Embryo testing

1ZA

1

A licence under paragraph 1 cannot authorise the testing of an embryo, except for one or more of the following purposes—

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 selection

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.

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 1ZB

1ZC

1

Regulations may make any amendment of paragraph 1ZA (embryo testing).

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.

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.

Licences for research

3

1

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

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 3

3A

1

A licence under paragraph 3 cannot authorise any activity unless the activity appears to the Authority—

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.

1

1

A consent under this Schedule, and any notice under paragraph 4 varying or withdrawing a consent under this Schedule, must be in writing and, subject to sub-paragraph (2), must be signed by the person giving it.

2

A consent under this Schedule by a person who is unable to sign because of illness, injury or physical disability (a “person unable to sign”), and any notice under paragraph 4 by a person unable to sign varying or withdrawing a consent under this Schedule, is to be taken to comply with the requirement of sub-paragraph (1) as to signature if it is signed at the direction of the person unable to sign, in the presence of the person unable to sign and in the presence of at least one witness who attests the signature.

3

In this Schedule “effective consent” means a consent under this Schedule which has not been withdrawn.

4A

1

This paragraph applies where—

a

a permitted embryo, the creation of which was brought about in vitro, is in storage,

b

it was created for use in providing treatment services,

c

before it is used in providing treatment services, one of the persons whose gametes were used to bring about its creation (“P”) gives the person keeping the embryo notice withdrawing P's consent to the storage of the embryo, and

d

the embryo was not to be used in providing treatment services to P alone.

2

The person keeping the embryo must as soon as possible take all reasonable steps to notify each interested person in relation to the embryo of P's withdrawal of consent.

3

For the purposes of sub-paragraph (2), a person is an interested person in relation to an embryo if the embryo was to be used in providing treatment services to that person.

4

Storage of the embryo remains lawful until—

a

the end of the period of 12 months beginning with the day on which the notice mentioned in sub-paragraph (1) was received from P, or

b

if, before the end of that period, the person keeping the embryo receives a notice from each person notified of P's withdrawal under sub-paragraph (2) stating that the person consents to the destruction of the embryo, the time at which the last of those notices is received.

5

The reference in sub-paragraph (1)(a) to a permitted embryo is to be read in accordance with section 3ZA.

Cases where consent not required for storage

9

1

The gametes of a person (“C”) may be kept in storage without C's consent if the following conditions are met.

2

Condition A is that the gametes are lawfully taken from or provided by C before C attains the age of 18 years.

3

Condition B is that, before the gametes are first stored, a registered medical practitioner certifies in writing that C is expected to undergo medical treatment and that in the opinion of the registered medical practitioner—

a

the treatment is likely to cause a significant impairment of C's fertility, and

b

the storage of the gametes is in C's best interests.

4

Condition C is that, at the time when the gametes are first stored, either—

a

C has not attained the age of 16 years and is not competent to deal with the issue of consent to the storage of the gametes, or

b

C has attained that age but, although not lacking capacity to consent to the storage of the gametes, is not competent to deal with the issue of consent to their storage.

5

Condition D is that C has not, since becoming competent to deal with the issue of consent to the storage of the gametes—

a

given consent under this Schedule to the storage of the gametes, or

b

given written notice to the person keeping the gametes that C does not wish them to continue to be stored.

6

In relation to Scotland, sub-paragraphs (1) to (5) are to be read with the following modifications—

a

for sub-paragraph (4), substitute—

4

Condition C is that, at the time when the gametes are first stored, C does not have capacity (within the meaning of section 2(4) of the Age of Legal Capacity (Scotland) Act 1991) to consent to the storage of the gametes.

b

in sub-paragraph (5), for “becoming competent to deal with the issue of consent to the storage of the gametes” substitute “ acquiring such capacity ”.

10

1

The gametes of a person (“P”) may be kept in storage without P's consent if the following conditions are met.

2

Condition A is that the gametes are lawfully taken from or provided by P after P has attained the age of 16 years.

3

Condition B is that, before the gametes are first stored, a registered medical practitioner certifies in writing that P is expected to undergo medical treatment and that in the opinion of the registered medical practitioner—

a

the treatment is likely to cause a significant impairment of P's fertility,

b

P lacks capacity to consent to the storage of the gametes,

c

P is likely at some time to have that capacity, and

d

the storage of the gametes is in P's best interests.

4

Condition C is that, at the time when the gametes are first stored, P lacks capacity to consent to their storage.

