(1)In this Act—
“the Authority” means the Human Fertilisation and Embryology Authority established under section 5 of this Act,
[F1“basic partner treatment services” means treatment services that are provided for a woman and a man together without using—
the gametes of any other person, or
embryos created outside the woman's body,]
[F1“competent authority”, in relation to an EEA state F2..., means an authority designated in accordance with the law of that state or territory as responsible for implementing the requirements of the first, second[F3, third and fourth] Directives,]
“directions” means directions under section 23 of this Act,
[F1“distribution”, in relation to gametes or embryos intended for human application, means transportation or delivery [F4to any person in or outside the United Kingdom for human application], and related terms are to be interpreted accordingly,]
[F1“human application” means use in a human recipient,]
“licence” means a licence under Schedule 2 to this Act and, in relation to a licence, “the person responsible” has the meaning given by section 17 of this Act, and
[F1“non-medical fertility services” means any services that are provided, in the course of a business, for the purpose of assisting women to carry children, but are not medical, surgical or obstetric services,]
[F5“nuclear DNA”, in relation to an embryo, includes DNA in the pronucleus of the embryo,]
[F1“processing”, in relation to gametes or embryos intended for human application, means any operation involved in their preparation, manipulation or packaging, and related terms are to be interpreted accordingly,]
[F1“procurement”, in relation to gametes or embryos intended for human application, means any process by which they are made available, and related terms are to be interpreted accordingly,]
[F1“serious adverse event” means—
any untoward occurrence which may be associated with the procurement, testing, processing, storage or distribution of gametes or embryos intended for human application and which, in relation to a donor of gametes or a person who receives treatment services or non-medical fertility services—
might lead to the transmission of a communicable disease, to death, or life-threatening, disabling or incapacitating conditions, or
might result in, or prolong, hospitalisation or illness, or
any type of gametes or embryo misidentification or mix-up,]
[F1“serious adverse reaction” means an unintended response, including a communicable disease, in a donor of gametes intended for human application or a person who receives treatment services or non-medical fertility services, which may be associated with the procurement or human application of gametes or embryos and which is fatal, life-threatening, disabling, incapacitating or which results in, or prolongs, hospitalisation or illness,]
[F1“store”, in relation to gametes[F6, embryos or human admixed embryos], means preserve, whether by cryopreservation or in any other way, and “storage” and “stored” are to be interpreted accordingly,]
[F7“tissue establishment” means a tissue bank or a unit of a hospital or another body which procures, tests, processes, preserves, stores or distributes human gametes or embryos,]
[F1“traceability” means the ability—
to identify and locate gametes and embryos during any step from procurement to use for human application or disposal,
to identify the donor and recipient of particular gametes or embryos,
to identify any person who has carried out any activity in relation to particular gametes or embryos, and
to identify and locate all relevant data relating to products and materials coming into contact with particular gametes or embryos and which can affect their quality or safety,]
“treatment services” means medical, surgical or obstetric services provided to the public or a section of the public for the purpose of assisting women to carry children.
(2)References in this Act to keeping, in relation to embryos[F8, gametes or human admixed embryos ], include keeping while preserved [F9in storage].
[F10(2A)For the purposes of this Act, a person who, from any premises, controls the provision of services for transporting gametes or embryos [F11to any person in or outside the United Kingdom for human application] is to be taken to distribute gametes or embryos on those premises.
[F12(2B) Any reference in this Act to a requirement of a provision of the first, second, third or fourth Directive—
(a)in the application of this Act in relation to Great Britain, is to be read as a reference to a requirement which that provision would require to be imposed if the provision formed part of the law of England and Wales or Scotland, and
(b)in the application of this Act in relation to Northern Ireland, is to be read as a reference to a requirement which that provision requires to be imposed.]
(3)For the purposes of this Act, a woman is not to be treated as carrying a child until the embryo has become implanted.]
Textual Amendments
F1Words in s. 2(1) inserted (25.5.2007 for certain purposes, otherwise 5.7.2007) by The Human Fertilisation and Embryology (Quality and Safety) Regulations 2007 (S.I. 2007/1522), regs. 1, 6(2)
F2Words in s. 2 omitted (31.12.2020) by S.I. 2019/482, reg. 2(3)(a)(i) (as substituted by The Human Fertilisation and Embryology (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1307), regs. 1, 4(a)); 2020 c. 1, Sch. 5 para. 1(1)
F3Words in s. 2(1) substituted (6.3.2018 for specified purposes, 1.4.2018 in so far as not already in force) by The Human Fertilisation and Embryology (Amendment) Regulations 2018 (S.I. 2018/334), regs. 1(3), 3(3)(a)(i)
F4Words in s. 2(1) inserted (6.3.2018 for specified purposes, 1.4.2018 in so far as not already in force) by The Human Fertilisation and Embryology (Amendment) Regulations 2018 (S.I. 2018/334), regs. 1(3), 3(3)(a)(ii)
F5Words in s. 2(1) inserted (1.10.2009) by Human Fertilisation and Embryology Act 2008 (c. 22), ss. 2, 68(2); S.I. 2009/2232, art. 2(a)
F6Words in s. 2(1) substituted (1.10.2009) by Human Fertilisation and Embryology Act 2008 (c. 22), s. 68(2), Sch. 7 para. 2(a); S.I. 2009/2232, art. 2(y)
F7Words in s. 2(1) inserted (31.12.2020) by S.I. 2019/482, regs. 1, 2(3)(a)(ii) (as amended by The Human Fertilisation and Embryology (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1307), regs. 1, 4(a)); 2020 c. 1, Sch. 5 para. 1(1)
F8Words in s. 2(2) substituted (1.10.2009) by Human Fertilisation and Embryology Act 2008 (c. 22), s. 68(2), Sch. 7 para. 2(b); S.I. 2009/2232, art. 2(y)
F9Words in s. 2(2) substituted (25.5.2007 for certain purposes, otherwise 5.7.2007) by The Human Fertilisation and Embryology (Quality and Safety) Regulations 2007 (S.I. 2007/1522), regs. 1, 6(3)
F10S. 2(2A)(2B) inserted (25.5.2007 for certain purposes, otherwise 5.7.2007) by The Human Fertilisation and Embryology (Quality and Safety) Regulations 2007 (S.I. 2007/1522), regs. 1, 6(4)
F11Words in s. 2(2A) inserted (6.3.2018 for specified purposes, 1.4.2018 in so far as not already in force) by The Human Fertilisation and Embryology (Amendment) Regulations 2018 (S.I. 2018/334), regs. 1(3), 3(3)(b)
F12S. 2(2B) substituted (31.12.2020) by S.I. 2019/482, regs. 1, 2(3)(b) (as substituted by The Human Fertilisation and Embryology (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1307), regs. 1, 4(c)); 2020 c. 1, Sch. 5 para. 1(1)
Commencement Information
I1S. 2 wholly in force at 1.8.1991 see s. 49(2), S.I. 1990/2165 and S.I. 1991/1440, art. 2(2)