24. Named Veterinary Surgeons

Introduction

24.1  The Animals (Scientific Procedures) Act 1986 Amendment Regulations 2012 (SI 2012/3039) amend the Animals (Scientific Procedures) Act 1986 (ASPA) to transpose 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.

24.2  This supporting guidance sets out the role of 'Named Veterinary Surgeon' (NVS) employed in scientific procedure establishments and breeding and supplying establishments under ASPA, and provides advice to veterinary surgeons deputising for the NVS. ASPA is a UK-wide Act and is administered by the Home Office in Great Britain and the Department of Health, Social Services and Public Safety (DHSSPS) in Northern Ireland. This guidance was issued after consultation with the Home Office and the Laboratory Animals Veterinary Association (LAVA) and taking into account ASPA and revised associated Home Office Guidance. 

24.3  A licensed breeding establishment is an establishment which is specified in a licence granted under ASPA section 2C authorising the licence holder to engage in the activity of breeding Schedule 2 animals for use in regulated procedures, or for the scientific use of their tissues, or of breeding any other protected animals primarily for those purposes. A licensed supplying establishment is an establishment which is specified in a licence granted under ASPA section 2C authorising the licence holder to engage in the activity of holding Schedule 2 animals bred elsewhere for supply to another establishment. A licensed user establishment is an establishment which is specified in a licence granted under ASPA section 2C authorising the licence holder to engage in the activity of using animals in regulated procedures. Some establishments may fall into more than one of these categories.

24.4  Licences granted under ASPA section 2C are known as ‘establishment licences’.

24.5  No regulated procedures may be carried out unless there is a project licence covering the work to be carried out and detailing the procedures, and a personal licence holder with authority to carry out those procedures.

NVS role and responsibilities

24.6  Scientific procedure establishments and breeding and supplying establishments are required to name a veterinary surgeon(s) in their licence schedule, who accepts responsibility under ASPA to provide advice on the health, welfare and treatment of animals within these establishments. Exceptionally, another suitably qualified expert may be nominated where it can be shown that they are more appropriate for this role. Please refer to the glossary at the end of this document for more information about a Suitably Qualified Person in this context. This guidance will refer to the NVS role.

24.7  Home Office Guidance Section 8.6 provides information on the NVS role and responsibilities. Paragraphs 24.12 – 24.28 below are extracted directly from the Home Office Guidance. This is also available on the GOV.UK website.

24.8  The NVS is expected to be familiar with the main provisions of ASPA, the Home Office Guidance and relevant Codes of Practice. 

24.9  The NVS is nominated by the establishment licence holder and specified in the establishment licence. They have responsibilities associated with ASPA. The NVS should also liaise with others with responsibilities under ASPA. 

24.10  By application to the Home Office, the establishment licence holder may nominate additional NVSs, each having clearly defined areas of responsibility and usually specified project work, locations, or species.

24.11  Veterinary surgeons are expected to undergo specific training for the role of NVS (see paragraphs 24.48 – 24.49 below and Home Office Guidance Section 9.7).  

Responsibilities under ASPA

Advice to the establishment licence holder

24.29  Under ASPA the prime responsibility of the NVS is to advise the establishment licence holder on veterinary matters, with specific reference to the health, welfare and treatment of animals. In order to fulfil this responsibility the NVS may need to consider advising on the following areas:

1. maintenance of health status and suitable preventive medicine protocols, and an appropriate programme for monitoring the health and welfare and quality of animals, and their environment;
2. provision of care, e.g. suitable environmental controls, development and monitoring of social and environmental enrichment programmes, or where there are concerns that staffing levels may compromise animal welfare;
3. maintenance of animals needing special attention, for example immuno-compromised mice;
4. provision of specialist veterinary facilities, in particular for aseptic surgery and post-operative care, quarantine, acclimatisation and other special animal welfare needs (usually, the NVS will be involved in the design and planning of new facilities for such purposes). The NVS should be familiar with LASA Guiding Principles for Preparing for and Undertaking Aseptic Surgery;
5. appropriate methods of euthanasia and means of assessing competence;
6. appropriate humane methods of identification;
7. whether animals are fit to go to a non-designated establishment; and
8. the supply and use of all prescription only medicines and controlled drugs for use on protected animals in the establishment (relevant legislation includes the Veterinary Medicines Regulations and the Misuse of Drugs Act 1971 and subordinate legislation). The NVS should be familiar with LAVA Guidance on ‘The control of acquisition, supply, administration (use), storage and disposal of medicines in establishments designated under the Animals (Scientific Procedures) Act 1986’. This is available to download in the 'Related documents' box.

