Pharmaceutical fraud is an issue that can pose a direct threat of mortal or physical danger to users of affected products. It therefore has a material impact on the public and can threaten the continuing existence of an affected company. We are able to support clients in dealing with all kinds of stakeholders based on our abundant experience and track record in handling cases of pharmaceutical fraud.
Japan has recently seen a number of serious cases of pharmaceutical fraud that resulted in pharmaceutical companies being subject to business suspension or improvement orders under relevant law on the grounds that the affected pharmaceutical products impaired the health of their users. As a result Japanese authorities are now imposing stricter supervision over the industry. In addition, regulatory authorities overseas, mainly the FDA in the US and the EMA in Europe, have strengthened supervision focused on data integrity, and there have been more and more cases in which pharmaceutical companies are alleged to have committed data integrity fraud.
Cases of pharmaceutical fraud require dealing with not only the relevant regulatory authorities but also various other kinds of stakeholders, including damage claims from buyers and users of the pharmaceutical products; inquiries from the media; and (for public companies) shareholders and securities exchanges.
We have abundant experience and an excellent track record handling cases of pharmaceutical fraud and are able to provide full legal support for our clients in this area.