Problems of Corporate and State Criminal Liability in the Pharmaceutical Production Chain: The Case of Acute Kidney Injury in Children in Indonesia
DOI:
https://doi.org/10.37253/conescintech.v6i1.12818Keywords:
Corporate criminal liability, state responsilibity, acute kidney injury in children, pharmaceutical oversight, human rightsAbstract
The 2022 outbreak of Atypical Progressive Acute Kidney Injury (APAK) among children in Indonesia triggred a serious public health crisis rooted in failures of pharmaceutical oversight and the drug production supply chain contaminated with ethylene glycol (EG) and diethylene glycol (DEG). This normative legal research analyses the issues of corporate criminal liability within the pharmaceutical production chain as well as state responsilibity for deficiencies in the conceptual approaches, the study finds that although national legal instruments, such as the Consumer Protection Law, provide as basis for criminal sanctions, their implementation remains limited to end-product manufacturers and has not effectively extended to raw material suppliers outside the primary corporate structure. The theories of identification, vicarious liability, and strict liability are considered relevant however, they require further strengthening to ensure fair and comprehensive law enforcement throughout the supply chain. On the other hand, the state is deemed to have failed to fulfill its constitutional and international obligations to protect children’s right to health. The findings indicate the existence of maladministration within the supervisory system of the Food and Drug Supervisory Agency (BPOM) and the Ministry of Health. Therefore, regulatory reform is needed to strengthen the principles of due diligence, supply chain liability, and pharmacovigilance systems in order to guarantee the protection of human rights an prevent similar incidents from recurring in the future.
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