Human Fertilisation and Embryology Act 2008

Part 1 — Amendments of the Human Fertilisation and Embryology Act 1990

Principal terms used in the 1990 Act

Meaning of “embryo” and “gamete”

1

• (1) Section 1 of the 1990 Act (meaning of “embryo”, “gamete” and associated expressions) is amended as follows.

• (2) For subsection (1) substitute—

(1) In this Act (except in section 4A or in the term “human admixed embryo”)— (a) embryo means a live human embryo and does not include a human admixed embryo (as defined by section 4A(6)), and (b) references to an embryo include an egg that is in the process of fertilisation or is undergoing any other process capable of resulting in an embryo.

• (3) In subsection (2), for paragraph (a) substitute—

(a) references to embryos the creation of which was brought about in vitro (in their application to those where fertilisation or any other process by which an embryo is created is complete) are to those where fertilisation or any other process by which the embryo was created began outside the human body whether or not it was completed there, and

.

• (4) For subsection (4) substitute—

(4) In this Act (except in section 4A)— (a) references to eggs are to live human eggs, including cells of the female germ line at any stage of maturity, but (except in subsection (1)(b)) not including eggs that are in the process of fertilisation or are undergoing any other process capable of resulting in an embryo, (b) references to sperm are to live human sperm, including cells of the male germ line at any stage of maturity, and (c) references to gametes are to be read accordingly.

• (5) After subsection (5) insert—

(6) If it appears to the Secretary of State necessary or desirable to do so in the light of developments in science or medicine, regulations may provide that in this Act (except in section 4A) “embryo”, “eggs”, “sperm” or “gametes” includes things specified in the regulations which would not otherwise fall within the definition. (7) Regulations made by virtue of subsection (6) may not provide for anything containing any nuclear or mitochondrial DNA that is not human to be treated as an embryo or as eggs, sperm or gametes.

Meaning of “nuclear DNA”

2

In section 2(1) of the 1990 Act (other terms), after the definition of “non-medical fertility services” insert—

“nuclear DNA”, in relation to an embryo, includes DNA in the pronucleus of the embryo,

.

Activities governed by the 1990 Act

Prohibitions in connection with embryos

3

• (1) Section 3 of the 1990 Act (prohibitions in connection with embryos) is amended as follows.

• (2) For subsection (2) substitute—

(2) No person shall place in a woman— (a) an embryo other than a permitted embryo (as defined by section 3ZA), or (b) any gametes other than permitted eggs or permitted sperm (as so defined).

• (3) In subsection (3)—

• (a) at the end of paragraph (b), insert “ or ”, and

• (b) omit paragraph (d) and the word “or” immediately before it.

• (4) In subsection (4), for “the day when the gametes are mixed” substitute “ the day on which the process of creating the embryo began ”.

• (5) After section 3 insert—

(3ZA) (1) This section has effect for the interpretation of section 3(2). (2) A permitted egg is one— (a) which has been produced by or extracted from the ovaries of a woman, and (b) whose nuclear or mitochondrial DNA has not been altered. (3) Permitted sperm are sperm— (a) which have been produced by or extracted from the testes of a man, and (b) whose nuclear or mitochondrial DNA has not been altered. (4) An embryo is a permitted embryo if— (a) it has been created by the fertilisation of a permitted egg by permitted sperm, (b) no nuclear or mitochondrial DNA of any cell of the embryo has been altered, and (c) no cell has been added to it other than by division of the embryo's own cells. (5) Regulations may provide that— (a) an egg can be a permitted egg, or (b) an embryo can be a permitted embryo, even though the egg or embryo has had applied to it in prescribed circumstances a prescribed process designed to prevent the transmission of serious mitochondrial disease. (6) In this section— (a) “woman” and “man” include respectively a girl and a boy (from birth), and (b) “prescribed” means prescribed by regulations.

• (6) The Human Reproductive Cloning Act 2001 (c. 23) (which is superseded by the preceding provisions of this section) ceases to have effect.

Prohibitions in connection with genetic material not of human origin

4

• (1) In section 4 of the 1990 Act (prohibitions in connection with gametes)—

• (a) in subsection (1), omit—

• (i) paragraph (c), and

• (ii) the word “or” immediately before it, and

• (b) in subsection (5), after “section 3” insert “ or 4A ”.

