ECJ: Requirements for the repackaging of medicinal products in view of the new anti-counterfeiting regulations

Co-Author: Cao, My Anh

The judgment of the ECJ of November 17, 2022 (Case C-204/20; in two parallel proceedings of the same date, similar decisions were rendered: Cases C-147/20 and C-224/20) concerns the repackaging of parallel-imported medicinal products. The plaintiff is a pharmaceutical company and owner of a German pharmaceutical trademark. The defendant is a parallel importer of medicinal products and distributed a medicinal product of the plaintiff from the Netherlands in Germany. In this case, the parties dispute the repackaging of pharmaceuticals into new folding cartons. Due to the requirements of Directive 2011/62/EU (Anti-Counterfeiting Directive), the defendant is confronted with the problem that pharmaceutical packages provided with anti-tampering devices must be opened for the purpose of replacing the package insert and provided with new anti-tampering devices, which is usually not possible without leaving a trace. Therefore, the defendant considers itself bound to repack the parallel-imported goods in new, intact folding boxes. In contrast, the plaintiff assumes a trademark infringement and argues that a new wrapping goes beyond what is required for the marketing of medicinal products in Germany and that the relabeling represents an equivalent safety guarantee.

In its decision, the ECJ clarified that the use of new packaging and relabeling for the repackaging of parallel-imported medicinal products are in principle equally suitable measures for fulfilling the safety characteristics pursuant to Art 47a of Directive 2001/83. Under certain conditions, however, the parallel importer may use new folding boxes for the distribution of his medicinal products. First, this is the case if the anti-tampering device with which the outer packaging of that medicinal product is provided could not objectively be replaced by an equivalent device within the meaning of Article 47a(1)(b) of Directive 2001/83 and the distribution of that medicinal product in its relabeled original packaging in the Member State of importation would thereby be prevented. Second, the applicant submits that a new folding box may be used where there is an obstacle to effective access to the market of a Member State which could make repackaging necessary by replacing the wrapper, if, on that market or a substantial part of it, there is such strong resistance to relabeled medicinal products on the part of a not inconsiderable proportion of consumers that an obstacle to effective access to the market must be presumed. Similarly, where a significant part of the consumers in the Member State of importation refuse to purchase a medicinal product whose outer packaging shows visible signs of opening caused by the replacement, in accordance with Article 47a(1) of Directive 2001/83, of the existing tamper-evident device by an equivalent device, there must be regarded as an obstacle to the effective access of that medicinal product to the market of that Member State, so that the repackaging of the medicinal product in a new outer packaging must be regarded as necessary for its distribution in that Member State.

In this case, the parallel importer is entitled to use new packaging, which must not be defective or of poor quality with regard to the brand concerned. It therefore, continues to depend on the objective necessity of a new folding box for distribution in Germany. This is in line with the previous case law of the ECJ. In this respect, neither the original drug manufacturers nor the parallel importers have to change. The decision has thus contributed to legal certainty. In particular, it is also clear that in the case of a newly labeled folding box, no violation of the new anti-counterfeiting regulations can be assumed.