Animal use Statistics – Europe’s proactive approach in funding alternatives
Last week, EU statistical reports on animal uses and the report on the implementation of the law on the protection of animals used for scientific purposes were published by the Commission. These much anticipated reports will generate a wide range of reactions from various stakeholders and citizens as a whole. It is important to build a shared understanding of the context surrounding the reports, what the data tells us and how they should be interpreted.
The report on animal use statistics summarises the data provided by all 28 Member States (including UK) on the use of animals in scientific procedures. It brings new and more comprehensive information and improves the way of reporting over what we have seen previously. It is important to note that even though these reports are not considered compulsory due to a recent change in legislation, we applaud the Commission on improving transparency on what is a provocative issue where feelings and tensions run high. The statistics are important to the user community as they provide useful indicators to scientists and shows where to focus efforts and bring about change.
With new legislation, and a new set of reporting rules, we simply can’t look back at previous statistical reports and make comparisons.
Let me explain why. With the new reporting methods, there was an introduction of new 'use' categories as well as new species (cephalopods, foetal forms of mammals) which significantly changed the scope. Also, the previous reports only gave detailed information on the first use of an animal, whereas now all subsequent uses must be reported – from the first use of an animal to any subsequent uses, in line with the 3R principles. Furthermore, there is reporting now on genetically altered animals (creation of any line, maintenance of lines with severe impairments) and additional information on NHPs, including generation of breeding. Importantly also, the actual severity experienced by animals being used is reported. The two reports lay out the findings of this reporting.
However, even though we cannot compare, questions are already being raised and statements made that there is no noticeable trend towards decreasing the numbers, specifically when the Commission’s final goal is full replacement of live animals used for scientific and educational purposes. The inference could be that Europe is not doing enough, lagging behind other global leaders. However, let me paint a different picture. I see huge strides being made in Europe.
Last September, the US EPA (Environment protection Agency) announced it will adopt a plan to eliminate all animal testing requirements at the EPA by 2035 and they would put a budget of 4.25 Mil US dollars towards alternative methods. The EPA was praised for this ‘significant’ contribution. However, this budget is small in comparison to the funding I am aware of in the EU.
In the EU we have the Framework Programmes for Research and Innovation which address some major societal challenges and have been used extensively to advance the 3Rs. For Framework Programme 6, on average 30 million per year was allocated, for FP7 45 million per year and Horizon 2020, 8th Framework Programme, this amount remains at 45 Mil a year, all towards development of alternative approaches to the use of animals in research. During Framework Programme 7 (FP7), altogether some €200 million have been dedicated to animal-free toxicology projects. H2020 built upon the successes of FP7 and provided further funding opportunities to advance the 3Rs for the benefit of animals and human safety, as well as for the advancement of science. Projects addressed predictive safety testing, including non-animal approaches.
Furthermore, the Innovative Medicines Initiative (IMI) is a public-private partnership between the European Union and EFPIA, it is the largest health partnership globally. With a budget of over 5 billion, IMI is pursuing the goal of developing the next generation of medicines, vaccines and treatments by improving research practice; getting new healthcare solutions to patients faster; and improving health outcomes thanks to new tools, methodologies, research infrastructure and big data. Many IMI projects have contributed enormously to animal welfare, these include (and non-exhaustive):
- ABIRISK - Anti-Biopharmaceutical Immunisation involving the prediction and analysis of clinical relevance to minimise the risk, developing tools for determining patient response directly without the use of animals;
- COMPACT - Collaboration on the optimisation of macromolecular pharmaceutical access to cellular targets: sets up sophisticated in vitro models of biological barriers and appropriate animal models to identify and exploit novel cell pathways for effective delivery of biopharmaceuticals;
- DDMoRe - Drug Disease Model Resources: A drug and disease model library was developed, as well as modelling and simulation solutions for better prediction and the reduction of animals used;
- EBiSC - European Bank for induced pluripotent Stem Cells: The use of iPS cells reduces the use of animals in research;
- eTOX - Integrating bioinformatics and chemoinformatics for the development of Expert systems allowing the in silico prediction of toxicities: combination of this knowledge enables creation of more reliable computer models;
- EQIPD - enable a smoother, faster and safer transition from preclinical to clinical testing and drug approval by establishing common guidelines to strengthen the robustness, rigor and validity of research data, ensuring better reproducibility and improved experimental design;
- iPiE - Intelligent Assessment of Pharmaceuticals in the Environment: based on existing data help identify which ‘legacy’ APIs are most likely to pose a risk to the environment and so should be prioritised for testing – reduction of overall number of animals used;
- MIP-DILI - Mechanism-Based Integrated Systems for the Prediction of Drug-Induced Liver Injury: developed new tests to help researchers detect potential liver toxicity, including combinations of non-animal models;
- PreDiCT-TB - Model-based preclinical development of anti-tuberculosis drug combinations: in silico modelling for the prediction of efficacy of novel drug regimens for tuberculosis;
- STEMBANCC - Stem cells for biological assays of novel drugs and predictive toxicology: supply of cells that mimic more accurately what happens in the human body therefore for requirement for animal cells;
- VAC2VAC – Vaccine batch to vaccine batch comparison by consistency testing: aims to develop and validate quality testing approaches for both human and veterinary vaccines using non-animal methods.
Then the question is, why do we continue to use animals? Clearly, the use of animals in research and testing is a controversial issue. However, scientific research involving the use of animals can provide much needed information – for instance they help to advance scientific knowledge, understand the basis of diseases, and to investigate and develop new medicines. Applying improved biological knowledge, technological advances, computer simulations and test tube methods will allow significant reduction of the number of animals actually used, however, these methods are not yet able to fully replicate the complexity and reactions of a living organism especially for systemic and chronic conditions.
Furthermore, basic or fundamental research helps advance scientific knowledge about how animals and humans behave, develop and function biologically. Targeted or applied research helps scientific understanding of diseases leading to and including the development of new medicines and vaccines.
When the Ebola epidemic struck in western Africa, it accelerated the development of a number of vaccines. The Ebola and Ebola+ calls through IMI resulted in two new life-saving vaccines, four new diagnostics as well as new identification and compliance tools, animal use was vital in the development of these lifesaving, game changing vaccines and biomarkers.
Today, Europe’s collaborative research community has responded to the global health crisis to fight against the coronaviruses, whereby the pharmaceutical industry is exploring, through IMI, potential actions to support the development of collaborative research programmes in order to fast-track the development of therapeutics and diagnostics for the coronavirus to complement the ongoing global activities on CoV vaccines. This again may lead to a rise in animal numbers, however with the expected outcome of life-saving vaccines.
Please read more on our commitment and efforts towards improved animal welfare here:
Or reach out to me at Kirsty Reid, Director of Science Policy, EFPIA