Last Updated February 20, 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.

Notice No 148 dated 29 September 1998, issued by the Pharmaceutical Safety Bureau of the MHLW, defines 'advertising' for the purposes of the PMD Act. This notice states that 'advertising' has all of the following three characteristics:

  • it has a clear intention to induce customers to make purchases;
  • the product names of particular medicines are clearly expressed; and
  • it can be seen by the general public.

Difference Between Advertising and Other Information

Advertising and other information are distinguished by the above definition of 'advertising'. First, advertising must be clearly intended to induce customers to make purchases. This requirement might be satisfied, for example, by an advertisement that lists a phone number to call to buy certain goods, suggesting a clear intention to induce customers to make purchases. However, it is not likely that a book in a medical library describing certain drugs and targeted at researchers would have such an intention.

As to the second requirement – the clear expression of product names – it may be met even in cases where particular product names are not mentioned; this would be the case if the general public could recognise particular medicines based on the pictures or descriptions of those medicines shown in the advertisement.

Finally, the third requirement (the ability to be seen by the general public) would not be likely to be satisfied if the relevant information is only provided to patients in a hospital, since the narrow scope of its distribution would limit the potential for the information to reach the general public.

Disease-awareness Campaigns

As long as disease-awareness campaigns are meant to inform the public in a general way about certain diseases and do not name specific medicines, they are not considered 'advertising' under the PMD Act. However, if the content of a disease-awareness campaign satisfies the three parts of the definition of advertising set out above, that disease awareness campaign will be subject to the advertising regulations under the PMD Act and the Standards.

The risk that a disease-awareness campaign is considered advertising prohibited under the PMD Act is high in the case of a disease-awareness campaign publicising prescription-only medicines to the general public, because the advertising of prescription-only medicines to the general public is prohibited under the PMD Act. In this regard, the JPMA Code of Practice suggests that the content of disease education activities targeting ordinary citizens and patients be closely inspected from the planning stages so that they will not be considered prohibited advertising.

Press releases regarding medicines are not prohibited. However, if a press release satisfies the three parts of the definition of advertising mentioned above, both the regulations concerning advertising under the PMD Act and the Standards will apply.

Generally, the restrictions under the PMD Act are more stringent when the target audience is the general public than when the target audience is healthcare professionals. For example, advertisements for pharmaceutical products used for cancer, sarcoma or leukaemia aimed at the general public are prohibited under Article 67 of the PMD Act.

In this regard, the JPMA Code of Practice states that pharmaceutical companies must ensure that their activities do not become inappropriate promotional activities for their own commercial purposes. It further states that pharmaceutical companies should take steps to avoid their activities becoming advertisements for ethical drugs to the general public or advertising that recommends unapproved drugs or off-label uses.

Comparative advertising for medicines is not prohibited but it is restricted by Japanese law and self-regulatory codes. The major restrictions are as follows:

According to the Commentary of Article 9 of the Standards, a pharmaceutical company’s comparative advertising must only feature its own products and the advertising must specify the name of those products. Comparisons with competitors’ products are prohibited. In addition, when a pharmaceutical company compares two of its own products, the company must ensure that it provides a sufficient explanation of the products.

Further, the JPMA Promotion Code stipulates that comparative advertising “shall be based on scientific data and, in principle, shall be made using generic names.”

Finally, the Consumer Affairs Agency has issued general guidelines for comparative advertising. These guidelines provide that a comparative advertisement shall be considered a Misleading Representation prohibited under the UPMRA if:

  • it makes comparisons using unproved or unprovable facts;
  • it emphasises unimportant matters as if they were important or makes comparisons based on an unfair selection of products; or
  • it merely slanders or defames competitors’ products.
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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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