The Human Fertilisation and Embryology (Quality and Safety) Regulations 2007
| Jurisdiction | UK Non-devolved |
(1) These Regulations may be cited as the Human Fertilisation and Embryology (Quality and Safety) Regulations 2007.(2) Except as provided by paragraph (3) , these Regulations shall come into force on 5 July 2007 (“the main commencement date”) .(3) These Regulations shall come into force on the day after the day on which they are made (“the initial commencement date”) so far as necessary to enable anything (including the fixing of fees) to be done for the purposes of granting, varying, suspending or revoking licences in respect of activities required by virtue of these Regulations to be authorised by a licence under the 1990 Act on the main commencement date.(4) In these Regulations—F10In relation to Northern Ireland, the Human Fertilisation and Embryology Authority
The 1990 Act is amended as follows. In section 1 (meaning of “embryo”, “gamete” and associated expressions) , after subsection (4) insert— 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.After section 1 insert— Reference to DirectivesIn this Act—“ in storage ” .(4) After subsection (2) , insert—After section 2 insert— procures, tests or processes gametes or embryos (or both) , on behalf of the holder of the licence, orsupplies to the holder of the licence any goods or services (including distribution services) which may affect the quality or safety of gametes or embryos.In this Act—In section 3 (prohibitions in connection with embryos) , for subsection (1) substitute— No person shall bring about the creation of an embryo except in pursuance of a licence.
- “the 1990 Act” means the Human Fertilisation and Embryology Act 1990 ,
- “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.
- “basic partner treatment services” means treatment services that are provided for a woman and a man together without using—
- (a) the gametes of any other person, or
- (b) embryos created outside the woman's body,
- “basic partner treatment services” means treatment services that are provided for a woman and a man together without using—
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(a) 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—
- (i) might lead to the transmission of a communicable disease, to death, or life-threatening, disabling or incapacitating conditions, or
- (ii) might result in, or prolong, hospitalisation or illness, or
- (b) any type of gametes or embryo misidentification or mix-up,
- (a) to identify and locate gametes and embryos during any step from procurement to use for human application or disposal,
- (b) to identify the donor and recipient of particular gametes or embryos,
- (c) to identify any person who has carried out any activity in relation to particular gametes or embryos, and
- (d) 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,
- “(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.
- “(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.
- “relevant third party premises”, in relation to a licence, means any premises (other than premises to which the licence relates) —
- (a) 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
- (b) 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.
- “(1) No person shall bring about the creation of an embryo except in pursuance of a licence.
- (1A) No person shall keep or use an...
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