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On 11 September, the 2023 statistics on animal research in the UK were released. We are encouraged by the continued decline in the number of animals experiencing ‘severe’ suffering. This represents significant progress since 2014 towards our goal of ending severe suffering in animal research. 

While ‘severe’ animal use in basic research increased slightly by 5%, regulatory use and applied/translational use decreased by 11.5% and 20.7% respectively. Mice remain the most commonly used species, accounting for 82.7% of all severe procedures. Batch potency testing and toxicity testing (LD50/LC50) account for 68% of all severe procedures involving mice.

The continuing reduction in severe procedures since 2014 reflects the efforts of the scientific community to minimise animal suffering. However, certain areas, such as batch potency testing, neuroscience, immune system and cardiovascular research, have proven more challenging to refine.

Our upcoming work will aim to address these crucial areas to advance the goals of our ‘Focus on Severe Suffering’ initiative.

Cancer research represents one of the highest uses of animals across both basic and translational research. In basic research, oncology ranks as the third highest sub-category for causing ‘severe’ animal suffering, while in translational research, human cancers rank the second highest. Approximately 95% of this research is conducted using mice. 

While guidelines like PREPARE and ARRIVE focus on planning, reporting, and ensuring reproducibility in all animal experiments, there has been a notable lack of standardised recommendations for the practical refinement of animal models in oncology. To address this gap, the Oncology Best-practices: Signs, Endpoints, and Refinements for in Vivo Experiments (OBSERVE) guidelines were developed.

The OBSERVE guidelines represent a consensus statement crafted by a select steering committee, led by Stéphanie De Vleeschauwer from KU Leuven, incorporating insights from experts across academia and industry.

In a stepwise approach, the OBSERVE guidelines aim to address multiple aspects of an in vivo cancer study, focusing on rodents:

1. Preparation and Refinement of Implantation Methods: Ensuring the appropriate setup and refinement of specific implantation techniques.
2. Assessment of Clinical Signs: Detailed descriptions of clinical signs associated with specific tumour types and guidance on how to assess these.
3. Monitoring and Humane Endpoints: Guidelines for monitoring tumour growth, assessing animal welfare through standardised monitoring sheets, and applying humane endpoints.

The OBSERVE guidelines offer practical, clear, and robust recommendations for scientists, veterinarians, and animal care staff to reduce the levels of suffering experienced by animals during cancer research.

Read the OBSERVE guidelines in full here.

Caring, empathetic staff play an essential role in reducing lab animal suffering and improving welfare. However, the emotional toll on staff, including animal technologists, veterinarians and scientists, can be significant – especially when animals suffer severely. Megan LaFollette, from the US  3Rs Collaborative, found that higher severity protocols lead to higher “compassion fatigue”. This state of physical and emotional exhaustion is common among professionals caring for, or using, lab animals and can lead to symptoms like depression, anxiety and even chronic physical ailments.

The RSPCA’s “Focus on Severe Suffering” initiative offers guidance on reducing suffering to improve animal welfare, but as set out above this will also improve human wellbeing. This is critically important, because the goal should be to support, and retain, caring people who empathise well with animals. The “Roadmap” to reducing severe suffering offers guidance on identifying refinements for both procedural and non-procedural effects, applying the theory of marginal gains. This approach is based on many small refinements collectively leading to significant overall improvements, enhancing the welfare of both animals and those who care for them.

The 3Rs Collaborative resource lists several sources of compassion fatigue, providing a very helpful tool to check in on staff wellbeing and to address any factors that may be contributing to emotional burnout, such as severe protocols.  This helps to uphold a culture of care, fostering positive outcomes for animals, those working with them and scientific outcomes.

Find more information on the RSPCA’s Roadmap to reduce and avoid severe suffering. If you would like us to visit your institution for a workshop to demonstrate the Roadmap in practice, contact us at animalsinscience@rspca.org.uk. 

On 20-21 November 2024, the RSPCA will hold an international meeting in France on ‘refining animal research with a focus on severe suffering’. Building on the success of previous meetings held in Brussels, Berlin, Athens, Stockholm and Leiden, the meeting will be the 6th in a series of international meetings in our ‘Focus on Severe Suffering’ initiative.

Find the reports from previous meetings here. 

The meeting will be held near Paris starting on 20 November from 9am, finishing on 21 November at 12 midday.

