Animals (Scientific Procedures) Act 1986

Preliminary

Protected animals

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• (1) Subject to the provisions of this section, “a protected animal” for the purposes of this Act means any living vertebrate other than man and any living cephalopod .

• (2) Any such vertebrate in its foetal, larval or embryonic form is a protected animal only from the stage of its development when—

• (a) in the case of a mammal, bird or reptile, two-thirds of the gestation or incubation period for the relevant species has elapsed; and

• (b) in any other case, it becomes capable of independent feeding.

• (2A) Any living cephalopod in its embryonic form is not a protected animal.

• (3) The Secretary of State may by order—

• (a) extend the definition of protected animal so as to include any description of invertebrates other than cephalopods ;

• (b) alter the stage of development specified in subsection (2) above;

• (c) make provision in lieu of subsection (2) above as respects any animal which becomes a protected animal by virtue of an order under paragraph (a) above.

• (4) For the purposes of this section an animal shall be regarded as continuing to live until the permanent cessation of circulation or the destruction of its brain.

• (5) In this section “vertebrate” means any animal of the Sub-phylum Vertebrata of the Phylum Chordata and “invertebrate” means any animal not of that Sub-phylum.

Regulated procedures

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• (1) Subject to the provision of this section, “a regulated procedure” for the purposes of this Act means any 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.

• (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) 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 ... procedures (whether the same or different) applied to the same animal; and

• (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.

• (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.

• (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.

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• (6) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (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 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.

Personal and project licences

Prohibition of unlicensed procedures

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No person shall personally apply a regulated procedure to an animal unless—

• (a) he holds a personal licence qualifying him to apply a regulated procedure of that description to an animal of that description;

• (b) the procedure is applied as part of a programme of work specified in a project licence authorising the application, as part of that programme, of a regulated procedure of that description to an animal of that description; and

• (c) the place where the procedure is carried out is a place specified in ... the project licence.

Personal licences

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• (1) A personal licence is a licence granted by the Secretary of State qualifying the holder personally to apply regulated procedures of specified descriptions to animals of specified descriptions ....

• (2) An application for a personal licence shall be made to the Secretary of State in such form and shall be supported by such information as he may reasonably require.

• (3) Except where the Secretary of State dispenses with the requirements of this subsection any such application shall be endorsed by a person who—

• (a) is for the time being specified in a relevant section 2C licence by virtue of section 2C(5)(d);

• (b) has knowledge of the education, training, experience and character of the applicant;

...

• (3A) For the purposes of subsection (3)(a), a section 2C licence is “relevant” if it authorises the holder to carry on an undertaking which involves the applying of regulated procedures to protected animals.

• (4) No personal licence shall be granted to a person under the age of eighteen.

• (4A) The Secretary of State shall not grant a personal licence to a person unless he is satisfied that the person—

• (a) has appropriate education and training ... for the purpose of applying the regulated procedures that the licence would qualify the person to apply ; and

• (b) is competent to apply those procedures in accordance with the conditions which are to be included in the licence and to handle and take care of laboratory animals.

• (5) A personal licence shall continue in force until revoked but the Secretary of State shall review each personal licence granted by him at intervals not exceeding five years and may for that purpose require the holder to furnish him with such information as he may reasonably require.

Project licences

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• (1) A project licence is a licence granted by the Secretary of State which specifies a programme of work and authorises the application, as part of that programme, of specified regulated procedures to animals of specified descriptions at a specified place or specified places.

• (2) A place may not be specified in a project licence unless it is a place at which a person is authorised by a section 2C licence to carry on an undertaking involving the applying of regulated procedures to protected animals.

• (3) But subsection (2) does not apply in any case in which it appears to the Secretary of State, on the basis of a scientific justification, that the programme or procedures authorised by the project licence require a different place to be specified.

• (4) In the circumstances set out in Article 40.4 of the Animals Directive, a project licence may specify a programme of work which consists of multiple generic projects.

...

Scientific procedure establishments

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Breeding and supplying establishments

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Fees

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The holder of a section 2C licence shall pay such periodical fees to the Secretary of State as may be prescribed by or determined in accordance with an order made by him.

...

Consultation

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• (1) Before granting a section 2C licence or a project licence under this Act the Secretary of State shall consult one of the inspectors appointed under this Act and may also consult an independent assessor or the Committee for the Protection of Animals Used for Scientific Purposes established by this Act.

• (1A) Before granting a personal licence under this Act the Secretary of State may consult one of those inspectors, an independent assessor or that Committee.

• (2) Where the Secretary of State proposes to consult an independent assessor he shall notify the applicant of that fact, and in selecting the assessor he shall have regard to any representations made by the applicant.

Conditions

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• (1) Schedule 2C makes provision as to the conditions that must be included in a licence granted under this Act.

