[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... 
https://www.minsalud.gov.co/salud/MT/Paginas/medicamentos-regulacion-precios.aspx

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 
público 
<https://www.minsalud.gov.co/sites/rid/Lists/BibliotecaDigital/RIDE/VS/MET/Metodologia-regular-precios-medicamentos-situaciones-declaracion-interes-publico.pdf>*. 
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.]
>
>     ARTICLE CONTINUES AFTER ADVERTISEMENT
>
>     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 
> <http://twitter.com/jamie_love>

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