The RSPCA is partnering with other organisations that share the aim of reducing and avoiding severe suffering – Afstal, FC3Rs, Gircor, OPAL, RNSBEA, RNC2EA, Sanofi, and DCL solutions – to maximise the success and impact of the meeting.

The event will be open to all those directly involved in animal research, and will be free to attend. It will offer a unique opportunity for attendees to engage in insightful sessions featuring case studies, exchanges of best practice, and discussions on refinement strategies in a variety of research fields that have the potential to cause severe suffering.

Stay tuned for more information as preparations unfold. In the meantime, sign up to our newsletter to receive a notification when registration opens.

Reducing severe suffering in animal research involves a series of steps which are outlined in our ‘Roadmap’. A key objective is to identify and reduce ‘cumulative suffering’ by reviewing both procedure-related and non-procedure-related experiences throughout an animal’s life. While refining the scientific procedure is crucial, it’s important to recognise that the procedures often last a short time in comparison to the other lifetime events an animal may experience. Therefore, maximum consideration should be given to how animals are handled, housed, and habituated, to minimise severity as much as possible. This is especially important in severe procedures, which have the greatest impact on animals.

On March 27, a team of Neuroscientists at the University of Bristol, led by Professor Emma Robinson, launched the 3Hs Initiative. The concept of the 3Hs is to focus on refinements to rodent Handling, Housing, and Habituation, increasing animals’ positive experiences while reducing cumulative suffering. 

Housing

Housing mice and rats in ‘standard’ laboratory cages contributes to cumulative suffering as animals are restricted in movement, choice of social partners, and a lack of stimulating or complex enrichment – which leads to negative welfare states. Practical solutions include providing playpens and sensory stimuli which can be maintained alongside standard caging, supporting positive welfare while also meeting the scientific objectives.

Handling

Physical restraint is widely used and considered necessary for both husbandry and scientific procedures. But restraint is aversive and causes distress, leading to negative associations between the human handler and animal. The 3Hs resource provides training on how to reduce and avoid restraining animals during common procedures, including techniques such as modified handling which minimises restraint during injections. 

Habituation

Habituating an animal to a procedure can play a key role in minimising levels of suffering. If animals are gradually habituated to a procedure and develop a positive association to it, restraint may no longer be necessary, greatly improving the experience of the animal. The 3Hs resource provides detailed instructions on refined habituation protocols, such as positive reinforcement using food rewards.

You can read more about the 3Hs approach, and download protocols and SOPs, here.

Botulinum toxin (Bt) is a neurotoxin which induces muscle paralysis by blocking neurotransmitters. Bt is used for treating medical conditions (such as migraines and lazy eye), and in cosmetic procedures to reduce the appearance of wrinkles.

The manufacture of Bt products is approved for medical purposes – and the use of animals in testing procedures is authorised for that reason. However, huge numbers of practitioners use them “off-label” for aesthetic treatments. “Off-label use” is known to be widespread, but it is not known what percentage is used for cosmetic versus medical applications. Indeed, there has been a documented surge in demand for Bt-based products within the cosmetic industry. In 2022, the International Society of Aesthetic Plastic Surgery estimated over 9 million “Botox” treatments were administered, a global increase of 26.1% compared to 7 million in 2021.

As Bt is a biological product, the potency of each batch needs to be tested and assured before it can be used in humans. The standard method, an LD50 assay using mice, determines the lethal dose that kills 50% of test animals. The increasing demand of Bt products has involved large numbers of animals undergoing ‘severe’ procedures. 

In recent years, there has been substantial progress towards the replacement of Bt testing in animals. The manufacturer of Botox®, Allergan, was the first to develop its own cell-based potency assay in 2011, aimed at replacing the use of animals in batch potency testing for Botox. Allergan is based in Ireland, and a review of the available statistics from 2013-2022 reveals a marked decrease in the number of animals used in regulatory testing and undergoing severe procedures.

Between 2013 and 2022, there was an 89% decrease in the number of severe procedures in Ireland. The statistical reports do not provide enough detail to exclusively credit this decline to the replacement of batch potency testing of Bt. However, it is certainly feasible that the approval and use of the cell-based potency assay has played a significant role. If this is the case, transitioning from traditional animal testing methods to in-vitro alternatives substantially reduced severe suffering.

