E-DRUG: Colombia rejects Abbott appeal on Kaletra price regulation; update
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In Colombia, Abbott has long charged thousands of dollars per person, per
year for HIV medicine Kaletra (lopinavir + ritonavir). In 2008, Colombian
civil society launched a compulsory license campaign, leading to a spring
2009 decision by Colombias National Medicines Pricing Commission (CNPMD,
formerly CNPM) to regulate Kaletras price. CNPMD fixed maximum prices of
$1,067 for the public sector and $1,591 for the private sector, down from
around $3,400 and representing average price reductions around 54% - 68%
Abbott appealed. On December 23, CNPMD responded, rejecting Abbotts
request and affirming the decision to regulate Kaletras price.
In summer 2009, evidence surfaced that Abbott was violating the pricing
order. CNPMD launched an investigation, results of which have not yet
been announced. A finding against Abbott could lead to sanctions imposed
by the competition authority. A compulsory license would be a logical
remedy.
Additionally, INVIMA, Colombias drug regulatory authority, has declined
to register generic versions of lopinavir + ritonavir (LPV/r), citing
Abbotts patents. But Colombias laws do not provide for linking drug
registration to patent status. In other words, INVIMA has so far granted
Abbott a de facto monopoly on LPV/r registration even though no law
authorizes such protection.
Therefore, on September 16, Colombian civil society filed an acción
popular, a mechanism under Article 88 of the Colombian Political
Constitution to protect collective rights, public services and
administrative morality. The action seeks orders that the Department of
Competition and Industry issue an open compulsory license on LPV/r, and
INVIMA permit the registration of generic LPV/r, provided applicants
satisfy the requirements of quality and good manufacturing practices.
On October 15, a Colombian judge admitted the action and certified
RECOLVIH, the Colombian network of people living with HIV, as plaintiff.
Finally, the Colombian government recently declared a state of Social
Emergency to avert the grave crisis affecting the viability of the
General System of Social Security in Health. On January 21, the
government assigned new broader price-regulating powers to CNPMD through
Decreto 126. The crisis underscores the need for competition and savings
on medicines including Kaletra, which remains one of the most costly to
the Colombian healthcare system.
Read prior posts on the Colombia case here:
http://www.essentialaction.org/access/index.php?/categories/8-Country%20Disputes%20and%20Other%20Issues
Peter Maybarduk
Public Citizen
Access to Medicines Project (formerly Essential Action)
+1 (202) 390 5375
peter.maybarduk@essentialinformation.org