Select Committee on Science and Technology Fifth Report

Conclusions and recommendations

1.  While it has been argued that there have been many scientific developments and changes in social attitudes, the Warnock Committee's approach to the status of the embryo remains valuable. While this gradualist approach to the status of the embryo may cause difficulties in the drafting of legislation, we believe that it represents the most ethically sound and pragmatic solution and one which permits in vitro fertilisation and embryo research within certain constraints set out in legislation. (Paragraph 28)

2.  We accept that a society that is both multi-faith and largely secular, there is never going to be consensus on the level of protection accorded to the embryo or the role of the state in reproductive decision-making. There are no demonstrably "right" answers to the complex ethical, moral and political equations involved. We respect the views of all sides on these issues. We recognise the difficulty of achieving consensus between protagonists in opposing camps in this debate, for example the pro-life groups and those advocating an entirely libertarian approach to either assisted reproduction or research use of the embryo. We believe, however, that to be effective this Committee's conclusions should seek consensus, as far as it is possible to achieve. Given the rate of scientific change and the ethical dilemmas involved, we conclude, therefore, that we should adopt an approach consistent with the gradualist approach, of which the Warnock Committee is one important example. This does not mean that we will shy from criticism of regulation to date, where we believe it warranted. But it does mean that we accept that assisted reproduction and research involving the embryo of the human species both remain legitimate interests of the state. Reproductive and research freedoms must be balanced against the interests of society but alleged harms to society, too, should be based on evidence. (Paragraph 46)

3.  We do not see why the area human reproductive technologies should do anything other than proceed under a precautionary principle currently prevalent in scientific, research and clinical practise. This means - as specified in paragraph 46 above - that alleged harms to society or to patients need to be demonstrated before forward progress is unduly impeded. (Paragraph 47)

4.  We believe that the research on human embryos can be undertaken without compromising their special status but that this research should have proper ethical oversight as set out in Chapter 8 and 9. We further conclude that, where necessary, embryos can be created specifically for research purposes. (Paragraph 51)

5.  We are concerned that any legal definitions of the embryo based on the way it was created or its capabilities would either be open to legal challenge or fail to withstand technological advance. The attempt to define an embryo in the HFE Act has proved counter-productive, and we recommend that any future legislation should resist the temptation to redefine it. We consider that a better approach would be to define the forms of embryo that can be implanted and under what circumstances. Using this approach, only those forms of embryo specified by the legislation, such as those created by fertilisation, could be implanted in the womb and thereby used for reproductive purposes. Other forms of embryo would be regulated insofar as they are created and used for research purposes. (Paragraph 54)

6.  We see little value in regulating the use of an egg in the process of fertilisation. A unique genetic entity is only formed at the union of the male and female pronuclei and this seems the most appropriate point at which to bring the creation under the protection of legislation. (Paragraph 56)

7.  We have been told that the 14-day rule is an arbitrary cut off point. For many, even those who support assisted reproduction and embryo research, an extension to the 14-day rule would be unacceptable. We accept that there is no case at present for an extension, or indeed reduction. However, we believe that, if scientists or clinicians were able to provide convincing justification for any change, this should be determined by Parliament. (Paragraph 59)

8.   In considering the subject comprehensively we should not shy away from addressing difficult subjects which may widely be considered 'taboo'. In this instance, however, we have heard no evidence which would lead us to conclude that there is any merit in relaxing the HFE Act's prohibition on placing human embryos in an animal for research purposes. Should the government receive expert advice to the contrary, given the ethical issues involved, any such change should be a matter for Parliament and primary legislation. (Paragraph 63)

9.  The ethical status of hybrids and chimeras is complex. While there is revulsion in some quarters that such creations appear to blur the distinction between animals and humans, it could be argued that they are less human than, and therefore pose fewer ethical problems for research than fully human embryos. We recognise concerns that hybrids and chimeras could be used for reproductive purposes and recommend that new legislation a) defines the nature of these creations, b) makes their creation legal for research purposes if they are destroyed in line with the current 14-day rule for human embryo cultures, and c) prohibits their implantation in a woman. (Paragraph 67)

10.  We recognise that human reproductive cloning, if possible at all, is not currently safe and that no clinician could legitimately pursue it under existing professional regulation. In addition, we recognise that research in developing reproductive cloning would very likely involve experimentation that is highly unethical. Nonetheless, the patchy legislation around the world suggests that the research will take place somewhere and someone may be able to demonstrate a technique that is safe, effective and reliable. (Paragraph 70)

