SUMMARY. people s right on health care, especially to warrant availability safe, beneficial,

ADLN Perpustakaan Universitas Airlangga

SUMMARY

Pharmaceutical license is one of the legal instrument that is used to meet the people’s right on health care, especially to warrant availability safe, beneficial, quality, and affordable medicine as it stated in article 98 Law number 36 year 2009 regarding Health. Availability of medicines and traditional medicines as it mentioned in article 98 a quo is one of subsystem of the National Health System, a system that act as the guidance to improve public health level. In the state administration, health care is an obligatory matter to be implemented by the government,

provincial government

and district/city

government. It is given that the right to health is part of human rights guaranteed by article 28 H of Indonesian Constitution 1945. Government and local government effort in serving health care can be done through the fulfillment of health facilities, establishment of legislation and license issuance. Security and use of pharmaceuticals and medical devices is a part of the administration of health care as it stipulated in Article 48 of the Health Act. In fact in today's society many problems and challenge in the pharmaceuticals manufacture, distribution and service has occurred, for example the circulation of counterfeit drugs, the lack affordability of pharmaceuticals and many traditional medicines that contains chemicals or does not have a marketing authorization. Regulation in the field of pharmacy which not in accordance with the law making principles is one of the factors that led to such conditions. Based on the background as exposed above, this research focuses on the problem of the legal principle on the formation of legislation in the field of pharmacy

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licenses. This study aims to analyze and find the essence of pharmaceutical licensing, analyze conformity of the legal principle of pharmaceutical license arrangement with the general principles of the formation of legislation, as well as analyzing and finding the law enforcement method of pharmaceutical license Form the methodology perspective, this research is a normative legal research. It is used statute approach (base don regulation in pharmaceitucal field and law making), conceptual approach (concept on law making and general comparison with the pharmaceutical regulation in England). Conceptually, the law making as part of government action, is based on several legal principles namely 1) general principle of good law making; 2) Formal and material principles of law making as it stated in the Law number 12 year 2011 regarding Law making process; 3) General principle of Clean Government as it stated in the Law number 28 year 1999 on the implementation of clean government from collusion, corruption and nepotism; and 4) Good governance principles. According to those four principles, 4 principles that have some similarities has been selected, videlicet: a. Principle of institutional or appropriate law maker; b. Principle of harmony between types, hierarchies and substance; c. Principle of efficiency and effectiveness. d. Principle of legal certainty. As a result of the regulation analysis based on those four principles, there are several regulation on pharmaceutical license that does not fit with the legal principle in law making, namely:

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a.

Decree of the Head of The National Drug and Food Monitoring Agency number HK.00.05.3.02152 year 2002 on the guidance for good manufacturing medicine is not suitable with the institution principle or appropriate law maker due to this decree has violated annex 212 of Law number 12 year 2011 on the Law making process and principle of delegatus non potest delegare, that delegation authority to one particular state administration could not be delegated further to other state administration, unless if only the possibilities for doing so has been clearly stated by the law which delegates that authority. In the Health Act has been stipulated that the authority of health care is conducted by thr Government, in this context the President, which is delegates to the Health Minister through the Government Regulation Number 72 Year 1998 Nomor 72 Tahun 1998 on Pharmacy and Medical Devices Security. Nevertheless, the Health Minister based on the Health Minister regulation Number 1799/Menkes/SK/XII/2010 regarding Pharmaceutical industry delegated this power vis-à-vis technical matter and certification to the Head of the National Drug and Food Monitoring Agency.

b.

The Regulation of Heath Minister number 889/MENKES/ PER/V/ 2011 concerning Registration, practice license, pharmacist work license, does not fulfill two principles on the law making principles namely 1) institutional principle or appropriate law maker; and 2) Principle of harmony between types, hierarchies and substance. This contradiction shows on the regulation of delegation authority from Minister of Health to the Head of Provincial Government Health institution and the Head of Health institution

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of Municipal/cities government. This delegation must be based on the Law number 32 year 2004 regarding the local government and further regulated by the Government Regulation number 38 Tahun 2007 concerning Division of Government affairs between Government, Provincial Government and District Government. c.

Article 19 and Article 26 of the Minister of Health regulation number 889/MENKES/ PER/V/ 2011 concerning Registration, Practice license and certificate for pharmaceutical workers, is contravene with the principle of legal certainty in particular formal aspect that is principle of trust. Such disharmony shows by the conflict of norm regarding the certification authority which has been delegated to the National Pharmaceutical Committee and professional organization.

d.

