transparency obligations overview

Latest update: 7 March 2019 | Important Notes

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.)

Medical Device Companies

BVMED & SPECTARIS are both members of MedTech: https://www.medtecheurope.org/about-us/members/.

Member Associations should transpose the Code at the national level by 1 January 2020 (see PART 3 Procedural Framework, under 2. Transposition Obligations of the MedTech Code).

SPECTARIS recommends to its members to disclose as of 1st January 2020 Educational Grants on the MedTech Europe Transparency platform.

The overview provided here is based on the MedTech Europe Code of Ethical Business Practice.

What is reported:

If not already obliged by local laws/regulations, companies need to make public the aggregate spend regarding educational grants on a yearly basis.

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 provided reflects the 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 case it is based on codes of conduct, your company only needs to disclose the transfers of value on the mentioned due date if your company is a member of the association that follows that code.
  • Including a jurisdiction in the Legislative Watch does not guarantee that jurisdiction is available for reporting via the MediSpend Transparency Reporting Solution.
  • Reporting date normally means the date the transfers of value need to be published. The deadline for e.g. submission/sending the complete information to the authority could be before that date, for example to give HCPs and/or HCOs and/or the authority/association who publishes the information, the possibility to check the data the pharmaceutical companies/medical device companies are going to disclose.
  • The information does not take into consideration (unless explicitly mentioned):
    • 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)


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