KULIAH Ib

PRINSIP REGULASI DAN ETIKA

FARMASI

Lucky S. Slamet
Program Pasca Sarjana Program Studi Ilmu
Kefarmasian
Universitas Pancasila
Tahun Akademis 2019
BAGIAN PERTAMA

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 KOMPONEN

• Pentingnya Legislasi dan Regulasi bidang

Obat
• Tujuan Legislasi dan Regulasi bidang Obat
• Sejarah Pengembangan, termasuk
pengembangan ruang lingkup
• Contoh evolusi Legislasi dan Regulasi Obat

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 MENGAPA DIPERLUKAN
LEGISLASI DAN REGULASI
BIDANG OBAT

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MENGAPA DIPERLUKAN LEGISLASI DAN
REGULASI BIDANG OBAT? (1)

• Produk Obat dipergunakan oleh masyarakat luas,

bahkan dapat dianggap sebagai Public Goods
• Kegiatan bidang Obat melibatkan banyak pihak (pasien,
dokter, apoteker, petugas kesehatan lain, industri,
distributor, akademisi, unit riset dll)
• Produk Obat dan kegiatannya dapat menimbulkan risiko
kesehatan yang bermakna, bahkan seringkali dapat
timbul konsekuensi yang serius akibat salah penggunaan
dan atau penyalahgunaan
• Pengawasan secara informal tidak cukup, mengingat
kompleksnya tantangan bidang obat.
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 MENGAPA DIPERLUKAN LEGISLASI DAN
REGULASI BIDANG OBAT? (2)

• Dasar pengaturan dan pengawasan obat secara

komprehensif dan terstruktur  produk obat merupakan
the most highly regulated Product
• Kegiatan bidang Obat meliputi berbagai tahapan yaitu
1. Lisensi industri, impor, ekspor,distribusi, promosi
2. Penilaian Khasiat, keamanan, dan mutu produk dan
pemberian persetujuan pendaftaran
3. Inspeksi dan surveillance industri, importir, distributor
dan apotek
4. Kontrol dan monitoring mutu dan keamanan obat di pasar
5. Kontrol dan monitoring promosi dan iklan obat
6. Pemberian informasi independen tentang obat
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 Legislasi dan Regulasi Obat :
Tujuan
• Menjamin keamanan, khasiat dan mutu obat serta
akses bagi masyarakat luas
• Menjamin ketepatan informasi obat tersedia untuk
publik

•Arah dan Orientasi Legislasi dan Regulasi pada Kebijakan Publik a.l
pengaturan posisi fungsi Pemerintah  pengawasan seluruh
kegiatan bidang obat secara komprehensif (full spectrum ) untuk
kepentingan publik
• WHO  Pemerintah harus memiliki Otoritas Nasional
Regulatori bidang Obat (NMRA : National Medicine Regulatory
Authority
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 Legislasi dan Regulasi Obat:
Sejarah Pengembangan
• Status struktur penunjang yg ada : UU tentang Obat,
suatu Badan/Agency, Komite Evaluasi Obat,
Laboratorium QA, Pusat Informasi Obat dll.
• Lingkup : the scope of legislative and regulatory
powers has been gradually expanded, atau legislasi
yang lebih ketat untuk perkuatan perlindungan publik
Mengantisipasi :
– Kompleksitas sektor farmasi yang semakin
sophisticated
– Tuntutan masyarakat, di beberapa negara karena
krisis yang timbul, misal kasus thalidomide

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 Legislasi dan Regulasi Obat:
Pengembangan Ruang Lingkup
Pola pikir konvensional atas ruang lingkup 
Pembatasan lingkup kontrol hanya terhadap beberapa
kelompok produk atau kegiatan bidang obat (misal hanya
kegiatan pendaftaran) akan menimbulkan :
REGULATORY GAP

Pengembangan Ruang Lingkup (rekomendasi WHO 2002) :

