APPENDIX 12
Memorandum from the British Medical Association
EXECUTIVE SUMMARY
The general view of the British Medical Association
is that the regulatory system established by the Human Fertilisation
and Embryology Act has worked effectively and has enabled the
UK to be a world-leader on issues around reproductive technology.
The regulatory framework provides the flexibility for the Human
Fertilisation and Embryology Authority to respond to new challenges
and technological developments as and when they arise. Assisted
reproduction is a topic on which most people hold strong views,
and those views frequently conflict. It is perhaps not surprising,
therefore, that some the HFEA's decisions have been controversial
and have not been universally accepted—particularly on matters
of public policy. The views of the HFEA are usually close to the
BMA's own views although there have been occasions when different
conclusions have been reached. On the whole, however, the BMA
considers that the HFEA provides a good model for regulation in
the area of medical practice.
There have been a number of developments over
the last 14 years, in the law, professional guidance and in societal
values and expectations. The time has now come to review the legislation,
to update it and to gain formal backing, both from Parliament
and the public, for the way in which the HFEA has interpreted
the legislation. In the BMA's view this does not require and should
not involve major changes to the legislation. Rather some small
amendments to the legislation would be helpful to consolidate
the current position and to ensure that the parameters within
which the HFEA has discretion to make decisions in the future,
are appropriately defined.
GENERAL PRINCIPLES
1. If the Act is to be amended, the BMA
would like to see some consideration given to the possibility
of including some broad guiding principles, to set the framework
within which decisions should be made. This mechanism has been
used to good effect in the Adults with Incapacity (Scotland) Act
2000 and has been recommended by the pre-legislative scrutiny
committee for inclusion in the forthcoming Mental Capacity Bill.
There are already certain principles implicit in the legislation
and in its implementation by the HFEA. These include:
— the "special status" of
the embryo, which is afforded some respect but not absolute protection;
— the need to take account of the welfare
of any child that might be born as a result of the treatment;
— that access to treatment should be
based on individual assessment of each case rather than applying
blanket restrictions to certain categories of people;
— the need for the use of embryos for
research to be justified; and
— assisted reproductive techniques
should not be used for "frivolous" reasons.
These principles could be set out explicitly
both to clarify broadly the approach taken by the legislation
and to guide the HFEA in making decisions in individual cases.
DEFINITIONS
2. Any review of the legislation needs to
take account of the rapid advances in scientific research, which
could require changing definitions of "gamete" and "embryo".
For example, in the future it may be possible to create gametes
from stem cells. It would also be helpful to broaden the definition
of "embryo" in the Act to state explicitly that this
includes an embryo created by cell nuclear replacement.
SCOPE OF
LICENSABLE ACTIVITIES
3. Under the 1990 Act there are clear criteria
for licensable activities namely:
— The creation and use of human embryos
in vitro.
— The storage of gametes and embryos.
— The use of donated sperm, oocytes
or embryos.
Despite the fact that these forms of assisted
reproduction are now considered standard medical procedures, the
BMA believes there are still good arguments for maintaining the
current level of regulation. The creation and, in some cases,
the destruction of human life in vitro continues to be
a highly emotive issue, primarily because of the "special
status" afforded to the embryo. Although not considered to
be morally equivalent to a person, embryos are equally not considered
to be the same as other tissue, which may be used for research
with only limited oversight. The BMA therefore believes it is
entirely appropriate that the creation and use of embryos outside
the body should be carefully monitored and controlled. Regulation
also reassures the public that scientists do not have unlimited
freedom and that any research involving human embryos needs to
be justified and individually licensed. Although technically routine
procedures, the use of donated gametes and embryos in treatment
also raise particular sensitivities and concerns about the welfare
of the children born.
4. With assisted reproduction more generally
there are concerns about the possibility of abuse and exploitation
of those people needing treatment, who may be vulnerable to unscrupulous
clinics that lack the necessary skills and expertise to provide
a safe and effective treatment service. There are also concerns
that some clinics might choose to cross the boundaries of what,
as a society, we consider to be acceptable practice. Since much
fertility treatment is provided in the private sector, bodies
such as the National Institute for Clinical Excellence and the
National Patient Safety Agency are not able to provide the protection
needed. Through its regulatory mechanism the HFEA provides reassurance
to the public generally and safeguards for those who are seeking
treatment. The BMA considers this to be an important role that
should continue.
