E-24/25 Isteka ehf. v The Icelandic Food and Veterinary Authority 

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E-24/25 Isteka ehf. v The Icelandic Food and Veterinary Authority 

EFTA-case

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Deadlines: Motivation ministry:    8 december 2025
Written observations:                    24 januari 2026

Keywords: protection of animals used for scientific purposes, applicability Directive
Subject: Directive 2010/63 (protection of animals used for scientific purposes).

Facts of the case:
The plaintiff is a pharmaceutical biotechnology company that collects blood from pregnant mares across Iceland. The blood is collected for the production of the hormone eCG, which is used in veterinary fertility drugs. The collection of blood from pregnant mares has been an established commercial practice in Iceland for over 40 years. The parties disagree on whether the activities fall under the scope of Art. 1(2) of Directive 2010/63 (protection of animals used for scientific purposes), which has been transposed into Icelandic law through Regulation No 460/2017. The plaintiff contends it should be exempted under Article 1(5), while the defendant (Icelandic Food and Veterinary Authority) maintains that the regulation applies and refuses to license the plaintiff unless the requirements are met.

Request for an advisory opinion:
1. Must the provision of Article 1(2) of Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes, cf. its Article 3(1), be interpreted as meaning that blood collection from pregnant mares for the production of PMSG/eCG hormone constitutes a “procedure” (Icelandic: “tilraun”) using animals that falls within the scope of that directive? 

2. If the first question is answered in the affirmative, so that blood collection from pregnant mares for the production of PMSG/eCG hormone is held to constitute a procedure within the meaning of the Directive, must the provisions of points (a), (d) or (f) of its Article 1(5) be interpreted in such a way that that directive nevertheless does not apply to the blood collection if the view is taken that it has been practised in Iceland to produce PMSG/eCG hormone for approximately 40 years? 

Cited (recent) case-law: -

Policy Area: LVVN