• (2) After section 4 of the 1990 Act insert—

(4A) (1) No person shall place in a woman— (a) a human admixed embryo, (b) any other embryo that is not a human embryo, or (c) any gametes other than human gametes. (2) No person shall— (a) mix human gametes with animal gametes, (b) bring about the creation of a human admixed embryo, or (c) keep or use a human admixed embryo, except in pursuance of a licence. (3) A licence cannot authorise keeping or using a human admixed embryo after the earliest of the following— (a) the appearance of the primitive streak, or (b) the end of the period of 14 days beginning with the day on which the process of creating the human admixed embryo began, but not counting any time during which the human admixed embryo is stored. (4) A licence cannot authorise placing a human admixed embryo in an animal. (5) A licence cannot authorise keeping or using a human admixed embryo in any circumstances in which regulations prohibit its keeping or use. (6) For the purposes of this Act a human admixed embryo is— (a) an embryo created by replacing the nucleus of an animal egg or of an animal cell, or two animal pronuclei, with— (i) two human pronuclei, (ii) one nucleus of a human gamete or of any other human cell, or (iii) one human gamete or other human cell, (b) any other embryo created by using— (i) human gametes and animal gametes, or (ii) one human pronucleus and one animal pronucleus, (c) a human embryo that has been altered by the introduction of any sequence of nuclear or mitochondrial DNA of an animal into one or more cells of the embryo, (d) a human embryo that has been altered by the introduction of one or more animal cells, or (e) any embryo not falling within paragraphs (a) to (d) which contains both nuclear or mitochondrial DNA of a human and nuclear or mitochondrial DNA of an animal (“animal DNA”) but in which the animal DNA is not predominant. (7) In subsection (6)— (a) references to animal cells are to cells of an animal or of an animal embryo, and (b) references to human cells are to cells of a human or of a human embryo. (8) For the purposes of this section an “animal” is an animal other than man. (9) In this section “embryo” means a live embryo, including an egg that is in the process of fertilisation or is undergoing any other process capable of resulting in an embryo. (10) In this section— (a) references to eggs are to live eggs, including cells of the female germ line at any stage of maturity, but (except in subsection (9)) not including eggs that are in the process of fertilisation or are undergoing any other process capable of resulting in an embryo, and (b) references to gametes are to eggs (as so defined) or to live sperm, including cells of the male germ line at any stage of maturity. (11) If it appears to the Secretary of State necessary or desirable to do so in the light of developments in science or medicine, regulations may— (a) amend (but not repeal) paragraphs (a) to (e) of subsection (6); (b) provide that in this section “embryo”, “eggs” or “gametes” includes things specified in the regulations which would not otherwise fall within the definition. (12) Regulations made by virtue of subsection (11)(a) may make any amendment of subsection (7) that appears to the Secretary of State to be appropriate in consequence of any amendment of subsection (6).

The Human Fertilisation and Embryology Authority

Membership of Authority: disqualification and tenure

5

Schedule 1 contains amendments of Schedule 1 to the 1990 Act (which are about disqualification for appointment to membership of the Authority and the tenure of office of members).

Additional general functions of Authority

6

• (1) In section 8 of the 1990 Act (general functions of the Authority), renumber the existing provision as subsection (1) of that section.

• (2) In that subsection—

• (a) omit the word “and” immediately after paragraph (c), and

• (b) after that paragraph insert—

(ca) maintain a statement of the general principles which it considers should be followed— (i) in the carrying-on of activities governed by this Act, and (ii) in the carrying-out of its functions in relation to such activities, (cb) promote, in relation to activities governed by this Act, compliance with— (i) requirements imposed by or under this Act, and (ii) the code of practice under section 25 of this Act, and

.

• (3) After that subsection, insert—

(2) The Authority may, if it thinks fit, charge a fee for any advice provided under subsection (1)(c).

Duties in relation to carrying out its functions

7

After section 8 (general functions of the Authority) insert—

(8ZA) (1) The Authority must carry out its functions effectively, efficiently and economically. (2) In carrying out its functions, the Authority must, so far as relevant, have regard to the principles of best regulatory practice (including the principles under which regulatory activities should be transparent, accountable, proportionate, consistent and targeted only at cases in which action is needed).

Power to contract out functions etc.

8

After section 8A of the 1990 Act (duty of Authority to communicate with competent authorities of other EEA states) insert—

