Analisis Yuridis Reverse Payment Settlement Agreement Pada Sektor Industri Farmasi Ditinjau Dari Perspektif Hukum Persaingan Usaha Di Indonesia

Latumahina, Bintang Pratama and Prof. Dr. Sukarmi, S.H., M.Hum and Moch. Zairul Alam, S.H., M.H (2023) Analisis Yuridis Reverse Payment Settlement Agreement Pada Sektor Industri Farmasi Ditinjau Dari Perspektif Hukum Persaingan Usaha Di Indonesia. Sarjana thesis, Universitas Brawijaya.

Abstract

Pada skripsi ini, penulis mengangkat permasalahan mengenai praktik Reverse Payment Settlement Agreement (RPSA) pada sektor industri farmasi ditinjau dari hukum persaingan usaha di Indonesia. Pemilihan permasalahan tersebut didasari oleh RPSA yang telah terjadi di Uni Eropa dan telah diklasifikasikan sebagai sebagai perjanjian yang bersifat naked restraint serta melanggar Pasal 101 TFEU secara restriction by object. RPSA berpotensi terjadi di Indonesia, akan tetapi hukum persaingan usaha di Indonesia belum mengatur terkait dengan batasan penggunaan hak eksklusif oleh pelaku usaha tanpa melalui perjanjian lisensi serta penilaian pesaing potensial dimana kedua hal tersebut merupakan hal yang penting untuk melakukan pemeriksaan terhadap RPSA. Berdasarkan hal tersebut, penelitian ini mengangkat rumusan masalah: (1) Bagaimana analisis potensi pelanggaran yang timbul dari reverse payment settlement agreement ditinjau dari Undang-Undang Nomor 5 Tahun 1999 Tentang Larangan Praktek Monopoli dan Persaingan Usaha Tidak Sehat? (2) Bagaimana pengaturan yang ideal untuk menangani kasus reverse payment settlement agreement di Indonesia?. Kemudian penulisan karya tulis ini menggunakan metode yuridis normatif dengan menggunakan pendekatan kasus (case approach), pendekatan perundang-undangan (statute approach), dan pendekatan perbandingan (comparative approach). Bahan hukum yang digunakan adalah bahan hukum primer, sekunder, dan tersier dengan menggunakan metode penafsiran gramatikal, penafsiran sistematis, dan penafsiran komparatif. Dari hasil penelitian dengan metode di atas, penulis memperoleh jawaban atas permasalahan yang ada bahwa RPSA berpotensi melanggar Pasal 11, Pasal 15 ayat (1) dan (3) huruf b, dan Pasal 25 ayat (1) huruf a dan c UU 5/1999. Selain itu, RPSA memiliki sifat-sifat anti persaingan. Berdasarkan analisis kasus Lundbeck melawan Komisi Eropa dalam Case C-591/16 didapati adanya batasan penggunaan hak eksklusif tanpa perjanjian lisensi serta penilaian pesaing potensial yang bersumber dari Case C-307/18 (Generics (UK)) v. Competition Markets and Authority) dan di Indonesia belum ditemukan adanya pengaturan yang memberikan batasan yang jelas terkait dengan penggunaan hak eksklusif tanpa melalui perjanjian lisensi serta penilaian pesaing potensial. Berdasarkan hal tersebut, perjanjian yang berkaitan dengan HKI tidak dapat dimaknai lagi sebatas perjanjian lisensi serta penulis merumuskan batasan penggunaan hak eksklusif oleh pelaku usaha, khususnya paten. Kemudian, KPPU harus membentuk pengaturan pesaing potensial yang didasarkan dari tiga aspek, antara lain: hambatan masuk pasar (barrier to entry), kekuatan dan probabilitas persaingan yang berpotensi terjadi (the likelihood and strength of potential competition), dan waktu persaingan di antara pelaku usaha yang ada di dalam pasar dan pesaing potensial terjadi (the timeframe in which potential competition could emerge)

English Abstract

In this thesis, the author raises issues regarding the practice of Reverse Payment Settlement Agreement (RPSA) in the pharmaceutical industry sector in terms of business competition law in Indonesia. The selection of the problem is based on the RPSA that has occurred in the European Union and already been classified as a naked restraint also violates Article 101 TFEU in a restriction by object. RPSA is potentially occur in Indonesia, but competition law in Indonesia has not regulated the restrictions on the use of exclusive rights by business actors without going through a license agreement and assessment of potential competitors where these two things are important to examine RPSA. Based on this, this study raised 2 (two) research questions: (1) How is the analysis of potential violations arising from the reverse payment settlement agreement in terms of Law Number 5 of 1999 concerning the Prohibition of Monopoly Practices and Unfair Business Competition? (2) What is the ideal arrangement to handle reverse payment settlement agreement cases in Indonesia?. Then the writing of this paper uses normative juridical research, which using several approaches such as case approach, statutory approach (statute approach), and comparative approach. The legal materials used by the author are primary, secondary, and tertiary legal materials that are analyzed using grammatical interpretation methods, systematic interpretation, and comparative interpretation. From the results of research with the method above, the author obtained answers to existing problems that RPSA has the potential to violate Article 11, Article 15 paragraphs (1) and (3) letter b, and Article 25 paragraph (1) letters a and c UU 5/1999. In addition, RPSA has anticompetitive properties. Based on the analysis of Lundbeck's case against the European Commission in Case C-591/16 P, it was found that there’s a restriction on the use of exclusive rights without a license agreement and an assessment of potential competitors sourced from Case C- 307/18 (Generics (UK)) v. Competition Markets and Authority) and in Indonesia there has been no arrangement that provides clear restrictions related to the use of exclusive rights without a license agreement and assessment of potential competitors. By that, agreements related to Intellectual Property Rights can no longer be interpreted as license agreements and the author formulates limits on the use of exclusive rights by business actors, especially patents. Then, KPPU must form a potential competitor arrangement based on three aspects, which include: the barrier to entry, the likelihood and strength of potential competition, and the timeframe in which potential competition could emerge.

Item Type:	Thesis (Sarjana)
Identification Number:	052301
Divisions:	Fakultas Hukum > Ilmu Hukum
Depositing User:	Samuri
Date Deposited:	16 Jan 2024 02:04
Last Modified:	16 Jan 2024 02:04
URI:	http://repository.ub.ac.id/id/eprint/210620

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