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New Belgian Healthcare Act: Impact on the health sector

The Belgian law of 30 October 2018 concerning several amendments to legislation applicable in the healthcare sector (the Healthcare Act) was published on 16 November 2018. The Healthcare Act introduces the following changes:

  • Introduction of mandatory electronic prescriptions. However, a royal decree has yet to set the date for the introduction of the electronic prescription regime and the end of paper prescriptions.
  • Clarification of various aspects of the law of 7 May 2017 regarding clinical trials. For example, it is now expressly stated that, subject to certain conditions, a nurse may carry out the necessary actions to obtain informed consent from clinical trial participants.
  • Modification of the law of 10 May 2015 regarding healthcare professionals, most notably in relation to several provisions on the opening, transferring and merging of pharmacies. It is now clarified that the “establishment permit” is personal and cannot be transferred. In addition, the conditions are specified under which pharmacies may use a location adjacent to the pharmacy, which is not covered by the establishment permit, to carry out its activities. The physical delivery of medicines must however still take place at the location covered by the establishment permit. However, royal decrees must be adopted to further implement these changes.
  • Introduction of a lower minimum fine of EUR 250.00 (increased in accordance with the Belgian indexation mechanism) for retailers contravening the ban on tobacco advertisements. The fines for manufacturers, importers, printers and publishers (which are higher) remain unchanged.
  • Insertion of a new legal provision relating to the information that healthcare professionals may provide to the public in connection with their practices. The law imposes less restrictive measures on dentists informing the public about their practices, but at the same time regulates advertisements for healthcare practices for all healthcare professionals.

This article was co-authored by Lola Stenuit. 

A prior version of this post was originally published by the same authors in Practical Law – Life Sciences, December 2018 Issue (Thomson Reuters).

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