Under EU law, parallel importation is lawful subject to specific derogations that seek to protect human health and industrial and commercial property. Medicinal products are subject to the same rules governing the internal market.
The established case law of the Court of Justice of the European Union (CJEU) provides that repackaging is permitted only if it passes the 'Necessity Test' - i.e. it is necessary in order for the parallel-imported product to gain effective access to the importing Member State.
On 17 November 2022, the CJEU adopted preliminary rulings on three separate cases referred by the national courts in Denmark and Germany. These rulings clarify the extent to which a trademark owner of a medicinal product may oppose a parallel importer making significant alteration(s) of the original packaging.
The new rulings were made, particularly in the context of the EU regulatory framework introduced in 2011, to prevent falsified medicines entering into the legitimate supply chain - i.e. the 'Falsified Medicine Framework' (FMF).
The FMF details the characteristics of the safety features for authentication purposes to ensure the security of the supply chain. It also prohibits wholesalers and persons authorised or entitled to supply medicinal products, such as pharmacists, from supplying products having packaging that shows signs of tampering.
The latest rulings clarify that parallel imported medicinal products should be subject to the same requirements of the FMF to protect public health and patient safety. Therefore, the safety feature of the original packaging of the imported product for product authentication should be preserved or otherwise replaced by an equivalent one.
The trademark proprietor may oppose the marketing by a parallel importer of a repackaged medicinal product in certain defined circumstances. Re-labelling, re-boxing or repackaging of a parallel-imported medicinal product should be guided and justified essentially by an informed impact assessment, by striking a right balance that:
- Meets the FMF requirement to ensure security of the supply chain;
- Gives effective access to the parallel imported medicinal product.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.