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Human Fertilisation and Embryology Act 1990

Type Public General Act

Publication 1990-11-01

Last updated 2024-11-28

State In force

Department Statute Law Database

Source legislation.gov.uk

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(b) paragraph B.2 were omitted.

11B

(1) The modifications to the second Directive are as follows.

(2) Article 2 is to be read as if, in paragraph 1, the reference to Member States were a reference to the Authority.

(3) Articles 3, 4 and 5 are to be read as if any reference to the competent authority or authorities were a reference to the Authority.

(4) Annex 1 is to be read as if, in the first paragraph, for “responsible person as defined in Article 17 of Directive 2004/23/EC” there were substituted “ person responsible in accordance with section 17 of the Human Fertilisation and Embryology Act 1990 ”.

(5) Annex 2 is to be read as if, in paragraph 2.1, the reference to the competent authority in the Member State were a reference to the Authority.

(6) Annex 3 is to be read as if, in paragraph 3.6, for “in force in Member States” there were substituted “ of the Human Fertilisation and Embryology Act 1990 ”.

(7) Annex 4 is to be read as if—

(a) in paragraphs 1.1.1 and 1.2.1, the reference to an authorised person were to—

(i) the person responsible in accordance with section 17 of this Act, or

(ii) a person authorised by the person responsible or the Authority to carry out the specified tasks;

(b) in paragraph 1.1.1(a), for “Article 13 of Directive 2004/23/EC” there were substituted “ the Human Fertilisation and Embryology Act 1990 ”;

11C

(1) The modifications to the third Directive are as follows.

(2) Annex 1 is to be read as if—

(a) in paragraph A.1—

(i) for “responsible person” there were substituted “ person responsible ”;

(ii) for “as provided in Article 17 of Directive 2004/23/EC” there were substituted “ in accordance with the requirements of sections 16 and 17 of the Human Fertilisation and Embryology Act 1990 ”;

(b) in paragraph A.4, for “laid down in this Directive” there were substituted “ required by the Human Fertilisation and Embryology Act 1990 ”;

(c) in paragraph C.6, for the words from “requirements of Council” to the end there were substituted “ requirements of the Medical Devices Regulations 2002 ”;

(d) in paragraph D.1, for “laid down in this Directive” there were substituted “ required by the Human Fertilisation and Embryology Act 1990 ”;

(e) in paragraph E.1, for “laid down in this Directive” there were substituted “ required by the Human Fertilisation and Embryology Act 1990 ”;

(f) in paragraph E.8, the reference to the competent authority were a reference to the Authority.

(3) Annex 2 is to be read as if—

(a) in the first paragraph, the reference to the competent authority were a reference to the Authority;

(b) in paragraph A, for the words from “the tissues and cells must” to the end there were substituted “ tissue establishment procedures must ensure that the licence conditions in paragraph 9 of Schedule 3A to the Human Fertilisation and Embryology Act 1990 are met ”;

(c) in paragraph B.3, for the words from “the standards” to the end there were substituted “ the requirements of paragraph 10 of Schedule 3A to the Human Fertilisation and Embryology Act 1990 ”;

(d) in paragraph B.8, the second sentence were omitted;

(e) in paragraph C.2, for “laid down in this Directive” there were substituted “ of Schedule 3A to the Human Fertilisation and Embryology Act 1990 ”;

(f) in paragraphs C.4 and C.5, any reference to the responsible person as defined or specified in Article 17 of Directive 2004/23/EC were a reference to the person responsible in accordance with section 17 of this Act;

(g) in paragraph D.5, the reference to the competent authority were a reference to the Authority;

(h) in paragraph E.2(h), for “as set out in Articles 5 to 6” there were substituted “ in accordance with paragraph 3 of Schedule 3A to the Human Fertilisation and Embryology Act 1990 ”.

A1

For the purposes of this Act, as it applies in relation to Great Britain, the fourth Directive is to be read subject to the modifications set out in paragraph 3A.

Directions

Modifications to the fourth Directive

3A

(1) The modifications to the fourth Directive are as follows.

(2) The Directive is to be read as if references to a third country were references to any country other than the United Kingdom.

(3) Article 2 is to be read as if for “the Union”, in each place where it occurs, there were substituted “Great Britain”.