11.  Even if human reproductive cloning were shown to be safe, effective and reliable we would still have grave concerns about many of its applications . However, there are clear examples where the situation is not so clear cut and the ethical debate is highly complex. Professor Ian Wilmut has described a scenario in which the aims are therapeutic and no clone is created of an individual who has ever been born. If there is to be a total prohibition of any form of reproductive cloning, it is important that it is supported by principled arguments why such a technique should be banned even if it were shown to be safe, effective and reliable. Without such arguments, an indefinite absolute ban could not be considered rational. The Minister's refusal to enter into any discussion of reproductive cloning is not an encouraging starting point for an open-minded review of the adequacy of existing legislation. (Paragraph 72)

12.  As with cell nuclear replacement, the risks of implanting a split embryo are high, but a distinction needs to be made between safety of the treatment and the fundamental ethical principles. If embryo splitting for treatment purposes is to be prevented, as with reproductive cloning, this should be based on coherent ethical argument, such as the right not to be purposefully created with a specific genetic identity. (Paragraph 76)

13.  We regret that the use of parthenogenesis to derive stem cells was not considered by either the Donaldson report or the House of Lords Stem Research Committee. This gives the impression that inadequate consideration has been given to these ethical issues before research projects were licensed by the HFEA. Nevertheless, we are pleased that this line of research is possible under the current legislation as we take the view that parthenogenesis raises fewer ethical issues than creating an embryo created using CNR, provided that it is not cultured for longer than 14 days. (Paragraph 78)

14.  Regardless of whether cell nuclear replacement is undertaken on eggs or embryos for the purposes of research on mitochondrial diseases, the aim of the research is the same. Given that we permit experimentation on embryos to investigate heritable diseases, we see no need to distinguish between the techniques in law. (Paragraph 81)

15.  Effective and safe germline therapy to treat serious genetic diseases would result in reduced child mortality and morbidity and fewer abortions and destroyed embryos. (Paragraph 82)

16.  We conclude that the absolute prohibition on genetic modification of the pre-14 day human embryo be removed for research purposes and recommend that future legislation, while prohibiting the modification of chromosomal DNA for reproductive purposes, should provide for regulations to be made to relax this ban under tightly controlled circumstances if and when the technology is further advanced. (Paragraph 83)

17.  If the purpose of regulation in assisted reproduction is to protect patients, there is no justification for exempting GIFT and IUI with partner sperm from the legislative framework. However, given our acceptance of the position that the state should intervene only in carefully defined and justified circumstances, where there are specific harms, in reproductive decisions, the common law rules of consent are sufficient to protect patients in the face of these risks. It is consistent with our ethical approach that, rather than adding to the list of regulated fertility treatments, we should be decreasing the level of state intervention. We accept that GIFT and IUI pose similar risks to IVF, but we have already concluded that these risks lie within accepted legal boundaries on what people can consent to. We have not been persuaded, therefore, that regulation should demand anything more than that the highest technical standards are observed. (Paragraph 84)

18.   The risks to users and their offspring from an internet sperm donation service need to be established. There is a case for regulating such services to ensure their quality. It is not clear whether they would be covered by the EU Tissue Directive. If not, we conclude that revised legislation should ensure that such commercial services are subject to the highest technical and safety standards. We would also consider it anomalous if gamete donation that is undertaken in a clinical setting required identifying information to be held in a central database but did not if the donor and recipient were "introduced" over the internet. Our concern is to ensure that the safety and quality standards expected of all assisted reproduction technologies are equivalent. (Paragraph 86)

19.  We conclude that while it is appropriate that commercial services involving fresh gametes should be subject to regulation, this should not extend beyond seeking to ensure that there are as few anomalies as possible between different options for donor insemination. (Paragraph 89)

20.  Subject to their safety, we recognise that artificial gametes have potential to treat infertility and reduce the need for gamete donors. It is important that, in the use of any cell cultures for reproductive purposes, the original donors must be traceable and their informed consent obtained. (Paragraph 91)

21.  The requirement to consider whether a child born as a result of assisted reproduction needs a father is too open to interpretation and unjustifiably offensive to many. It is wrong for legislation to imply that unjustified discrimination against "unconventional families" is acceptable. (Paragraph 102)

22.   The State employs social services to protect children from harm. If it has reason to believe that children born as a result of assisted reproduction are at increased risk then healthcare professionals can alert social services at an early stage. Indeed, the law has declined to intervene to protect the welfare of a child not yet born, being satisfied that the foetus in utero cannot be made a ward of court, and that appropriate action could be taken if required following live birth. (Paragraph 104)

