Chapter 1. Notification and Publication of Conflict of Interest in Relation to Research Presentations as a Member of the Society

Article 1. Notification for research presentations

When members of the Society give research presentations at Annual Meetings, they shall notify matters relating to conflict of interest prescribed in Appendix 1 in advance to the Secretariat of the Society, using a separate designated form.

Article 2. Publication of notified matters

The notified matters in the preceding article shall be disclosed, as appropriate at the time of research presentations at Annual Meetings held by the Society, or in journals (including abstracts at Annual Meetings) where the Society is involved in their publication.

Chapter 2. Handling of Conflict of Interest Matters in Relation to Activities as Officers of the Society

Section 2.1. General Provisions: Management, Use, and Publication of Conflict of Interest Information

Article 3. Principles regarding management

1. Conflicts of interest which are disclosed and reported to the Society by the individuals concerned on the basis of these Bylaws shall be referred to as conflict of interest information and handled in accordance with provisions prescribed in the Bylaws.
2. Conflict of interest information shall be stored and handled in the same manner as personal information at the Secretariat of the Society. Appropriate provisions shall be separately prepared for the management of this information.

Article 4. Deletion of unnecessary information

The conflict of interest information disclosed by Directors, Auditors, or committee members who have completed their term of office and by individuals whose appointment to a committee member has been withdrawn shall be deleted from the records of the Society, two (2) years after the completion of the term of office and immediately after the determination of the withdrawal of appointment, respectively. However, this shall not apply when the Board of Directors determines that it is inappropriate to delete the information. In cases where the information has previously been published or the review stipulated in the provisions of Section 2.6 has been conducted, documents and data relevant to previously published information and the review shall be excluded from disposal or deletion.

Article 5. Internal use of conflict of interest information

1. In order to assess whether or not conflict of interest exists and its degree between a relevant individual and the Society, and in order to take action based on the assessment, Directors, relevant officers and associated institutions of the Society may use conflict of interest information as necessary in accordance with these Bylaws. This includes explaining specific situations causing a conflict of interest to Society members not mentioned above.
2. The use of conflict of interest information based on the preceding paragraph shall be limited in scope to that which is necessary. It shall not be disclosed to individuals other than relevant individuals as described in the preceding paragraph.

Article 6. Disclosure and publication of conflict of interest information

1. Conflict of interest information, in principle, shall not be disclosed to the public with the exception of the cases in the preceding article.
2. Conflict of interest information may be disclosed or published inside or outside the Society to the extent necessary by means of a consultation with the Board of Directors when necessary to ensure social and legal accountability in relation to activities of the Society, Committees (including auxiliary permanent subcommittees) and temporary committee activities. This does not prevent an appointed Director in charge making decisions with the advice from the Conflict of Interest Committee.
3. In cases where the preceding paragraph applies, the persons concerned whose conflict of interest information is to be disclosed or published may express their opinions to the Board of Directors or the appointed Directors in charge of the decision. This shall not apply in cases where the situation dictates the necessity of taking the immediate action of disclosure or publication and there is no time for further discussion.

Article 7. Conflict of Interest Committee

1. The Conflict of Interest Committee shall be composed of a few number of Directors appointed by the Board of Directors, Councilors and one (1) external committee member.
2. In accordance with the detailed enforcement regulations, a Director appointed by the President of the Board of Directors, JSMO by way of a resolution of the Board shall serve as the Chair of the Conflict of Interest Committee.
3. The Conflict of Interest Committee shall handle conflict of interest issues in accordance with provisions of these Bylaws.
4. With regard to reporting of conflict of interest matters and handling of conflict of interest information in relation to members of the Conflict of Interest Committee, provisions for committee members apply. Provisions for external committee members shall be separately stipulated.

Section 2.2. Directors and Auditors

Article 8. Reporting of conflict of interest matters by the Directors and Auditors

1. Until the Officers are elected at the General Assembly, the Directors and Auditors of the Society shall report in writing the primary matters to be reported relating to conflict of interest prescribed in Appendix 2 to the Board of Directors in advance of the assumption of office.
2. The Directors and Auditors of the Society shall additionally report required matters to the Board of Directors when they execute their duties in the following situations where:
   • (1) Conflict of interest of the Society needs to be explained;
   • (2) Conflict of interest of concerned officers needs to be explained when they handle individual cases;
   • (3) The Board of Directors specifies secondary matters to be reported and requests their report;
   • (4) The Conflict of Interest Committee identifies matters to be reported.
3. If the Conflict of Interest Committee indicates that there is a problem with a Director's assumption of office or his/her involvement in a specific case with regard to reported conflict of interest matters, a meeting of the Board of Directors shall be held immediately to determine whether or not the Board of Directors approves the indication. If the indication is approved, the relevant Director shall resign or avoid involvement in the case.

