SCHEDULES

Section 11 etc.

SCHEDULE 2E+W+S+N.I. Activities for which licences may be granted

Licences for treatmentE+W+S+N.I.

1(1)A licence under this paragraph may authorise any of the following in the course of providing treatment services—E+W+S+N.I.

(a)bringing about the creation of embryos in vitro,

[F1(b)procuring, keeping, testing, processing or distributing embryos,

(c)procuring, testing, processing, distributing or using gametes]

[F2(ca)using embryos for the purpose of training persons in embryo biopsy, embryo storage or other embryological techniques,]

(d)[F3other] practices designed to secure that embryos are in a suitable condition to be placed in a woman F4... ,

(e)placing any [F5permitted embryo] in a woman,

(f)mixing sperm with the egg of a hamster, or other animal specified in directions, for the purpose of testing the fertility or normality of the sperm, but only where anything which forms is destroyed when the test is complete and, in any event, not later than the two cell stage, and

(g)such other practices[F6, apart from practices falling within section 4A(2),] as may be specified in, or determined in accordance with, regulations.

(2)Subject to the provisions of this Act, a licence under this paragraph may be granted subject to such conditions as may be specified in the licence and may authorise the performance of any of the activities referred to in sub-paragraph (1) above in such manner as may be so specified.

(3)A licence under this paragraph cannot authorise any activity unless it appears to the Authority to be necessary or desirable for the purpose of providing treatment services.

[F7(4)A licence under this paragraph cannot authorise altering the nuclear or mitochondrial DNA of a cell while it forms part of an embryo, except for the purpose of creating something that will by virtue of regulations under section 3ZA(5) be a permitted embryo.]

[F8(4A)A licence under this paragraph cannot authorise the use of embryos for the purpose mentioned in sub-paragraph (1)(ca) unless the Authority is satisfied that the proposed use of embryos is necessary for that purpose.]

(5)A licence under this paragraph shall be granted for such period not exceeding five years as may be specified in the licence.

[F9(6)In this paragraph, references to a permitted embryo are to be read in accordance with section 3ZA.]

Annotations:

Amendments (Textual)

F1Sch. 2 para. 1(1)(b)(c) 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, 29(a)(i)

F3Word in Sch. 2 para. 1(1)(d) 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, 29(a)(ii)

Commencement Information

I2Schedule 2 para. 1 wholly in force at 1.8.1991 see s. 49(2) and S.I. 1991/1400, art. 2(2)

[F10Embryo testingE+W+S+N.I.

Annotations:

Amendments (Textual)

F10Sch. 2 paras. 1ZA-1ZC and cross-headings inserted (1.10.2009) by Human Fertilisation and Embryology Act 2008 (c. 22), s. 68(2), Sch. 2 para. 3; S.I. 2009/2232, art. 2(v)

1ZA(1)A licence under paragraph 1 cannot authorise the testing of an embryo, except for one or more of the following purposes—E+W+S+N.I.

(a)establishing whether the embryo has a gene, chromosome or mitochondrion abnormality that may affect its capacity to result in a live birth,

(b)in a case where there is a particular risk that the embryo may have any gene, chromosome or mitochondrion abnormality, establishing whether it has that abnormality or any other gene, chromosome or mitochondrion abnormality,

(c)in a case where there is a particular risk that any resulting child will have or develop—

(i)a gender-related serious physical or mental disability,

(ii)a gender-related serious illness, or

(iii)any other gender-related serious medical condition,

establishing the sex of the embryo,

(d)in a case where a person (“the sibling”) who is the child of the persons whose gametes are used to bring about the creation of the embryo (or of either of those persons) suffers from a serious medical condition which could be treated by umbilical cord blood stem cells, bone marrow or other tissue of any resulting child, establishing whether the tissue of any resulting child would be compatible with that of the sibling, and

(e)in a case where uncertainty has arisen as to whether the embryo is one of those whose creation was brought about by using the gametes of particular persons, establishing whether it is.

(2)A licence under paragraph 1 cannot authorise the testing of embryos for the purpose mentioned in sub-paragraph (1)(b) unless the Authority is satisfied—

(a)in relation to the abnormality of which there is a particular risk, and

(b)in relation to any other abnormality for which testing is to be authorised under sub-paragraph (1)(b),

that there is a significant risk that a person with the abnormality will have or develop a serious physical or mental disability, a serious illness or any other serious medical condition.

