Updated 22 November 2016
25.1 The Animals (Scientific Procedures) Act 1986 Amendment Regulations 2012 (SI 2012/3039) amend the Animals (Scientific Procedures) Act 1986 (ASPA) to transpose (or in other words implement) European Directive 2010/63/EU on the protection of animals used for scientific purposes. Directive 2010/63/EU sets out revised measures for the protection of animals used for scientific purposes. Please note that ASPA in this guidance means the consolidated amended version of the Act incorporating the changes brought about by the Directive.
Regulated and non-regulated procedures
25.2 A procedure is regulated under ASPA if it is carried out on a 'protected animal'* for a scientific or educational purpose and may cause that animal a level of pain, suffering, distress or lasting harm equivalent to, or higher than, that caused by inserting a hypodermic needle according to good veterinary practice. This is referred to as the 'lower threshold'. (See ASPA Section 2(1))
* A 'protected animal' means all living vertebrates, other than a human, including certain immature forms, and any living (non-embryonic) cephalopod.
25.3 There are also some procedures that are not regulated under ASPA (See ASPA Section 2(8). These are:
a. Non experimental clinical veterinary practices (referred to in this document as ‘recognised veterinary practice’): The clinical investigation and management of the health or welfare of animals is generally considered to be recognised veterinary practice when it involves an intervention which is of direct benefit to the animal or its immediate peer group. This Chapter provides further advice on what is considered recognised veterinary practice.
b. Non experimental agricultural practices and practices undertaken for the purpose of recognised animal husbandry: These are not regulated procedures as long as they comply with other animal welfare legislation and regulations and are being used to manage or conserve animals. The procedures will, however, become regulated if they are being performed for a scientific purpose and may cause pain, suffering, distress or lasting harm above the lower threshold.
c. Veterinary clinical trials: Veterinary clinical trials required to be carried out for marketing authorisations of veterinary medicinal products are a requirement of the Veterinary Medicines Regulations 2011 (et seq.). Applications for Animal Test Certificates should be submitted to the Veterinary Medicines Directorate. All procedures applied to animals during the course of the trial must be consistent with recognised veterinary practice and the investigating veterinary surgeon must act in accordance with the Veterinary Surgeon’s Act, otherwise the study, or those aspects of the study that are not consistent with recognised veterinary practice, will also need to be regulated under ASPA. If what is proposed is likely to exceed recognised veterinary practice, the Veterinary Medicines Directorate should be consulted.
d. Identifying animals: Ringing, tagging or marking an animal primarily to identify it as a specific individual, or using any other humane way to do so, are not regulated procedures if they cause no more than momentary pain or distress (or none at all) and no lasting harm.
(For more information about regulated and non-regulated procedures see Home Office Guidance issued March 2014)
Interface between the Veterinary Surgeons Act 1966 and the Animals (Scientific Procedures) Act 1986
25.4 It is accepted that it is for the RCVS to provide guidance to its members on what is recognised veterinary practice. RCVS advice is intended to assist veterinary surgeons, veterinary nurses, veterinary students, teachers in veterinary schools and in extra mural practices, and Home Office inspectors and officials. It is accepted, however, that the Courts interpret the law and that RCVS guidance reflects the views of the professional regulatory body. Moreover, it is also recognised that RCVS guidance cannot cover all current situations and must continue to evolve.
Recognised veterinary practice
25.5 Interpretation of the term 'recognised veterinary practice' is the key underlying all three elements in the terms of reference. The term should be interpreted as ‘procedures and techniques performed on animals by veterinary surgeons in the course of their professional duties, which ensure the health and welfare of animals committed to their care’.
25.6 The following definitions are used to clarify the terms:
a. Procedure and techniques are terms used for a veterinary investigation, diagnosis or treatment including any prophylactic measures taken to prevent or control disease.
b. A veterinary surgeon is a registered member of the RCVS. Some delegation must be permitted consistent with the criteria for delegating acts of veterinary surgery set out in the report of the RCVS Deregulation Working Party 1996.
c. Professional duties are those carried out by, or under the responsibility of, a veterinary surgeon when his or her normal work (including, private and academic clinical practice and professional duties in animal welfare organisations, government service and commerce) involves techniques and procedures applied to animals committed to his or her care.
