Contributed By Jones Day
Penalties or Measures Imposed by Regulators
In practice, Japanese regulatory authorities, such as the MHLW or the Prime Minister, will be likely to issue an administrative guidance against a pharmaceutical company to remedy the illegal conduct – if the company does not follow such guidance, the authority will issue an administrative disposition.
For example, under the PMD Act the MHLW or the competent prefectural governor may take the following administrative dispositions, among others:
A company that has had its manufacturing and/or marketing licence withdrawn has the right to appeal such a disposition above under the Administrative Appeal Act (Act No 160 of 15 September 1962, as amended).
The JPMA Code Compliance Committee may take actions against pharmaceutical companies that violate the JPMA Promotion Code to address the companies’ violations in accordance with the ,Rules of Actions against the Breach of the Promotion Code'. Actions the aforementioned committee may take include, among others, serious warning, suspension of membership or expulsion from the JPMA.
The Fair Trade Council may order companies violating the Fair Competition Code to take certain measures. If the violator does not comply with such an order, the council may impose a penalty, including a fine of up to JPY1 million or expulsion from the council. The council may also request the Consumer Affairs Agency to take necessary actions.
Penalties Imposed by Courts
Courts may impose criminal penalties on pharmaceutical companies and/or on their officers and employees who violate the relevant laws. The major criminal sanctions for the violation of pharmaceutical advertising rules and rules on inducements to prescribe are as follows:
While only individuals are subject to criminal sanctions under the Penal Code, both individuals and companies may be subject to criminal sanctions under the PMD Act, the UPMRA and the UCPA (PMD Act Article 90 (ii), UPMRA Article 38 (1) and UCPA Article 22 (1) (iii)).
Kamiyacho Prime Place
1-17, Toranomon 4-chome