Article 9. Reporting the changes in conflict of interest matters

If any changes occur in conflict of interest matters, the Directors and Auditors shall immediately report the detail of the changes to the Board of Directors.

Section 2.3. Presidents and Vice-Presidents of Annual Meetings and Committee Chairs

Article 10. Presidents and vice-presidents of Annual Meetings

1. Presidents and vice-presidents of Annual Meetings held by the Society shall report in writing the matters prescribed in Appendix 3 for presidents and vice-presidents of Annual Meetings to the Board of Directors in advance of the selection. If some of the required information has already been reported as a Director for example, duplicated information need not be reported.
2. If any changes occur in conflict of interest matters during the term of office, presidents and vice-presidents of Annual Meetings shall immediately report the changes to the Board of Directors.
3. The Board of Directors shall take into account reported conflict of interest matters when considering the selection of presidents and vice-presidents of Annual Meetings as well as the suitability of them in holding office.

Article 11. Committee Chairs

1. Committee Chairs, in advance of their selection, shall report to the Board of Directors in writing the matters prescribed in Appendix 3 for Committee Chairs, and if applicable, any matters specific to each committee specified by the Board of Directors.
2. If any changes occur in conflict of interest matters, Committee Chairpersons shall immediately report the details of changes to the Board of Directors on each occasion.
3. The Board of Directors shall take into account reported conflict of interest matters when considering the selection of Committee Chairs as well as the suitability of them in holding office.

Section 2.4. Committee Members

Article 12. Reporting conflict of interest matters and extension of the scope of reporting

1. An individual appointed to a committee member shall report in writing the primary matters to be reported prescribed in Appendix 4 to the Committee Chair upon taking up the appointment.
2. When necessary for specific activities in an individual committee, specific provisions for the committee may be stipulated so that more detailed and extended reports can be made.

Article 13. Procedures in cases where conflict of interest is suspected

1. When considering the matters reported on the basis of the preceding article, a Committee Chair may withdraw the appointment of a committee member following a discussion with him/her if, as a result of consultation with the Conflict of Interest Committee, there is a suspicion that his/her interest and that of the committee activity would conflict. The Committee Chair shall clearly indicate the reasons in writing for the withdrawal of the appointment.
2. When a Committee Chair confirms that no potential conflict of interest exists in relation to the appointment of a committee member, the concerned person shall be appointed and the Committee Chair shall report this decision to the Board of Directors along with the report submitted based on the preceding article.

Article 14. Request for a review

If a candidate for committee member expresses objections to the Committee Chair's withdrawal of the appointment, he/she may request a review by the Conflict of Interest Committee in order to seek cancellation of the withdrawal within seven (7) days from the receipt of the notification of withdrawal.

Article 15. Consideration of conflict of interest matters

A Committee Chair shall consider reported conflict of interest matters with regard to specific activities of each committee member within the committee.

Article 16. Secondary reporting

A Committee Chair may request each committee member to report, in writing, the secondary matters to be reported prescribed in Appendix 4 with regard to the member's specific activities within the Committee if necessary. The Committee Chair shall take into account the reported conflict of interest matters in connection with the member's specific activities within the Committee.

Article 17. Changes in conflict of interest matters and their reporting

If any changes occur in conflict of interest matters in their term of office, committee members shall immediately report the detail of the change to their Committee Chair. The Committee Chair shall take into account the disclosed conflict of interest matters in connection with the members' specific activities within the Committee.

Section 2.5. Members of Extraordinary Committees etc

Article 18. Application of provisions to committee members

1. When Committees are specially established (including subsidiary bodies, such as working groups and subcommittees; hereinafter "Extraordinary Committees") based on a resolution by the Board of Directors or Permanent Committees, the members of Extraordinary Committees may if necessary be required to report conflict of interest matters,. In these cases the provisions of the preceding section shall apply.
2. When the preceding paragraph applies, the Board of Directors or the Chairs of Permanent Committees may set forth provisions different from those matters prescribed in Appendix 4, provided these apply only within the Extraordinary Committee concerned.

Section 2.6. Review Procedures

Article 19. Request for a review

1. If the appointment of a committee member has been withdrawn pursuant to Article 13, Paragraph 1, (hereinafter, this includes withdrawal of an appointment to the involvement in an Extraordinary Committee based on Article 18), the person concerned with any objection to the withdrawal may request a review by submitting a review request form addressed to the Conflict of Interest Committee to the Secretariat of the Society during the period prescribed in Article 14.
2. A review request form shall state concisely in writing specific counterarguments and objections against the reasons for withdrawal indicated by the Committee Chairs. In this request, additional associated information may also be presented in writing to demonstrate the basis for rebuttal in addition to the information that has already been disclosed to the Committee Chairs. The additional information shall be treated as conflict of interest information if the rebuttal is justified.

