Introduction

1.These explanatory notes relate to the Human Fertilisation and Embryology Act 2008 which received Royal Assent on 13 November 2008. They have been prepared by the Department of Health in order to assist the reader of the Act. They do not form part of the Act and have not been endorsed by Parliament.

2.The notes need to be read in conjunction with the Act. They are not, and are not meant to be, a comprehensive description of the Act. So where a section or part of a section does not seem to require any explanation or comment, none is given.

List of Abbreviations Used in the Explanatory Notes

3.The following terms are used throughout the Explanatory Notes:

Background

Review of the 1990 Act

4.The provisions of the 1990 Act were enacted after consideration of the report of the Committee of Inquiry into Human Fertilisation and Embryology, chaired by Dame (now Baroness) Mary Warnock. This report was published in July 1984 and considered the social, ethical and legal implications of developments in the field of human reproduction, most notably the birth in 1978 of the first child conceived through IVF.

5.The 1990 Act regulates the creation, keeping and use of embryos outside the human body and the storage and use of gametes to create embryos. The 1990 Act prohibits certain activities from being carried out without a licence. Other activities including placing non-human embryos or gametes in a woman, are subject to an absolute prohibition.

6.Licences can be granted for the purpose of fertility treatment, for storage and for research. Following amendments made to the 1990 Act by the 2007 Regulations, a licence is also required under the 1990 Act in respect of non-medical fertility services. Non-medical fertility services are defined as any services that are provided, in the course of a business, for the purpose of assisting women to carry children, but which are not medical, surgical or obstetric services. For example internet-based businesses that arrange for donated sperm to be delivered to women at home for self-insemination.

7.The 1990 Act imposes mandatory conditions on each type of licence and enables other conditions to be imposed. Activities under the 1990 Act are overseen by the HFEA, a statutory licensing authority.

8.In January 2004, the Government announced a review of the 1990 Act citing developments in reproductive medicine since the passage of the original legislation, and conducted a public consultation during the latter half of 2005. The Government followed this by publishing the White Paper: Review of the Human Fertilisation and Embryology Act: Proposals for revised legislation (including establishment of the Regulatory Authority for Tissue and Embryos) in December 2006 (Cm 6989) containing policy proposals.

9.Following publication of the White Paper a draft Bill was published in May 2007 for scrutiny by a Joint Committee of both Houses. Policy proposals from the White Paper as updated following pre-legislative scrutiny are implemented by the Human Fertilisation and Embryology Act 2008.

Overview

10.The purpose of the Act is to amend the law relating to assisted reproduction treatment and embryo research. The Act amends many of the provisions of the 1990 Act, but the main features of the existing model of regulation are retained.

11.The Act is in three Parts. Part 1 comprises amendments to the 1990 Act, Part 2 makes provision about who is to be treated as the parent of a child who is born, after the coming into force of the Part, as a result of assisted reproduction treatments, and Part 3 makes miscellaneous and general provision.

Part 1

12.Part 1 (including Schedules 1 to 5) makes a range of amendments to the 1990 Act to take account of scientific developments, to reflect changes in social attitudes and to update the HFEA’s ability to regulate according to principles of better regulation.

13.To assist the reader of the Act, the Department of Health has produced an illustrative consolidated text of the 1990 Act as amended. This is available on the Department of Health website. This includes amendments made by the 2007 Regulations and shows the effect of the amendments made by the Act. The text has no official status.

Part 2

14.Part 2 replaces existing provision under the 1990 Act to determine legal parenthood for future cases involving assisted reproduction. The Act introduces a new concept of parenthood for a mother’s female partner in certain circumstances, making equivalent provision to that for opposite sex couples.

15.The 1990 Act provided that where an unmarried couple were “treated together” in a licensed clinic using donated sperm, the male partner would be regarded as the father of any child born as a result. “Treated together” in this context is a somewhat loose concept. Part 2 makes provision that both the prospective mother and the man (or in the case of persons in a same-sex relationship, the woman) who is intended to be the second parent of the child must consent in writing to what is intended.

