Tag Archives: Belgium

Belgium Amends Compassionate Use and Medical Need Program Rules to Expand Access

On 13 December 2020, Belgium amended its rules regarding compassionate use and medical need programs to confirm that authorized programs can continue to operate after the marketing authorization for the concerned product has been granted but while the decision on reimbursement is still pending. The Law of 25 March 1964 (“Medicines Law”) regulates the use … Continue Reading

Advice by In-House Counsel Protected by Legal Privilege under Belgian Law

Under Belgian law, legal advice provided by in-house counsel to their employers is covered by the protection for legal privilege.  That is the conclusion reached by the Brussels Court of Appeal in its judgment of 5 March 2013 in the Belgacom case (Case 2011/MR/3).  In addition to the legal advice itself, the legal privilege covers all related … Continue Reading

Belgium – Regulatory Overview

Article originally published in the Life Sciences Handbook, 2012 1. What is the regulatory framework for the authorisation, pricing and reimbursement of drugs, biologicals and devices (as they are termed in your jurisdiction)? Legislation The main legislative acts regulating medicinal products are the: „„ Medicines Law 1964. „„ Royal Decree of 14 December 2006 on … Continue Reading