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IPR Border Enforcement Industry Perspective
Surabaya-Medan, August 2015 Widyaretna Buenastuti Public Affairs & Communications Director – Pfizer Chairwoman -MIAP
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Outline - Kerangka Industry Expectation Pharma case Example
Best Practice Enforcement Difficulties Faced Discussion Issue Ekspektasi Industri Kasus di bidang Farmasi Pelaksanaan Penindakan Hukum yang terbaik Kesulitan yang Dihadapi Bahan Diskusi
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Industry Expectation Industry Expectation Ekspektasi Industry
Legal Certainty Transparency Minimal recurrence Business continuity Consumer Safety Kepastian Hukum Transparansi Berulangnya kejadian yang serupa di minimalisir Keberlangsungan usaha Keamanan bagi Konsumen
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©rouse2012
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Counterfeit Viagra (China)
Copyright© Pfizer 2011
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Counterfeit Viagra (China)
Copyright© Pfizer 2011
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Counterfeit Ponstan (Colombia)
Copyright© Pfizer 2011
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Safety is less concern for Illegal producers….
+ + + Copyright© Pfizer 2011
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Original Producer Do not Ship Medicines in plastic bags …
Copyright© Pfizer 2015
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… or wrapped in foil and carbon paper …
Copyright© Pfizer 2015
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… or commingled with… Copyright© Pfizer 2015
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… in stereo speakers … Copyright© Pfizer 2015
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… in boxes for televisions …
Copyright© Pfizer 2015
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… in stuffed animals … Copyright© Pfizer 2015
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… and in hollow blocks of marble
Copyright© Pfizer 2015
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Best enforcement practice pelaksanaan penindakan hukum yang terbaik
Sharing Information Mechanism is Available Preserve Evidence Good Systems in place – Raids, Customs, Prosecutions Deterrent penalties Effective Customs process Local Cooperation International Cooperation Mekanisme berbagi informasi tersedia Mengamankan barang bukti System yang baik dari Razia, Bea Cukai hingga Penuntutan Hukuman yang membuat Jera Proses Bea Cukai yang effektif Kerjasama Lokal Kerjasama Internasional
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Difficulties Faced Kesulitan yang Dihadapi
Industry Expectation Ekspektasi Industry Legal Certainty Ex officio authority of C&E officers IPR holders/Importer Shall injunction need court decision or can be directly executed Transparency Operational Budget Length of time to proceed Minimal recurrence IPR awareness System detection Kepastian Hukum Kewenangan Pejabat Bea & Cukai Ex-officio Pemegang HaKI/Importir Penangguhan Sementara perlu Penetapan Pengadilan atau bisa langsung? Transparansi Operational Budget Lama waktu untuk memproses Berulangnya kejadian yang serupa di minimalisir Pemahaman IPR Pendeteksian dari system
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For Discussion Purpose Bahan Diskusi
Apakah Obat Ilegal atau Palsu masuk dalam kategori perlindungan Hak Kekayaan Intelektual atau perlindungan terhadap Kesehatan? (What category fits best for Illegal drugs or counterfeit drugs, protecting IPR or protecting Health?) Bab X UU no tentang Kepabeanan UU tentang Kesehatan Permendag no 54/10/2009 tentang Ketentuan Umum Import Apakah peraturan perundang-undangan yang ada cukup untuk menegakan hukum atas pelanggaran HaKI? (Does the prevailing laws and regulations enforceable towards IPR infringement/violations?)
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