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Consent to use or storage of gametes, embryos or human admixed embryos etc. |
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1 | Schedule 3 to the 1990 Act (giving of consent to use or storage of gametes or |
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embryos) is amended as follows. |
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2 | In the title to that Schedule, for “OF GAMETES OR EMBRYOS”, substitute |
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“OR STORAGE OF GAMETES, EMBRYOS OR HUMAN ADMIXED |
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General requirements as to consent |
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3 | For paragraph 1 substitute— |
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“1 (1) | A consent under this Schedule, and any notice under paragraph 4 |
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varying or withdrawing a consent under this Schedule, must be in |
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writing and, subject to sub-paragraph (2), must be signed by the |
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(2) | A consent under this Schedule by a person who is unable to sign |
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because of illness, injury or physical disability (a “person unable to |
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sign”), and any notice under paragraph 4 by a person unable to |
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sign varying or withdrawing a consent under this Schedule, is to |
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be taken to comply with the requirement of sub-paragraph (1) as |
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to signature if it is signed at the direction of the person unable to |
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sign, in the presence of the person unable to sign and in the |
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presence of at least one witness who attests the signature. |
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(3) | In this Schedule “effective consent” means a consent under this |
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Schedule which has not been withdrawn.” |
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4 (1) | Paragraph 2 (terms etc. of consent) is amended as follows. |
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(2) | In sub-paragraph (1), for the “or” at the end of paragraph (b) substitute— |
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“(ba) | use for the purpose of training persons in embryo biopsy, |
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embryo storage or other embryological techniques, or”. |
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(3) | After sub-paragraph (1) insert— |
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“(1A) | A consent to the use of any human admixed embryo must specify |
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use for the purposes of a project of research and may specify |
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conditions subject to which the human admixed embryo may be |
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(4) | For sub-paragraph (2) substitute— |
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“(2) | A consent to the storage of any gametes, any embryo or any |
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human admixed embryo must— |
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(a) | specify the maximum period of storage (if less than the |
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statutory storage period), |
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(b) | except in a case falling within paragraph (c), state what is |
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to be done with the gametes, embryo or human admixed |
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embryo if the person who gave the consent dies or is |
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unable, because the person lacks capacity to do so, to vary |
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the terms of the consent or to withdraw it, and |
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(c) | where the consent is given by virtue of paragraph 8(2A) or |
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13(2), state what is to be done with the embryo or human |
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admixed embryo if the person to whom the consent relates |
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| and may (in any case) specify conditions subject to which the |
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gametes, embryo or human admixed embryo may remain in |
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(2A) | A consent to the use of a person’s human cells to bring about the |
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creation in vitro of an embryo or human admixed embryo is to be |
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taken unless otherwise stated to include consent to the use of the |
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cells after the person’s death. |
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(2B) | In relation to Scotland, the reference in sub-paragraph (2)(b) to the |
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person lacking capacity is to be read as a reference to the person— |
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(a) | lacking capacity within the meaning of the Age of Legal |
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Capacity (Scotland) Act 1991, or |
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(b) | being incapable within the meaning of section 1(6) of the |
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Adults with Incapacity (Scotland) Act 2000.” |
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(5) | For sub-paragraph (4) substitute— |
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“(4) | A consent under this Schedule may apply— |
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(a) | to the use or storage of a particular embryo or human |
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(b) | in the case of a person providing gametes or human cells, |
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to the use or storage of— |
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(i) | any embryo or human admixed embryo whose |
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creation may be brought about using those |
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gametes or those cells, and |
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(ii) | any embryo or human admixed embryo whose |
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creation may be brought about using such an |
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embryo or human admixed embryo. |
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(5) | In the case of a consent falling within sub-paragraph (4)(b), the |
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terms of the consent may be varied, or the consent may be |
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withdrawn, in accordance with this Schedule either generally or in |
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(a) | a particular embryo or particular embryos, or |
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(b) | a particular human admixed embryo or particular human |
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Information to be given to a person giving consent |
