|National Committee subgroup issues critical opinion on EURL ECVAM report
An opinion, by members of the National Committees for the protection of animals used for scientific purposes, whose job is to advise EU competent authorities and animal welfare bodies, has been highly critical of the European Commission’s EURL ECVAM body, which recommended in a 2020 report, that animals should no longer be used for the development and production of antibodies for research, regulatory, diagnostic, and therapeutic applications for human and animal health.The controversial report, Recommendation on non-animal-derived antibodies, by EURL ECVAM (EU Commission Reference Laboratory for alternatives to animal testing) was subsequently followed up by board members of the Scientific Advisory Committee (ESAC) of EURL ECVAM, claiming that non-animal derived antibodies were ready to replace animal derived ones for all known applications.Concern at these findings led to a formal response from EARA, the European Federation of Pharmaceutical Industries and Associations (EFPIA) and EARA member AnimalhealthEurope, which highlighted the concerns of the biomedical community.The European National Committees (NC) sub-working group, which has now examined the recommendations, said in its opinion, 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.The NC opinion supported the use of non-animal derived antibodies and believes 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 has concluded that the EURL ECVAM recommendation, ‘does not provide balanced information on the limitations of non-animal derived antibodies’.It added that scientific evidence is missing that non-animal-derived antibodies can fully replace hybridoma technology and polyclonal animal sera and advised that ‘care should be taken not to generalise statements obtained on individual antigens or antibody types to the diverse range of potential antigens and applications’.Consequently, the NC subgroup said that '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'.In a statement to EARA, two of the NC subgroup 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.”EARA COMMENT: 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 the 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 subgroup 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 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.See also the EARA feature The vital role of antibodies in biomedical research.UK to boost alternatives spending
The UK government has announced a series of measures aimed at encouraging the use of non-animal alternatives in biomedical research.Announced by Andrew Griffith MP, Minister for Science, Research and Innovation, during a Westminster Hall debate this week (see Briefing issue 6) on animal testing, the initiatives included:
Other initiatives announced include a hike in fees for licences and a review of five-year licences with a view to making them three years in duration.The sparsely attended Westminster Hall debate by MPs (see transcript) considered two e-petitions: End the use of animals for toxicity tests & prioritise non-animal methods (NAMs), and Ban the use of dogs for testing and research purposes in the UK, where a number of MPs recited much of the misinformation from animal rights groups, with no counter response other than from the government minister.Many of the MPs questioned why the numbers of animals used in research were not dropping given that ‘non-animal methods are more accurate’ and saw this as a failure of regulation – rather than evidence that alternatives are not the universal panacea to the questions confronting scientists on human and animal diseases. No one mentioned that even when a NAM is introduced, it is likely to still need validation using animals, or that animal methods are often used alongside, or complementary to NAMs.George Eustice MP, a former Defra minister, brought up another common theme about the need to change the culture of science. “We have ended up with cultural attitudes around the use of animals in scientific procedures that masquerade as science, when actually the science does not require those animals to be used in such numbers at all.”Tracey Crouch MP brought some clarity and said, ‘I have absolutely no doubt that the success of my breast cancer treatment is down to past experiments that have taken place on animals. It is hard to remove that from the equation’. She then went on to a theme commonly used in animal research debates, which was to confuse concerns about animal welfare with questions about whether animal research is actually necessary.Labour Shadow science minister Chi Onwurah, started off by stating, ‘I believe strongly that human rights and animal rights are intrinsically linked. Those who are cruel to animals or ignore their rights often do the same to humans’, then later acknowledged that we are not yet in a position to move beyond the use of animals in science.Science minister Andrew Griffith made clear the government’s position stating, ‘we are not quite at that moment when we can fully replace animal testing’.Deadline reminder – EMA 3Rs animal research guidelines
- Funding for the 3Rs will immediately double to £20 million in 2024-25;
- Government to publish a plan this summer to accelerate the development, validation and uptake of technologies and methods to reduce reliance on the use of animals in science;
- The Ipsos MORI survey on public attitudes to animals in science to restart.