Advice to the project licence holders

24.30  The NVS should advise on:

1. strategies to minimise the severity of regulated procedures, and how particular adverse effects may be controlled, e.g. refinements to methods of dosing and sampling; clinical monitoring; use of anaesthesia and analgesia; appropriate humane end-points;
2. use of prescription only medicines and controlled drugs for scientific purposes;
3. the health status needed and suitability of animals for planned studies;
4. the impact of the procedures proposed on the animals, and any specific husbandry and care needs during the procedures; and,
5. the fate of animals at the end of regulated procedures or at the end of use at that establishment.

24.31  To provide suitable up to date advice, it is essential to hold (and hold securely) copies of, or have ready access to, all project licences and any conditions attached. The NVS should expect that their advice on these issues would be sought, normally at an early stage of drafting a project licence and for any subsequent substantive amendments.

Advice to personal licence holders

24.32  For research workers using animals the NVS should provide:

1. practical advice on techniques, particularly surgical approaches and suitable anaesthetic regimens and peri-operative care;
2. advice on the recognition of pain, suffering distress and lasting harm, and ill-health, and physiological and behavioural disturbances in animals (such as arise from fear or boredom);
3. advice on the recognition and assessment of severity and any potential breach of the severity limit; and
4. advice on the recognition of humane end-points   

24.33  Advice may involve consultation with other named persons and experts.

Advice to the animal care staff

24.34  Commonly a senior animal technician holds the position of NACWO and is the main point of contact on matters relating to the general care and husbandry of animals in the establishment. They are likely to be the person who contacts the NVS in cases where the health or welfare of an animal gives rise to concern. The NVS should foster a good working relationship with the NACWO(s) and other animal care staff.

24.35  The NVS should provide advice on maintaining health status and animal welfare issues, including socialisation and enrichment.

Contracts and visits

24.36  A veterinary surgeon may be contracted as the NVS on a full-time or part-time basis depending upon, for example, the size of the establishment and the nature and complexity of the research programmes. The contractual hours and resources (e.g. the assistance given by other veterinary surgeons, management support and facilities) should be adequate to enable the NVS to fulfil their role. Whether full-time or part-time the responsibilities and statutory duties of the NVS are the same.

24.37  Whether the appointment is full-time or part-time, the NVS must arrange to visit the facilities on a regular basis for both advisory and veterinary care roles, rather than waiting to be called out in an emergency. In this way the NVS should become familiar with the animals, the research workers and their areas of scientific interest, as well as the procedures carried out on animals within the establishment. The frequency of these visits should be determined by the NVS according to the number and species of animals involved and the nature and severity of procedures performed. An appropriate schedule of visits should be agreed in advance in consultation with the responsible staff of the establishment, in particular with the NACWO and the establishment licence holder. The visiting schedule should be regularly reviewed and amended as necessary.

24.38  The job description and/or contract of the NVS should define the responsibilities involved and provide a reporting structure that gives the NVS direct access to the establishment licence holder.

24.39  The names of the veterinary surgeons deputising for the NVS are not included on the establishment licence. Therefore, they should be recorded at the establishment and made known to the establishment licence holder, the NACWO, licensees and other relevant staff in the establishment. The means of contacting an appropriate veterinary surgeon at all times should be clearly defined and available.

Insurance

24.40  The NVS and deputising veterinary surgeons are required to have professional indemnity insurance or equivalent arrangements. Such cover may be held individually or through an employer. The chosen level of indemnity related to NVS duties should be discussed with the insurance providers, for example the Veterinary Defence Society. The level of cover can then be confirmed.

Liaison and reporting

24.41  The establishment licence holder is ultimately responsible for ensuring that the facilities, animal welfare and care, staffing levels and expertise in the establishment meet the requirements of ASPA and the Codes of Practice. The NVS is answerable to the establishment licence holder in an advisory role and for providing the contracted service. Therefore the NVS should make reports (it is suggested at least annually) directly to the establishment licence holder. The Home Office expects that named persons (including the NVS) must be able to access licences and other documents about the production, care and use of animals at the establishment and that they must be given appropriate training and resources.

24.42  Periodic meetings with the Home Office Inspector are desirable and may assist the NVS to fulfil the statutory role. The NVS should be available for discussion with the Home Office Inspector if the latter makes a request.

