Colombia Caves to Health Extremists to Violate the Property and Human Rights of Foreigners

http://www.forbes.com/feeds/prnewswire/2009/05/11/prnewswire200905112122PR_NEWS_USPR_____DC15231.html

Victory! Colombian Government Cuts Price of Abbott's Lifesaving AIDS Drug Kaletra 55%, Says AHF

Forbes.com


May 11, 2009


05.11.09, 9:28 PM ET

Advocates Claim Victory as Government Cuts & Freezes Price at $1,067 USD for Public Institutions and $1,591 USD for Hospitals, Clinics & Private Sector--55% Less than Abbott's Previous Colombian Price. Since January, Colombian, Mexican & US AIDS Advocates Protested Steep Price of Drug in Developing Countries; Compulsory License in Colombia Would Further Cut Price to Less Than $600/Patient/Yearly

MEXICO CITY, May 11 /PRNewswire-USNewswire/ -- Colombian and international AIDS advocates and activists claimed victory today after the government of Colombia announced that it will cut the price of Abbott Laboratories' lifesaving AIDS drug, Kaletra to $1,067 USD for the public sector hospitals and clinics and $1,591 USD for the private sector. Government officials had asked the Chicago-based pharmaceutical giant to voluntarily lower the price; however, the company refused. As a result, Colombia invoked its power to cut and freeze the price of the key AIDS drug. The cut represents a roughly 55% price reduction in Colombia, where Abbott previously charged the private sector approximately $3,500 USD per patient yearly for the drug.

"Colombia's action today to cut the price for Abbott's Kaletra is of major importance, a move that will undoubtedly help save many, many lives by making lifesaving AIDS drug regimens more widely available in the country. We salute the tireless AIDS activists and advocates on the ground who raised awareness through protests and media outreach that helped keep this issue in the forefront. I am not aware of another instance in which the government of a country came in and cut and put a price ceiling on an AIDS drug." said Clint Trout, MPH "However while this is an important victory, we call on the Colombian government to accede to local activists demands to issue a compulsory license for Kaletra, which would allow Colombia to purchase the medication at less than $600 per patient per year and would save many additional lives."

[ILLEGAL EXPROPRIATION OF FOREIGN ASSETS, IN VIOLATION OF THE WTO TRIPS AGREEMENT]

In January of this year, as part of an ongoing multinational campaign to lower drug prices and improve access to lifesaving AIDS treatments globally, AIDS advocates from three countries--Colombia, Mexico and the United States--held simultaneous protests in the three countries. The protests targeted Chicago-based Abbott Laboratories over the pricing of Kaletra, which can be a key component of lifesaving AIDS drug treatment regimens, particularly as part of what are known as 'second-line' treatments and salvage therapy. The advocates vowed to seek compulsory licenses in Mexico if Abbott did not reduce prices for the drug and have officially requested a compulsory license in Colombia. The Colombian Government is expected to rule on the compulsory license this week.

"In our protests in the three countries in January, we pressed Abbott to reduce the price of Kaletra in Colombia and Mexico," said Michael Weinstein, AIDS Healthcare Foundation President. "The lives of people living with--and dying from--HIV/AIDS in Colombia and Mexico are just as important as those of people living with AIDS here in the United States. In March, we claimed partial victory when Abbott cut the price of Kaletra by twenty percent in Mexico. Today's action by the Colombian government helps bring about an end to Abbott's price-gouging policies that shamefully continue to place profits ahead of saving lives. We call on the Colombian government to use these savings to improve treatment and care for persons living with HIV/AIDS in Colombia."

In late March, a coalition of AIDS activists [EXTREMISTS] known as the Coalicion de Activistas por el Acceso Universal spearheaded by AIDS Healthcare Foundation (AHF), which operates four free treatment clinics in Mexico (Puerto Vallarta, Cancun, Tuxtla Gutierrez and Pachuca), declared victory in its campaign to lower drug prices and improve access to lifesaving AIDS treatments in Mexico. As a result of that coalition's prolonged, multinational campaign to raise awareness about the high price charged by Abbott Laboratories Inc. for its key AIDS drug, Kaletra in Mexico, the company cut its price by twenty percent--from $4688.00 pesos MXN per patient per month to $3750.40 MXN. The new lower price was published for the first time in med-March on the website of CENSIDA, Mexico's National Center for the Prevention and Control of HIV/AIDS.