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5 | In paragraph 3 (procedure for giving consent), in sub-paragraph (2), after |
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“paragraph 4” insert “and, if relevant, paragraph 4A”. |
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Variation and withdrawal of consent |
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6 (1) | Paragraph 4 (variation and withdrawal of consent) is amended as follows. |
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(2) | In sub-paragraph (1), for “or embryo” substitute “, human cells, embryo or |
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(3) | In sub-paragraph (2)— |
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(a) | for “The” substitute “Subject to sub-paragraph (3), the”, and |
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(b) | for the “or” at the end of paragraph (a) substitute— |
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“(aa) | in training persons in embryo biopsy, embryo |
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storage or other embryological techniques, or”. |
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(4) | After sub-paragraph (2) insert— |
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“(3) | Where the terms of any consent to the use of an embryo (“embryo |
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A”) include consent to the use of an embryo or human admixed |
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embryo whose creation may be brought about in vitro using |
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embryo A, that consent to the use of that subsequent embryo or |
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human admixed embryo cannot be varied or withdrawn once |
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embryo A has been used for one or more of the purposes |
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mentioned in sub-paragraph (2)(a) or (b). |
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(4) | Subject to sub-paragraph (5), the terms of any consent to the use of |
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any human admixed embryo cannot be varied, and such consent |
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cannot be withdrawn, once the human admixed embryo has been |
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used for the purposes of any project of research. |
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(5) | Where the terms of any consent to the use of a human admixed |
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embryo (“human admixed embryo A”) include consent to the use |
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of a human admixed embryo or embryo whose creation may be |
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brought about in vitro using human admixed embryo A, that |
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consent to the use of that subsequent human admixed embryo or |
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embryo cannot be varied or withdrawn once human admixed |
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embryo A has been used for the purposes of any project of |
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Withdrawal of consent to storage: notification of interested persons |
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7 | After paragraph 4 insert— |
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“4A (1) | This paragraph applies where— |
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(a) | a permitted embryo, the creation of which was brought |
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about in vitro, is in storage, |
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(b) | it was created for use in providing treatment services, |
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(c) | before it is used in providing treatment services, one of the |
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persons whose gametes were used to bring about its |
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creation (“P”) gives the person keeping the embryo notice |
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withdrawing P’s consent to the storage of the embryo, and |
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(d) | the embryo was not to be used in providing treatment |
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(2) | The person keeping the embryo must as soon as possible take all |
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reasonable steps to notify each interested person in relation to the |
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embryo of P’s withdrawal of consent. |
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(3) | For the purposes of sub-paragraph (2), a person is an interested |
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person in relation to an embryo if the embryo was to be used in |
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providing treatment services to that person. |
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(4) | Storage of the embryo remains lawful until— |
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(a) | the end of the period of 12 months beginning with the day |
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on which the notice mentioned in sub-paragraph (1) was |
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(b) | if, before the end of that period, the person keeping the |
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embryo receives a notice from each person notified of P’s |
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withdrawal under sub-paragraph (2) stating that the |
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person consents to the destruction of the embryo, the time |
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at which the last of those notices is received. |
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(5) | The reference in sub-paragraph (1)(a) to a permitted embryo is to |
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be read in accordance with section 3ZA.” |
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Application of consent provisions to non-medical fertility services |
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8 | In paragraph 5 (use of gametes for treatment of others), in sub-paragraph (1), |
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after “treatment services” insert “or non-medical fertility services”. |
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In vitro fertilisation and subsequent use of embryo |
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9 (1) | Paragraph 6 (in vitro fertilisation and subsequent use of embryo) is amended |
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(2) | In sub-paragraph (1)— |
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(a) | after “person’s gametes” insert “or human cells”, |
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(b) | after “to any embryo” insert a comma, |
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(c) | after “those gametes” insert “or human cells,”, and |
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(d) | for “paragraph 2(1)” substitute “paragraph 2(1)(a), (b) and (c)”. |
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(3) | In sub-paragraph (2)— |
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(a) | for the words from “each person” to “creation of” substitute “each |
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relevant person in relation to”, and |
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(b) | for “paragraph 2(1)” substitute “paragraph 2(1)(a), (b), (ba) and (c)”. |
