Contributed By Jones Day
Each Japanese law has one or more government agencies that are responsible for enforcement (ie, the regulatory authority). With regard to the PMD Act, as well as the Standards, the MHLW and the competent prefectural governor are the regulatory authorities. In the case of the UPMRA, the Prime Minister, the Consumer Affairs Agency, the Japan Fair Trade Commission and the competent prefectural governor are the regulatory authorities.
The main role of courts in administrative law enforcement (including for the PMD Act) is to impose criminal penalties on companies and their employees that violate the law. In the case of a serious violation, the regulatory authority will ask the Public Prosecutor’s Office to prosecute the company or its employee, and the Public Prosecutor’s Office will file charges against the company. The court will then render a final judgement.
With regard to the enforcement of self-regulatory codes, the codes usually establish an organ that is in charge of enforcing the code. In the case of the JPMA Promotion Code, the JPMA Code Compliance Committee is responsible for enforcement. As for the Fair Competition Code, the Fair Trade Council of the Ethical Pharmaceutical Drug Marketing Industry (the 'Fair Trade Council'), which consists of the pharmaceutical companies designated by the code, is responsible for the code’s enforcement.
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