5. The HFEA's 2003 report on sex selection
recommended that sperm sorting by flow cytometry should also be
brought within the HFEA's licensing powers because of a "theoretical
risk to health with the use of the technique". This clearly
leaves open the possibility of extending the licensing role of
the HFEA to incorporate a range of additional treatments including
GIFT (gamete intra-fallopian transfer) and ovulation induction
both of which have been associated with high order multiple births
and expose the mother and the children to an element of risk.
The BMA believes, however, that a "theoretical risk to health"
is not an appropriate level at which to set the requirement for
licensing since this would encapsulate vast areas of medical practice
that do not raise the type of sensitivities referred to above.
6. The licensing of treatments is an onerous,
time-consuming and costly task both for the HFEA and the clinics
concerned. Although there are direct benefits to patients, in
terms of providing safeguards, there are also practical drawbacks
including the cost of the licence fee (which is passed on to patients)
and the requirement for centralised data collection. For many
people, regulation in this area is also perceived as encroaching
on individuals' reproductive freedom by imposing state intervention
in what is, essentially, a private matter. The BMA believes that
any addition to the scope of licensable activities must be justified
and shown to be proportionate in relation to the level of risk
involved or the possibility of abuse or harm. The BMA is not convinced,
at the current time, that there are good arguments for extending
the scope of licensable activities.
7. Some changes are likely be needed to
the role of the HFEA, however, in order to implement the EU Human
Tissues Directive which will require a "competent authority"
to oversee any use of gametes in treatment. The HFEA appears to
be the most appropriate body to take on this task but the BMA
does not believe that this task needs to be undertaken at the
same level as the current licensing activities. Rather the HFEA
could take on more of a guidance and oversight role for current
non-licensable activities. The BMA does not believe that these
activities should be subject to criminal sanctions. The way in
which this works in practice will, of course, depend on the interpretation
of the wording of the Directive.
8. In addition to complying with the EU
Directive, giving the HFEA more of an oversight and guidance role
in relation to other uses of gametes would also provide reassurance
to the public about the safety and efficacy of new procedures
without necessarily extending the full regulatory mechanism. If
a clinic wanted to carry out a new procedure intended to improve
sperm motility before artificial insemination (such as when it
was first suggested that Pentoxifylline—a caffeine analogue—could
be added to sperm samples, for example) this would be covered
by the Directive. We envisage that the competent authority could
review the research to assess safety and efficacy before advising
whether sperm that had been subjected to such procedures should
be used in treatment.
RANGE OF
LICENCES ISSUED
9. The HFEA currently has the authority
to issue three types of licence: treatment, research and storage.
There may also be some scope for a "clinical research"
licence to cover the initial use of a new procedure in clinical
practice, such as the use of frozen-thawed oocytes in treatment.
This would enable the HFEA to authorise a limited number of procedures
with specific requirements for monitoring and feedback. A research
licence is inappropriate in such cases because embryos that are
subject to research cannot be replaced. A treatment licence does
not give as much scope for limiting treatment or monitoring and
reviewing its outcome as could be included in a clinical research
licence.
EMBRYO RESEARCH
10. The BMA has had policy supporting carefully
controlled research involving embryos since 1985 and believes
it is essential that this research continues and continues to
be subject to statutory regulation.
11. In the mid-1980s there was extensive
debate within the BMA about the creation of embryos for research
purposes. Despite some concerns it was recognised that there are
some areas of research in which embryos must be created as an
intrinsic part of the research process. For example, when new
methods of infertility treatment are being developed (such as
intracytoplasmic sperm injection—ICSI), it is an essential
part of the research carefully to assess the effect of the treatment
on the development of the embryo, to ensure that the embryo itself
is not damaged. Failure to allow this type of research would have
resulted either in embryos created in this way being replaced
without proper checks on their safety or an end to the development
of such new treatments for infertility. The BMA therefore refused
to rule out the possibility of embryos being created for this
purpose although it also stressed that the "prime objectives"
of IVF concerned the provision of infertility treatment.
WELFARE OF
THE CHILD
12. The BMA supports the requirement for
clinics to take account of the welfare of the child before providing
treatment and believes that this general provision should be retained.
Although there has been some argument against this requirement
and some problems with interpretation, the BMA has taken the view
that such assessments are useful but should be undertaken fairly
and without prejudice. The vast majority of those seeking assisted
reproduction are ordinary people who are simply unable to conceive
without assistance, rather than the type of cases that might legitimately
raise concerns such as where previous children have been taken
into care. The assessments should seek to identify those few cases
in which a future child is at clear risk of serious harm, rather
than seeking to restrict treatment to couples who conform to some
traditional notion of an "ideal" family set up.
