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.

The advertising of medicines in Japan is regulated by both Japanese laws and regulations as well as self-regulatory codes created by trade associations in the pharmaceutical industry. The main law that regulates pharmaceutical advertising is the Pharmaceuticals and Medical Devices Act (Act No 145 of 10 August 1960, as amended) (the 'PMD Act'). The major self-regulatory codes include the codes created by the Japan Pharmaceutical Manufacturers Association (JPMA) and those created by the Japan Self-Medication Industry (JSMI).

Laws and Regulations

In Japan, the Act against Unjustifiable Premiums and Misleading Representations (Act No 47 of 19 May 1997, as amended) (UPMRA) provides some general rules concerning advertising. However, in the case of pharmaceutical advertising, the PMD Act, which is the main law that regulates drugs, has several special articles that regulate pharmaceutical advertisements. More specifically, Articles 66, 67 and 68 of the PMD Act provide for the

  • prohibition of advertisements for unauthorised drugs;
  • prohibition of false or exaggerated advertisements;
  • prohibition of advertisements endorsed by a doctor;
  • prohibition of obscene statements or diagrams; and
  • regulation of advertisements for drugs for designated diseases.

As for the prohibition of advertisements for unauthorised drugs, the PMD Act states that no person shall advertise the name, manufacturing process, indications or performance of a drug before obtaining the necessary marketing authorisation from the Japanese government.

As for the prohibition of false or exaggerated advertisements, the PMD Act states that no person shall, explicitly or implicitly, advertise, describe or circulate the name, manufacturing process, indications or performance of a drug using false or exaggerated statements.

As for the prohibition of advertisements endorsed by a doctor, the PMD Act states that the advertisement, description or circulation of statements giving the false impression of an endorsement by a medical doctor or other person of the efficacy or performance of a drug shall be prohibited.

As for the prohibition of obscene statements or diagrams, the PMD Act states that no person shall use obscene statements or diagrams or those suggesting illegal abortions in connection with the advertisement of drugs.

Finally, as for the regulation of advertisements for drugs for designated diseases, the PMD Act states that no person shall advertise to the general public drugs intended for use in the cure of cancer, sarcoma or leukaemia, and that are likely to be highly dangerous if used without the direction of medical doctors or dentists.

The Ministry of Health, Labour and Welfare (MHLW) is the competent governmental authority with regard to medicines in Japan and has promulgated the PMD Act Enforcement Ordinance, the PMD Act Enforcement Regulations and various other notices for the enforcement of the PMD Act. One among these is the 'Standards for Appropriate Advertising concerning Medical Goods' (Notification No 0929-4 of the Pharmaceutical Safety and Environmental Health Bureau of 29 September 2017) (the 'Standards'), which were issued by the MHLW in the form of an official notice and which have as their central function the regulation of pharmaceutical advertising.

The Standards provide the standards of conduct that must be adhered to by any person or entity when advertising drugs; their purpose is to prevent companies from giving a false impression of drugs to the general public and to prevent drug abuse and the deterioration of drug reliability. The Standards consist of two parts: The first part relates to the interpretation of 'False or Exaggerated Advertisements', under Article 66 (1) of the PMD Act and the second part goes to the purpose of the Standards themselves (preventing false impressions, drug abuse and the deterioration of drug reliability).

The first part of the Standards sets forth specific rules regarding:

  • expressions relating to product name;
  • expressions relating to manufacturing process; and
  • expressions relating to indication, dosage, administration and safety.

The second part of the Standards prescribes the rules or restrictions regarding:

  • the inducement of excessive use or abuse of drugs;
  • advertising prescription-only medicines;
  • expressions relating to performance on advertising to the general public;
  • drug addictiveness warnings;
  • precautions;
  • slander of other companies’ products;
  • endorsements by healthcare professionals;
  • premium advertising;
  • unpleasant advertising;
  • email advertising;
  • statements on television or radio programmes; and
  • the use of a drug as a cosmetic or as food.

In order to prevent dissemination of inappropriate information during the course of promotion activities, the MHLW issued its new 'Guidelines Concerning Detailing Activities of Ethical Drugs' (the 'Detailing Guidelines') on 25 September 2018. The Detailing Guidelines include

  • basic principles for detailing activities;
  • responsibilities of company management, including organisational measures (such as establishing independent supervisory divisions for monitoring the activities), employee training and record keeping;
  • responsibilities of individuals who conduct detailing activities; and
  • guidelines on offering information on unauthorised drugs and off-label uses.

The Detailing Guidelines will take effect on 1 April 2019, although the provisions related to company responsibilities will not take effect until 1 October 2019.

The MHLW issued a paper regarding possible amendments to the PMD Act on 25 December 2018. This paper outlines the potential reforms, some of which relate to pharmaceuticals advertisement. More specifically, the paper proposes introducing administrative fines for violations of the regulations on advertisements under the PMD Act and authorising regulators to order pharmaceutical companies to correct improper advertisements. The bill concerning these amendments has not yet been prepared but is expected to be submitted to the Japanese Diet in 2019.

Self-regulatory Codes

With regard to prescription-only medicines, a trade association of leading Japanese pharmaceutical research companies issues the major self-regulatory codes. In particular, the JPMA Code of Practice (the 'JPMA Code') is the main regulatory code that regulates pharmaceutical advertisements. The JPMA Code has two chapters. The first chapter is the Code of Practice (the 'JPMA Code of Practice') and the second chapter is the Promotion Code (the 'JPMA Promotion Code'). This code establishes the rules that all member companies must comply with when promoting prescription-only medicines. The JPMA Code provides, more than the Standards, detailed and strict rules for prescription-only medicines, such as the standards for activities of medical representatives, promotional materials, drug samples and scientific meetings.

The JPMA has also issued several additional guidelines relating to pharmaceutical promotion. For example, among these are the Guidelines for the Drafting of Prescription Pharmaceutical Products Informational Material (the 'JPMA Drafting Guidelines'), discussed below in Section 5.

With regard to advertising over-the-counter (OTC) medicines, the Japan Self-Medication Industry (JSMI), a trade association of Japanese over-the-counter manufacturers, issued the Guidelines for Proper Advertising of Over-the-Counter Medicines (the 'OTC Guidelines'). The OTC Guidelines apply to the advertising of non-prescription drugs to the general public. In particular, the OTC Guidelines regulate advertising through newspapers, magazines, television, radio, websites and other forms of mainstream media to ensure the appropriateness of publicity and advertising activities of non-prescription drugs.

A self-regulatory code will apply to the member companies of the particular trade association that created the code. For example, the codes created by the JPMA apply only to pharmaceutical companies that are JPMA member companies.

Conduct that violates self-regulatory codes does not necessarily violate Japanese laws and regulations; such conduct is only illegal if it independently violates Japanese laws and regulations. However, a violator may face sanctions under the self-regulatory codes, potentially damaging its reputation.

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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