• (2) A licence granted under this Act may include such other conditions as the Secretary of State thinks fit.

• (3) Breach of a condition in a licence does not invalidate the licence; but as to the consequences of a breach, see section 11 (failure to comply with licence conditions etc).

• (4) If a personal licence includes a condition permitting the holder to use assistants to perform, under the holder’s direction, tasks not requiring technical knowledge, nothing done by an assistant in accordance with the condition contravenes section 3.

Variation and revocation

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• (1) Subsections (2) to (5) apply where it appears to the Secretary of State that the holder of a licence under this Act is failing or has failed to comply with—

• (a) a condition of the licence, or

• (b) a provision of this Act.

• (2) The Secretary of State may issue the holder of the licence with a notice (“a compliance notice”) which—

• (a) specifies the condition or provision that the Secretary of State considers the holder is failing or has failed to comply with;

• (b) specifies the action the Secretary of State considers should be taken by the holder to ensure that the failure is not continued or repeated;

• (c) specifies any action the Secretary of State considers should be taken by the holder to eliminate or reduce any consequences of the failure;

• (d) requires the holder to take that action within such time as is specified in the notice; and

• (e) explains the effect of subsection (3).

• (3) If a compliance notice has been issued and it appears to the Secretary of State that the holder of the licence has failed to comply with it, the Secretary of State may revoke the licence (unless the compliance notice has been withdrawn, or the notice has been varied and the holder is in compliance with the notice as varied).

• (4) If it appears to the Secretary of State that—

• (a) remedial action needs to be taken to safeguard the welfare of protected animals for the time being kept by or on behalf of the holder of the licence, and

• (b) the holder of the licence is not willing or able to take that action,

the Secretary of State may take that action (whether or not a compliance notice has already been issued).

• (5) If the Secretary of State does not act under subsection (2) or (4) the Secretary of State may suspend, revoke or vary the licence.

• (6) A licence under this Act may also be suspended, revoked or varied by the Secretary of State in any case in which it appears to the Secretary of State that it is appropriate to do so or at the request of the holder.

• (7) A reference in this section to suspending a licence is a reference to suspending the operation of the licence either for a specified period or until further notice.

Right to make representations

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• (1) Where the Secretary of State proposes—

• (a) to refuse a licence under this Act;

• (b) to revoke or vary a licence under this Act otherwise than at the request of the holder; or

• (c) to suspend a licence, otherwise than at the request of the holder, under section 11,

he shall serve on the applicant or the holder a notice of his intention to do so.

• (2) The notice shall state the reasons for which the Secretary of State proposes to act and give particulars of the rights conferred by subsection (3) below.

• (3) A person on whom a notice is served under subsection (1) above may make written representations and, if desired, oral representations to a person appointed for that purpose by the Secretary of State if before such date as is specified in the notice (not being less than twenty-eight days after the date of service) he notifies the Secretary of State of his wish to do so.

• (4) The holder of a licence ... who is dissatisfied with any condition contained in it may, if he notifies the Secretary of State of his wish to do so, make written representations and, if desired, oral representations to a person appointed for that purpose by the Secretary of State; but the making of such representations shall not affect the operation of any condition unless and until it is varied under section 11 above.

• (5) The person appointed to receive any representations under this section shall be a person who holds or has held judicial office in the United Kingdom or

• (a) a person who satisfies the judicial-appointment eligibility condition on a 5-year basis;

• (b) an advocate or solicitor in Scotland of at least 5 years’ standing; or

• (c) a member of the Bar of Northern Ireland or solicitor of the Court of Judicature of Northern Ireland of at least 5 years’ standing,

and the Secretary of State may, if he thinks fit, appoint a person with scientific or other appropriate qualifications to assist the person receiving the representations in his consideration of them.

• (6) The person appointed to receive any such representations shall after considering them make a report to the Secretary of State; and the Secretary of State shall furnish a copy of the report to the person who made the representations and take it into account in deciding whether to refuse the application or to revoke, suspend or vary the licence , as the case may be.

• (6A) Where subsection (1)(c) applies and the suspension is for a specified period of twelve months or less, this section has effect as if—

• (a) in subsection (3), for the words “may make written representations and, if desired, oral representations to a person appointed for that purpose by the Secretary of State” there were substituted “may make written representations to the Secretary of State”; and

• (b) subsections (5) and (6) were omitted.

• (7) The Secretary of State may by order make rules with respect to the procedure to be followed in the making and consideration of representations under this section, including provision requiring any such representations to be made within a specified time.

• (8) A notice under subsection (1) above may be served either personally or by post.

Suspension in cases of urgency

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• (1) If it appears to the Secretary of State to be urgently necessary for the welfare of any protected animals that a licence ... under this Act should cease to have effect forthwith he shall by notice served on the holder suspend its operation for a period not exceeding three months.