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Select Committee on Science and Technology Fifth Report


2  Background

Regulation

THE HUMAN FERTILISATION AND EMBRYOLOGY (HFE) ACT 1990

11. The creation of the Human Fertilisation and Embryology (HFE) Act 1990 (hereafter known as the HFE Act) was stimulated by the report of the Committee of Inquiry into Human Fertilisation and Embryology which was chaired by Baroness Warnock and reported in 1984.[8] Warnock's Committee was set up by the Government following the birth of the first 'test tube' (in vitro fertilisation) baby in 1978 since it was considered that the new methods of assisting conception raised legal, social and ethical issues which needed to be addressed.[9]

12. The HFE Act was originally introduced to bring within regulation three aspects of assisted reproduction where there were ethical or patient issues to be addressed, namely:

  • the creation or use of embryos outside the body (i.e. in vitro fertilisation, hereafter known as IVF) ;
  • the use of donated eggs or sperm in treatment; and
  • the storage of embryos, sperm or eggs.

The Act also covered the use of human embryos in research. Since 1990, there have been significant developments both in medicine and science that have made it necessary to modify the original legislative scheme in this area. Most significantly, in 2001, regulations were introduced to extend the list of purposes for which such research could be licensed by the HFEA. Under these amendments, the use of human embryos for research was to be licensable not only for the essentially reproductive purposes as set out in the 1990 Act, but also for increasing knowledge about the development of embryos, increasing knowledge about serious disease, and enabling any such knowledge to be applied in developing treatments for serious disease. The 2001 provisions allowed for 'therapeutic cloning' i.e through cell nuclear replacement (CNR), the creation of an embryo by taking an egg (or oocyte) from which the nucleus had been removed, and replacing it with the nucleus of a donor cell (e.g. a human skin cell). Work such as this is designed to facilitate the production of stem cells from early-stage embryos which could be used to grow perfectly matched brain cells, blood, heart muscle and other tissue for treatment or repair in disease.[10] To date, the HFEA has awarded licences for therapeutic cloning via CNR to two UK research groups.[11]

13. Under the current law, research must relate to one or more of the following purposes:

  • to promote advances in the treatment of infertility;
  • to increase knowledge about the causes of congenital diseases;
  • to increase knowledge about the causes of miscarriage;
  • to enhance knowledge in the development of more effective contraception;
  • detection of genetic or chromosomal abnormalities before implantation;
  • to increase knowledge about the development of embryos;
  • to increase knowledge about serious disease; or
  • to enable any such knowledge to be applied in developing treatment for serious disease.[12]

14. There are strict limits on what the HFEA can licence. The legislation prohibits placing in a woman (a) a live embryo other than a human embryo, or (b) any live gamete other than human gametes. In addition, under the HFE Act, a licence cannot authorise:

i.  keeping or using an embryo after the appearance of the primitive streak;

ii.  placing an embryo in any animal;

iii.  keeping or using an embryo in any circumstances in which regulations prohibit its keeping or use; or

iv.  replacing a nucleus of a cell of an embryo with a nucleus taken from a cell of any person, embryo or subsequent development of an embryo.[13]

The primitive streak is taken to have appeared in an embryo not later than the end of the period of 14 days beginning with the day when the gametes are mixed, not counting any time during which the embryo is stored, interpreted as meaning that there is a prohibition on keeping an embryo for more than 14 days.[14] It is also of interest to note that reproductive cloning (placing in a woman a human embryo produced through methods other than fertilisation) is prohibited since this is illegal in the UK under the Human Reproductive Cloning Act which was passed in November 2001.[15]

15. The question of the creation of animal-human hybrid or chimera embryos is not addressed in the HFE Act, although the mixing of human and animal gametes is prohibited, with a provision to allow testing fertility of human sperm through fertilisation of a hamster egg (the 'hamster test'). Where an area of research practice does not fall within the scope of the HFE Act or other legislation, for example under the Home Office through the Animals (Scientific Procedures) Act 1986, the implication is that such research could be undertaken free from regulation.[16]

THE HUMAN FERTILISATION AND EMBRYOLOGY AUTHORITY (HFEA)

16. The HFEA, a statutory body and the first of its type in the world, was created in 1991 following the passing of the HFE Act in 1990. The recommendation for a regulatory body of this nature had also originally been made by the 1984 report of the Committee of Inquiry into Human Fertilisation and Embryology (the Warnock Report).[17] The HFEA regulates and monitors each of the clinics providing IVF, donor insemination and/or the storage of human ova, sperm or embryos in the UK. In addition, the HFEA is responsible for licensing and monitoring all UK human embryo research. [18]

17. The HFE Act requires centres undertaking research involving the creation and/or use of human embryos to first obtain a licence from the HFEA. Licences for the creation and use of human embryos for research are awarded by the HFEA after evaluation by an HFEA Research Licence Committee and peer review, initiated by the HFEA regulation department, to determine whether an application:

  • comes within the statutory requirements of the HFE Act;
  • requires human embryos to fulfil its aims and objectives;
  • requires the numbers and types of embryos described in the application; and
  • meets the requirements of the HFEA code of practice.