Article 20. Handling of review request forms and submission of supplemental documents and materials

1. On receiving a review request form, the Secretariat shall immediately send a copy of the form to the Chairs of the Committee concerned and members of the Conflict of Interest Committee. If materials relating to the additional information have also been submitted, the Secretariat shall send only a list of the materials. The Chair of the Committee concerned and members of the Conflict of Interest Committee may read the materials at any time at the Secretariat.
2. An individual requesting a review may submit documents supplemental to the review request form and associated materials until seven (7) days preceding the first Committee meeting for the review. In this case the provisions of the preceding paragraph shall apply.

Article 21. Review procedures

1. On receiving a review request, the Conflict of Interest Committee shall hold a meeting to conduct the review within 14 days to 1 month.
2. The Conflict of Interest Committee shall conduct hearings with the Chair of the Committee concerned and the individual requesting the review in person to hear their opinions, except when the Chairs or individual concerned does not attend on the designated date of the hearing.
3. The Conflict of Interest Committee shall come to a decision on the review within one (1) month from the date of the first Committee meeting unless there are any special circumstances.

Article 22. Finality of the decision by the Conflict of Interest Committee

The decision on the review request for the withdrawal of an appointment to a Committee by the Conflict of Interest Committee shall be final.

Supplemental provisions

Article 1. Date of enforcement

These Bylaws shall come into effect on April 1, 2008.

Article 2. Special regulations on the application of the Bylaws to officers

Regarding officers of the Society who are already holding office at the time of the enforcement of the Bylaws, the Bylaws shall apply, requiring them to submit the relevant reports.

Article 3. Date of enforcement of revised Bylaws

The revised Bylaws shall come into effect on March 20, 2010.

Appendix 1. Matters to be Reported by Presenting Authors at Annual Meetings

When presenting at Annual Meetings, (1) the presenting author (or the representative presenting author if several persons are presenting a single title) and (2) a principal investigator (investigator) involved in the research on which the presentation is based shall report the following by the designated deadlines.

Companies and so forth subject to be reported (hereinafter "subject companies") shall be companies, organizations and bodies that manufacture pharmaceutical products and medical equipment, or those which conduct medical related research. These include companies and bodies that engage in activities to fund medical research or activities related to medicine or healthcare. Companies involved in the research on which the presentation is based shall also be subject to disclosure even if they are not specified above.

1. [Main duty] The name of the affiliated institution and their position or title at the affiliated institution (present post).
2. [Additional duties] If the presenting author serves as an officer or personnel at subject companies outside the main duty, the name of subject companies.
3. [Advice etc.] The names of subject companies other than institutions or companies aforementioned in 1 or 2, from which the presenting authors are rewarded continuous income such as salary, remuneration (for continuous services; e.g. advisory fees), patent royalties etc amounting to 1,000,000 yen or more per year.
4. [Stocks and equities] The names of subject companies when the presenting authors, or their relatives who share the same livelihood, gain profit (e.g. dividends; including stock dividends) from the owned stocks and equities of the subject companies amounting to 1,000,000 yen or more during the fiscal year (hereinafter, this refers to the period from April 1 to March 31) previous to the time the form is submitted, or the names of subject companies if the presenting authors or their relatives who share the same livelihood own 5% or more of the stocks and equities of the companies involved in the research on which the presentation is based.
5. [Lecture fees etc.] The names of subject companies when the presenting authors or their relatives who share the same livelihood are paid annual lecture fees of 500,000 yen or more (when calculated by each company / individual) in the fiscal year previous to the time the form is submitted.
6. [Manuscript fees] The names of subject companies when the presenting authors or their relatives who share the same livelihood are paid annual manuscript fees or remuneration (relating to one-off services such as consultation fees) of 500,000 yen or more (when calculated by each company / individual) in the fiscal year previous to the time the form is submitted.
7. [Research funding and contributions] The names of subject companies when the affiliated institutions of the presenting authors or their relatives who share the same livelihood (with either as the "addressee") are provided annual research grants (including contributions and trust accounts) of 2,000,000 yen or more (when calculated by each company / individual in the previous?? period from April 1 to March 31).
8. [Contracted research] The names of subject companies when contracted research projects of which the presenting authors or their relatives who share the same livelihood are the principal investigator are provided with an annual research fund of 2,000,000 yen or more in total (when calculated by company / individual in the period from April 1 to March 31) in the fiscal year previous to the time the form is submitted .If a research contract agreement has been signed with the affiliated institution, the amount of research funding shall be the amount already paid or to be paid to the institution.
9. [Specialist advice and testimony] The names of subject companies when, in the fiscal year previous to the time of submission of the form, the presenting authors or their relatives who share the same livelihood are rewarded with 1,000,000 yen or more in total per company (when calculated by company / individual) for specialist testimony, appraisal, advice, evaluation or comment, upon request from the parties or subject companies in similar circumstances involved in lawsuits or corresponding disputes. This shall apply when these testimonies etc. are provided as a result of a court order.