5

Condition D is that P has not subsequently, at a time when P has capacity to give a consent under this Schedule—

a

given consent to the storage of the gametes, or

b

given written notice to the person keeping the gametes that P does not wish them to continue to be stored.

6

In relation to Scotland—

a

references in sub-paragraphs (3) and (4) to P lacking capacity to consent are to be read as references to P being incapable, within the meaning of section 1(6) of the Adults with Incapacity (Scotland) Act 2000, of giving such consent,

b

the references in sub-paragraphs (3) and (5) to P having capacity are to be read as references to P not being so incapable, and

c

that Act applies to the storage of gametes under this paragraph to the extent specified in section 84A of that Act.

11

A person's gametes must not be kept in storage by virtue of paragraph 9 or 10 after the person's death.

Creation, use and storage of human admixed embryos

12

1

A person's gametes or human cells must not be used to bring about the creation of any human admixed embryo in vitro unless there is an effective consent by that person to any human admixed embryo, the creation of which may be brought about with the use of those gametes or human cells, being used for the purposes of any project of research.

2

A human admixed embryo the creation of which was brought about in vitro must not be received by any person unless there is an effective consent by each relevant person in relation to the human admixed embryo to the use of the human admixed embryo for the purposes of any project of research.

3

A human admixed embryo the creation of which was brought about in vitro must not be used for the purposes of a project of research unless—

a

there is an effective consent by each relevant person in relation to the human admixed embryo to the use of the human admixed embryo for that purpose, and

b

the human admixed embryo is used in accordance with those consents.

4

If the Authority is satisfied that the parental consent conditions in paragraph 15 are met in relation to the proposed use under a licence of the human cells of a person who has not attained the age of 18 years (“C”), the Authority may in the licence authorise the application of sub-paragraph (5) in relation to C.

5

Where the licence authorises the application of this sub-paragraph, the effective consent of a person having parental responsibility for C—

a

to the use of C's human cells to bring about the creation of a human admixed embryo in vitro for use for the purposes of a project of research, or

b

to the use for those purposes of a human admixed embryo in relation to which C is a relevant person by reason only of the use of C's human cells,

is to be treated for the purposes of sub-paragraphs (1) to (3) as the effective consent of C.

6

If C attains the age of 18 years or the condition in paragraph 15(3) ceases to be met in relation to C, paragraph 4 has effect in relation to C as if any effective consent previously given under sub-paragraphs (1) to (3) by a person having parental responsibility for C had been given by C but, subject to that, sub-paragraph (5) ceases to apply in relation to C.

7

Sub-paragraphs (1) to (3) have effect subject to paragraphs 16 and 20.

13

1

A human admixed embryo the creation of which was brought about in vitro must not be kept in storage unless—

a

there is an effective consent by each relevant person in relation to the human admixed embryo to the storage of the human admixed embryo, and

b

the human admixed embryo is stored in accordance with those consents.

2

Where a licence authorises the application of paragraph 12(5) in relation to a person who has not attained the age of 18 years (“C”), the effective consent of a person having parental responsibility for C to the storage of a human admixed embryo in relation to which C is a relevant person by reason only of the use of C's human cells is to be treated for the purposes of sub-paragraph (1) as the effective consent of C.

3

If C attains the age of 18 years or the condition in paragraph 15(3) ceases to be met in relation to C, paragraph 4 has effect in relation to C as if any effective consent previously given under sub-paragraph (1) by a person having parental responsibility for C had been given by C but, subject to that, sub-paragraph (2) ceases to apply in relation to C.

4

Sub-paragraph (1) has effect subject to paragraphs 16 and 20.

14

For the purposes of paragraphs 12 and 13, each of the following is a relevant person in relation to a human admixed embryo the creation of which was brought about in vitro (“human admixed embryo A”)—

a

each person whose gametes or human cells were used to bring about the creation of human admixed embryo A,

b

each person whose gametes or human cells were used to bring about the creation of any embryo, the creation of which was brought about in vitro, which was used to bring about the creation of human admixed embryo A, and

c

each person whose gametes or human cells were used to bring about the creation of any other human admixed embryo, the creation of which was brought about in vitro, which was used to bring about the creation of human admixed embryo A.

Parental consent conditions

15

1

In relation to a person who has not attained the age of 18 years (“C”), the parental consent conditions referred to in paragraphs 6(3A) and 12(4) are as follows.

2

Condition A is that C suffers from, or is likely to develop, a serious disease, a serious physical or mental disability or any other serious medical condition.