The HFEA has the power to grant research licences for up to three years for individual research projects.[19]

THE EFFECTIVENESS OF THE UK REGULATORY SYSTEM

18. The UK is recognised as a good example of how to develop workable regulation in this area of research. For example, Professor Anne McLaren of the Wellcome Trust Gurdon Institute has told us that the UK has a "sensible and scientifically-based regulatory system that has functioned with few major problems for the past 16 years".[20] From an international perspective, Professor Hui Z. Sheng of the Shanghai Jiao Tong University, School of Medicine, China, also supported the UK regulatory environment in this area of research. Professor Sheng told us that the UK is "currently a world leader not only in embryological research and cloning, but also in policy making in this field". She explained that the UK Government "has established an image to be able to balance scientific development and ethical issues with confidence and vision" and that "its regulatory policy in embryological research has provided a permissive but strictly regulated environment". Moreover, Professor Sheng believed that "UK policy has positively influenced the policy making in other countries, including China, Japan, USA et al".[21]

PUBLIC CONSULTATION ON REVIEW OF THE HFE ACT

19. The Government announced in 2004 that it intended to review the provisions of the Human Fertilisation and Embryology Act 1990 (the HFE Act), and in preparation, held a public consultation exercise which ran from 16 August to 25 November 2005. This posed a range of questions about how the law might be updated, including how it deals with issues such as embryo screening for inherited disorders, sex selection and possible future technologies such as artificial gametes. Specifically with relevance to this inquiry, the Government asked whether:

i.  there is a case at present for either an extension or a reduction to the 14-day time limit for keeping an embryo;[22]

ii.  research undertaken on embryos using the cell nuclear replacement technique for the purpose of studying mitochondrial diseases should be permissible in law, subject to licensing.[23]

In addition, the Government invited views on

i.  removing the current prohibition on "replacing a nucleus of a cell of an embryo with a nucleus taken from the cell of any person, another embryo or a subsequent development of an embryo" for research purposes, subject to licensing;[24]

ii.  whether the law should permit altering the genetic structure of an embryo for research purposes, subject to licensing;[25]

iii.  whether the law should permit the creation of human-animal hybrid or chimera embryos for research purposes only (subject to the limit of 14 days culture in vitro, after which the embryos would have to be destroyed);[26]

iv.  whether the current list of legitimate purposes for licensed research involving embryos remains appropriate;[27]

v.  whether the purposes for which research using embryos may legitimately be undertaken should, as now, be defined in law and research projects should continue to be approved by a national body in order to ensure compliance with the law, national consistency and appropriate ethical oversight;[28]

vi.  whether additional regulatory requirements should apply to the procurement and use of gametes for purposes of research;[29] and

vii.  on the desirability of allowing the creation of embryos for the treatment of serious diseases (as distinct from research into developing treatments for serious diseases which is already allowed).[30]

THE OUTCOME OF THE CONSULTATION

20. The White Paper which eventually resulted from the consultation and the review of the legislation covered many issues, but of central interest to this inquiry is the Government's response to the question of hybrid and chimera embryos. The Government stated that:

It therefore proposed that "revised legislation will clarify the extent to which the law and regulation applies to embryos combining human and animal material".[32] Moving on to what the policy should be towards such embryos, the review concluded that:

    The Government will propose that the creation of hybrid and chimera embryos in vitro, should not be allowed. However, the Government also proposes that the law will contain a power enabling regulations to set out circumstances in which the creation of hybrid and chimera embryos in vitro may in future be allowed under licence, for research purposes only.[33]