24.43  The NVS at a licensed user establishment should liaise closely with their colleagues at other associated establishments (e.g. where a research project involves collaboration between two or more establishments) and, especially if animal health problems arise in recently acquired animals, with colleagues at supplying and breeding establishments.

Conflict of interest

24.44  Given their role in providing independent advice on animal health and welfare the NVS must avoid perceived or real scientific, financial or other conflicts of interest. This includes:

• financial interests such as directorships and significant shareholdings;
• significant scientific and/or financial interests in the outcome of a programme of work;
• interests of close relations and/or friends which may be relevant, for example if a partner or sibling is a director or major shareholder of the establishment; and
• any other relevant matters.

24.45  People nominated for these roles should provide their establishment licence holder with a declaration (available on the research and testing using animals page of the GOV.UK website) detailing any relevant potential conflicts of interest. For more information about conflicts of interest see Home Office Guidance 3.13.8. You must inform your establishment licence holder promptly about any significant changes to your declaration.

24.46  Where the NVS also has a significant interest in the scientific or financial outcome of a programme of work, including holding a project licence, the establishment licence holder must make alternative provision such as nominating another NVS to be responsible for the veterinary oversight of the animals in question. If there is any other potential significant conflict of interest, or areas of doubt, the NVS should consult the Home Office.

Confidentiality

24.47  The NVS and veterinary surgeons deputising for the NVS must maintain client confidentiality as set out in the Code of Professional Conduct and supporting guidance. Contracts and client records, together with project and personal licences, should be stored securely to prevent any unauthorised access.

Training and continuing professional development

24.48  The Home Office requires that a new NVS attend a course, approved by the RCVS and recognised by the Home Office, specifically on the role of the NVS, either before or at a minimum within one year of accepting appointment. In any event a new NVS should undertake training on the needs of the laboratory animals on which they will provide advice. Please refer to Home Office Guidance 9.7 for more information about training requirements available on the GOV.UK website.

24.49  The NVS, and veterinary surgeons assisting or deputising for the NVS, must maintain and develop the knowledge and skills relevant to their professional practice and competence. [See also RCVS Code of Professional Conduct for Veterinary Surgeons 3.3 regarding RCVS requirements for CPD with which all veterinary surgeons must comply].  

Training of other staff

24.50  The NVS should be familiar with the range of scientific procedures carried out and may take part in the training of technicians and personal licence holders relating to animal welfare and health. In addition the NVS may be involved in training in the conduct of minor procedures, surgical methods, anaesthetic regimens, peri-operative care and assessment of competence. If the NVS will be conducting regulated procedures for a scientific purpose, they must hold an appropriate personal licence. 

VSA: ASPA interface – other issues

24.51  The NVS must understand and recognise the circumstances when they are acting as a veterinary surgeon under the Veterinary Surgeon’s Act and when they are undertaking a regulated procedure under ASPA (which requires personal and project licence authority). In either case the procedure may be the same, for example taking a blood sample or re-suturing a wound that has opened. It is the purpose for which the procedure is performed that determines whether the procedure constitutes recognised veterinary practice i.e. non-experimental clinical veterinary practice or a regulated procedure. The Royal College of Veterinary Surgeons will advise if a procedure is considered as clinical veterinary practice. The Home Office can advise if the action or omission is a regulated procedure.

Provision of veterinary services

Comprehensive veterinary service

24.52  The NVS should ensure there are appropriate arrangements for the provision of veterinary services, including 24-hour emergency cover (see RCVS Code of Professional Conduct for Veterinary Surgeons and supporting guidance for details). The NVS may delegate these duties to suitably competent deputies. The establishment licence holder is responsible for providing the necessary resources for the provision of such cover and services. Staff at the licensed establishment are expected to contact the NVS or delegated deputy, to seek veterinary advice or assistance, as appropriate; but the RCVS Code does not stipulate that staff of the designated establishment must be on site 24 hours a day. (See also 24.17, bullet point number 4).

24.53  The delivery of veterinary treatment and services should take into consideration the experimental procedures which the protected animals are being or will be subjected to, and whether data, or other products, being collected as part of the programme of work may be compromised as a result of the veterinary intervention.

Delegation

To other veterinary surgeons

24.54  Where colleagues provide some of the veterinary services and/or deputise for duties associated with ASPA, the NVS should make appropriate arrangements to ensure that delegated services are delivered. The NVS should make clear which duties and tasks are being delegated, how these should be fulfilled and how the delivery of such services should be documented. The NVS should liaise with the colleagues involved to ensure they are appropriately briefed on the scientific objectives of projects at the establishment and on the constraints and humane end-points in these projects.

