2. [ F16 Licensing of undertakings U.K.
(1) Subject to the provision of this section, “ a regulated procedure ” for the purposes of this Act means any [ F5 procedure applied to a protected animal for a qualifying purpose which may have the effect of causing the animal a level of pain, suffering, distress or lasting harm equivalent to, or higher than, that caused by the introduction of a needle in accordance with good veterinary practice. ] [ F6 (1A) A procedure is applied to an animal for “a qualifying purpose” if—
(a) it is applied for an experimental or other scientific purpose (whether or not the outcome of the procedure is known); or
(b) it is applied for an educational purpose. ]
(2) [ F7 A procedure applied to an animal for a qualifying purpose ] is also a regulated procedure if—
(a) it is part of a series or combination of F8 ... procedures (whether the same or different) applied to the same animal; and [ F9 (ab) each of the other procedures in the series or combination is applied for a qualifying purpose; and ]
(b) the series or combination may have the effect mentioned in subsection (1) above; and
(c) the animal is a protected animal throughout the series or combination or in the course of it attains the stage of its development when it becomes such an animal. [ F10 (2A) A procedure applied to an animal for a qualifying purpose is also a regulated procedure if—
(a) at the time the procedure is applied the animal has not attained the stage of its development when it is a protected animal;
(b) the animal is to be allowed to live until after it attains that stage of its development; and
(c) the procedure is likely to have the effect mentioned in subsection (1) after the animal attains that stage (whether or not it is also likely to have that effect before the animal attains that stage). ]
(3) Anything done for the purpose of, or liable to result in, the birth or hatching of a protected animal is also a regulated procedure if it may as respects that animal have the effect mentioned in subsection (1) above. [ F11 (3A) The modification of an animal’s genes is a regulated procedure if—
(a) the animal is a protected animal and the modification may have the effect mentioned in subsection (1); or
(b) the animal is to be allowed to live until after it attains the stage of its development when it is a protected animal and the modification may have the effect mentioned in subsection (1) after it has attained that stage (whether or not it is also likely to have that effect before the animal attains that stage).
(3B) The breeding of an animal is a regulated procedure if—
(a) the animal is bred from an animal whose genes have mutated or been modified or from a descendant of an animal whose genes have mutated or been modified;
(b) the animal is to be allowed to live until after it has attained the stage of its development when it is a protected animal; and
(c) after the animal has attained that stage the animal may experience pain, suffering, distress or lasting harm of a level mentioned in subsection (1) by reason of the mutation or modification referred to in paragraph (a).
(3C) For the purposes of subsections (3A) and (3B), references to the modification of an animal’s genes include the modification before the animal comes into being of any genetic material by virtue of which it comes into being ]
(4) In determining whether any procedure may have the effect mentioned in subsection (1) above the use of an anaesthetic or analgesic, decerebration and any other procedure for rendering an animal insentient shall be disregarded; and the administration of an anaesthetic or analgesic to a protected animal, or decerebration or any other such procedure applied to such an animal, for the purposes of any experimental or other scientific procedure shall itself be a regulated procedure. F12 (5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . F12 (6) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . [ F13 (7) Killing a protected animal is a regulated procedure only if—
(a) it is killed for experimental or other scientific use;
(b) the place where it is killed is—
(i) a place that is specified in a licence granted under section 2C, or
(ii) a place that is specified in a project licence by virtue of section 5(3), and
(c) the method employed to kill the animal is not—
(i) a method that is appropriate to that description of animal under Schedule 1, or
(ii) in a case within paragraph (b)(i), a method that is specified as being appropriate to that description of animal in the licence granted under section 2C.
(8) Notwithstanding anything in this section, the following are not regulated procedures—
(a) non-experimental agricultural practices;
(b) non-experimental clinical veterinary practices;
(c) practices undertaken for the purposes of recognised animal husbandry;
(d) the administration of any substance or article to an animal for research purposes in accordance with an animal test certificate granted under the Veterinary Medicines Regulations 2011 [ F14 or the Veterinary Medicines Regulations 2013 ] ;
(e) the ringing, tagging or marking of an animal, or the application of any other humane procedure for the primary purpose of enabling an animal to be identified, provided that it causes only momentary pain or distress (or none at all) and no lasting harm.
