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Corruption and Conflicts of Interest in the Pharmaceutical Market: Regulation of Pharmaceutical Companies’ Gift-Giving Practices

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Competition Law and Policy in the Japanese Pharmaceutical Sector

Abstract

Pharmaceutical companies often give gifts to doctors or pay them to recommend or prescribe their products. Such practices not only pose a risk to patients’ recovery, but also cause excessive medication use, increase medical costs and undermine merit-based competition amongst pharmaceutical companies, causing severe inefficiency in society. Japan’s regulatory approach towards pharmaceutical companies’ gift-giving practices is lenient and ineffective, with the criminal code prohibiting bribery only in relation to public officials. Most doctors who privately provide medical services are not able to be reached by the law. Furthermore, only the individual, not the company, is penalised under the criminal code. Although the Antimonopoly Act and the Act against Unjustifiable Premiums and Misleading Representations regulate attempts to entice customers using unfair means, a violation results only in a cease-and-desist order. The detailed rules set out in the Fair Competition Code are rarely enforced by the industry’s self-regulatory body, which issues only a warning and guidance to violators. Disclosure, rather than prohibition, has become the primary way to control pharmaceutical companies’ profiteering practices. However, disclosure alone is insufficient to ensure a proper distance remains between doctors and pharmaceutical companies. Given the serious harms and inefficiencies that may be caused by gift-giving practices, such regulatory systems must be overhauled to effectively prevent such unfair and inefficient methods of competition.

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Notes

  1. 1.

    In Japan, hospitals and clinics formerly dispensed drugs directly to patients. This practice was considered problematic because doctors tended to prescribe excessive medications in order to earn a higher income (Rodwin [44]: 190). To resolve this issue, the government adopted a policy that prescription drugs should be provided by independent pharmacies established outside these institutions. Japan implemented an insurance-payment system under which hospitals and clinics, as well as pharmacists, earn more if they comply with the government’s policy. Currently, only 30% of prescription drugs are dispensed within hospitals and clinics. Critics argue the current insurance-payment system only benefits pharmacies, which provide medication following a doctor’s prescription, without creating any material added value. To counter such criticism, the Ministry of Health, Labour and Welfare (MHLW) encourages pharmacies to offer more assistance, such as monitoring and advising on patients’ drug use [32].

  2. 2.

    Iryohin, Iyakukiki to no hinsitsu, yukosei oyobi anzensei no kakuho to ni kansuru horitsu (Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices [PMD Act]), Act No. 145 of 1960, as last amended by Act No. 63 of 1989, Art 49; Yakuzaishi ho (Pharmacists Act), Act No. 146 of 1960, as last amended by Act No. 63 of 2019, Art 23.

  3. 3.

    The information provided by the medical representative is an important source of pharmaceutical information for doctors, although today more online tools are used, particularly since the outbreak of the COVID-19 pandemic in 2020 [57].

  4. 4.

    Hayashi [12] estimates that a weekly pharmaceutical briefing at a relatively small university hospital with 340 medical staff would result in an annual expenditure of over 25 million JPY.

  5. 5.

    Another harm the gift-giving practice might cause is patients’ distrust of physicians, which could discourage them from visiting doctors or complying with instructions. The Japan Pharmaceutical Manufacturers Association (JPMA) [16] found that 85% of respondents trust prescribed drugs, while about half consider drugs to be overused. The same study also reveals those who do not trust prescribed drugs tend to comply with instructions on how to take less medication (70%) compared to those who trust them (90%). Such a correlation was observed in the past by Yomiur. ‘Kokumin ha “kusuri zuki” ja nai’ (‘Japanese people are not “medicine lovers”’) (Yomiuri Shimbun, 4 April 1977). In the 1970s, medical institutes provided medication, and the doctors’ overmedication practices, called kusuri-zuke (pouring drugs)—which was motivated by greed—was a social issue. In the survey, about 45% of the respondents said they ‘more or less’ trust their doctors, while 13.4% of the respondents said they did not trust their doctors very much or at all. The most common reasons for such mistrust were because they were ‘money-making’ (54.4%) and ‘they give me too much medicine’ (39.2%).

  6. 6.

    Keiho, Act No. 45 of 1907, as last amended by Act No. 72 of 2008.

  7. 7.

    See e.g. Kokusitsu daigaku hojin ho (National University Corporation Act), Act No. 112 of 2003, last amended by Act No. 11 of 2019, Art 19; Dokusitsu gyosei hojin kokuritsu byoin kiko ho (Act on the National Hospital Organisation, Independent Administrative Agency), Act No. 191 of 2002, as last amended by Act No. 67 of 2004, Art 14.

  8. 8.