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(4) | In sub-paragraph (3), for the words from “person” to “creation of” substitute |
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“relevant person in relation to”. |
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(5) | After sub-paragraph (3) insert— |
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“(3A) | If the Authority is satisfied that the parental consent conditions in |
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paragraph 15 are met in relation to the proposed use under a |
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licence of the human cells of a person who has not attained the age |
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of 18 years (“C”), the Authority may in the licence authorise the |
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application of sub-paragraph (3B) in relation to C. |
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(3B) | Where the licence authorises the application of this sub- |
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paragraph, the effective consent of a person having parental |
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(a) | to the use of C’s human cells to bring about the creation of |
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an embryo in vitro for use for the purposes of a project of |
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(b) | to the use for those purposes of an embryo in relation to |
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which C is a relevant person by reason only of the use of |
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| is to be treated for the purposes of sub-paragraphs (1) to (3) as the |
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(3C) | If C attains the age of 18 years or the condition in paragraph 15(3) |
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ceases to be met in relation to C, paragraph 4 has effect in relation |
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to C as if any effective consent previously given under sub- |
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paragraphs (1) to (3) by a person having parental responsibility for |
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C had been given by C but, subject to that, sub-paragraph (3B) |
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ceases to apply in relation to C. |
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(3D) | Sub-paragraphs (1) to (3) have effect subject to paragraphs 16 and |
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(3E) | For the purposes of sub-paragraphs (2), (3) and (3B) each of the |
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following is a relevant person in relation to an embryo the creation |
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of which was brought about in vitro (“embryo A”)— |
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(a) | each person whose gametes or human cells were used to |
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bring about the creation of embryo A, |
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(b) | each person whose gametes or human cells were used to |
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bring about the creation of any other embryo, the creation |
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of which was brought about in vitro, which was used to |
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bring about the creation of embryo A, and |
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(c) | each person whose gametes or human cells were used to |
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bring about the creation of any human admixed embryo, |
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the creation of which was brought about in vitro, which |
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was used to bring about the creation of embryo A.” |
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Use of embryos obtained by lavage etc. |
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10 (1) | Paragraph 7 (embryos obtained by lavage etc.) is amended as follows. |
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(2) | In sub-paragraph (3), for “This paragraph does” substitute “Sub-paragraphs |
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(3) | After sub-paragraph (3) insert— |
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“(4) | An embryo taken from a woman must not be used to bring about |
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the creation of any embryo in vitro or any human admixed embryo |
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Consents in relation to storage |
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11 (1) | Paragraph 8 (storage of gametes and embryos) is amended as follows. |
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(2) | In sub-paragraph (2), for the words from “person” to “creation of” substitute |
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“relevant person in relation to”. |
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(3) | After sub-paragraph (2) insert— |
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“(2A) | Where a licence authorises the application of paragraph 6(3B) in |
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relation to a person who has not attained the age of 18 years (“C”), |
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the effective consent of a person having parental responsibility for |
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C to the storage of an embryo in relation to which C is a relevant |
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person by reason only of the use of C’s human cells is to be treated |
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for the purposes of sub-paragraph (2) as the effective consent of C. |
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(2B) | If C attains the age of 18 years or the condition in paragraph 15(3) |
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ceases to be met in relation to C, paragraph 4 has effect in relation |
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to C as if any effective consent previously given under sub- |
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paragraph (2) by a person having parental responsibility for C had |
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been given by C but, subject to that, sub-paragraph (2A) ceases to |
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(2C) | For the purposes of sub-paragraphs (2) and (2A), each of the |
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following is a relevant person in relation to an embryo the creation |
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of which was brought about in vitro (“embryo A”)— |
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(a) | each person whose gametes or human cells were used to |
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bring about the creation of embryo A, |
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(b) | each person whose gametes or human cells were used to |
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bring about the creation of any other embryo, the creation |
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of which was brought about in vitro, which was used to |
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bring about the creation of embryo A, and |
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(c) | each person whose gametes or human cells were used to |