The Health Minister regulation number 006 year 2012 regarding the Industry and Traditional Medicines businesses is the regulation that in its forming does not fulfill the principle of institutional or the appropriate law maker and Principle of harmony between types, hierarchies and substance.

According to explanation above, the conclusion that made by this research are: a.

The essence of pharmaceutical licensing is a guarantee to the fulfillment of people’s right to Health care as stated in Article 28 H of the Indonesian Constitution 1945. Pharmaceutical licensing in Indonesia includes License of Pharmaceutical industry, license of Traditional medicine industry, License of Pharmaceutical distribution, License of Pharmaceutical Wholesaler, License of Drug retailer, License of pharmacies and Pharmacist working permit. Looking

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through the pharmaceutical types of licensing above, than thos licensing has purposes for: 1) Control on the manufacture, distribution and pharmaceutical services; 2) Selecting quality of pharmacy personnel who have the ability and authority to perform pharmaceutical services. b.

Based on the legal principle of law making that had been explained, it can be concluded that the regulation on Pharmaceutical licensing is not fulfill the legal principle in particular the principle of institution or appropriate law maker; Principle of harmony between types, hierarchies and substance; Principle of efficiency and effectiveness and Principle of legal certainty.

c.

Law enforcement on pharmaceutical licensing as an effort to improve compliance of businesses of pharmaceutical industry can only be done through administrative enforcement, because many of existing regulation of pharmaceutical licensing is in the form of Minister Regulation and regulation of Head of the National Drug and Food Monitoring Agency. In the context of legal reform in pharmaceutical licensing system in Indonesia,

especially related to the government obligation to provide warranty of Health care and security on the pharmaceutical products that safe, quality, beneficial and affordable medicines as subsystem of National Health System, it is suggest that: a.

Regulation on pharmaceutical license must be in the form of Law concerning Pharmaceutical, which in its law making based on good law making principle and good governance principle.

b.

In relation to technical matters on pharmaceutical performing can become substance that is regulated by the Minister of Health regulation and regulation of Head of the National Drug and Food Monitoring Agency. However, it is to

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be noted that according to Law making act, those technical regulation can not contain any legal sanction. Therefore, in terms of criminal law enforcement on the substance of technical regulation must be stipulated in the Pharmaceutical act.

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ABSTRACT

This dissertation is the result of the research on the implementation of legal principles in pharmaceutical license in Indonesia. The objective of the research is to find basis for legal reform, especially pharmaceutical regulation that guarantee manufacturing, distribution, and medicine services to warrant availability of safe, beneficial, excellent and affordable medicines and warranty the quality of pharmacy professionals. In practically existing legal form in pharmaceutical license, namely Ministry regulation and the regulation of Head of the National Drug and Food Monitoring Agency (BPOM) which those existing regulation could not be implemented well. Based on the legal principles of legislative drafting including the principle of clean government and the principles of good governance, then there are some the regulations of pharmaceutical license disharmonize with the legal principles namely principle of institutional or appropriate law maker, principle of harmony between types, hierarchies and substance and principle of efficiency and effectiveness in order to solve the problem. It is argue that with. Hence, legal reform in pharmaceutical regulation is neede as legal basis to warrant availability of safe, beneficial, excellent and affordable medicines, as well as strengthen the law enforcement pharmaceutical license matter.

Keyword : law making - pharmaceutical license - law enforcement.