Unfortunately, the LD50 test continues to be used for batch potency testing of other versions of ‘Botox’ type products in Ireland and globally. Because each manufacturer produces Bt slightly differently, an alternative to the animal test needs to be validated for every company, and regulators in all jurisdictions where the product will be used need to accept these. Unfortunately, more animals will experience severe suffering until this is achieved. Also, manufacturers who are successfully using a cell-based alternative for batch potency tests may still use animals for other parts of the production process. The significant animal suffering still involved in the production of these products highlights the importance, and urgency, of enabling more rapid transitions to non-animal technologies and approaches.

The Canadian Council on Animal Care (CCAC) publishes an annual report on the number of animals used in Canada for the purposes of research, teaching, and testing at CCAC member institutions. Canada employs a system of five ‘categories of invasiveness’ ranging from A to E, which roughly align with UK ‘severity classifications’. Category D describes  ‘experiments which cause moderate to severe distress or discomfort’, while Category E describes ‘procedures which cause severe pain near, at, or above the pain tolerance threshold of unanesthetized conscious animals’.

On October 19, 2023, the CCAC released the 2022 data report on animal use of animals used in Canada. These statistics include data on severity, which is important for transparency and ethical considerations.2022

In 2022, 105,253 animals were used in the most severe category of protocols, Category E. This represented 2.8% of all animals used in research and testing in those Canadian institutions certified by CCAC. 

What types of use were most likely to be severe?:

• 50.1% were used for regulatory testing to protect humans, animals, or the environment
• 30% were used for fundamental scientific research
• 11.8% were used for medical and veterinary studies related to human and animal diseases
• 7.8% were used for developing medical products
• 0.3% were used for educational purposes in post-secondary institutions

What animals were most often used in Category E studies?:

• 41,375 Rainbow trout
• 17,995 Mice
• 14,435 Salmon
• 14,267 Sticklebacks
• 5,690 Guinea pigs
• 2,478 Rats
• 3,660 Northern pikeminnows

This data report highlights the severe suffering experienced by fishes in fundamental research and regulatory testing. Notably, the data reveals that 37,027 rainbow trout were subjected to Category E procedures, specifically for regulatory testing purposes. This figure accounts for 35% of all Category E procedures reported by the CCAC. The report emphasises the urgent need for a critical evaluation of practices to minimise this suffering in regulatory testing. In line with this objective, we are organising a one-day workshop in Surrey dedicated to the application of humane endpoints in regulatory toxicology for fishes. Further information about this event can be found here.

The full CCAC data report and data files are available on the CCAC website.

On April 4, 2023, the European Commission released the latest statistics on the use of animals in research and testing in the EU and Norway in 2020. The UK is no longer included in the statistics since withdrawing from the EU, so the statistics from previous years have been recalculated.

This information is very important for promoting transparency and openness. It also plays a vital role in directing efforts more effectively towards the 3Rs in animal research. This summary of the data outlines the number of animals reported to have experienced ‘severe’ suffering.

Key findings

• Mice are the species most likely to experience severe suffering
• Batch potency testing is responsible for the largest number of severe procedures (134,017)
• Ecotoxicity testing has the highest proportion of severe procedures – 42% of all ecotoxicity testing procedures were severe
• The production of monoclonal antibodies by the ascites methods has increased by 12%. However, the number of severe procedures has decreased significantly

Overview

In the EU and Norway, 10% of procedures (796,750 in total) were severe, which is the same proportion of severe procedures as reported in 2019. The absolute number of severe procedures fell by almost 10%, from 884,186 in 2019, presumably because fewer animals were used overall due to the pandemic.

Which animals experienced the most ‘severe’ suffering?

Which types of use were most likely to be severe?

In 2020, the highest number of severe procedures were for regulatory purposes, translational and applied research, and basic research.

The graph below summarises which sub-categories of purposes have the highest number and proportion of severe procedures. 

Batch potency testing had the highest overall number of severe procedures, followed by animal diseases and disorders, and studies on the nervous system. Encouragingly, there has been a 23% decrease in ‘severe’ actual severity associated with batch potency testing since 2019.

The use of the mouse ascites method for the production of monoclonal antibodies continues to be of concern. Alternative approaches are available and this method has not been used in the UK for example since 2012. Although use of this method decreased by 35% between 2018 and 2019, 2020’s figures saw it increase by 12%. This increase, and its use generally, was almost entirely reported by one member state – France. Improved application of refinement techniques and earlier endpoints are probably responsible for the reduction in the associated severity reported – 34% now being reported as severe, compared to over 90% in the past. The statistical report highlights that further efforts are apparently taking place to review ongoing projects involving the use of mouse ascites.

