Belgium Eases Conditions for Parallel Imports of Pharmaceuticals
Today, 16 September 2022, marks the entry into force of a Royal Decree of 4 September 2022 "amending the Royal Decree of 19 April 2001 on the parallel import of medicines for human use and the parallel distribution of medicines for human and veterinary use" (the RD; see attached copy). The RD was published in the Belgian Official Journal on 15 September 2022.
Easing the conditions for obtaining a parallel import licence, the RD removes the condition that the medicinal product for which a parallel import licence is sought must have "the same therapeutic indications" (“dezelfde therapeutische indicaties”/“les mêmes indications thérapeutiques”) as the Belgian reference medicinal product. Following the removal of this condition, it suffices for the parallel importer to demonstrate that:
- the imported medicinal product has been granted a marketing authorisation in the EEA state of exportation;
- a reference medicinal product exists in Belgium; and
- without having to be identical in all respects to the reference medicinal product, the imported medicinal product at least:
- has the same qualitative and quantitative composition in active substances;
- is therapeutically equivalent; and
- has the same pharmaceutical form.
As follows from the Council of State’s advisory opinion on the draft RD (see attached copy), the “same therapeutic indications" condition was removed because it imposes an additional requirement which is not foreseen by the case law of the Court of Justice of the European Union. More precisely, it would allegedly follow from the Delfarma judgment of 3 July 2019 (Case C-387/18; see, Van Bael & Bellis Life Sciences News and Insights of 5 August 2019) and the kohlpharma II judgment of 8 October 2020 (Case C-602/19; see, Van Bael & Bellis Life Sciences News and Insights of 13 October 2020) that the condition “could qualify as a measure having equivalent effect within the meaning of Article 34 TFEU, which cannot be justified on the basis of Article 36 TFEU”.
As the amendment facilitates parallel imports significantly, it will likely lead to an increase in the number of parallel imported products in Belgium.