Belgium: Minister of Economy imposes maximum price for orphan drug

On 6 September 2019, the Minister of Economy announced in a communication that a maximum price for Leadiant Biosciences' orphan drug, CDCA, which is used to treat the rare neurological disease, cerebrotendinous xanthomatosis (CTX), had been imposed.

In Belgium, a drug manufacturer must file a request with the Ministry of Economy to fix the price of a drug or to request an increase of such price. A specific commission within the Ministry of Economy then produces an opinion on the request and finally, the Minister of Economy will adopt a final position based on this opinion. A similar process is followed in other European countries.

In the present case, the Minister of Economy followed the opinion of the commission and decided that the price of EUR14,000 per month requested by Leadiant Biosciences was too high and lowered it by 75%. The Minister stated that the requested price was outrageous as CDCA was previously available on the Belgian market for only a fraction of the price and used off-label (as it was approved for other therapeutic indications).

The Minister of Economy also used his injunctive powers to request that the Belgian Competition Authority prioritise a claim filed with it against Leadiant Biosciences earlier this year by the consumer protection group, Test-Achats, due to the fact that the price increase requested for the CDCA drug was a 300% increase of its previous price. This bold move reflects the broader tendency in Belgium and the EU to try to lower drug prices and thereby curtail the hefty and unjustified profits (according to the Minister) of the pharmaceutical industry.

This article was authored by Trainee Claire Caillol.

A prior version of this post was originally published by the same authors in Practical Law – Life Sciences, September 2019 Issue (Thomson Reuters).