23.  The exclusive requirement to consider the welfare of the child for fertility treatments where fertilisation takes place outside the woman or involves donated sperm is illogical. If the legislation aims to regulate the treatment of infertility or subfertility then it should cover all forms of interventions. If it wishes to do both then this needs to be clearly stated and justified. (Paragraph 106)

24.  The welfare of the child provision discriminates against the infertile and some sections of society, is impossible to implement and is of questionable practical value in protecting the interests of children born as a result of assisted reproduction. We recognise that there will be difficult cases but these should be resolved by recourse to local clinical ethics committees. The welfare of the child provision has enabled the HFEA and clinics to make judgements that are more properly made by patients in consultation with their doctor. It should be abolished in its current from. The minimum threshold principle should apply but should specify that this threshold should be the risk of unpreventable and significant harm. Doctors should minimise the risks to any child conceived from treatment within the constraints of available knowledge but this should be encouraged through the promotion of good medical practice not legislation. (Paragraph 108)

25.  If ensuring that your child is less likely to face a debilitating disease in the course of their life can be termed eugenics, we have no problem with its use. State programmes that impose a genetic blueprint are another matter. They should be outlawed as part of any regulation of assisted reproduction. Use of the word eugenics must not be used as an emotive term of abuse to obscure rational debate. (Paragraph 117)

26.  It is possible to sex a child using ultrasound and seek a termination and if PGD reduces the demand for abortion then this is a good thing. While we recognise that abortion legislation recognises the right of the woman, our gradualist approach to the status of the embryo leads us to conclude that there is a mismatch between the protection afforded an embryo created in vitro before it is implanted and one at a later stage of development in a woman's uterus. (Paragraph 120)

27.  We have concerns about the criteria imposed by the HFEA. PGD is limited in that it can only be used to screen out disorders and thus it cannot be used to create "designer babies" . We see no reason why a regulator should seek to determine which disorders can be screened out using PGD. Nevertheless, clinical decisions should operate within clear boundaries set by Parliament and informed by ethical judgements. (Paragraph 125)

28.  We conclude that there are no compelling reasons for a statutory authority to make judgements on whether or not a family can seek preimplantation tissue typing, provided they fall within parameters set by Parliament. (Paragraph 130)

29.  The UK should carefully consider the current evidence there available now about such imbalances and harms before allowing blanket changes our laws and regulations on sex selection. (Paragraph 141)

30.  The onus should be on those who oppose sex selection for social reasons using PGD to show harm from its use. However, the use and destruction of embryos does raise ethical issues and there are grounds for caution. The issue requires greater analysis than has been afforded it by the HFEA and we urge greater efforts to establish the demographic impacts across all sectors of society and the implications for the creation and destruction of embryos in vitro before new legislation is introduced. On balance we find no adequate justification for prohibiting the use of sex selection for family balancing. (Paragraph 143)

31.  We recommend that the Government clarify the position relating to any financial obligations of donors before 1990. It would be regrettable if such donors did not come forward under the mistaken impression that they would become financially liable for the upbringing of children born as a result of an altruistic donation. (Paragraph 151)

32.  We have sympathy with the view that if children born following donor insemination have a right to know their genetic parents, donors have some the rights to non-identifying information about any children born as a result of their donation. We recommend that the Government address this anomaly in its review of the HFE Act. (Paragraph 152)

33.  We regret the Department's poor use of evidence in policy-making and its failure to commission and have published the necessary research underpinning its decision on the removal of donor anonymity. (Paragraph 155)

34.  Given the threat to donor supply, it would have been better to have attempted to conduct research on parental attitudes to secrecy in the context of anonymity versus identifiable donors before changing the system entirely to one where anonymity is ended. (Paragraph 158)

35.  While the arguments for and against changing the status of donors are complex, opinions seem to centre on the relative weight given to the pain of infertility and the welfare of the offspring. Despite this, most would agree that, in principle, openness is a good thing. The task is to promote as much openness as possible without sacrificing the availability of donated gametes. In our view the benefits from the removal of anonymity are not such that the change justifies the likely impact on the number of donors. We therefore favour a twin track approach. While patients and donors should be aware of the benefits of openness and the regulator should provide for those who wish to adopt this strategy. (Paragraph 159)

36.  We have been told that, the earlier the child is told that they were born from donor gametes the better, yet parents wishing to tell their child that he or she was born using donor gametes may wish to avoid telling them if they then are unable to know anything about the donor. We recommend that certain non-identifying information is available to the child so that they can request it upon being told by their legal parents that they were conceived using donor insemination. (Paragraph 160)

