Belgium - New Royal Decree Establishes Import Regimes for Unlicensed Medicines
- 09/10/2024
- News
The Belgian Official Journal of 30 September 2024 contains a Royal Decree of 12 September 2024 (the RD) which will make it possible to import into Belgium medicines that do not benefit from a marketing authorisation (see, attachment). The RD creates two import regimes. The first seeks to satisfy special needs (speciale behoeften/besoins spéciaux) that result from shortages during the time of critical unavailability of a given medicine. The second modifies the rules that allow the Minister of Social Affairs and Public Health (the Minister) to import unlicensed medicines to combat the suspected or observed threat of pathogens, toxic agents, chemical agents, or nuclear radiation. The new rules will enter into force on 1 November 2024.
Special Needs
The new Article 105/1 of the Royal Decree of 14 December 2006 governing medicines for human use defines an elaborate set of both substantive conditions and formalities which a wholesaler has to satisfy before being able to import the unlicensed medicine from another EU Member State. The wholesaler must submit a request to the Minister on a form prepared by the Federal Agency for Medicines and Health Products (FAMHP). If the Minister does not object to the importation within 10 working days following the submission, and barring any stop-the-clock situation, the wholesaler will have permission to import the medicine at issue. The list of substantive conditions includes the requirement that the shortage will give rise to a critical unavailability of a medicine that
- is necessary for the prevention, diagnosis, or treatment of acute conditions, irreversible progressive conditions, chronical diseases, or conditions that cause an immediate threat or serious impairment for the patient; or
- treats vulnerable patient populations, including children; or
- treats patient groups whose change of treatment may cause special difficulties; or
- prevents or treats conditions subject to a notification duty; or
- implements a national disease combatting programme.
The RD contains a long list of broad concepts that give the Minister maximal flexibility in deciding whether or not to object to a specific medicine import. More generally, the RD also confers the power on the Minister to refuse the importation “if the unavailability [at issue] can be remedied in another fashion that is less intrusive”. Additionally, if the Minister allows the importation, he or she will be able to “determine the conditions for distributing, supplying and administering the medicines” and define precautionary measures, including quality and safety guarantees.
The RD also exempts the marketing authorisation holder in the exporting Member State, the producer, and the physician from liability for the unlicensed use of the medicine. However, the physician will remain liable for the choice of therapy which seems to mean that he or she will be responsible for the choice of the original and unavailable medicine which gave rise to the importation of the unlicensed substitute. The RD also seems to specify the obvious in that the Law of 25 February 1991 governing liability for deficient products will continue to apply.
Importation of Medicines to Combat Health Threats
The RD modifies the existing Article 110 of the Royal Decree of 14 December 2006 governing medicines for human use which gives the Minister the power to import specific unlicensed medicines during health crises, as was for example the case during the Covid-19 crisis. The principal modification now requires the administering physician to obtain the prior written consent of the patient. The medicine will be administered in a hospital.
The RD expands the existing regulatory Belgian and European framework governing shortages which already covers matters such as the notification of supply cessations, export limitations, and the powers of substitution by pharmacists (see, for example, Van Bael & Bellis Life Sciences News and Insights of 20 December 2019 and of 2 November 2023).