Stem cell research

21. Within this Report we discuss the creation of human and animal chimera or hybrid embryos for a number of purposes, a prime example of which is for the derivation of stem cells. Most cells found within adults are specialised cell types, for example, muscle, skin or hair. Stem cells, however, are unique in that they can both multiply to produce more stem cells and 'differentiate' into specialised cell types as they multiply. This ability makes stem cells potentially important for use in medicine as it opens up the possibility that these cells may be used to create any type of cell for use as a treatment to replace diseased and damaged cells. There are three broad categories of mammalian stem cells:

i.  Pluripotent stem cells. These can differentiate into the many cell types of the body. Embryonic stem cells, derived from the inner cell mass of blastocysts (see diagram 1) are the best known example. Embryonic stem cells are 'immortal', which means that they can be multiplied in the laboratory for many years to produce very large numbers of cells. These cells can also be directed to differentiate in vitro into clinically relevant cell types (e.g. for the heart muscle, nerve or skin). Embryonic stem cells, however, do not have the capacity to develop into a functional human embryo.

ii.  Tissue stem cells. These are found in adult tissues, for example, in the bone marrow where the adult stem cells differentiate to produce the many blood cell types e.g. red blood cells and white blood cells of the immune system such as lymphocytes. Adult stem cells are presently much less able to multiply, and are generally not able to differentiate into as many cell types as embryonic stem cells. In adult organisms, stem cells act as a repair and regeneration system for the body, replenishing specialized cells.

iii.  Cord blood stem cells, which are found in the umbilical cord.

22. As discussed above, embryonic stem cells may be obtained from blastocysts. The term 'blastocyst' refers to the human embryo approximately five days after fertilisation and is the stage of development that the embryo must reach before it can implant in the uterus. The structure of the blastocyst is more complex than earlier embryo stages because as well as increasing in cell number, the cells have become organised into two types: the trophectoderm, whose main role is in implantation into the uterine lining, and the inner cell mass which will give rise to the foetus itself, and from which embryonic stem cells may be derived. See Figure 1.

Figure 1: Schematic diagram to illustrate blastocyst formation. The diagram demonstrates cell division after fertilisation and through to the morula stage (in which 16 -32 cells are present) until the blastocyst is created. The stages of development depicted usually occur within the fallopian tubes. Blastocyst formation is required prior to implantation of the embryo within the uterus.



23. Currently, human embryonic stem cell lines are primarily derived from 'spare' human embryos under licence from the HFEA.[34] Under such licence, for example, researchers in the UK derive stem cells from human embryos screened out for implantation in a woman after pre-implantation genetic diagnosis (PGD). Such embryos include those which will not be implanted into a woman undergoing IVF since they may carry the genetic instructions responsible for causing diseases such as cystic fibrosis.[35] There is a high wastage rate. Most of the embryos used in attempts to derive stem cell lines will not yield results: according to Dr Lyle Armstrong at Newcastle University, "on average, 15% of embryos will give rise to a ESC [embryonic stem cell] line".[36] Other avenues for the production of human stem cells include through therapeutic cloning, and the HFEA has, to date, granted two licences to enable researchers to study the derivation of human embryonic stem cell lines using this method.[37]

24. Because of their ability to reproduce themselves, and to differentiate into other cell types, stem cells offer the prospect of developing cell-based therapy to treat a wide range of degenerative diseases, such as Parkinson's disease and muscular dystrophy.[38] Stem cell therapy may also be of use as a mechanism for repair or replacement of damaged tissues, and we heard from Cancer Research UK that future stem cell research could "uncover ways of improving outcomes after treatment for cancer, potentially providing us with the ability to regenerate or replace normal tissue following surgical removal of cancerous tissue, or its destruction by chemotherapy or radiotherapy".[39] Furthermore, as detailed by the House of Lords Select Committee on human cloning and stem cell research, "stem cell treatments, unlike most conventional drugs treatments, have the potential to become a life-long cure",[40] and stem cell research has been heralded by the UK Stem Cell Initiative as representing "a substantial opportunity for future innovation in the life sciences".[41]

Previous interest in the area

CHRONOLOGY OF RELEVANT REPORTS AND DEVELOPMENTS

25. There have been a number of reports and developments of interest to this inquiry. Some have been mentioned earlier but it may be helpful to set them out here in order to provide a chronology of developments. This illustrates how recent has been the growth of awareness of the potential of animal-human hybrid and chimera embryos for research purposes and of concern about this issue.

i.  Report of the Committee of Inquiry into human fertilisation and embryology (Cm 9314), 1984. The Warnock report. (See paragraph 11)

ii.  Human Fertilisation and Embryology: A Framework for Legislation (Cm 259). This White Paper, which was published in November 1987, preceded the HFE Act and indicated Government commitment to legislation in this area.

