A highly critical opinion has now been officially published reviewing the controversial 2020 report, by the EU Commission’s EURL ECVAM body, which said that animals could no longer be used for the development or production of antibodies for research, diagnosis, purification of compounds or therapy.

The EURL ECVAM report recommendations had led to an outcry by the biomedical community, including a formal response from EARA, the European Federation of Pharmaceutical Industries and Associations (EFPIA) and AnimalhealthEurope, which highlighted the continuing importance of animal-derived antibodies.

As a result, a sub-working group of the European National Committees (NC) for the protection of animals used for scientific purposes, whose job is to advise EU competent authorities and animal welfare bodies, was set up to examine the recommendations and it has now backed the EARA-supported position.

The NC group said that a much more nuanced approach is needed to antibody production than recommended by EURL ECVAM, which is part of the EU Joint Research Centre.

It supported the use of non-animal-derived antibodies, believing that they should be used if they are suitable and where they are demonstrated to be at least equivalent, or better, to address the specific research question.

However, and damningly, the NC subgroup report concluded that the EURL ECVAM recommendation, ‘does not provide balanced information on the limitations of non-animal derived antibodies’ and added, ‘an uncritical and full application of the recommendation during the approval process of animal experiments in Europe could create a serious hindrance to the future development of antibodies as diagnostics, in research, for purification of compounds and as therapeutics’.

EARA executive director, Kirk Leech, said: “The view, that there was no longer any need to use animal-derived antibodies was made explicit, by Maurice Whelan, of EURL ECVAM, in a planned debate with EARA and EFPIA representatives at a European Commission National Contact points meeting, and at subsequent events. At this and other meetings, EURL ECVAM suggested that vested interests and conservatism were the only reasons that researchers still used animal-derived antibodies. We eagerly await the EURL ECVAM response.”

In a statement to EARA, two of the NC group authors – Prof. África González Fernández, of the University of Vigo, Spain, and Prof. Alban de Kerchove d’ Exaerde, from EARA member the Université Libre de Bruxelles, Belgium, said: “The NC sub-working group produced a consensus document after numerous meetings between its members (mostly researchers) from different European countries. With two exceptions (Netherlands, Sweden), it was subsequently signed by the majority of the sub-group members. It states that all current technologies for the development of antibodies are complementary. Given the current state of knowledge, it is not possible to eliminate any one of them, and the researcher must decide, depending on the objective, which procedure to use.

“The issue was sparked by the publication of the EURL ECVAM Recommendation on Non-Animal-Derived Antibodies, which caused a major outcry in the scientific community. It stipulated that animals could no longer be used for the development or production of antibodies for research, diagnosis, purification of compounds or therapy. The scientific community reacted strongly against this recommendation in numerous publications and documents, stating that phage technology cannot currently replace the production of animals’ antibodies and that such regulations could have a severe impact on the research and development of new therapeutic tools (e.g., immunotherapies). We believe that this consensus document finally settles the issue and we are pleased with the majority support obtained.”

National Committees for the protection of animals used for scientific purposes were created by each Member State according to Art. 49 of the Directive 2010/63/EU. These National Committees advise competent authorities and animal-welfare bodies, on issues such as the care and use of laboratory animals, and exchange information on project evaluation and best practice in the light of the Directive’s objective of legislative harmonisation.

In 2021, at the 3rd European National Committees Network meeting, the EURL ECVAM recommendations were the focus of an intense discussion. A number of committee members challenged the recommendations that suggested that animals were no longer to be used for production of antibodies. As a result, the Dutch National Committee (NCad) offered to organise a National Committee (NC) sub-working group to assess the objections.

 

The sub-group report has now been published, minus the endorsement of NCad – which includes in its membership Reineke Hameleers, the CEO of Eurogroup for Animals. At the time the Eurogroup said there was an urgent need ‘to stop using animals for antibody development and production’. 

The NC sub-working group report is fully in line with the EARA, EFPIA and AnimalhealthEurope formal response to the EURL ECVAM report.