Directions and guidance
I124 Directions as to particular matters.
1
If, in the case of any information about persons for whom treatment services F1, other than basic partner treatment services,F1 were provided, the person responsible does not know that any child was born following the treatment, the period specified in directions by virtue of section 13(4) of this Act shall not expire less than 50 years after the information was first recorded.
2
3
F3In relation to gametes or embryos that are not intended for human application,F3 directions may authorise, in such circumstances and subject to such conditions as may be specified in the directions, the keeping, by or on behalf of a person to whom a licence applies, of gametes or embryos in the course of their carriage to or from any premises.
F43A
In relation to gametes and embryos that are intended for human application, directions may authorise the keeping of gametes or embryos by or on behalf of a person to whom a licence applies, in the course of their carriage—
a
between premises to which licences relate,
b
between such premises and relevant third party premises,
c
between premises referred to in paragraphs (a) and (b) and tissue establishments accredited, designated, authorised or licensed under the laws, or other measures, of an EEA state other than the United Kingdom or of Gibraltar which implement the first, second and third Directives, or
d
between premises referred to in paragraphs (a) and (b) and tissue establishments in a country which is not an EEA state, pursuant to directions given under subsection (4),
in such circumstances and subject to such conditions as may be specified in the directions.
F44
Directions may authorise any person to whom a licence applies to receive gametes or embryos from outside the United Kingdom or to send gametes or embryos outside the United Kingdom in such circumstances and subject to such conditions as may be specified in the directions, and directions made by virtue of this subsection may provide for sections 12 to 14 of this Act to have effect with such modifications as may be specified in the directions.
F54A
In giving any directions under subsection (4) authorising any person to whom a licence applies to import into the United Kingdom from a country which is not an EEA state, or to export from the United Kingdom to such a country, gametes or embryos intended for human application, the Authority shall—
a
include directions specifying the measures that persons to whom a licence applies shall take to ensure that all such imports or exports meet standards of quality and safety equivalent to those laid down in this Act, and
b
have regard to ensuring traceability.
F55
A licence committee may from time to time give such directions as are mentioned in subsection (7) below where a licence has been varied or has ceased to have effect (whether by expiry, suspension, revocation or otherwise).
6
A licence committee proposing to suspend, revoke or vary a licence may give such directions as are mentioned in subsection (7) below.
7
The directions referred to in subsections (5) and (6) above are directions given for the purpose of securing the continued discharge of the duties of the person responsible under the licence concerned (“the old licence”), and such directions may, in particular—
a
require anything kept or information held in pursuance of the old licence to be transferred to the Authority or any other person, or
b
provide for the discharge of the duties in question by any individual, being an individual whose character, qualifications and experience are, in the opinion of the committee, such as are required for the supervision of the activities authorised by the old licence, and authorise those activities to be carried on under the supervision of that individual,
but cannot require any individual to discharge any of those duties unless the individual has consented in writing to do so.
8
Directions for the purpose referred to in subsection (7)(a) above shall be given to the person responsible under the old licence or, where that person has died or appears to the licence committee to have become unable because of incapacity to discharge the duties in question, to some other person to whom the old licence applies or applied or to the nominal licensee.
9
Directions for the purpose referred to in subsection (7)(b) above shall be given to the individual who under the directions is to discharge the duty.
10
Where a person who holds a licence dies, anything done subsequently by an individual which that individual would have been authorised to do if the licence had continued in force shall, until directions are given by virtue of this section, be treated as authorised by a licence.
11
Where the Authority proposes to give directions specifying any animal for the purposes of paragraph 1(1)(f) or 3(5) of Schedule 2 to this Act, it shall report the proposal to the Secretary of State; and the directions shall not be given until the Secretary of State has laid a copy of the report before each House of Parliament.
F612
Directions may require a unique code to be assigned to each donation of gametes and embryos intended for human application received pursuant to a licence.
13
The Authority may give directions as to the information to be provided to it and any measures to be taken by the person responsible in the event of—
a
any occurrence which may adversely influence the quality or safety of gametes or embryos intended for human application,
b
any adverse incident which may be linked to the quality or safety of gametes or embryos intended for human application, or
c
any misidentification or mix-up of gametes or embryos intended for human application.
14
In this section, “tissue establishment” has the meaning given by Article 3(o) of the first Directive.F6