The European Parliament submitted the following written question to the Commission: Reports of experiments being carried out on monkeys at the Catholic University of Leuven (KU Leuven) prove that animals are still being used cruelly and unethically in scientific research in European countries. Experts stress that these experiments are largely useless and serve only to satisfy the curiosity of scientists. In this context, it is surprising that the Belgian Government last year allocated EUR 2 million for research concerning the brains of rhesus macaques at KU Leuven, but only EUR 350 000 to alternative brain research methods.

In this connection:

1. What is the inspection scheme for establishments authorised to carry out animal experiments, and what is the process for verifying that the experiments in question are necessary and cannot be substituted for, in accordance with Directive 2010/63/EU on the protection of animals used for scientific purposes?
2. What measures for the development of alternative test methods, which under Directive 2010/63/EU on the protection of animals used for scientific purposes are ultimately intended to replace animal experimentation, have been implemented after the adoption of that directive?

Mr Sinkevičius, on behalf of the Commission, answered that the Directive 2010/63/EU  on the protection of animals used for scientific purposes lays out the requirements for Member States on regular inspections to verify compliance with the directive.

One third of user establishments, and all establishments holding non-human primates, must be inspected at least annually. The frequency of inspections is based on a risk analysis taking into account the number and types of projects and species housed, and the compliance record of the establishment.

Projects using live animals can only be authorised if a favourable project evaluation, carried out by a competent authority, has evaluated its compliance with the requirement of replacement, that is, the use of non-animal alternatives where scientifically possible.

The directive sets new mechanisms to speed up the development and validation of alternative approaches. It created a legal basis for the European Union Reference Laboratory for alternatives to animal testing (EURL ECVAM), whose remit now covers all areas of scientific use of animals.

The European Union Network of Laboratories for the Validation of Alternative Methods (EU-NETVAL) contributes to the development and validation of alternatives. The EURL ECVAM Network for Preliminary Assessment of Regulatory Relevance (PARERE) provides a single point of contact for advice on the regulatory relevance and suitability of new alternative approaches to speed up the validation process.

The Commission also supports research into alternative approaches. Over the last two decades, the EU research programmes have funded more than 200 projects with over EUR 700 million. The new Programme for research and innovation is expected to continue developing improved alternative methods to animal use.