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Human Fertilisation And Embryology Bill [HL]


 

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These notes refer to the Human Fertilisation and Embryology Bill [HL] as introduced in the House of Lords on 8th November 2007 [HL Bill 6]

HUMAN FERTILISATION AND EMBRYOLOGY BILL [HL]


EXPLANATORY NOTES

INTRODUCTION

1.     These explanatory notes relate to the Human Fertilisation and Embryology Bill [HL] as introduced in the House of Lords on 8th November 2007. They have been prepared by the Department of Health in order to assist the reader of the Bill and to help inform debate on it. They do not form part of the Bill and have not been endorsed by Parliament.

2.     The notes need to be read in conjunction with the Bill. They are not, and are not meant to be, a comprehensive description of the Bill. So where a clause or part of a clause 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:

DI - Donor Insemination
DNA -Deoxyribose Nucleic Acid (genetic material)
ECHREuropean Convention on Human Rights (2004/23/EC)
EU DirectiveThe European Union Tissue and Cells Directive
HFEA -Human Fertilisation and Embryology Authority
IVF -In vitro fertilisation
IA -Impact Assessment
SI -Statutory Instrument
The 1990 Act -The Human Fertilisation and Embryology Act 1990
The 2007 regulations - The Human Fertilisation and Embryology (Quality and Safety) Regulations (SI 2007/1522) implementing the European Union Tissue and Cells Directive.

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 in vitro fertilisation.

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 available 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. In particular, they include a very small number of 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 would be implemented by the Human Fertilisation and Embryology Bill [HL].

OVERVIEW

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

11.     The Bill is in three Parts. The first Part comprises amendments to the 1990 Act, the second Part makes provision about who is to be treated, after the coming into force of the Part, as the parent of a child who has been born as a result of assisted reproduction treatments, and the third Part 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 societal attitudes and to update the HFEA's ability to regulate according to principles of better regulation.

13.     To assist the reader of the Bill, the Department of Health has produced an illustrative consolidated text of the 1990 Act as amended. This will be available on the Department of Health website and in hard copy. This includes amendments made by the 2007 Regulations and shows the effect of the amendments made by the Bill. 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 Bill 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 currently provides that where an unmarried couple are "treated together" in a licensed clinic using donated sperm, the male partner will 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 to such in writing.

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 Bill contains amendments to 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 Bill (and the free standing provisions in Part 3 of the Bill) extend to England and Wales, Scotland and Northern Ireland. The other provisions of the Bill 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 Bill 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 Bill 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 HFEA will have powers to assist any other public authority in the UK as provided for in clause 9 of the Bill.

Wales

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

Scotland

22.     Because the Sewel Convention provides that Westminster will not normally legislate with regard to devolved matters in Scotland without the consent of the Scottish Parliament, if there are amendments relating to such matters which trigger the Convention, the consent of the Scottish Parliament will be sought for them.

Northern Ireland

23.     The Bill does not contain any provisions that would invoke a legislative consent motion. Consequential amendments for Northern Ireland have been included.

COMMENTARY ON CLAUSES

PART 1: AMENDMENTS OF HUMAN FERTILISATION & EMBRYOLOGY ACT 1990

Clause 1: Meaning of "embryo" and "gamete"

24.     This clause 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).

25.     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.

26.     The definition of an "embryo" under the new section 1(1)(a) of the 1990 Act has been limited to exclude 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 "inter-species" embryos and are regulated under new section 4A of the 1990 Act inserted by clause 4.

27.     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.

28.     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)).

Clause 2: Meaning of "nuclear DNA"

29.     This clause inserts a new definition into section 2 of the 1990 Act to clarify that, the use of the term "nuclear DNA" includes DNA in both the nucleus and pronucleus of an embryo.

Clause 3: Prohibitions in connection with embryos

30.     Clause 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.

31.     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 that has not had cells added (apart from by division of the embryo's own cells). Permitted eggs are defined as eggs produced or extracted from the ovaries of a woman and permitted sperm as sperm produced 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 clause 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.

32.     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 is made regarding mitochondrial donation in clause 26, which inserts new section 35A into the 1990 Act.

1 Mitochondria are found outside the nucleus of the cell and contain a small amount of DNA. They are involved in energy production and are present in most cells in the body. If a woman's egg is fertilised by sperm the mitochondria from her egg will become the mitochondria for every cell of the embryo formed. Therefore, if a woman has a genetic medical condition associated with her mitochondria, these will be inherited via her eggs.

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

33.     This clause 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 "inter-species embryos" and include:

         Human-animal hybrid embryos: embryos 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(5)(a));

         Cytoplasmic hybrids (Cybrids): embryos created by techniques used in cloning, using human cells and animal eggs. The embryos would be mostly human except for the presence of animal mitochondria (see the notes on clause 3 for more information on mitochondria) (section 4A(5)(b));

         Human transgenic embryos: embryos created by the introduction of animal DNA into one or more cells of the embryo (section 4A(5)(c));

         Human-animal chimeras: human embryos, altered by the addition of one or more cells from an animal (section 4A(5)(d)).

