Belgium

Belgian Constitutional Court overrules sales restriction for wholesale distributors of medicines

Kaat Van Delm

On 17 October 2019, the Belgian Constitutional Court rendered a final judgment , annulling Article 3.2° of the new legislation applicable to shortages of medicines in Belgium. The Article had banned the parallel export of medicines by Belgian wholesale distributors, requiring them to only supply medicines for human use to other Belgian wholesale distributors, licensed Read More

Belgium: Minister of Economy imposes maximum price for orphan drug

Claire Caillol

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 Read More

Belgian Constitutional Court suspends sales restriction for wholesale distributors of medicines

Kaat Van Delm

On 18 July 2019, the Belgian Constitutional Court suspended Article 3.2 of the legislation applicable to shortages of medicines in Belgium, after receiving multiple applications for both suspension and annulment of the Article. The Article obliged Belgian wholesale distributors to only supply their medicines for human use to other Belgian wholesale distributors, licensed pharmacies or Read More

Excessive pricing practices in the pharmaceutical sector – NCAs’ scrutiny continues

Nele De Backer

Last week, the Belgian and Italian consumer associations Test Aankoop/Test Achats and Altroconsumo filed complaints with their respective national competition authorities, alleging that the pharmaceutical group Biogen is abusing its dominant position by charging excessively high prices for the medicine Spinraza, which it has the exclusive right to market as an orphan drug until 2029. Read More

Belgium introduces “linked” reimbursement procedure for personalised medicines and companion diagnostics

Tine Carmeliet

From 1 July 2019, laboratory tests that predict whether a patient could therapeutically benefit from “personalised” medical treatment will be reimbursed quickly via a new procedure. In the context of personalised medicine, patients are tested before the start of a treatment and are only given a particular medicine when it has been demonstrated that they Read More