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 of medicinal products that have not (yet) received a marketing authorization (“compassionate use”, “CU”) and for off-label use (“medical need”, “MNP”). The Belgian Federal Agency for Medicines and Health Products (“FAMHP”) must grant an authorization to allow the use of medicinal products in a compassionate or medical need context
Continue Reading Belgium Amends Compassionate Use and Medical Need Program Rules to Expand Access

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 correspondence, requests for advice, and documents created in preparation of the advice. 
Continue Reading Advice by In-House Counsel Protected by Legal Privilege under Belgian Law

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: