ANALISIS IMPLEMENTASI THE AGREEMENT ON TRADE-RELATED ASPECTS OF INTELLECTUAL PROPERTY RIGHTS PASAL 31 DAN PASAL 31BIS TERKAIT PRAKTIK KEBIJAKAN COMPULSORY LICENSE PADA PRODUK OBAT PATEN DI NEGARA BERKEMBANG

TANRI IHSAN ERBAKAN NIM. A1011161088

Abstract


Abstract

 

Patent rights, which should be a step to appreciate inventors' inventions, have instead opened up a gap for companies to exercise monopoly rights on their products, which have an impact, especially on drug accessibility for developing countries. In order to realize the view that Intellectual Property Rights (IPR) do not only provide benefits for inventors, the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) with articles 31 and 31 bis provides provisions for countries to carry out Compulsory Licensing policies with the intention to overcome accessibility problems in the country. This research used normative legal research method with case approach. The results of this research were; 1) In the TRIPS arrangement, a country that has announced that it is in a State of Emergency condition becomes the main requirement in implementing a compulsory licensing policy, with the addition of article 31 bis which expands the compulsory licensing policy by permitting the export-import of patent products resulting in a compulsory license to the Least-developed countries. 2) There are no State of Emergency guidelines that have been approved by international countries or within TRIPS itself, although efforts to draft these principles have been initiated by several international organizations. 3) Thailand and India have succeeded in reducing the prices of patent medicines through compulsory licensing policies, although this success still leaves problems, especially those from Research and Development companies protesting that the compulsory licensing policy can eliminate the protection of patent rights for their products.

 

Abstrak

Hak Paten yang seharusnya menjadi Langkah untuk mengapresiasi penemuan inventor malah membuka celah bagi perusahaan untuk melakukan hak monopoli terhadap produknya yang berdampak khususnya mengenai aksesibilitas obat bagi negara berkembang. Untuk mewujudkan pandangan Hak Kekayaan Intelektual (HKI) tidak hanya memberikan kemanfaatan bagi inventor semata, The Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) dengan pasal 31 dan pasal 31 bis atas hasil memberikan ketentuan bagi negara – negara untuk melakukan kebijakan Lisensi Wajib (Compulsory License) demi mengatasi permasalahan aksesibilitas dalam negaranya. Jenis penelitian dalam penulisan skripsi ini adalah penelitian hukum normatif dengan menggunakan jenis pendekatan kasus (Case Approach). Adapun hasil dalam penelitian ini adalah; 1) Dalam pengaturan TRIPS, negara yang telah mengumumkan sedang berada dalam kondisi State of Emergency menjadi syarat utama dalam melaksanakan kebijakan lisensi wajib, dengan penambahan pasal 31 bis yang memperluas kebijakan lisensi wajib dengan diiizinkannya ekspor-impor produk paten yang dihasilkan lisensi wajib kepada negara Least-Developed Country. 2) Belum adanya pedoman yang State of Emergency yang disetujui oleh negara – negara Internasional maupun didalam TRIPS sendiri meski usaha untuk merancang prinsip – prinsip tersebut telah diiniasikan beberapa organisasi internasional. 3) Negara Thailand dan Negara India telah berhasil menurunkan harga – harga obat – obatan paten melalui kebijakan lisensi wajib, meski keberhasilan tersebut masih menyisakan permasalahan khususnya yang datang dari perusahaan Research and Develompent memprotes bahwa kebijakan lisensi wajib dapat menghilangkan perlindungan hak paten yang seharusnya mereka dapatkan pada produknya.

 

KATA KUNCI: Hak Kekayaan Intelektual, The Agreement on Trade-Related Aspects of Intellectual Property Rights, Paten, Lisensi Wajib.


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References


DAFTAR PUSTAKA

Buku

Ali, Zainuddin, 2014, Metode Penelitian Hukum, Sinar Grafika: Jakarta.

Anwar, Chairul, 1992, Hukum Paten dan Perundang – undangan Paten Indonesia,

Djambatan: Jakarta,

Campbell Black, Henry, 1968, Black’s Law Dictionary 4th edition, West Publishing.

Damos Dumoli Agusman. 2010, Hukum Perjanjian Internasional (kajian teori dan

praktik indonesia). Penerbit PT Refika Aditama, Bandung.

Danzon and Towse, Differential Pricing for Pharmaceuticals: Reconciling Access,

R&D and Patents, AEI-Brookings Joint Center for Regulatory Studies.

Djaman, Fidel, 1994, Beberapa Aspek dan Kebijakan Penting di Bidang Hak Milik

Intelektual, Varia Peradilan: Jakarta

Hidayah, Khoirul, 2017, Hukum HKI, Setara Press: Malang.

