Legal & Regulatory > Belgium > Regulatory Reforms

The key facts about regulatory reforms in Belgium. Prepared in association with ALTIUS, a leading law firm in Belgium, this is an extract from The Pharma Legal Handbook: Belgium, available to purchase here for USD 99.

1. Are there proposals for reform or significant change to the healthcare system?

As of recently, attempts have been made to remedy the unavailability of medicines on the Belgian market. The Act of 7 April 2019 on the unavailability of medicines introduced two measures in this regard: firstly, certain wholesalers (full-line wholesalers, entrusted with a public service obligation) were prohibited from exporting medicines. Secondly, the modalities and enforcement of the already existing delivery obligation for pharmaceutical companies, regular wholesalers and parallel importers to full-line wholesalers was enhanced. The Act entered into force on 18 May 2019.

After suspending the provision of the Act of 7 April 2019 on the export prohibition in a decision of 18 July 2019, the Belgian Constitutional Court recently annulled this prohibition by decision of 17 October 2019.

Meanwhile another bill has been introduced in Parliament on 28 August 2019, proposing different measures to take action against the unavailability of medicines in Belgium.

2. When are they likely to come into force?

Please refer to Question 1 above.