Perlindungan Konsumen Obat dalam Peraturan Perundang-undangan di Indonesia

NORMA SARI, Prof.Dr.Hj.Siti Ismijati Jenie, S.H.,C.N.,;Prof.Dr. Achmad Mursyidi, M.Sc.,Apt.

2018 | Disertasi | S3 Ilmu Hukum

Upaya mempertahankan kesehatan dilakukan dengan beberapa cara salah satunya dengan mengkonsumsi obat. Konsumen obat perlu dilindungi karena penggunaan obat harus mengikuti prosedur tertentu untuk mendapatkan manfaat maksimal dan agar tidak berakibat fatal. Pemerintah sudah menerapkan sejumlah peraturan untuk mengatur dan mengontrol proses yang panjang dan kompleks dari pra produksi sampai konsumsi untuk keselamatan. Penelitian ini bertujuan mengkaji dan menganalisis perlindungan konsumen obat pada kerangka umum perlindungan dan tahapan pra produksi sampai konsumsi dalam peraturan perundang-undangan di Indonesia Penelitian ini merupakan penelitian hukum normatif yang menggunakan metode studi kepustakaan. Data penelitian dikumpulkan melalui metode studi kepustakaan terhadap data sekunder meliputi bahan hukum primer, sekunder dan tersier. Analisis yang digunakan adalah deskriptif kualititaif dengan intrepertasi sistematis. Hasil penelitian menunjukkan Peraturan perundang-undangan di Indonesia sudah berusaha memberikan perlindungan kepada konsumen obat dengan tepat. Namun bagaimanapun juga, masih terdapat beberapa titik kelemahan untuk diperbaiki. Kerangka umum peraturan perlindungan konsumen sudah berupaya memastikan pemenuhan hak-hak konsumen obat. Namun titik lemah dalam hal seperti (i) perlakuan sama tetapi tidak adil investor dalam negeri dengan asing di industri farmasi sebagaimana termuat dalam UU Penanaman Modal, (ii) peluang investasi obat bagi investor asing sebesar 100 % dana dalam Perpres Tentang Daftar Negatif Investasi, dan (iii) BPJPH tugasnya terlalu besar dengan posisi dan kewenangan terbatas pada UU JPH; mengakibatkan hasil yang kurang maksimal. Kemajuan ditemukan pada UU Paten yang mengatur kewajiban pemegang paten dan impor paralel. Peraturan pra produksi yakni Permenkes Tentang Peta Jalan Pengembangan Bahan Baku Obat perlu dinaikkan levelnya pada Undang-undang. Peraturan produksi sudah relatif menjamin hak-hak dasar konsumen. Peraturan distribusi masih memiliki celah pada pengendalian suap bagi non ASN. Fase konsumsi sudah mengatur secara lengkap model pelayanan kefarmasian di berbagai tempat.

The preservation of health has been achieved in many ways but through the consumption of medicines. As taking drugs must follow certain procedures to obtain maximum benefits for health otherwise might cause very fatal results for the body, the consumers of medicines have been required for a protection. There are a number of regulations enacted by the government of Indonesia to manage and control the long and complex processes of pre-production until consumption of drugs in order to ensure their safety for consumers. The study aimed to examine and analyze the general frameworks of the regulations on the drug consumer protections as well as the pre-productions, productions, distributions and consumptions of drugs in Indonesia. The research had been pursued with the normative law approach relying on the library research method. The data and resources were a number of related regulations on the drug consumer productions both the primary, secondary and tertiary ones. All of them had been analyzed and interpreted through descriptive-qualitative approach. As the result, the study showed that the existing regulations in Indonesia have been intended to protect the consumers of drugs appropriately. However, there are several loopholes and weaknesses within those regulations to get improved. The general frameworks of the regulations to protect consumers have attempted to ensure the fulfillment of rights belonged to drug consumers. Yet, several detrimented issues like on (i) the equal-but-unfair treatments for both local/national and foreign investors in the drug industries under the Capital Investment Act, (ii) the very wide investment opportunities for foreign companies to invest at this area up to 100% - as stated in the List of Negative Investment ordinance, and (iii) the overload jobs of Halal Product Guarantee Organizer with the limited authority as listed on Halal Product Guarantee Act, have hindered further protections for consumers. Aside of the limitations, there were a progress in the Patent Law that govern the compulsory paten and parallel imports, the promotion of the ministry rules on the Roadmap of the development of raw materials of medicines to become an Act, and the existing of a number of regulation on the drug production to protect basic consumer rights. At the consumption level, there are a-stage-by-stage pharmaceutical rules governing the provision of drugs for consumers alongside a further requirement to anticipate and control bribes and other gratification in the area of the drug distributions.

Kata Kunci : Hukum Perlindungan Konsumen, Perlindungan Kosumen Obat/Consumer Protection Law, Drug Consumer Protection,