Archemin

Advice & reporting for the chemical and pharmaceutical industries

Belgian measures to limit the unavailability of medicines suspended by the Constitutional Court

Mon, 22/07/2019 - 10:51am -- Ludwig Everaert

International trade of medicines intended for the Belgian market has been identified as one of the reasons for shortages in certain medicines.

Art 3,2° of the law of the law of 7 April 2019 amending the Belgian Medicines Law with regard to the unavailability of medicines which was published in the Belgian State Gazette of 8 May 2019 has been uspended by a decision of the Constitutional Court of 18 July 2019 (p 73344 of the State Gazette of 22 July 2019). The aim of the suspended article was to restrict local distributors to supply the Belgian market only within the framework of their public service obligations.

Outlines of the (now suspended) changes to the Medicines Law

In the interest of public health, pharmaceutical companies are obliged to supply medicinal products to wholesalers who are registered as distributors for the Belgian local markets. These distributors have a legal supply obligation. The law provides that distributors are allowed to deliver only to (hospital) pharmacies or other distributors. Implementing decisions (royal decrees) should be published soon. The revised Medicines law is expected to improve the enforceability of this obligation to supply.

The rights to export of manufacturers and wholesalers who are non-distributors remain unaffected.

datum: 
Thursday, 18 July, 2019