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Japan
transparency obligations overview

Latest update: 14 September 2018 | Important Notes
PHARMACUETICAL

Report Due Date

Each member company shall prepare its own in-house “Policy for Transparency” as a code of practice, referring to the Transparency Guideline for the Relation between Corporate Activities and Medical Institutions.

Authority

The Japan Pharmaceutical Manufacturer’s Association (“JPMA”)

Who Must Report

Pharmaceutical member companies of JPMA

Covered Recipients

Healthcare professionals (HCPs) and medical institutions
MEDICAL DEVICE

Report Due Date

No set due date, but during the company’s following fiscal year.

Authority

The Japan Federation of Medical Device Associations (“JFMDA”)

Who Must Report

Medical device member companies of JFMDA

Covered Recipients

Medical institutions, other organizations, medical professionals

Pharmaceutical Companies

What is reported:

There is no minimum threshold for reporting.

  • R&D expenses such as joint research expenses, research commissioning expenses, clinical study expenses (expenses related to clinical research in and after Phase 1), post-marketing clinical study expenses, adverse drug reaction/infection case reporting expenses, post-marketing surveillance expenses and other expenses
  • Payments related to academic research grants, including scholarship donations, general donations, donation to academic societies, etc., and expenses of co-sponsored conferences, etc.
  • Honoraria, including lecture fees, manuscript writing fee/supervising fees and consulting/commissioning fees
  • Payments related to provision of information, including expenses for meetings, lectures, educational sessions expenses as well as medical/pharmaceutical literature and other supplies
  • Other payments
  • Excluded payments:
    • Samples
    • Payments made by overseas affiliates
    • Payments made to recipients whose primary place of practice is outside of Japan
    • Payments to patient organizations

How to Report

Member companies are to establish in-house policy for transparency. It is desirable to declare the member company’s stance and include the following items in the in-house “Policy for Transparency”:

  • Disclosure method. The payments, etc. in the previous fiscal year shall be disclosed after financial closing through each company’s website, etc.
  • 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.
  • Targets of disclosure. (See above under “What is reported”.)

Note

JPMA members should also disclose relationships with patient organisations. See: Patient Organization Transparency Guidelines (not available in English)

Medical Device Companies

What is reported:

  • Research and development expenses
  • Academic research support expenses
  • Manuscript writing fees, etc.
  • Expenses related to information provision
  • Other expenses

How to Report

Draw up procedures to obtain approval for information disclosure from the medical institutions and other organizations (procedures for trust agreement as prerequisite for information disclosure, etc.).

Establish a system for the early compilation and release of payment information.

It is desirable that the company include the following items in its transparency guidelines:

  • Basic policies as a member company
  • Disclosure methods
  • Timing of disclosure
  • Scope of disclosure (see above under “What is reported”)
Important notes:
  • This information is provided for your convenience and should not be construed as legal advice. The applicability of these requirements to your organization depends on individual circumstances. The information is not exhaustive.
  • Kindly check with your legal department and do not depend solely on the information provided here. Moreover, the rules mentioned could be subject to interpretation of local authorities/courts in the applicable jurisdiction. Lastly, be mindful of the latest update mentioned above. These rules and regulations change frequently, so it is important to determine whether the information reflects that most recent changes and is still applicable.
  • Reporting dates are related to the transparency obligation regarding transfers of value by pharmaceutical companies and/or medical device companies (excluding suppliers of in vitro diagnostics) to HCPs and HCOs. These often are based on laws or rules in codes of conduct of industry associations. (In such cases, your company only needs to disclose the transfers of value on the mentioned due date if your company is a member of that association).
  • “Due date” means the date on which the transfers of value need to be published. For example, the deadline for submitting/sending the complete information to the authority could be before the due date to give HCPs/HCOs the opportunity to check the data that the pharmaceutical companies/medical device companies are going to disclose.
  • The information does not take into consideration:
    • Transparency related to clinical trials (unless it concerns transfers of value as mentioned above)
    • Transparency related to patient organizations (unless the patient organization is considered an HCO)
  • If your company is a member of MedTech/EFPIA (or if the industry association your company belongs to is a member of MedTech/EFPIA), the due dates are as mentioned above for MedTech/EFPIA (end of June), unless a law/regulation specifically states otherwise (e.g., the jurisdiction is suspended/exempted from following MedTech/EFPIA).

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