Abstract
This chapter provides an overview of the Antimonopoly Act (AMA), clarifies its characteristics and examines AMA cases in the pharmaceutical sector. The AMA aims to promote fair and free competition and the democratic and healthy development of the national economy as well as to secure the interests of the general public. To this end, it prohibits private monopolisation, unreasonable restraints on trade and unfair trade practices, and regulates business combinations. The AMA is enforced primarily by the Japan Fair Trade Commission, an independent administrative body. Meanwhile, the Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices (PMD Act) gives the Ministry of Health, Labour and Welfare (MHLW) the authority to approve and grant licenses for the manufacture and sale of pharmaceutical products. Under the Health Insurance Act, the MHLW sets National Health Insurance Price List, which determines not only the cost, but also the medicines that can be used for treatment under the universal health insurance system. The MHLW also issues administrative guidance. As such, the pharmaceutical sector is heavily regulated. Despite such regulations, intense competition exists in the sector, and the number of AMA cases is increasing.
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Notes
- 1.
Act No. 145 of 1960, as last amended by Act No. 37 of 2019.
- 2.
Act No. 70 of 1922, as last amended by Act No. 40 of 2020.
- 3.
Act No. 54 of 1947, as last amended by Act No. 45 of 2019.
- 4.
15 U.S.C. 45.
- 5.
Act No. 89 of 1896, as last amended by Act No. 34 of 2019.
- 6.
64 Shinketsu-shu 401 (Cathode-ray Tube Price Cartel).
- 7.
56-II Shinketsu-shu 262 (NTT East).
- 8.
45 Shinketsu-shu 148 (Nordion).
- 9.
66 Shinketsu-shu 283 (Koa Isei).
- 10.
66 Shinketsu-shu 335 (Calvin Tablets).
- 11.
On 30 June 2021, after completion of the draft, the Tokyo District Court ruled that four major pharmaceutical wholesalers had engaged in unreasonable restraint of trade by participating in bid rigging for the supply of pharmaceuticals to 57 hospitals operated nationwide by the Organization for Promotion of Regional Medical Functions. Three companies were each fined 250 million JPY and each of the seven former executives were handed a suspended sentence of 18Â months in prison. The fourth company involved was the first to file a leniency application with the JFTC before the commencement the investigation, meaning the company would not be accused of such practice. See JFTC, JFTC Policy on Criminal Accusation and Compulsory Investigation of Criminal Cases Regarding Antimonopoly Violations (7 October 2005, as last amended 16 December 2020).
- 12.
JFTC Public Notice No. 15 of 18 June 1982, as last amended by JFTC Public Notice No. 18 of 28 October 2009.
- 13.
Act No. 120 of 1956, as last amended by Act No. 51 of 10 June 2009.
References
Endo, M., Yamashita, T., & Yago, Y. (2012). Tokyo denryoku kabushiki kaisha ni taisuru dokusen kinshi ho ihan higi jiken no shori ni tsuite [On TEPCO]. Kosei Torihiki, 743, 80–82.
European Commission. (2020). Mergers: Commission waives the commitments made by Takeda to obtain clearance of its acquisition of Shire. 28 May 2020. https://ec.europa.eu/commission/presscorner/detail/en/IP_20_967.
JFTC. (2017). Kabushiki kaisha Nid ni taisuru kankoku ni tsuite (On Recommendations to Nid). 23 February 2017. https://www.jftc.go.jp/houdou/pressrelease/h29/feb/170223.html.
JFTC. (2018). Daikibo kouri gyosha tono torihiki ni kansuru nonyu gyosha ni taisuru jittai chosa (Results of survey on trading between large-scale retailers and suppliers). 31 January 2018. https://www.jftc.go.jp/houdou/pressrelease/h30/jan/180131.html.
JFTC. (2019a). Heisei 30 nenndo ni okeru shuyo na kigyo ketsugo jirei (Major business combination cases in fiscal year 2018 (FY2018) business combinations report). https://www.jftc.go.jp/dk/kiketsu/jirei/30nendo.html. Accessed 4 November 2020.
JFTC. (2019b). M3 kabushiki kaisha ni yoru kabushiki kaisha nihon arutomaku no kabushiki shutoku ni kansuru shinnsa kekka ni tsuite (On M3's acquisition of Nihon Ultmark). 24 October 2019. https://www.jftc.go.jp/houdou/pressrelease/2019/oct/191024m3.html.
JFTC. (2020a). Approval of the Commitment Plan submitted by Cooper Vision Japan, Inc. 4 June 2020. https://www.jftc.go.jp/en/pressreleases/yearly-2020/June/200604.html.
JFTC. (2020b). Approval of the Commitment Plan submitted by Nihon Medi-Physics Co., Ltd. 12 March 2020. https://www.jftc.go.jp/en/pressreleases/yearly-2020/March/200312.html.
MHLW. (2020). Yakka kijun syusai hinnmoku risuto oyobi kohatsu iyakuhinn ni kansuru joho ni tsuite (Reiwa 2 nenn 8 gatsu 26 nichi tekiyo) (On Drug Price List [Effective from 26 August 2020]). https://www.mhlw.go.jp/topics/2020/04/tp20200401-01.html.
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Negishi, A. (2022). Antimonopoly Act and Its Application to the Pharmaceutical Industry in Japan. In: Negishi, A., Wakui, M., Mariyama, N. (eds) Competition Law and Policy in the Japanese Pharmaceutical Sector. Kobe University Monograph Series in Social Science Research. Springer, Singapore. https://doi.org/10.1007/978-981-16-7814-1_6
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