On Wednesday May 8^th 2024, the Belgian Parliament adopted a new law to combat the costs arising from the unavailability of medicinal products that subsequently have to be replaced by more expensive alternatives (the so-called “Onbeschikbaarheidsbijdrage / Contribution d’indisponibilité”). The new mechanism is outlined in Art. 21-24 and 26-29 of the new law.

The mechanism, which is intended to provide the National Institute for Health and Disability Insurance (NIHDI) with additional funds to cover medicine unavailability expenses, will be financed through a new annual tax on the MAs and parallel import licenses of reimbursed medicinal products, i.e., on those products listed in the NIHDI list of reimbursable medicinal products. The Federal Agency for Medicines and Health Products (FAMHP) will perform the invoicing tax. The amount of the tax is currently set at EUR 665.99 for the first MA or parallel import license within a medicinal product group and EUR 427.54 for subsequent MAs or licenses, but this amount can still be reevaluated based on the evolving needs of the NIHDI.

The law will soon be published in the Belgian Official Gazette and will enter into force on the 1^st of January 2025, after which the first invoices for this can be expected.

The new tax constitutes another interesting development for pharma companies as the Belgian government continues to reform its reimbursement landscape in line with the NIHDI 2023 roadmap. In fact, on the 2^nd of May, the Parliament already approved two additional reimbursement reforms with more interesting developments to follow for sure.
 

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