37.  In recognition of concerns about the supply of donors, the Department of Health has launched a PR campaign to recruit new donors. By the time revised legislation is placed before Parliament, data should be available that give an indication as to whether the removal of anonymity will have a long-lasting effect on the supply of donors. With this information, Parliament can decide to what extent the removal of anonymity is a price worth paying. (Paragraph 161)

38.  We look forward to the results of the HFEA's consultation on the remuneration of embryo and gamete donors. We are concerned that the HFEA should be placed in a position in which it is forced to make decisions that could provide an incentive or disincentive to donors. This is a political decision best left to Parliament . (Paragraph 163)

39.  While we believe that clinicians should adopt a more sympathetic attitude to infertility counselling, counsellors must work harder to develop an evidence base to support their practice. Only in this way can they hope or deserve to receive the respect of their clinical colleagues. We see no role for legislation or regulation in facilitating this process. (Paragraph 169)

40.  The HFEA is able to attach conditions to any licence that it awards and it could already use its existing licensing system to ensure that certain techniques were only used as part of a clinical trial. We recognise that powers to award a clinical trials licence might have advantages for the HFEA but we would be nervous about the creation of any further bureaucratic hurdle introduced to the setting up of clinical trials. (Paragraph 173)

41.  It is not appropriate that embryos donated for research should be used to train staff and it could be argued that the HFEA is acting illegally by awarding research licences in the knowledge that the primary purpose is training. Furthermore, training in the handling of embryos should not be limited to those centres that are undertaking research. Training staff to handle embryos for the purposes of providing treatment should be possible under treatment licences as long as it is made clear to donors of embryos what they will be used for. (Paragraph 174)

42.  The budget allocations for the 2004 Spending Review were published in March 2005 without any specific reference to stem cell research. We recognise that the Research Councils have no interest in investing in research teams if they have no interest in sustaining them in the medium term. However, we recommend that they monitor the success of applications in this area made in open competition and bid for ring-fenced funds in future Spending Reviews if funding in stem cell research projects declines (Paragraph 182)

43.  That the embryo only gradually acquires human rights is a widely accepted view. In this light, the maximum sentence of 10 years for breaching some of the prohibitions in the HFE Act seem unduly harsh. (Paragraph 184)

44.  The legal role of the person responsible is outdated. While the law did not confer liability on the person responsible for the misdemeanours of a member of staff, it still seems sensible to separate responsibility in respect of compliance with the HFE Act and compliance with technical standards. Standards would become the responsibility of the Trust Chief Executive (or equivalent in the private sector) while responsibility for compliance with the provisions of the HFE Act would be retained by a senior member of the clinic. (Paragraph 185)

45.  We agree that the regulator needs a wider range of sanctions but we are concerned that the emphasis is on penalty and not on improving standards and systems. The incompetent and the unethical needs to be closed down but the vast majority in the middle need to operate in a regulatory environment which encourages them to improve. There should be no deterrent to self-reporting. (Paragraph 187)

46.  The primary aim of healthcare regulation should be to protect patients. We believe that this can best be achieved by creating a culture in which good practice is encouraged rather than the focus being on penalising poor service. If individual practitioners have performed below acceptable standards, the professional regulators should act in a manner that protects patients. We recognise the Government's efforts to improve professional regulation through the creation of the Council of Healthcare Regulatory Excellence. While these changes need to "bed down", we welcome the commitment to strengthen regulation. (Paragraph 193)

47.  We share the widespread concerns about the extent of the scientific and clinical expertise of Authority members, but recognise that the principle of the lay majority is important and should not easily be discarded. We believe that ultimate authority on issues of public concern should lie outside of the scientific and medical communities. At the same time, it is important that any decisions are informed by the science and medicine. (Paragraph 199)

48.  We have sympathy with the view that those with principled opposition to assisted reproduction should be represented have been unreasonably excluded from a place at the principal forum for debates on assisted reproduction and embryo research. It cannot, however, be a simple matter of reworking the job description for Authority members, since the presence of those opposed to assisted reproduction and embryo research would change the very nature of the organisation. The representation of views needs to be considered as part of a thorough assessment of the regulatory and advisory structures operating in this field. The composition of the regulator must either be substantially reformed or mechanisms found to improve the range and quality of advice it receives. (Paragraph 208)