24.55  When procedures regulated under ASPA are conducted at places other than licensed establishments, such as on farms or at fisheries, a local veterinary practitioner will often provide veterinary services if they are required. Good liaison between the NVS, the local practitioner, and the licence holders involved is strongly recommended to ensure neither welfare nor science is compromised.

24.56  The NVS should be aware that research procedures on animals in the wild, or obtained from the wild, may require appropriate licences from, for example, English Nature, in addition to Home Office Project and Personal licence authorities, and it would be advisable to check that all of these approvals are in place.

To persons who are not veterinary surgeons

24.57  The NVS may delegate some veterinary procedures or treatment to animal care staff, within the provisions of the Veterinary Surgeons Act 1966. Special instructions should be given and these must adequately inform animal care staff on the appropriate and responsible use of minor medical treatments, for example, dealing with and recording minor injuries or topical lesions in group-housed animals. Where written instructions are not provided the NVS must ensure staff are adequately informed verbally.

24.58  Periodically, the NVS should check that delegated procedures or treatments and preventive medicine programmes have been carried out to a satisfactory standard and appropriate records kept. Where minor medical treatments are initiated, varied or discontinued by animal care staff, the action taken, the justification for the action, and the outcome should be recorded and the records regularly reviewed by the NVS.

Prescription only medicines and controlled drugs

24.59  The NVS must comply with the requirements of the Veterinary Medicines Regulations relating to the supply and use of controlled drugs, prescription-only medicines and other therapeutic substances used on animals. The NVS should be familiar with LAVA Guidance on ‘The control of acquisition, supply, administration (use), storage and disposal of medicines in establishments designated under the Animals (Scientific Procedures) Act 1986’. This is available to download in the 'Related documents' box.

Animals causing concern

24.60  Under ASPA section 2C(7), if the NVS considers that the health or welfare of any protected animal kept at the establishment gives rise to concern, they must notify the personal licence holder. If there is no personal licence holder (as when the animal has not undergone a regulated procedure), or if one is not available, the NVS must take steps to ensure that the animal is cared for and, if necessary, that it is humanely killed using an appropriate method in accordance with ASPA section 15A. Normally problems should be resolved through discussion with the personal licence holder or project licence holder involved. There may be occasions when it is advisable to consult the establishment licence holder or consult or notify the Home Office Inspector.

Fate of animals at the end of regulated procedures

24.61  At the end of a series of regulated procedures for a particular purpose (typically a single project licence protocol), ASPA section 15 requires that any animal that is suffering, or likely to suffer, adverse effects as a result of the procedures applied must be humanely killed. The relevant personal licence holder must, in the first instance, make this decision. If the animal is not suffering, a veterinary surgeon (or other competent person) must determine that the animal can be kept alive.

24.62  No certificate is necessary and the principle of veterinary direction can be applied. The decision of whether an animal may remain alive can be taken by a person the NVS considers able to do so and according to specific criteria, which the NVS has defined. The test for determining whether an animal may be kept alive is that it is not suffering and is not likely to suffer adverse effects as a result of the regulated procedures. In practical terms the decision must be that the animal’s general state of health and wellbeing has been fully restored. It must be free of residual adverse effects that would be considered above the lower threshold for regulation. If, as a consequence of any previous regulated procedures, maintaining the animal’s state of health or wellbeing requires interventions or measures that would themselves cross the lower threshold the animal cannot be kept alive.

24.63  Animals kept alive at the end of the series of regulated procedures must be kept at the establishment under the supervision of the NVS (or SQP) until they are re-used, killed, re-homed, transferred to another establishment or discharged from the controls of the Act (including re-homing or setting free into the wild).

24.64  If, while under the supervision of the NVS, the health or wellbeing of an animal being kept alive under ASPA deteriorates and, in the judgement of the NVS, cannot be promptly remedied by veterinary treatment, the NVS should arrange for the animal to be humanely killed by a competent person in accordance with ASPA section 15A.

24.65  When a relevant protected animal [1] is to be set free or re-homed (including being sent to a slaughterhouse or farm), the establishment or project licence holder must provide reassurances to the Secretary of State that  the animals to be discharged do not pose a danger to public health, animal health or the environment. In practice the NVS, or veterinary surgeon delegated by them, is in the best position to provide these reassurances. The NVS should ensure that the animal is in a suitable state of health before setting free or re-homing.

