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PCB and UB statement on urgent injunction requested by Lex Ànima

On 17 February 2022, Lex Ànima and two attorneys applied for an urgent injunction to stop the research being carried out by the PCB under the contract with Vivotecnia. This urgent injunction was refused in less than 24 hours as the courts found there was no special urgency. In parallel, a request to revoke approval was filed through the usual channels.

The PCB, within the 5-day period given to oppose to the requested suspension of the contract, submitted a written statement against the injunction. On 1 March 2022, Administrative Law Court No. 6 of Barcelona ruled to deny the injunction application. Therefore, it must be noted that none of the injunction requests have been accepted and, as such, the PCB can continue with the project.

The PCB would like to reiterate that there is currently no alternative to using these animals that would be recognised and could be used in place of the methodology laid out for this study. The PCB has reviewed all the proposals of supposed alternatives submitted by an association and none of them are regulatory, meaning they are not accepted as a method for use in preclinical drug studies. They are methods being studied that may potentially become legally accepted alternatives within a few years. As the Federation of Spanish Scientific Societies maintains, the use of animals is a necessary practice for advancing in the study of treatments, surgical techniques and vaccines, among others.

It is important to note that this study is part of a RETOS project led by GAT Therapeutic, a company at the PCB, in collaboration with the PCB itself, and has been approved and funded by the Ministry of Science and Innovation. The project requires a beagle animal house, which the PCB doesn’t have, so the PCB held a public tender, according to regulations and in no way violating European law. In both the contract and the public tender process, the PCB required the company awarded the contract to have Good Laboratory Practice (GLP) certification to carry out the chronic toxicity study, as it is required by law, and Vivotecnia has provided proof of its certification.  Furthermore, the pharmacokinetic study, as it is not a safety study, does not require the application of GLP by law, as is true of all pharmacodynamic studies, and it was therefore not required. It is important to understand the difference between GLP and animal welfare, as animal welfare is always an imperative regardless of whether the study is done under GLP.

In this type of study, the user centre is Vivotecnia, located in the Autonomous Community of Madrid and the national legal framework (RD53/2013) applies. It is the user centre’s responsibility to submit the documents required for the competent body in the Autonomous Community of Madrid to authorise the experiments and, therefore, neither has the PCB applied for authorisation nor is it the purview of the Government of Catalonia to grant it.

What the PCB has done is to ensure Vivotecnia has valid current authorisations from the Autonomous Community of Madrid as a user centre and, specifically, authorisation to carry out the pharmacokinetic and toxicology studies on beagles as per the contract.

The PCB, UB and their respective Ethics Committees for Animal Experimentation (CEEAs) ensure work with lab animals meets the European regulations and laws to safeguard and ensure animal welfare and apply the concepts of Replacement, Reduction and Refinement.