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Belgium
transparency obligations overview

Latest update: 14 September 2018 | 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

Notes

Some codes describe transparency obligations. See Chapter 5bis: Transparency of the Code
See part III of the Mdeon Code
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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