A Ban on Animal-Derived Antibodies will Stifle European Competitiveness in the Life Sciences

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On 14th May 2020, the EU Reference Laboratory for Alternatives to Animal Testing (EURL ECVAM), released a recommendation on Non-Animal-Derived Antibodies, which recommended that “animals should no longer be used for the development and production of antibodies for research, regulatory, diagnostic and therapeutic applications”. It added that “In the EU, the provisions of Directive 2010/63/EC should be respected and EU countries should no longer authorise the development and production of antibodies through animal immunisation, where robust, legitimate scientific justification is lacking”.

 The short statement which follows outlines major concerns from the university sector with the EURL ECVAM recommendations. It has been developed by the League of European Research Universities (LERU), an association of 23 leading research-intensive universities in Europe. 

 LERU agrees that we should avoid the use of animals for antibodies wherever possible and fully supports efforts to develop alternatives. However, LERU believes that it is premature at present to completely abolish the use of animals for generating (monoclonal) antibodies or for (polyclonal) antibody production. This is because animal-derived antibodies have many unique features which cannot be (easily) mimicked by alternative methods. As such, LERU believes that animal and non-animal derived antibodies should in fact be considered as complementary technologies. A ban on animal-derived antibodies would have serious implications, both in terms of therapeutic use, and in terms of research in the life sciences more generally. We therefore recommend that the EC and other authorities: 

 I.                     Conclude that it is premature to ban the use of animal-derived antibodies at the present time. Indeed, in view of the current pandemic situation, we could argue we need all of the options which we can lay our hands on.

 II.                   Foster a wider debate amongst scientists on the use of alternatives to animal-derived antibodies, taking into account the scientific, technical and ethical issues of doing so before making any decisions on such a crucial technology.

III.                 Ensure that there is a suitable robust and scientifically-sound method to guide decisions on authorisation of the use of animals for the generation and production of antibodies. This should be developed in close conjunction with experts  to ensure that it is workable and brings no undesired consequences.

Year of publication:
Oct 2020
Type of paper:
Statement
Author(s):
  • Paul Declerck and Maarten Dewilde (KU Leuven)
  • Eero Lehtonen (University of Helsinki)