Introduction: Liberal Reproductive Medicine Legislation Which Fails to Assess Social
and Ethical
Consequences?
Time and again, the dynamics of the scientific and technical advances in medicine
(see also [Table 1]) and changing societal attitudes to wanting children and
relationships between partners give grounds to demand a modern, “up-to-date reproductive
medicine law”
in Germany [1]. On the other hand, there is doubt that such a law is necessary
at all, with reference being made to the most recent amendment made to the German
Embryo Protection Act
(EPA), which introduced pre-implantation genetic diagnosis (PIGD) [2]. In
contrast to this, however, a group of six legal experts from Augsburg and Munich have
put a draft
reproductive medicine law up for discussion which suggests moving away from the “strategy
of outdated
law” employed up until now [3]. The draft contains new regulations for
artificial insemination, pre-implantation genetic diagnosis (PIGD), sperm and egg
donation, embryo
transfer, surrogacy, and how to deal with “excess” embryos and clones. The authors
of the so-called
“Augsburg-Munich Draft of a Reproductive Medicine Act” justify the need for reform
in that “the actual
developments in technology have created many legal loopholes in embryo protection:
The more outdated the
EPA [Embryo Protection Act] becomes in terms of biotechnology, the more it loses its
normative
regulatory effect. This means that regulatory sovereignty moves from parliamentary
legislators to
professional medical bodies” [3]. Based on the “initial presumption that every
person is completely free”, the draft law proposes an overall liberal regulation of
reproductive
medicine in Germany. Its declared intention is, firstly, to “take into account the
relevant interests in
the fundamental rights argument […] – and not to exclude these prematurely, for example
due to ethical,
religious or other preferences” [3]. And indeed, neither the civil status of
the parents nor societal attitudes towards the family and wanting children play any
role in the draft
law.
Table 1 Methods of assisted reproduction.
|
1.
|
Insemination
|
Insertion of prepared sperm into the uterus of the patient who would like to become
pregnant
|
|
2.1
|
In vitro fertilisation (IVF)
|
Fertilisation of an egg cell with a sperm cell outside the female body in a cell
culture dish (“in vitro”)
|
|
2.2
|
Intracytoplasmic sperm injection (ICSI)
|
IVF procedure during which a sperm cell is directly injected into an egg cell in
order to fertilise it (especially for patients with extremely low sperm counts)
|
|
3.
|
Embryo transfer
|
Transfer of an in vitro fertilised embryo into the uterus of the patient who would
like to become pregnant (for example following cryopreservation)
|
|
4.
|
Polar body diagnosis (PBD)
|
Investigation of the first (and, if possible, of the second) polar body following
extracorporeal fertilisation, in order to determine any changes in the (haploid)
female chromosome set before the embryo is formed.
|
|
5.
|
Pre-implantation genetic diagnosis (PIGD)
|
Investigation of the embryonal or trophectodermal cells of an in vitro conceived
embryo in order to detect chromosomal changes or hereditary diseases
|
By making the assumption of freedom in the German Constitution and reproductive self-determination
the
starting point of their regulation proposal, the authors orient themselves towards
an understanding of
individual freedom which is drawn up “negatively” like the fundamental rights of the
German Constitution
as rights of defence of the individual against the state. Derived from these, they
also assess
elementary duties to protect in as far as they are relevant for the childʼs wellbeing.
Nonetheless,
issues of “positive” freedom, which apply themselves to the factors that enable individual
freedom, are
completely ignored. This makes sense if one wishes to avoid legislators being implicated
in a dispute
about the normativity of forms of family life. The “biopolitical compromise” which
is aimed towards, is
intended precisely to avoid excessive “standardisation of the biological” [3].
Of course, the question then arises as to how reproductive autonomy should be lived
out nowadays in the
light of pluralised forms of relationships, the complex issues of who should provide
for families, and
the fact that prospective parents can seek different reproductive medicine offers
across borders.
Since it was made aware of a lack of regulation in many problem areas of the German
Embryo Protection Act
of 1990, the German Medical Association (GMA) has been regulating assisted reproduction
for years. In
the amendment to the Associationʼs (Draft) Directive from the year 2006, it is stated
that they take
into account “the debate in the public domain about the opportunities, legitimacy
and ethical boundaries
of reproductive medicine, the evolution of social values on family, marriage and relationships,
and the
criteria of medical ethics”. [4]. The GMA therefore wishes to adapt the
“outdated” but nonetheless valid legal regulations of the EPA to todayʼs reality,
first and foremost
with the help of an ethical (and legal) reflection on the role of the doctor in assisted
reproduction.
