Argentina: AIDS Treatment Interrupted

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For the second time in two months, the Ministry of Health in Argentina has failed in its responsibility to provide a continuous supply of life-saving medications to people living with HIV/AIDS (PLWHAs), who depend on the government for their triple therapy drug cocktails. The companies responsible for supplying government health centers with AIDS drugs--including Indinavir, 3TC, d4T, and other antiretrovirals (ARVs)--have repeatedly failed to meet their contractual obligations. Faced with unreliable delivery and an erratic supply, the Ministry has resorted to parceling out dosages, forcing PLWHAs to return more and more frequently to pick up smaller and smaller rations of their medications, often distributed in plastic bags after long hours of waiting.

Several organizations, including Fundación Spes, the Community Homosexual Argentina (CHA), la Red de Personas Viviendo con VIH/SIDA, and la Sociedad Argentina de SIDA, accuse the government of failing to hold the Ministry's suppliers accountable. They also say the Ministry is refusing to comply with national AIDS laws by failing to conduct the appropriate quality control tests on some of the imported/or generic copies of the drugs, currently provided to over 15,000 individuals living with HIV/AIDS through the public health system.

Activists are demanding that the Argentinean government take immediate action to resolve the irregularities in drug delivery, guarantee and standardize the quality of ARV medication provided in the public and private sectors, and stop compromising the health and lives of some of its most physically vulnerable inhabitants.

Write to:

Sr. Héctor Lombardo, Minister of Health
Ministerio de Salud de la Nacion
Av. 9 de Julio 1925-6th Fl., ofic. 613
Buenos Aires, Argentina
FAX +54/1/4379-9143
Hlombardo@msal.com.ar
Dra. Mabel Bianco, Directora Unidad Coordinadora Ejecutora de VIH/SIDA y ETS
Ministerio de Salud de la Nacion
Av. 9 de Julio 1925-6th Fl., ofic. 613
Buenos Aires, Argentina
FAX +54/1/4379-9143
Mbianco@msal.gob.ar

And please send a copy of your letter to:

Javier Hourcade
SPES Foundation
Buenos Aires, Argentina
Tele/fax: +5411-4807-3444
spes@ciudad.com.ar

SAMPLE LETTER

Dear

It is imperative that the National Ministry of Health act immediately to restore the constant and even distribution of quality-tested AIDS medications to individuals living with HIV/AIDS in the public health system, as mandated by its signing into law a National AIDS Policy in 1990 (Act N. 23.7983). By neglecting your obligation to provide "adequate, continuous and regular" treatment, a responsibility recognized and upheld by the Supreme Court, you severely and irreparably compromise the health of those for whom you are legally responsible.

All Argentineans possess the governmentally guaranteed right to receive HIV/AIDS treatment. The government must assume the regulatory and supervisory role necessary for the provision of highly active antiretroviral therapy (HAART) to persons living with HIV/AIDS (PLWHAs). Testing the bioavailability and bioequivalency of antiretrovirals (ARVs) are among your obligations. Risks from taking low-quality ARVs include therapeutic failure, the development of resistant strains, toxic or adverse reactions, and waste of already meager resources. Because of this, the Joint United Nations Programme on HIV/AIDS (UNAIDS) specifies that antiretrovirals require "special attention" to ensure that only drugs of acceptable quality are made available.

As for the bodily integrity of the people you put at risk by failing to meet the minimum standards of care for PLWHAs, unanticipated treatment interruption almost always results in an increase in viral load to detectable levels. Usually viral load returns to the levels it was at before treatment began.

These drugs, in short, cannot be provided piecemeal. You are required to provide a "reliable, long-term and regular" supply of those drugs. By refusing to comply with your own laws, you put the lives of all, not just the lives of people living with HIV/AIDS, at risk, as you promote the rise and spread of new and drug-resistant strains of the human immunodeficiency virus. Other negative consequences of the unreliable supply and distribution of ARVs include decreasing treatment efficacy, treatment failure, and compromising patients' commitment to adherence.

We implore you to take immediate action to:

  • Institute appropriate testing and regulation of the supply of antiretroviral medications. Guarantee the quality and quantity of necessary HIV/AIDS medications provided by the State. Conduct bioequivalency and bioavailability tests on all ARVs provided by the State.
  • Stop buying from companies that do not deliver drugs on time. You are responsible for ensuring the correct use of and adherence to ARVs, to avoid the emergence of drug resistance and transmission of resistant strains. Identify and de-license, rather than collude with, corrupt and delinquent drug production companies selected for ARV production or procurement by the state.
  • Comply with laws mandating adequate HIV care. Enforce existing laws, and where necessary enact new legislation to ensure not only a theoretically adequate but an actual and practical supply of tested, safe, life-saving drugs to people living with HIV/AIDS.
  • End all practices which may inflict permanent damage or even death on individuals who depend on the provision of life-enhancing care by the State.