Untuk perlindungan publik, regulasi obat harus komprehensif
mencakup seluruh produk dengan klaim medis dan seluruh
kegiatan farmasi

EVOLUSI LEGISLASI DAN REGULASI OBAT

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 EXAMPLE
THE EVOLUTION OF INTERNATIONAL
LEGISLATION AND REGULATION ON DRUG
• In England (1540) the manufacturer of a compound
preparation “Mithridatium” was subjected to supervision
under Aphothecaries Wares, Drugs and Stuffs Act.
• The first Pharmacopoeias was the first Spanish
Pharmacopoeias issued in 1581
• The standars for the manufacture of “Mithiridatum” were
established in England in the London Pharmacopoeia in 1618
• The modern medicines regulation started after
breakthrough process in the 19th century life sciences, esp
chemistry, physiology and pharmacology
• Some events have catalysed the development of medicine
regulation more than the evolution of knowledge base, i.e
events due to Sulfanilamide elixir, Thalidomide etc
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 EXAMPLE
THE EVOLUTION OF U.S. DRUG LAW

• Food and Drug law dates back to the beginning of

Commerce, arising with laws to protect consumers of food
from false weights and measures.
• US Food & Drug Law derives primarily from British Food
Laws adopted by the colonies & the states after the
revolutionary war
• Until the mid-19th century, almost all Food & Drug
Regulation occurred at the local level, reflecting the
prevailing pattern & commerce
• With regional & national expansion of food distribution,
the state became more involved; the few federal laws
focused primarily on imports, taxes & duties rather than
consumer protection
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 EXAMPLE
THE EVOLUTION OF U.S. DRUG LAW
• The vaccine Act of 1902 marked the federal government’s
century into domestic drug regulation, and included pre-
market approval.
• The Food & Drug Act of 1906
 The first comprehensive federal law regulating foods & drugs,
was strictly an enforcement statute, designed to punish
violations.
 required only that drugs meet standards of strength and
purity. The burden of proof was on FDA on the drug labeling
prior to marketing
• Federal Food, drug and cosmetic Act (1938) : revised the
1906 drug law – after the tragedy of 107 people died
caused by the elixir of sulfanilamide, required a
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 EXAMPLE
THE EVOLUTION OF U.S. DRUG LAW

• In addition to strengthening enforcement & federal

jurisdiction, the 1938 act included government pre-market
clearance of drugs for safety

• FDCA has been amended numerous times, strengthening

the regulation of drugs, food & color additives, and medical
devices, & more recently promoting the availability of
generic drugs, new therapeutic agents, nutrition information
for foods & dietary supplements

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 EXAMPLE
THE EVOLUTION OF U.S. DRUG LAW
• The FDC passed by Congress, containing new provisions:
 Extending control to cosmetics & therapeutic devices.
Requiring new drugs to be shown safe before marketing starting
a new system of drug regulation
Eliminating the Sherley Amendment requirement to prove intent
to defraud in drug misbranding cases
 Providing that sale tolerances be set for unavoidable poisonous
substances
Authorizing stds of identity,quality, &fill-of-container for foods
Authorizing factory inspections
Adding the remedy of court injunctions to the previous penalties
of seizures & prosecutions.
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 EXAMPLE
THE EVOLUTION OF U.S. DRUG LAW

• Durham-Humphrey Amendment (1951) : defined R/ drugs as

those unsafe for SM and should only under a doctor’s
supervision
• Kefauver-Harris Drug Amendments (1962) : tighten control
over drug prior to marketing due to ‘the Thalidomide reports’, a
manufacturer is responsible not only on safety, but also
effectiveness for the intended use. After marketing, ADR must
be reported to FDA, and complete information on risk and
benefit must be available
• Orphan Drug Act (1983) : encourage development of products
which are for treating diseases. The law allows manufacturer to
take tax deduction for ¾ of the cost of CT

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 EXAMPLE
THE EVOLUTION OF U.S. DRUG LAW

• Drug Price Competition and Patient Term Restoration Act

(1984) : expands the # of drugs for ANDA – make it less
costly and time consuming for generics to reach the market
• Generic Drug Enforcement Act (1992) : imposes debarment
and other remedies for criminal convictions based on
activities relating to the approval of ANDAs
• Prescription Drug User Fee Act ( 1992) : regulates user fees
for certain NDA and supplements, an annual establishment
fee, and annual product fees.

