ECJ precludes repackaging of parallel imported medicines

European Union

In Aventis Pharma Deutschland GmbH v Kohlpharma GmbH, the European Court of Justice (ECJ) has clarified the consequences of central authorization of pharmaceutical products under Regulation (EEC) 2309/93.

Aventis markets an insulin product and holds one central marketing authorization for packs containing 10 cartridges (marketed in Germany), and one for packs containing five cartridges (marketed in France). The defendants, Kohlpharma and MTK Pharma Vertriebs, bought up five-cartridge packs in France, repackaged them into 10-cartridge packs, and marketed them in Germany.

Aventis applied to the German courts for an order prohibiting the defendants from importing and marketing the repackaged insulin product. It argued that the importers could have bundled two original five-cartridge packs together rather than repackaging the product into 10-cartridge packs.

Aventis won at first instance and the case was appealed. The German appellate court referred the matter to the ECJ.

The ECJ found that the European Commission authorization granted to Aventis in relation to sales in Germany is designed to determine the dimensions, presentation and form of the packaging to be used for the pharmaceutical product. While, as a general rule, parallel importers may repackage and re-label goods under the original mark where it is necessary to market a product from one EU member state in another, the ECJ decided that because Aventis had been granted a central authorization for its product (and consequently approval for a particular presentation of that product), the bundling together and re-labelling of two packages for sale as a single unit is precluded. The ECJ made this decision, presumably, because such bundling may obscure much of the information intended to prevent consumers from being misled.

Aventis had no authorization for two five-cartridge packs to be bundled and sold as a single unit in Germany. Accordingly, Aventis's suggestion that the defendants bundle two five-cartridge packs rather than supply a single 10-cartridge product was not an allowable option.

Yvonne McNamara, McCann FitzGerald, Dublin

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