[Ip-health] Colombia beats Abbott: Kaletra prices to drop 2/3

[peter.maybarduk@essentialinformation.org]

Friends,
As we reported last week, Colombia's National Medicines Pricing
Commission(CNPMD) recently affirmed its decision to regulate the price of
Abbott Laboratories' HIV medicine Kaletra (lopinavir + ritonavir),
rejecting Abbott's appeal.

Abbott's high prices came under scrutiny in 2008 when Colombian civil
society launched a compulsory license campaign, leading eventually to the
Pricing Commission's decision to fix Kaletra's price at about two-thirds
off the drug giant's rate in the spring of 2009.

Nevertheless, Abbott continued to charge its higher monopoly prices, in
apparent violation of the government's price order.  The Pricing
Commission announced an investigation, while civil society filed a lawsuit
to obtain a compulsory license authorizing generic competition with
Kaletra.

Today, Colombia's El Tiempo newspaper reports Abbott has finally agreed to
sell Kaletra at CNPMD's price.  The change will save Colombia's HIV
programs about US$12 million this year, just as Colombia seeks cost-saving
solutions to a recently-declared Social Emergency to =93avert the grave
crisis affecting the viability of the General System of Social Security in
Health.=94

Thanks are due to the hard-working advocates at La Mesa de Organizaciones
con Trabajo en VIH/SIDA, IFARMA, RECOLVIH, G&M de Colombia Abogados,
Mision Salud and Comunicacion Positiva, among others.  Congrats on a
well-deserved victory.

Generic prices for lopinavir + ritonavir are still much lower than
Abbott's, and competition is the best means to keep prices falling over
time.  Abbott says it won't abandon its legal challenges to the price
order.  But we can count on Colombia's civil society to keep the pressure
on.

El Tiempo's article is available here:
http://www.eltiempo.com/colombia/bogota/ARTICULO-WEB-PLANTILLA_NOTA_INTERIO=
R-7227993.html

More information on the Colombia Kaletra case is available here in English
(scroll down):
http://www.essentialaction.org/access/index.php?/categories/8-Country%20Dis=
putes%20and%20Other%20Issues

Archives available here in Spanish:
http://www.mirada-latina.org/joomla/index.php?option=3Dcom_content&task=3Db=
logsection&id=3D23&Itemid=3D128

Last week's post is below.

Peter Maybarduk
Public Citizen
Access to Medicines Project (formerly Essential Action)
+1 202 390 5375


On Mon, Feb 8, 2010 at 1:12 PM, <peter.maybarduk@essentialinformation.org>
wrote:

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 Colombia=92s National Medicines Pricing Commission (CNPMD,
formerly CNPM) to regulate Kaletra=92s price.  CNPMD fixed maximum prices o=
f
$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 Abbott=92s
request and affirming the decision to regulate Kaletra=92s 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, Colombia=92s drug regulatory authority, has declined
to register generic versions of lopinavir + ritonavir (LPV/r), citing
Abbott=92s patents.  But Colombia=92s 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 =96 even though no law
authorizes such protection.

Therefore, on September 16, Colombian civil society filed an =93acci=F3n
popular,=94 a mechanism under Article 88 of the Colombian Political
Constitution to protect collective rights, public services and
=93administrative morality.=94  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 =93avert the grave crisis affecting the viability of the
General System of Social Security in Health.=94  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%20Dis=
putes%20and%20Other%20Issues

Peter Maybarduk
Public Citizen
Access to Medicines Project (formerly Essential Action)
+1 (202) 390 5375