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(1)In this Act, except where otherwise stated—
(a)embryo means a live human embryo where fertilisation is complete, and
(b)references to an embryo include an egg in the process of fertilisation,
and, for this purpose, fertilisation is not complete until the appearance of a two cell zygote.
(2)This Act, so far as it governs bringing about the creation of an embryo, applies only to bringing about the creation of an embryo outside the human body; and in this Act—
(a)references to embryos the creation of which was brought about in vitro (in their application to those where fertilisation is complete) are to those where fertilisation began outside the human body whether or not it was completed there, and
(b)references to embryos taken from a woman do not include embryos whose creation was brought about in vitro.
(3)This Act, so far as it governs the keeping or use of an embryo, applies only to keeping or using an embryo outside the human body.
(4)References in this Act to gametes, eggs or sperm, except where otherwise stated, are to live human gametes, eggs or sperm but references below in this Act to gametes or eggs do not include eggs in the process of fertilisation.
[F1(5)For the purposes of this Act, sperm is to be treated as partner-donated sperm if the donor of the sperm and the recipient of the sperm declare that they have an intimate physical relationship.F1]
Modifications etc. (not altering text)
Reference to Directives
In this Act—
“the first Directive” means Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells,
“the second Directive” means Commission Directive 2006/17/EC of 8 February 2006 implementing Directive 2004/23/EC of the European Parliament and of the Council as regards certain technical requirements for the donation, procurement and testing of human tissues and cells, and
“the third Directive” means Commission Directive 2006/86/EC of 24 October 2006 implementing Directive 2004/23/EC of the European Parliament and of the Council as regards traceability requirements, notification of serious adverse reactions and events and certain technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells.]
(1)In this Act—
“” means the Human Fertilisation and Embryology Authority established under section 5 of this Act,
[F3“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,]
[F4F3“”, in relation to an EEA state other than the United Kingdom or in relation to Gibraltar, means an authority designated in accordance with the law of that state or territory as responsible for implementing the requirements of the first, second and third Directives,]
F4“directions” means directions under section 23 of this Act,
[F5“distribution”, in relation to gametes or embryos intended for human application, means transportation or delivery, and related terms are to be interpreted accordingly,]
F6“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
[F7“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,]
[F8F7“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,]
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,]
[F11F10“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,]
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,]
F13“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.
[F15(2A)For the purposes of this Act, a person who, from any premises, controls the provision of services for transporting gametes or embryos is to be taken to distribute gametes or embryos on those premises.
(2B)In this Act, any reference to a requirement of a provision of the first, second or third Directive is a reference to a requirement which that provision requires to be imposed.]
F15(3)For the purposes of this Act, a woman is not to be treated as carrying a child until the embryo has become implanted.
Third party agreements
(1)For the purposes of this Act, a “third party agreement” is an agreement in writing between a person who holds a licence and another person which is made in accordance with any licence conditions imposed by the Authority for the purpose of securing compliance with the requirements of Article 24 of the first Directive (relations between tissue establishments and third parties) and under which the other person—
(a)procures, tests or processes gametes or embryos (or both), on behalf of the holder of the licence, or
(b)supplies to the holder of the licence any goods or services (including distribution services) which may affect the quality or safety of gametes or embryos.
(2)In this Act—
“relevant third party premises”, in relation to a licence, means any premises (other than premises to which the licence relates)—
on which a third party procures, tests, processes or distributes gametes or embryos on behalf of any person in connection with activities carried out by that person under a licence, or
from which a third party provides any goods or services which may affect the quality or safety of gametes or embryos to any person in connection with activities carried out by that person under a licence;
“third party” means a person with whom a person who holds a licence has a third party agreement.
(3)References in this Act to the persons to whom a third party agreement applies are to—
(a)the third party,
(b)any person designated in the third party agreement as a person to whom the agreement applies, and
(c)any person acting under the direction of a third party or of any person so designated.]
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