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Germany
transparency obligations overview

Latest update: 14 September 2018 | Important Notes

Report Due Date

FSA: Annually, no later than six months from the end of the reporting period
AKG: Six months from the end of the reporting period

Authority

FSA
AKG

Who Must Report

FSA: The rules apply to all member companies of FSA (i.e. German companies and companies acting in Germany) regardless of whether any marketing authorisation has already been granted to the respective company
AKG: Members of AKG

Covered Recipients

HCPs and HCOs

Pharmaceutical Companies

What is reported:

FSA: The FSA Transparency Code provides for the following categories:

  • Donations and other unilateral payments
  • Payments in connection with further training events
  • Fees for service or consultancy contracts
  • Payments in connection with research & development

For each individual recipient, the disclosure must contain individual information, specifying the recipient’s name, regarding the totality of transfers of value granted during the reporting period to the extent that such benefits fall under the respective categories. However, the disclosure shall be made on an aggregated basis and without the individual recipients being named if such benefits fall under the category “research and development.

AKG: “All cash-equivalent benefits in connection with continuing education events pursuant to § 19, any other unilateral benefits and any benefits granted to members of the health professions or health organisations on the basis of reciprocal agreements, are to be published in an annual list which is available to the general public.” (See also “Transparency” guidelines issued by the Board. Not available in English. Refer to resources below.)

How to Report

FSA: The disclosure of the information shall be made on a publicly accessible website under the responsibility of the company. The information may also be published on a pan-European website of affiliated companies if the information relating to the member company of the FSA can be accessed there separately.

AKG: The list is to be broken down into the categories:

  1. Research and development
  2. Donations and other unilateral cash or non-cash benefits
  3. Cash-equivalent benefits inconnection with continuing education events
  4. Service and consultancy fees

Publication in the research and development category is to be in the form of an aggregated list. Publication in the other categories should generally enable allocation of the entry to individuals. In case of any legal grounds or grounds relating to the individual company which preclude individual publication, publication shall be in the form of an aggregated list. The list can be published on the company’s website and can also take the form of a reference to other publications.

Resources

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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