(3)For the purposes of sub-paragraph (1)(c), a physical or mental disability, illness or other medical condition is gender-related if the Authority is satisfied that—

(a)it affects only one sex, or

(b)it affects one sex significantly more than the other.

(4)In sub-paragraph (1)(d) the reference to “other tissue” of the resulting child does not include a reference to any whole organ of the child.

Sex selectionE+W+S+N.I.

1ZB(1)A licence under paragraph 1 cannot authorise any practice designed to secure that any resulting child will be of one sex rather than the other.E+W+S+N.I.

(2)Sub-paragraph (1) does not prevent the authorisation of any testing of embryos that is capable of being authorised under paragraph 1ZA.

(3)Sub-paragraph (1) does not prevent the authorisation of any other practices designed to secure that any resulting child will be of one sex rather than the other in a case where there is a particular risk that a woman will give birth to a child who will have or develop—

(a)a gender-related serious physical or mental disability,

(b)a gender-related serious illness, or

(c)any other gender-related serious medical condition.

(4)For the purposes of sub-paragraph (3), a physical or mental disability, illness or other medical condition is gender-related if the Authority is satisfied that—

(a)it affects only one sex, or

(b)it affects one sex significantly more than the other.

Power to amend paragraphs 1ZA and 1ZBE+W+S+N.I.

1ZC(1)Regulations may make any amendment of paragraph 1ZA (embryo testing).E+W+S+N.I.

(2)Regulations under this paragraph which amend paragraph 1ZA may make any amendment of sub-paragraphs (2) to (4) of paragraph 1ZB (sex selection) which appears to the Secretary of State to be necessary or expedient in consequence of the amendment of paragraph 1ZA.

(3)Regulations under this paragraph may not enable the authorisation of—

(a)the testing of embryos for the purpose of establishing their sex, or

(b)other practices falling within paragraph 1ZB(1),

except on grounds relating to the health of any resulting child.

(4)For the purposes of this paragraph, “amend” includes add to and repeal, and references to “amendment” are to be read accordingly.]

[F11Licences for non-medical fertility servicesE+W+S+N.I.

Annotations:

Amendments (Textual)

F11Sch. 2 para. 1A and cross-heading 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, 29(b)

1A(1)A licence under this paragraph may authorise any of the following in the course of providing non-medical fertility services—E+W+S+N.I.

(a)procuring sperm, and

(b)distributing sperm.

[F12(1A)A licence under this paragraph cannot authorise the procurement or distribution of sperm to which there has been applied any process designed to secure that any resulting child will be of one sex rather than the other.]

(2)Subject to the provisions of this Act, a licence under this paragraph may be granted subject to such conditions as may be specified in the licence and may authorise the performance of any of the activities referred to in sub-paragraph (1) above in such manner as may be so specified.

(3)A licence under this paragraph shall be granted for such period not exceeding five years as may be specified in the licence.]

Licences for storageE+W+S+N.I.

2(1)A licence under this paragraph or paragraph 1 or 3 of this Schedule may authorise the storage of gametes or embryos or both.E+W+S+N.I.

[F13(1A)A licence under this paragraph or paragraph 3 may authorise the storage of human admixed embryos (whether or not the licence also authorises the storage of gametes or embryos or both).]

(2)Subject to the provisions of this Act, a licence authorising such storage [F14as is mentioned in sub-paragraph (1) or (1A)] may be granted subject to such conditions as may be specified in the licence and may authorise storage in such manner as may be so specified.

(3)A licence under this paragraph shall be granted for such period not exceeding five years as may be specified in the licence.

Annotations:

Amendments (Textual)

Commencement Information

I3Schedule 2 para. 2 wholly in force at 1.8.1991 see s. 49(2) and S.I. 1991/1400 art. 2(2)

[F15Licences for researchE+W+S+N.I.