16.Part 2 also makes provision in relation to parenthood in respect of children born after a surrogacy arrangement, which is intended to put same sex couples and unmarried opposite sex couples in the same position as married couples.

Part 3

17.Part 3 of the Act amends the Surrogacy Arrangements Act 1985, miscellaneous provisions and general provisions about order and regulation-making powers, powers to make consequential and transitional provisions, and commencement.

Territorial Extent

18.Part 2 of the Act (and the free-standing provisions in Part 3 of the Act) extend to England and Wales, Scotland and Northern Ireland. The other provisions of the Act amend existing legislation and have the same extent as the provisions being amended. This means, in particular, that the amendments of the 1990 Act in Part 1 of the Act extend to England and Wales, Scotland and Northern Ireland.

19.The subject-matter of the 1990 Act and subject-matter of the Surrogacy Arrangements Act 1985 are reserved matters as respects Scotland and Northern Ireland. Part 2 of the Act deals with a subject (the legal parenthood of children resulting from assisted reproduction) that is already dealt with by sections 27 to 30 of the 1990 Act. Part 2 therefore also relates to a reserved matter.

20.The Act gives the HFEA powers to assist any other public authority in the UK as provided for in section 9 of the Act.

Wales

21.The Act does not confer any functions on the Welsh Ministers or the National Assembly for Wales, and in general applies to Wales in the same way as it applies to England.

Commentary on Sections

Part 1: Amendments of Human Fertilisation and Embryology Act 1990

Section 1: Meaning of “embryo” and “gamete”

22.This section amends section 1 of the 1990 Act so as to ensure that the Act applies to all live human embryos regardless of the manner of their creation, and to all live human gametes (eggs and sperm).

23.An embryo will continue to be defined under the new section 1(1) in broad terms as a “live human embryo” but the definition no longer assumes that an embryo can only be created by fertilisation. This brings the term “embryo” up to date with technologies that have been developed since the time of enactment of the 1990 Act.

24.The definition of an “embryo” in the new section 1(1)(a) of the 1990 Act excludes certain types of embryos created by combining together human and animal gametes, or human embryos altered using animal DNA or animal cells. Such entities are defined as “human admixed embryos” by new section 4A of the 1990 Act as inserted by section 4.

25.The term “gametes” under section 1(4) of the 1990 Act has been amended to expressly encompass not only mature eggs and sperm, but also immature gametogenic cells such as primary oocytes, and spermatocytes.

26.A regulation-making power has been taken to expand the definitions of “embryo”, “eggs”, “sperm” or “gametes”, where this is considered by the Secretary of State to be necessary or desirable in light of developments in science or medicine (see new section 1(6)).

Section 2: Meaning of “nuclear DNA”

27.This section inserts a new definition into section 2 of the 1990 Act to clarify that any reference to “nuclear DNA” includes DNA in both the nucleus and pronucleus of an embryo.

Section 3: Prohibitions in connection with embryos

28.Section 3 amends section 3 of the 1990 Act, which covers prohibitions connected with embryos. Section 3(2) prohibits the placing in any woman of any embryo other than a permitted embryo or any gametes other than permitted eggs or permitted sperm.

29.A permitted embryo is defined as an embryo which has been formed by the fertilisation of a permitted egg by a permitted sperm, whose nuclear or mitochondrial DNA has not been altered and which has not had cells added (except by division of the embryo’s own cells). Permitted eggs are defined as eggs produced by or extracted from the ovaries of a woman and permitted sperm as sperm produced by or extracted from the testes of a man. These eggs and sperm must also not have been subject to any alterations to their nuclear or mitochondrial DNA. This section ensures embryos created by artificial gametes or genetically modified gametes could not be placed in a woman. Similarly, genetically modified embryos or embryos created by cloning cannot be placed in a woman. This prevents reproductive cloning and supersedes the Human Reproductive Cloning Act 2001.