49.  We have heard that membership of the HFEA has so far been reserved for proponents of assisted reproduction and embryo research. It is therefore not surprising that its individual members would wish to see greater availability of licensable activities. Nevertheless, by promoting gamete donation in its corporate publications it has acted outside its statutory remit and crossed a boundary that risks compromising public trust. (Paragraph 217)

50.  It is reasonable for the Authority to draw attention to problematic areas in legislation, indeed it would be negligent if it were not to do so, but there is a clear distinction between drawing attention to problems and inconsistencies and espousing solutions. (Paragraph 218)

51.  We conclude that the HFEA could not have discharged its statutory duty without developing a policy-making function; nevertheless, any revised legislation should more clearly define the presence or absence of a policy-making role for the regulator. (Paragraph 219)

52.  The HFEA must be aware that many individuals and organisations will pore over its statements for evidence of misdeeds. It is unfortunate that it has provided so much ammunition to its critics. As the Science and Technology Committee, we are pleased that the HFEA sees the value of scientific research; however, we accept that it is not its role to encourage licensable embryo research, merely to consider whether applications that it receives conform to the wishes of Parliament. (Paragraph 221)

53.  It is right and proper that the HFEA should seek to update the protocols set out in the Code of Practice, which is, in effect, a rule book for centres licensed under the Act. The HFEA has not so far employed the internet to its full potential and we believe that its policy decisions should be consolidated in a single document as far as possible and as quickly as possible into a single digital entity. (Paragraph 226)

54.  Advocates of the role of the HFEA have argued that it has succeeded in maintaining public confidence in a highly contentious area. If this is the case, it is hard to see how this can be maintained if its inspection processes are attracting sustained criticism. (Paragraph 234)

55.  The EU Tissue Directive will provide a welcome impetus to improve and maintain the technical standards in treatment centres. However, we urge the Government and the HFEA to ensure that the standards applied are appropriate and proportionate (Paragraph 236)

56.  We welcome the HFEA's decision to appoint an in-house professional inspectorate. However, it is important that these inspectors have the confidence of the assisted reproduction community and we recommend that its views are taken into account before appointments are made. (Paragraph 238)

57.  It is unacceptable for the HFEA to attempt to withhold information relating to licence applications if it has no legal basis for doing so. Information relating to licence applications and licence committees should be made available on the internet as a matter of course. (Paragraph 240)

58.  There may have been good reasons why licence committees were unable to hear directly from the patients, but cases must be dealt with sensitively and without needlessly erected bureaucratic walls. We are pleased that the HFEA has decided to adopt a more open policy in the future. (Paragraph 241)

59.  We welcome the efforts that the HFEA has made to improve its research licensing procedures and we hope that these prove effective. However, we believe that there needs to be a thorough analysis of the process by which research involving embryos is approved so that we do not lose sight of what the process is trying to achieve. (Paragraph 243)

60.  The regulation of preimplantation testing is highly unsatisfactory. We recognise that the HFEA has legal jurisdiction but this does not mean that it has a duty to regulate its use beyond ensuring that it is performed to the highest standards within statutory boundaries. (Paragraph 245)

61.  The development of the HFEA's policy and licensing decisions on preimplantation tissue typing has been highly unsatisfactory. We share the Chair's contentment with its current policy and agree that revised legislation must make it clear that preimplantation genetic diagnosis and preimplantation tissue typing can be undertaken within legal restraints . (Paragraph 252)

62.  If the HFEA is to retain its current functions, it is important that it has access to the best relevant data to support its decision-making. While research is not defined as part of its remit as such, it should have the budget to fund small scale unlicensable academic studies. (Paragraph 255)

63.  The MRC Working Group contained a social researcher but the report gave little attention to the social impacts of assisted reproduction, despite being cited frequently in HFEA policy documents. We recommend that the HFEA ask the Economic and Social Research Council to set up a working group to look specifically at the social impacts of and attitudes to assisted reproduction . (Paragraph 256)

64.  The confidentiality provisions in the HFE Act have hampered efforts to establish the risks associated with assisted reproduction. We conclude that they are unnecessarily onerous and inconsistent with the widespread use of assisted reproductive technologies. We recommend that the data from the HFEA's register should be applied as far as is possible to research studies. (Paragraph 259)

