Starting from 1 January 2026, Belgium will allow the use of innovative therapies for severe or life-threatening conditions even before they receive official approval from the European Medicines Agency (EMA), reports Le Soir, citing information from the office of Health Minister Frank Vandenbroucke.
The new procedure, named “Early and Fast Equitable Access,” is part of a reform of the medication reimbursement system that is still being developed.
This system aims to enable reimbursement for innovative medicines that have demonstrated clear potential through clinical studies, especially for conditions with no alternative treatments available in Belgium.
The National Institute for Health and Disability Insurance (RIZIV) will set the criteria that products must meet to qualify. An expert committee will evaluate the applications.
Pharmaceutical companies wishing to introduce their medicine in Belgium through this procedure must also commit to applying for a European market authorisation from the EMA within six months.
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