13. The need to take account of the "need
of . . . [the] child for a father" was included in the Act
following an unsuccessful attempt in Parliament to restrict treatment
to married couples. The BMA agrees that the general needs of the
child should be considered but has consistently rejected the idea
of applying inflexible rules on access to fertility treatment
believing instead that each application should be considered on
its merits. Assessments should be made on the individual factors
in each case rather than according to blanket restrictions applied
to certain categories of people. The research undertaken by Professor
Golombok's team at City University shows that it is the quality
of parenting that affects the psychological development of the
child and parent-child relationship, rather than the gender or
sexuality of the parents. In practice the requirement to take
account of the child's need for a father does not prevent single
women or lesbian couples from receiving treatment. It has, however,
been used to refuse treatment either to individual women or through
a clinic's policy. Given that the BMA does not believe that treatment
should be restricted in the way the requirement intended, and
the risk that it could be used in a discriminatory manner, the
BMA would be happy to see this notion subsumed into the wider
concept of the child's general welfare.
CONSENT PROVISIONS
14. The BMA supports the requirement for
written consent in the HFE Act and believes that the consent of
both parties should continue to be required for the use of embryos
for treatment, research or donation.
15. Under the Act the consent of both parties
is also required for storage and, if one of the parties withdraws
consent, the embryos must be removed from storage and allowed
to perish. The BMA believes, as recommended by the Warnock Committee
and the White Paper, that the consent of both parties should be
required for the destruction of stored embryos. If agreement
cannot be reached about their use or destruction, the embryos
should remain in storage until the end of the statutory storage
period (five years) whereupon they should be allowed to perish.
In a case such as that of Natallie Evans, for example, continued
storage for a time-limited period would allow a "cooling
off period" after the breakdown of the relationship. This
would give time for reflection after the initial break-up during
which it might be possible, in some cases, for the parties to
reach agreement. A man who did not wish to have a child with his
ex-partner might, for example, be willing to allow his partner
to use the embryos, by varying his consent to become a "donor".
This would allow the embryos to be used without him having any
legal or financial responsibility for the resulting child.
16. The BMA also supports the recommendations
in the 1998 McLean review that:
— The requirement for written consent
should be extended to all forms of fertility treatment undertaken
in licensed clinics. This would ensure clarity about whether a
man and a woman are being "treated together" for the
purposes of the Act and also give certainty about the scope of
the consent.
— Where an individual is incompetent
and is expected to regain competence but will be left infertile,
the HFEA should be able to authorise the storage of any gametes
removed, until the patient is able to make a decision about continued
storage and use or until the statutory storage period has expired
(five years). If the patient dies, the gametes should be allowed
to perish.
— The HFEA should not be permitted
to authorise the export of gametes that have been unlawfully obtained.
DONATION OF
GAMETES
17. In 1991 the HFEA issued directions permitting
payment of up to £15 plus reasonable expenses, or "treatment
services" in return for gamete donation. In practice, women
are generally not paid for egg donation but many receive treatment
services in the form of free or reduced price IVF treatment. Egg
sharing (where half of a woman's eggs are given away and half
are used for her own treatment) is permitted subject to HFEA guidelines.
Egg giving (where all of a woman's eggs are given away in the
first cycle and she keeps all of the eggs from her second cycle)
is now prohibited by the HFEA. The BMA is opposed to all payment
for gamete and embryo donation—believing that donation should
be a gift freely given as with blood and organs. In relation to
egg sharing, the BMA also has concerns about the validity of the
consent obtained where there is such a large incentive—receiving
treatment services worth a few thousand pounds—for the woman
to consent. (The incentive would, however, be reduced for many
people if there was greater availability of IVF treatment within
the NHS as recommended by NICE.) The HFEA announced in 1993 and
1996 that it intended to phase out payment to donors in the longer
term but this policy was reversed in 1998. The BMA would like
to see all payment for donation restricted to only legitimate
expenses and so would like to see the provision for directions
removed from section 12(e). This is consistent with the current
position on payment for blood and organs and the recommendations
of the Brazier review group on surrogacy.
