PERTANGGUNGJAWABAN PIDANA DALAM PEREDARAN OBAT TANPA IZIN EDAR : ANALISIS YURIDIS TERHADAP PUTUSAN PENGADILAN NEGERI SERANG NOMOR 551/Pid.Sus/2025/PN Srg

Abstract

The distribution of medicines without marketing authorization or pharmaceutical products that fail to meet the required standards of safety, efficacy, usefulness, and quality constitutes a criminal offense in the health sector with significant implications for public protection and legal certainty. The increasing circulation of pharmaceutical products through informal distribution channels, accompanied by the widespread misuse of certain drugs such as Tramadol and Trihexyphenidyl (Hexymer), demonstrates that administrative supervision alone is insufficient without effective criminal law enforcement. This study aims to analyze the legal framework governing criminal liability for the distribution of medicines without marketing authorization under Law Number 17 of 2023 concerning Health and to examine the application of criminal liability in the Decision of the Serang District Court Number 551/Pid.Sus/2025/PN Srg by assessing the fulfillment of the elements of the criminal offense, the element of culpability, and the legal reasoning adopted by the judges. This research employs a normative legal research method using statutory, conceptual, and case approaches through the examination of legislation, legal doctrines, court decisions, and relevant legal literature. The findings indicate that criminal liability for the illegal distribution of pharmaceutical products is not merely established by proving the act of distribution but also requires proof of intent, criminal responsibility, and the absence of justifying or excusing grounds. In Decision Number 551/Pid.Sus/2025/PN Srg, the panel of judges successfully established the elements of distribution and culpability based on witness testimonies, the defendant's statement, documentary and physical evidence, as well as laboratory examination results. Nevertheless, the court's ratio decidendi still requires stronger legal reasoning, particularly regarding the relationship between the failure to satisfy pharmaceutical standards, the loss of quality assurance resulting from unauthorized distribution channels, and the fulfillment of the elements under Article 435 of Law Number 17 of 2023 concerning Health. This study concludes that the imposition of criminal liability in the case is fundamentally consistent with the principles of legality and culpability; however, a more comprehensive legal analysis is necessary to strengthen consistency, legal certainty, and effectiveness in enforcing criminal law within the health sector.

Keywords: Criminal Liability, Illegal Distribution of Medicines, Pharmaceutical Products, Health Law, Court Decision