Analisis Perbedaan Pembuktian Unsur Mengedarkan pada Tindak Pidana Mengedarkan Sediaan Farmasi Tanpa Izin Edar (Studi Putusan Pengadilan Negeri No.56/Pid.Sus/2022/PN.Pct dan Putusan Ma No.2574 K/Pid.Sus/2023)

Abstract

The circulation of illegal pharmaceutical preparations is a serious problem that threatens the health of Indonesian society. Law Number 17 of 2023 concerning Health has explicitly regulated the prohibition of circulating pharmaceutical preparations without distribution permits, with threats of imprisonment and significant fines as stipulated in Articles 435 and 436. This research aims to analyze three main issues: (1) the regulation of criminal acts of circulating pharmaceutical preparations without distribution permits according to Indonesian criminal law; (2) the correlation between proving elements of criminal acts and the form of judge's decisions; and (3) the judge's considerations and proof of circulation elements in District Court Decision No.56/Pid.Sus/2022/PN.Pct and Supreme Court Decision No.2574 K/Pid.Sus/2023. This research employs a normative juridical method with a descriptive approach and qualitative analysis through literature study of legal norms relevant to the research problems. The research findings indicate that the regulation of criminal acts of circulating pharmaceutical preparations without distribution permits is governed by Law Number 17 of 2023 concerning Health, particularly Article 435 which regulates the circulation of pharmaceutical preparations that do not meet safety, efficacy, and quality standards, and Article 436 which regulates pharmaceutical practice without expertise and authority. This criminal act constitutes an unlawful act that harms society as it contradicts proper social conduct and endangers public health. The correlation between proving elements of criminal acts and judge's decisions is based on the evaluation of valid evidence, where judges build conviction through various approaches, whether formalistic, substantialist, or progressive while maintaining integrity, professionalism, and independence to achieve a balance between legal certainty, justice, and utility. Analysis of both decisions shows that despite differences in perspectives between the first-instance judge and the cassation level, both decisions have reflected legal certainty. The Supreme Court considered that the defendant's receipt of Rp200,000.00 for the purchase of Eximer pills through the witness's transfer constituted circulation because a sale and purchase transaction had occurred, while the defendant had no permit to circulate the drug and was not an authorized health worker, considering that Eximer pills are prescription medications requiring a doctor's prescription.