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bring about the creation of any human admixed embryo, |
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the creation of which was brought about in vitro, which |
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was used to bring about the creation of embryo A.” |
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(4) | After sub-paragraph (3) insert— |
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“(4) | Sub-paragraph (1) has effect subject to paragraphs 9 and 10; and |
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sub-paragraph (2) has effect subject to paragraphs 4A(4), 16 and |
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12 | After paragraph 8 insert— |
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“Cases where consent not required for storage |
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9 (1) | The gametes of a person (“C”) may be kept in storage without C’s |
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consent if the following conditions are met. |
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(2) | Condition A is that the gametes are lawfully taken from or |
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provided by C before C attains the age of 18 years. |
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(3) | Condition B is that, before the gametes are first stored, a registered |
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medical practitioner certifies in writing that C is expected to |
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undergo medical treatment and that in the opinion of the |
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registered medical practitioner— |
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(a) | the treatment is likely to cause a significant impairment of |
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(b) | the storage of the gametes is in C’s best interests. |
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(4) | Condition C is that, at the time when the gametes are first stored, |
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(a) | C has not attained the age of 16 years and is not competent |
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to deal with the issue of consent to the storage of the |
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(b) | C has attained that age but, although not lacking capacity |
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to consent to the storage of the gametes, is not competent |
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to deal with the issue of consent to their storage. |
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(5) | Condition D is that C has not, since becoming competent to deal |
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with the issue of consent to the storage of the gametes— |
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(a) | given consent under this Schedule to the storage of the |
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(b) | given written notice to the person keeping the gametes that |
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C does not wish them to continue to be stored. |
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(6) | In relation to Scotland, sub-paragraphs (1) to (5) are to be read |
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with the following modifications— |
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(a) | for sub-paragraph (4), substitute— |
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“(4) | Condition C is that, at the time when the gametes |
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are first stored, C does not have capacity (within |
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the meaning of section 2(4) of the Age of Legal |
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Capacity (Scotland) Act 1991) to consent to the |
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storage of the gametes.”, and |
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(b) | in sub-paragraph (5), for “becoming competent to deal |
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with the issue of consent to the storage of the gametes” |
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substitute “acquiring such capacity”. |
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10 (1) | The gametes of a person (“P”) may be kept in storage without P’s |
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consent if the following conditions are met. |
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(2) | Condition A is that the gametes are lawfully taken from or |
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provided by P after P has attained the age of 16 years. |
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(3) | Condition B is that, before the gametes are first stored, a registered |
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medical practitioner certifies in writing that P is expected to |
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undergo medical treatment and that in the opinion of the |
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registered medical practitioner— |
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(a) | the treatment is likely to cause a significant impairment of |
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(b) | P lacks capacity to consent to the storage of the gametes, |
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(c) | P is likely at some time to have that capacity, and |
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(d) | the storage of the gametes is in P’s best interests. |
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(4) | Condition C is that, at the time when the gametes are first stored, |
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P lacks capacity to consent to their storage. |
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(5) | Condition D is that P has not subsequently, at a time when P has |
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capacity to give a consent under this Schedule— |
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(a) | given consent to the storage of the gametes, or |
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(b) | given written notice to the person keeping the gametes that |
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P does not wish them to continue to be stored. |
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(6) | In relation to Scotland— |
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(a) | references in sub-paragraphs (3) and (4) to P lacking |
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capacity to consent are to be read as references to P being |
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incapable, within the meaning of section 1(6) of the Adults |
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with Incapacity (Scotland) Act 2000, of giving such |
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(b) | the references in sub-paragraphs (3) and (5) to P having |
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capacity are to be read as references to P not being so |
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(c) | that Act applies to the storage of gametes under this |
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paragraph to the extent specified in section 84A of that Act. |
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11 | A person’s gametes must not be kept in storage by virtue of |
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paragraph 9 or 10 after the person’s death.” |
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