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.

Generally, the same laws, regulations and self-regulatory codes concerning pharmaceutical advertising will also apply to advertising on the internet for medical products. In addition, the Commentary to the JPMA Promotion Code provides specific rules concerning access restrictions on internet-accessible information related to prescription-only medicines.

As advertising prescription-only medicines to the general public is prohibited under the Standards, when a pharmaceutical company provides healthcare professionals with product-related information concerning prescription-only medicines through the internet, the company must restrict access to the relevant websites so that only healthcare professionals have access to such information.

The question, therefore, is what is considered a sufficient access restriction. In this regard, the Commentary provides the conditions set forth below; if all these conditions are satisfied, then an access restriction will be considered sufficient:

  • the name of the pharmaceutical company is provided, the website states that the information is targeted at healthcare professionals and the person intending to access the information understands that the information is targeted at healthcare professionals;
  • the information is appropriate for healthcare professionals; and
  • if a company website targeting healthcare professionals links to an external website, the contents of the external website and the external website itself are appropriate for healthcare professionals and the owner or author of the external website can be clearly verified.

As long as a pharmaceutical company uses a sufficient access restriction, it is not required to use any particular method of establishing passwords.

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.

{{searchBoxHeader}}

Select Topic(s)

loading ...
{{topic.title}}

Please select at least one chapter and one topic to use the compare functionality.