iii.   Human Fertilisation and Embryology Act 1990. The Act provided for regulation of the creation or use of embryos outside the body; the use of donated eggs or sperm in treatment; and the storage of embryos, sperm or eggs.

iv.  Stem Cell Research: Medical Progress with Responsibility. Sir Liam Donaldson chaired the report of this expert advisory group, commissioned to assess the anticipated benefits of research on stem cells and cell nuclear replacement and to advise whether further research uses of embryos should be permitted. Recommendations of the report included to extend the purposes of permissible research via affirmative regulations to those detailed in the subsequent 2001 revisions stated below. The report also recommended that "mixing of human adult (somatic) cells with the eggs of any animal species should not be permitted".[42]

v.  The Human Fertilisation and Embryology (Research Purposes) Regulations 2001. Extended the purposes for which research licences could be authorised namely: increasing knowledge about the development of embryos; increasing knowledge about serious disease; or enabling any such knowledge to be applied in developing treatments for serious disease (see paragraph 12).[43]

vi.  The Human Reproductive Cloning Act 2001. This Act created an offence of placing a human embryo in a woman other than created by fertilisation.[44]

vii.  House of Lords Select Committee report on Stem Cell Research (2002).[45] In direct reference to human embryos only, the Committee believed that "embryos should not be created specifically for research purposes unless there is a demonstrable and exceptional need which cannot be met by the use of surplus embryos".[46] The Committee also discussed the issue of animal-human hybrid and chimera embryos and took issue with the suggestion of Sir Liam Donaldson's expert group that there is a need for an outright ban on such research.[47]

viii.  House of Commons Science and Technology Select Committee report on Human Reproductive Technologies and the Law, 2005. [48] See below.

ix.  UK Stem Cell Initiative. Report and Recommendations. The UK Stem Cell Initiative was chaired by Sir John Pattison and reported in November 2005. In response to the report's recommendation that stem cell research needed sustained and increased funding, the Government increased its funding over the two year period 2006-07 to 2007-08 from £50 million to £100 million.[49]

x.  Government Consultation on the Review of the Human Fertilisation and Embryology Act. Launched in August 2005, the consultation posed a wide range of questions about how the law might be updated.[50]

xi.   Review of the Human Fertilisation and Embryology Act: Proposals for revised legislation (including establishment of the Regulatory Authority for Tissue and Embryos) (Cm 6989). December 2006.

PREVIOUS SCIENCE AND TECHNOLOGY SELECT COMMITTEE INTEREST

26. As indicated above, the House of Commons Science and Technology Select Committee reported on Human Reproductive Technologies and the Law in 2005. Within this report, and with respect to human-animal chimera and hybrids, the Committee recommended that new legislation was required to (a) define the nature of these creations, (b) make their creation legal for research purposes if they are destroyed in line with the current 14-day rule for human embryo cultures, and (c) prohibit their implantation in a woman.[51] In addition, the Committee was of the opinion that there was a need for "a new Parliamentary Standing Committee on Bioethics" to undertake annual scrutiny of the Regulatory Agency for Fertility and Tissues [the White Paper's proposed replacement of the current HFEA], make recommendations on the need to amend or introduce legislation and scrutinise draft legislation brought before Parliament.[52] These recommendations are the starting point for our current inquiry.


8   Department of Health and Social Security, Report of the Committee of Inquiry into Human Fertilisation and Embryology ("The Warnock Report"), Cm 9314, July 1984 Back

9   Ibid Back

10   "UK gives go-ahead for human cloning", New Scientist, 27 February 2002,http://www.newscientist.com/article.ns?id=dn1975 Back

11   Use of animal eggs in embryo research, http://www.hfea.gov.uk/cps/rde/xchg/SID-3F57D79B-949AF4FE/hfea/hs.xsl/377.html Back

12   The HFE Act was amended in 2001 through the Human Fertilisation and Embryology (Research Purposes) Regulations 2001 (SI 2001/188), www.opsi.gov.uk/SI/si2001/20010188.htm  Back

13   The Act specifies the replacement of an embryo's nucleus and therefore does not cover therapeutic cloning which uses an enucleated egg. Back

14   Human Fertilisation and Embryology Act 1990. Back

15   Human Reproductive Cloning Act 2001, www.opsi.gov.uk/acts/acts2001/20010023.htm Back

16   Ev 127 Back

17   Department of Health and Social Security, Report of the Committee of Inquiry into Human Fertilisation and Embryology ("The Warnock Report"), Cm 9314, July 1984 Back

