Discover the latest updates on pricing legislation in Belgium
The Belgian Royal Decree of 29 November 2024, amending the Royal Decree of 10 April 2014, has officially come into effect. This update revises the conditions, timelines, and practical procedures for submitting price-setting and price increase requests for medicines. New submissions must comply with the updated regulations. But what exactly has changed, and what does this mean for you? Read our overview!
1. Exemption from the Old Drugs Cliff (ODC)
Products that are reimbursed for 12 years but have not yet lost their patent protection can request an exemption from the ODC. Under the new legislation, the request must be submitted six months prior to ODC, and the procedure will take 90 days.
2. New pricing commission
A new Pricing Commission met at the beginning of December 2024, consisting of three sections: reimbursable medicines, non-reimbursable medicines and implants and hearing aids. Members may participate in one or more sections depending on their affiliation and expertise.
3. Updated Royal Decree of 10/04/2014 on pricing requests
- Norway is now included as a reference country alongside EU countries.
- The overview of EU + NO ex-factory prices must specify whether the products are reimbursed or not, and provide the cost per unit.
- Comparisons with Belgian competitors must indicate the treatment cost.
- Generics, hybrids, and copy medicines can follow the calculations outlined in a Circular Letter, which became applicable alongside the Royal Decree update.
- Price increases for generics, hybrids, and copy medicines may exceed the prices mentioned in the Circular Letter if there is a risk of supply shortages. In such cases, the dossier must comply with Article 4 or 12, requiring a full dossier including Cost-Price Structure and Calculated Justifications.
What this means for you
We have updated our Working Instructions to reflect the new legislation. If you are planning to submit dossiers in the coming days or weeks, we recommend incorporating these updates into your approach.
Do you have questions about the new legislation? Our team is here to help.
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