34.     Regulation-making powers have been provided under new section 4A(5)(e) and 4A(7) to enable the Secretary of State to include within the definition of inter-species embryos other types of embryos or to amend the definitions in section 4A(5)(a) to (e) respectively.

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

36.     Section 4A(3) provides that any inter-species 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 inter-species embryo began.

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

37.     Further provisions about the licensing of activities involving inter-species embryos are made in clauses 11, 12, 13, 15 and paragraphs 5 and 6 of Schedule 2 to the Bill.

Clauses 5: Membership of the Authority: disqualification and tenure

38.     Clause 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.

Clause 6: Additional general functions of the Authority

39.     Clause 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.

40.     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.

Clause 7: Duties in relation to carrying out its functions

41.     This clause 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.

Clause 8: Power to contract out functions etc.

42.     Clause 8 inserts new sections 8B and 8C into the 1990 Act 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.

43.     Similarly, the HFEA will have power to contract-out certain of its functions to a non-public organisation. 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. The Secretary of State can by order prevent any function of the HFEA from being contracted out. New section 8C(1)(a) also prevents the contracting out of any function which, by virtue of any enactment, may be exercised only by members of the Authority (8C(1)(c)).

44.     Clause 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.

Clause 9: Power to assist other public authorities

45.     Clause 9 introduces new section 8E into the 1990 Act 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.

Clause 10: Power to delegate and establish committees

46.     Clause 10 introduces new section 9A into the 1990 Act. Subsection (1) of 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 will 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.

Clause 11: Activities that may be licensed

47.     This clause refers to Schedule 2 to the Bill 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 inter-species embryos.

Licences for treatment

48.      Paragraph 2 of Schedule 2 to the Bill amends paragraph 1 of Schedule 2 to the 1990 Act to enable treatment licences to be granted for the use of embryos for training purposes, but only where the HFEA is satisfied that such use is necessary. 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 Bill substitutes new provision for paragraph 1(4) of Schedule 2 so as 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 clause 3.

Embryo testing

49.     The Bill adds paragraphs 1ZA to 1ZC to Schedule 2 to the 1990 Act which concern embryo testing, and practices designed to secure that a resulting child will be of one sex rather than the other.

50.     Embryo testing involves 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 preimplantation 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.

51.     Sub-paragraph 1(c) refers to 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.

52.     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.

53.     A provision of clause 14 is closely related to the provisions on embryo testing discussed above. Clause 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 clause 14).

Tissue typing

54.     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 sibling including stem cells found in umbilical cord blood and bone marrow.

Testing in the event of uncertainty

55.     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

56.     Currently as a matter of policy, the HFEA does not allow sex selection except for medical reasons. This position is maintained in the Bill. 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 note in paragraph 51). Paragraph 1ZB does not prevent any embryo testing practices that may be permitted under paragraph 1ZA (see paragraph 51).

57.     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.

58.     Paragraph 4 of Schedule 2 to the Bill 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

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

Purposes for which embryo research may be undertaken

60.     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.

61.     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 currently listed in the 1990 Act and the regulations made in 2001. It also makes three significant changes to the previous position on licensable research using embryos.

62.     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.

63.     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.

64.     New paragraph 3A(1)(b) extends an existing provision, giving 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.

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

Genetic modification of cells

66.     Currently, paragraph 3(4) of Schedule 2 to the 1990 Act prohibits alteration of the genetic structure of the cell of an embryo, except in such circumstances as may be specified in regulations. No such regulations have in fact been 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.

Inter-species embryos

67.     Paragraph 3(2) of Schedule 2 to the 1990 Act, as inserted by paragraph 6 of Schedule 2 to the Bill, 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 inter-species embryo must be destroyed as soon as the research is complete and no later than the two-cell stage.

68.     New paragraph 3(3) enables licences to be issued to create, keep and use inter-species embryos defined under new section 4A(5)(a) to (d) as inserted by clause 4 for the purposes of a project of research specified in the licence.

69.     Where regulations under section 4A(5)(e) provide for any other thing to be treated as an inter-species embryo, paragraph 3(5) provides a further regulation making power to allow such inter-species embryos to be created and kept and used for the purposes of a project of research.

70.     New paragraph 3(6) provides that no research licence can be granted unless the proposed use of embryos or inter-species embryos is necessary for the purposes of the research.

71.     New paragraphs 3(7), (9) and (10) of Schedule 2 to the 1990 Act deal with time limits and conditions applying to research licences.

Licences for storage (of inter-species embryos)

72.     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 Bill inserts new sub-paragraph (1A) into paragraph 2 of Schedule 2 to the 1990 Act allowing the storage of inter-species 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.

 
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