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.

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:

  • name of the product (both brand name and generic name);
  • therapeutic category;
  • regulatory classification;
  • indications;
  • dosage/administration;
  • warnings/contraindications/precautions;
  • presence on the National Health Insurance (NHI) reimbursement price list;
  • name of marketing authorisation holder (contact and address for more product information);
  • limitation of administration period;
  • conditions for approval; and
  • creation date of the advertisement.

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.

Pharmaceutical advertising may refer to data on file or other clinical studies not included in the Summary of Product Characteristics (SmPC). However, references to data on file or clinical studies are limited in certain ways by law and by self-regulatory codes.

First, the general rules on advertising (such as prohibition of false or exaggerated advertisements and advertising that recommends unapproved drugs or off-label uses) under the PMD Act will apply.

Second, references to data on file or other clinical studies shall be subject to the specific regulations provided by the JPMA Drafting Guidelines. For example, statements shall only concern indications approved in Japan. In addition, the study must be published in a peer-reviewed journal.

Pharmaceutical companies may provide reprints of journal articles to healthcare professionals, subject to the conditions set forth in both laws and regulations and self-regulatory codes. Major restrictions on reprints are as follows:

  • the reprint must be authorised by the author(s) under copyright law;
  • the contents of the journal article shall not violate the PMD Act. In particular, the contents of the journal article shall not be false or exaggerated advertising, advertising that recommends unapproved drugs or off-label uses or advertising that slanders and/or defames competitors’ products; and
  • in principle, the reprint must be related to the company’s own product and supplied in response to a request from a healthcare professional. In other words, a pharmaceutical company must refrain from actively inducing a healthcare professional to request such a reprint.
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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