30.A regulation-making power has been provided under new section 3ZA(5) of the 1990 Act to allow the meaning of permitted eggs and permitted embryos to be extended to include eggs or embryos that have been treated in such a way as specified in regulations to prevent the transmission of serious mitochondrial disease(1). In the future, it may be possible to create embryos using an affected woman’s egg, her partner’s sperm and healthy donated mitochondria. This regulation-making power will enable such embryos and eggs to be implanted in a woman if the technology became available and was proven safe. Further provision regarding mitochondrial donation is made in section 26, which inserts new section 35A into the 1990 Act.

Section 4: Prohibitions in connection with genetic material not of human origin

31.This section inserts new section 4A into the 1990 Act to provide that certain types of embryo, which contain both human and animal DNA, are subject to regulation under the 1990 Act. These are defined as “human admixed embryos” and include:

• Cytoplasmic hybrids (Cybrids): embryos created by techniques used in cloning, using human gametes or cells and animal eggs. The embryos would be mostly human except for the presence of animal mitochondria (see the notes on section 3 for more information on mitochondria) (section 4A(6)(a));

• Human-animal hybrid embryos: any other embryo created using a human egg and the sperm of an animal, or an animal egg and a human sperm or by combining a pro-nucleus of an animal with a human pro-nucleus (section 4A(6)(b));

• Human transgenic embryos: embryos created by the introduction of animal DNA into one or more cells of the embryo (section 4A(6)(c));

• Human-animal chimeras: human embryos, altered by the addition of one or more cells from an animal (section 4A(6)(d))

• Any embryo which does not fall within any of the categories already mentioned and which contains both human nuclear or mitochondrial DNA and nuclear or mitochondrial DNA of an animal, but where the animal DNA is not predominant (section 4A(6)(e)).

32.Section 4A(2) prohibits mixing human gametes with the gametes of an animal and creating, keeping or using a human admixed embryo without a licence.

33.Section 4A(3) provides that any human admixed embryo created under licence cannot be kept after the earliest of either:

• the appearance of the primitive streak (an indicator for the start of a process by which the cells of the embryo begin to separate into three distinct cells types which will go on to form different types of tissue); or

• 14 days from the day on which the process of creating the human admixed embryo began.

This is consistent with the time limits for keeping human embryos in vitro for research purposes.

34.New section 4A(5) contains a regulation-making power that enables the circumstances in which a human admixed embryo can be kept or used to be restricted. This power could be used, for example, if it became necessary to shorten the 14-day time limit, for which human admixed embryos may be kept in some circumstances. This mirrors an existing power in relation to human embryos in section 3(3)(c) of the 1990 Act. This regulation-making power is subject to the affirmative procedures.

35.Further provisions about the licensing of activities involving human admixed embryos are made in sections 11, 12, 13, and 15, paragraphs 5 and 6 of Schedule 2 and paragraph 13 of Schedule 3.

36.New section 4A(11)(a) provides a regulation-making power to amend (but not repeal) the definitions of a human admixed embryo under paragraphs (a) to (e) of subsection (6). Section 4A(11)(b) provides a regulation-making power to amend the definition of the terms “embryo”, “eggs” or “gametes” for the purpose of section 4A. Both these powers can only be exercised if it appears to the Secretary of State necessary or desirable to do so in the light of developments in science or medicine. Both powers are subject to the affirmative resolution procedure.

Section 5: Membership of the Authority: disqualification and tenure

37.Section 5 introduces Schedule 1 which contains amendments to Schedule 1 to the 1990 Act. These relate to the conditions for disqualification for appointment to the chair, deputy chair and membership of the HFEA. In particular, those who have been the subject of bankruptcy orders or certain criminal convictions cannot be appointed to the HFEA.

Section 6: Additional general functions of the Authority

38.Section 6 amends section 8 of the 1990 Act relating to general functions of the Authority. It adds to the list of the HFEA’s general functions in (i) requiring the Authority to maintain a statement of general principles and (ii) requiring the HFEA to promote compliance with the requirements imposed by the 1990 Act and with the Code of Practice under section 25 of the 1990 Act.

