Parallellimport av läkemedel - Ompaketeringsundantaget och skyddet mot förfalskade läkemedel

Sammanfattning: Within the EU, a regional exhaustion principle applies. This means that goods placed on the market by the trademark owner, or by someone with the consent of the trademark owner, can be freely distributed by anyone within the Union. This allows for parallel importation. Parallel importation refers to a phenomenon where an undertaking buys goods in one Member State, without the consent of the trademark owner, in order to export them to another Member State for sale there. In principle, the trademark owner has the right to prevent the sale of goods whose condition has changed or impaired. In relation to medicinal products, this principle is not always self-evident. The pharmaceutical industry is specific in such a way that quality and patient safety is crucial. Therefore, the market participants must consider specific rules. These rules may, for example, require the parallel importer to open a package in order to replace the leaflet with one in the domestic language of the importing Member State. Other national rules may require the parallel importer to change the packaging to a different size. The assessment of repackaging in the light of the principle of exhaustion has been subject to extensive development in the case law of the Court of Justice of the European Union. In order to assess the legality of the repackaging procedure, certain conditions have been developed. Given that the criteria took shape in the CJEU’s decision in Bristol-Myers Squibb, they are referred to as the BMS criteria. In short, the criteria states that repackaging may only take place when the trademark owner’s conduct involves an artificial partitioning of the market between the Member States. Repackaging must be necessary for the sale of the parallel imported medicinal product. However, repackaging must not damage the reputation of the brand or the original condition of the medicinal product. In addition, there are certain information requirements. On February 9, 2019, requirements were introduced for prescription-only medicines. Since then, these must be equipped with specific safety features. These should, amongst other things, make it possible to check whether the medicine package has been previously opened. For parallel importers, who are forced to open the packaging in order to provide it with new package leaflets, the new requirements could cause problems. The regulations were previously interpreted by parallel importers, as well as Danish and possibly Swedish authorities, as a requirement to repackage. In November 2022, the CJEU answered a number of questions related to the safety features regulation. The rulings clarified the relationship between the safety features framework and the BMS criteria, as well as the scope for Member States to prescribe additional safety requirements. Repackaging remains an exception. The CJEU also clarified that the regulatory framework is fully harmonized. The essay examines how the regulatory framework on safety features has changed the meaning of the BMS criteria. These have not changed in legal terms. Traces of previous security features do not constitute objective necessity to repackage. However, some practical modifications of the criteria are identified. For example, repackaging is necessary when it is objectively impossible to reseal a package with a new security feature. It is concluded that the scope of the exemption is unclear. This may lead to varying application within the Union. As a direct result, the trademark owner’s actual scope to exercise its right may vary from one Member State to another. The thesis also examines the scope for national variations in the approach to parallel importation and security features within the Union. The fact that the regulations are fully harmonized means that the scope for varying legislation is limited. However, some practical differences are identified. These may be due to varying consumer attitudes in different Member States and are fully justified by the BMS criteria. Furthermore, other variations are identified, arising from unclear definitions. In conclusion, the thesis argues that there is a need for a clarification of the legal framework in order to achieve uniform application within the Union.