25.7 In all circumstances, the individual has to consider the primary purpose and whether he or she is acting in a professional capacity as a veterinary surgeon or as a research scientist. Although the procedures and techniques may be identical, analysis of the purpose for which they are applied should help the veterinary surgeon to determine if the intervention is of direct benefit to the animal or its immediate group (i.e. others of the same species) and therefore recognised veterinary practice, or, if the intervention is for an experimental or other scientific purpose and controlled by ASPA.
25.8 Recognised veterinary practice does NOT include:
a. Experiments using animals primarily for research where the procedure is not part of normal veterinary clinical practice or a veterinary clinical investigation.
b. Deliberately exposing animals, including those used in unprotected control groups, to trauma or infectious agents where there is a risk to health and wellbeing.
c. Use of an animal in teaching, if the procedure would not normally be used to teach acts of veterinary surgery as defined in Veterinary Surgeons Act 1966, section 27.
d. Clinical investigations which would not be for the benefit of that animal or its immediate group.
25.9 When animals are used for experimental or other scientific purposes, veterinary surgeons are treated in the same way as non-veterinary surgeons, which means that Home Office authorities under ASPA must be sought. Failure to comply with Home Office regulations by deliberately misinterpreting the recognised veterinary practice exemption under section 2(8)(b or d), will be treated as infringements of the ASPA and may also be regarded as professional misconduct and subject to full RCVS disciplinary action.
The use of animals in clinical teaching
25.10 Under the terms of the Veterinary Surgeons Act, the RCVS is responsible for monitoring veterinary education and professional training and is well placed to give guidance to the profession on ways in which animals are used in clinical teaching and clinical investigation. The responsibility for the animal's welfare lies with the supervising veterinary surgeon, and any ‘unnecessary suffering’ would be in breach of UK animal welfare legislation and subject to possible prosecution.
25.11 Veterinary graduates will have been properly trained at the time of registration and continuing professional development is a professional obligation for veterinary surgeons throughout their careers. The training will, in most instances, be achieved using clinical cases where there will be an individual veterinary surgeon responsible to the animal and the owner.
25.12 The teaching of skills to veterinary students is controlled by the Veterinary Surgeons (Practice by Students) (Amendment) Regulation 1993 made under the Veterinary Surgeons Act 1966. Such use of animals applies to all veterinary students in their clinical years and is the responsibility of the clinicians in charge. The procedures and techniques are limited to those that would be undertaken by the supervising veterinary surgeon in the course of his/her professional duties. The purpose is not experimental or scientific, but the student may acquire competence in those techniques that he/she will use as a qualified veterinary surgeon (see 25.6(c) above).
25.13 Animals used for training and teaching purposes would normally be those presented to veterinary surgeons in the course of their professional activities.
25.14 Open discussions with colleagues at the local level should be encouraged. The ethical review process in the veterinary schools required under ASPA would be a suitable forum for considering the ethical issues on the appropriate use of animals in clinical teaching.
25.15 It is recommended that the RCVS should be the focus for professional advice in the UK and that a mechanism should be set up for collating information and identifying precedents. Based on this evidence, RCVS guidance should be under constant review.
25.16 The use of cadavers for teaching and investigation is encouraged. If, having obtained the owner's informed consent, the animal is euthanised by overdose of an anaesthetic agent and confirmed as dead by the cessation of the circulation, the cadaver can be used for teaching purposes. This preparation would be recognised veterinary practice.
25.17 Perfusion of animals before death to obtain fixed anatomical specimens is not considered recognised veterinary practice and should be regulated under ASPA.
25.18 Acts of veterinary surgery may be carried out on animals by veterinary surgeons to train non-veterinary surgeons in certain procedures covered by Schedule 3 or Exemption Orders made under the Veterinary Surgeons Act. For example, veterinary nurses, and technicians employed in cattle embryo transfer teams.
Clinical investigation accepted as recognised veterinary practice
25.19 When conducting clinical investigation (without ASPA authorities), care must be taken to ensure that appropriate veterinary treatment and care is provided for all animals used in the study. The use of untreated 'control' groups needs careful consideration, to ensure that no avoidable suffering results as a consequence of withholding treatments. The inclusion of placebo treated 'control' groups will require ASPA authority if likely to cause pain, suffering, distress or lasting harm to those animals.