39.New section 8(2) gives the Authority power to charge for advice given under section 8(1)(c). It is intended that the charge would recover all or part of the costs of providing the advice.

Section 7: Duties in relation to carrying out its functions

40.This section requires the HFEA to carry out its functions effectively, efficiently and economically and to have regard to the principles of best regulatory practice in doing so.

Section 8: Power to contract out functions etc.

41.Section 8 inserts into the 1990 Act new sections 8B and 8C which give the HFEA power to make arrangements with a government department, a public authority or the holder of a public office for the carrying out of any function of the Authority. However, the HFEA will retain responsibility for carrying out its functions. This new flexibility will, for example, permit the Authority to arrange with another public body for that body to conduct inspections on behalf of the HFEA.

42.Similarly, the HFEA will have power to contract-out certain of its functions to a body that is not a public authority. The functions that may be contracted out do not include licensing, the right of entry and power of search and seizure; or the power to make subordinate legislation. New section 8C(1)(a) prevents the contracting out of any function which, by virtue of any enactment, may be exercised only by members of the Authority. The Secretary of State can by order prevent any function of the HFEA from being contracted out (section 8C(1)(c)).

43.Section 8 also inserts new section 8D which provides the necessary authority for those exercising HFEA functions under an agency arrangement or contract, to receive and disclose information, such as that contained on the HFEA register, where this is necessary or expedient for the purpose of exercising the relevant function.

Section 9: Power to assist other public authorities

44.Section 9 inserts in the 1990 Act a new section 8E which allows the HFEA to provide assistance to any other public authority in the UK. The HFEA may charge a fee for these services. It is intended that the fee would recover the costs of providing the assistance. This allows the HFEA to carry out functions on behalf of another organisation.

Section 10: Power to delegate and establish committees

45.Section 10 inserts new section 9A into the 1990 Act. Subsection (1) of section 9A provides that the HFEA may delegate its functions to a committee or a member of the Authority, or to the Authority's staff. Subsection (2) provides that the HFEA may establish committees and sub-committees which may, in accordance with subsection (3), include people who are not members of the Authority. This provision replaces that in section 9 of the 1990 Act requiring licence committees to be comprised only of members of the Authority. These new provisions enable the HFEA to delegate any function, apart from those which can only be exercised by members, to its staff or to a committee. These functions can include licence decisions and development of the Code of Practice.

Section 11: Activities that may be licensed

46.This section introduces Schedule 2 to the Act which amends Schedule 2 to the 1990 Act. These amendments relate to licensable activities, specifically embryo testing and amending the purposes for which research licenses can be granted including the creation, keeping and use of human admixed embryos.

Licences for treatment

47.Paragraph 2 of Schedule 2 to the Act amends paragraph 1 of Schedule 2 to the 1990 Act to enable treatment licences to be granted for the use of embryos for training persons in embryo biopsy, embryo storage and other embryological techniques, but only where the HFEA is satisfied that such use is necessary for that purpose. Paragraph 1 is also amended to ensure that only “permitted embryos” within the meaning of new section 3ZA can be placed in a woman. The Act substitutes a new provision for paragraph 1(4) of Schedule 2 to prevent a treatment licence authorising the alteration of the nuclear or mitochondrial DNA of a cell while it forms part of an embryo. This is subject to any regulations under new section 3ZA(5) as inserted by section 3.

Embryo testing

48.Paragraph 3 of Schedule 2 to the Act adds to Schedule 2 to the 1990 Act new paragraphs 1ZA to 1ZC which relate to embryo testing and practices designed to secure that a resulting child will be of one sex rather than the other.

49.Embryo testing can involve invasive procedures such as embryo biopsy, involving removal of a cell or cells from the embryo for subsequent analysis. The effect of the new provisions is that testing of an embryo can only be authorised for the purposes in new paragraph 1ZA(1)(a) to (e). For example, sub-paragraph (1)(a) could authorise testing to establish whether an embryo contained an abnormal number of chromosomes likely to result in miscarriage, sometimes referred to as pre-implantation genetic screening. Sub-paragraph (1)(b) could, for example, authorise testing to establish the presence or absence of a genetic disorder in a case where there was a particular risk of such an abnormality being present, sometimes referred to as preimplantation genetic diagnosis. A particular risk might be evidenced, for example, by a family history of the disease.