The full report on EU and Norway animal research statistics can be found on the ALURES database.

Our 5th RSPCA international meeting will include the usual popular combination of case studies and opportunities for discussion and networking, with a special focus on cumulative severity.

This 1.5 day, face to face meeting will be held in Leiden, The Netherlands, in association with the Netherlands National Committee for the Protection of Animals used for Scientific Purposes (NCad), Leiden University Medical Center, Dutch Association for Laboratory Animal Science (DALAS) and the University of Leiden. Please click here for further information, and we hope to see you there.

The Focus on Severe Suffering initiative has had a successful year in 2022, with inspiring UK-based and international events, lots of positive support from the scientific community, and published statistics showing further decreases in procedures causing severe suffering in both the UK and European Union. This has been due to a number of factors, including refined humane endpoints, improved husbandry and support for animals, better communication between people with different roles (especially where animal technologists and care staff have been consulted) and more involvement from bodies such as the Animal Welfare and Ethical Review Body (AWERB), Animal Welfare Bodies (AWBs) and Institutional Animal Care and Use Committees (IACUCs).

We have also had positive feedback about the Roadmap approach to reviewing severe procedures. There is a flyer (PDF 638 KB) about the Roadmap (right), which you might like to print and display, or share with colleagues. We are keen for more establishments to trial the Roadmap – which can also be used to refine moderate or mild severity procedures – and would be happy to discuss its use, or run workshops to help trial it, in person or online. Please contact us using the form at the foot of this page if you would like to know more.

The most up-to-date data currently available on the use of animals in research and testing in the European Union (EU), and Norway, was published by the European Commission on 15 July 2022. This information is important for openness and transparency and can also help to focus 3Rs efforts more effectively. Below is a summary of the data, which is for 2019, setting out the number of animals reported to have experienced ‘severe’ suffering, and in which areas of science.

As in previous years, the mouse is the species most likely to experience ‘severe’ suffering, and batch potency testing of vaccines and other substances (such as botulinum toxin) is the category responsible for the largest proportion of ‘severe’ animal uses.

But on a positive note, the number of ‘severe’ animal uses fell by 65,661 in comparison with the 2018 data. This means that the percentage of ‘severe’ uses decreased from 10% to 9%, which is a small step in the right direction.

999,264 uses of animals (9% of the total) were reported as causing ‘severe’ pain, suffering, distress or lasting harm. This included:

• 344,582 in basic research (7.2% of all uses for basic research involved severe suffering)
• 310,367 in applied research (10.9% of all uses for applied research involved severe suffering)
• 291,166 for regulatory purposes (12.2% of all uses for ‘regulatory’ purposes involved severe suffering)

Main categories of use causing severe suffering

• 215,735 – Batch potency testing (represents 21.6% of all uses of animals that were ‘severe’)
• 132,695 – Studies of animal diseases and disorders (represents 13.3% of all uses of animals that were ‘severe’)
• 104,164 – Nervous system (represents 10.4% of all uses of animals that were ‘severe’)
• 77,654 – Immune system (represents 7.8% of all uses of animals that were ‘severe’)
• 52,574 – Oncology (represents 5.3% of all uses of animals that were ‘severe’)

Which types of use were most likely to be severe?

The production of monoclonal antibodies by the ascites method was the most likely to cause ‘severe’ suffering – 91% of all uses for monoclonal antibody production using this method were severe. The ascites method was still being used in six Member States; principally in France, which accounted for around 36,000 out of 37,477 uses in this category. Note – alternative approaches are available to replace the mouse ascites method, and this method has not been used in the UK since 2012.

Severe suffering was reported in 39% of animals used for acute toxicity studies in ecotoxicity, and in 29% of animals used in LD50 and LC50 tests for acute and sub-acute toxicity testing.

Which animals experienced the most ‘severe’ suffering?

• 647,525 – Mice (11.7% of all mouse use was severe)
• 201,100 – Fishes other than zebrafish (9.8% of all use of fishes was severe) 
• 64,070 – Rats 
• 25,094 – Zebrafish
• 18,273 – Domestic fowl
• 16,127 – Guinea pigs (12.9% of all guinea pig use was severe)
• 7,382 – Xenopus (27.8% of all Xenopus use was severe)
• 6,336 – Rabbits

5,253 uses of animals for the creation of new genetically altered lines (1% of uses in this category) and 50,018 uses of animals for the maintenance of established lines of genetically altered animals (7.06% of uses in this category) were categorised as ‘severe’.