(4) Article 5(1) is to be read as if—

(a) for “laid down in Directive 2004/23/EC” there were substituted “ required by the Human Fertilisation and Embryology Act 1990 ”;

(b) the references to the competent authority or authorities were references to the Authority.

(5) Article 6 is to be read as if—

(a) in paragraph 2—

(i) the reference to the competent authority or authorities were a reference to the Authority;

(ii) the words from “The information laid out” to the end were omitted;

(b) in paragraph 3—

(i) the first reference to the competent authority or authorities were a reference to the Authority;

(ii) the reference to the competent authority or authorities in sub-paragraph (b) were a reference to the authority or authorities in the third country concerned responsible for regulating tissue establishments in that country.

(6) Article 7 is to be read as if—

(a) in paragraph 2, for “laid down in Directive 2004/23/EC” there were substituted “ required by the Human Fertilisation and Embryology Act 1990 ”;

(b) in paragraph 3, the reference to the competent authority or authorities were a reference to the Authority.

(7) Annex 1 is to be read as if—

(a) in paragraph A.4, for “TE compendium code” there were substituted “ reference number previously allocated to the tissue establishment by the Authority ”;

(b) in paragraph B.4, the reference to the Responsible Person were a reference to the person responsible in accordance with section 17 of this Act;

(d) in paragraph F.3, the references to a third country competent authority or authorities were references to the authority or authorities in the third country responsible for regulating tissue establishments in that country.

(8) Annex 3 is to be read as if—

(a) in the first paragraph, the reference to the competent authority or authorities were a reference to the Authority;

(b) in paragraph A.1, for “as laid down in Directive 2004/23EC” there were substituted “ in accordance with sections 16 and 17 of the Human Fertilisation and Embryology Act 1990 ”;

(d) in paragraph B.7, the reference to a third country competent authority or authorities were a reference to the authority or authorities in the third country responsible for regulating tissue establishments in that country.

(9) Annex 4 is to be read as if—

(a) in paragraph 1, for “laid down in Directive 2004/23/EC” there were substituted “ required by the Human Fertilisation and Embryology Act 1990 ”;

(b) in paragraph 4, the reference to a third country competent authority or authorities were a reference to the authority or authorities in the third country responsible for regulating tissue establishments in that country;

(d) in paragraph 7, for “EU data protection rules” there were substituted “ data protection legislation within the meaning of section 3(9) of the Data Protection Act 2018 ”;

(e) in paragraph 8, for the words from “requirements” to the end there were substituted “ quality and safety standards required by the Human Fertilisation and Embryology Act 1990 ”.

Interpretation of this Schedule

Conditions of licences: human application

Duties of the Authority in relation to serious adverse events and serious adverse reactions

Meaning of “mother”.

Effect of sections 27 and 28.

Parental orders in favour of gamete donors.

Disclosure of information

Mitochondrial donation

Fees

Conscientious objection.

Regulations.

Power to make consequential provision

11A

(1) This paragraph applies where—

(a) the gametes of a person (“P”) are in storage,

(b) P’s consent to the storage of the gametes is required under paragraph 8(1),

(d) the gametes are being kept for use for the purposes of providing treatment services to—

(i) P, or

(ii) P and another person together.

(2) The person keeping the gametes in storage (“K”) must, in each consent period, request P to renew consent to storage of the gametes within the renewal period.

For the meaning of “consent period” and “renewal period”, see paragraph 11B.

(3) A request under sub-paragraph (2) must be given in writing before the start of the renewal period.

(4) The duty in sub-paragraph (2) ceases to apply if K is notified that P has died.

(5) The duty in sub-paragraph (2) does not apply in relation to any consent period if—

(a) K has at any time been informed in writing that P has been certified as lacking capacity to renew consent to storage of the gametes, and

(b) K has not subsequently been informed in writing, before the start of the renewal period which relates to that consent period, that P has been certified as having capacity to renew consent to storage of the gametes.

(6) P renews consent by informing K in writing that P consents to the storage of the gametes.

(7) If P’s consent is not renewed under sub-paragraph (6) before the end of the consent period, K must, as soon as possible after the end of that period, give a notice to P stating that if P does not renew consent before the end of the renewal period, the gametes will be removed from storage and disposed of.

(8) P’s consent to the storage of the gametes is to be taken as having been withdrawn at the end of a renewal period that relates to a consent period if—

(a) K has complied with the requirements of sub-paragraphs (2) and (7) in relation to that consent period, and

(b) P’s consent is not renewed under sub-paragraph (6) before the end of the renewal period.