By taking on regulations from the German Civil Code on the civil status of mother,
father and child and
by interpreting them in the context of the availment of assisted reproduction, the
GMA takes a clear
stance on the issue of social and value-based forms of life as factors enabling basic
freedoms in the
practice of assisted reproductive medicine. Of course, soon after publishing the amendment
to its
(Draft) Directive, the GMA had to respond to the question of whether it, by limiting
heterogeneous
insemination to heterosexual couples, still takes into account the reality of relationships
as they are
lived out nowadays [5]. The following discussion of the social and ethical
implications of reproductive medicine addresses the question of whether the fact that
offers of sperm,
egg and embryo donation are dependent on issues of civil status is still in keeping
with todayʼs
reality. Even if one, like the Augsburg-Munich Draft of a Reproductive Medicine Act,
argues in favour of
a broad relinquishment of criminal sanctions in a future reproductive medicine law,
it still remains to
be determined whether this must necessarily involve the unlimited ethical approval
of all permitted
measures.[*]
Shared Parenthood Via Sperm, Egg and Embryo Donation
Sperm donation
Medical and legal aspects
In Germany, treating unwanted childlessness with sperm donation is permitted. To do
this,
prepared sperm cells from a man who is neither the husband nor the partner of the
patient are
used to induce pregnancy. The most common procedure is heterologous insemination (HI),
during
which the prepared donor sperm is injected directly into the womb of the patient who
wishes to
become pregnant. Donor sperm can also be used for more invasive methods of assisted
reproduction
(IVF and IVF/ISCI) and tends to be used for couples with extremely limited fertility
or when the
male partner is sterile. A less common reason for using the method is a genetic predisposition
of the male partner which should not be passed on to the offspring.
Donor sperm for HI are usually procured from sperm banks which make their donors fulfil
various
requirements. In general, donors should be between 18 and 40 years old, in good health
both
physically and mentally and should have no hereditary diseases. The sperm bank documents
the
donorʼs personal details (name, date of birth, address, civil status, educational
level,
employment and other details) and keeps them for 30 years (§ 15 para. 2 German Transplant
Act
[TA]). Once they have reached the age of 18, all children have the right to find out
about their
genetic origins (§ 1598a of the German Civil Code; § 1600d of the German Civil Code;
Article 7
of the UN Convention on Childrenʼs Rights [6]). This guarantees the
right to know oneʼs own genetic origins which the German Federal Constitutional Court
derives
from the right to protection of oneʼs privacy [7]. Depending on the
age of the patient, the chances of success are between 10 and 15 % for each round
of HI
treatment. The cost of HI is not paid by German health insurance companies and must
be paid by
the couples themselves.
Heterosexual couples who have given consent for HI treatment to go ahead are subsequently
not
allowed to dispute paternity (§ 1600d of the German Civil Code). Only the children
conceived by
HI have the option of doing this. In the case of lesbian or single women, there is
the problem
that there is no second parent to whom legal paternity is transferred. In this case,
both the
prospective parents and the sperm donor run the risk of the donor being given paternity
of the
child. In the case of lesbian couples, the social mother can apply to adopt the baby
as a
stepchild following the birth in order to protect the donor from any legal implications.
In
Germany, this problematic has resulted in the GMA [4] and the Working
Group for Heterogeneous Insemination [8] reserving treatment for
heterosexual couples only, as the legal protection of the sperm donor is problematic
in the
constellations mentioned, and it cannot be clearly ruled out that even the doctor
may be
implicated in place of a legal father whose identity can no longer be determined.
