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.

If providing information on unauthorised medicines or unauthorised indications is considered advertising under the PMD Act, such provision of information is prohibited. Article 68 of the PMD Act expressly prohibits advertising unauthorised medicines or unauthorised indications. The JPMA Promotion Code provides that member companies must provide information such as indications, dosage and administration, which should not deviate from the approved items for the drugs.

However, if providing information on unauthorised medicines or unauthorised indications falls outside the definition of advertising under the PMD Act, such provision of information may be allowed. In this regard, the Commentary of the JPMA Promotion Code lists several cases in which the provision of information is permitted, where the information provision is for the purpose of medical/pharmaceutical experts’, as well as the general public’s, right to know about scientific/medical advancements. These cases include:

  • presenting research findings at academic societies or scientific journals;
  • displaying exhibition materials at an international academic society (limited to unapproved drugs which have been approved in at least one country);
  • supplying previously reviewed academic literature; and
  • disclosing information to stockholders as required by law.

Moreover, the Commentary notes that, even if the activity consists of providing information as permitted above, the company must take special care not to be involved in inappropriate promotional activities for its own commercial purposes.

Once they take effect, the new Detailing Guidelines will require pharmaceutical companies to comply with the following conditions for providing information on unauthorised medicines and unauthorised indications:

  • separating information on unauthorised medicines and unauthorised indications from other promotion activities;
  • providing such information only to individuals who have actually requested it;
  • providing only accurate information that is based on scientific and objective evidence, without omissions, emphasises, exaggerations or misleading summaries;
  • providing information relating to a clinical trial involving a pharmaceutical company only if the research adheres to Good Clinical Practice, the Clinical Research Act or some other equivalent rules;
  • providing negative information such as information relating to adverse effects;
  • clearly indicating that such indication, dosage or method of administration has not been approved; and
  • preparing and maintaining records detailing information that has been provided on unauthorised medicines and unauthorised indications.

The aforementioned Commentary of the JPMA Promotion Code lists two cases in which providing information on unauthorised medicines or unauthorised indications during a scientific conference directed at healthcare professionals is allowed.

The first case is the presentation of clinical research results during a scientific meeting. However, seminars sponsored by pharmaceutical companies are not covered by this exception.

The second case is the display, by a pharmaceutical company, of educational samples of an unapproved medicine at an exhibition during an international scientific meeting. This only applies, however, when such an unapproved medicine has been approved in at least one other country. If no countries have approved the product, the company may not display a sample of the product. In addition, the pharmaceutical company may not distribute samples of unapproved medicines and related scientific materials to anyone during the meeting.

As mentioned in 3.1 Restrictions on Provision of Information on Unauthorised Medicines or Indications, the new Detailing Guidelines provide certain conditions on providing information on unauthorised medicines or unauthorised indication.

The Commentary of the JPMA Promotion Code allows the supply, by a pharmaceutical company, of peer-reviewed scientific journal articles, such as reprints of medical journals, upon the request of a medical doctor. However, companies shall not proactively induce a medical doctor to request such scientific journal articles.

As mentioned in 3.1 Restrictions on Provision of Information on Unauthorised Medicines or Indications, the new Detailing Guidelines provide certain conditions on providing information on unauthorised medicines or unauthorised indication.

There are no Japanese laws or self-regulatory codes that expressly regulate the sending of information on unauthorised medicines or indications to healthcare institutions to enable them to prepare budgets. Given that there are no laws or self-regulatory codes that permit such transmission of information, there remains a risk that such conduct would be considered a “promotional activity on unauthorised medicines or unauthorised indications,” which is prohibited under Article 68 of the PMD Act.

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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