(8A) References in this section to “a procedure” include both invasive and non-invasive procedures. ]
(9) Schedule 1 to this Act may be amended by orders made by the Secretary of State. Extent Information E3 In its application to Northern Ireland, this section has effect subject to the modifications set out in s. 29, see s. 29(1) Textual Amendments F5 Words in s. 2(1) substituted (1.1.2013) by The Animals (Scientific Procedures) Act 1986 Amendment Regulations 2012 (S.I. 2012/3039) , regs. 1(2) , 4(2) (with Sch. 3 ) F6 S. 2(1A) inserted (1.1.2013) by The Animals (Scientific Procedures) Act 1986 Amendment Regulations 2012 (S.I. 2012/3039) , regs. 1(2) , 4(3) (with Sch. 3 ) F7 Words in s. 2(2) substituted (1.1.2013) by The Animals (Scientific Procedures) Act 1986 Amendment Regulations 2012 (S.I. 2012/3039) , regs. 1(2) , 4(4)(a) (with Sch. 3 ) F8 Word in s. 2(2)(a) omitted (1.1.2013) by virtue of The Animals (Scientific Procedures) Act 1986 Amendment Regulations 2012 (S.I. 2012/3039) , regs. 1(2) , 4(4)(b) (with Sch. 3 ) F9 S. 2(2)(ab) inserted (1.1.2013) by The Animals (Scientific Procedures) Act 1986 Amendment Regulations 2012 (S.I. 2012/3039) , regs. 1(2) , 4(4)(c) (with Sch. 3 ) F10 S. 2(2A) inserted (1.1.2013) by The Animals (Scientific Procedures) Act 1986 Amendment Regulations 2012 (S.I. 2012/3039) , regs. 1(2) , 4(5) (with Sch. 3 ) F11 S. 2(3A)-(3C) inserted (1.1.2013) by The Animals (Scientific Procedures) Act 1986 Amendment Regulations 2012 (S.I. 2012/3039) , regs. 1(2) , 4(6) (with Sch. 3 ) F12 S. 2(5)(6) omitted (1.1.2013) by virtue of The Animals (Scientific Procedures) Act 1986 Amendment Regulations 2012 (S.I. 2012/3039) , regs. 1(2) , 4(7) (with Sch. 3 ) F13 S. 2(7)-(8A) substituted for s. 2(7)(8) (1.1.2013) by The Animals (Scientific Procedures) Act 1986 Amendment Regulations 2012 (S.I. 2012/3039) , regs. 1(2) , 4(8) (with Sch. 3 ) F14 Words in s. 2(8)(d) inserted (11.4.2021) by Medicines and Medical Devices Act 2021 (c. 3) , ss. 14(2) , 50(2)(c)
(1) The Secretary of State must exercise his or her functions under this Act with a view to ensuring compliance with the principles of replacement, reduction and refinement.
(2) For the purposes of this Act—
(a) the principle of replacement is the principle that, wherever possible, a scientifically satisfactory method or testing strategy not entailing the use of protected animals must be used instead of a regulated procedure;
(b) the principle of reduction is the principle that whenever a programme of work involving the use of protected animals is carried out the number of protected animals used must be reduced to a minimum without compromising the objectives of the programme;
(c) the principle of refinement is the principle that the breeding, accommodation and care of protected animals and the methods used in regulated procedures applied to such animals must be refined so as to eliminate or reduce to the minimum any possible pain, suffering, distress or lasting harm to those animals. ] Textual Amendments F15 S. 2A inserted (1.1.2013) by The Animals (Scientific Procedures) Act 1986 Amendment Regulations 2012 (S.I. 2012/3039) , regs. 1(2) , 5 (with Sch. 3 ) Textual Amendments F16 Ss. 2B, 2C and cross-heading inserted (1.1.2013) by The Animals (Scientific Procedures) Act 1986 Amendment Regulations 2012 (S.I. 2012/3039) , regs. 1(2) , 6 (with Sch. 3 )
