EU Regulations Archives

A new feature has been incorporated into the public EU databases that record the annual numbers of animals used in biomedical research and the non-technical summaries of research studies (NTS).

It is now possible to export all the data from the EU Statistical ALURES database and the EU Non-Technical Summaries (NTS) ALURES database for further analysis by clicking on the ‘Download full dataset’ option on top bar of the main page.The download page can also be accessed directly here.

For more information on NTS see the EARA feature Non-technical summaries explained or sign up for the next EARA NTS training workshop on 15 April.

EARA has updated its popular website information page 40 reasons why animals are needed for biomedical research, which presents compelling reasons, in bitesize form, why the use of animals continues to be essential in medical advances and scientific discovery.

The new page includes updated case studies, research breakthroughs, information about regulations, expert quotes, as well as additional links to resources and information for each evidence-based fact presented.

An article by EARA, that explains the important role that non-technical summaries (NTS) play in improving transparency and openness between the general public and biomedical researchers that use animals, has been published.

In addition to a formal research project proposal, NTS are required by law in the European Union to explain clearly how and why animals have to be used in the context of that specific research project, and why the proposed procedures, species and number of animals to be used are absolutely necessary for the project’s objectives.

The article explains the key aspects that contribute to a good NTS, including the use of straightforward language without scientific jargon, with good practice examples for NTS mandatory categories, and the background as to why NTS are needed.

In addition, EARA is offering a series of workshops aimed at equipping researchers and animal welfare bodies with the skills needed for effective NTS writing. These sessions will provide practical guidance, tailored feedback, and expert advice on how to communicate complex research processes clearly and responsibly.

To find out more about these workshops contact Nuno Gonçalves ngoncalves@eara.eu.

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.

The claims made in a new book, by medical sociologist Pandora Pound, that research using animals is obsolete and ‘thwarting medical practice’ has been questioned in a review, commissioned by EARA.

In his review of Rat Trap – the capture of medicine by animal research and how to break free, biomedical researcher Georgios Petrellis, asks whether Pound has been too selective in her examination of the facts.

Using case studies from EARA publications, Petrellis says in his review: “Pound persistently mentions basic research studies that have not yet been translated to cures and downplays the valuable contributions animals have made in understanding fundamental biological mechanisms, such as how cancer cells survive and spread.”

He concludes by adding: “Ultimately, Rat Trap feels like a textbook for opponents of animal research and activists, rather than a balanced narrative on the role and evolution of animal research in biomedical innovation.”

Commenting on the Petrellis review, EARA executive director, Kirk Leech, said: “Pound believes that social science and the Psychology of Resistance to Change will help to explain this ‘reluctance’ to transition to non-animal research.

“However, this resistance to change is not based on a vested interest standpoint, but one based on the available science, i.e. that a full transition cannot yet be currently met as the alternatives to animal use in many areas are just not there. The European Commission pointed this out in its recent response to the European Citizens’ Initiative petition.”

EARA has expressed its deep concern, at the implications for public health and biomedical research, of calls by animal groups for an EU roadmap to phase out all animal research.

Last week the European Parliament’s Committee on the Environment, Public Health and Food Safety (ENVI) held a hearing for the petitioners of the European Citizens’ Initiative (ECI), Save cruelty-free cosmetics – Commit to a Europe without animal testing, to present their demands.

After setting out their arguments about replacing animal testing for risk and safety assessment of hazardous ingredients used in cosmetics and other chemicals, the petitioners, from PETA and Cruelty Free Europe, moved on to a call for a roadmap to be devised, by the end of 2024, to end the use of animals in all EU biomedical research.

While no life science representatives were invited to speak at the hearing, EARA has responded with a public statement on behalf of the biomedical research sector.

EARA said that the petitioners had completely overlooked the contribution of animal testing to the rapid development of every Covid-19 vaccine: “Unfortunately, the ECI call for a phase-out plan by the end of 2024 is not based on scientific evidence, but on emotion.

“The development of new drugs and surgical techniques will be dramatically impeded without continued animal research, with basic and fundamental research potentially coming to a complete stop.

“The ECI exaggerates the current existence of viable alternatives to animal models, and by conscious omission diminishes the role of animals in scientific research.”

Further statements condemning the rush to animal research phase-out have come from the Alliance of Science Organisations in Germany; a French/Dutch joint statement by AVIESAN and ZonMw; Biomedical Alliance in Europe; EU-Life and LERU; European Brain Council; German Cancer Research Center; Confederation of Scientific Societies of Spain (COSCE), Dutch Transparency Agreement on Animal Research, Science Europe and Infrafrontier.

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A wide-ranging petition calling for greater controls on animal testing and a roadmap to phase it out in the EU has passed its first hurdle.

The EU Citizens’ Initiative (ECI) Save cruelty free cosmetics – commit to a Europe without animal testing met its 31 August deadline to achieve more than one million signatures (1.4 million).

There are three parts to the petition, that is fronted by animal rights group PETA. The first two call for an end to the current legal requirement to use animal testing to protect industry workers and the environment from potentially toxic chemicals in cosmetics and other products.

The third part calls for ‘a legislative proposal plotting a roadmap to phase-out all animal testing in the EU before the end of the current legislative term’ – echoing the vote last year by the European Parliament.

Once the signatures have been checked the EU Commission has six months to respond and suggest follow-up measures. In 2013, a similar ECI led to the organisation of a scientific conference in Brussels to discuss non-animal methods in animal testing.

A detailed explanation of the ECI and the current cosmetic ban are set out in articles just published by TVV, the advocacy group for animal research in Germany.

The current EU ban on cosmetic testing only covers the small quantities of the same chemicals in consumer items.

See also the previous EARA News Digest article on the debate surrounding the future non-animal alternatives for toxicity testing.

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