65.  The confidentiality provisions in the HFE Act have hampered efforts to establish the risks associated with assisted reproduction. We conclude that they are unnecessarily onerous and inconsistent with the widespread use of assisted reproductive technologies. We recommend that the data from the HFEA's register should be applied as far as is possible to research studies. We have criticised the excessive use of the precautionary principle in assisted reproduction. However, we recognise that there are public concerns about possible adverse risks associated with assisted reproduction Treatment centres should, as a condition of their licence, maintain a database in a suitable form which is available for peer reviewed research projects. As result, there will be a justifiable burden on clinics. (Paragraph 264)

66.  While the value of the Register for research has been open to question, it should have been able to provide data on the uptake of IVF and donor insemination and success rates to inform policy development on assisted reproduction and its provision. However, in recent years these data have not been published, which is unfortunate. We consider it to be a fundamental role of a regulator to provide information about the industry it is regulating. (Paragraph 265)

67.  We take seriously the possible risks of assisted reproduction technologies. For this reason, we encourage research in this area, both to inform professional practice and in order that intending parents can be adequately and appropriately informed of any risk to which they are considering providing consent. (Paragraph 267)

68.  No-one wishes to expose patients and children to physical harm or psychosocial stresses, but all medical practice has inherent risks and the only solution is a rational approach to risk assessment and management, coupled with strategies to undertake and apply the results of medical, scientific and social research. (Paragraph 277)

69.  We welcome the setting up of an international Horizon Scanning Expert Panel as a positive step in improving the HFEA's use of evidence. We are unclear why there is not even one social researcher on the panel and urge the HFEA to rectify this. (Paragraph 278)

70.  By most standards, the safety of IVF lies within the boundaries of acceptability. Nevertheless, any risks must not be underplayed and patients should be made fully aware of them before treatment. We hope the Medical Research Council will look favourably on proposals to undertake national studies to establish the safety and effectiveness of assisted reproduction techniques. (Paragraph 279)

71.  We welcome the changes in the funding arrangements for the HFEA, which recognise that the HFEA, as presently constituted, has a wider duty to the public beyond its role as a regulator. (Paragraph 280)

72.  The principles of good regulation adopted by the Better Regulation Task Force are appropriate and valuable. We regret that in many areas the HFEA falls short of these ideals. We recognise that the HFEA has improved its performance but it has been stretched by too much poorly targeted regulation. This needs to be addressed by refocusing its efforts. We will discuss our solutions in Chapter 9. (Paragraph 291)

73.  We have heard concerns that some of the services being offered to patients in IVF clinics are not justified by evidence of their value. We believe that clinics, private and NHS, must make it clear when they are offering services and treatments that lie outside the NICE guidelines. Practitioners need to be aware that their patients are desperate for a child and vulnerable to exploitation. We recommend that the Healthcare Commission prioritise its activities in this area. (Paragraph 293)

74.  The issue to be resolved is not whether there should be league tables but how to ensure that the data are sound and provide useful information to patients. Not all of the factors that influence the success of IVF are clearly understood but we see an important role for the regulator in developing metrics. We welcome the HFEA's work on developing better comparators but it should resist publication of success rates for different clinics until it is satisfied that they are not misleading. (Paragraph 296)

75.  Despite being a pioneer in IVF, the UK lags behind many of its European neighbours in quality of the treatment it offers. We believe that, while regulation is not necessarily an appropriate tool to improve standards, the Healthcare Commission has a role in identifying the reasons why some other countries perform better than we do as a means of underpinning changes in UK practice. (Paragraph 298)

76.  We welcome the increased responsibility taken by professional bodies to draw up and maintain guidelines on clinical and laboratory standards. (Paragraph 300)

77.  We call on both Houses in the new Parliament to set up a joint committee to consider the scientific, medical and social changes in relation to abortion that have taken place since 1967, with a view to presenting options for new legislation. This committee should be broadly based and should include nominees from the Commons Select Committees for Science and Technology and Health and the Lords Science and Technology Committee. (Paragraph 309)

78.  We recommend that any new legislation introduced to amend the HFE Act should not include abortion, which should be dealt with in a separate Bill. (Paragraph 310)

79.  We recommend that the Department includes with its review of the HFE Act an assessment of surrogacy arrangements. This should use the Brazier Report as a starting point and consider what developments there have been since 1998. We regret the Government's inaction. Consideration should be given to introducing separate legislation covering surrogacy. (Paragraph 313)

80.  We recommend that the Government publish any revised Bill on assisted reproduction and embryo research in draft. We recommend that this Bill, and any new Abortion Act, be subject to pre-legislative scrutiny. (Paragraph 314)

81.  We recommend that the Parliamentary parties should give a clear undertaking that Members will be given a free vote on any new legislation concerning assisted reproduction and embryo research. (Paragraph 315)