Argentina's Constitution affirms the enjoyment of the rights to life, health and integrity (physical, mental, moral) by all inhabitants of its territory, and protects them from injury, whether caused by an individual or by the State itself. Yet your standards of medical care ignore and actively flout these provisions. Moreover, they violate internationally recognized rights to life and to the highest attainable standard of health, rights that are enshrined in international covenants, which Argentina has ratified. International bodies have also delineated the responsibilities States incur in providing HIV/AIDS treatment and care. The United Nations' International Guidelines on HIV/AIDS and Human Rights exhort States to enact legislation to provide for the regulation of HIV-related goods, "so as to ensure widespread availability ofÉsafe and effective medication" (Guideline 6), and to ensure that "neither expired drugs nor other invalid materials are supplied."

When, in 1990, Act N.23.7983 was passed and the fight against AIDS was deemed a national priority, you recognized the urgency of protecting and promoting universally recognized human rights standards as part of the national response to the HIV/AIDS epidemic. We implore you to not falter in this vision or in your provision of adequate, consistent and quality care for people living with HIV/AIDS in Argentina.

Yours sincerely,

BACKGROUND

Approximately 130,000 adults and children are living with HIV/AIDS in Argentina, and it is estimated that there are approximately 100,000 persons infected with undetected, asymptomatic HIV. Forty-three percent of known cases are concentrated in Buenos Aires. While the annual cost of treatment with HAART (Highly Active Antiretroviral Therapy)--the standard therapy for treating HIV/AIDS--is approximately US$10,000/year, Argentina is one of several Latin American countries which provides these medications for all its inhabitants through licensing production to national laboratories. In 1990 the government declared AIDS a national priority and established a plan to address the epidemic there. The budget for AIDS-related expenditures is currently 70 million pesos (approximately US$70 million).

Recently, however, PLWHAs receiving medications through the public health system in Buenos Aires have faced increasingly fractured drug dispensation schedules and even total shortages of drugs that require strict adherence and dosage regimens. Long lines, hours of waiting, and allotments of drugs of dubious origin, parceled out in plastic bags, propelled AIDS activists into the streets to protest. Dispensation of drugs, at one time monthly, now requires patients to present themselves at the dispensary as often as every 3-5 days.

Local drug production or procurement companies compete (pursuant to the provisions of the "Ley de Contabilitad") for public licenses, to become the official supplier of a certain drug to the State. Fierce competition allows the State to provide a license to the cheapest bidder. Sometimes the chosen company is one that imports copies of the drug from another country. Such solutions can provide excellent medications at affordable prices, provided State regulation is adequate. However, in no case does Argentina require the company to analyze the quality or efficacy of their drug. Nor does the Administracion Nacional de Medicamentos, Alimentos y Tecnologia (ANMAT), the body responsible for acquiring HIV drugs and certifying them for State distribution, insist on performing tests to ensure the drug's integrity. (There are approximately 20 ARVs on the market in Argentina, half of which were acquired by ANMAT.)

Patent-based drug manufacturers who oppose generic drugs make a number of arguments against their use. For example, they allege that generic drugs may be substandard or even counterfeits, or that they may be difficult to support or service. The issue of the quality of medications is a valid and important concern. It is a concern that should apply to all medications. The same regulations and quality controls can and should be applied consistently to all medications, whether generic or not.

As for delays causing drug shortages at the health centers, companies licensed to provide the drugs have not been held accountable beyond the imposition of token fines. This penalty "is minimal compared with the amount these companies gain through being awarded the state contract," according to the Spes Foundation, a non-governmental organization campaigning for government accountability.

Though the problem of delays in distribution, shortages, and lack of quality control of HIV/AIDS medications has plagued the government public health system for years, organizations have recently come together to protest these potentially life-threatening injustices. On August 4, 2000, the Argentina Network of People Living with HIV/AIDS organized a march in front of the National Ministry of Health. All participants wore surgeon's masks, to protect the dignity and privacy of people living with HIV/AIDS, the public disclosure of whose status could mean the loss of jobs and family support, as well as additional vulnerability incurred because of extreme social stigma.