Case 16/2008

Decision No. 16/2008
Download Judgment: English Spanish
Country: Uruguay
Region: Americas
Year: 2008
Court: Tribunal de Apelaciones [Court of Appeals]
Health Topics: Medicines
Human Rights: Right to health
Tags: Access to drugs, Access to medicines, Drug quality, Drug safety, Generic drugs, Pharmaceuticals

The claimant brought an amparo action against Resolution 266/007, which awarded a contract for “Provision of Antiretroviral Medications” to a bidder offering 80% generic products, arguing that the Resolution violated the claimant’s right to health. The lower court rejected the protection action, and the claimant appealed the decision, submitting copious amounts of documents and evidence to the Court.

The Court confirmed the lower court's decision to dismiss the protection action.

The Court considered the claimant’s procedural violations sufficient to rule against the claimant. The claimant’s use of amparo, which is supposed to be an “agile proceeding” for actual or imminent harms, was inappropriate considering that the proceedings took two months and included over 500 pages of documents.

Regardless of the procedural violations, the Court went on to examine the merits of the claim. It found no "material difference" between original and generic pharmaceuticals had been shown and thus no violation of the claimant's right to health. Likewise, the Resolution was considered legal as bio-equivalency and bio-availability studies were not required at the date of issuance.

“If the Administration itself denied the claimant the suspensory effect of the action, and if in so doing explicitly based its decision on ‘…the immediate needs of users, and as a result, on human health, causing serious harm,’ then the administrative ruling would seem, rather than violating the right to health, to be protecting it.” (p. 2)

“Si la propia Administración quitó a la recurrencia de la actora el efecto suspensivo, y si al hacerlo explicitó el fundamento de su decisión en ‘...inaplazables necesidades de los usuarios, y por ende, de la salud humana, ocasionando graves perjuicios’, parece que más que atentar contra el derecho a la salud, la decisión administrativa la está protegiendo.” (p. 2)

“…we have not been able to see that there are material differences between those pharmaceuticals referred to as originals, generics, or copies, as court medical expert Dr. Guillermo López has noted, that result in ‘serious adverse reactions, much less lethal reactions.’” (p. 3)

" hemos podido percibir que existan diferencias sustanciales entre los fármacos llamados originales, genéricos, o copias, como dice el médico legista Dr. Guillermo López, que afecten con "reacciones adversas graves y mucho menos letales". (pp. 2-3)