82.  In our view, Parliament's ability to revisit contentious issues relating to the creation of new life and the permissible uses of human embryos is vital. We recommend that new legislation is more explicit and provides Parliament with greater powers to debate and amend legislation. We propose mechanisms for achieving this in Chapter 9. (Paragraph 316)

83.  We recognise that there need to be some prohibitions on research in law, as we set out in Chapter 9, but we think there is much merit in a system of local oversight to provide faster, more proportionate, oversight of research on human embryos (Paragraph 342)

84.  There are merits in the creation of a nationally coordinated network of clinical ethics committees to parallel the arrangement for local research ethics committees. Should the evaluation of these committees demonstrate their value, they should be provided with national guidelines for their conduct in the area of assisted reproduction but their decisions should be directed needs of patients and the families and the concerns of health care professionals. (Paragraph 346)

85.  We believe that the Government is correct that smaller advisory committees with specific briefs would be more effective. Nevertheless, we favour the rationalisation of these committees where there is clear overlap and human genetics and embryology fall into this category. We recommend the formation of a single commission to develop policy issues relating to the assisted reproduction, embryo research and human genetics. (Paragraph 353)

86.  Any national policy-making committee should not attempt to interfere with individual clinical decisions. If the value of local clinical ethics committees can be established, they should be given a defined brief that clearly distinguishes their role from the Commission, which should issue guidelines for their operation . (Paragraph 355)

87.  We remain convinced that a larger role for our democratically accountable Parliament would give the public greater confidence that the big ethical issues of the day are being given adequate attention. (Paragraph 357)

88.  There is sufficient overlap between the policy and advisory functions of the HFEA and the Human Genetics Commission to provide a strong case for merger. (Paragraph 366)

89.  We see great merits in the professional bodies taking control of the technical and management standards and welcome the offer of the Royal College of Obstetricians to take responsibility under the auspices of the regulator in drawing up and maintaining these standards for centres concerned with the provision of storage or treatment services in compliance with the EU Tissue Directive. (Paragraph 369)

90.  If the regulator can be assured that external forms of accreditation such as ISO 9001 comply with legislation following the transposition of the EU Directive into UK law, then such accredited facilities should be free to operate without additional scrutiny. (Paragraph 370)

91.  The creation of the Regulatory Authority for Fertility and Tissue seems to be the result of political pressure to be seen to be reducing bureaucracy rather than a logical move . Nevertheless, we share the Department's wish to see fewer appendages to central Government and recognise that the merger of the regulatory functions of the HFEA and the HTA has its merits as long as its implementation recognises that there are big differences in the activities they regulate, as well as similarities. However, its activities should be restricted to the oversight of assisted reproduction to technical standards and quality management. (Paragraph 377)

92.  We have recommended that the confidentiality provisions in the HFE Act need to be relaxed. This should be accompanied by efforts to use UK data to inform the international monitoring of the risks of assisted reproduction. (Paragraph 380)

93.  We see major advantages in creating international standards in the handling and export of human gametes and embryos to improve the consistency and quality of procedures, protect those at risk of exploitation and improve the monitoring of treatments and risks. (Paragraph 382)

94.  We believe that any attempts to curtail reproductive tourism would not be justified by the seriousness of the offence. Moreover, it would be impossible to enforce if the treatment was legal in the country concerned. Nevertheless, anyone considering such a course of action should be aware of any risks involved. It would be inappropriate for the HFEA to encourage patients to go overseas for treatments that were either prohibited or prevented in the UK; however, we consider the HFEA's guidance to be misleading and complacent. We recommend that it provide more detailed guidance on treatment overseas based on evidence not on prejudice. (Paragraph 386)

95.  Charters, declarations and treaties no doubt keep diplomats busy and fulfilled but there are some ethical issues which are the domain of nation states and cultures. We should respect the cultures and desires of others and not seek to impose our own ideas. Such charters can only produce vague, lowest common-denominator agreements that are of questionable clarity and dubious effectiveness. Further attempts should be resisted until legislation and regulation are more widespread and the common threads can be identified. (Paragraph 388)

96.  The Government claims that our regulation of assisted reproduction is highly regarded with little substance to support this view, which betrays a worrying complacency. We recommend that the Government, as a first step in its review of the HFE Act, conduct a review of regulatory models overseas and their effectiveness in maintaining public confidence, protecting patients and promoting safe and effective treatment. Given that the Progress Educational Trust has made a start, it would be well placed to continue this work, with appropriate funding, on behalf of the Department of Health (Paragraph 390)

