Guidance

User guide to annual statistics of scientific procedures on living animals, Great Britain

Updated 13 July 2023

Applies to England, Scotland and Wales

1. Introduction

This user guide accompanies the Home Office collection ‘Statistics of Scientific Procedures on Living Animals, Great Britain’. The statistics in the collection relate to regulated scientific procedures performed using living animals under the Animals (Scientific Procedures) Act 1986 (ASPA).

1.1 Uses of the statistics

The expected uses of the statistics are listed using the standard categorisation for Official Statistics.

a) Informing the general public’s choices:

• about the state of the economy, society and the environment – figures on animal scientific procedures are used by the media
• about the performance of government and public bodies – figures on levels and trends in animal scientific procedures are requested via Parliament Questions and Freedom of Information Act request

b) Government policy making and monitoring

c) Resource allocation – typically by central and local government

2. Data coverage and source

2.1 Legislation and purpose of collection

This annual statistics publication relates to scientific procedures performed using living animals subject to the provisions of ASPA. Section 21A ASPA requires licensing and oversight of all places, projects, and people who want to conduct scientific procedures on living animals. The act also states that annual statistics on protected animals (this release) should be published annually and laid in Parliament.

2.2 Data source

All scientific procedures carried out on living animals in the UK, subject to ASPA, must be authorised under a project licence, granted by the Home Secretary.

Each project licence holder must collect and store their own data, which can be subject to inspection (announced and unannounced) by the Animals in Science Regulation Unit. The statistics are collected via online data returns submitted by project licence holders at the end of each calendar year, or within 28 days of the termination of the licence when this occurs during the year. Since the 2021 collection, this data is held in and extracted from the Animals in Scientific Procedures e-Licensing (ASPeL) system.

2.3 Data coverage

Within the UK, the Home Office collects and publishes information on regulated procedures for Great Britain, while in Northern Ireland the Department of Health separately collects and publishes this information under devolved arrangements.

Regulated procedures are defined in ASPA as any procedure applied to a protected animal for an experimental or other scientific purpose, or for an educational purpose, that may have the effect of causing an animal pain, suffering, distress or lasting harm equivalent to, or higher than, that caused by the introduction of a needle in accordance with good veterinary practice.

Protected animals are defined in the ASPA as any living vertebrate other than man and any living cephalopod. As ASPA indicates, the breeding of an animal is a regulated procedure if the animal is bred from, or is the descendant of, an animal whose genes have mutated or been modified.

The annual statistics publication predominately focuses on experimental procedures and procedures counted under the creation and breeding of genetically altered (GA) animals separately.

Experimental procedures include all animals used in basic research, regulatory use, translational/applied research, protection of the natural environment, higher education and training, preservation of species and forensic enquiries.

Creation and breeding of GA animals includes some animals that were bred with the intention of producing GA animals, but resulted in non-GA animals being born. In addition, some animals used for the creation of a new genetic line would also have been genetically normal animals, for example, those used for superovulation (production of eggs). These animals were not used in experimental procedures.

Establishment type is no longer reported as it is not collected by the ASPeL system. An individual establishment could be categorised as multiple types, and type was not an indicator of the procedures conducted by establishments.

2.4 Counting rules

The figures provided in the statistical report refer to the numbers of procedures (completed) rather than the numbers of animals used (for the first time), unless indicated otherwise. However, in most cases, the number of procedures corresponds to the number of animals used. In instances where the number of procedures is higher than the number of animals used, this is due to a re-use of animals.

Each procedure (which may consist of several stages) is counted once for the year in which it was completed.

A study involving procedures on a number of animals is counted once for each animal. Where an animal that has previously been used in a completed procedure is used again for a further procedure (‘re-use’) it is counted as a separate procedure, but the animal itself is not recounted. The circumstances in which the re-use of an animal is permitted are limited (see section 5.19 of Guidance on the Operation of the Animals (Scientific Procedures) Act 1986).

Procedures on adult or free-living animals (including neonatal and juvenile mammals, and newly hatched birds) are counted. Details of procedures on immature forms (for example, larvae, embryos) are not counted unless they have reached the free-feeding stage (for example, zebrafish from 5 days post-fertilisation and tadpoles).

Animals in the wild involved in rodenticide trials are also not counted. A rodenticide trial is the testing of any substance that is used to kill rats, mice, and other rodent pests. Information is collected on the number of project licences which undertake rodenticide trials.