• [1] A relevant protected animal is one that: a) is being or has been used in a regulated procedure; b) is being or has been kept for use in a regulated procedure; c) has been bred for use in a regulated procedure; or d) is being or has been kept for the purpose of being supplied for use in a regulated procedure.

Certification

24.69  Where it is proposed to transport an animal, including to another establishment, the NVS may be involved in certifying fitness for transport. This should be in accordance with relevant transport regulations.

24.70  The NVS may also be involved in meeting other regulatory requirements for the import or export of protected animals, including certifying health and fitness of animals for transport, where appropriate.

Work outside designated establishments

24.71  The NVS may be called upon to advise project licence holders about the use and fate of animals that have undergone procedures at non-licensed establishments (referred to as "places other than licensed establishments" or POLEs), such as at a farm or in the wild.

24.72  If an animal taken from the wild for use in regulated procedures, whether to be undertaken in the wild or to be transported back to a licensed establishment, is found to be in poor health or injured, it may not be used for regulated procedures unless or until it has been examined by a veterinary surgeon or other competent person. Action must be taken to minimise the suffering of the animal [PPL Standard condition 14]. If the person examining the animal is not a veterinary surgeon, they should have been appropriately trained to follow the veterinary surgeon’s advice on examination, decision making and action to be taken.

24.73  Some programmes of work involve release into the wild during the course of a series of regulated procedures with the expectation of gathering further data (e.g. from transmitters). The NVS should advise on criteria for suitability for release of animals which will be incorporated into the project licence. 

24.74  Animals may also be released into the wild at the end of a series of regulated procedures, whether they were conducted at a licensed establishment or wholly in the wild. The NVS should undertake the actions noted in paragraphs 24.61 and 24.62 relating to assessment of keeping animals alive and release from the controls of ASPA. In addition, the NVS should advise on a suitable rehabilitation programme for wild animals to prepare the animals for release.

24.75  The NVS should be aware that research procedures on animals in the wild, or obtained from the wild, may require appropriate licences from, for example, English Nature, in addition to Home Office Project and Personal licence authorities, and it would be advisable to check that all of these approvals are in place.

Participation in the ethical review process

24.76  Animal Welfare and Ethical Review Bodies (AWERBs) should, in most respects, continue and develop the work of the local Ethical Review Processes (ERPs) they replaced on 1 January 2013. 

24.77  The Home Offices specifies that the NVS should be an active member of, and play a central role in, the AWERB at your establishment. At least one NVS at the establishment must be a full member of the AWERB. Please refer to Home Office Guidance Section 10 for more information about AWERBs.

Records

24.78  It is important to appreciate the full implications of advice given by the NVS in the light of the statutory responsibility to advise on animal health and welfare. Considerable care must be taken to avoid ambiguity and undue delay and sometimes it may be necessary to give advice in writing.

24.79  The NVS should maintain a written record or copy of formal advice given, which should be readily available for review. This applies whether the advice is given in writing or verbally.

24.80  Records should be at least sufficient to show any treatments given to animals or groups of animals and, together with records maintained by other named persons, identify and monitor incidence of disease in the colonies, so that control or corrective action can be taken. As well as a written record of advice or treatment given, there should normally be an indication of the outcome e.g. recovery and continued use in the experimental procedure, or withdrawal from the procedure, or killed. Results of required microbiological surveillance programmes should also be recorded.

24.81  Health records for all protected animals bred, kept or used at the establishment should be maintained under the supervision of and regularly reviewed by the NVS and any subsequent action recorded. Health records must be kept to a proper professional standard, in a format acceptable to the Secretary of State and must be retained for a minimum of five years after disposal of the animal. The records should be made available to the Home Office on request.

24.82  Records should be kept safely and be readily available to the animal care staff and the Home Office Inspector.

24.83  In breeding colonies, the recording of colony data is the establishment licence holder's responsibility. However, the NVS should agree acceptable performance targets with the care staff and should review the records on a regular basis, to provide assurances that problems are not going unnoticed. The NVS should advise on strategies to minimise the numbers of breeding colonies and offer advice on minimum numbers of animals bred. 

24.84  Individual history files must be kept for dogs, cats and non-human primates [PEL Standard condition 9]. These must include relevant reproductive, veterinary and social information and must be kept for a minimum of three years after the disposal or departure of the animal. The NVS should assist in the maintenance of such records.