SASIA, Pablo Javier y otros v. Central Unit of State Acquisition of Medication and Related Goods (Unidad Centralizada de Adquisición de Medicamentos y Afines del Estado)

Sentencia Nº16/2008
Download Judgment: English Spanish
Country: Uruguay
Region: Americas
Year: 2008
Court: Civil Appeals Court, 5th District [Tribunal Apelaciones Civil 5ºTº]
Health Topics: Health care and health services, Health systems and financing, Medicines
Human Rights: Right to health
Tags: Access to drugs, Access to medicines, Access to treatment, Antiretrovirals, ARVs, Drug quality, Drug safety, Generic drugs, Health expenditures, Health funding, Health spending

This case was brought against the Central Unit of State Acquisition of Medication and Related Goods for supplying generic versions of antiretroviral drugs that were allegedly of lower quality than their original versions. The complainants alleged that their constitutional right to health had been violated.

The complainants had lost at the trial court level and appealed to the Civil Appeals Court under a writ of amparo (a remedy for the protection of a constitutional right).

The Court held that the appeal did not meet the requirements for a writ of amparo, which requires (1) an actual or imminent harm to a constitutional right, and (2) an arbitrary or illegitimate act committed by the injuring party.

First, the Court found that the case did not involve actual or imminent harm because the evidence took more than two months to produce to show an allegedly imminent harm. Furthermore, if the Court did stop the provision of the drugs on the basis of the urgent needs of consumers, it would undermine the right to health by depriving individuals who needed the medication of their access to it.

Second, the Court held that the case did not meet the requirement of an arbitrary or illegitimate act because the facts of the case did not show a clear attack on a constitutionally protected right. The Court reasoned that the medical examiner did not find substantial differences between original drugs and their generic versions, and even if there were differences, when the resolution to supply the drug was passed, previous studies of bioequivalence and bioavailability were not obligatory.

“Si la propia Administración quitó a la recurrencia de la actora el efecto suspensivo, y si al hacer lo explicitó el fundamento de su decisión en "...inaplazables necesidades de los usuarios, y porende, de la salud humana, ocasionando graves perjuicios", parece que más que atentar contra el derecho a la salud, la decisión administrativa la está protegiendo.” Page 2.

“If the Administration removed from the recourse of the complainant/appellant the suspensive effect and in doing so based its decision in “urgent needs of the consumers/users, and therefore of human health, causing serious damage,” it seems that rather than undermining the right to health, the administrative decision is protecting it. ”

“Específicamente, señala el a-quo al finalizar el Considerando IV que ‘ hemos podido percibir que existan diferencias sustanciales entre los fármacos llamados originales, genéricos, o copias, como dice el médicolegista Dr. Guillermo López, que afecten con "reacciones adversas graves y mucho menos letales.’” Pages 2-3.

“Specifically, the a-quo points out at the end of paragraph IV: Considering that, ‘...we have not been able to perceive that there exist substantial differences between the drugs labeled original, generics, or copies,’ as was said by medical examiner Dr. Guillermo Lopez, that can produce ‘serious adverse reactions, much less lethal reactions.’”