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Daftar Aturan Hukum

Undang-Undang Dasar Negara Republik Indonesia Tahun 1945 Pharmaceutische Stoffen Keuring Ordonantie (Undang-Undang Pemeriksaan Bahan Farmasi), Staatsblad 1936 No. 660 Gevarlijke Stoffen Ordonantie (Undang-Undang Bahan Berbahaya), Staatsblad 1949 Nomor 377 Undang-Undang Nomor 5 Tahun 1997 tentang Psikotropika (Lembaran Negara Republik Indonesia Nomor 10 Tahun 1997, Tambahan Lembaran Negara Republik Indonesia Nomor 3671) Undang-Undang Nomor 20 Tahun 1997 tentang Penerimaan Negara Bukan Pajak (PNBP) bagi penerbitan perizinan kefarmasian yang menjadi kewenangan Pemerintah Pusat Lembaran Negara Republik Indonesia Nomor 35 Tahun 1997, Tambahan Lembaran Negara Republik Indonesia Nomor 3686) Undang-Undang Nomor 29 Tahun 2004 tentang Praktik Kedokteran (Lembaran Negara Republik Indonesia Nomor 116 Tahun 2004, Tambahan Lembaran Negara Republik Indonesia Nomor 4436) Undang-Undang Nomor 32 Tahun 2004 tentang Pemerintahan Daerah (Lembaran Negara Republik Indonesia Tahun 2004 Nomor 125, Tambahan Lembaran Negara Republik Indonesia Nomor 4437) sebagaimana telah diubah kedua kalinya dengan Undang-Undang Nomor 12 Tahun 2008 (Lembaran Negara Republik Indonesia Tahun 2008 Nomor 59, Tambahan Lembaran Negara Republik Indonesia Nomor 4844); Undang-Undang Nomor 25 Tahun 2009 tentang Pelayanan Publik (Lembaran Negara Republik Indonesia Nomor 127 Tahun 2009, Tambahan Lembaran Negara Republik Indonesia Nomor 5046) Undang-Undang Nomor 28 Tahun 2009 tentang Pajak Daerah dan Retribusi Daerah (Lembaran Negara Republik Indonesia Nomor 130 Tahun 2009, Tambahan Lembaran Negara Republik Indonesia Nomor 5049) Undang-Undang Nomor 35 Tahun 2009 tentang Narkotika (Lembaran Negara Republik Indonesia Nomor 143 Tahun 2009, Tambahan Lembaran Negara Republik Indonesia Nomor 5062) Undang-Undang Nomor 36 Tahun 2009 tentang Kesehatan (Lembaran Negara Republik Indonesia Nomor 144 Tahun 2009, Tambahan Lembaran Negara Republik Indonesia Nomor 5063)

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Undang-Undang Nomor 44 Tahun 2009 tentang Rumah Sakit (Lembaran Negara Republik Indonesia Nomor 153 Tahun 2009, Tambahan Lembaran Negara Republik Indonesia Nomor 5072) Undang-Undang Nomor 12 Tahun 2011 tentang Pembentukan Peraturan PerundangUndangan. (Lembaran Negara Republik Indonesia Nomor 82 Tahun 2011, Tambahan Lembaran Negara Republik Indonesia Nomor 5234) Peraturan Pemerintah Nomor 72 Tahun 1998 Tentang Pengamanan Sediaan Farmasi (Lembaran Negara Republik Indonesia Nomor 138 Tahun 1998, Tambahan Lembaran Negara Republik Indonesia Nomor 3726) Peraturan Pemerintah Nomor 38 tahun 2007 tentang Pembagian Urusan Antara Pemerintah, Pemerintah Provinsi dan Pemerintah kabupaten/Kota (Lembaran Negara Republik Indonesia Nomor 82 Tahun 2007, Tambahan Lembaran Negara Republik Indonesia Nomor 4737) Peraturan Pemerintah Nomor 51 Tahun 2009 tentang Pekerjaan Kefarmasian (Lembaran Negara Republik Indonesia Nomor 124 Tahun 2009, Tambahan Lembaran Negara Republik Indonesia Nomor 5044) Peraturan Pemerintah Nomor 13 Tahun 2009 tentang Jenis dan Tarif Atas Jenis Penerimaan Negara Bukan Pajak Yang Berlaku Pada Departemen Kesehatan (Lembaran Negara Republik Indonesia Nomor 153 Tahun 2009, Tambahan Lembaran Negara Republik Indonesia Nomor 4975)

Peraturan Menteri Kesehatan Republik Indonesia Nomor 167/Kab/B.VII/72 tentang Pedagang Eceran Obat sebagaimana diubah dengan Keputusan menteri Kesehatan Nomor 1331/MENKES/SK/X/2002 yang mengatur tentang tata cara mendirikan usaha di bidang perdagang obat yang biasa disebut dengan Pedagang Eceran Obat (Toko Obat). Peraturan Menteri Kesehatan Republik Indonesia Nomor 282/MENKES/PER/III/2007 tentang Apotek Rakyat yang mengatur tentang tata cara pendirian Apotek Rakyat di Indonesia. Peraturan Menteri Kesehatan Republik Indonesia Nomor 1010/Menkes/Per/XI/2008 tentang Registrasi Obat. Peraturan Kepala Badan Pengawas Obat dan Makanan Nomor HK.00.06. 32.3.295 tahun 2009 tentang Pedoman Pengawasan Promosi dan Iklan Obat. Peraturan Menteri Kesehatan Republik Indonesia Nomor 1799/Menkes/SK/XIl/2010 tentang Industri Farmasi. Peraturan Menteri Kesehatan RI Nomor 1148/MENKES/PER/VI/2011 tentang Pedagang Besar Farmasi.

