Belgium Creates Exceptional Regime for Temporary Reimbursement of Medicines
The Royal Decree of 26 January 2021, which entered into force on 13 February 2021, establishes a regime for the temporary reimbursement of medicines “under exceptional circumstances or in situations of force majeure” that must be defined by the Council of Ministers (the Royal Decree).
The temporary reimbursement will be achieved following a short procedure that only involves a proposal by the Service Medical Treatment of the National Institute for the Insurance of Disease and Invalidity (Dienst voor geneeskundige verzorging van het Rijksinstituut voor Ziekte-en Invaliditeitsverzekering/Service des soins de santé de l'Institut national d'assurance maladie-invalidité), an opinion by the Commission for the Reimbursement of Medicines (Commissie Tegemoetkoming Geneesmiddelen/Commission de remboursement des médicaments) (CRM) and a final reasoned decision by the Minister for Social Affairs and Public Health (Minister van Sociale Zaken en Volksgezondheid/Ministre des Affaires sociales et de la Santé publique). Crucially, the marketing authorisation holder (MAH) of the medicine at issue will not be heard. This is a dramatic departure from the regular reimbursement procedure governed by the Royal Decree of 1 February 2018 which can only be initiated by an application of the MAH and which provides for a repeated back and forth between the MAH and the CRM.
The temporary reimbursement is designed to ensure that patients will not be deprived of “proper therapeutical means” (deugdelijke therapeutische middelen/moyens thérapeutiques valables) for financial reasons or otherwise. The new regime came into being because of the Covid-19 pandemic, but its application clearly transcends this crisis.
The temporary reimbursement of a given medicine will apply during a stated period, during the time of the specific crisis that prompted the reimbursement or until the medicine becomes reimbursable as a result of a reimbursement decision which is based on a regular reimbursement application.