97.  We have argued that there should be balance between the freedom of individuals to make their own reproductive choices and the legitimate interests of the state, but that any intervention into reproductive choice must have a sound ethical basis and also take into account evidence of harm to children or to society. We propose that the current regulatory model, which provides the HFEA with a large amount of policy-making flexibility, should be replaced with a system which devolves clinical decision-making and technical standards down to patients and professionals while at the same time strengthening Parliamentary and ethical oversight. This system has three strands: a dedicated Government regulator to ensure high standards of treatment; professional regulation to ensure the highest level of conduct by practitioners; and a system of ethical oversight. (Paragraph 391)

98.  Legislation should reflect the fact that assisted reproduction is now a standard clinical procedure and its focus should be on improving clinical standards and ensuring safety. Intending parents should be able to seek appropriate services, subject to the professional regulation of safety and quality. This would ensure that reproductive decisions remain primarily in the private domain, governed by professional ethics and the law of consent. However, legislation will be needed to offer appropriate protection for the human embryo and to accommodate status and other legal issues. (Paragraph 392)

99.  The legislation will not define the embryo, although it will not come under the protection of the law until it has reached the two cell stage after around 36 hours. It will introduce a definition of gamete to encompass all haploid human cells but a distinction will be made between mature gametes on one hand and immature and artificial gametes on the other. Only embryos created through the union of human sperm and egg can be implanted in a woman, unless otherwise specified. Embryos formed by any process identified in the legislation must be destroyed at a specified stage of development if they are not implanted in a woman. This stage should be set at 14 days but this should be capable of amendment by Parliament. Research on any embryo containing human chromosomal material is permissible up until the specified stage of development if it has received approval from a local research ethics committee and—where appropriate—peer review from a public research funding agency. (Paragraph 393)

100.  Legislation will create the Regulatory Agency for Fertility and Tissues funded by fees from accredited facilities. It would have an advisory body drawn from the relevant professional bodies. The Agency will:

a)  Ensure that clinics using procedures covered by the Act are appropriately accredited, through the use of an in-house inspectorate or recognised external accreditation bodies;

b)  Regulate gamete and embryo donation and donation services, including the maintenance of a national database;

c)  Set maximum limits for multiple pregnancies for treatment centres using procedures falling within the legislation; (Paragraph 395.c))

d)  Collect and analyse outcome data;

e)  Validate new materials or processes for the handling or embryos of gametes;

f)  Provide information to patients, including the cost of treatment. It could intervene to ensure that patients were not charged excessive costs by private clinics;

g)   Ensure that research proposals have received adequate ethical and scientific review and publish a lay summary of all approved research projects covered by the legislation;

h)  Be supported by an advisory body for technical standards under the auspices of the Royal College of Obstetricians and Gynaecologists and the Royal College of Pathologists.

i)  Undertake the role currently envisaged for the Human Tissue Authority. There should be provision for secondary legislation to bring regulation of non-reproductive tissues into line with that for assisted reproduction and embryo research in consultation with relevant professional bodies and accreditation services. (Paragraph 395.)

101.  Professional bodies under the auspices of the Royal College of Obstetricians and Gynaecologists would draw up technical standards for clinics offering assisted reproduction and undertaking embryo research as a basis for accreditation. The guidelines should set out how assisted reproduction techniques should be undertaken but would not specify what those techniques would be used for. These standards should be consistent with the EU Tissue and Cells Directive (Paragraph 396)

102.  We have argued for greater Parliamentary oversight over issues relating to assisted reproduction and embryo research. To achieve this we propose a new Parliamentary Standing Committee on Bioethics. This would undertake annual scrutiny of the Regulatory Agency for Fertility and Tissues, make recommendations on the need to amend or introduce legislation and scrutinise draft legislation brought before Parliament within its remit. (Paragraph 399)

103.  We propose the creation of a new Human Genetics, Fertility and Tissue Commission would expand the remit of the Human Genetics Commission to include the issues currently the domain of the HFEA and the relevant areas from the Human Tissue Authority. The bodies would provide advice and recommendations on issues which it considered that there were societal implications, such as selection for social reasons and preimplantation tissue typing, but would not provide clinical guidance. It would be informed by public consultations and could commission social science research. (Paragraph 400)

104.  Embryo research would need to be undertaken in an accredited facility, have been scrutinised by a local or regional research ethics committee, which would ensure that adequate consent had been sought from donors, and have been scientifically peer reviewed. (Paragraph 401)

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