Hartono, Sunaryadi, 1982, Hukum Ekonomi Pembangunan Indonesia, Bina Copta:

Bandung.

John F. William, A Manager Guide to Patents, Trade Marks and Copyright, Kogan

Page: London.

Kansil, Nico, 1993, Perlindungan Hukum Hak Milik Intelektual, Makalah Seminar

Nasional Kejatan Hak Milik Intelektual, UNDIP.

Kesowo, Bambang, 2004, Pengantar Umum Mengenai Hak Atas Kekayaan Intelektual,

Penerbit ITB: Bandung.

Kusumaatmadja, Mochtar & Goes, R. Etty, 2013, Pengantar Hukum Internasional, PT.

Alumni; Bandung.

Mashdurohatun, Anis, 2013, Hak Kekayaan Intelektual (HKI) Dalam Perspektif

Sejarah di Indonesia, Madina; Semarang.

_________________, 2013, Hak Kekayaan Intelektual (HKI), Madina: Semarang.

M. Hadjon, Philipus dan Sri Djamiati, Tatiek, 2005, Argumentasi Hukum, Gadjah

Mada University Press: Yogyakarta.

Mahadi, 1981, Hak Milik Dalam Sistem Hukum Perdata Nasional, BPHN: Jakarta.

Parthiana, I Wayan, 2002, Hukum Perjanjian Internasional Bag. 1, Penerbit Mandar

Maju, Bandung.

Patterson, Daniel (ed), 2010, A Companion to Philosophy of Law and Legal Theory,

Wilery -Blackwell.

PH. Collins, 1999, Law Dictionary 1st edition, Routledge.

Rachmadi Usman, 2003, Hukum Hak Atas Kekayaan intelektual: Perlindungan dan

Dimensi Hukumnya di Indonesia, P.T. Alumni: Bandung.

Roisah, Kholis, 2005, Konsep Hukum Hak Kekayaan Intelektual, Setara Press: Malang.

Saidin, Ok, 2010, Aspek Hukum Hak Kekayaan Intelektual (Intellectual Property

Rights), PT. Raja Grafindo Persada; Jakarta.

Saleh, Ismail, 1990, Hukum dan Ekonomi, PT. Gramedia: Jakarta.

Sefriani, 2011, Hukum Internasional: Suatu Pengantar, PT. Rajagrafindo Persada;

Jakarta

Setyrowati, Krisnani, dkk, 2005, Hak Kekayaan Intelektuan dan Tantangan

Implementasinya di Peguruan Tinggi, Kantor HKI-IPB: Bogor.

Shaw, N. Malcolm, 2008, Hukum Internasional, Cambridge University Press.

Soekanto, Soerjono 1986, Pengantar Penelitian Hukum, UI Press ;Jakarta

________________, & Sri Mamudji, 2001, Penelitian Hukum Normatif (Suatu Tinjauan Singkat), Rajawali Pers: Jakarta.

Sugiyono, 2021, Metode Penelitian Kuantitatif, Kualitatif, dan R&D. Alfabeta:

Bandung

Suyud Margono & Amir Angkasa, 2002, Komersialisasi Aset Intelektual: Aspek

Hukum Bisnis, PT. Gramedia Widiasarana Indonesia, Jakarta.

Sudargo Gautama, 1990, Segi-segi Hukum Hak MIlik Intelektual, PT. Erasco:

Bandung.

Syamsuni, 2007, Ilmu resep, EGC, Jakarta

Thontowi, Jawahir & Iskandar, Pranoto, 2006, Hukum Internasional Kontemporer, PT.

Refika Aditama, Bandung.

Widjaja,Gunawan, 2004, Lisensi atau Waralaba: Suatu panduan praktis, Raja

Grafindo Persada: Jakarta.

World Trade Organization, Modules I the Introduction to The TRIPS Agreement

Peraturan Perundang – Undangan

Agreement on Trade-Related Aspects of Intellectual Property Rights

Declaration on The TRIPS Agreement and Public Health

General Agreement on Tariffs and Trade

Statuta Mahkamah Internasional

Konvensi Wina 1969 Tentang Perjanjian Internasional

Undang – Undang Nomor 13 Tahun 2016 tentang Paten

Undang – Undang Nomor 36 ahun 2009 Tentang Kesehatan

Peraturan Menteri Kesehatan RI Nomor 917/MENKES/PER/X/1993

Peraturan Menteri Kesehatan No. HK.02.02/MENKES/068/I/2010

Penjelasan Umum Undang – Undang Nomor 14 Tahun 2001 tentang Paten

Thailand Patent Act. Section 5

India’s Patent Act section 84

Jurnal

A. Subramanian, Trade-Related Intellectual Property Rights and Asian Developing

Countries: An Analytical View, Paper Presented at the Conference on Emerging Global Trading Environmental and Developing Asia, UNCTAD; Manila.