50.Sub-paragraph (1)(c) could authorise establishing the sex of an embryo where there is a particular risk that any resulting child will have or develop a gender-related serious physical or mental disability, serious illness or other serious medical condition. This provision enables sex selection not only for conditions which are clearly linked to sex chromosomes, for example Duchenne Muscular Dystrophy but also where there is a particular risk of gender-related conditions for example a strong family history of breast cancer where the mother has also been affected (and therefore is probably a carrier of the faulty gene), and wishes to avoid passing this condition on to a daughter.

51.Paragraph 1ZA(1)(b) is subject to the further provisions set out in sub-paragraph (2). Sub-paragraph (2) provides that in order for testing to be authorised under sub-paragraph (1)(b), the HFEA must be satisfied 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.

52.A provision of section 14 is closely related to the provisions on embryo testing discussed above. Section 14 amends the 1990 Act to make it a condition of a treatment licence that, in the circumstances described, embryos that are known to have an abnormality as described are not to be preferred to embryos not known to have such an abnormality. The same restriction is also applied to the selection of persons as gamete or embryo donors. Similarly for sex selection, embryos of a particular sex that are at a particular risk, compared to embryos of that sex in general, of a gender-related disability, illness or medical condition, should not be preferred to those that are not known to be at risk (see note on section 14).

Tissue typing

53.Paragraph 1ZA(1)(d) is concerned with “tissue typing” – establishing whether the embryo would result in a child whose tissue was compatible with that of an existing child (the sibling). Embryo testing for this purpose could be licensed where the sibling suffers from a serious medical condition that could be treated with matched tissue from the child to be born including stem cells found in umbilical cord blood and bone marrow or “other tissue”. Paragraph 1ZA(4) provides that the reference to “other tissue” in paragraph 1ZA(1)(d) does not include a whole organ. This provision ensures that tissue typing cannot be licensed if the match was to be carried out because the older sibling required a whole organ.

Testing in the event of uncertainty

54.Paragraph 1ZA(1)(e) is intended to ensure that embryos can be tested in order to resolve any uncertainty that has arisen as to the identity of the persons who provided the gametes used to create the embryo.

Sex selection

55.Previously, as a matter of policy, the HFEA has not allowed sex selection except for medical reasons. This position is maintained in the Act. Paragraph 1ZB deals more generally with practices of sex selection, for example sperm sorting, and precludes them from being authorised by a licence other than where there is a particular risk that a woman will give birth to a child who will have or will develop a gender-related serious physical or mental disability, serious illness or other serious medical condition (see paragraph 52 of these notes). Paragraph 1ZB does not prevent any embryo testing practices that may be permitted under paragraph 1ZA.

56.Paragraph 1ZC provides regulation-making powers to amend new paragraph 1ZA (embryo testing), and to make consequential amendments of the new paragraph 1ZB (sex selection). However, regulations may not authorise testing embryos to establish their sex or other practices of sex selection, except on grounds relating to the health of any resulting child.

57.Paragraph 4 of Schedule 2 to the Act makes an amendment that is intended to prevent sex selection, in the context of the provision of non-medical fertility services. A licence cannot authorise the procurement or distribution of sperm to which any process has been applied which is designed to result in a child of a specific sex.

Licences for research

58.Under paragraph 3 of Schedule 2 to the 1990 Act, a research licence may authorise the creation, keeping and/or use of human embryos for the purposes of a project of research. Paragraph 6 of Schedule 2 to the Act substitutes new paragraphs 3 and 3A for the existing provision.

Purposes for which embryo research may be undertaken

59.A research licence may not authorise any activity unless the HFEA considers it to be necessary or desirable for one of the specified research purposes.