The Colombian [EXTREMIST] organizations: Mesa de Organizaciones con Trabajo en VIH/SIDA, the Red Colombiana de Personas Viviendo con VIH o con SIDA, Mission Salud, and IFARMA requested a compulsory license for Kaletra from the Ministry of Commerce in 2008 and have been leading the push for the compulsory license and lower prices with assistance from AHF and Washington-based Essential Action. The Ministry of Commerce has requested the Ministry of Social Protection to rule whether or not Kaletra is a medication "in the public interest." This ruling is expected this week.

Abbott has long been the target of multinational protests and legal actions over the pricing of its AIDS drugs including Kaletra and Norvir. Over the past several years as many of Abbott's industry peers have significantly lowered the prices of their own lifesaving AIDS medicines on their own volition and in response to worldwide humanitarian need, Abbott has remained steadfast in its refusal to do so, or it has countered advocates' and governments' demands with only modest price reductions.

According to the website, www.aidsmeds.com , "Kaletra, a protease inhibitor (sold under the brand name Aluvia in some parts of the world), is actually two drugs combined into a single capsule: lopinavir and low doses of ritonavir (Norvir), another protease inhibitor manufactured by Abbott Laboratories. This is because ritonavir increases the amount of lopinavir in the blood, thus making it more effective against HIV."

Kaletra in Colombia

-- Colombia is a lower-middle income country with an average income per capita of $2,600 per year.(1) The country has one of the most serious HIV/AIDS problems in the region: 170,000 people living with AIDS and a rapidly rising HIV prevalence (currently 0.7%).(2) An average of 10,000 people each year die from AIDS in the country.(3)

-- Colombia is unable to provide antiretroviral therapy to those who need it. UNAIDS estimates that 33,000 people with AIDS who need ARV therapy now (62% of the total) are not currently accessing it.(4) Colombia's government is spending $70 million each year for AIDS drugs (all national funding).(5)

-- Abbott promotes Colombia as receiving a preferred price of $1,000 per patient per year for lower-middle income countries on its website.(6) However, in reality Abbott charged Colombia $8,400 per patient per year up through mid-2007.(7)(8) Abbott is currently charging $3,500 in Colombia.(9)

-- Abbott uses unorthodox and unethical marketing strategies in Colombia to promote Kaletra. This includes offering classes, dinners, and trips to patients on Kaletra.(10) As a result, Kaletra is the 2nd-most widely prescribed AIDS medicine in Colombia, highly unusual for a 2nd-line medication. Kaletra accounts for 1/3 of Colombia's AIDS drug costs.(11)

-- On April 7, 2008, the Mesa de Organizacions con Trabajo en VIH/SIDA and the Red Colombiana de Personas Viviendo con VIH o con SIDA requested an open license on Kaletra. The local Colombian generics industry has the capacity to manufacture Kaletra at much lower costs AND Colombia has an agreement with the Clinton Foundation through which it could get a generic version of Kaletra for approximately $600 per patient per year.(12) Abbott did not respond.

About AHF

AIDS Healthcare Foundation (AHF) is the nation's largest non-profit HIV/AIDS healthcare provider. AHF currently provides medical care and/or services to more than 100,000 individuals in 21 countries worldwide in the US, Africa, Latin America/Caribbean and Asia. Additional information is available at www.aidshealth.org

(1) United Nations Development Program ( www.undp.org )

(2) Resumen de Situacion de la Epidemia por VIH/SIDA en Colombia. (Dec 2007) Ministerio de Proteccion Social, Colombia.

(3) UNAIDS http://www.unaids.org/en/CountryResponses/Countries/default.asp

(4) World Health Organization (April 2008). Universal Access Report.

(5) 2008 UNGASS Report, Colombia.

(6) http://www.abbott.com/global/url/content/en_US/40.5.10:10/general_content/General_Content_00327.htm

(7) Garavito, L, Gomez, F. (2006) Analisis regulatorio del mercardo institucional de medicamentos antiretrovirales en Colombia.

(8) Personal Communication with Abbott Laboratories in Colombia.