2.5 Exclusions

The controls of ASPA, and therefore the statistics in the annual release, exclude:

• non-experimental agricultural practices
• non-experimental clinical veterinary practices
• practices undertaken for recognised animal husbandry
• the administration of any substance or article to an animal for research purposes in accordance with an animal test certificate granted under the Veterinary Medicines Regulations 2013 Sect 3 (2) (b)

The annual statistics also exclude:

• ‘genetically normal’ (that is, non-GA) animals that were bred for scientific procedures but were killed or died without being used in procedures
• animals that were subject to procedures for the purposes of genotyping (the process of investigating the genetic makeup of an animal)

The Home Office published additional statistics on breeding and genotyping of animals for scientific procedures for 2017 as experimental statistics.

3. Data quality and methodology

3.1 Data quality

The UK Statistics Authority has designated these statistics as National Statistics, in accordance with the Statistics and Registration Service Act 2007, signifying compliance with the Code of Practice for Statistics.

National Statistics status

National Statistics status means that our statistics meet the highest standards of trustworthiness, quality, and value, and it is our responsibility to maintain compliance with these standards.

The designation of these statistics as National Statistics was confirmed in 2023 following a compliance check by the Office for Statistics Regulation. The statistics last underwent a full assessment against the code of practice in 2012.

Since the latest review by the Office for Statistics Regulation, we have continued to comply with the Code of Practice for Statistics, and have made the following improvements:

• resumed relationship building with establishments conducting regulated procedures, including planned initiatives to improve understanding of project licence holder data collection and quality processes
• improved transparency of the data collection and quality assurance processes in this user guide
• provided context to the revisions and corrections table
• provided clarity on the responsibilities of other government departments in relation to these statistics
• started work on future user engagement, including discussion with animal protection and welfare group representatives
• started investigation of how to provide further commentary on potential causes for changes over time, with consideration as to the role of other government departments
• addition of a glossary to the publication

Any further plans for user engagement, improvements to the publication, and improvements to quality assurance processes will continue to be documented in this user guide.

The following improvements were made in response to earlier reviews by the Office for Statistics Regulation:

• transitioned to a new online data collection system, with data validation to prevent invalid combinations of data being entered
• created a reproducible analytical pipeline (RAP) to automate quality assurance processes and the production of statistical outputs, in line with RAP principles
• for the 2017 data onwards, data collected on ‘other’ species is subject to data quality checks which have allowed for further analyses of the animals returned under ‘other’ (non-Schedule 2) species categories
• each year, we consult with colleagues in the Animals in Science Regulation Unit to ensure the collection remains suitable for its purpose

3.2 Quality assurance

These statistics are compiled by statisticians within the Home Office. They undertake a wide range of quality assurance checks with the expert assistance of colleagues in the Animals in Science Regulation Unit (ASRU), and with follow-up contact with data suppliers as needed. These checks follow the QAAD guidance (Quality Assurance of Administrative Data) and include:

• compiling the administrative data to highlight outliers and possible errors
• variance checks, such as, investigating substantial changes in figures compared with the previous year
• including safeguards within the return to improve data quality
• ensuring all returns are accounted for, and that no duplicate returns are provided
• querying incomplete data, or invalid data/combinations of data, provided in returns
• investigating returns which contain unusual data or unusual combinations of data
• explaining to users about the data quality and the impact upon the statistics

Project licence holders are responsible for the collection and submission of their data. These internal records are subject to audit (announced and unannounced) by ASRU officials. The project licence holders submit their data to the ASPeL online system. ASPeL’s data is assessed and processed by the statistical production team. A combination of automated and manual checks are conducted to identify potential data quality issues. Issues identified are investigated by the statistical production team and ASRU officials to establish cause (for example, a misclassification in the project licence holder’s data return). Where appropriate ASRU will contact the project licence holder to prompt an amendment of their return. Where this is not possible or appropriate the statistical transformation team are able to directly amend the data used in the publication.

3.3 Data quality issues

Changes to data collection from 2014

Following the European Directive 2010/63/EU being transposed into UK law (the animals in scientific procedures act 1986) in January 2013, the 2014 collection underwent substantial changes. As a result, some inconsistencies were expected in the reporting of the 2014 information.

Previously the Home Office counted ‘procedures started’ but post 2014 this changed to ‘procedures completed’. As a result, procedures started before 2014 but completed in 2014 should have been reported in both the pre-2014 and 2014 figures.

