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[e-drug] Colombian Groups Seek Generic AIDS Drug; Secret Treaty May Interfere with Generic Meds

  • From: "Sarah Rimmington" <srimmington@essentialinformation.org>
  • Date: Thu, 07 Aug 2008 12:56:03 -0400

E-DRUG: Colombian Groups Seek Generic AIDS Drug; Secret Treaty May Interfere with Generic Meds

Colombian Health Organizations Seek Generic AIDS Drug

On July 16, Colombian public health and HIV/AIDS organizations stepped
up their efforts to facilitate access to an important HIV/AIDS treatment
by filing requests with the Colombian Government for an open compulsory
license on lopinavir/ritonavir (brand-name Kaletra). [1] If issued, the
compulsory license would permit the introduction of significantly more
affordable generic versions of the drug throughout the country in
exchange for royalty payments to the patent holder, Chicago-based Abbott

The compulsory license request comes more than three months after the
civil society groups first requested a voluntary license directly from
Abbott. [2] To date, the company has not responded to the groups' request.

HIV/AIDS is a serious health problem in Colombia. Official statistics
show that from 1983 through 2007, approximately 57,500 people were
diagnosed with the disease, though the true number of cases is estimated
to be closer to 171,500. The groups that initiated the compulsory
license request estimate that about 23,000 of the people living with
HIV/AIDS in Colombia currently require antiretroviral (ARV) treatment,
but only about 12,000 receive it. HIV/AIDS is the third leading cause of
death for men between the ages of 15 and 44 in Colombia.

"My government must not let its people die when there exists a simple,
affordable solution to helping people with HIV/AIDS live normal lives,"
says Francisco Rossi of IFARMA-HAI (Health Action International), one of
the Colombian organizations that initiated the compulsory license requests.

Lopinavir/ritonavir (LPV/r) is an important "second-generation"
treatment for HIV/AIDS. In Colombia, only the brand-name version of the
product (Kaletra) is available to patients. Kaletra is so expensive that
it is unaffordable for much of the population. In a country with an
average income of US$3250, Abbott sells Kaletra to public sector
suppliers for approximately $1683 per patient, per year, and to private
sector suppliers for as much as $4449. However, generic LPV/r is
currently available in both Peru and Bolivia for less than $800 per
patient, per year. It will also soon be available throughout Latin
America for as little as $550 as a result of a recent Clinton Foundation
deal. Abbott charges patients in Colombia more for Kaletra than it
charges other countries in the region, where the company sells it for as
little as $1000 per patient, per year.

Colombian civil society estimates that with competition the government
alone could save well over $1 million annually. Civil society
organizations suggested that these savings could be invested in many
possible ways, such as scaling up the numbers of patients receiving
HIV/AIDS treatment and strengthening Colombia's health system. [3]
Patients and private insurers buy significantly larger quantities of
drugs than the government, and thus the cost savings resulting from the
introduction of generic competition for LPV/r would also be much larger
for them.

The Colombian government can legally issue compulsory licenses on
pharmaceutical patents under World Trade Organization and Andean
Community rules. Under domestic law, the Colombian government is obliged
to reply to the compulsory license request within a reasonable amount of
time. Colombian civil society organizations will be meeting with
government officials to discuss the request in coming weeks.

Meanwhile, at the International AIDS Conference in Mexico City
yesterday, health advocates from around the world demonstrated and
released a letter in support of the Colombian civil society request. [4]
"Issuing a compulsory license in this case will help promote access to
medicines for all," wrote the groups. The high price charged by Abbott,
the patent holder for this medicine, constitutes a barrier to access and
hinders efforts to make antiretroviral treatment available in Colombia
to all who need it." [5]

Web links
[2] http://lists.essential.org/pipermail/ip-health/2008-April/012527.html

Secret Treaty May Interfere with Generic Medicines

A new international treaty now under negotiation, known as the
Anti-Counterfeiting Trade Agreement (ACTA), may interfere with efforts
to promote generic and price competition for the pharmaceutical
industry, according to public health campaigners.

The United States, the European Union, Japan, South Korea, Canada,
Mexico, Australia and New Zealand are now negotiating ACTA. [1]

The text remains secret, but the treaty aims to establish a heightened
common international standard for border controls and copyright,
trademark and patent enforcement.

Over the last couple years, the brand-name pharmaceutical industry and
its allies have increasingly called attention to the issue of
counterfeit medicines. Industry, the U.S. government and the World
Health Organization have implemented a daunting array of projects to
address pharmaceutical counterfeits. ACTA would extend far beyond these
initiatives, however.

Public health advocates say that counterfeits are a legitimate public
health concern, but a subset of a bigger problem: substandard medicines,
in both rich and poor countries. A public health agenda would focus on
the quality of medicines, not narrow patent and trademark issues, they
say. [2]

Pharma, however, is interested in the narrow focus on patent and
trademark issues. Arguments from Pharma and its allies about
counterfeiting blur the lines between fakes and generics -- undermining
public confidence in generics. [3]

Pharma also uses counterfeits as a justification to oppose reimportation
of pharmaceuticals (commonly known as parallel trade or parallel
importation outside of the United States). Because reimported drugs move
outside of brand-name firms' control, and may be repackaged, the
argument runs, there is no certainty that a reimported pharmaceutical is

Because the ACTA text remains secret, exactly what it contains is
unknown. But PhRMA, the U.S. brand-name drug industry association, has
suggested that the treaty should impose liability on manufacturers of
active pharmaceutical ingredients (APIs), if those APIs are used to make
counterfeits -- a liability system that may make API manufacturers
reluctant to sell to legal generic drug makers, and thereby
significantly damage the functioning of the legal generic pharmaceutical
industry. Other industry recommendations would interfere with drug

The G8's recent Declaration on the World Economy implored negotiators to
include ACTA negotiations this year. [4]

For more on ACTA, see:

Web links:
[3] See, for example:
[4] http://www.whitehouse.gov/news/releases/2008/07/20080708-2.html

Essential Action is a public health and corporate accountability group
located in Washington, DC. Essential Action's Access to Medicines
Project has worked on global access to medicines issues for more than a

For more information on our work go to www.essentialaction.org/access/
Published by Essential Action's Access to Medicines Project
P.O. Box 19405, Washington, DC, 20036, USA
Tel: (1) (202) 387-8030

Editors: Sarah Rimmington srimmington@esssentialinformation.org
Robert Weissman rob@essential.org

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Sarah Rimmington
Essential Action, Access to Medicines Project
Washington, DC
Tel: (202) 387-8030
Cell: (202) 422-2687