Pharmacological Effect – Medicinal Product or Medical Device?

What is a 'pharmacological effect' – on the judgment of the Court of Justice of the European Union (EuGH) 'Femannose N' of 13.3.2025, Case C‑589/23.

1. Background of the Decision

The Court of Justice of the European Union (EuGH) had to decide in the course of a preliminary ruling procedure on the classification of the product 'Femannose N', which was marketed as a medical device. It contains D-mannose, a substance that binds reversibly to bacteria and prevents their adherence to the bladder wall.

A German competition association sued against the marketing as a medical device and argued that it was an unlicensed medicinal product. The Higher Regional Court (OLG) Cologne decided, as the Regional Court (LG) Cologne had already done, that D-mannose exerts a pharmacological effect, which led to its classification as a medicinal product. The Federal Court of Justice (BGH) ultimately referred this question to the EuGH for a decision. The background of the dispute was the question of what should be understood as a 'pharmacological effect' within the meaning of medicinal product law.

2. Definition from Case Law

Case law regularly applies a definition according to which this means

an interaction between the molecules of the substance in question and a cellular component, usually referred to as a receptor,

which either results in a direct reaction (response) or blocks the reaction (response) to another agent. The presence of a dose-response relationship, although not a completely reliable criterion, provides an indication of a pharmacological effect

(as, for example, the Federal Court of Justice (BGH) in the referral decision of 14.09.2023 – I ZR 4/21, para. 11 with reference to the MEDDEV Guidelines of the European Commission – 'Medical Devices: Guidance document – Borderline products, drug-delivery products and medical devices incorporating, as integral part, an ancillary medicinal substance or an ancillary human blood derivative', MEDDEV 2.1/3 rev 3).

In essence, the dispute concerned the question of whether a substance that itself does not enter into direct interaction with bodily cells falls under this definition of medicinal product.

3. Core Statements of the EuGH Judgment

The EuGH decided that a substance which, by means of reversible binding to bacteria, prevents them from binding to human cells, exerts a 'pharmacological effect' within the meaning of Art. 1 No. 2 (b) of Directive 2001/83/EG:

• The classification as a medicinal product does not depend on whether the binding is reversible or irreversible.
• A pharmacological effect already exists if the substance blocks pathological processes by entering into a molecular interaction with pathogenic agents.
• Products with such a mode of action fall under medicinal product law and not under the provisions for medical devices.

4. Effects on Manufacturers and Distributors

The decision has far-reaching consequences for the distinction between medicinal products and medical devices:

• Products containing substances that are in molecular interaction with pathogenic agents and thereby achieve a preventive or therapeutic effect must be classified as medicinal products.
• Undertakings must undergo a medicinal product authorisation procedure in accordance with Directive 2001/83/EG for such products.
• Incorrect classification can lead to competition law warnings and regulatory measures (for example, distribution bans).

Recommendation for Undertakings

• Manufacturers and retailers should review existing products, in particular if their effect is based on molecular interaction with pathogenic agents. A renewed risk assessment under medicinal product law is urgently recommended.
• Planned new product launches should already be examined during the development phase as to whether a pharmacological effect exists. If so, approval as a medicinal product must be sought.
• Advertising and marketing must be adapted to the new legal situation. Marketing as a medical device could entail competition law risks.
• Consult a lawyer: If there is any uncertainty as to whether a product falls within the definition of a medicinal product, early legal clarification should be sought from the specialists in legal matters relating to medicinal products and medical devices at AVANTCORE Rechtsanwälte in order to avoid costly authorisation procedures, regulatory measures or competition law warnings.