British Journal of Oral and Maxillofacial Surgery (1984) 22, 349-351 0 1984 The British Association of Oral and Maxillofacial Surgeons
ANIMAL RESEARCH: Dr. J. F. Gracey,
THE LAW AND ETHICS
THE events leading up to the introduction of the Cruelty to Anilmals Act in 1876, the only UK statute dealing with the control of experiments calculated to cause pain in vertebrates, is briefly outlined. Reference is made to the situation then appertaining to anaesthetics, to the first (1875) and second (1906) Royal Commissions, the latter reviewing the working of the Act and adopting the central theme of the statute, namely: the pain condition which requires that in all cases where the animal is suffering severe pain which is likely to endure, the animal must be painlessly destroyed, even though the object of the experiment has not been attained. Much discretion is left to the Home Secretary by this Statute, in developing its practical implementation which is considered far in advance of that of any other major country. It is not without significance that the proposed European Convention for the Protection of Vertebrate Animals Used For Experimental and Other Scientific Purposes (soon to be ratified) leans heavily on the British legislation. Other relevant legislation concerned with animal care includes the Protection of Animals Act 1911 (Scotland, 1912) (the principal statute dealing with cruelty to animals) the Veterinary Surgeons Act of 1966 which defines ‘Veterinary Surgery’ and restricts the practice of diagnosis and treatment (medically and surgically) on animals, the Protection of Animals (Anaesthetics) Acts 1954 and 1964, which are designed to prevent unnecessary suffering to an animal during an operation and the Agriculture (Miscellaneous Provisions) Act of 1968 which deals with unnecessary suffering in farm animals; Summary
‘A person shall not perform on a living animal any experiment calculated to pain except subject to the restrictions imposed by this Act’ (Section 2). The restrictions of which four are mandatory and four capable of being dispensed with by means of Certificates are as follows:(1) Experiments must be performed with a view to the advancement by new discovery or physiological knowledge or of knowledge which will be useful for saving or prolonging life or alleviating suffering. (2) The experiment must be performed by a person holding a licence in a Registered Place (Condition 1). (3)*’ The animal must during the whole of the experiment be under the influence of some anaesthetic of sufficient power to prevent the animal feeling pain. (4)‘” The animal must, if the pain is likely to continue after the effect of the anaesthetic has ceased, or if any serious injury has been inflicted on the animal, be killed before it recovers from the influence of the anaesthetic. (5)‘” The experiment shall not be performed as an illustration of lectures in medical schools, hospitals, colleges or elsewhere. (6) There shall be no exhibitions to the general public of painful experiments on vertebrates. 349
(7) The experiment shall not be performed for the purpose of attaining manual skill. (8) There is a prohibition on experiments on dogs, cats and horses. ” Restrictions 3, 4 and 5 can be lifted by the use of Certificate A (which allows procedures no more severe than simple inoculation or superficial venesectionCondition 4), Certificate B (which allows anaesthesia with recovery-Condition 5) and Certificate C (which allows scientific demonstrations in acute experimentsCondition 6) respectively. Certificates E, EE and F allow experimental work on cats, dogs and horses respectively. Condition 7 deals with curare and curariform substances and requires 48 hours notice to the Home Office of their intended use. Condition 8 states that the licensee must keep a written record of all his experiments and make an annual return within 14 days of the end of each year. Condition 9 refers to publications of experimental work under the Act and the submission of reprints. Previously an intention to make a film on animal experimentation necessitated prior permission from the Home Secretary but this has recently been rescinded. Section 10 of the Act requires all Registered Places to be regularly visited by Inspectors to ensure compliance with the provisions of the Act and standards of animal care. There are at present 15 Inspectors for some 600 Registered Places and 19,500 licensees, with offices in London, Swindon, Shrewsbury, Harrogate and Cupar (Fife). The Act applies to all of the United Kingdom and is administered in Northern Ireland by D.H.S.S. The Irish Free State (Consequential Adaptation of Enactments) Order 1923 duly modified the interpretation of ‘United Kingdom’ for Eire. Applications for licences are made to the Home Office who also provide guidance on all matters relating to proposed experiments. These at present must be supported by the President of a learned body and a Professor in a recognised discipline. Licences are normally issued for five years and may be subject to particular conditions. Both licences and certificates are legal documents and no delegation is permissable. The ethical and humane techniques of animal research work were first embodied in the declarations of the early Royal Commissions and can be illustrated Reduction and Refinement (Russell & Burch, by the words, Replacement, Principles of Humane Experimental Techniques. Methuen, 1959). Replacement technique refers to any method utilising non-sentient material instead of conscious living vertebrates, such as cells, bacteria and other lowly forms of living things, as well as computer simulation. Reduction indicates the desirability to reduce the overall number of animals used in experiments, tests and procedures. Refinement, the ability to improvise, has as its object the need to reduce pain, discomfort and stress to an absolute minimum. Inherent in refinement is the important category of efficiency, which can only be acquired through proper training and experience. In addition to the performance of humane and meticulous techniques, consideration has also to be given to expert care in high class accommodation and to the procurement of stock from accredited sources. The European Convention will set standards in animal care and accommodation (only recommendations exist at present), and will indicate that most small laboratory animals and dogs and cats will have to be supplied by Registered Breeding Establishments. All, or any, of the provisions of the European Convention may be upgraded by a U.K. statute which will probably be enacted in two years’ time.
While the Cruelty to Animals Act 1876 deals with ‘experiments’ in vertebrate animals calculated to cause pain the European Convention will broaden the sphere to include ‘procedures’ which may possibly cause pain, suffering, distress or lasting harm and ensure that where unavoidable they shall be kept to a minimum. ‘Man in his quest for knowledge, health and safety has a need to use animals where there is a reasonable expectation that the result will be to extend knowledge or be to the overall benefit of man or animal, just as he uses them for food, clothing and as beasts of burden’. ‘Man has a moral obligation to respect all animals and to exercise due consideration for their capacity for suffering’.