Last Updated June 11, 2019

Law and Practice

Contributed By Jones Day

Authors



Jones Day assists with all facets of clients' marketing, promotion, and advertising efforts by devising marketing strategies, developing packaging and labelling, obtaining internal and governmental approvals and implementing compliant advertising campaigns, including print, radio and television advertising, website development and social media platforms. The firm's Life Sciences team helps clients to preserve their advertising position and challenge infringing competitors. Its lawyers provide assistance with pharmaceutical, medical device and biological regulations, including counselling and representation on diverse issues such as product development, product clearance and approval, clinical trials, biosafety, licensing agreements, facility and establishment registration, product listing, government inspections, product and ingredient notifications, recalls, corrective actions, regulatory and due diligence projects, and audits and compliance with good manufacturing practices and the quality systems regulation. The team has successfully defended clients against FDA enforcement actions including warning letters, seizures, product recalls, inspections, civil monetary penalties, adverse agency determinations, consent decrees and corporate integrity agreements. The views and opinions set forth herein are the personal views or opinions of the author; they do not necessarily reflect views or opinions of the law firm with which [he or she] is associated.

There is no law or regulation that provides exactly which information must be included in pharmaceutical advertising aimed at the general public.

However, under the PMD Act and the Standards, if advertising contains information as to the names of the products, their manufacturing process or their indication, dosage, administration or safety, the advertising must follow the following rules.

As for the names of the products that require marketing authorisation under the PMD Act ('Authorised Products'), Article 1 of the Standards provides that companies shall use only authorised brand names or the generic names of the relevant products.

The Standards also allow the two types of names above or names listed on the Japanese Pharmacopeia to be used for products that do not require marketing authorisation ('Non-Authorised Products'). However, the brand names of Non-Authorised Products must not contradict the actual manufacturing method, efficacy or safety of the products.

As for the manufacturing process, Article 2 of the Standards provides that companies shall not express the manufacturing process of the product as being different from the product’s actual manufacturing process or the manufacturing process, which may lead the general public mistakenly to believe in the superiority of the product.

As for indication, dosage, administration and safety, Authorised Products, Article 3 (1) and (4) of the Standards prohibit companies from using expressions for Authorised Products, which are beyond the scope of or deviate from the authorised indication, dosage, administration or safety of the products (ie “off-label promotion”).

As for Non-Authorised Products, Article 3 (2) and (4) of the Standards provide that companies shall not use expressions beyond the scope of the product’s efficacy, dosage, administration or safety as generally recognised in the field of medicine or pharmacy.

In addition to the above, the Standards include several other relevant rules, including prohibitions on certain claims relating to efficacy or safety of products and prohibitions on slander and/or defamation of competitors’ products.

Beyond the question of which information to include, the OTC Guidelines identify specific statements that must or may not be used in advertisements for each category of OTC medicines. For instance, advertisements for cold medicines must use the phrase “relief of cold symptoms” but not “this will not make a patient sleepy.” Also, advertisements for cold medicines on television or through streaming video on the internet must display the statement “this product shall be used after receiving an explanation from a pharmacist and after carefully reading the warning label” for a second or more with clear and distinct characters.

As for the price of the medicine, this information can be mentioned in advertising aimed at the general public, although doing so is not required by either laws or self-regulatory codes.

Jones Day

Kamiyacho Prime Place
1-17, Toranomon 4-chome
Minato-ku
Tokyo 105-0001
Japan

+81 334333939

+81 354012725

www.jonesday.com/tokyo/

Authors



Jones Day assists with all facets of clients' marketing, promotion, and advertising efforts by devising marketing strategies, developing packaging and labelling, obtaining internal and governmental approvals and implementing compliant advertising campaigns, including print, radio and television advertising, website development and social media platforms. The firm's Life Sciences team helps clients to preserve their advertising position and challenge infringing competitors. Its lawyers provide assistance with pharmaceutical, medical device and biological regulations, including counselling and representation on diverse issues such as product development, product clearance and approval, clinical trials, biosafety, licensing agreements, facility and establishment registration, product listing, government inspections, product and ingredient notifications, recalls, corrective actions, regulatory and due diligence projects, and audits and compliance with good manufacturing practices and the quality systems regulation. The team has successfully defended clients against FDA enforcement actions including warning letters, seizures, product recalls, inspections, civil monetary penalties, adverse agency determinations, consent decrees and corporate integrity agreements. The views and opinions set forth herein are the personal views or opinions of the author; they do not necessarily reflect views or opinions of the law firm with which [he or she] is associated.

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