Belgium
Starting January 1st, 2025, new legislation will come into force that requires the pharmaceutical industry to compensate for the additional costs caused by the unavailability of essential reimbursable medicines. This law aims to ensure patients still have access to vital medications when alternatives are unavailable on the Belgian market.
Scope:
If an essential reimbursable medicine is unavailable, it is checked whether there are reimbursable and available alternatives on the Belgian market. If no alternatives are available, the preferred option remains the importation of the unavailable medicine by the responsible company itself on the basis of an approved derogation by the FAHMP. If importation based on an approved derogation is not possible, the reimbursement of the additional cost of the alternative medicine is possible for a limited selection of essential medicines. For these cases, the shortage compensation allowance will be invoked.
Financing Mechanism:
From 1 January 2025, the FAHMP will impose an annual shortage compensation allowance. Companies that have at least one marketing authorisation (MA) (or parallel import license) on 1 April of year N, with at least one medicine on the list of reimbursable medicines, will have to contribute.
This contribution is based on an amount per MA of the above-mentioned company for one (or more) reimbursable medicines, and limited to what is necessary to cover the additional costs resulting from the unavailability of an essential reimbursable medicine from August 1 of year N-1 to July 31 of year N.
A maximum amount per MA is set by law. FAHMP divides the additional cost (RIZIV receivable) by the number of MAs. If this amount is lower than the legal maximum, the lower amount will be invoiced. If the amount is higher than the legal maximum, the maximum will be invoiced. The legal maximum is set to cover a cost of 3.6 million euros.
Since the legislation comes into effect on January 1st, 2025, the first compensation is planned for a shorter period (than described above), from January 1st, 2025, to July 31st, 2025. The industry’s contribution will be collected for the first time at the end of 2025, after FAHMP has received the receivable from RIZIV (incurred expenses within the scope of the compensation mechanism).
Legislative framework:
- RD Compensation: Royal Decree of 26 April 2024 amending the Royal Decree of 1 February 2018 establishing the procedures, deadlines and conditions regarding the compensation of the compulsory insurance for medical care and benefits in the cost of pharmaceutical specialties (published on 30 May 2024).
- Law of 18 May 2024 containing various provisions on health and finance (published on 4 June 2024), arts 21 – 24 and art 26.
- RD of 14 December 2006: arts 105, 105/2 (inserted by RD ‘special needs’) and 110 (amended by the aforementioned RD)