Pharmaceutical CompaniesWhat 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.)
- 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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