The Belgian Constitutional Court (“CC”), on 6 November 2025, annulled some provisions of the Law of 18 May 2024 containing various provisions on health and finance, striking down the pharma industry ‘unavailability contribution’.
Background
Parts of the above Law sought to protect patients from bearing additional costs when reimbursable medicines become unavailable and must be replaced with non-reimbursable alternatives. To finance this, an ‘unavailability contribution’ was introduced, charged to pharma companies holding marketing authorisations or parallel import licences for reimbursable medicines, and calculated as a fixed amount per authorisation or licence.
Decision
In essence, the CC:
- followed the argument that the per-authorisation fee structure violated the equality/non-discrimination principle by treating different categories of MA holders the same: generics/biosimilars/parallel importers would hold more authorisations than originators, without the number of authorisations/licences necessarily being linked to the risk of unavailability;
- further accepted that holding multiple authorisations (e.g. for different dosages) or import licences from various Member States may in fact reduce the risk of unavailabilities rather than increase it, seemingly clashing with the idea that holding more authorisations/licences should mean contributing a larger share of the total unavailability contribution.
What’s next?
The unavailability contribution has been struck down for now, but the provision empowering the government to define the terms for compensating additional costs due to the unavailability of reimbursed medicines remains intact, allowing for an alternative form of unavailability contribution in the future.
The full judgment is available in Dutch and French.
ALTIUS’s Life Sciences team closely monitors regulatory developments in the pharma sector. For more information on this topic, please contact Kirian Claeyé ([email protected]) and Bart Junior Bollen ([email protected]).