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Statutory Instruments

2009 No. 1918

Human Fertilisation And Embryology

The Human Fertilisation and Embryology (Special Exemption) Regulations 2009

Made

15th July 2009

Coming into force

1st October 2009

The Secretary of State for Health makes these Regulations in exercise of the powers conferred by sections 43(1) and 45(1) to (3A) of the Human Fertilisation and Embryology Act 1990( 1 ).

A draft of this instrument has been approved by a resolution of each House of Parliament pursuant to section 45(4) of that Act.

Citation, commencement and interpretation

1. —(1) These Regulations may be cited as the Human Fertilisation and Embryology (Special Exemption) Regulations 2009 and shall come into force on 1st October 2009.

(2) In these Regulations

the Act” means the Human Fertilisation and Embryology Act 1990, and

embryo” and “gametes” have the same meaning as they have by virtue of section 1(1), (4) and (6) of the Act in the other provisions of the Act (apart from section 4A)( 2 ).

Keeping and examining gametes and embryos in connection with crime

2. —(1) Subject to the provisions of this regulation a person to whom a licence applies( 3 ) or a person specified by the Authority may—

(a) keep or examine embryos; and

(b) storegametes,

in connection with the investigation of, or proceedings for, an offence under the Act.

(2) This regulation applies only to embryos and gametes

(a) of which the Authority has taken possession; or

(b) which are being or have been transferred from the person by whom they were being kept to another person in accordance either with directions( 4 ) or with other arrangements made by the Authority in connection with the investigation of, or proceedings for, an offence under the Act.

(3)Embryos and gametes to which this regulation applies shall be kept or examined in accordance with paragraphs (4), (5) and (6).

(4)Embryos and gametes shall be kept so as to secure, so far as reasonably practicable, that their condition does not deteriorate.

(5) Where embryos or gametes are kept or examined in any place where—

(a) any activity governed by the Act is carried out in pursuance of a licence; or

(b) gametes are stored under regulation 3,

the containers of embryos or gametes to which this regulation applies shall be labelled in such a way as to make them easily distinguishable from containers of embryos or gametes kept in pursuance of a licence or referred to in sub-paragraph (b).

(6)Embryos and gametes shall be kept or examined in such conditions as are reasonable to secure that access to them is denied to persons other than those referred to in paragraph (1) who are concerned with the particular investigation or proceedings in connection with which those embryos or gametes are being kept or examined.

Storage of gametes for other purposes

3. —(1) Subject to the provisions of this regulation, a person may storegametes which are to be used only for a purpose or purposes falling within paragraph (2), but only in so far as such purposes do not consist of or include treatment services( 5 ) or any purpose falling within paragraph (3).

(2) A purpose falls within this paragraph if it consists of—

(a) research on gametes;

(b) the development or testing of pharmaceutical or contraceptive products; or

(c) teaching requiring the use of gametes.

(3) A purpose falls within this paragraph if it consists of or includes any of the following—

(a) the use of gametes in any mixing of live egg and live sperm whether human or not;

(b) the use of gametes in bringing about the creation of an embryo;

(c) the use of gametes in bringing about the creation of a human admixed embryo( 6 );

(d) any use of gametes which could not be authorised by a licence;

(e) the supply of gametes to any person to whom a licence applies for use in any activity authorised by that licence;

(f) the supply of gametes to any person for money or other benefit unless the giving of the money or other benefit is authorised by directions in the case of gametes supplied in pursuance of a licence; or

(g) the export of gametes from the United Kingdom.

(4)Gametes for the supply of which a person has given money or other benefit may not be stored by that person under this regulation unless the giving of the money or other benefit was authorised by directions in the case of gametes obtained in pursuance of a licence.

(5) The conditions in paragraphs (6), (7) and (8) shall apply to the storage of gametes under this regulation.

(6) Where gametes are stored in any place where—

(a) any activity governed by the Act is carried out in pursuance of a licence; or

(b) embryos or gametes are kept or examined under regulation 2,

the containers of gametesstored under this regulation shall be labelled in such a way as to make them easily distinguishable from containers of embryos or gametes kept in pursuance of a licence or referred to in sub-paragraph (b).

(7) Access to gametes shall be limited to persons participating in the activities specified in paragraph (2), and (in the case of teaching) their students, but only under the supervision of their teacher.

(8)Gametes shall be stored in such conditions as are reasonable to secure that access to them is denied to persons other than those referred to in paragraph (7).

Revocation

4.The Human Fertilisation and Embryology (Special Exemption) Regulations 1991( 7 ) are revoked.

Signed by authority of the Secretary of State for Health.

Gillian Merron

Minister of State,

Department of Health

15th July 2009

( 1 )

1990 c. 37 . Section 45 was amended by section 30 of the Human Fertilisation and Embryology Act 2008 (c. 22) (“the 2008 Act”).

( 2 )

Subsections (1) and (4) of section 1 were substituted by subsections (2) and (4) of section 1 of the 2008 Act. Subsection (6) of section 1 was inserted by subsection (5) of section 1 of the 2008 Act.

( 3 )

“A person to whom a licence applies” is defined in section 17(2) of the Act.

( 4 )

See sections 23 and 24 of the Act.

( 5 )

“Treatment services” are defined in section 2(1) of the Act.

( 6 )

“Human admixed embryo” is defined in section 4A(6) to (12) of the Act. Section 4A was inserted into the Act by subsection (2) of section 4 of the 2008 Act.

Status: This is the original version (as it was originally made). This item of legislation is currently only available in its original format.
The Human Fertilisation and Embryology (Special Exemption) Regulations 2009 (2009/1918)

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Status of this instrument

footnotecommentarytransitional and savingsin force statusrelated provisionsgeo extentinsert/omitsource countin force adj
Defined TermSection/ArticleIDScope of Application
embryoreg. 1.embryo_rtEVipL
gametesreg. 1.gametes_rtn13Uc
the Actreg. 1.the_Act_rttY8Pr
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