Annotations:

Amendments (Textual)

F15 Sch. 2 paras. 3, 3A and cross-headings substituted for Sch. 2 para. 3 (1.10.2009) by Human Fertilisation and Embryology Act 2008 (c. 22), s. 68(2), Sch. 2 para. 6; S.I. 2009/2232, art. 2(v)

3(1)A licence under this paragraph may authorise any of the following—E+W+S+N.I.

(a)bringing about the creation of embryos in vitro, and

(b)keeping or using embryos,

for the purposes of a project of research specified in the licence.

(2)A licence under this paragraph may authorise mixing sperm with the egg of a hamster, or other animal specified in directions, for the purpose of developing more effective techniques for determining the fertility or normality of sperm, but only where anything which forms is destroyed when the research is complete and, in any event, no later than the two cell stage.

(3)A licence under this paragraph may authorise any of the following—

(a)bringing about the creation of human admixed embryos in vitro, and

(b)keeping or using human admixed embryos,

for the purposes of a project of research specified in the licence.

(4)A licence under sub-paragraph (3) may not authorise the activity which may be authorised by a licence under sub-paragraph (2).

(5)No licence under this paragraph is to be granted unless the Authority is satisfied that any proposed use of embryos or human admixed embryos is necessary for the purposes of the research.

(6)Subject to the provisions of this Act, a licence under this paragraph may be granted subject to such conditions as may be specified in the licence.

(7)A licence under this paragraph may authorise the performance of any of the activities referred to in sub-paragraph (1), (2) or (3) in such manner as may be so specified.

(8)A licence under this paragraph may be granted for such period not exceeding three years as may be specified in the licence.

(9)This paragraph has effect subject to paragraph 3A.

Purposes for which activities may be licensed under paragraph 3E+W+S+N.I.

3A(1)A licence under paragraph 3 cannot authorise any activity unless the activity appears to the Authority—E+W+S+N.I.

(a)to be necessary or desirable for any of the purposes specified in sub-paragraph (2) (“the principal purposes”),

(b)to be necessary or desirable for the purpose of providing knowledge that, in the view of the Authority, may be capable of being applied for the purposes specified in sub-paragraph (2)(a) or (b), or

(c)to be necessary or desirable for such other purposes as may be specified in regulations.

(2)The principal purposes are—

(a)increasing knowledge about serious disease or other serious medical conditions,

(b)developing treatments for serious disease or other serious medical conditions,

(c)increasing knowledge about the causes of any congenital disease or congenital medical condition that does not fall within paragraph (a),

(d)promoting advances in the treatment of infertility,

(e)increasing knowledge about the causes of miscarriage,

(f)developing more effective techniques of contraception,

(g)developing methods for detecting the presence of gene, chromosome or mitochondrion abnormalities in embryos before implantation, or

(h)increasing knowledge about the development of embryos.]

GeneralE+W+S+N.I.

4[F16(1)A licence under this Schedule can only authorise activities to be carried on—E+W+S+N.I.

(a)on premises specified in the licence or, in the case of activities to which section 3(1A)(b) or (1B) or 4(1A) applies, on relevant third party premises, and

(b)under the supervision of an individual designated in the licence.

(1A)A licence which authorises activities falling within paragraph 1 or 1A above may not also authorise activities falling within paragraph 3 above.]

F16(2)A licence cannot—

(a)F17. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(b)apply to more than one project of research,

(c)authorise activities to be carried on under the supervision of more than one individual, or

[F18(d)apply to premises of the person who holds the licence in different places.]F18

Annotations:

Amendments (Textual)

F16Sch. 2 para. 4(1)(1A) substituted (25.5.2007 for certain purposes, otherwise 5.7.2007) for Sch. 2 para. 4(1) by The Human Fertilisation and Embryology (Quality and Safety) Regulations 2007 (S.I. 2007/1522), regs 1, 29(c)

F17Sch. 2 para. 4(2)(a) omitted (25.5.2007 for certain purposes, otherwise 5.7.2007) by virtue of The Human Fertilisation and Embryology (Quality and Safety) Regulations 2007 (S.I. 2007/1522), regs 1, 29(d)

F18Sch. 2 para. 4(2)(d) 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, 29(e)

Commencement Information

I4Schedule 2 para 4 wholly in force at 1.8.1991 see s. 49(2) and S.I. 1991/1400, art. 2(2)