on transparent rules and fair processes that provide business certainty for
> pharmaceutical innovators.”
> --
> Andrew S. Goldman
> Counsel, Policy and Legal Affairs
> Knowledge Ecology International
> andrew.goldman at keionline.org // www.twitter.com/ASG_KEI
> tel.: +1.202.332.2670
> www.keionline.org
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James Love.  Knowledge Ecology International
KEI DC tel: +1.202.332.2670, US Mobile: +1.202.361.3040, Geneva Mobile:
+41.76.413.6584, twitter.com/jamie_love

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