3

Condition B is that either—

a

C is not competent to deal with the issue of consent to the use of C's human cells to bring about the creation in vitro of an embryo or human admixed embryo for use for the purposes of a project of research, or

b

C has attained the age of 16 years but lacks capacity to consent to such use of C's human cells.

4

Condition C is that any embryo or human admixed embryo to be created in vitro is to be used for the purposes of a project of research which is intended to increase knowledge about—

a

the disease, disability or medical condition mentioned in sub-paragraph (2) or any similar disease, disability or medical condition, or

b

the treatment of, or care of persons affected by, that disease, disability or medical condition or any similar disease, disability or medical condition.

5

Condition D is that there are reasonable grounds for believing that research of comparable effectiveness cannot be carried out if the only human cells that can be used to bring about the creation in vitro of embryos or human admixed embryos for use for the purposes of the project are the human cells of persons who—

a

have attained the age of 18 years and have capacity to consent to the use of their human cells to bring about the creation in vitro of an embryo or human admixed embryo for use for the purposes of the project, or

b

have not attained that age but are competent to deal with the issue of consent to such use of their human cells.

6

In relation to Scotland, sub-paragraphs (1) to (5) are to be read with the following modifications—

a

for sub-paragraph (3) substitute—

3

Condition B is that C does not have capacity (within the meaning of section 2(4ZB) of the Age of Legal Capacity (Scotland) Act 1991) to consent to the use of C's human cells to bring about the creation in vitro of an embryo or human admixed embryo for use for the purposes of a project of research.

b

in sub-paragraph (5)(a), for “have capacity to consent” substitute “ are not incapable (within the meaning of section 1(6) of the Adults with Incapacity (Scotland) Act 2000) of giving consent ”, and

c

in sub-paragraph (5)(b), for “are competent to deal with the issue of” substitute “ have capacity (within the meaning of section 2(4ZB) of the Age of Legal Capacity (Scotland) Act 1991) to ”.

Adults lacking capacity: exemption relating to use of human cells etc.

16

1

If, in relation to the proposed use under a licence of the human cells of a person who has attained the age of 18 years (“P”), the Authority is satisfied—

a

that the conditions in paragraph 17 are met,

b

that paragraphs (1) to (4) of paragraph 18 have been complied with, and

c

that the condition in paragraph 18(5) is met,

the Authority may in the licence authorise the application of this paragraph in relation to P.

2

Where a licence authorises the application of this paragraph, this Schedule does not require the consent of P—

a

to the use (whether during P's life or after P's death) of P's human cells to bring about the creation in vitro of an embryo or human admixed embryo for use for the purposes of a project of research,

b

to the storage or the use for those purposes (whether during P's life or after P's death) of an embryo or human admixed embryo in relation to which P is a relevant person by reason only of the use of P's human cells.

3

This paragraph has effect subject to paragraph 19.

Consent to use of human cells etc. not required: adult lacking capacity

17

1

The conditions referred to in paragraph 16(1)(a) are as follows.

2

Condition A is that P suffers from, or is likely to develop, a serious disease, a serious physical or mental disability or any other serious medical condition.

3

Condition B is that P lacks capacity to consent to the use of P's human cells to bring about the creation in vitro of an embryo or human admixed embryo for use for the purposes of a project of research.

4

Condition C is that the person responsible under the licence has no reason to believe that P had refused such consent at a time when P had that capacity.

5

Condition D is that it appears unlikely that P will at some time have that capacity.

6

Condition E is that any embryo or human admixed embryo to be created in vitro is to be used for the purposes of a project of research which is intended to increase knowledge about—

a

the disease, disability or medical condition mentioned in sub-paragraph (2) or any similar disease, disability or medical condition, or

b

the treatment of, or care of persons affected by, that disease, disability or medical condition or any similar disease, disability or medical condition.

7

Condition F is that there are reasonable grounds for believing that research of comparable effectiveness cannot be carried out if the only human cells that can be used to bring about the creation in vitro of embryos or human admixed embryos for use for the purposes of the project are the human cells of persons who—

a

have attained the age of 18 years and have capacity to consent to the use of their human cells to bring about the creation in vitro of an embryo or human admixed embryo for use for the purposes of the project, or

b

have not attained that age but are competent to deal with the issue of consent to such use of their human cells.

8

In this paragraph and paragraph 18 references to the person responsible under the licence are to be read, in a case where an application for a licence is being made, as references to the person who is to be the person responsible.