A concept paper from the European Medicinces Agency (EMA) is proposing to modernise its current guideline on the 3Rs to address specific microphysiological systems, such as organ-on-chips, or other in vitro methods. The current guideline was adopted almost seven years ago.The EMA has now released a Concept Paper to revise the current guideline on the 3Rs principles. According to the concept paper, current guidance does not take into account the evolution of ‘scientific, technological and regulatory knowledge on 3R testing approaches, in particular NAMs (new approach methodologies) such as organ-on-chip models’.The EMA has identified two needs – ‘more specific guidance to define the regulatory acceptance criteria for specific models’, including their context of use (COU); and definitions for the ‘most important 3Rs-related terms’.The concept paper is open for public consultation until 28 February, 2024.Canadian regulators consultation plans for enviromental protection reform
A timeline for developing new rules and strategies to implement last year’s legislative reforms to the Canadian Environmental Protection Act (CEPA) have been sketched out. One of the planned consultations, for the summer and autumn of 2024, is on a ‘draft strategy to replace, reduce or refine vertebrate animal testing’. This will be published along with a host of other public consultations throughout the year, but the Canadian government has stressed its desire that these will not run concurrently and each consultation will be open for 60 days.EARA COMMENT: The reforms, adopted in June 2023, gave the Canadian government two years to overhaul legislation on chemical management and finalise a framework for incorporating a new right to a healthy environment.
The recent publication of the article, Animal Ghosts at Canadian Universities, late last year, unfortunately highlights the lack of openness and transparency in Canada. There is therefore an urgent need for the biomedical sector in Canada to work together to make a stronger public case, for where the use of animals in scientific research is still needed, and to inform the public about where their use is being reduced.
EARA will be addressing this issue and outlining what can be done to improve this situation in a keynote speech at the CALAS/ACSAL Symposium, 22-25 June in Saskatoon, Canada.
EventsRSPCA Focus on Fish, 29 February, online
This online event, led by the UK’s RSPCA, brings together experts to share the latest knowledge and approaches to refining fish use to reduce suffering and improve welfare.FSVO/UFAW Symposium, 6-7 March, Bern, Switzerland
The Swiss Federal Food Safety and Veterinary Office (FSVO) and UFAW symposium will discuss Humanely Ending the Life of Animals.
Institute of Animal Technology Congress 2024, 12-15 March, Scotland, UK
The IAT's purpose is to advance knowledge and promote excellence in the care and welfare of animals in research and to enhance the standards and status of those professionally engaged in the care, welfare and use of animals in science. The annual conference attracts over 400 delegates from the UK, Europe and the USA. Register here.Alzheimer’s Research UK conference, 20-21 March, Liverpool, UK, and online
The UK’s largest dementia research conference will provide a chance to gain insights from those working across basic, translational and clinical dementia research.Developing and communicating best practice in in vivo research, 26 March, Bristol, UK
The Physiological Society invites in vivo researchers to hear talks, engage in discussion and exchange ideas on best practice in their work with animals. The event will include talks from scientists at the School of Physiology, Pharmacology and Neuroscience at the University of Bristol, alongside representatives from funding bodies including the NC3Rs and MRC.EARA Media Training in Israel, 8 April, online
The EARA online media training session for Israel researchers and animal research stakeholders. These sessions will give scientists using animals in their research the necessary tools to confidently engage with the media and the public in a transparent manner. Register here.Improving Welfare and Reproducibility in Zebrafish Research, 9-11 April, Exeter, UK
The University of Exeter will be holding this workshop funded by the NC3Rs. This in-person workshop is aimed at zebrafish researchers, facility managers and other technical staff, but will be of interest to anyone involved in the care, use and regulation of laboratory zebrafish.EARA Media Training in Greece, 11 April, online
The EARA online media training session for Greek researchers and animal research stakeholders. These sessions will give scientists using animals in their research the necessary tools to confidently engage with the media and the public in a transparent manner. Register here.3Rs Sharing Conference, 17 April, San Fransisco, USA
An in-person discussion-focused 3Rs conference hosted by the 3Rs Collaborative and the New Jersey Association for Biomedical Research. BRAD 2024 Webinar, 18 April, online 12-1pm EST
Dr Charles P. France, at the University of Texas Health Science Center at San Antonio, will present on “The Importance of Animals in Addressing the Drug Abuse Crisis” for the Biomedical Research Awareness Day (BRAD) 2024 webinar.
