With activists calling for a new roadmap to end animal research, a senior Commission official has emphasised that a phase out of testing is already built into existing EU legislation.
Speaking at the EARA annual General Assembly today, about EU Directive 2010/63 (on the use of animals for scientific purposes), Susanna Louhimies, of DG Environment at the EU Commission, said the EU was a global leader in transparency: “The EU is in a unique position in the world with a phasing-out strategy already firmly embedded in the legislation.”
Asked by the audience if there was a timeline for phase-out she replied: “When the science is ready.”
In her presentation, Opportunities for improving scientific rigour and transparency of animal use in bio-medical research, Ms Louhimies looked at recent EU legislative developments that are leading to a new level of transparency on the use of animals in research and then went on to explain the current efforts to improve 3Rs implementation, scientific rigour and reproducibility.
Regarding legislative developments, the most recent changes to EU Directive 2010/63 mean that from 2021 all non-technical summaries (NTS) must be published within six months of authorisation and sent electronically to the Commission to go on an open access, searchable database.
New fixed templates would improve the overall quality of NTS – although eight Member States are not legally required to use these. Ms Louhimies also said that the document produced by EARA to give guidance on how to fill out an NTS would be provided to all Member States.
“The improved NTS will give a better understanding of specific areas of animal use and allow the opportunity to gain insights into the areas of high volumes and severities,” she said.
Another example of the higher level of transparency now required also applied to the statistical data that is supplied by Member States on animal use, including the ‘ground-breaking’ information on those animals that were bred for research purposes, but never used.
Referring to the most recent data from 2017, Ms Louhimies explained that there was now a greater level of detail than ever, with the total number of animals needed in the EU to support research and testing calculated at 23,262,568 (which includes research, testing, creation and maintenance of genetically altered animals and those bred but not used).
“Improved statistical transparency means we can set a baseline, identify areas with the highest use of animals and severities and make an assessment of the differences between Member States,” she said.
The data already showed that since statistics were first collected in 2008 and 2017 there had been a decrease of more than 20% in animal use. Generally all animal species have decreased, except rabbits (+5.6%), fish (+12.2%) and Old World monkeys (+3.5%) - New World monkeys have reduced by 47.3%, while other mammals have gone up by +361% (9,535 – 26,335).
From 2021 onwards there will be more detailed data on the type of colonies that non-human primates have come from and in animal categories to reduce the numbers in the ‘other’ column - this would include sea bass, salmon and turkeys. There will also be some new purpose categories – developmental biology (basic research) and animal nutrition (translational and applied research).
Turning her attention to the activities aimed at improving 3Rs implementation and its science, these included helping scientists, animal welfare boards, competent authorities and inspectors to improve the application of the 3Rs in project applications and evaluations, as well as during a project.
One of the key educational tools produced by the Commission to help with this is the series of Caring for Animals guides. There are also plans to develop open access, interactive e-learning modules that focus on the 3Rs. However, Ms Louhimies admitted that ‘one problem is how to search for sources for non-animal alternatives’. It was also a fact that it is down to Member States to set up their own training resources as this was not something that could be provided at EU level.
Finally, looking ahead Ms Louhimies identified another topic of increasing interest – the development and use of non-animal-derived mono- and polyclonal antibodies, however she said that there was currently ‘a lot of misunderstanding about the existence of non-animal derived antibodies.’