9

In relation to Scotland—

a

references in sub-paragraphs (3) to (5) to P lacking, or having, capacity to consent are to be read respectively as references to P being, or not being, incapable (within the meaning of section 1(6) of the Adults with Incapacity (Scotland) Act 2000) of giving such consent, and

b

sub-paragraph (7) is to be read with the following modifications—

i

in paragraph (a), for “have capacity to consent” substitute “ are not incapable (within the meaning of section 1(6) of the Adults with Incapacity (Scotland) Act 2000) of giving consent ”, and

ii

in paragraph (b), for “are competent to deal with the issue of” substitute “ have capacity (within the meaning of section 2(4ZB) of the Age of Legal Capacity (Scotland) Act 1991) to ”.

Consulting carers etc. in case of adult lacking capacity

18

1

This paragraph applies in relation to a person who has attained the age of 18 years (“P”) where the person responsible under the licence (“R”) wishes to use P's human cells to bring about the creation in vitro of an embryo or human admixed embryo for use for the purposes of a project of research, in a case where P lacks capacity to consent to their use.

2

R must take reasonable steps to identify a person who—

a

otherwise than in a professional capacity or for remuneration, is engaged in caring for P or is interested in P's welfare, and

b

is prepared to be consulted by R under this paragraph of this Schedule.

3

If R is unable to identify such a person R must nominate a person who—

a

is prepared to be consulted by R under this paragraph of this Schedule, but

b

has no connection with the project.

4

R must provide the person identified under sub-paragraph (2) or nominated under sub-paragraph (3) (“F”) with information about the proposed use of human cells to bring about the creation in vitro of embryos or human admixed embryos for use for the purposes of the project and ask F what, in F's opinion, P's wishes and feelings about the use of P's human cells for that purpose would be likely to be if P had capacity in relation to the matter.

5

The condition referred to in paragraph 16(1)(c) is that, on being consulted, F has not advised R that in F's opinion P's wishes and feelings would be likely to lead P to decline to consent to the use of P's human cells for that purpose.

6

In relation to Scotland, the references in sub-paragraphs (1) and (4) to P lacking, or having, capacity to consent are to be read respectively as references to P being, or not being, incapable (within the meaning of section 1(6) of the Adults with Incapacity (Scotland) Act 2000) of giving such consent.

Effect of acquiring capacity

19

1

Paragraph 16 does not apply to the use of P's human cells to bring about the creation in vitro of an embryo or human admixed embryo if, at a time before the human cells are used for that purpose, P—

a

has capacity to consent to their use, and

b

gives written notice to the person keeping the human cells that P does not wish them to be used for that purpose.

2

Paragraph 16 does not apply to the storage or use of an embryo or human admixed embryo whose creation in vitro was brought about with the use of P's human cells if, at a time before the embryo or human admixed embryo is used for the purposes of the project of research, P—

a

has capacity to consent to the storage or use, and

b

gives written notice to the person keeping the human cells that P does not wish them to be used for that purpose.

3

In relation to Scotland, the references in sub-paragraphs (1)(a) and (2)(a) to P having capacity to consent are to be read as references to P not being incapable (within the meaning of section 1(6) of the Adults with Incapacity (Scotland) Act 2000) of giving such consent.

Use of cells or cell lines in existence before relevant commencement date

20

1

Where a licence authorises the application of this paragraph in relation to qualifying cells, this Schedule does not require the consent of a person (“P”)—

a

to the use of qualifying cells of P to bring about the creation in vitro of an embryo or human admixed embryo for use for the purposes of a project of research, or

b

to the storage or the use for those purposes of an embryo or human admixed embryo in relation to which P is a relevant person by reason only of the use of qualifying cells of P.

2

“Qualifying cells” are human cells which—

a

were lawfully stored for research purposes immediately before the commencement date, or

b

are derived from human cells which were lawfully stored for those purposes at that time.

3

The “commencement date” is the date on which paragraph 9(2)(a) of Schedule 3 to the Human Fertilisation and Embryology Act 2008 (requirement for consent to use of human cells to create an embryo) comes into force.

