TINJAUAN YURIDIS PERLINDUNGAN HUKUM BAGI PELAKU USAHA APOTEK TERHADAP PEDAGANG BESAR FARMASI YANG MELANGGAR PEDOMAN TEKNIS CARA DISTRIBUSI OBAT YANG BAIK DALAM PENYALURAN OBAT (STUDI KASUS APOTEK SUMBER WARAS)

Pandansari, Anastasia Ayu Dewi (2022) TINJAUAN YURIDIS PERLINDUNGAN HUKUM BAGI PELAKU USAHA APOTEK TERHADAP PEDAGANG BESAR FARMASI YANG MELANGGAR PEDOMAN TEKNIS CARA DISTRIBUSI OBAT YANG BAIK DALAM PENYALURAN OBAT (STUDI KASUS APOTEK SUMBER WARAS). S1 thesis, Universitas Atma Jaya Yogyakarta.

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Abstract

Legal protection is one of the State's efforts to provide justice and the fulfillment of rights regulated by applicable laws and regulations. This is something that is expected for pharmacies as business actors for the negligence of pharmaceutical wholesalers in distributing drugs which results in drugs arriving at pharmacies not in accordance with their quality, safety, and usefulness. Legal protection for pharmacies for drugs that do not comply is regulated in the appendix to the Regulation of the Food and Drug Supervisory Agency Number 9 of 2019 concerning Technical Guidelines for Good Drug Distribution. On the other hand, compensation for losses which is the responsibility of PBF as a business actor is regulated in Article 19 of the Law of the Republic of Indonesia Number 8 of 1999 concerning Consumer Protection. This shows that with the existence of these two laws and regulations, legal protection for pharmacies as business actors in terms of drug distribution channels and law enforcement has been fulfilled. However, in practice there are cons where Pharmacy Wholesalers do not fulfill their responsibilities and obligations in drug distribution channels. This study uses empirical juridical research methods. The purpose of this study is to find out how the legal protection for Pharmacy business actors against Pharmaceutical Wholesalers who violate the technical guidelines for Good Drug Distribution Methods in drug distribution. The results of the research and discussion show that legal protection for pharmacies as business actors has been guaranteed in the drug distribution channel, namely by replacing new drug products by Pharmaceutical Wholesalers or the pharmaceutical industry (Principal) for drugs that do not match the quality, safety and benefits due to the negligence of the Wholesalers. Pharmacy in the implementation of drug distribution. On the other hand, it is also guaranteed by the administration of administrative sanctions by the Head of the Food and Drug Supervisory Agency for the actions of Pharmaceutical Wholesalers who violate the technical guidelines for Good Drug Distribution Methods in drug distribution. The imposition of administrative sanctions aims to provide a deterrent effect on Pharmaceutical Wholesalers, because it can be said that the administration of administrative sanctions provides considerable losses for Pharmaceutical Wholesalers as business actors. From a civil law perspective, the actions of Pharmaceutical Wholesalers that violate the technical guidelines for Good Drug Distribution Methods can be qualified as Unlawful Acts. The definition of unlawful acts is broadly regulated in the Hoge Raad Decision dated January 31, 1919. If the dispute resolution in the drug distribution channel of the Pharmacy still feels aggrieved by the actions of the Pharmacy Wholesalers, the Pharmacy can file a claim for compensation on the basis of Article 1365 of the Law -Civil Law which regulates the elements of Unlawful Acts. This shows that legal protection for pharmacies as business actors is also guaranteed by the State in resolving disputes through litigation.

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