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Belgium
transparency obligations overview

Last reviewed: January 2024 | Important Notes

Report Due Date

31 May (published on 30 June)

Authority

Federal Agency for Medicines and Health Products (“FAMHP”)

Who Must Report

Pharmaceutical companies and medical device companies

Covered Recipients

Healthcare professionals, healthcare organizations & patient organizations

Pharmaceutical Companies and Medical Device Companies

What is reported:
Per the Belgian Transparency Platform (Betransparent.be):

The categories of premiums and benefits as referred to above are as follows:

  1. With regard to premiums and benefits granted directly or indirectly to healthcare professionals:
    • The contributions to the costs of scientific manifestations, such as registration costs and travel and subsistence costs.
    • The fees, payment and reimbursement of costs for services and consultancy.
  2. With regard to premiums and benefits granted directly or indirectly to healthcare organisations:
    • Contributions to the cost of scientific manifestations, such as registration and travel and subsistence costs, and sponsorship agreements with healthcare organisations or with third parties appointed by these organisations to organise the scientific event.
    • Fees, payments and reimbursement of costs for services and consultancy.
    • Donations and grants that support healthcare.
  3. With regard to premiums and benefits granted directly or indirectly to patient organisations:
    • Fees, payments and reimbursement of expenses for services and consultancy:This can be a reasonable fee granted to a patient organisation for its services as an expert or consultant, e.g. participation in a meeting with patient experts; speaker services; giving advice to a pharmaceutical or medical device company on priorities for patients in clinical trials or the relevance of specific research for patients.
    • Financial or other support:This includes amongst others financial support granted to a patient organisation for the organisation of a scientific event; to support disease awareness campaigns; to support the development of informative material for patients or a website for patients.The disclosed data contains, inter alia, the amount of the premiums and benefits and the name of the beneficiary. However, premiums and benefits granted for experiments are disclosed on a non-individual, aggregate basis.

How to Report

Report through:
beTransparent website

Resources

www.betransparent.be/ Moniteur-Belge-2016-12-27-Belgisch-Staatsblad.pdf
beTransparent website

Note

Pharma: members of pharma.be also need to report based on art. 49 of the pharma.be-Code (reporting on ToV to patient organizations): https://pharma.be/nl/pharma-be/deontologische-code.html

“Each pharmaceutical company shall make available to the public once a year a list of patient organisations to which it provided support during the past calendar year as referred to under Article 46, first paragraph, of the present Code. It mentions for each patient organisation the nature of the support provided. The description must be sufficiently complete to allow the average user to form a picture of the scope of the support. The description must state the amounts of money involved if the support is financial and the costs invoiced. If considerable non-financial support is involved that cannot be ascribed a meaningful financial value, the non-financial benefit received by the patient organisation must be described clearly.”

(…) “Each pharmaceutical company likewise publishes an annual list of patient organisations to which it has provided considerable services on a contractual basis. This list must contain a description of the nature of the services provided sufficiently complete to allow the average user to form a picture of the scope of the support, however without thereby disclosing confidential information. Moreover the companies must make known the total amount that they have paid per patient organisation in the period concerned.”

Device: Due to the legal disclosure requirements, no reporting is needed for beMedTech’s member companies on the MedTech Europe Transparency platform.

 

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 – in most cases – 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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