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Peraturan Menteri Kesehatan Republik Indonesia Nomor 007 Tahun 2012 tentang Registrasi Obat Tradisional. Keputusan Kepala Badan Pengawas Obat dan Makanan Nomor : HK.00.05.3.02152 Tahun 2002 tentang Pedoman Penerapan Cara Pembuatan Obat Yang Baik; Keputusan Kepala Badan Pengawas Obat dan Makanan Nomor 03.1.23.06.11.5629 Tahun 2011 tentang Persyaratan Teknis Cara Pembuatan Obat Tradisional Yang Baik. Peraturan Kepala Badan Pengawas Obat dan Makanan Nomor HK.03.1.3.12.11.10692 Tahun 2011 tentang Pengawasan Pemasukan Obat Impor. Keputusan Kepala Badan Pengawas Obat dan Makanan Nomor 03.1.23.06.11.5629 Tahun 2011 tentang Persyaratan Teknis Cara Pembuatan Obat Tradisional Yang Baik, mengatur bahwa Cara Pembuatan Obat/Obat Tradisional Yang Baik. Keputusan Kepala Badan Pengawas Obat dan Makanan Nomor 03.1.23.06.11.5629 Tahun 2011 tentang Persyaratan Teknis Cara Pembuatan Obat Tradisional Yang Baik aman, berkhasiat, berkualitas dan terjangkau. Peraturan Kepala Badan Pengawas Obat dan Makanan Republik Indonesia Nomor HK. 03.1.3.12.11.10693 Tahun 2011 tentang Pengawasan Pemasukan Bahan Obat

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DAFTAR ISI

HALAMAN JUDUL............................................................................................. i LEMBAR PENGESAHAN .................................................................................. iii PENETAPAN PANITIA PENGUJI NASKAH DISERTAS I ............................. iv UCAPAN TERIMA KASIH ................................................................................. v RINGKASAN ....................................................................................................... viii SUMMARY .......................................................................................................... xiv ABSTRACT .......................................................................................................... xx PERUNDANG-UNDANGAN.............................................................................. xxi DAFTAR ISI ......................................................................................................... xxiv

BAB I PENDAHULUAN 1.1 Latar Belakang Masalah ........................................................................ 1 1.2 Rumusan Masalah.................................................................................. 28 1.3 Tujuan Penelitian ................................................................................... 30 1.4 Manfaat Penelitian ................................................................................. 30 1.5 Originalitas Gagasan Dalam Penelitian ................................................. 31 1.6 Kerangka Konseptual............................................................................. 40 1.7 Metode Penelitian .................................................................................. 57 1.8. Pertanggungjawaban sistematika .......................................................... 62

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BAB II PERIZINAN KEFARMASIAN DALAM SISTEM KESEHATAN NASIONAL 2.1 Aspek Kefarmasian Dalam Sistem Kesehatan Nasional ....................... 64 2.1.1 Sistem Kesehatan Nasional Dalam Pembangunan Kesehatan .... 64 2.1.2 Hubungan Kefarmasian Dalam Sistem Kesehatan Nasional ....... 77 2.2 Perizinan Kefarmasian di Indonesia ...................................................... 83 2.2.1 Ruang Lingkup dan Jenis Perizinan Dalam Kefarmasian ........... 83 2.2.2 Instrumen Keuangan Dalam Penerbitan Perizinan Kefarmasian.. 134