    Over the last two decades, the court decisions in which bribery by individuals working for pharmaceutical companies to doctors was found illegal include Sendai High Court decision of 31 August 2009, No. 68 of 2009 (U) (bribery of a municipal hospital doctor); Tokyo High Court decision of 21 April 2004, No. 2446 of 2002 (U) (bribery of a university doctor); Nagoya District Court decision of 31 March 31 1999, 1679 Hanrei Jihou 155 (payment of 256 million JPY as compensation for favourable treatment in joint R&D). Other high-profile cases made known to the public through the media include Hirakata Municipal Hospital, in which the director was arrested and convicted (Asahi, 12 May 2001, 33); Nara Prefectural Medical University (Yomiuri, Osaka edn) 17 December 2000, 3); Kyoto University Hospital (Yomiuri, 27 November 1996, 25) (payment to a university lecturer for clinical trials).

  9. 9.

    Asahi, 4 April 1997 (Toyama edn) (Toyama City Hospital’s head of surgery collected money to finance a year-end party); Yomiuri, 12 March 1999, 19 (University staff requested money to celebrate the retirement of a professor); Yomiuri, 17 August 1999, 26 (Osaka edn) (A professor forced pharmaceutical companies to pay him or else he would no longer procure their products).

  10. 10.

    PMDA (n 2).

  11. 11.

    MHLW, Iryoyo iyakuhin no hanbai joho teikyo katsudo ni kansuru gaidorainn (Guidelines for Sales Information Provision Activities for Medical Drugs), 25 September 2008.

  12. 12.

    Rinsho shiken ho (Clinical Trials Act), Act No. 16 of 2009, as last amended by Act No. 63 of 2019.

  13. 13.

    Shiteki dokusen no kinshi oyobi kosei torihiki no kakuho ni kansuru horitsu (Act on Prohibition of Private Monopolisation and Maintenance of Fair Trade (AMA)), Act No. 54 of 1947, as last amended by Act No. 45 of 2019.

  14. 14.

    AMA Article 19 is unique in that it allows the competition authority to intervene in the practice even without finding serious restriction of competition. Where the same practice has serious adverse effects on competition, AMA Articles 2(5) and 3 apply and the JFTC not only orders the practice to stop (Article 7), but also orders the payment of an administrative fine (Article 7–9). However, the JFTC must first establish that the company has unfairly excluded its rivals and substantially restricted competition in the relevant market.

  15. 15.

    Futo keihin rui oyobi huto hyoji boshi ho (Act Against Unjustifiable Premiums and Misleading Representations), Act No. 134 of 1962 as last amended by Act No. 16 of 2019.

  16. 16.

    JFTC, Iryoyo iyakuhin gyo kokuji (Notification of Ethical Drugs Business), JFTC Notification No. 54 of 11 August 1997, as last amended by Cabinet Office Notification No. 124 of 1 April 2016.

  17. 17.

    Iryoyo iyakuhin seizo hanai gyo ni okeru keihin rui no teikyo no seigen ni kansuru kosei kyoso kiyaku (Fair Competition Code Concerning Restrictions on the Provision of Premiums in the Ethical Drug Manufacturing and Sales Industry), approved by the JFTC on 10 March 1984, last revision 1 April 2016.

  18. 18.

    The Fair Trade Council of the Ethical Pharmaceutical Drugs Marketing Industry, Jisha iyakuhin no koen kai to ni kansuru kijun (Operational standards for seminar on medicines of their own), notified to the JFTC on 20 January 1998, last revision 21 February 2020.

  19. 19.

    Keihin rui teikyo no gensoku ni kansuru kijun (General principles relating to premiums), notified to the JFTC on 20 January 1998, last revision 11 December 2015.

  20. 20.

    Jijo Nikkan Yakgyo, Database, News clips, 24 May 2019, 27 May 2016, 22 May 2015 and 22 May 2014. Several cases became known through newspapers, including Warnings against Novartis (Mainichi, 28 August 2014, 28); e (Yomiuri, 15 December 2001, 19); Guidance to Aventis Pharma (Yomiuri, 30 October 2003, 39); Warning to Eli Lilly Japan (Yomiuri, 10 April 2001, 22); Warning to Kyowa Hakko (Asahi, 11 January 2001, 18); Warning to Kyowa Hakko (Asahi, 21 August 1998, 37); Warning to Zeria Pharmaceutical (Nikkei, 16 November 1994, 38); etoToyama Chemical (Nikkei Sangyo, 2 March 1993, 14).

  21. 21.

    Asahi, 12 May 2001, 33 explains there had been no case where the Council imposed a monetary penalty or expelled the member company at that time. This is the latest information that the author could find in the newspaper archives relating to the issue.

  22. 22.

    Waseda Chronicle, Seiyaku kaisha to ishi: money database (Pharmaceutical companies and doctors: Money Database), < https://db.wasedachronicle.org/ > 

  23. 23.

    Supreme Court, 14 March 1978, 32 Minshu 2 (SHUFUREN Juice)

  24. 24.

    Fujii et al. [7] show pharmacists are, in fact, receiving stationery and lunches at seminars hosted by pharmaceutical companies.

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Acknowledgements

I would like to express my sincere gratitude to Dr Joseph Pozsgai-Alvarez, Osaka University, for his valuable advice, which prompted me to research the issue.

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Wakui, M. (2022). Corruption and Conflicts of Interest in the Pharmaceutical Market: Regulation of Pharmaceutical Companies’ Gift-Giving Practices. 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_5

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