If you’d like to look at the EU data in more detail, see the Commission’s ALURES database.

The most up-to-date data currently available on the use of animals in research and testing in the UK was published on 30 June 2022. A total of 3.06 million scientific procedures were completed on animals in 2021, which is an increase of 6% from the 2.88 million procedures in 2020. This is due to two national lockdowns during 2020, which affected activity at research establishments. 

However, it was positive to see that the percentage of ‘severe’ procedures fell once again, from 4% of all experimental procedures in 2020 to 3.4% in 2021. Below is a summary of the data on the number of animals reported to have experienced ‘severe’ suffering, and in which areas of science.

As in previous years, more mice experience ‘severe’ pain, suffering, distress or lasting harm than any other species. The percentage of guinea pigs experiencing severe suffering is highest, because of the use of this species in quality control batch potency testing. Batch potency testing of vaccines and other substances (such as botulinum toxin) is the category responsible for the most uses of animals reported as ‘severe’. 

58,003 experimental procedures using animals (3.4% of the total) were reported as causing ‘severe’ pain, suffering, distress or lasting harm

40,126 for regulatory purposes  (11% of all use for regulatory purposes was ‘severe’)

12,003 in basic research

5,874 in applied research

Main categories of research and testing involving severe suffering
(data represent the number of ‘procedures’ undertaken that were reported as causing ‘severe’ suffering)

31,645   Batch potency testing

5,067     Acute and sub-toxicity tests

2,870   Immune system

2,613     Cardiovascular system

2,041     Human infectious disorders

Which animals experienced the most ‘severe’ suffering?
(data represent the number of ‘procedures’ undertaken involving those animals)

48,090  Mice  (5.2 % of all mouse use was ‘severe’)
1,145    Rats
1,256    Guinea pigs  (25.6% of all guinea pig use was ‘severe’)
6,318    Fish

In addition, 28,782 (2.2%) of the procedures involved in the creation of new lines, and maintenance of established lines, of genetically altered animals (not used in experimental procedures) were categorised as ‘severe’.
Source: Home Office Annual Statistics of Scientific Procedures on Living Animals, Great Britain, 2021 – published 30 June 2022

We are taking registrations for our free international meeting, on 24 and 25 August 2022, which we are jointly convening with the Karolinska Institutet, Stockholm. This face to face event will include case studies describing how severe suffering was reduced in basic and applied research, with a separate session on regulatory toxicology.

We will also explore how National Committees, ethics committees and Animal Welfare Bodies can contribute, especially within tasks relating to following the development and outcome of projects. The final session will discuss how industry bodies, accrediting organisations and other professional bodies can help to develop a strategic approach to reducing severe suffering.

With twenty presentations from motivational speakers, and plenty of opportunities for questions, discussion and networking, this event will inform and inspire you to address severe suffering at your establishment and within other bodies you may be involved with.

We are delighted to offer free registration, and refreshments, thanks to the generosity of the Karolinska Institutet and RSPCA donors.

Not all severe suffering is predictable – sometimes it can occur due to an unplanned, critical incident. The Critical Incident Reporting System in Laboratory Animal Science (CIRS-LAS) has been set up to enable users to add unplanned events to a database (anonymously, if required). The aim is to achieve a constructive, open and transparent error culture in laboratory animal science.

The CIRS-LAS database is open to contributors worldwide, to enable mutual learning and to help prevent avoidable incidents from being repeated. It is searchable by different keywords including species, incident type and disease model. We think it looks useful to browse through and reflect on whether there is a risk of any of the incidents, and how this could be reduced. Many would also be useful examples within education and training. It is easy to report incidents, and of course the more entries there are, the more useful the database will be.

CIRS-LAS is available in English, French and German at www.CIRS-LAS.de 

For further information, please contact: info@cirs-las.de

Mortality, including animals ‘found dead’, is one of the three main causes of severe suffering. A recent paper by Jessica Cait and others at the University of Guelph, Canada, has highlighted a cause of morbidity and mortality in rodents that many people may not be aware of – conventional laboratory housing. Conventional housing was defined as small cages with just food, water and litter, as opposed to ‘enriched housing’ which included one or more of the following: nesting material, nest boxes, running wheels, and/or opportunities to perform other natural behaviours, like foraging or exploring.