(8B) (1) Arrangements may be made between the Authority and a government department, a public authority or the holder of a public office (“the other authority”) for— (a) any functions of the Authority to be exercised by, or by members of the staff of, the other authority, or (b) the provision by the other authority of administrative, professional or technical services to the Authority. (2) Arrangements under subsection (1)(a) do not affect responsibility for the carrying-out of the Authority's functions. (3) Subsection (1)(a) does not apply to any function of making subordinate legislation (within the meaning of the Interpretation Act 1978). (8C) (1) This section applies to any function of the Authority other than— (a) any function which, by virtue of any enactment, may be exercised only by members of the Authority, (b) a function excluded from this section by subsection (2), or (c) a function excluded from this section by the Secretary of State by order. (2) A function is excluded from this section if— (a) it relates to the grant, revocation or variation of any licence, (b) it is a power or right of entry, search or seizure into or of any property, or (c) it is a function of making subordinate legislation (within the meaning of the Interpretation Act 1978). (3) The Authority may make arrangements with any person (“the authorised person”) for the exercise by that person, or by the employees of that person, of any function of the Authority to which this section applies. (4) Any arrangements made by the Authority under this section— (a) may be revoked at any time by the Authority, and (b) do not prevent the Authority from exercising any function to which the arrangements relate. (5) Subject to subsection (6), anything done or omitted to be done by or in relation to the authorised person (or an employee of the authorised person) in, or in connection with, the exercise or purported exercise of any function to which the arrangements relate is to be treated for all purposes as done or omitted to be done by or in relation to the Authority. (6) Subsection (5) does not apply— (a) for the purposes of so much of any contract between the authorised person and the Authority as relates to the exercise of the function, or (b) for the purposes of any criminal proceedings brought in respect of anything done or omitted to be done by the authorised person (or any employee of the authorised person). (7) Section 38A(2) of this Act (which relates to the keeping of embryos, human admixed embryos and gametes) applies in relation to the authorised person or any employee of the authorised person, when exercising functions of the Authority, as it applies in relation to any member or employee of the Authority exercising functions as member or employee. (8D) (1) This section applies to— (a) the Authority, (b) any public authority or other person exercising functions of the Authority by virtue of section 8B, (c) any member of staff of any person falling within paragraph (b), (d) any person exercising functions of the Authority by virtue of section 8C, (e) an employee of any person falling within paragraph (d), or (f) any person engaged by the Authority to provide services to the Authority. (2) No obligation of confidence is to prevent the disclosure of information by a person to whom this section applies to another such person if the disclosure is necessary or expedient for the purposes of the exercise of any function of the Authority.

Power to assist other public authorities

9

After section 8D (inserted by section 8 above) insert—

(8E) (1) The Authority may if it thinks it appropriate to do so provide assistance to any other public authority in the United Kingdom for the purpose of the exercise by that authority of its functions. (2) Assistance provided by the Authority under this section may be provided on such terms, including terms as to payment, as it thinks fit.

Power to delegate and establish committees

10

For section 9 (licence committees and other committees) of the 1990 Act substitute—

(9A) (1) The Authority may delegate a function to a committee, to a member or to staff. (2) The Authority may establish such committees or sub-committees as it thinks fit (whether to advise the Authority or to exercise a function delegated to it by the Authority). (3) Subject to any provision made by regulations under section 20A (appeals committees), the members of the committees or sub-committees may include persons who are not members of the Authority. (4) Subsection (1) has effect subject to any enactment requiring a decision to be taken by members of the Authority or by a committee consisting of members of the Authority.

Scope of licences

Activities that may be licensed

11

• (1) In section 11 of the 1990 Act (licences for treatment, storage and research), in subsection (1)(b), for “and embryos” substitute “ , embryos or human admixed embryos ”.

• (2) Schedule 2 contains amendments of Schedule 2 to the 1990 Act (which relates to the activities for which licences may be granted under the Act).

• (3) The Human Fertilisation and Embryology (Research Purposes) Regulations 2001 (S.I. 2001/188) (which are superseded by the amendments made by Schedule 2) cease to have effect.

Licence conditions

General conditions of licences

12

• (1) Section 12 of the 1990 Act (general conditions of licences under that Act) is amended as follows.

• (2) In subsection (1)—

• (a) in paragraph (c) (condition relating to compliance with Schedule 3 to the Act), omit “or non-medical fertility services”, and

• (b) in paragraphs (e) and (f) (which relate to the supply of gametes or embryos), for “or embryos” substitute “ , embryos or human admixed embryos ”.

• (3) In subsection (2)—

• (a) omit the “and” at the end of paragraph (a), and

• (b) at the end of paragraph (b) insert

, and (c) every licence under paragraph 3 of that Schedule, so far as authorising activities in connection with the derivation from embryos of stem cells that are intended for human application.

Consent to use or storage of gametes, embryos, human admixed embryos etc.

13

Schedule 3 contains amendments of Schedule 3 to the 1990 Act (which relates to consent to the use or storage of gametes or embryos).

Conditions of licences for treatment

14

• (1) Section 13 of the 1990 Act (conditions of licences for treatment) is amended in accordance with subsections (2) to (4).

• (2) In subsection (5)—

• (a) omit “, other than basic partner treatment services,”, and

• (b) for “a father” substitute “ supportive parenting ”.

• (3) For subsection (6) substitute—