Charges and Embargoes
Federal judge Ernesto Kreplak of La Plata has indicted Nélida Agustina Bisio, former head of ANMAT, and Gabriela Carmen Mantecón Fumadó, former national director of INAME, without preventive detention. They are considered prima facie necessary participants in the crime of adulterating medicinal substances, linked to 90 deaths, at least two cases of very serious injuries, 41 serious injuries, and one minor injury.[S1]
The judge ordered each a $500,000 million embargo and a general inhibition of assets. Both remain free but are barred from leaving the country, must report monthly to the Federal Police, surrender travel documents, and avoid contact with ANMAT and INAME personnel.[S1]
Judge's Findings
Kreplak noted that while the health minister knew general aspects of the case, there is insufficient evidence to attribute criminal responsibility to him. Political decisions from the ministry aimed to stop the companies from operating, unlike the delays and omissions within ANMAT and INAME.[S1][S3]
The judge was particularly harsh on Mantecón Fumadó, stating she had full knowledge of the laboratories' malfunction and sufficient powers to act. He criticized her handling of warning letters, including delaying a letter for Laboratorios Ramallo and shelving a draft warning against HLB Pharma for over four months.[S1][S3]
Bisio's Role
Bisio, as ANMAT's top authority, could not distance herself from INAME's actions since it depended directly on her agency. She signed the May 12, 2025, order banning the use and sale of fentanyl lot 31.202 only after deaths had occurred. Kreplak described her attitude as passive and permissive, favoring the labs' continued operations.[S1][S3]
A key episode was the January 14, 2025, meeting where health authorities agreed with lab representatives to postpone warning letters, allowing time for internal corrections. The next day, the company sent INAME a supposed plan to fix deficiencies found in inspections from November-December 2024.[S1]
Case Details
The case now includes 134 victims, 90 deaths, and 47 complaints. The embargoes consider potential civil indemnities, the number of expert reports, and the economic magnitude of the attributed responsibility.[S3]
