Belgium

The Belgian Health Authorities (FAMHP) have recently published a guidance document on the interpretation of Article 10 of the Law of 25 March 1964 regarding premiums and benefits. This document aims to further clarify the legal framework governing the granting of such premiums and benefits.

The guidance applies to all pharmaceutical and medical device companies concerned with medicinal products and medical devices for human use. The document is available in Dutch (NL) and French (FR) and can be found in the attachments.

The fundamental principle remains unchanged: there is a general prohibition on granting premiums and benefits to Healthcare Professionals (HCPs) and Healthcare Organisations (HCOs), except for the following three regulated exceptions:

  1. Gifts of limited value
  2. Participation in scientific events
  3. Fees for services

The guidance also addresses other types of financial contributions. Although these contributions do not fall under the above exceptions, such funding can take place under strict conditions.

The guidance provides specific clarification on what is permitted within these exceptions, including conditions, practical examples, and clear criteria for compliance.

You can find the NL and FR version of this guidance below:

NL: Richtsnoer voor de toepassing van artikel 10 van de wet op geneesmiddelen voor menselijk gebruik | FAGG

FR : Lignes directrices relatives à l’application de l’article 10 de la loi sur les médicaments à usage humain | AFMPS

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