BAB III PENERAPAN PRINSIP HUKUM DALAM PENGATURAN PERIZINAN KEFARMASIAN 3.1 Prinsip Hukum Dalam Pembentukan Perizinan Kefarmasian ............... 148 3.2 Prinsip Kefarmasian Dalam Pengaturan Perizinan Kefarmasian...... ..... 170 3.2.1. Prinsip Kefarmasian Dalam Pembuatan Sediaan Farmasi....... ... 170 3.2.2. Prinsip Kefarmasiaan Dalam Penyaluran Sediaan Farmasi ..... ... 172 3.2.3. Prinsip Kefarmasian Dalam Pelayanan Sediaan Farmasi........ .. . 176 3.3. Penerapan Prinsip Hukum Dalam Pengaturan Perizinan Kefarmasian .......................................................................................... 182 3.2.1 Peraturan Perundang-undangan Tentang Perizinan Kefarmasian ................................................................................ 182 3.2.2 Analisis Peraturan Perundang-undangan Tentang Peraturan Perizinan Kefarmasian ............................................... 193

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BAB IV PENEGAKAN HUKUM ADMINISTRASI DALAM PERIZINAN KEFARMASIAN 4.1 Pengawasan Terhadap Perizinan Kefarmasian ...................................... 213 4.1.1 Organ Pengawasan Terhadap Perizinan Kefarmasian ................. 213 4.1.2 Prosedur Pengawasan Perizinan Kefarmasian ............................. 223 4.2 Penerapan Sanksi Administrasi Dalam Pelanggaran Perizinan Kefarmasian ........................................................................................... 237 4.2.1 Bentuk-bentuk Sanksi Dalam Perizinan Kefarmasian................. 237 4.2.2 Prosedur Penerapan Sanksi Administrasi Dalam Pelanggaran Perizinan Kefarmasian ........................................... 260 4.3. Tanggung Gugat Pemerintah Dalam Perizinan Kefarmasian .......... .... 276

BAB V PENUTUP 5.1 Kesimpulan ........................................................................................... 282 5.2 Saran ...................................................................................................... 284

DAFTAR BACAAN

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DAFTAR TABEL

Tabel 1

:

Obat

Tradisional

dan

Suplemen

Makanan

Pelangsing

7

Obat Tradisional dan Suplemen Makanan Penambah Stamin Pria

8

Mengandung Bahan Kimia Obat Tabel 2

:


:

Obat Tradisional lainnya Yang Mengandung Bahan Kimia Obat

9


:

Penggunaan Obat Esensi Generik

13

Tabel 5

:

Principles of Good Governance

51

Tabel 6

:

Pengaturan Hak Asasi Manusia tentang Kesehatan

65

Tabel 7

:

Jenis Usaha Produksi Obat

100

Tabel 8

:

Jenis Usaha Produksi Obat Tradisional

102

Tabel 9

:

Perbedaan Apotek dan Apotek Rakyat

120

Tabel 10

:

Perbandingan Perizinan di Inggris dan di Indonesia

128

Tabel 11

:

Sifat Perizinan Kefarmasian

130

Tabel 12

:

Tarif PNBP Perizinan Kefarmasian

140

Tabel 13

:

Jenis Pajak Daerah dan Retribusi Daerah

143

Tabel 14

:

Perbandingan Peraturan Kebijakan dan Peraturan Perundangundangan

195

Tabel 15

:

Pengaturan yang tidak sesuai dengan asas pembentukan peraturan perundang-undangan

212

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DAFTAR SKEMA

Skema 1

: Hierarkhi Peraturan Perundang-undangan

203

Skema 2

: Profil Hasil Sampling dan Pengujian Laboratorium Produk

226

Terapatik/Obat Skema 3

: Hasil Pengujian Sampel Obat Tradisional Impor

228

Skema 4

: Hasil Pemeriksaan Sarana Produksi Obat Tradisional

229

Skema 5

: Hasil Pemeriksaan Sarana Distribusi Obat Tradisional

232

Skema 6

: Hasil Pemeriksaan Sarana Distribusi Obat

233

Skema 7

: Prosentase Profil Sarana Pelayanan Obat

236

Skema 8

: Profil Pemeriksaan Iklan Obat

237

Skema 9

: Profil Rincian Tindak Lanjut Hasil Pemeriksaan Industri

248

Farmasi Skema 10

: Profil Hasil Pemeriksaan PBF (Produk Terapetik)

252

Skema 11

: Profil Pemeriksaan dan Tindak Lanjut Pada Sarana Pelayanan

255

Kefarmasian

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SUMMARY. people s right on health care, especially to warrant availability safe, beneficial,

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