The Japan Pharmaceutical Manufacturers Association
“Transparency Guideline for the Relation between Corporate Activities and Medical Institutions"

http://www.jpma.or.jp/english/policies_guidelines/pdf/transparency_gl.pdf

  1. Purpose
    The purpose of this Guideline is to gain wide understanding of the pharmaceutical industry’s contribution to life science such as medicine and pharmacy, and that corporate activities are conducted with high ethical standards, by making the relation between member company’s activities and medical institutions, etc. transparent. Each member company shall prepare its own in-house “Policy for Transparency” as a code of practice, referring to this Guideline.
  2. Contents of publication
    It is desirable to declare the member company’s stance and include the following items in the in-house “Policy for Transparency”.
    (1)Disclosure method
    The payments, etc. in the previous fiscal year shall be disclosed after financial closing through each company’s website, etc.
    (2)Timing of disclosure
    The payments in each fiscal year shall be disclosed in the following fiscal year. However, for “A. Research and development expenses” included in (3) Targets of disclosure, only the “annual total amount” shall be disclosed in the following fiscal year up to fiscal 2015. From fiscal 2016 and onwards, “annual total amount” and the items specified in (3) Targets of disclosure shall be disclosed from fiscal 2017.
    (3)Targets of disclosure
    A. Research and development expenses
    Research and development expenses include expenses of clinical studies, clinical trials for new drugs and post-marketing clinical studies conducted under public regulations such as the GCP ordinance. Also expenses for adverse drug reactions / infection case reporting and post-marketing surveillance activities that are conducted under public regulations such as GPSP ordinance and GVP ordinance are included.
    Joint research expenses
    (Clinical) (Note 1)Name of the relevant institution (Note 3) : Number of cases, XX yen
    (Others) (Note 2)Annual number of cases/total amount, name of the relevant institution (Note 3)
    (Clinical) (Note 1)Name of the relevant institution (Note 3) : Number of cases, XX yen
    (Others) (Note 2)Annual number of cases/total amount, name of the relevant institution (Note 3)
    Clinical study expenses (Clinical studies)
    Name of the relevant institution (Note 3) : Number of cases, XX yen
    Post-marketing clinical study expenses
    Name of the relevant institution (Note 3) : Number of cases, XX yen
    Adverse drug reaction / infection case reporting expenses
    Name of the relevant institution (Note 3) : Number of cases, XX yen
    Post-marketing surveillance expenses
    Name of the relevant institution (Note 3) : Number of cases, XX yen
    Other expenses
    Annual total amount

    (Note 1) Clinical: Expenses related to clinical research in and after Phase I
    (Note 2) Others: Expenses other than those for clinical research in and after Phase I
    (Note 3) As the “Name of the relevant institution”, “Name of the institution”, “Name of the organization within the institution”, or “Affiliation/title/name of an individual” shall be published based on the contents of the contract.

    B. Academic research support expenses
    Scholarship donations and general donations for promotion of academic research or research support, etc., donations to academic societies, etc. for supporting conferences, and expenses for co-sponsored conferences with academic societies, etc.
    Scholarship donation
    XX Department of XX University: Number of donations, XX yen
    General donation
    XX University (XX Foundation): Number of donations, XX yen
    Donation to academic society, etc.
    XXth XX Academic Society Meeting (XX Regional Meeting, XX Study Group Meeting): XX yen
    Expenses of co-sponsored conference, etc.
    XXth XX Academic Society Meeting, XX Seminar: XX yen
    C. Manuscript/writing fees, etc.
    Fees for lectures and writing or supervision of the manuscript for provision of scientific information, etc. on the company’s pharmaceutical products, medicine, and pharmacy or fees that are related to research and development, and fees paid for commissioning of operations including consulting contracts, etc.
    Lecture fees
    Professor (Director) XX, XX Department of XX University (XX Hospital): Number of services, XX yen
    Manuscript writing fee / supervising fees
    Professor (Director) XX, XX Department of XX University (XX Hospital): Number of services, XX yen
    Consulting / commissioning fees
    Professor (Director) XX, XX Department of XX University (XX Hospital): Number of services, XX yen
    D. Information provision-related expenses
    Expenses of lecture meetings and explanation meetings for providing information, etc. related to the company’s pharmaceutical products, medicine and pharmacy to healthcare professionals
    Expenses for meetings including lectures, etc.
    Annual Number of meetings and total amount
    Explanation meeting expenses
    Annual Number of meetings and total amount
    Medical / pharmaceutical literature, etc. supply expenses
    Annual total amount
    E. Other expenses
    Expenses for hospitality, etc as social courtesy
    Expenses for hospitality, etc.
    Annual total amount