Animals (Scientific Procedures) Act 1986: Licensing Charter

(Please note that this Charter is to be reviewed. A revised version will be posted on this website in due course).

This document sets out the standards of service to which the Home Office commits itself in operating the licensing and inspection systems under the Animals (Scientific Procedures) Act 1986.

Introduction

2. The 1986 Act regulates experiments and other scientific procedures that may cause pain, suffering, distress or lasting harm to protected animals. The Act transposes European Directive 86/609/EEC on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific procedures.

3. Fuller information can be found in the Home Office Guidance on the Operation of the Animals (Scientific Procedures) Act 1986, which is available from the Stationery Office. It will be found on their website www.official-documents.co.uk

Project and personal licences

4. Under the Act, two kinds of licence are required: the procedures must be part of a programme of work authorised by a project licence and any person carrying out regulated procedures must possess a personal licence. Project licences will only be issued if the likely benefits (to man, animals or the environment) outweigh the costs to the animals involved and if there are no alternatives which replace animal use, reduce the number of animals needed or refine the experimental design to minimise suffering. Under the terms of the 1986 Act, project licences are granted for a maximum of 5 years and personal licences must be reviewed at least every 5 years.

Certificates of designation

5. With a few exceptions (such as fieldwork sites), any place where regulated procedures are carried out must also be covered by a certificate of designation. Certificates remain in force until revoked.

Administration of the 1986 Act

6. Responsibility for the Act throughout Great Britain rests with the Home Office (and in Northern Ireland with the Department of Health and Social Services and Public Safety). The Animal Procedures Section - part of the Animal Procedures & Coroners Unit (AP&CU), which in turn is part of the Community Policy Directorate (CPD) - administers the Act on behalf of the Home Secretary. The Animals (Scientific Procedures) Inspectorate - also part of CPD, but not part of AP&CU - advises on whether, and on what terms, licences and certificates should be granted or amended. The Inspectorate also visits establishments (often without notice) to determine whether the conditions of licences and certificates are being met, and must report any instances where they are not.

Animal Procedures Committee

7. The Animal Procedures Committee (APC) is an independent body established by sections 19 and 20 of the 1986 Act to advise the Home Secretary on matters concerned with the Act and his functions under it. When there is doubt about whether to license a particular piece of work, the Home Secretary may seek advice from the APC (or other independent assessors). The Home Secretary may refer other matters to the Committee and the APC may also consider topics of its own choosing. The Committee must consider both the legitimate requirements of science and industry and the protection of animals against avoidable suffering and unnecessary use. The Committee can be contacted via http://www.apc.gov.uk/contact.html .

8. Neither the Inspectorate nor the Committee has powers to grant, refuse, vary or revoke licences or certificates. This responsibility lies with AP&CU, acting on behalf of the Home Secretary.

Statement of aims and standards

9. The Animal Procedures Section (AP&CU) and the Inspectorate aim:

• To deal with all applications for new licences and certificates, or for their amendment, promptly and fairly, having regard to the statutory requirements governing scientific procedures involving protected animals.
  
• To handle all infringements under the Act promptly and fairly, with the action taken designed primarily to prevent recurrence.
  
• To ensure that all applicants for, and holders of, licences or certificates are fully informed of the reasons for any adverse decision taken.
  
• To respond courteously, promptly and helpfully to all correspondence and enquiries.
  
• To ensure that the licensing and inspection systems place no unreasonable demands, delays or costs on commercial, academic or other scientific research and testing.

10. To this end, the Animal Procedures Section will:

• Acknowledge all new licence and certificate applications on receipt.
  
• Ensure that properly completed applications for new licences and certificates, and for amendments, are made available for consideration by the Inspectorate within 10 working days of receipt.
  
• Issue new licences and certificates, and amendments to licences and certificates, within 15 working days of receiving the Inspectorate's recommendation to the Secretary of State.
  
• On receipt from the Inspectorate of a report of a possible infringement, we will write to those involved advising them of the nature of the incident(s) reported. A decision on the action to be taken will, wherever possible, be taken within 20 working days of receiving the report from the Inspectorate.
  
• Ensure that other correspondence receives, within 20 working days, a definitive response, an indication of when such a response can be given, or an explanation of why such a response cannot be given.
  