UAR Openness in Animal Research, 2-3 May, West Midlands, UK
Billed as A conference to celebrate a decade of the Concordat, the world’s first transparency agreement on animal research, Understanding Animal Research (UAR) is hosting a conference dedicated to openness in animal research.
#BOARD24 – Be Open about Animal Research Day, 3 May, worldwide
EARA is holding its Be Open about Animal Research Day initiative (#BOARD24) earlier this year to coincide with the UAR conference. It is the 4th edition of our 24-hour campaign where institutions working with animal research share their experience in communication through statements, case studies and videos. Find out more here.Canadian Neuroscience Meeting, 19-22 May, Vancouver, Canada
The Canadian Association of Neuroscience will hold its 17th annual Canadian Neuroscience Meeting to present neuroscience research and network with neuroscience leaders from Canada and abroadScand-LAS 2024 Conference: Science & Care, 21-24 May, Tampere, Finland
Founded in 1970, Scand-LAS has around 350 members, mainly from the Nordic and Baltic countries. Membership is open to everyone working within the field of LAS. The scientific program can be found here.Minipig Research Forum, 22-24 May, Amsterdam, Netherlands
The Minipig Research Forum (MRF) is a forum where minipig users can share their knowledge and experience of working with minipigs. The MRF was launched in 2007 and has more than 450 members.ESLAV-ECLAM-AAALAC Conference, 17-18 June, Amsterdam, Netherlands
The conference, organised by EARA members the European Society of Laboratory Animal Veterinarians (ESLAV), European College of Laboratory Animal Medicine (ECLAM) and AAALAC, will be followed by the ESLAV-ECLAM Summer School.CALAS/ACSAL Symposium, 22-25 June, Saskatoon, Canada
EARA member the Canadian Association for Laboratory Animal Science (CALAS/ACSAL) is hosting its annual symposium, a networking and education event for the Canadian Laboratory Animal Science community. This year's theme is “Lighting the Path to Discovery.”
FENS Forum 2024, 25-29 June, Vienna, Austria
The Federation of European Neuroscience Societies, the Austrian Neuroscience Association, and the Hungarian Neuroscience once again hold Europe's largest neuroscience congress, encompassing all neuroscience fields, offering plenary and special lectures, symposia, workshops, events, and career and networking opportunities. EARA will be speaking at the Forum.XXIII Meeting of the FEPS and XLI Meeting of the Spanish Society for Physiological Sciences, 4-6 September, Granada, Spain
EARA is coordinating a session on improving public understanding of animal research at this meeting held by EARA member, the Federation of European Physiological Societies (FEPS). EUROTOX 2024 Conference, 8-11 September, Copenhagen, Denmark
The 58th Congress of the European Societies of Toxicology has the theme “Toxicology – A Quest for safe Chemicals and Medicines”, with topics on the safety of drugs and environmental chemicals, new and emerging technologies, personalised medicine, human health effects caused by exposure to chemicals, as well as safety issues arising from climate changes.ANZCCART Conference, 10-12 September, Christchurch, New Zealand
The Australian & New Zealand Council for the Care of Animals in Research and Teaching (ANZCCART) conference is centred around the use of animals in education, teaching and training in Australia and New Zealand.EUSAAT Congress on Alternatives to Animal Testing, 18-20 September, Linz, Austria
The congress provides an opportunity to share scientific experience on alternatives to animal use in the life sciences, to get updated on the EU 3Rs policy and to discuss new concepts of implementing the 3Rs in academic education at the European and the international level.
Neuroscience 2024, 5-9 October, Chicago, USA
The Society for Neuroscience (SfN) annual meeting is a congregation for scientists to discover new ideas, share their research, and experience the best the field of neuroscience has to offer.
AALAS 75th National meeting, 3-7 November, Nashville, USA
The American Association for Laboratory Animal Science (AALAS) meeting invites members and nonmembers come together to take part in workshops, lectures, poster sessions, and exhibits concerned with the production, care, and use of laboratory animals.