Guidelines Concerning Appropriate Competition in Japan Pharmaceutical Manufacturers Association Meetings

July 1, 2015

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The Japan Pharmaceutical Manufacturers Association ("JPMA") (hereinafter referred to as "JPMA") has established the following guidelines to strengthen and facilitate the compliance system by JPMA's member companies (hereinafter referred to as "Member Companies") The JPMA established the "JPMA Charter of Corporate Behavior" in 1997 and the "JPMA Compliance Program Guidelines" in 2001 (the Guidelines were revised in 2011) to strengthen and facilitate the operation of a compliance system by the member companies of the JPMA (hereinafter referred to as "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.
JPMA has now formulated a new set of guidelines for conduct (hereinafter referred to as the "Guidelines") in response to the IFPMA Guidance on Appropriate Competition formulated by the International Federation of Pharmaceutical Manufacturers' Associations (IFPMA) in November 2014. The IFPMA has formulated a new set of Guidelines for Conduct (hereinafter referred to as the "Guidelines"). The Guidelines are designed to ensure that executives and employees of member companies and JPMA are aware of the Antimonopoly Law and other applicable laws and regulations at meetings organized by JPMA (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 JPMA must be fully aware that any violation of the Competition Law may result in severe legal sanctions and loss of social credibility, 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 the attendees must promptly report to the JPMA secretariat any concerns regarding the competition law in the circulated agenda.
  3. If the JPMA secretariat 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 JPMA shall promptly report such concerns to the secretariat of the JPMA. (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 JPMA shall, in principle, attend the meeting.
  5. Discussions at the meeting should not exceed the scope of the scheduled agenda.
  6. The JPMA secretariat, chairperson and attendees should immediately express any competition law concerns about the content of the discussion, and the chairperson should postpone the discussion of any such concerns until after consultation with the attorney.
  7. The JPMA's secretariat shall prepare minutes of the meeting and circulate them to those present.

2. Prohibited matters regarding the content of meetings

(2) Officers and employees of member companies and JPMA 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 territories, production territories, 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 areas, non-purchase (sale) of specific suppliers and customers, resale price restraints, etc.
  6. Other matters that may violate competition laws.

3. Compliance education

(i) The member companies and the JPMA's secretariat shall make these Guidelines known to their respective officers and employees, and conduct training sessions on these Guidelines and other competition laws as necessary to improve their knowledge and raise their awareness.

4. Retention of minutes, etc.

The JPMA secretariat shall keep this Guideline, meeting agendas and minutes, policies and statements regarding compliance with the Competition Law, and other documents that can be used as evidence of compliance with the Competition Law, for a period separately determined by the JPMA.

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

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