Frequently asked questions on medicine reimbursement in Belgium
Are you overwhelmed by the many pricing regulations and procedures in the Benelux healthcare system? e&a consultants is happy to help with clear-cut answers. Browse our frequently asked questions.
1. How long does a procedure for medicine reimbursement in Belgium take?
The standard procedure takes up to 180 days and starts once you have submitted your reimbursement dossier to the Commission for Reimbursement of Medicine (CRM). If needed, your company can request additional time to answer questions by the CRM or formulate a reply to their reports. These clock stops, limited to 90 days each, can prolong the 180-day procedure and can be requested up to two times throughout the procedure.
The royal decree of 1 February 2018 provides a detailed overview of the reimbursement procedure and deadlines. You can consult it here.
Need support in applying for medicine reimbursement? e&a consultants has the experience and legal knowledge to draw up strong dossiers and submit them to the right authorities.
2. How are medicine prices regulated in Belgium?
The Minister of Economy determines the pricing of medicine based on several factors, of which the most important ones are:
- The cost-price structure of the medicine, which includes all costs incurred to make the drug available to Belgian patients
- The price of your medicine in other EU countries
- The prices of comparable pharmaceutical products on the Belgian market
For the maximum ex-factory price of a drug, the FPS economy is guided by the royal decree of 10 April 2014, where you can find more information on the pricing procedure and requirements for a correct pricing dossier.
Do you want to submit a reimbursement request? Make sure your dossier includes
the price request sent to the FPS economy. e&a consultants can help you submit a complete and convincing dossier.
3. When may you enter into managed entry agreements?
A managed entry agreement (MEA) is a confidential agreement you enter into with the government in case there are clinical or budgetary uncertainties for your medicine at the time of application, e.g. it is not clear what the expenses will be for your drug or how many patients will need it, etc.
Have you submitted a reimbursement dossier for an orphan drug, a medicine with added value or a medicine that claims equal value to one currently in MEA? Then your dossier may end up in a MEA.
e&a consultants can support you throughout this process. We have extensive experience leading MEAs or if you want to lead them yourself, we can prepare your employees through effective role-play training.
4. What impact do EU medicine prices have on the Belgian pharma market?
Whenever a medicine has been reimbursable for 12 years in Belgium, the basis of reimbursement may decrease. The amount is limited by the EU6 safety net. This means a decrease in price cannot go below the lowest price of these six reference EU countries: Germany, France, the Netherlands, Ireland, Finland and Austria. This safety net only applies to original medicines without a generic or biosimilar alternative on the market.
You can find more information on the EU6 safety net here.
5. I want to bring my medicine to the market in Luxembourg. What do I have to do?
First, you need to apply for a marketing authorisation with the Luxembourg authorities, even if you already have a European authorisation. Afterwards, you will receive a country of reference for the composition of your pricing or reimbursement dossier. For example, if your medicine is available on the Belgian market, Belgium can be your country of reference. Your request can be submitted once your product is available in the country of reference.
Do you want to go to market in Belgium and/or Luxembourg? e&a consultants can write and submit strong and comprehensible dossiers for both countries.