Belgium: New proposal to cease reimbursement of costly medicinal products after patent expiry

In December 2017, the Commission of Social Affairs of the Belgian Chamber of Representatives approved the Minister of Health's proposal to cease the reimbursement of certain medicinal products which after patent expiry remain much more expensive than less costly alternatives. The proposal, which has not been published, must be formally approved by the Chamber of Representatives before entering into force.

According to the proposal, if a certain medicinal product, two years after the expiry of its patent, remains substantially more expensive than alternative medicines that belong to the category of "least costly medicines", it will no longer be reimbursed.

If the proposal is approved, it will likely change the current regime, under which manufacturers have to reduce the prices of such medicinal products gradually. It is expected that manufacturers of medicinal products will be more inclined to reduce prices at an earlier stage (at the latest within two years from the patent expiry deadline) to ensure that their medicinal products continue to be reimbursed.

According to the Minister of Health's statement, this measure will benefit patients and the Belgian health insurance, which is expected to save up to EUR 38 million. These savings will be invested in the reimbursement of innovative medicines.

A prior version of this post was originally published by the same authors in Practical Law - Life Sciences, December 2017 issue (Thomson Reuters).