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.

Advertising Prescription-only Medicines

Advertising prescription-only medicines to the general public is prohibited in Japan. Article 5 (1) of the Standards expressly prohibits such advertising. In addition, Article 67 (1) of the PMD Act prohibits advertising drugs for specified diseases and regenerative medicines to the general public.

Advertising Over-the-counter Medicines

Advertising OTC medicines to the general public is not prohibited but is restricted by the PMD Act and the Standards, as well as by self-regulatory codes.

Advertising for OTC medicines is subject to the rules concerning advertising under the PMD Act and the Standards, which are described above in Section 1. In this regard, it should be noted that Article 6 of the Standards stipulates a particular restriction on advertisements to the general public concerning the efficacy of drugs for diseases, which cannot be expected to be cured without a doctor’s or dentist’s diagnosis or treatment. This Article provides that such advertisements must not suggest that the diseases can be cured without such a diagnosis or treatment when the advertisements are targeted at the general public.

In addition, the OTC Guidelines regulate advertising through newspapers, magazines, television, radio, websites and other forms of mainstream media to ensure the appropriateness of the publicity and advertising activities for non-prescription drugs.

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.

There are no laws or regulations that expressly impose restrictions on interactions between patients or patient organisations and industry.

As for the main self-regulatory codes, the JPMA Code of Practice sets forth the rules concerning collaboration with patient groups. First, when a pharmaceutical company has any relationships or collaboration with patient institutions, the company must respect the independence of the institutions and the company’s activities must meet a high ethical standard. Further, the company must make an effort to promote sufficient mutual understanding with patient groups regarding the purpose and scope of the collaboration.

Second, the fact of the sponsorship itself is required to be disclosed. Further, the purpose and scope of the sponsorship shall be agreed upon between both parties and shall be made in writing and recorded in order to ensure transparency. Finally, the member companies that are collaborating with patient organisations shall establish internal company guidelines based on the 'Guideline on Collaboration with Patient Organisations' issued by the JPMA.

Article 66 (2) of the PMD Act provides that advising, describing or circulating statements that lead to the false impression that a physician or other person has certified the indications or properties of drugs will be construed as false or exaggerated advertising, which is prohibited under Article 66 (1) of the PMD Act. In addition, Article 10 of the Standards explicitly prohibits endorsements by healthcare professionals in advertisements for medicines. This is because such advertising may give the erroneous impression that opinion leaders or other such individuals recommend or guarantee the medicines being advertised.

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.