Three novelties in the Belgian reference reimbursement system relevant for patent litigation

The Belgian Act of 6 November 2023 introduces three novelties in the Belgian reference reimbursement system which are relevant for patent litigation:

1. An innovator can now obtain the deferral of the opening of the cluster not only on the basis of infringement of a patent relating to its main active ingredient (such as a product patent) but on the basis of any patent (including for example a dosage regimen patent) and of a data exclusivity violation. Such deferral can be achieved by launching preliminary injunction proceedings or accelerated proceedings on the merits on the basis of patent infringement or a data exclusivity violation and sending a copy of the deed initiating these proceedings to the National Institute for Health and Disability Insurance (“NIHDI”) at least 20 days before the new reimbursement basis comes into force.
2.  If an innovator obtained the deferral of the opening of the cluster and a final court decision later allows the generic to be marketed, then the manufacturer of the original medicine will now be liable vis-à-vis the Belgian State for the extra cost caused by the deferral of the reduced reimbursement basis.
3. For products for which the reimbursement basis is reduced as of 1 January 2023, the opening of the cluster is no longer final. If the clustered opened due to generic entry on the market, and within 24 months the generic becomes unavailable as a result of (i) alleged patent infringement or a data exclusivity violation, (ii) suspension of its registration or (iii) a proven case of force majeure, then the reimbursement basis of the original medicine (and, where applicable, the retail price), will revert back to its initial amount. The same applies for an original medicine which had been withdrawn from the list of reimbursable medicines: it can be reinstated on the list at its initial amount and retail price. Both measures must be notified to the NIHDI at least 20 days before the monthly application of the reference reimbursement system.

These changes largely benefit originators but at the same time require them to exercise caution in using these new tools. For example, originators have more basis to prevent the opening of the cluster, but will be liable towards the Belgian State if they are proven wrong later on. Also, the original reimbursement basis can be reinstated if the generic becomes unavailable, but this can be used by generic manufacturers in preliminary injunction cases to reassure the judge that opening the cluster is now no longer final. So there’s something in it for everyone.