But this is subject to sub-paragraphs (9) and (10).

(9) If, in a case referred to in sub-paragraph (8)(a) and (b), P dies before the end of the renewal period—

(a) P’s consent is not to be taken as withdrawn under sub-paragraph (8), but

(b) if at the end of the period of 10 years beginning with the day on which P died there is still effective consent from P to the storage, P’s consent is to be taken as withdrawn at that time.

(10) If, in a case referred to in sub-paragraph (8)(a) and (b), before the end of the renewal period P is certified as lacking capacity to renew consent—

(a) P’s consent is not to be taken as withdrawn under sub-paragraph (8), but

(b) if at the end of the period of 10 years beginning with the day on which P was so certified there is still effective consent from P to the storage, P’s consent is to be taken as withdrawn at that time.

(11) But P’s consent is not to be taken as withdrawn under sub-paragraph (10)(b) if, before the time it would be taken to be withdrawn under that sub-paragraph—

(a) P is certified as having capacity to renew consent to storage of the gametes, and

(b) P renews consent to storage of the gametes by informing K in writing that P consents to their storage.

(12) In a case where P renews consent under sub-paragraph (11)(b), this paragraph applies subsequently as if references to a consent period were to—

(a) the period of 10 years beginning with the day on which P so renewed consent, and

(b) each successive period of 10 years.

11B

(1) For the purposes of paragraph 11A, each of the following is a “consent period”—

(a) the period of 10 years beginning with the relevant day, and

(b) each successive period of 10 years.

(2) In sub-paragraph (1)(a) “relevant day” means—

(a) the day on which the gametes are first placed in storage, or

(b) in a case where sub-paragraph (3) or (5) applies, the day on which P gives consent to the storage of the gametes.

(3) This sub-paragraph applies where the gametes are taken from or provided by P before P attains the age of 18 years and, at the time the gametes are first stored—

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

(b) P 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.

(4) In relation to Scotland, sub-paragraph (3) is to be read as if, for paragraphs (a) and (b), there were substituted “P does not have capacity (within the meaning of section 2(4) of the Age of Legal Capacity (Scotland) Act 1991) to consent to storage of the gametes”.

(5) This sub-paragraph applies where the gametes are taken from or provided by P after P attains the age of 16 years and, at the time the gametes are first stored, P lacks capacity to consent to their storage.

(6) In paragraph 11A “the renewal period”, in relation to a consent period, means the period which—

(a) begins 12 months before the end of the consent period, and

(b) ends 6 months after the end of the consent period.

(7) In paragraph 11A “certified” means certified in writing by a registered medical practitioner.

(8) In paragraph 11A and this paragraph, in relation to Scotland, references to a person lacking or having capacity to consent or renew consent are to be read as references to the person being or not being incapable (within the meaning of section 1(6) of the Adults with Incapacity (Scotland) Act 2000) of consenting or renewing consent.

11C

(1) This paragraph applies where—

(a) an embryo, the creation of which was brought about in vitro, is in storage,

(b) the embryo is being kept for use for the purposes of providing treatment services to—

(i) a person (“P”) whose gametes or human cells were used to bring about the creation of the embryo, or

(ii) P and another person together,

(d) there is effective consent from P to the storage of the embryo.

(2) The person keeping the embryo in storage (“K”) must, in each consent period, request P to renew consent to storage of the embryo within the renewal period.

For the meaning of “consent period” and “renewal period”, see paragraph 11D.

(3) A request under sub-paragraph (2) must be given in writing before the start of the renewal period.

(4) The duty in sub-paragraph (2) ceases to apply if—

(a) K is notified that P has died, or

(b) K is notified under paragraph 4A(1)(c) of the withdrawal of a person’s consent to storage of the embryo.

(5) The duty in sub-paragraph (2) does not apply in relation to any consent period if—

(a) K has at any time been informed in writing that P has been certified as lacking capacity to renew consent to storage of the embryo, and

(b) K has not subsequently been informed in writing, before the start of the renewal period which relates to that consent period, that P has been certified as having capacity to renew consent to storage of the embryo.

(6) P renews consent by informing K in writing that P consents to the storage of the embryo.