18. Donor anonymity is a difficult issue,
which is explored in some detail on pages 285-291 of Medical
Ethics Today. On this issue the BMA's Medical Ethics Committee
and its Representative Body reached opposing conclusions. The
ethics committee considered that, on balance, the interests of
the children born following donation to have access to information
about their genetic heritage should take precedence. The Representative
Body, on the other hand, was concerned about the effect on the
number of donors available and on parents' willingness to inform
their children that they were conceived using donated gametes.
The BMA's current policy therefore is to support continued anonymity
although this issue may be debated again at our annual meeting
in June.
19. Since the use of ICSI (intracytoplastic
sperm injection) has become widespread, demand for donor sperm
has dropped considerably and so the impact of removing anonymity
from sperm donors is likely to be lower than would previously
have been the case. The more problematic area is likely to be
donor eggs, which are already in short supply. Many women who
donate eggs currently do so as part of an egg sharing scheme and
it is not known whether removal of anonymity will have any effect
on their willingness to donate. The fact that the potential donor
may not herself get pregnant may have an impact on her willingness
to donate if anonymity is removed. Despite these practical differences,
the BMA believes that the same rules should apply to both male
and female donors.
20. The BMA believes very strongly that
the assurances given to past donors about anonymity (in section
31(5) of the Act) must be respected and any change in practice
about anonymity must not apply retrospectively. In such cases,
the donor's right to privacy and respect for the basis on which
the consent was given, outweigh any interest the people born following
donation have in knowing their genetic origins. This situation
is fundamentally different from the situation with adoption where
changes were made retrospectively since, in the light of what
happened with adoption, the Government gave an explicit promise
to donors that no changes would apply retrospectively and people
offered to donate on that basis.
21. UK DonorLink has been established to
facilitate the voluntary exchange of information and contact between
donors and those conceived following donor insemination before
1991. The BMA would like to see a similar voluntary system established
for conceptions since 1991 and is pleased to see that provision
is made for this in the draft Human Fertilisation and Embryology
Authority (Disclosure of Donor Information) Regulations 2004.
SURROGACY
22. The BMA supports the recommendations
made by the Brazier Committee in 1998 that:
— payment to surrogate mothers should
be restricted to legitimate and documented expenses—including
loss of earnings;
— any payment over and above legitimate
expenses would result in ineligibility for parental orders;
— surrogacy agencies should be registered
by the Department of Health; and
— a code of practice should be drawn
up setting out good practice for surrogacy arrangements and this
should be binding on all agencies.
Although the committee recommended a new Surrogacy
Act to consolidate legislation in this area, given the shortage
of Parliamentary time the BMA would support these provisions being
included in any amendment to the HFE Act.
NEW DEVELOPMENTS
23. The BMA is generally supportive of the
way in which the HFEA approaches new developments, although it
has not always agreed with the decisions reached (see below).
The BMA's general approach is to balance the likely benefits and
harms of new developments with an overarching principle that advances
in reproductive technology, particularly those that involve the
creation or use of human embryos, should not be used for "frivolous
reasons". The BMA takes the view that bodies like the HFEA
(and the BMA itself) should take account of societal opinions
but that their role is not simply to reflect those views in its
policy decisions. Rather their aim should be to promote and facilitate
informed debate and, in some cases to lead and shape public opinion.
EMBRYONIC STEM
CELL RESEARCH
24. The BMA supported the Regulations extending
the purposes for which embryos may be used in research, to enable
research into the development of embryonic stem cells.
25. The BMA recognises that the development
of tissue for transplantation using stem cells has the potential
to benefit vast numbers of people who suffer from disorders that
threaten or impede their lives. It could potentially offer a means
of overcoming the severe shortage of tissue available for transplantation
and by using tissue generated from the patient's own genetic material,
the need to take strong immuno-suppressive drugs could be avoided.
Research indicates that embryonic stem cells could be stimulated
to develop into whatever tissue was needed by the patient, such
as:
— neural tissue for the treatment of
degenerative diseases such as Parkinson's disease;
— bone marrow for leukaemia sufferers;
— muscle tissue for the repair of a
damaged heart; or
— skin for treating burns victims.
26. Given the BMA's long-standing support
for embryo research, the BMA believes that there were very strong
grounds for extending the areas of research that should be permitted,
to offer the greatest hope to people who suffer from life-threatening
and very debilitating conditions.