Conditions for grant of exemption in paragraph 20

21

1

A licence may not authorise the application of paragraph 20 unless the Authority is satisfied—

a

that there are reasonable grounds for believing that scientific research will be adversely affected to a significant extent if the only human cells that can be used to bring about the creation in vitro of embryos or human admixed embryos for use for the purposes of the project of research are—

i

human cells in respect of which there is an effective consent to their use to bring about the creation in vitro of embryos or human admixed embryos for use for those purposes, or

ii

human cells which by virtue of paragraph 16 can be used without such consent, and

b

that any of the following conditions is met in relation to each of the persons whose human cells are qualifying cells which are to be used for the purposes of the project of research.

2

Condition A is that—

a

it is not reasonably possible for the person responsible under the licence (“R”) to identify the person falling within sub-paragraph (1)(b) (“P”), and

b

where any information that relates to P (without identifying P or enabling P to be identified) is available to R, that information does not suggest that P would have objected to the use of P's human cells to bring about the creation in vitro of an embryo or human admixed embryo for use for the purposes of the project.

3

Condition B is that—

a

the person falling within sub-paragraph (1)(b) (“P”) is dead or the person responsible under the licence (“R”) believes on reasonable grounds that P is dead,

b

the information relating to P that is available to R does not suggest that P would have objected to the use of P's human cells to bring about the creation in vitro of an embryo or human admixed embryo for use for the purposes of the project, and

c

a person who stood in a qualifying relationship to P immediately before P died (or is believed to have died) has given consent in writing to the use of P's human cells to bring about the creation in vitro of an embryo or human admixed embryo for use for the purposes of the project.

4

Condition C is that—

a

the person responsible under the licence (“R”) has taken all reasonable steps to contact—

i

the person falling within sub-paragraph (1)(b) (“P”), or

ii

in a case where P is dead or R believes on reasonable grounds that P is dead, persons who could give consent for the purposes of sub-paragraph (3)(c),

but has been unable to do so, and

b

the information relating to P that is available to R does not suggest that P would have objected to the use of P's human cells to bring about the creation in vitro of an embryo or human admixed embryo for use for the purposes of the project.

5

The HTA consent provisions apply in relation to consent for the purposes of sub-paragraph (3)(c) as they apply in relation to consent for the purposes of section 3(6)(c) of the Human Tissue Act 2004; and for the purposes of this sub-paragraph the HTA consent provisions are to be treated as if they extended to Scotland.

6

In sub-paragraph (5) “the HTA consent provisions” means subsections (4), (5), (6), (7) and (8)(a) and (b) of section 27 of the Human Tissue Act 2004.

7

In this paragraph references to the person responsible under the licence are to be read, in a case where an application for a licence is being made, as references to the person who is to be the person responsible.

8

Paragraphs 1 to 4 of this Schedule do not apply in relation to a consent given for the purposes of sub-paragraph (3)(c).

Interpretation

22

1

In this Schedule references to human cells are to human cells which are not—

a

cells of the female or male germ line, or

b

cells of an embryo.

2

References in this Schedule to an embryo or a human admixed embryo which was used to bring about the creation of an embryo (“embryo A”) or a human admixed embryo (“human admixed embryo A”) include an embryo or, as the case may be, a human admixed embryo which was used to bring about the creation of—

a

an embryo or human admixed embryo which was used to bring about the creation of embryo A or human admixed embryo A, and

b

the predecessor of that embryo or human admixed embryo mentioned in paragraph (a), and

c

the predecessor of that predecessor, and so on.

3

References in this Schedule to an embryo or a human admixed embryo whose creation may be brought about using an embryo or a human admixed embryo are to be read in accordance with sub-paragraph (2).

4

References in this Schedule (however expressed) to the use of human cells to bring about the creation of an embryo or a human admixed embryo include the use of human cells to alter the embryo or, as the case may be, the human admixed embryo.

5

References in this Schedule to parental responsibility are—

a

in relation to England and Wales, to be read in accordance with the Children Act 1989,

b

in relation to Northern Ireland, to be read in accordance with the Children (Northern Ireland) Order 1995, and

c

in relation to Scotland, to be read as references to parental responsibilities and parental rights within the meaning of the Children (Scotland) Act 1995.

6

References in this Schedule to capacity are, in relation to England and Wales, to be read in accordance with the Mental Capacity Act 2005.

7

References in this Schedule to the age of 18 years are, in relation to Scotland, to be read as references to the age of 16 years.

1

The Authority shall prepare—

a

a report for the period beginning with the 1 August preceding the relevant commencement date (or if that date is a 1 August, beginning with that date) and ending with the next 31 March, and

b

a report for each succeeding period of 12 months ending with 31 March.

