In the latest issue of the Global Access to Medicines Bulletin, you can read about Colombian civil society’s efforts to make generic versions of an important treatment for HIV/AIDS available. You can also learn how a small group of countries are quietly negotiating a new international treaty — known as the Anti-Counterfeiting Trade Agreement (ACTA) — that may interfere with efforts to promote generic and price competition in the pharmaceutical industry.
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Global Access to Medicines Bulletin
Issue No. 6, August 7, 2008
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).  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.  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.  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.  “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.” 
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. 
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. 
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. 
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 legitimate.
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 reimportation.
The G8’s recent Declaration on the World Economy implored negotiators to conclude ACTA negotiations this year. 
For more on ACTA, see:
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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 decade.
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 [email protected]
Robert Weissman [email protected]
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