_____________, 1995, Putting Some Numbers on the TRIPS Pharmaceutical Debate, 10 (2-3) INT’L.J. TECH. MGMT., 252 – 268, UNCTAD.

Angie, Anthony, “Finding the peripheries: Sovereignty and Colonialism in Nineteenth-

Century International Law, Harvard International Law Journal Vol.40.

Anna Lanoszka, 2003, The Global Politics of Intellectual Property Rights and

Pharmaceutical Drug Policies in Developing Countries, International Political Science Review Vol 24.

Carlos Correa, 2002, Integrating Public Health Concerns Into Patent Legislation in

Developoung Countries, South Centre: Geneva.

___________, 2007, Trade Related Aspects of Intellectual Property Rights, A Commentary on the TRIPS Agreement, (New York: Oxford University Press.

___________, 2002, The Implication of the Doha Declaration on the TRIPS Agreement and Public Health, Health Economics and Drugs, EDM series No. 12.

Centre’s Security Sector Reform Working Group, 2005, State of Emergency, Geneva

Center for the Democratic Control of Armed Forces.

Department of Disease Control: ‘Compulsory License for Patented Medicines and

Medical Devices’. 2006, The Department of Disease Control Notification B.E. 2549

Department of Disease Control: 2007, ‘Compulsory License for Patented Medicines

and Medical Devices: Lopinavir/Ritonavir’. The Department of Disease Control Notification, B.E. 2550

Deli Yang, 2011, Compulsory Licenseing: For Better or For Worse, the Done Deal

Lies in the Balance, Department of Business Administration;Trinity University, San Antonio.

Ellen ’t Hoen, 2016, Private Patents and Public Health: Changing Intellectual

Property Rules for Access to Medicines 1st Edi, Health Action International.

___________, 2014, Access to cancer treatment: A study of medicine pricing issues with recommendations for improving access to cancer medication’ OXFAM, Medicines Law & Policy.

Grabowski, 2002, Patents, Innovation and Access to New Pharmaceuticals, Journal of

International Economic Law, Vol. 5, No. 4.

Hendra Djaja, 2014, Penegakan Prinsip Special and Differential Treatment dalam Perspektif Hukum Perdagangan Internasional, Jurnal Cakrawala Hukum, Vol.19

Henry and Lexchin, 2002, The Pharmaceutical Industry as a Medicines Provider,

Lancet, Volume 360.

Hill et al, “Minimum costs for producing Hepatitis C direct-acting antivirals for use

in large-scale treatment access programs in developing countries,” Clinical Infectious Diseases 2014

John H. Jackson, 1969, World Trade and the Law of GATT, A Legal Analysis of the

General Agreement of Tariff and Trade (Chadottes Ville Vs The Machie Company Law Publishers.

Kamal Saggi, 2009, The MFN Clause Welfare and Multilateral Cooperation Between

Countries of Unequal Size, Journal of Development Economics 88, J.Jdeveco, ISSN 0304-3878.

Maskus, 2002, Ensuring Access to Essential Medicines: Some Economic

Considerations, Draft

Michael Meyer-Resende, Hannah-Jil Prillwitz, 2002, State of Emergency and The Rule

of Law: a Primer, Democracy Reporting International.

Ministry of Public Health, 2007 ‘Compulsory License for Patented Medicines and

Medical Devices: Clopidogrel’. The Department of Disease Control Notification B.E. 2550.

Ministry of Public Health, 2008, ‘Compulsory License for Patented Medicines and

Medical Devices: Erlotinib’. The Department of Disease Control Notification, B.E. 2551.

Ocaña, Barragán & García, J. Zubieta, 2013, Critical Factors toward Successful R&D

Projects in Public Research Centers: a Primer, Journal of Applied Research and Technology Volume 11, Issue 6.

Oliver Long, 1997, Law and its Kimitation in the GATT Multilateral Trade System

Dardreacht: Martinus Nijhoff.

Sunyowati, Dina, 2013, Hukum Internasional Sebagai Sumber Hukum Dalam Hukum

Nasional (Dalam Perspektif Hubungan Hukum Internasional dan Hukum Nasional di Indonesia) dalam Jurnal Hukum dan Peradilan Volume 2.