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 EXAMPLE
THE EVOLUTION OF U.S. DRUG LAW

• FDA Modernization Act (1997) : contains

some of the most significant changes to the Food, Drug
and Cosmetic Act in 35 years, such as
– reauthorization of PDUFA through FY 2002
– changes of assessment and collection of user fee,
i.e.waiver of fee for orphan products, pediatrics suppl.
– codifies FDA’s accelerated approval and fast track.
– issuance of guidance for NDA reviewer

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BAGIAN KE DUA

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 LEGISLASI DAN REGULASI OBAT
YANG EFFEKTIF

• Prinsip dasar Legislasi dan Regulasi

bidang Obat
• Komponen kritis Legislasi dan Regulasi
bidang Obat yang Efektif

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4 PRINSIP DASAR LEGISLASI DAN
REGULASI OBAT

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LEGAL BASIS UNTUK SEMUA FUNGSI

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SUMBER DAYA (MANUSIA, TEKNOLOGI
DAN BIAYA) YG MEMADAI

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TRANSPARANSI DAN AKUNTABILITAS
PUBLIK

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MEMILIKI "INDEPENDENCE"

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 10 KOMPONEN KRITIS LEGISLASI
DAN REGULASI OBAT YANG EFEKTIF

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KEJELASAN TUJUAN DAN SASARAN
LEGISLASI DAN REGULASI

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MEKANISME JAMINAN TRANSPARANSI
DAN AKUNTABILITAS REGULASI

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 KUALIFIKASI DAN STANDAR YG
DIPERSYARATKAN BAGI PELAKSANA
BIDANG OBAT

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 DEFINISI KATEGORI OBAT DAN
KEGIATAN PENGAWASAN YANG DIATUR

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 PENETAPAN PERSYARATAN DAN KONDISI UTK
TINDAK LANJ. PELANGGARAN SPT PEMBEKUAN,
DAN PEMBATALAN IJIN EDAR DAN IJIN SARANA
PRODUKSI DAN DISTRIBUSI

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 PENETAPAN DAN PENDEFINISIAN
PELANGGARAN, PEMBATASAN, SANKSI
HUKUM DAN HUKUMANNYA

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DEFINISI JELAS PERAN, TANGGUNG JAWAB,
HAK DAN FUNGSI PIHAK YANG TERLIBAT
DALAM PRODUKSI, DISTRIBUSI,
PERDAGANGAN DAN PENGGUNAAN OBAT

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PENETAPAN NORMA, STANDAR, DAN
SPESIFIKASI PENGKAJIAN KHASIAT,
KEAMANAN DAN MUTU OBAT

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 JAMINAN MEKANISME PEMANTAUAN DAN
KAJIAN IMPLEMENTASI OLEH PEMERINTAH
DAN MITRA KERJANYA YG INDEPENDEN

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KEPASTIAN HUKUM ATAS FUNGSI DAN
KEWENANGAN NATIONAL REGULATORY
AUTHORITY

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PENUTUP
Legislasi dan Regulasi Obat :
Arah dan Orientasi
• Masalah yg dihadapi (bukan orientasi manajemen)
• Kebutuhan masyarakat (akibat adanya perubahan dan
tantangan)

Legislasi dan Regulasi Obat harus dg Orientasi

Kebijakan Publik
Sumber : Effective Drug Regulation, a Multi Country Study (WHO 2002)

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TERIMA KASIH

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