Pengumuman Rumah sakit penjual Vaksin palsu yang dilakukan oleh menteri
kesehatan yang disiarkan sejumlah media massa pada tanggal 14 Juli 2016 kurang
tepat dan dapat menimbulkan keresahan di tengah masyarakat khususnya para orang
tua yang melakukan vaksinasi pada rumah sakit dan praktek bidan yang diumumkan
dimaksud.
TANGGUNG JAWAB PEREDARAN SEDIAN FARMASI (OBAT)
Menurut PP No. 72 tahun 1998 tentang Pengamanan Sediaan Farmasi dan Alat
Kesehatan :
Pasal 16 ayat (1) a berbunyi “ Penyaluran sediaan farmasi dan alat kesehatan hanya
dapat dilakukan oleh badan usaha yang telah memiliki izin sebagai penyalur dari
menteri sesuai dengan ketentuan peraturan perundang-undangan yang berlaku untuk
menyalurkan sediaan farmasi yang berupa bahan obat, obat dan alat kesehatan “
Pasal 36 berbunyi “ Untuk melindungi masyarakat dari bahaya yang disebabkan oleh
penggunaan sediaan farmasi dan alat kesehatan yang tidak memenuhi persyaratan
mutu, keamanan dan kemanfaatan, DILAKUKAN PENGUJIAN KEMBALI sediaan farmasi
dan alat kesehatan yang diedarkan”
Pasal 37 berbunyi “ Pengujian kembali sediaan farmasi dan alat kesehatan yang
diedarkan dilaksanakan oleh menteri”
Pasal 64 berbunyi “Pengawasan terhadap segala kegiatan yang berhubungan dengan
pengamanan sediaan farmasi dan alat kesehatan dilakukan oleh Menteri “
Berdasarkan uraian ketentuan tersebut diatas, Menteri Kesehatan memiliki
kewenangan dan bertanggung jawab atas peredaran dan mutu obat yang beredar di
Indonesia. Apakah Menteri Kesehatan selama ini telah melakukan tugas dan tanggung
jawabnya, mengingat peredaran vaksin palsu sudah begitu lama sekitar 13 (tiga belas)
tahun.
Sepanjang rumah sakit telah membeli sediaan obat yang diperjual belikan di apotik
rumah sakit berasal dari perusahaan pengedar farmasi yang telah mendapat ijin dari
menteri kesehatan, maka rumah sakit belum layak diumumkan ke publik. Mengingat
yang berhak menyatakan vaksin itu palsu adalah pemilik merek vaksin yang
sebenarnya (produsen pemilik paten).
Dimana peran pengawasan dari pemilik paten vaksin yang dipalsukan? Mengapa
Menteri Kesehatan lebih gencar mengumumkan rumah sakit dan bidan penjual vaksin
palsu dari pada daftar merek vaksin yang dipalsukan? Hal ini dapat meresahkan
masyarakat kalangan bawah dan dapat membentuk opini seolah – olah rumah sakit
besar paling aman untuk melakukan Vaksinasi.
Adalah sepatutnya Menteri Kesehatan lebih gencar mengumumkan merek vaksin yang
dipalsukan supaya masyarakat lebih waspada, hal ini juga dapat mendorong pemilik
merek vaksin untuk lebih ketat menjaga produknya dari tindakan pemalsuan.
MENJERAT PELAKU PEMALSUAN DAN PENGEDAR VAKSIN PALSU
KETENTUAN PIDANA PASAL 74 Berbunyi :
Barang siapa dengan sengaja memproduksi dan/atau mengedarkan sediaan farmasi
berupa obat atau bahan Obat yang tidak memenuhi persyaratan sebagaimana
dimaksud Pasal 2 ayat (1) dan ayat (2) a, dipidana penjara paling lama 15 (lima belas)
tahun dan pidana denda paling banyak Rp 300.000.000,- (tiga ratus juta rupiah) sesuai
dengan ketentuan dalam pasal 80 ayat (4) UU No. 23 Tahun 1992 tentang Kesehatan.
Jakarta, 14 Juli 2016
Salam,
MANGATUR NAINGGOLAN LAW FIRM
Mangatur Nainggolan, S.E., S.H.
Advokat/ Praktisi Hukum Kesehatan/ 081398941976
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