The Economist, 2000, Who Owns The Knowledges Economy?, The Economist, Edisi 8

April.

The Institute of Company Secretaries of India, 2014, Professional Programme

Intellectual Property Rights – Law and Practice, Tan Prints : New Delhi.

Tomi Suryo Utomo, 2009, Implementasi Lisensi Wajib Terhadap Produk Obat Yang Dipatenkan Pasca Deklarasi DOHA, lumal llmu Hukum REFLEKSI HUKUM

Wheaton, James, 1986, “Generic Competition and Pharmaceutical Innovation: The

Drug Price Competition and Patent Term Restoration Act of 1984”, Catholic University Law Review, 433.

White & Case, 2012, Indian Patent Office Grants Compulsory License for Bayer’s

Nexavar: Implications for Multinational Drug Companies, Client Alert.

WHO, Pharmaceuticals in the Trade Related Aspects of the Intellectual Property Rights

(TRIPS) Agreement of the World Trade Organisation: A Briefing on TRIPS

White & Case, 2012, ‘Indian Patent Office Grants Compulsory License for Bayer’s

Nexavar: Implications for Multinational Drug Companies’ Client Alert.

Skripsi / Thesis/ Disertasi

Eniola Olufemi Adesola, 2014, Thesis: Compulsory Patent Licensing and Access to

Essential Medicines in Developing Countries After The Doha Declaration, University of South Africa; Pretoria.

George, Neil, 2016, Using compulsory licenses to access pharmaceuticals, Eu-HEM

thesis, University of Oslo.

Artikel

Adi Permana, Orasi Ilmiah Prof. Heni Rachmawati, Intervensi Teknologi dalam Obat,

Tersedia pada [https://www.itb.ac.id/berita/detail/57066/orasi-ilmiah-prof-heni-rachmawati-intervensi-teknologi-dalam-obat]

Anonim, Sikap Negara-Negara Berkembang Terhadap Hukum Internasional

Tersedia pada [http://www.negarahukum.com/hukum/sikap-negara-negara-berkembang-terhadaphukum-internasional.html]

Dinas Provinsi Kalimantan Barat, “Pengertian Obat Generik dan Obat Paten”

Tersedia pada [https://dinkes.kalbarprov.go.id/pengertian-obat-generik-dan-obat-paten]

Geeta, India: Compulsory License and Issues Related To It, tersedia pada

[https://www.mondaq.com/india/patent/953332/compulsory-licenses-and-issues-related-to-it]

Naraya Health, All You Need To Know About

Cancer, tersedia pada [https://www.narayanahealth.org/blog/all-you-need-to-know-about-kidney-cancer]

R. Anderson, 2014, “Pharmaceutical industry gets high on fat profits,” BBC News

Tersedia pada (http://www.bbc.com/news/business-28212223)

Rizki, Teknik Analisis Data Kualitatif, Kuantitatif, Menurut Para Ahli (Lengkap),

Tersedia pada[https://dosenbahasa.com/cara-menulis-catatan-kaki-dari-internet]

Trading Economic, ‘India - GDP per capita’, 2016 tersedia pada

[https://tradingeconomics.com/india/gdp-percapita-us-dollar-wb-data.html]

Universitas Katolik Indonesia Atmajaya, 2021, Ancaman Paten terhadap kesehatan

Publik, tersedia pada [https://m.atmajaya.ac.id/Web/KontenUnit.aspx?gid=artikel-hki&ou=hki&cid=ancamanpaten-terhadap-kesehatan-publik-dan-safeguards-TRIPs],

United States Patent and Trademark Office, Trade related aspects of IP rights

tersedia pada [https://www.uspto.gov/ip-policy/patent-policy/trade-related-aspects-ip-rights]

WIPO, Advice on Flexibilities under the TRIPS Agreement, Tersedia pada

[https://www.wipo.int/ip-development/en/policy_legislative_assistance/advice_trips.]

World Trade Organization, The Doha Round

Tersedia pada [https://www.wto.org/english/tratop_e/dda_e/dda_e.htm]

_____________________, TRIPS, Trade-Related Aspects of Intellectual Property

Rights tersedia pada [ https://www.wto.org/english/tratop_e/trips_e/trips_e.htm ]

_____________________, Implementation of paragraph 6 of the Doha Declaration on the TRIPS Agreement and public health, World Trade Organization tersedia pada [https://www.wto.org/english/tratop_e/trips_e/implem_para6_e.htm]

¬¬¬_____________________, Members Accepting Amendments of the TRIPS

Agreement, tersedia pada [http://www.wto.org/english/tratop e/tripse/amendment-e.htm]


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