An amendment to the Royal Decree of 10 April 2014 regarding the procedure for setting a price for medicinal products now allows the price administration of the Belgian Ministry of Economic Affairs (Ministry) to request accounting or bookkeeping information and documentation from pharmaceutical companies in relation to medicinal product price-setting dossiers submitted.
A pharmaceutical company that introduces a medicinal product to the Belgian market will consequently need to take into consideration that price-setting dossiers may now be more thoroughly vetted by the price administration of the Ministry in accordance with the amendment.
The amendment, which entered into force on 1 October 2017, was introduced because, in practice, the price administration was confronted with price-setting dossiers that did not allow it to carry out a proper assessment of the cost structure breakdown of medicinal products. The amendment is intended to solve this shortcoming by giving the administration the right to request additional information so that the Ministry can set a realistic maximum price for medicinal products.
A prior version of this post was originally published by the same authors in Practical Law – Life Sciences, October 2017 Issue (Thomson Reuters).