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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