A 2010 directive called for replacement, reduction and refinement of animal experiments. More than 10 years on, MEPs are concerned the rules have had little impact - and want targets and a strategy to bring in alternatives
MEPs want the European Commission to put forward a clear strategy for phasing out animal research.
“What we are asking from the Commission is to do more of what it already does, but in a coordinated manner and with concrete goals that can replace animals in specific scientific areas,” said centre right MEP Michal Wiezik in the debate in the European Parliament last week.
A 2010 EU directive set out to fully replace testing on animals with alternative in vitro models based on human or animal cells and tissues, engineered tissues, computer models and human volunteer studies. But proper data collection only started recently, and whether the Commission’s efforts have translated into significant progress in the member states is difficult to tell.
Green MEP Francisco Guerriero said that without binding targets, there are no incentives for progress. “Why don’t we have an action plan setting out a proactive strategy to phase out animal experiments with milestones and timetables? Is the Commission just expecting member states by their own initiative to invest in the phasing out of animal testing? Since when has this reality really worked in EU policy?”
For now, the Commission has no plans to set binding targets or a phase out strategy, but promises to continue searching for alternatives and to streamline legislation. It is looking into reducing dependency on animal tests in human and veterinary medicines, medical devices, food and feed safety, biocides, pesticides, and chemicals.
“At the global level, [the 2010] directive is unique, as its ultimate goal is the full replacement of animal use in science,” said EU transport commissioner Adina Vălean. She told MEPs current rules are already the most stringent and ambitious in the world, and cover all the necessary bases. “The directive ensures that other EU initiatives, such as for research programmes, are aligned with the aims established by the directive, and this horizontal approach makes additional strategy documents and actions redundant,” Vălean said.
Animal testing is a heated subject. While animal rights activists say it’s cruel and must be abolished, researchers say the use of animal models is essential in many areas of science.
However, seven in 10 Europeans think the EU should set binding targets and deadlines to phase out animal testing, according to a July 2020 poll commissioned by the lobby group Cruelty Free Europe.
The Commission has been working on reducing use of animal tests in science for three decades, since it first outlined legislation covering the use and protection of animals for scientific purposes in 1986. But in terms of numbers, the use of animals in research has not seen a big drop in the last decade. In 2011, 11.5 million animals were used, in 2017, the number was around 9.4 million, according to the Commission’s data.
At the same time, more and more alternatives to animal testing are being introduced. From only seven OECD test guidelines for identifying chemicals that cause DNA or chromosomal damage in 1991, the number has increased to 29 guidelines based on 49 alternative methods today.
But equally, more and more increasingly informative animal models are being developed. Examples include mouse models in which human genes are introduced, or particular genes are knocked out, and which make it possible to understand the functions of specific genes and how their up- or down-regulation influences physiology as a whole.
Kirk Leech, executive director at the European Animal Research Association, says testing on animals remains crucial in a number of areas including biologics, vaccine development, and toxicity testing of drugs. “You could argue legally any drugs …. ha[ve] to go through a number of different animals before they go into human trials,” he told Science|Business.
While alternatives work is some fields, they cannot provide a blanket solution. Animal rights activists are pressuring scientists to switch to non-animal models but there isn’t always a choice. “Some people say, if you do it here, why can’t you do it everywhere? But science is not a magic trick. There’s not one solution to the problem,” said Leech.
It’s also not a money issue, or a case of vested interest, continues Leech. Animal testing can be very expensive. As one very stark case in point, macaques and other non-human primates are needed to develop and test vaccines against human pathogens like SARS-CoV-2, which do not infect other lab animals in a way that adequately models human disease.
Demand for non-human primates has increased in response to the huge expansion in vaccines development during the COVID-19 pandemic and currently there is a global shortage. China stopped exports when the pandemic broke out, and other exporters including Mauritius and Cambodia have not managed to fill the market gap. In October 2020, the US National Institutes of Health warned demand was outstripping supply and said it was setting up an expert panel to prioritise the use of non-human primates, on a project by project basis.
To back its animal research legislation, over the last 20 years, the EU has invested around €800 million in projects related to non-animal testing models. “Non-animal approaches built around stem cells, engineered tissues, organ-on-chip, genomic techniques, computer modelling and artificial intelligence are already proving themselves as the tools of choice for research and testing,” according to a recent update from the Commission’s science hub, the Joint Research Centre.
The EU has also improved reporting, which means there is now reliable data on how many animals are used in research each year. EU level data are already available. From 2023, national data will also be published.
Mice, zebrafish, rats and birds make up over 92% of the total number of animals used in research. The use of non human primates increased between 2015 and 2017, while the use of dogs and cats decreased slightly. In around half of experiments, suffering of the animals was said to be mild.
Parliament is not convinced organisations are trying their hardest to find replacements, or that it’s still necessary to test on animals in certain fields at all. Green MEP Tilly Metz said the consequence of a lack of strategy is that 10 million animals are used in EU laboratories every year with limited returns. “Indeed, there is a high failure rate – above 90% of new drugs tested on animals – and also a growing number of scientific reviews indicating that they contribute very little in understanding human diseases,” she said.
In fact, 45% of animal research is in basic research, followed by 23% in applied research and another 23% to satisfy toxicity testing and other regulations.
All experiments involving the use of animals are subject to ethical review in Europe. Researchers must prove there are no non-animal alternatives, and justify the use of a specific animal. A monkey cannot be used where a mouse would do. “Legally, you have to show that the animal you are going to use is the only way you can come to a scientific conclusion on this question. The directive globally has the highest standards of animal welfare,” said Leech.
But the EU’s tough rules cannot prevent animal rights violations. In April, Cruelty Free International released video from the Spanish contract research organisation Vivotecnia showing dogs being thrown into barren cages by the scruff of the neck, rodents decapitated using scissors and animals cut into without anaesthesia.
Vivotecnia runs tests on monkeys, dogs, rabbits, rats, mini pigs and mice for a variety of industries, including biopharmaceuticals. The company has previously had EU and Spanish government funding.
“It is unthinkable that this should be happening in Europe. The European Commission tells us that Directive 2010/63 not only protects animals used in science but that it also provides a strategy to replace animal testing. It does neither,” said Katy Taylor, director of science and regulatory affairs at Cruelty Free International, in response to the video.
The video caused a storm of protest in Spain and elsewhere. The city of Madrid suspended animal testing at the facility in response, but has since lifted the suspension, according to Cruelty Free International. Vivotecnia’s website is not accessible currently.