Contributed By Jones Day
There is no national law or regulation that explicitly provides which information must be included in pharmaceutical advertising directed at healthcare professionals.
However, if such advertising contains information relating to the names of the products, the manufacturing process and the indication, dosage, administration or safety of or in relation to the drugs, as well as other relevant items, the advertising shall be subject to the Standards, as described above in 4.2.
As for self-regulatory codes, the JPMA Drafting Guidelines provides that advertising directed at healthcare professionals must contain the following information in principle:
Even if an advertisement is intended to promote only the name of a product, statements made in the advertisement shall contain at least the brand name, therapeutic category, regulatory classification, generic name and presence on the NHI reimbursement price list.
Beyond the question of which information to include, the JPMA Promotion Code identifies specific statements that may or may not be used in advertisements to healthcare professionals. For example, it prohibits stating that “there are few adverse reactions” without also citing the conditions of use or without providing a summary of relevant data, including the relevant adverse reactions, to back up such a safety claim. The JPMA Promotion Code also attempts to promote the quality and clarity of the information being presented. For example, the advertising materials must not only emphasise the efficacy of the product but must also include product safety information, including adverse reactions, in order to create a fair and balanced statement of the advertising. Further, the contact and address for seeking more information on the product must be described clearly.
As for the price of the medicine, the advertising must mention whether or not the medicine is registered on the NHI reimbursement price list, rather than the price itself.
Kamiyacho Prime Place
1-17, Toranomon 4-chome