Guidelines for Appropriate Competition in the Meetings of the Japan Pharmaceutical Manufacturers Association (JPMA)

July 1, 2015

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The Japan Pharmaceutical Manufacturers Association, Inc. The Japan Pharmaceutical Manufacturers Association (hereinafter referred to as "JAPMA") has established the following guidelines for the strengthening and facilitation of compliance systems by JAPMA member companies (hereinafter referred to as "member companies") In 1997, the Pharmaceutical Manufacturers Association of Japan (hereinafter referred to as "the Association") established the "Pharmaceutical Manufacturers Association of Japan Charter of Corporate Behavior" and in 2001 the "Pharmaceutical Manufacturers Association of Japan Compliance Program Guidelines" (the Guidelines were revised in 2011) to strengthen and facilitate the operation of a compliance system by the Association's member companies (hereinafter referred to as "the Member Companies"). The Pharmaceutical Manufacturers Association of Japan (PMAJ) has been calling on its member companies to conduct their business activities appropriately with a high level of ethics and legal compliance.
Following the International Federation of Pharmaceutical Manufacturers & Associations' Associations' (IFPMA) formulation of the "IFPMA Guidance on Appropriate Competition" in November 2014, the Pharmaceutical Manufacturers Association of Japan (hereafter referred to as "the Association") has now formulated a new set of guidelines for conduct (hereafter referred to as the "Guidelines"). The IFPMA has established the IFPMA Guidelines for Good Competition (hereinafter referred to as the "Guidelines"). The Guidelines are designed to ensure that executives and employees of member companies and the Pharmaceutical Manufacturers Association of Japan (hereinafter referred to as "PMA") are aware of and comply with the Antimonopoly Law and other applicable laws at meetings organized by the PMA (hereinafter referred to as "meetings"). The Guidelines are designed to ensure that executives and employees of member companies and the Pharmaceutical Manufacturers Association of Japan (hereinafter referred to as "the Association") comply with the Antimonopoly Law and other applicable competition laws and regulations (hereinafter referred to as "competition laws") and conduct their collective activities appropriately. The following is a guide to ensure that officers and employees of the Pharmaceutical Manufacturers Association of Japan (hereinafter referred to as "the Association") comply with the Antimonopoly Law and other applicable competition laws and regulations (hereinafter referred to as "Competition Laws") and conduct their association activities appropriately at meetings organized by the Association (hereinafter referred to as "meetings").
All executives and employees of member companies and the Pharmaceutical Manufacturers Association of Japan (hereinafter referred to as "the Association") must be fully aware that any violation of the Competition Law may result in severe legal sanctions and loss of public trust, and must act appropriately and in compliance with these Guidelines when attending meetings.

Guidelines Concerning Appropriate Competition

1. Matters related to the operation of meetings

  1. The purpose of the meeting must be legitimate and the meeting must be conducted in compliance with competition laws.
  2. The agenda must be circulated to the attendees prior to the meeting, and attendees should promptly report any concerns regarding competition law in the circulated agenda to the Secretariat of the JRA.
  3. If the Secretariat of the JMAA determines, based on reports from the attendees of the meeting, that an agenda item (including pre-distributed materials, if any) is scheduled that raises concerns about competition law, the Secretariat of the JMAA shall promptly report such concerns to the Secretariat of the JMAA. (2) If the Secretariat determines, based on reports from the participants of the meeting, that an agenda item (including pre-distributed materials, if any) is scheduled, the Secretariat shall postpone the meeting or have a lawyer present at the meeting.
  4. The secretariat of the JPCA should, in principle, attend the meeting.
  5. Discussions at the meeting should not exceed the scope of the planned agenda.
  6. The Secretariat, Chairperson and attendees of the meeting should immediately express any competition law concerns regarding the content of the discussion, and the Chairperson, upon receipt of such expression, should postpone the discussion until such time as the concerns have been discussed with the attorney.
  7. The Secretariat of the Pharmaceutical Association shall prepare minutes of the meeting and circulate them to the attendees.

2. Prohibited matters regarding the content of meetings

Member companies and executives and employees of the Pharmaceutical Manufacturers Association of Japan (PMAJ) shall not discuss or exchange information with other member companies regarding the following matters concerning products or services sold, purchased or provided by the member companies.

  1. Prices, pricing strategies, price structures, discounts, credit terms, sales costs, production costs, etc. of member companies
  2. Sales volume, sales capacity, production volume, production capacity, inventory volume, etc. of each member company
  3. Sales regions, production regions, sales destinations, etc. of member companies
  4. Investment plans of each member company (including investment and discontinuation of facilities and development of new technologies) Sales plans, production plans, demand forecasts, demand trends, etc.
  5. Supply restrictions, allocation of customers and sales territories, non-purchase (sale) of specific suppliers and customers, resale price restraints, etc.
  6. Other matters that may violate competition laws.

3. Compliance education

(i) Member companies and the Secretariat of the JRA should make these Guidelines known to their respective executives and employees, and conduct training sessions on these Guidelines and other competition laws as necessary to improve their knowledge and awareness of these Guidelines.

4. Retention of minutes, etc.

The Secretariat of the JCMA should keep this Guideline, meeting agendas and minutes, policies and statements regarding compliance with competition laws, and other documents that can be used as evidence of compliance with competition laws for a period of time separately determined by the JCMA.

These Guidelines shall become effective as of July 1, 2015.

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