25.20 The use of any novel treatments must reasonably be expected to result in a similar or better outcome than that following conventional treatment. The veterinary surgeon must have some background knowledge of the treatment in order to make a professional judgement. When what is to be done has an experimental component, authority under ASPA may be necessary.
25.21 When there is a desire to pursue scientific investigation on clinical cases and with the owner's informed consent, it may be possible to bring the animals into ASPA authority and discharge them at the end of the investigation.
25.22 Veterinary surgeons conducting clinical trials within the terms of an Animal Test Certificate (ATC) issued by the Veterinary Medicines Directorate do not generally require ASPA authority (see para. 25.3 (c) above).
25.23 The circumstances described above highlight the interface between the Veterinary Surgeons Act and ASPA with respect to clinical investigation. In these and similar circumstances, veterinary surgeons are invited to approach the RCVS and a Home Office inspector at a preliminary stage to determine whether ASPA authority is needed.
Diagnostic tests and application of new therapies
25.24 There are many examples where veterinary surgeons apply diagnostic tests and techniques to clinical cases that have already been developed for use in other species or human patients. Similarly, treatments used in human medicine may be introduced for use in animals where potential benefits might be expected for the individual animal or its immediate group, for veterinary public health or for environmental protection. This is legitimate.
25.25 Unless regulated under ASPA it would NOT be acceptable, and may bring the profession into disrepute, for a veterinary surgeon to use an animal in the development of a diagnostic test or a new form of treatment where:
a. the test or treatment has not previously been made available to the veterinary profession and there is no background evidence to predict a clinical application in the species or other veterinary benefit;
b. there is deliberate deception that would enable a veterinary surgeon or a non-veterinary surgeon to avoid regulation under ASPA.
Flow chart together with non-exhaustive examples
An ASPA flow chart together with non-exhaustive examples (Performance of procedures by veterinary surgeons) is available to view in the 'Related documents' box on the right.
New technology tests
25.26 Veterinary surgeons or veterinary nurses involved with the use of tests using genomic or other similar new technology (including proteomic and metabolite technology) within the context of ‘recognised veterinary practice’, are subject to the same restrictions, safeguards and guidance as those involved with tests using biochemical or other technology, such as:
- compliance with the Veterinary Surgeons Act 1966, to ensure that , subject to the specified exemptions in the Act and subordinate legislation, only veterinary surgeons practise veterinary surgery;
- consideration of the RCVS Code of Conduct the interface between the Veterinary Surgeons Act and the Animals (Scientific Procedures) Act 1986;
- consideration of the published information on the clinical benefits of the test, particularly if the test is new;
- consideration of the test as predictive or diagnostic;
- consideration of the specificity and sensitivity of the test;
- consideration of positive and negative predictive values;
- consideration of the environmental or other factors when the test relates to a complex condition;
- publicity is legal, decent, honest and truthful and therefore with no misleading claims;
- publicity is of a professional nature;
- consideration of responsibilities to patients and clients, such as informed consent from the client and, if appropriate, informed consent for the use of any excess collected with a sample and not used in the test;
- appropriate professional guidance and advice when test results are communicated to clients; and,
- consideration of responsibilities to the general public, including the use of professional status to provide only factual information to the general public about veterinary products and services and the need for cooperation with colleagues and other health care professionals when appropriate.
The usual safeguards should be applied, as appropriate, even if the genomic or other test provides no diagnosis of disease. For example, such information may be used for breeding purposes or by insurance companies and may have a significant effect on the welfare of the animal or animals tested. Client confidentiality will apply to the results of such tests.
25.27 Section 2(8) of the Animals (Scientific Procedures) Act 1986 exempts procedures conducted as part of any recognised veterinary, agricultural or animal husbandry practice. Taking blood from healthy donors with the permission of the owner and with the intention of administering the blood or its products to a recipient is recognised veterinary practice where there is an immediate or anticipated clinical indication for the transfusion. Such a clinical procedure would be acceptable on the scale of an individual veterinary practice or between other practices in the locality. However, the collection of blood for the preparation of blood products on a larger commercial scale for general therapeutic use in animals may require licences under the Animals (Scientific Procedures) Act 1986; this larger commercial scale activity would need to be licensed under the Veterinary Medicines Regulations.