PERLINDUNGAN HUKUM KONSUMEN DALAM PEREDARAN OBAT, ALAT KESEHATAN, DAN MAKANAN DI INDONESIA: KAJIAN PUSTAKA
DOI:
https://doi.org/10.5281/zenodo.23905130Keywords:
consumer legal protection, medicines, medical devices, food, BPOM supervision, marketing authorisationAbstract
Legal protection for consumers in the distribution of medicines, medical devices and food constitutes the state’s efforts to guarantee consumers’ rights to security, comfort, safety, and accurate and honest information. Health products pose a high risk if they are produced, distributed or marketed without meeting standards of safety, efficacy or benefit, and quality. This study aims to analyse the forms of consumer legal protection, as well as the role of regulation and supervision in ensuring safety and consumer rights in the distribution of medicines, medical devices and food in Indonesia. The method used is a literature review employing a normative legal approach. The results of the study indicate that consumer legal protection is realised through two main forms, namely preventive protection and repressive protection. Preventive protection is carried out through the issuance of marketing authorisations, the evaluation of safety, efficacy or benefit, and quality; the supervision of good manufacturing practices; labelling; and the regulation of promotions to prevent misleading claims. Repressive protection, on the other hand, is carried out through post-market surveillance, product sampling and testing, product recalls, the revocation of marketing authorisations, administrative sanctions, and the enforcement of business operators’ liability. The Indonesian Food and Drug Authority (BPOM) plays a central role in carrying out registration, issuing marketing authorisations, pre- and post-market surveillance, intelligence gathering, investigations, and the prosecution of violations. The Ministry of Health also plays a role in the supervision and regulation of pharmaceutical products and medical devices to ensure they meet the standards and requirements set out in legislation. The main challenges to consumer protection at present are the proliferation of illegal medicines, counterfeit products, high-risk foodstuffs, and the circulation of products via e-commerce channels that have not yet been fully verified. Therefore, there is a need to strengthen regulations, enhance cross-sectoral supervision, educate the public, ensure transparency of product information, and enforce strict sanctions. Synergy between the government, the BPOM, the Ministry of Health, business operators, digital platforms and consumers is key to achieving effective legal protection in the distribution of medicines, medical devices and food in Indonesia.
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