The systematic review of 214 studies, using 6,495 animals, found that conventional housing significantly exacerbated disease severity in studies of anxiety, cancer, cardiovascular disease, depression and stroke. It also increased the risk of death at any point in time by 48%, due to the chronic stress of being housed in a suboptimal environment. 

‘Enriched housing’ actually increased median survival by 9.3%. The authors point out that this exceeds the effects of leading life-extending compounds resveratrol (which increases median survival by 4.1%) and metformin (which increases mean lifespans by 5.8%). They also suggest that typical research rodents should be termed ‘CRAMPED’ (cold, rotund, abnormal, male-biased, poorly surviving, enclosed and distressed). 

The implications of the review, for both animal welfare and translatability, are all too clear. The paper would make a helpful discussion starter around reviewing housing, husbandry and care for any species, to reduce morbidity and mortality and improve welfare – even if standards are already better than ‘conventional’ cages (or pens, or tanks). This website also includes guidance on reviewing and refining animals’ lifetime experiences, and avoiding mortality.

Reference: Conventional laboratory housing increases morbidity and mortality in research rodents: results of a meta-analysis Cait et al. (2022) BMC Biology, doi.org/10.1186/s12915-021-01184-0

We are looking forward to our first in-person meeting since 2019, when we will hold a one-day event in central Manchester on 20 April. Looking forward and looking back – opportunities to focus on ‘severe’ suffering will include case studies from researchers at the University of Manchester and a session on tackling severe suffering in models of animal diseases and disorders. The ‘looking back’ element will address retrospective assessment of severe procedures by the AWERB (Animal Welfare and Ethical Review Body). For more information, see our Events page.

We are very grateful to our partners BIC Study for producing a version of our short (3-min) video ‘Can we end severe suffering’ with subtitles in the Korean language – which can be viewed here (on Vimeo). Please feel free to share this with colleagues and organisations you work with in South Korea.

The most up-to-date data currently available on the use of animals in research and testing in the UK, and the EU, was published on 15 July 2021. This information is important for openness and transparency and can also help to focus 3Rs efforts more effectively. Below is a summary of the data relating to the number of animals reported to have experienced ‘severe’ suffering, and in which areas of science.

The mouse is the species most likely to experience ‘severe’ pain, suffering, distress or lasting harm. In both the UK and EU, batch potency testing of vaccines and other substances (such as botulinum toxin) for quality control purposes is the category responsible for the most uses of animals reported as ‘severe’.

UK

Data for 2020
Source: Home Office. See Tables 3.1 and 3.2 of the Data Tables associated with the Statistics of scientific procedures on living animals, Great Britain 2020 – published 15 July 2021.

Summary

58,499 experimental procedures using animals (4% of the total) were reported as causing ‘severe’ pain, suffering, distress or lasting harm.

44,093 – for regulatory purposes (9% of all use for regulatory purposes was ‘severe’)
10,867 – in basic research
3,511 – in applied research

Main categories of research and testing involving severe suffering
(data shown represent the number of ‘procedures’ undertaken that were reported as causing ‘severe’ suffering)

35,997 – Batch potency testing (represents 61.5% of all experimental procedures involving animals that were ‘severe’)
2,592 – Nervous system
2,567 – Immune system
1,512 – Human infectious disorders
1,479 – Batch safety testing
1,303 – Oncology

Which animals experienced the most ‘severe’ suffering?
(data shown represent the number of ‘procedures’ undertaken involving those animals)

50,136 – Mice (6.1% of all mouse use was ‘severe’)
1,136 – Rats
1,553 – Guinea pigs (25.6% of all guinea pig use was ‘severe’)
4,826 – Fish

What about for the creation and maintenance of genetically altered animals?

In addition, 27,896 (1.9%) of the procedures involved in the creation of new lines, and maintenance of established lines, of genetically altered animals (not used in experimental procedures) were categorised as ‘severe’.

EU and Norway

Data for 2018
Source: European Commission. Summary Report on the statistics on the use of animals for scientific purposes in the Member States of the European Union and Norway in 2018 – published 15 July 2021.
NB. data for this period includes Norway for the first time, and also that for the UK who was still a member of the EU for that reporting period. EU data can also be viewed via the Commission’s ALURES database.

