On May 17, 2024, Belgium notified under the TRIS-procedure the draft Royal Decree, amending the Decree of the Regent of 6 February 1946, that would change the status of ephedrine- and pseudoephedrine-based substances from over the counter to prescription-only medicines. BAPIE represents the industry sector of parallel import, distribution and export of medicines in Belgium and therefore wishes to react on this notification to express its concern in the procedure.
First and foremost if the medical basis for this amendment ultimately would be found to be unsubstantiated (no hard evidence is found on the topic to our knowledge), then there’s no justification to introduce this reclassification which has disruption of the internal market as a consequence, as outlined below. Specifically, we refer to the fact that OTC products, in general, are easier to order and obtain in larger quantities compared to prescription medicines. This is largely due to the less fragmented and more harmonized nature of the OTC market, facilitating a more consistent and ample supply across the EU Single Market. Reclassifying these products from OTC to prescription medicines is likely to increase the risk of market fragmentation and alter the market dynamics of these products, ultimately leading to a negative impact on their supplied volumes.
Overall most of BAPIE’s members are trading oral pseudo-ephedrine medicines with an OTC status throughout the EU. Switching the status in Belgium solely will lead to more administrative and regulatory obstacles to trade. The pathway of the principle of mutual recognition will be left as packaging requirements are going to be dealt with in a different way, certainly in relation with the Falsified Medicines Directive that imposes serialization and comes with unique identifiers and Anti-Tampering-Devices obligations. The cost impact and cost assessments that lead through these extra obligations will possibly lead to less market dynamics and fragmentation.
This short and punctual assessment clearly demonstrates that possible new obligations will, amongst others, touch article 34 of the Treaty on the functioning of the European Union (TFEU). Therefore we as sector federation of parallel importers/distributors and exporters of medicines in Belgium, we ask to refrain from this switch to prescription medicines of OTC PSE-containing oral medicines.