Appendix 2. Matters to be Reported by Directors and Auditors

Companies or institutions subject to be reported (hereinafter "subject companies") shall be companies, organizations and bodies that manufacture pharmaceutical products and medical equipment, or those which conduct medical related research. These include companies and bodies that engage in activities to fund medical research, or in activities related to medicine or healthcare or their evaluations. Amounts shall be calculated based on a period of one year or one fiscal year from April 1 to March 31.

I. Primary matters requiring disclosure

1. The name of the affiliated institution and their current position or title at the affiliated institution . If the Directors or Auditors serve as officers or personnel at subject companies outside their main duties, the names of subject companies.
2. The names of subject companies when outside their main duty Directors or Auditors, or their relatives who share the same livelihood are rewarded continuous income such as salary, remuneration (for continuous services; e.g. advisory fees), or patent royalties amounting to 1,000,000 yen or more annually in the two (2) fiscal years previous to the assumption of office, as well as the amount paid or expected to be paid in the relevant period for each company/recipient.
3. The names of subject companies when the Directors or Auditors, or their relatives who share the same livelihood are paid lecture fees of 500,000 yen annually or more in the two (2) fiscal years previous to the assumption of office, as well as the amount paid in the relevant period for each company/recipient.
4. The names of subject companies when the Directors or Auditors, or their relatives who share the same livelihood, are paid a temporary annual salary of 500,000 yen or more (including manuscript fees and remuneration (which are related to one-off jobs such as consultations) in the two fiscal years previous to the assumption of office, as well as the amount paid in the two (2) previous fiscal years for each company/recipient.
5. The names of subject companies when contracted research projects of which the Directors or Auditors, or their relatives who share the same livelihood, are the principal investigators are provided with an annual research fund of 2,000,000 yen or more in total in the two (2) fiscal years previous to the assumption of office. If a research contract agreement has been signed with the affiliated institution, the amount of research funding shall be amount already paid or to be paid to the institution.
6. The names of subject companies when the affiliated institutions of the Directors or Auditors, or their relatives who share the same livelihood (with either as "addressee"), are provided annual research grants (including contributions and trust accounts) of 2,000,000 yen or more in the two (2) fiscal years previous to the assumption of office.
7. The names of subject companies of which the Directors or the Auditors, or their relatives who share the same livelihood, are the representative, officer or executive, or of which they own 10% or more of the entire stock, capital or other investment in the two (2) fiscal years previous to the assumption of office, as well as the specified period of time they are involved, and a description of their involvement. If non-disclosure agreements prevent the disclosure of relevant information or limit the extent of disclosure, the information shall be disclosed to an extent which does not violate the non-disclosure agreement, together with a description of the situation.
8. The names of subject companies when in the fiscal year previous to the assumption of office, the Directors or Auditors, or their relatives who share the same livelihood, are rewarded with 1,000,000 yen or more in total per company for specialist testimony, appraisal, advice, evaluation or comment upon request from the parties or subject companies in similar circumstances involved in lawsuits or corresponding disputes. This shall apply to testimonies as such made as a result of a court order.
9. The name of subject companies, when the Directors or the Auditors, or their relatives who share the same livelihood own 10,000,000 yen or more of the subject companies' stocks, capital or other equities in the fiscal year previous to the start of the term of office,, as well as names of the stockholders, the number of stocks owned (number of units) and their value. The value shall be the market value if there is one, or if not, face value shall apply.

II. Secondary matters to be reported (Additional matters for disclosure)

Matters that the Board of Directors recognizes should be disclosed.

Appendix 3. Matters to be Reported by Committee Chairs and Presidents and Vice-Presidents of Annual Meetings

I. Matters to be reported by Committee Chairs

The same provisions apply as those for Directors and Auditors.

II. Matters to be reported by presidents and vice-presidents of Annual Meetings

The same provisions apply as those for Directors and Auditors.

Appendix 4. Matters to be Reported by Committee Members

I. Primary matters to be reported (matters to be reported when appointed to a committee)

Persons appointed as committee members shall report items 1 or 8 in the primary matters to be reported for Directors and Auditors prescribed in Appendix 2.

II. Secondary matters to be reported (Additional matters for disclosure)

If a committee member or his/her relatives who share the same livelihood are involved in companies, organizations or bodies (including those not covered by the primary matters to be reported, hereinafter "interested companies") that have interests in the activities of committees or their outsourced operations, committee members shall report the matters described in item 9 of the primary matters to be reported and the secondary matters to be reported for the Directors and Auditors in relation to the interested companies.