Scientists in the UK who work with animals are required by law to submit reports to the Home Office about their use, and the figures are collated and released annually by the department. The statistics are used to inform government policies on animal use in scientific work and to provide information for the scientific community, animal welfare organisations and the general public.
The statistics relate to scientific procedures and the species defined in the Animals (Scientific Procedures) Act 1986. Until now figures have referred to the number of procedures and the number of animals involved that were started in the latest calendar year. In some cases animals are used for more than one procedure.
This year’s statistics (for procedures carried out in 2014) will be issued on Thursday October 22. For the first time they will include additional data. (See below). The new statistics will report the number of animals used and the number of procedures that have been completed in that year. The Home Office detailed tables will show whichever is the most appropriate. For example: for source, it will refer to animals, for purpose of procedure, it will refer to procedures.
FRAME is dedicated to the development of new and valid methods that will replace the need for laboratory animals in medical and scientific research, education, and testing. Where the use of animals is currently necessary, FRAME supports the reduction of numbers involved to an unavoidable minimum and refinement of experimental procedures to minimise any suffering caused.
In order for FRAME to meet those goals we monitor and analyse the UK annual Statistics of Scientific Procedures on Living Animals each year. This allows us to identify trends in animal usage and to prioritise research programmes to promote the Three Rs, and to resolve areas of current and future concern.
Under the 1986 Act, anyone carrying out animal-based experiments must apply in advance to the Home Office for a licence. Any scientific procedure carried out on any living vertebrate animal or cephalopod, which is likely to cause that animal pain, suffering, distress or lasting harm is a regulated procedure requiring licence authority.
The Act defines a regulated procedure as follows:
(i) A “regulated procedure” is defined by Section 2(1) of the Act as “any experimental procedure applied to a protected animal for a qualifying purpose which may have the effect of causing the animal a level of 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”. (As given in the 2012 Amendment to the Act.)
(ii) “Pain, suffering, distress and lasting harm” encompass any material disturbance to normal health (defined as the physical, mental and social well-being of the animal). They include disease, injury and physiological or psychological discomfort, whether immediately (such as at the time of an injection) or in the longer term (such as the consequences of the application of a carcinogen). (Source?)
Licence holders are required to submit a return even if no work has been undertaken (nil returns). A record is kept of all licensees from whom returns have been received. To ensure that the published data are as complete as possible the Home Office will not publish the statistics unless the number of missing returns represents less than 0.5 percent of all the returns expected.
Returns previously included:
- Species of animal
- Genetic status of animal (whether genetically modified – GM – or carrying a harmful mutation – HM.
- Primary purpose (Fundamental biological research, Applied studies – human medicine or dentistry, and veterinary medicine, Protection of man, animals or the environment, Education and training; Forensic enquiries; Direct diagnosis; Breeding;)
- Source of animals (now place of birth)
- Target body system (included in purpose in list below)
- Use of anaesthesia (no longer included – it was felt that actual severity would be more informative)
- Type of procedure (Fundamental and applied studies; Toxicity tests, or other safety evaluation) (included in purpose in list below)
- Field of research (included in purpose in list below)
- Production of biological materials (the information collected for this is not as detailed in the new returns. In the list below it comes under purpose)
- Techniques of particular interest (for example, the application of a substance to the eye or exposure to ionising radiation; this is now very limited – see list below)
- Legislative requirements (now more detailed)
- Species of animal
- Number of animals
- Re-use of animals
- Place of birth (all species except non-human primates)
- Place of birth (non-human primates) includes more detail than above
- Non-human primate generation e.g. 1st generation captive bred
- Genetic status
o 1) ‘Not genetically altered’ includes all wild-type animals, including inbred strains. This includes genetically normal parents of genetically altered offspring and genetically normal offspring. Genetically altered animals (GAAs)’ includes all genetically modified animals (transgenic, knock-out and other forms of genetic alteration) and mutations, whether naturally occurring or induced.
o 2) ‘GAAs without a harmful phenotype’ includes all GAAs that do not show an overtly harmful phenotype, or individuals of strains on which a formal welfare assessment has been carried out, which showed the strain to have either no phenotype or a phenotype of sub-threshold severity. This category can apply to any purpose given in Column N. It includes animals used for the creation of new strains, animals used in further procedures and animals used for maintenance of established colonies.
o 3) ‘GAAs with a harmful phenotype’ includes all GAAs that exhibit an overtly harmful phenotype. This category can apply to any purpose given in Column N. It includes animals used for the creation of new strains, animals used in further procedures and animals used for maintenance of established colonies, but only if a harmful phenotype manifests. If the strain is known to have a harmful phenotype but some individuals do not exhibit that phenotype, then do not use this category, use ‘Genetically altered animals without a harmful phenotype’ for those individuals.
- Creation of new genetically altered animal line
- Purpose (For example: basic or translational, body system, type of disorder, regulatory toxicity/routine production or quality control)
- Testing by regulation
- Legislative requirements (origin of legislation)
- Actual severity
- Techniques of special interest (now limited to household product testing, ascites models for monoclonal antibody production, safety testing products containing tobacco, safety testing products containing alcohol)
Other changes are:
The change from reporting the end of procedure, rather than the start, might lead to some initial double counting, if an experiment was begun in 2013 and ended in 2014, for example. This could artificially inflate the figures this year making totals look higher than they actually were. The Home Office statistics will include a discussion of the potential effect of this change in the reporting process.
There is a new requirement to collect and publish information about the actual severity of the procedures carried out. This will be a very welcome improvement on the limited reporting of predicted severity band of the active project licences. This will provide a much more accurate picture of the impact that experimentation has on animals and will provide essential scope for targeting Three Rs initiatives of the most severe procedures.
More detailed information on the origin and breeding generation of primates will give important insight into parameters that can have a high impact on primate welfare that is already compromised by captivity and procedures. Knowing how far the animals have to travel to laboratories and how domesticated they are in terms of captive breeding will enable a more accurate prediction of the cumulative harms they encounter.
The new statistics will report more detailed information on what type of legislation requires animal tests (e.g. medical device legislation or biocides legislation) and the origin of the legislation (e.g. to satisfy EU or non EU regulations). This is important for identifying areas of high regulatory use to provide opportunities to challenge those requirements and work with legislative authorities to encourage development, validation and acceptance of alternatives.