Third-party protection in parallel importation of medicinal products – referral decision of the BVerwG to the EuGH of 20.03.2025

A parallel import of medicinal products occurs when a medicinal product approved in one EU country is imported into another EU country and sold there without the involvement of the original manufacturer itself.

This is possible if the product is approved in both countries. The importer frequently adapts the packaging and labelling to comply with national regulations.

What is the significance of parallel importation of medicinal products?

The main reason for parallel imports is the price differential (so-called arbitrage business) between different countries. Medicinal products are cheaper in some EU member states than in others, often due to state price regulation. Parallel importers exploit these price differences to purchase medicinal products more cheaply and resell them profitably in countries with higher prices.

Originators often view parallel imports critically, as they can undermine their pricing policy and market strategy. They argue that parallel imports do not take account of their research expenditures and lead to market distortions.

Disputes frequently arise over trade mark rights, packaging changes or distribution restrictions that pharmaceutical manufacturers introduce to hinder parallel imports. Court proceedings often clarify whether these measures are permissible or violate EU competition law.

In this context, a recent decision of the Federal Administrative Court (BVerwG) should also be seen. The BVerwG has addressed the question of whether the statutory labelling requirements of pharmaceutical law exist solely in the public interest or can also infringe the rights of third parties, namely an originator. Whilst the Higher Administrative Court for the State of North Rhine-Westphalia (OVG NRW) has rejected a breach of rights – even taking EU law into account – the BVerwG has by decision of 20.03.2025 referred this legal question to the Court of Justice of the European Union (EuGH) for a ruling. However, only a detailed press release is currently available on this decision.

1. Facts and decision of the OVG NRW

The OVG NRW (judgment of 14 December 2021, Az. 9 A 1531/16) had to deal with the approval of a parallel import of a medicinal product whose primary packaging did not comply with the labelling requirements of the Medicines Act (AMG). The claimant, holder of the German marketing authorisation for the medicinal product, contended that the parallel import approval granted to her infringed her own rights. The central disputed issue was whether the labelling requirements of § 10 Abs. 8 Satz 3 AMG have third-party protective effect.

The OVG NRW decided that the claimant was not infringed in her own rights by the parallel import approval. It established:

• The labelling requirements of the AMG served primarily consumer protection and did not have third-party protective effect in favour of the holder of the original marketing authorisation.
• Trade mark law claims also did not establish standing to sue in administrative court proceedings.
• A breach of labelling obligations did not justify the assumption of a subjective-public legal position of the claimant.

2. Decision of the BVerwG (according to the Court's press release)

Following the claimant's appeal, the Federal Administrative Court (BVerwG, decision of 20 March 2025, Az. 3 C 9.23) has stayed the proceedings and referred several legal questions to the Court of Justice of the European Union (EuGH) for a preliminary ruling. It considered the assumption of the OVG NRW that the claimant was not infringed in her own rights by a deviation from the labelling requirements to be questionable under federal law. In the view of the BVerwG, the provisions on the labelling of medicinal products are also intended to protect the holder of the medicinal product marketing authorisation against the placing on the market of parallel imports that are not properly labelled.

The BVerwG established that under national law there is no possibility of deviation from the labelling requirements. However, it saw the need to clarify whether such a possibility could arise from Art. 63 para. 3 of Directive 2001/83/EC.

3. Referral questions to the EuGH

The BVerwG referred the following questions to the EuGH for a preliminary ruling:

1. Applicability of the labelling requirements: Do the labelling requirements of Art. 54, 55 para. 3 and 63 para. 1 of Directive 2001/83/EC apply to a parallel imported medicinal product?
2. Definition of direct supply to patients: Is Art. 63 para. 3 of Directive 2001/83/EC to be interpreted as meaning that a medicinal product is not supplied directly to patients if it is subject to a requirement for medical prescription?
3. Direct effect of Art. 63 para. 3 of Directive 2001/83/EC: Can a parallel importer rely on this provision before the German courts if it has not been or has not been fully transposed into national law?
4. Compatibility with the TFEU: Do Art. 34 and 36 TFEU preclude the application of national labelling requirements where relabelling of a parallel imported medicinal product is not possible due to substantial impairment of shelf life?

Significance and outlook

The referral questions concern central EU law issues on the compatibility of national labelling requirements with the principle of free movement of goods. The EuGH's decision will determine whether national requirements for the labelling of primary packaging in cases such as the present one remain or whether European law permits more flexible handling.

Until the EuGH ruling, it remains open whether the marketing authorisation holder of an original medicinal product actually has a subjective right of defence against a parallel import approval on the grounds of insufficient labelling or whether Union law primarily governs access to the internal market.

For questions concerning the parallel importation of medicinal products, the lawyers at AVANTCORE Rechtsanwälte are available as experts both in regulatory as well as in trade mark law respects.