New measures to limit unavailability of medicines

Update 10.05.2019 – publication of the law in the Belgian Official Journal

A new law states that full line wholesalers can only provision the Belgian marker, in the framework of their public service services. Medicines intended for the Belgian market can only be supplied to Belgian pharmacies or other wholesaler-distributors. Implementation decrees will supplement the law. For example, medicines that cannot be delivered for three days in a row are considered unavailable. The obligation to deliver from pharmaceutical companies to full line wholesalers will also be set on three working days.

The export of medicines intended for the Belgian market is one of the causes of temporary unavailability of a medicine. In the interest of the patient, therefore, the law amending the law of 25 March 1964 on medicines with regard to the unavailability of medicines was approved by parliament on 28 March 2019 and proclaimed on 7 April 2019.

Main guidelines of the new law
In the interest of public health, there is a delivery obligation for medicine manufacturers to the full line wholesalers so that they can meet their obligations to supply the Belgian market. The new law strengthens the delivery obligation. Moreover, implementation decrees will further tighten the modalities of this obligation to deliver: the delivery deadline will then be set at 3 working days.

The delivery obligation ensures that the Belgian patient can always have access to the necessary medicines. It is not justified that this obligation to supply would also apply to medicines intended for export abroad by the full line wholesaler. The new law states that full line wholesalers can only deliver to (hospital) pharmacies or other wholesaler distributors. Manufacturers are  now certain that the medicines they supply to full line wholesalers in the framework of their delivery obligation reach the Belgian patients. Manufacturers and normal wholesalers may still export.

In an implantation decree  there will also be a stricter definition of unavailability. If a manufacturer does not deliver in three working days, this must be reported to the FAMHP. To date, this was obligatory from 14 days. The FAMHP will be able to more rapidly notify everyone and where necessary, take additional actions.

Other measures regarding unavailability
A working group at the FAMHP with representation by pharmacists, manufacturers and full line wholesalers was set up about in 2013 to work out a solution. The adopted law flows directly from the recommendation of the working group. A previous result from this working group and the FAMHP was putting the list of unavailable medicines online with a daily update.

The FAMHP also undertakes actions for unavailabilities that are not caused by exporting to foreign countries, such as a production problem. There is a decision tree that proposes various actions depending on how critical the shortage of the medicine is. In the worst case scenario, import from abroad is possible.

The FAMHP is also working on a platform on which pharmacists, manufacturers and wholesalers can report unavailabilities. This will streamline information so that additional measures can be taken if necessary.

Last updated on
13/05/2019