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All Journal Decisio: Jurnal Ilmiah Hukum Humaniorum Journal
Ratih Kemala
IBLAM School of Law
Humanities Education Environmental Science Languange, Linguistic, Communication & Media Law, Crime, Criminology & Criminal Justice Library & Information Science Other

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Analisis Yuridis terhadap Tindak Pidana Peredaran Sediaan Farmasi yang Tidak Memenuhi Standar Keamanan, Khasiat, Kemanfaatan dan Mutu (Studi Putusan Pengadilan Negeri Serang Nomor 551/Pid.Suss/2025/PN Srg) Ria Natalia; Ratih Kemala
Decisio: Jurnal Ilmiah Hukum Vol 3 No 2 (2026): DECISIO
Publisher : LPPM Iblam School of Law

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.52249/decisio.v3i2.58

Abstract

The circulation of pharmaceutical preparations that do not meet standards of safety, efficacy, usefulness, and quality constitutes a serious problem in the health law system because it may endanger public safety. This study aims to analyze the legal regulation of pharmaceutical preparations circulation in the Indonesian health law system and the application of such legal provisions in the a quo case, namely Serang District Court Decision Number 551/Pid.Sus/2025/PN Srg. This research uses a normative legal research method with statutory and case approaches. The results show that the regulation of pharmaceutical preparations has been clearly stipulated in Law Number 17 of 2023 concerning Health, particularly regarding the obligation to fulfill standards of safety, efficacy, usefulness, and quality, as well as the prohibition on distributing medicines without legal authority. In the a quo case, the defendant was legally and convincingly proven to have possessed and distributed hard drugs, namely Tramadol and Hexymer, without authorization and without pharmaceutical competence, thereby fulfilling the elements of a criminal offense as regulated under Article 435 paragraph (2) of Law Number 17 of 2023 concerning Health. The court’s decision imposing a prison sentence of 1 year and 9 months is considered consistent with the provisions of health law because it takes into account the fulfillment of the criminal elements, trial facts, and the principle of proportionality in sentencing. This study recommends strengthening the supervision of hard drug distribution by the government and the Indonesian Food and Drug Authority, as well as ensuring consistent law enforcement against perpetrators of illegal pharmaceutical preparations circulation.
Benturan Antara Prinsip Pendaftaran Pertama Dan Persamaan Pada Pokoknya Dalam Hukum Merek Indonesia: Studi Kasus Sengketa Merek “Geprek Bensu” Heli Karolin; Ratih Kemala
HUMANIORUM Vol 4 No 3 (2026): Jurnal Humaniorum
Publisher : PT Elaborium Elevasi Indonesia

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.37010/hmr.v4i3.171

Abstract

This study examines the normative relationship between Indonesia’s constitutive trademark system, commonly described as the first-to-file principle, and the statutory standard of persamaan pada pokoknya. Its novelty lies in separating the functions and legal consequences of Article 3, Article 21(1), Article 21(3), and the cancellation mechanism, and then testing their application in the “Geprek Bensu” dispute. This normative legal research applies statutory, case, and conceptual approaches to Law Number 20 of 2016 on Trademarks and Geographical Indications as amended by Law Number 6 of 2023, its implementing regulation, Decision Number 57/Pdt.Sus-Merek/2019/PN Niaga Jkt.Pst, and Supreme Court Decision Number 575 K/Pdt.Sus-HKI/2020. The materials were analyzed through grammatical and systematic interpretation, while the ratio decidendi was identified from the legal issues, judicial reasoning, and operative orders. The study finds that trademark rights arise after registration, whereas filing priority determines the order of competing applications. Persamaan pada pokoknya and bad faith are separate grounds that may support refusal or cancellation and require distinct proof. In the dispute, the Commercial Court rejected the claim in convention, partly granted the counterclaim, and ordered the cancellation of six later registrations; the Supreme Court rejected the cassation after examining the complete marks and the parties’ promotional relationship. The study recommends more explicit substantive-examination reasoning without reducing trademark ownership to filing priority alone.
Co-Authors Heli Karolin Ria Natalia