Question to the EC: Reinstatement of the operating permit of the Laboratory of Pharmacology and Toxicology (LPT) in Lower Saxony

See the joint question to the European Commission by Francisco Guerreiro (Greens/EFA), Tilly Metz (Greens/EFA), Sylwia Spurek (S&D), Jytte Guteland (S&D), Anja Hazekamp (GUE/NGL), Manuela Ripa (Greens/EFA), Martin Buschmann (NI), Sirpa Pietikäinen (EPP) on the reinstatement of the operating permit of the Laboratory of Pharmacology and Toxicology (LPT) in Lower Saxony.

Subject: Reinstatement of the operating permit of the Laboratory of Pharmacology and Toxicology (LBT) in Lower Saxony 

In January 2020, the Laboratory of Pharmacology and Toxicology (LPT) in Lower Saxony, Germany, had its operating permit revoked by the authorities owing to irresponsible activities by its operators and untenable conditions in which animals were being kept. In August 2020, on the basis of a decision by the Hamburg Higher Administrative Court, the LPT in Hamburg-Neugraben had its operating licence reinstated (1). 

When reports about the situation at the LPT first began to emerge, the Commission expressed its concerns and requested clarification on the steps the German authorities intended to take on the matter (2). It appears that the Commission has not yet decided on the next steps in the procedure (3). 

1. In the light of the ongoing infringement procedure against Germany for non-compliance, will the Commission ensure that the practices of the LPT facility are compliant with Directive 2010/63/EU? If so, how? 

2. When can we expect decisions on this infringement procedure?

3. How does the Commission intend to prevent such blatant breaches of Directive 2010/63/EU from occurring in future? Does it, for example, plan to introduce supervision or additional requirements for inspections pursuant to Article 34 of the directive?

Supporter(4)

(1)       https://www.ndr.de/nachrichten/hamburg/Hamburger-Tierversuchslabor-LPT-darf-unter-Auflagen-weitermachen,tierversuche236.html

(2)       Answer to Written Question P-004125/2019 provided by Commissioner Sinkevičius on behalf of the Commission on 12 February 2020.

(3)       Answer to Written Question E-002597/2020 provided by Commissioner Sinkevičius on behalf of the Commission on 9 July 2020.

(4)        This question is supported by a Member other than the authors: Eleonora Evi (NI)

Answer in writing

1. Directive 2010/63/EU on the protection of animals used for scientific purposes (‘the directive’)[1] governs the authorisation of establishments breeding, supplying and using animals for scientific purposes. In the ongoing infringement procedure referred to by the Honourable Members, the Commission considered that Germany failed to correctly transpose into domestic law the provisions of the directive including in areas such as inspections, competences and the administrative procedures for authorising project applications and invited Germany to bring its national legislation into conformity with the directive. It is the responsibility of the German authorities to determine whether the Laboratory of Pharmacology and Toxicology in question fulfils all the conditions laid out by the directive and, accordingly, whether its authorisation shall be granted, suspended or withdrawn.

2. The Commission services are in contact with the German authorities with a view to ensuring the correct transposition of the directive into German law. Depending on the progress made, the Commission may decide to either close the case or refer Germany to the Court of Justice of the EU.

3. Article 34 of the directive requires Member States to ensure that the competent authorities carry out regular inspections of all breeders, suppliers and users, including their establishments, to verify compliance with the requirements of the directive. The Commission services are in contact with the German authorities with a view to ensuring the correct transposition of the directive, including its Article 34, into German law. The Commission does not plan to introduce additional requirements for inspections beyond those set out in the directive.

[1] 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 Text with EEA relevance, OJ L 276, 20.10.2010, p. 33‐79.

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