• Ensure that it is always possible to obtain the advice of an inspector in normal working hours by telephone or fax within the same day. In an emergency, where animal welfare is at risk, advice is always obtainable by telephoning the Home Office on 020 7217 8361 (or out of working hours 0870 000 1585) when contact will be made with the Inspectorate.

11. The Inspectorate is committed to processing applications as expeditiously as possible but no targets have been, or indeed can be, set for the time needed to consider any particular application. This depends greatly on the nature of the application. A well-drafted application for a replacement licence to continue existing work or for a minor amendment to an existing licence could possibly be assessed quickly. One for a new, scientifically complex study could take many months, especially if advice is needed from experts outside the Home Office or if the application needs to be referred to the Animal Procedures Committee.

12. Similarly, it is not possible to give commitments about the amount of time needed by the Inspectorate to investigate infringements.

13. Licence and certificate holders, applicants and others can help us by:

• Ensuring that we are informed promptly of any change in correspondence address or contact details.
  
• Accurately quoting relevant licence or certificate numbers in all correspondence and on the telephone.
  
• Ensuring that all applications are properly completed, carry the necessary signatures and are submitted in duplicate.
• Drafts (without signature) can be accepted, but must clearly be marked as such.
  
• Enclosing original certificates of training, where necessary.
  
• Ensuring, when making any requests for amendments, that the complete, unaltered licence or certificate, including its schedules, are returned; and that two copies of the amended, replacement or additional pages are provided. (Please indicate clearly whether the pages supplied replace or supplement the existing schedules.) It is recommended that a third copy is supplied with the changes highlighted. Licence and certificate holders must not make any changes to the face of the licence/certificate or its schedules.
  
• Promptly advising the Home Office of any instances where the terms and conditions of the Act, or of licences or certificates, may have been breached. Those who seek to cover up infringements may be dealt with more severely.

14. In addition, licensees must not start work until all the necessary authorities have been granted. We would strongly recommend that work should not start until the licensees are in possession of, and have carefully checked, the necessary licences. Project licence holders should also ensure that details of the plan of work and procedures described in sections 18 and 19 of the schedule to the licence, and any additional conditions imposed on those procedures, are known to all relevant personal licensees and others with relevant responsibilities under the 1986 Act.

Standards of service

15. Information will be provided, in appendices to the annual statistics of scientific procedures on animals, about performance against the standards set out above.

Information and openness

16. The following documents are available from The Stationery Office (formerly HMSO) on 0345-02 34 74 or from elsewhere on this website:

• Code of Practice for the Housing and Care of Animals Used in Scientific Procedures (ISBN 0-10-210789-0).
  
• Code of Practice for the Housing and Care of Animals in Designated Breeding and Supplying Establishments (ISBN 0-10-212595-3).
  
• Code of Practice for the Humane Killing of Animals under Schedule 1 to the Animals (Scientific Procedures) Act 1986 (ISBN 0-10-265397-6).

17. Statistics of scientific procedures on animals are published annually.

18. The Animal Procedures Committee publishes, also through the Stationery Office and on the Internet, an annual report which details business undertaken by the Committee during the year, as well as the outcomes of discussions on contemporary issues. Other useful information has been published in the annual reports of the Animal Procedures Committee. In particular, the 1997 report (ISBN 0-10-252499-8) contains descriptions of how the cost/benefit assessment required by section 5(4) of the Act is carried out, and the measures taken to promote consistency within the Inspectorate.

19. Notes to applicants are issued with each licence or certificate application form. These explain how the forms should be completed. In addition, guidelines on specific types of application are available. Copies of many of these documents and the application forms are available from the licensing and training section of this website, or on disk. Other material will be added to our website in due course.

20. The documents described above provide information about how the Act is operated and the general criteria on which decisions about licence applications are made. The Home Office is, however, bound by section 24 of the Act, which requires that information given, or believed to have been given, in confidence shall not be disclosed other than for the purpose of discharging functions under the 1986 Act. Section 24 is under review.

Consultation and communication

21. The Home Office cannot normally consult with, or provide advice directly to, all licence holders on changes to policy or practice. However, we undertake to write, as necessary, to holders of certificates of designation. In doing so, we ask that certificate holders ensure that relevant information is brought to the attention of licensees and others with responsibilities under the Act, and that their views are considered in formulating any response.

