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

Andrea Carolina Reyes Rojas subdireccion at mision-salud.org
Thu Sep 22 11:03:08 PDT 2016

Dear Jamie and Andy, thank you.

It would be great to have a copy of the petition.

Despite not knowing the USTR's request, it is a fact that the deadline 
to submit comments changed. The initial one was 20th september. Now it 
is the 27th september... 

Proyectos en curso ​ ​​
Se publica para comentarios el proyecto de Circular por la cual se 
establece una*Metodología que regule precios de medicamentos en 
situaciones excepcionales en las que se haya declarado el interés 
Los comentarios se recibirán desde el 14 de septiembre de 2016 hasta el 
27 de septiembre de 2016 y deben ser remitidos al correo 
electrónicorpmsituacionesexcepcionales at minsalud.gov.co

El 21/09/2016 a las 9:39, Jamie Love escribió:
> 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 <mailto: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/
>     <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 <mailto:andrew.goldman at keionline.org>
>     // www.twitter.com/ASG_KEI <http://www.twitter.com/ASG_KEI>
>     tel.: +1.202.332.2670 <tel:%2B1.202.332.2670>
>     www.keionline.org <http://www.keionline.org>
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> -- 
> James Love.  Knowledge Ecology International
> http://www.keionline.org/donate.html
> 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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