Ethical issues
The childʼs right to know his/her own origins and the fact that sperm donations are
reserved
exclusively for “stable relationships” – for reasons of maintenance and inheritance
law – make
it clear that in the German legal system, parenthood is still understood as a biosocial
form of
living involving a mother and a father. This results in different binding effects
of social
parenthood on the one hand and biological/genetic parenthood on the other. While the
former can
in principle be ended, the latter lasts a lifetime. By excluding women who are in
a same-sex
relationship or no relationship at all from receiving heterogeneous insemination [4], the GMA is linking this medical practice to elementary parental
duties which exist for the protection of the childʼs wellbeing for reasons of laws
governing the
protection of the private sphere and maintenance. However, the idea that only heterosexual
couples should be given this right, for reasons of the successful psychosocial development
of
the child, seems questionable. For example, a representative study on the situation
of children
living with same-sex couples comes to the conclusion “that children and young people
living in
LGBT families develop just as well as children living in other types of family” [9]. In this context, the criticism that the current civil status
regulations of the GMA no longer represent the life situations of same-sex partners/single
parents, constitutes a significant objection. The question arises as to whether, in
the light of
this changing reality, the GMA should still encourage doctors to ensure that a stable
relationship is forthcoming for reasons of the childʼs wellbeing. It is, of course,
the right of
the doctor to refuse assisted reproduction for conscientious reasons, for example
due to fears
for the childʼs wellbeing [4]. However, we should ask ourselves
whether refusing reproductive assistance on the basis of the sexual orientation of
the couple
constitutes discrimination and disproportionately restricts reproductive autonomy
[10]. Violations of the articles referring to equality (Art. 3 of the
German Constitution), to the free development of personality (Art. 2 para. 1 and Art.
1 para. 1
of the German Constitution), and to the right to start a family (Art. 6 para. 1 of
the German
Constitution) are relevant in this regard. However, if one focuses exclusively on
the wellbeing
of the child, it is conceivable to insist in particular that the couple to be parents are
in a “stable” relationship – completely independently of the partnersʼ sexual orientation.
The
consequence of this view would be that custody rights and maintenance duties in the
case of
assisted reproduction would be regulated in the same way as with adoption law. This
would take
into account the fact that, in the case of the biological father not being around,
the parental
bond to the child must be shaped in a lasting, reliable way.
If one focuses on the childʼs right to two parents, the issue of how to act in the
case of
heterologous insemination of single women remains unresolved. From the point of view
of the
child, who has the right to social support from both parents, it would be conceivable
to allow
other persons from the motherʼs support network (e.g. boyfriend or a relative) to
take on the
role of the absent social father, at least legally [10]. This would
simultaneously decrease the potential risk of sperm donors being made responsible
for providing
for the child as social father in the event that the child filed a lawsuit. Especially
if one
had good reason to want to ensure the childʼs constitutional right to find out his/her
biological origins, the biological father could be reasonably expected to go through
with the
potential encounter, as he would have to fear no legal responsibilities towards a
child whose
social father he never wished to become.
Egg donation
Medical and legal aspects
In the case of egg donation, an embryo, which was created outside the body by fertilising
a
donated egg with a sperm from the partner, is transferred into the female patient
in order to
impregnate her. This is the only option available to women who would like to bear
a child
themselves, but whose ovarian reserves have been exhausted before this has been possible.
Causes
of the exhaustion of ovarian reserves can be age, a genetic predisposition, or previous
gamete-damaging therapies – for example in the case of oncological diseases. Female
patients who
do not wish to use their own egg cells as they are afraid of passing on a genetic
disease to
their children, can also use donor eggs. However, egg donation is forbidden in Germany
(§ 1
para. 1 No. 1 and 2 and para. 2 EPA) [16]. Nonetheless, independently
of the issue of the legalisation of egg donation, the question of motherhood is clarified
by
§ 1591 of the German Civil Code: The mother of a child is the woman who has borne
said
child.
From a medical point of view, egg donation is not risk-free for the donor, as she
must undergo
controlled ovarian hyperstimulation treatment followed by follicular puncture. The
ripe egg
cells are usually cryopreserved so that it is not necessary to synchronise the patientʼs
menstrual cycle with that of the donor. In most countries, egg donors receive financial
compensation for their trouble (commercial donation); however altruistic donations
are also
possible from relatives or close friends. In some European countries, so-called “egg
sharing”
has become popular, as part of which women undergoing IVF/ICSI treatment donate some
of their
eggs in order to be partially or fully exempted from their own treatment costs in
return. The
health requirements demanded of the egg donor are similar to those involved in sperm
donation,
however the egg donor should not be older than 30 due to the increased risk of aneuploidy
with
age. As commercial donors in particular tend to be very young, chances of pregnancy
are high –
at up to 50 % at each round of treatment. Due to the huge trouble that the egg donor
has to go
to, egg donation is associated with high financial costs for the prospective parents
which
cannot be reimbursed by German health insurance companies.