22. Inspectors are available to discuss and help refine proposals ahead of the submission of applications. They remain accessible for consultation and maintain close contact with licensees and certificate holders to monitor compliance with legislative and administrative controls and the progress of authorised work.

23. There is a regular newsletter issued by the Home Office to certificate holders.

24. Certificate holders have regular contact with inspectors for consultation and discussion during visits of inspection. There are also lines of communication with bodies representing various interests such as the Laboratory Animal Science Association, the Institute of Animal Technology, the Royal College of Veterinary Surgeons, the British Laboratory Animal Veterinary Association, the Association of the British Pharmaceutical Industry, the Research Defence Society, and some animal welfare organisations.

Courtesy and helpfulness

25. The function of the Inspectorate is to advise the Secretary of State. In practice, however, the requirements of the 1986 Act (i) to minimise costs (by use of alternatives which replace animal use, reduce suffering or use fewer animals); and (ii) to weigh the remaining costs against the potential benefits are best achieved by the Inspectorate working closely with applicants, licensees and certificate holders (without prejudice to the operation of the local ethical review processes) to ensure compliance with the letter and spirit of the Act.

26. Licensing staff in AP&CU and inspectors are available to handle enquiries from applicants and licensees. The former will normally be able to deal with administrative matters such as progress with applications; the latter will deal with detailed technical questions and policy issues. For advice on more complex or novel issues, the enquirer will be referred to more senior staff in AP&CU. Where the inspector is not available, the enquirer will be informed of the date and time when the inspector is next expected to be in the office. In case of emergency another inspector will be asked to respond.

27. We would, however, ask that you do not attempt to visit any of our licensing offices except by prior arrangement. Staff have been instructed, on security grounds, not to admit anyone without appointment.

28. In contacts with licence and certificate holders, inspectors should always make themselves known by name. Home Office staff are required to maintain a high standard of helpfulness when dealing with telephone enquiries.

Representations and other forms of appeal

29. Section 12 of the 1986 Act provides that, where the Secretary of State proposes to refuse, or to vary or revoke, a licence or certificate (otherwise than at the request of the holder), the applicant or holder shall be notified in writing, giving the reasons for the decision. That person then has the right to make oral or written representations to a person appointed by the Secretary of State, provided notification of the intention to do so is received within 28 days. The person appointed must be someone who holds or has held judicial office in the United Kingdom, or a barrister, solicitor or advocate of at least seven years' standing. The Secretary of State may also appoint a person with scientific or other appropriate qualifications to assist the person receiving the representations in this consideration of them.

30. Other avenues of appeal are:

• by judicial review of the Secretary of State's decision;
  
• by reference to the Parliamentary Commission for Administration (the Ombudsman).

Complaints

31. The system of controls is designed to foster mutual trust and co-operation. We hope, therefore, that complaints about the actions of staff will be rare. Where they do occur and concern inspectors, they should be made in the first instance to the appropriate Superintending Inspector for that area or to the Chief Inspector. Complaints about the administrative staff should be made to the Head of the Animal Procedures Section. In both cases, every effort will be made to deal with the complaint within 20 working days. Anyone unhappy with the response to a complaint dealt with under the procedures set out above should write to the Head of AP&CU or, in the case of the Inspectorate, to the Director of Community Policy Directorate. Establishments and scientists have an open invitation to refer to the Chief Inspector or to the head of AP&CU any case where they perceive inconsistency.

Proportionality and value for money

32. The use of animals in scientific experiments is a contentious and emotive issue. Whilst we do wish to minimise the burden of regulation, the need to minimise animal use and suffering, and to maximise the standards of care, are paramount.

33. Under the 1986 Act fees are levied on designated establishments. The size of the fee for any particular establishment is dependent upon whether it is designated as a breeder, supplier or user establishment, and on how many personal licensees work primarily at the establishment. The total income from the fees must, under HM Treasury rules, cover the costs of the inspection and licensing system, the Home Office budget for sponsoring research and the costs of the Animal Procedures Committee. The Home Office will forewarn establishments of any proposed changes to the level of the fees before the beginning of the relevant financial year.

34. The Home Office undertakes to keep the licensing arrangements under review to ensure that administrative costs are kept to the minimum necessary to maintain an effective service.

How to contact us

35. You should normally try to contact your local regional office first. For contact details go to Who does what