60.The list of permitted research purposes was extended by the Human Fertilisation and Embryology (Research Purposes) Regulations (SI 2001/188) (“the 2001 Regulations”), which allowed embryos to be created and used for research into stem cell therapies and the treatment of serious disease. New paragraph 3A brings together all the research purposes listed in the 1990 Act and the 2001 Regulations. It also makes three significant changes to the previous position on licensable research using embryos.

61.The list of purposes for which research may be licensed has been expanded in new paragraph 3A(2)(a) to include research which is undertaken to increase knowledge, not only about serious diseases, but also about other serious medical conditions. This includes conditions such as neural trauma or other tissue damage, which would not be considered to be diseases and therefore would not previously have been permitted.

62.New paragraph 3A(2)(b) allows for research into the development of treatments for other serious medical conditions, as well as for serious disease. Research may lead to an understanding of how to change stem cells into particular tissues, which may have the potential to regenerate or repair tissue damage caused by disease or trauma.

63.New paragraph 3A(1)(b) extends an existing provision, to give the HFEA power to not only issue licences where it is necessary or desirable for one of the principal purposes, but also where the research will increase knowledge about serious disease or other serious medical conditions, or develop treatments for them.

64.The 2001 Regulations have been superseded and are therefore revoked by Part 2 of Schedule 8 to the Act.

Genetic modification of cells

65.Previously paragraph 3(4) of Schedule 2 to the 1990 Act prohibited alteration of the genetic structure of the cell of an embryo, except in such circumstances as may be specified in regulations. No such regulations were in fact made. This prohibition is not included in the re-enacted paragraph 3. Therefore research involving the genetic modification of embryos may now be authorised under a research licence.

Human admixed embryos

66.Paragraph 3(2) of Schedule 2 to the 1990 Act, as inserted by paragraph 6 of Schedule 2 to the Act, continues to allow the mixing of sperm with the egg of a hamster, or other animal specified in directions, for the purposes of research into the normality or fertility of sperm. Any resulting human admixed embryo must be destroyed as soon as the research is complete and no later than the two-cell stage.

67.New paragraph 3(3) enables licences to be issued to create, keep and use human admixed embryos (as defined by new section 4A(5)(a) to (e) inserted by section 4 of the Act) for the purposes of a project of research specified in the licence.

68.New paragraph 3(5) provides that no research licence can be granted unless the proposed use of embryos or human admixed embryos is necessary for the purposes of the research.

69.New paragraphs 3(6), (8) and (9) of Schedule 2 to the 1990 Act deal with time limits and conditions applying to research licences.

Licences for storage (of human admixed embryos)

70.Under paragraph 2 of Schedule 2 to the 1990 Act, a storage licence may authorise the storage of gametes or embryos, or both. Paragraph 5 of Schedule 2 to the Act inserts new sub-paragraph (1A) into paragraph 2 of Schedule 2 to the 1990 Act allowing the storage of human admixed embryos (regardless of whether the licence holder is already licensed to store embryos or gametes). Any such licence would be subject to the same conditions and time limits under paragraph 2(2) and (3) of Schedule 2 to the 1990 Act as licences to store embryos and gametes.

Section 12: General conditions of licences

71.Section 12 sets out general conditions that apply to every licence granted under the 1990 Act. The 2007 Regulations amended section 12 to except non-medical fertility services from the ambit of Schedule 3 to the 1990 Act. Neither the remit of the EU Directive or the powers under which it was implemented allowed for the consent provisions in Schedule 3 to the 1990 Act about the use and storage of gametes and embryos to be applied in the case of persons providing gametes for the purpose of the provision of non-medical fertility services. This section amends section 12 of the 1990 Act to rectify that situation.

72.Section 12 also amends section 12 of the 1990 Act to ensure that no money or other benefit can be given or received for the supply of human admixed embryos (unless authorised by directions) and that if human admixed embryos are supplied to a person to whom another licence applies they must be provided with any information that the HFEA may specify in conditions. These amendments ensure that any research licence granted in connection with human admixed embryos will be subject to the same relevant licence conditions as for embryos or gametes.