(9) Local price survey.

(10) AHF can provide 1st hand accounts on request.

(11) Garavito, L, Gomez, F. (2006) Analisis regulatorio del mercardo institucional de medicamentos antiretrovirales en Colombia.

(12) Clinton HIV/AIDS Initiative. www.clintonfoundation.org

SOURCE AIDS Healthcare Foundation

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[THE COLOMBIAN GOVERNMENT ACTIONS VIOLATE THE WTO TRIPS AGREEMENT IN SEVERAL IMPORTANT WAYS].

• The WTO TRIPS flexibilities” contained within TRIPS Article 31, the Doha Declaration on TRIPS and Public Health, the TRIPS Council Decision on Paragraph 6 and the proposed Article 31bis Waiver to the TRIPS Agreement concerning same emphasize that intellectual property are property rights, first and foremost, within the meaning of TRIPS Preamble Paragraph 4, and are deserving of adequate protection against governmental expropriation.

• Since property rights are natural, individual-based human rights, within the meaning of the 1948 Declaration, the 1948 American Declaration on the Rights and Duties of Man, the 1976 International Covenant on Economic, Social and Cultural Rights, and ultimately, the United States Constitution (1787) and its accompanying Bill of Rights (1791), then governments must pay heed to the strict substantive and procedural conditions imposed on unauthorized governmental ‘takings’ of private IP rights set forth within WTO TRIPS Article 31(a), (d), (h), (i), (j) and (k); 44.2; and 62.44.

• While the TRIPS Agreement may have grandfathered the highly disputed Paris Convention grounds for issuing compulsory licenses (incorporated by reference within TRIPS Article 2 and the Preamble to TRIPS Article 31) (‘the broad mouth of the funnel’), these bases remain tightly circumscribed by the substantive and procedural conditions imposed by the subsections to TRIPS Article 31. These provisions were arguably intended to ensure protection of patentees’ affirmative right to substantive and procedural due process of law against wanton governmental seizures of exclusive private property (human) rights within the meaning of the Fifth Amendment of the U.S. Bill of Rights and other U.S. constitutional provisions (‘the narrow neck of the funnel’).

• This means that when a government or an intergovernmental organization such as the WHO, etc. wishes to ‘take’ patented private medicine or medical technology products for a ‘public use’ (i.e., on the basis of an identified and declared ‘public interest’), that government or intergovernmental organization must pay itself, or cause a selected third party licensee to pay, full, complete and adequate fair market value compensation for such patents. After all, this is consistent with established U.S. Supreme Court jurisprudence and with the understanding of the parties to the WTO TRIPS and WIPO Agreements. And, fair market value means ‘arms-length’ pricing agreed to between a willing buyer and a willing seller; not some unilaterally predetermined price deemed to be ‘fair’ by a national or regional government or intergovernmental body.

[See: ITSSD Comments on ‘Desk Review of the Intergovernmental Working Group on Public Health, Innovation and Intellectual Property from a Right to Development Perspective’, accessible on the ITSSD website at: http://www.itssd.org/ITSSD%20comments%20on%20Desk%20Review%20of%20IGWG%20CIPIH%20from%20a%20Rt%20to%20Development%20Perspective%20_2_.pdf ].


[See: Desk Review of the Intergovernmental Working Group on Public Health, Innovation and Intellectual Property from a Right to Development Perspective, High-Level Task Force on the implementation of the Right to Development, United Nations High Commissioner on Human Rights, A/HRC/12/WG.2/TF/CRP.5, at: http://www2.ohchr.org/english/issues/development/right/docs/A-HRC-12-WG2-TF-CRP5.doc; http://www2.ohchr.org/english/issues/development/right/high_level_task_force_Right_to_Development_5th.htm ].


[See: ITSSD Comments Concerning (Document SCP/13/3) Exclusions from Patentable Subject Matter and Exceptions and Limitations to the Rights , World Intellectual Property Organization (WIPO) Standing Committee on the Law of Patents (March 2009) at: http://www.itssd.org/ITSSD%20Comments%20Concerning%20Document%20SCP%2013-3%20-%20Patent%20Exclusions,%20Exceptions%20&%20Limitations%20-%203-27-09%20-II.doc].