(7) If P’s consent is not renewed under sub-paragraph (6) before the end of the consent period, K must, as soon as possible after the end of that period, give a notice to P stating that if P does not renew consent before the end of the renewal period, the embryo will be removed from storage and disposed of.

(8) P’s consent to the storage of the embryo is to be taken as having been withdrawn at the end of a renewal period that relates to a consent period if—

(a) K has complied with the requirements of sub-paragraphs (2) and (7) in relation to that consent period, and

(b) P’s consent is not renewed under sub-paragraph (6) before the end of the renewal period.

But this is subject to sub-paragraphs (9) and (10).

(9) If, in a case referred to in sub-paragraph (8)(a) and (b), P dies before the end of the renewal period—

(a) P’s consent is not to be taken as withdrawn under sub-paragraph (8), but

(b) if at the end of the period of 10 years beginning with the day on which P died there is still effective consent from P to the storage, P’s consent is to be taken as withdrawn at that time.

(10) If, in a case referred to in sub-paragraph (8)(a) and (b), before the end of the renewal period P is certified as lacking capacity to renew consent—

(a) P’s consent is not to be taken as withdrawn under sub-paragraph (8), but

(b) if at the end of the period of 10 years beginning with the day on which P was so certified there is still effective consent from P to the storage, P’s consent is to be taken as withdrawn at that time.

(11) But P’s consent is not to be taken as withdrawn under sub-paragraph (10)(b) if, before the time it would be taken to be withdrawn under that sub-paragraph—

(a) P is certified as having capacity to renew consent to storage of the embryo, and

(b) P renews consent to storage of the embryo by informing K in writing that P consents to its storage.

(12) In a case where P has renewed consent under sub-paragraph (11)(b), this paragraph applies subsequently as if references to the consent period were to—

(a) the period of 10 years beginning with the day on which P so renewed consent, and

(b) each successive period of 10 years.

(13) Where P’s consent is taken as withdrawn under this paragraph, K must, as soon as possible, take all reasonable steps to give notice of the withdrawal to each person whose gametes or human cells were used to bring about its creation.

(14) Storage of the embryo remains lawful until—

(a) the end of the period of 6 months beginning with the day on which P’s consent is taken as withdrawn under this paragraph, or

(b) if, before the end of that period, K receives a notice from each person notified under sub-paragraph (13) stating that the person consents to the disposal of the embryo, the time at which the last of those notices was received.

11D

(1) For the purposes of paragraph 11C, each of the following is a “consent period”—

(a) the period of 10 years beginning with the day on which the embryo is first placed in storage, and

(b) each successive period of 10 years.

(2) In paragraph 11C “the renewal period”, in relation to a consent period, means the period which—

(a) begins 12 months before the end of the consent period, and

(b) ends 6 months after the end of the consent period.

(3) In paragraph 11C “certified” means certified in writing by a registered medical practitioner.

(4) In paragraph 11C, in relation to Scotland, references to a person lacking or having capacity to renew consent are to be read as references to the person being or not being incapable (within the meaning of section 1(6) of the Adults with Incapacity (Scotland) Act 2000) of renewing consent.

Modification of the definition of partner donation in the second Directive

B1

For the purpose of this Schedule, Article 1 of the second Directive is to be read as if for paragraph (b) there were substituted—

(b) “partner donation” means the donation of reproductive cells between— (i) a man and a woman; or (ii) a woman and a woman, who declare that they have an intimate physical relationship;

7A

(1) In relation to a donation within paragraph 7 which meets the conditions in this paragraph, licence conditions must not include the requirement in section 3.2 of Annex III to the second Directive, that donors must be negative for HIV.

(2) The first condition is the donor has a plasma HIV RNA load of no more than 200 copies per millilitre on—

(a) a date no more than 6 months and no less than 21 days before the date of the donation; and

(b) a date no more than 7 days before the date of the donation.

(3) The second condition is the donor has been receiving antiretroviral treatment for a period of at least 6 months up to and including the date of the donation.

(4) The third condition is the donor and the recipient declare that they have a qualifying relationship.

(5) “Qualifying relationship” means a relationship between—

(a) friends;

(b) family; or

(6) The fourth condition is the recipient declares that they—

(a) reasonably believe, on the facts known to them at the time, that the donor has tested positive for HIV;

(b) understand the health risks involved in being treated with the donation; and

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