Additionally, there were discrepancies of a small number of duplicate returns, and misclassifications of reported severity in the 2014 collection. Home Office statisticians have since reviewed their processes and quality assurance checks in light of these issues.

Rounding

Data may be rounded to simplify the presentation of the figures. However, all numeric and percentage calculations are based on unrounded data. Where data are rounded, they may not sum to the totals shown, or, in the case of percentages, to 100%, because they have been rounded independently.

The rounding conventions used in the release, unless otherwise stated, are as follows:

• over 1 million - presented as millions and rounded to 2 decimal places, for example, 2,121,582 = 2.12 million
• 10,000 to 999,999 - rounded to the nearest thousand, for example, 343,465 = 343,000
• 1,000 to 9,999 - rounded to the nearest hundred, for example, 8,465 = 8,500
• 10 to 999 - rounded to the nearest 10, for example, 47 = 50
• less than 10 - unrounded, whole numbers
• percentages greater than 1% - rounded to the nearest percent, for example, 1.43% = 1%
• percentages less than 1% - rounded to one significant figure, for example, 0.43% = 0.4%, and 0.043% = 0.04%

The data in the data tables are unrounded. All percentages in the data tables are rounded to the nearest 0.1%.

Revisions

It is standard practice across all Home Office statistical releases to incorporate revisions to previous years’ data in the latest release. Corrections and revisions follow the Home Office’s statement of compliance with the Code of Practice for Official Statistics.

4. Related statistics and reports

4.1 Great Britain

On 8 November 2018 the Home Office published ‘Additional statistics on breeding and genotyping of animals for scientific procedures, Great Britain 2017’. These experimental statistics were collected by the Home Office under the EU Directive (2010/63/EU) and cover the number of ‘genetically normal’ (that is, non-genetically altered (non-GA)) animals that were bred for scientific procedures but were killed or died without being used in procedures, and the number of animals (GA and non-GA) subject to tissue sampling for the purposes of genotyping. The Home Office is not required to collect and release these additional statistics following exit from the EU. Future publication of this data is under review.

The statistics presented in Statistics on animals in scientific procedures have been collected since 2001 and are available online. Data was collected under different categories prior to 2014, meaning some of the data (for example, for species, purpose, genetic status, severity) is not comparable or does not exist.

Older editions of this statistical release may be found in the national archives. However, not all previous publications are available online. Annual publications giving detailed figures for scientific procedures under ASPA have been published as ‘Statistics of Scientific Procedures on Living Animals’ since 1987. Detailed figures for experiments on living animals under the Cruelty to Animals Act 1876 were published as ‘Statistics of experiments on living animals’ between 1977 and 1986. Less detailed information about experiments on living animals for the years prior to 1977 was published in the form of a ‘Return to an Address of the Honourable the House of Commons’.

Forthcoming publications are pre-announced on the ‘Statistics: release calendar’ on the GOV.UK website.

4.2 Northern Ireland

Statistics for scientific procedures in Northern Ireland can be found on the Northern Ireland Department for Health website. The data for Northern Ireland are collected in the same manner and undergo similar quality assurance processes as the data for Great Britain, meaning the 2 datasets can be used for comparison.

4.3 European Union

In 2018, the Animals in Science Regulation Unit (ASRU) made arrangements for EU exit by preparing legislation, known as a Statutory Instrument, to amend ASPA and deliver EU exit. This Statutory Instrument, UK Statutory Instrument 2019, No.72 The Animals (Scientific Procedures) Act 1986 (EU Exit) Regulations 2019, was enacted on 31 January 2020, the day of EU exit. The legislation had the result of removing the requirements for mandatory reporting of information on scientific procedures to the European Commission (EC).

The UK will no longer submit information on scientific procedures on animals to the EC. Therefore, UK data will no longer be incorporated into EC published reports on procedures on living animals in the EU.

4.4 Other related information

A consolidated version of ASPA can be found online, as well as guidance on the operation of ASPA.

The Annual report of the Home Office Animals in Science Regulation Unit sets out information about the work of the Home Office.

Information about the Animals in Science Committee.

Information about the National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs) can be found on their website.

4.5 Feedback and enquiries

We welcome feedback on the annual statistics release.

If you have any feedback or enquiries about this publication, please contact the Statistical Transformation team, the Home Office Unit which produced the statistics, via HOAIStatisticalTransformation@homeoffice.gov.uk.