18   What is the role of the HFEA, www.hfea.gov.uk/cps/rde/xchg/SID-3F57D79B-13B4CD03/hfea/hs.xsl/385.html#What_is_the_role_of_the_HFEA Back

19   How to apply for a research licence, www.hfea.gov.uk/cps/rde/xchg/SID-3F57D79B-E00DEEE7/hfea/hs.xsl/376.html Back

20   Ev 52 Back

21   Ev 148 Back

22   Department of Health, Review of the Human Fertilisation and Embryology Act: A Public Consultation, November 2005, Para 9.15, www.dh.gov.uk/en/Consultations/Closedconsultations/DH_4123863 Back

23   Ibid, para 9.22 Back

24   Ibid, para 9.23 Back

25   Ibid, para 9.28 Back

26   Ibid, para 9.35 Back

27   Department of Health, Review of the Human Fertilisation and Embryology Act: A Public Consultation, November 2005, Para 9.15, www.dh.gov.uk/en/Consultations/Closedconsultations/DH_4123863, para 9.38 Back

28   Ibid, para 9.41 Back

29   Department of Health, Review of the Human Fertilisation and Embryology Act: A Public Consultation, Para 9.45, www.dh.gov.uk/en/Consultations/Closedconsultations/DH_4123863  Back

30   Ibid, Para 9.47 Back

31   Department of Health, Review of the Human Fertilisation and Embryology Act: Proposals for revised legislation (including establishment of the Regulatory Authority for Tissue and Embryos), Cm 6989, December 2006, Para 2.82, www.hfea.gov.uk/cps/rde/xbcr/SID-3F57D79B-9E450A32/hfea/White_Paper_Dec_06_web_version.pdf Back

32   Ibid Back

33   Department of Health, Review of the Human Fertilisation and Embryology Act: Proposals for revised legislation (including establishment of the Regulatory Authority for Tissue and Embryos), Cm 6989, December 2006, Para 2.82, www.hfea.gov.uk/cps/rde/xbcr/SID-3F57D79B-9E450A32/hfea/White_Paper_Dec_06_web_version.pdf Back

34   The HFEA has, however, granted two licences to enable researchers to study the derivation of human embryonic stem cell lines using nuclear transfer (therapeutic cloning).Information is available from the HFEA website at: http://www.hfea.gov.uk/cps/rde/xchg/SID-3F57D79B-7821EC74/hfea/hs.xsl/377.html  Back

35   Ev 129 Back

36   Ev 79 Back

37   Use of animal eggs in embryo research, www.hfea.gov.uk/cps/rde/xchg/SID-3F57D79B-7821EC74/hfea/hs.xsl/377.html  Back

38   Ev 72 Back

39   Ev 102 Back

40   House of Lords, Stem Cell Research, First Report from the Select Committee on Stem Cell Research, Session 2001-02 HL Paper 83-i, www.parliament.the-stationery-office.co.uk/pa/ld200102/ldselect/ldstem/83/8301.htm Back

41   UK Stem Cell Initiative: Report and Recommendations, November 2005,
www.advisorybodies.doh.gov.uk/uksci/uksci-reportnov05.pdf 
Back

42   Department of Health,Stem Cell Research: Medical Progress with Responsibility, July 2000, www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_4065084 Back

43   www.opsi.gov.uk/SI/si2001/20010188.htm Back

44   www.opsi.gov.uk/acts/acts2001/20010023.htm Back

45   www.parliament.the-stationery-office.co.uk/pa/ld200102/ldselect/ldstem/83/8301.htm Back

46   HL Paper (Session 2001-02) 83-i, para 4.28 Back

47   House of Lords Select Committee report on Stem Cell Research (2002), Para 8.18 - 8.19 Back

48   House of Commons Select Committee on Science and Technology, Fifth Report of Session 2004-05, Human Reproductive Technologies and the Law,HC 7, para 67, http://www.publications.parliament.uk/pa/cm200405/cmselect/cmsctech/7/7i.pdf Back

49   UK Stem Cell Initiative: Report and Recommendations, November 2005,
www.advisorybodies.doh.gov.uk/uksci/uksci-reportnov05.pdf 
Back

50   Information on the consultation available at: http://www.dh.gov.uk/Consultations/ResponsesToConsultations/ResponsesToConsultationsDocumentSummary/fs/en?CONTENT_ID=4132358&chk=CnrKSR Back

51   HC (2004-05) 7, para 67, www.publications.parliament.uk/pa/cm200405/cmselect/cmsctech/7/7i.pdf Back

52   HC (2004-05) 7, para 399 Back


 
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