Laboratorio Welt S.A s/infracción ley 16.463

L. 1301. XLI.
Download Judgment: Spanish
Country: Argentina
Region: Americas
Year: 2010
Court: Supreme Court of Justice [Corte Suprema Justicia de la Nación Argentina]
Health Topics: Medicines, Public safety
Human Rights: Right to property, Right to work
Tags: Health regulation, Medicines, Safety regulation

The National Administration of Drugs, Foods and Medical Devices [ANMAT] fined the Laboratorio Welt S.A and its director to (ARS 20 000) twenty thousands and (ARS 10 000) ten thousands Argentine pesos for violating articles 2 and 19.b of law 16.463 and article 9 from decree 150/92. The laboratory did not comply with resolution 1930/95 from the ANMAT because the in vivo medical study done with  a liquid injection was understood as a medicine by the ANMAT so the regulation n°853 and resolution ex MSyAs n°102/98 were applicable and that activity was regulated by its police power.

The Laboratory Welt appealed to the First Instance Criminal Economic Court [Juzgado Nacional de Primera Instancia en lo Penal Económico n° 6.] that revoked the economic sanction for considering that the legality principle has been affected. It understood that the disposition n°6826/02 of the ANMAT was issued after the inspection therefore not applicable because the activity was already regulated by resolution 1930/95 so it was not a conduct that was regulated at the time of the facts.

The ANMAT brought an extraordinary appeal to the Supreme Court of Justice for considering that the judgment was violating the division of power, property right violation and the violation of the public health guaranteed by the National Constitution and International Treaties which entails institutional gravity.

The Supreme Court of Justice found that the complaint was inadmissible in the terms of art. 280 of the National Code of Civil and Commercial Procedure.