INDONESIA Law and Practice Contributed by: Wincen Santoso and Muhammad Pravest Hamidi, Santoso, Martinus & Muliawan Advocates
Regulation (PR) No 80 of 2017 on Indonesian Food and Drug Authority (“PR 80/2017”) and is a non-min- isterial government institution tasked with overseeing drug control. Under PR 80/2017, the BPOM operates under and is accountable to the President through the MOH. Medical devices The MOH is the primary regulatory body responsible for the supervision and regulation of medical devic- es in Indonesia. As part of the central government, it operates under PR No 161 of 2024 on Ministry of Health (“PR 161/2024”). Under PR 161/2024, the MOH formulates and enforces health policies, includ- ing those related to medical devices. 1.2 Challenging Decisions of Regulatory Bodies Pharmaceuticals and Medical Devices Regulation Under Law No 5 of 1986 on the State Administrative Court, as lastly amended by Law No 51 of 2009 (“Law 5/1986 as amended”), there exists a legal avenue for challenging administrative decisions. This legislation allows any party who believes that their rights have been infringed upon by a state administrative deci- sion to file a lawsuit in the State Administrative Court ( Pengadilan Tata Usaha Negara , or PTUN). For a decision to be the object of a PTUN lawsuit, it must meet the criteria of being concrete, individ- ual and final. The BPOM is a governmental agency responsible for regulating and controlling drugs and food products, whereas the MOH is responsible for regulating and controlling medical devices. As such, the BPOM’s and the MOH’s decisions are considered state administrative decisions. These decisions can be challenged in the State Administrative Court, pro- vided they meet the aforementioned criteria. To challenge a BPOM and MOH decision, the claimant must demonstrate that the decision directly affects their legal rights or interests and is flawed either pro- cedurally or substantively. The lawsuit must be filed within 90 days from when the decision was issued or became known to the claimant. The State Administra- tive Court will then review the case to determine the legality and justification of the decision. If the court
deems the decision unlawful, it can annul the decision and order corrective actions. 1.3 Categories of Pharmaceuticals and Under Law 17/2023 as amended and GR 28/2024, drugs are categorised into prescription-only drugs and non-prescription drugs. Prescription-only drugs consist of potent drugs, nar- cotics, and psychotropics, which must be dispensed exclusively by licensed pharmacists operating within pharmaceutical service facilities. Non-prescription drugs, which are further divided into OTC drugs and limited OTC drugs, may be obtained from pharmaceu- tical service facilities or other facilities in accordance with laws and regulations. Medical Devices Pharmaceuticals Law 17/2023 as amended provides that certain potent drugs may be dispensed by a pharmacist without a prescription. Under GR 28/2024, these drugs are specified in a list issued by the MOH and reviewed based on developments in healthcare needs, science, and technology. In addition to these categories, Law 17/2023 also delineates the classification of natural medicines into traditional herbal remedies (jamu), standardised herbal medicines, phytopharmaceuticals, and other natural medicines. Medical Devices Based on the risk posed to patients by the use of medical devices, MOH 62/2017 categorises medical devices into Class A (low risk), Class B (low-to-mod- erate risk), Class C (moderate-to-high risk) and Class D (high risk). For in vitro diagnostic medical devices, MOH 62/2017 provides classification based on the risk posed by misinterpretation of diagnostic results to individuals and the public – ie, Class A (low risk both to individu- als and the public), Class B (moderate risk to individu- als but low risk to the public), Class C (high risk to individuals but moderate risk to the public), and Class D (high risk both to individuals and the public).
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