Summary

1,064,925 uses of animals (10% of the total) were reported as causing ‘severe’ pain, suffering, distress or lasting harm.

346,113 – uses in applied research
(11.7% of all uses for applied research involved severe suffering)
336,521 – uses for regulatory purposes
(17.4% of all uses for ‘regulatory’ purposes involved severe suffering)
310,571 – uses in basic research
(6.2% of all uses for basic research involved severe suffering)

Main categories of use involving severe suffering
(data shown represent the number of uses of animals in that category that were reported as causing ‘severe’ suffering)

253,764 – Batch potency testing (represents 23.8% of all uses of animals that were ‘severe’)
124,739 – Animal diseases and disorders (represents 11.7% of all uses of animals that were ‘severe’)
NB. the inclusion of Norway’s data sees a 340% increase in this category compared to previous years, largely linked to the undertaking in that country of studies relating to farmed and wild fish
90,288 – Nervous system (represents 8.5% of all uses of animals that were ‘severe’)
69,536 – Immune system (represents 6.5% of all uses of animals that were ‘severe’)
61,114 – Diagnosis of diseases (represents 5.7% of all uses of animals that were ‘severe’)
52,177 – Oncology (represents 4.9% of all uses of animals that were ‘severe’)

Which types of use were most likely to be severe?

The production of monoclonal antibodies by the ascites method was the most likely (94%) to cause ‘severe’ suffering. This method was still being used in 6 Member States – principally in France where around 53,000 out of 54,941 uses in this category took place. Note – alternative approaches are available to replace the mouse ascites method, and this method has not been used in the UK since 2012.
Severe suffering was seen in 41% of animals used for the diagnosis of diseases, and in 38% of the animals involved in acute toxicity studies in the area of ecotoxicity.

Which animals experienced the most ‘severe’ suffering?
(data shown represent the number of uses of those animals that were reported as involving severe suffering)

732,860 – Mice (13.1% of all mouse uses involved ‘severe’ suffering)
191,796 – Fish other than zebrafish
62,171 – Rats
25,150 – Zebrafish
17,534 – Guinea pigs (13.4% of all guinea pig uses involved ‘severe’ suffering)
3,922 – Amphibians other than Rana or Xenopus (50.2% of all ‘other’ amphibian uses involved ‘severe’ suffering)
2,482 – Syrian hamsters (22.7% of all Syrian hamster uses involved ‘severe’ suffering)

What about for the creation and maintenance of genetically altered animals?

7,653 uses of animals for the creation of new genetically altered lines (1.3% of uses in this category) and 52,256 uses of animals for the maintenance of established lines of genetically altered animals (5.6% of uses in this category) were categorised as ‘severe’.

NB. Where animals are found dead with no clear reason, this results in reporting these as ‘severe’.

Note
It is not easily possible to make direct comparisons of severity data across Member States as the numbers, and proportions of animals falling into this category, are heavily influenced by the type of research and testing undertaken in that country. For example, a Member State with a high proportion of its animal use in the category of regulatory testing is currently likely to have a higher proportion of animal use causing ‘severe’ suffering.

Our series of RSPCA-led Expert Working Groups has produced guidance on reducing (and ideally avoiding) severe suffering in potentially severe procedures including sepsis, rheumatoid arthritis, experimental autoimmune encephalitis (EAE) and spinal cord injury. Each group includes scientists, animal technologists and lab animal veterinarians from industry and academia, to bring a range of expertise and perspectives and ensure all the recommendations are feasible and will achieve real results.

The next topic in the series is bone marrow ablation and reconstitution. The group has been set up and has started working on its report – we are aiming to finalise the new guidance in 2022.

We are delighted to present the RSPCA’s new ‘Focus on Severe Suffering’ web resource, with our colleagues at the Laboratory Animal Science Association (LASA), Laboratory Animals Veterinary Association (LAVA) and the Institute of Animal Technology (IAT). We all share the aim of reducing suffering and improving the welfare of laboratory animals for as long as their use continues, and we want this resource to help all those involved in the care and use of lab animals to reduce or avoid ‘severe’ suffering. 

Whatever your role and wherever you are in the world, we hope that this resource will inform, guide and inspire you. Many of the principles – like the Roadmap – apply to any level of severity, so you can use them to apply refinement in general and feed into your establishment’s Culture of Care. Please use these pages, share them with colleagues and tell us what you achieve.