PERAN GUGATAN MASYARAKAT DALAM KASUS GANGGUAN GINJAL AKUT PROGRESIF ATIPIKAL (GGAPA) DAN PENGARUHNYA TERHADAP KEBIJAKAN PEMERINTAH TENTANG PENGAWASAN OBAT

Miche Leo Fullgita, Richo Andi Wibowo, S.H., LL.M., Ph.D

2026 | Tesis | S2 Magister Hukum Kesehatan

Penelitian ini bertujuan untuk mengetahui dan menganalisis peranan gugatan masyarakat dalam kasus Gagal Ginjal Akut Atipikal Progresif (GGAPA) dalam perbaikan kebijakan pemerintah, terutama kebijakan yang berkaitan dengan pengawasan obat.

Penelitian ini menggunakan metode deskriptif dan termasuk jenis penelitian Yuridis-Normatif yan g m e m pe l ajari te ori$$, kon se p, asas, dan pe raturan pe run dan g-un dan gan yan g re l e van$$. Pe n e l i ti an hukum n orm ati f juga m e rupakan je n i s pe n e l i ti an hukum yan g m e n ggun akan bahan pustaka dan data se kun de r. Data se kun de r yan g di gun akan ti dak han ya be rasal dari studi ke pustakaan tetapi juga m e wawan carai be be rapa n arasum be r un tuk m e n dukun g, m e m ban tu, m e n je l askan$$, dan m e n guatkan data se kun de r yan g dipe rol e h.

Penelitian ini menunjukkan bahwa gugatan yang ditujukan kepada pemerintah baik melalui PTUN maupun gugatan class action melalui Pengadilan Negeri, tidak ada satupun yang menyatakan bahwa pemerintah bersalah atau kasus keracunan obat yang menyebabkan ratusan anak meninggal dunia. Pemerintah terus berbenah dengan memperbaiki beberapa regulasi, meskipun putusan pengadilan menyatakan pemerintah tidak bersalah. Kementerian Kesehatan menerbitkan Suplemen I, Suplemen II dan Suplemen III Farmakope Indonesia Edisi VI dan memperketat izin Pedagang Besar Farmasi. Sementara itu, BPOM telah menerbitkan beberapa regulasi baru yang berkaitan dengan peningkatan farmakovigilan dan memperketat pengawasan obat.

The outbreak of drug-related poisoning associated with Acute Kidney Injury (AKI) in children in Indonesia, which resulted in the deaths of hundreds of children, triggered widespread public concern and legal action against the government. This study aims to analyze the role of public lawsuits in encouraging improvements in government policies, particularly those related to pharmaceutical regulation and drug supervision.

This research employs a descriptive method with a normative juridical approach, focusing on the examination of legal theories, concepts, principles, and relevant statutory regulations. The study primarily relies on secondary data, including legal documents, legislation, and scholarly literature. To complement and strengthen the analysis, interviews with several key informants were also conducted.

The findings reveal that lawsuits filed against the government both through the Administrative Court (PTUN) and class action lawsuits submitted to the District Courts did not result in any judicial ruling declaring the government legally liable for the drug poisoning incidents linked to AKI in children. However, despite the absence of legal liability established by the courts, the government has undertaken several regulatory reforms. The Ministry of Health issued Supplement I, Supplement II, and Supplement III to the Indonesian Pharmacopoeia Sixth Edition and tightened licensing requirements for pharmaceutical wholesalers. In addition, the National Agency of Drug and Food Control (BPOM) introduced new regulations aimed at strengthening pharmacovigilance and improving drug monitoring systems.

This study concludes that although public lawsuits did not legally establish government fault, they have played a significant role in stimulating regulatory improvements and strengthening drug oversight policies in Indonesia.

Kata Kunci : Keracunan Obat, Gagal Ginjal Akut, Kementerian Kesehatan, BPOM