27. In all of its communication on this
subject, however, the BMA has made clear that if a similar level
of success could be achieved using adult, rather than embryonic,
stem cells this would be preferable because of the special status
afforded to human embryos. However, at this stage the research
suggests that there are likely to be limitations to the type of
tissues that can be derived from adult stem cells, thus limiting
the potential benefits. The BMA has argued that, until such time
as there is clear evidence of the safety and efficacy of the use
of adult stem cells, research using both adult and embryonic stem
cells should progress in parallel.
28. The BMA has also supported the creation
of embryos by cell nuclear replacement (so-called "therapeutic
cloning") but only where that is a necessary part of the
research project that has been approved by the HFEA as meeting
the necessary criteria for embryo research and on the strict condition
that CNR embryos are never implanted. (Replacement of CNR embryos
would, in any case, be illegal under the Human Reproductive Cloning
Act 2001.)
PGD AND TISSUE
TYPE COMPATIBILITY
29. The BMA supported the HFEA's decision
to licence the use of PGD combined with tissue typing for the
Hashmis. The Hashmis wished to avoid the birth of another child
with beta thalassaemia and also to select the embryo that would
be the most likely to produce a child who would be a compatible
donor for their three-year-old son. This would allow stem cells
from umbilical cord blood to be used in treatment. The BMA went
further than the HFEA and also expressed support for the Whitakers
who wanted to use PGD solely to provide a compatible donor for
their son who suffered from Diamond-Blackfan anaemia. The reasons
for this are summarised below.
30. A key concern in both of these cases
was the possibility of psychological harm resulting to the child
who would be selected and born to be a donor. Although likely
to be as loved as any other child, concerns were expressed that
the child might resent being "selected", feel less wanted
or less respected as an individual. These arguments were considered
carefully but the BMA's annual meeting concluded that these hypothetical
risks of harm needed to be balanced against other harms, primarily
the real harm to the sibling who would suffer or die without this
treatment. It has been argued that if selection by tissue typing
were permitted, children would be born as a means to someone else's
ends rather than for their own sake. In reality, however, parents
have children for many reasons often more to do with their own
wishes and desires than the interests of the future child. Despite
these complex, and sometimes apparently selfish, motives most
children are loved for themselves. The BMA has opposed the selection
of embryos for trivial reasons or for meeting the desire of parents
for some particular characteristics, but saving or improving the
life of a very sick child is not a trivial matter.
31. Another area of concern was that if
a child was selected to be a donor and treatment with stem cells
from umbilical cord blood was not successful, there would be tremendous
pressure for the child to donate bone marrow. The BMA, in stating
its views, emphasised that parents must be counselled in advance
and informed that if umbilical cord blood did not work, then the
child would not automatically be accepted as a donor but a careful
analysis of the risks and benefits would be needed. The same safeguards
should apply to these children as to other children who donate
bone marrow to siblings, where the physical risks to the potential
donor are balanced against the likely psychological benefits and
the benefit to the family unit as a whole. The BMA concluded that
selection by tissue typing was not necessarily incompatible with
the welfare of the future child and its annual meeting therefore
supported the HFEA's decision in the Hashmi case.
32. In the Whitaker case the embryos were
not being created and tested in order to avoid a disorder but
simply to select those that would provide the best possible tissue
match. The HFEA's objection was that an invasive procedure would
be carried out on an in vitro embryo for the benefit of
another person (ie the sibling rather than the embryos themselves).
But it is questionable whether PGD to avoid a serious disorder
is carried out for the benefit of the embryos themselves, since
those found to be affected by the disorder would be destroyed.
The acceptability of any intervention also needs to be considered
in the context of the status accorded to the embryo and what interference
and invasive procedures are permissible. In the UK, human embryos
may be used for research to pursue questions important to the
public good such as to improve fertility treatment and contraceptive
measures and the Medical Ethics Committee considered it would
also be acceptable to permit the use of embryos to save a child's
life.
33. The HFEA had not argued that the child
him or herself would be at risk of physical harm caused by the
PGD procedure. Even if there was perceived to be some increased
risk to the child as a result of the procedure, however, the BMA
does not consider that this would necessarily mean that it should
be prohibited. Parents expose their children to other risks for
the benefit of other people, such as participation in research,
provided those risks are minimal. Any risk of harm also needs
to be balanced against the psychological benefits to the donor,
and the family unit as a whole, from saving the life of a dying
child. Having considered all of these issues, the BMA concluded
that there were no morally relevant differences between the two
cases. The BMA wrote to the HFEA in July 2003, following debate
at the BMA's annual meeting, informing the HFEA of this decision
and asking it to reconsider its decision.
May 2004
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