Select Committee on Animals In Scientific Procedures Minutes of Evidence


Background Memorandum by Huntingdon Life Sciences

Introduction:

  Huntingdon Life Sciences was established in 1952 and provides research and development services to the pharmaceutical, biotechnology, agrochemical and chemical industries worldwide.

In conducting our operations and animal studies we work under the Animals [Scientific Procedures] Act 1986, (A[SP]A). Compliance with the Act and authority to conduct work under it, is demonstrated by the Certificate of Designation issued by the Secretary of State.

  HLS constantly strives to implement the 3R's (Refinement, Replacement and Reduction) in its R&D programmes. We believe that we comprehensively recognise animal welfare as being important to us for three reasons:

    —  Our fundamental personal and corporate obligations to the animals that we must use in our R&D programmes;

    —  In order to comply with the Animals [Scientific Procedures] Act, which effectively is our licence to operate;

    —  To support and secure the delivery of good science and valid results which are the corner stone of the business.

  We are based on two sites within the United Kingdom separated by a distance of some 70 miles. About half of the Company revenues are sales based on in-vivo studies, the remaining half being made up of in-vitro bio-test systems and chemistries.

  Whilst a limited amount of in-vivo research and efficacy studies are performed on behalf of third party clients, the vast majority of our animal studies are for regulatory safety assessment submissions (compound development). Again all of our work is for third party clients and as such we are bound by confidentiality clauses to protect intellectual property.

  In 2000 our animal use was: 71,507 (circa 2.75 per cent of the national total for 1999):

    —  Dogs/primates/cats = 2.9 per cent of the total;

    —  Rodents/birds and fish = 92 per cent of the total;

    —  Rabbits/farm animals/ferrets/other = 5.1 per cent of the total.

Why are "in-vitro" safety evaluation studies conducted at HLS?

  Most of the animal experiments conducted at Huntingdon Life Sciences and a substantial proportion of the procedures undertaken within the UK are dedicated to satisfying regulatory requirements for chemical and biological product development. An International framework of regulations has been enacted to control the introduction and usage of chemicals in order to ensure consistent quality and to protect human and environmental health.

  These regulations require that an adequate evaluation of both the efficacy of the product and its potential to cause adverse effects is performed. This provides the basis for a risk/benefit assessment to be made for each chemical before authorisation to market is granted. With such an approach, it is implicit that a greater degree of adverse effects may be tolerated given a greater degree of benefit to mankind in use of the product.

  In order to accommodate this principle, regulations have been developed for particular types of chemical including pharmaceuticals, industrial chemicals, agrochemicals etc, so that the testing requirements can be designed to meet the particular conditions of use, or exposure. Whilst national regulations pertain, they have been reasonably harmonised, especially for pharmaceuticals, in order to optimise testing procedures for international products and reduce animal use.

  The burden of responsibility rests with the developer/manufacturer of the chemical to ensure that adequate data are available for the Regulatory Authorities to complete the risk/benefit assessment. However, to facilitate this, the regulatory framework clearly defines minimum testing standards. In order to achieve a consistent approach and maintain rigorous standards, a hierarchy of testing procedures is prescribed including numbers of animals, choice of species, route of administration, test duration and the range of investigations conducted. In this way, the safety assessment process is able to identify hazard and in the context of exposure, predict the risk for man and/or the environment.

How does this Translate into our Day to Day Activities?

  Referring only to our animal studies, the majority of our day to day activities are limited to performing safety assessment studies for compounds under development. A typical study will consist of a control group (not receiving test material) and three (dose) groups receiving test material in increasing (but controlled) amounts.

  Test substance administration may be by a variety of routes including oral, inhalation or by injection. The number of animals will vary depending upon the type of study and the species used in the study. This will vary from as few as four for a metabolism study, up to 700 for a two year (life-span) rodent oncogenicity study.

  At the end of the in-life phase the animals are euthanased and are the subject of full necropsy and histopathological examinations to determine any compound induced effects. In addition, during the in-life phase, the animals will receive daily health checks, periodic blood tests and various clinical examinations to monitor animal welfare and to detect signs of compound toxicity. These clinical examinations may include behavioural, ophthalmological, neurological and electrocardiographic (ECG) tests.

  In addition to safety assessment studies we also undertake safety pharmacology, and metabolism studies.

Who Oversees, Conducts and Controls this Work?

  The scientific aspects of the studies are overseen by graduate and post graduate scientists.

  Conduct of the scientific procedures is performed in the main by animal technicians holding a personal licence under the A[SP]A. The welfare of all animals is supervised on a daily basis by a Named Animal Care and Welfare Officer (NACWO) and the health of the animals is under the overall supervision of the Named Veterinary Surgeon (NVS). HLS has an NVS at both of its sites and they are supported by three full time veterinary clinicians.

  The Certificate Holder of both sites is accountable to the Home Office for the conduct of the NACWO's and NVS's.

  HLS has some 16 NACWO's, all of whom have successfully attended and passed the Institute of Animal Technology (IAT) training course for new NACWO's. We believe this may be unique for the size of establishment and number of NACWO's.

  Both NVS's have undergone the RCVS registered training for NVS's and the Certificate Holder is both a veterinary surgeon and holder of the Diploma in Laboratory Animal Science from the RCVS.

  HLS has some 48 IAT, Registered Animal Technicians (RanTechs) within its animal technology group and runs annual courses on site for various IAT qualifications. These courses are open to technicians from other establishments as well as our own staff.

  HLS has operated an ERP from April 1999 with the Committee meeting on a monthly basis. In addition to having three lay members of staff on the ERP, we have two external experts who attend on a quarterly basis to provide independent guidance and advice on matters of animal welfare and ethics. The ERP meetings are chaired by the Certificate Holder.

  Both sites receive regular unannounced visits from the Home Office Inspectorate in addition to visits by appointment when the inspector wishes to specifically meet with named individuals such as project and personal licence holders.

  We are the subject of extensive "peer review" in the form of client inspections and study audits.

How Do We Perceive A[SP]A?

  HLS believes the Act (A[SP]A) provides a "privilege" by allowing experiments to be performed on animals, which may cause pain, suffering, distress or lasting harm to them for the benefit of mankind, animals under our care and the environment. Along with this privilege come obligations and we believe it is the provisions of the Act, which set out these obligations that we must fulfil if we are to retain the privilege. It is this guiding principle, which we follow in complying with the provisions of the Act.

  We have already stated our observations on the strengths and weaknesses of the Act in our written submission to the Inquiry and would not seek to repeat them here. We would however, make the observation that there seems to be too great a "disconnect" between the Home Office Inspectorate and the functioning of the APC leading often to concurrent and parallel initiatives, especially on matters of consultation.

  In our mind the Act provides for some of the best welfare standards in laboratory animal science in the world.

  The Inspectorate implement the Act with firmness, professional integrity and with due regard for scientific progress.

  The APC is well positioned and appointed to advise the government on strategic developments under the Act.

  This concludes are background memorandum supplied in connection with our impending visit to the House of Lords to give verbal evidence to the Inquiry.

David Whittaker

Certificate Holder

June 2001


 
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