1A

In subsection (1)(a) “the relevant commencement date” means the day on which paragraph 3 of Schedule 7 to the Human Fertilisation and Embryology Act 2008 comes into force.

1B

The Authority shall send each report to the Secretary of State as soon as practicable after the end of the period for which it is prepared.

5

If by virtue of paragraph 20 of Schedule 3 (existing cells or cell lines) qualifying cells, as defined by paragraph 20(2) of that Schedule, of a person (“P”) are used to bring about the creation in vitro of an embryo or human admixed embryo without P's consent, steps shall be taken to ensure that the embryo or human admixed embryo cannot subsequently be attributed to P.

4ZA

For the purposes of subsection (4), the storage of gametes in accordance with the Human Fertilisation and Embryology Act 1990 is to be treated as a medical procedure.

4ZB

A person under the age of 16 years shall have legal capacity to consent to the use of the person's human cells in accordance with Schedule 3 to the Human Fertilisation and Embryology Act 1990 for the purposes of a project of research where the person is capable of understanding the nature of the research; and in this subsection “human cells” has the same meaning as in that Schedule.

7

No provision in this Part of this Act shall permit a person to give a consent to the storage of gametes under the Human Fertilisation and Embryology Act 1990 on behalf of a child.

84AApplication to storage of gametes without adult's consent where adult is incapable

1

The storage of gametes under paragraph 10 of Schedule 3 to the Human Fertilisation and Embryology Act 1990 (storage of gametes without patient's consent where patient is incapable) is to be treated as an intervention in the affairs of an adult under this Act.

2

Sections 2 to 5, 8, 11, 14 and 85 of this Act apply to a registered medical practitioner's decision under that paragraph as they apply to decisions taken for the purposes of this Act.

3

Section 52 of this Act applies to a practitioner's decision under that paragraph as it applies to decisions taken for the purposes of section 47 of this Act.

4

Part 5 of this Act (other than section 52) does not apply to the storage of gametes under that paragraph.

5

Section 83 of this Act applies to a practitioner's decision under that paragraph as if the practitioner were exercising powers under this Act.

6

Nothing in this section authorises any person, other than the person whose gametes are to be stored, to consent to the storage of the gametes.

84BApplication to use of human cells to create an embryo in vitro without adult's consent

1

The use of an adult's human cells to bring about the creation in vitro of an embryo or human admixed embryo for use for the purposes of a project of research—

a

without the adult's consent, and

b

where the adult is incapable,

is to be treated as an intervention in the affairs of an adult under this Act.

2

Sections 2 to 5, 8, 11, 14 and 85 of this Act apply to decisions made under paragraphs 16 and 18 of Schedule 3 to the Human Fertilisation and Embryology Act 1990 (when consent to the use of human cells is not required due to adult being incapable of consenting) as they apply to decisions taken for the purposes of this Act.

3

Section 51 of this Act does not apply to the use of an adult's human cells to bring about the creation in vitro of an embryo or human admixed embryo for use for the purposes of a project of research.

4

Section 83 of this Act applies to a decision made under paragraphs 16 and 18 of Schedule 3 to the Human Fertilisation and Embryology Act 1990 as if the person making the decision were exercising powers under this Act.

5

Expressions used in this section and in Schedule 3 to the Human Fertilisation and Embryology Act 1990 have the same meaning in this section as in that Schedule.

52

Each of the powers of seizure conferred by the provisions of paragraph 7(1) and (2) of Schedule 3B to the Human Fertilisation and Embryology Act 1990.

2ZA

The activities within the remit of the Authority do not include the use, for a scheduled purpose, of relevant material where the use of the material requires consent under paragraph 6(1) or 12(1) of Schedule 3 to the Human Fertilisation and Embryology Act 1990 (use of human cells to create an embryo or a human admixed embryo) or would require such consent but for paragraphs 16 and 20 of that Schedule.

6

In this Act “embryo” and “gametes” have the same meaning as they have by virtue of section 1(1), (4) and (6) of the Human Fertilisation and Embryology Act 1990 in the other provisions of that Act (apart from section 4A).

3A

Research is not intrusive to the extent that it consists of the use of a person's human cells to bring about the creation in vitro of an embryo or human admixed embryo, or the subsequent storage or use of an embryo or human admixed embryo so created.

3B

Expressions used in subsection (3A) and in Schedule 3 to the Human Fertilisation and Embryology Act 1990 (consents to use or storage of gametes, embryos or human admixed embryos etc.) have the same meaning in that subsection as in that Schedule.