Belgium modifies legislation regarding unavailability of medicines

On 28 March 2019, the Chamber of Representatives approved a law which changes the rules applicable to shortages of medicines. This law will amend the Law of 25 March 1964 concerning medicinal products. So far, only the draft bill has been made available, as the changes have not yet been published in the Belgian Official Gazette.

Following the changes, the Belgian government will be able to define by royal decree when medicines are "temporarily unavailable", a concept which until now has not been clearly defined. As the Belgian Federal Agency for Medicines and Health Products (FAMHP) requires marketing authorisation holders to submit a notification on the temporary unavailability of medicines, defining this concept will also clarify when such notification is necessary. This will also enable the government to issue a temporary recommendation clarifying which medicine(s) constitute a valid therapeutic equivalent to the unavailable medicine.

The changes will also restrict wholesale distributors to only supplying medicines for human use to the following Belgian entities:

• Wholesale distributors.
• Licensed pharmacies.
• Civilian, university and military hospitals.

An exception thereto is the supply used in the framework of clinical trials, which is permitted if it does not present a risk to the supply of the medicine in the wholesale distributor's territory. If the wholesale distributor has a licence thereto, it will still be allowed to export abroad, though in such cases it will lose its priority regarding receipt of deliveries from the medicine manufacturers.

Separately, the Belgian Minister of Health also announced on her website that a royal decree will be issued, introducing an obligation binding on wholesale distributors to deliver medicines within 72 hours.

A prior version of this post was originally published by the same authors in Practical Law - Life Sciences, April 2019 Issue (Thomson Reuters).