Ethical issues
The German Embryo Protection Act does not permit egg donation because, on the one
hand, it leads
to a splitting of genetic motherhood, and on the other hand because it leads to a
splitting of
biological and social motherhood. It has not been scientifically proven that egg donation
puts
the childʼs wellbeing at a higher risk than is the case with sperm donation. If one
assumes that
the quality of the relationship between parent and child is especially crucial for
the positive
identity development of the child, and that the child must of course be able to find
out about
his/her origins within this relationship, it is not very plausible that there should
be a
categorical difference to sperm donation in this regard. However, due to the more
invasive
nature of ovarian hyperstimulation and follicular puncture, the health risks for the
egg donor
must be weighed up appropriately. For this reason, the commercialisation of this treatment
should not be permitted under any circumstances. This can be best achieved through
“egg sharing”
– the unpaid donation of excess egg cells – as it minimises commercial incentives.
Things are different, however, if a womanʼs own egg cells have been frozen for reasons
relating
to her life, in order to be thawed out at a “suitable” time for starting a family.
This “social
freezing” as a fertility reserve available for use at any time can lead to the optimisation
of
the plannability of a pregnancy made possible by reproductive medicine in such a way
that it can
be made to fit in with any life plans [11]. In addition to this, the
success rate is lower once the age threshold of approx. 35 years is passed. After
this age,
there are higher health risks for the prospective mother and child. In general, the
problem
arises as to whether, by medicalising pregnancy, this process creates stronger incentives
for
wanting to solve problems of juggling career and family in a way which would be better
addressed
by social policy. A distinction must be made between this and the possibility of cryopreserving
egg cells when younger women become seriously ill and fear that they may become infertile
– for
example due to cancer therapy. Even though the prospective parents are faced with
significant
psychological difficulties in this dramatic life situation, the vitrification of a
patientʼs egg
cells allows her to make decisions about her future later on [11].
Embryo donation
Medical and legal aspects
Embryo donation involves a donated embryo being transferred into the uterus of the
patient who
wishes to become pregnant. This allows couples in which neither partner has any fertilisable
gametes to be treated. Embryo donation can also be used to facilitate a pregnancy
if one partner
or both have a genetic condition which they do not want to pass on to their offspring,
or
following multiple miscarriages, or for lesbian couples and single women who wish
to have a
child but who either do not wish to or cannot use HI.
Conceiving embryos for the purposes of embryo donation is in principle not allowed
by the German
Embryo Protection Act (§ 1 para. 1 No. 2 EPA). The justification the law gives for
this ban on
embryo donation focuses on the wellbeing of the prospective child, whose ability to
develop an
identity is, in the eyes of the legislators, endangered by the split motherhood caused
by embryo
donation [12]. There is, however, no outright ban of embryo donation
in the EPA: The pre-emptive punishment mentioned in § 1 para. 1 No. 2 of the EPA is
intended to
“make an outright ban of so-called embryo donation unnecessary. Such a ban in criminal
law would
not be without its associated concerns, at least in those cases in which embryo donation
offers
the only way of preventing an embryo from dying” [12]. In this way, a
loophole was consciously included in the EPA in order to avoid the throwing away of
“excess”
embryos. It would, however, also be conceivable to give them up for donation as long
as they
were not created due to a planned decision for this purpose before fertilisation took
place. A
heated debate is currently going on as to whether impregnated, pre-nucleotide oocytes
are egg
cells as defined by the EPA, which is especially linked to the question of to what
extent the
EPA contains a unified definition of fertilisation.
The embryos available for embryo donation originate from conventional IVF/ICSI treatments.
For
many couples, the number of impregnated egg cells in the pronuclear stage during IVF
treatment
is higher than the number required for the imminent embryo transfer. In this case,
most couples
decide to have cells in the pronuclear stage cryopreserved in order to keep them for
another
embryo transfer. If, once the family planning has been completed, additional cells
in the
pronuclear stage are still available, they can either be destroyed or given up for
donation. The
same applies to embryos which have been put into storage – in much smaller numbers
– because it
became impossible to transfer them into the woman for sudden medical or psychological
reasons.
The chance of success following the transfer of donated embryos is, to a great extent,
dependent
on the age of the donor and, according to data collected outside of Germany, is between
25 and
40 % at each round of treatment.
The costs incurred by embryo donation are much lower than those incurred by egg donation,
as the
embryos already exist and just have to be approved for donation. The only costs incurred,
therefore, are for storage following approval, preparation for the embryo transfer
and the
embryo transfer itself. Embryo donation per se is non-commercial; neither the donor nor
the fertility centre responsible for storage receives any money for the approval or the
placement of the embryos.
As is the case with egg donation, the women who carry the children to term enjoy legal
certainty
in terms of motherhood, while the legal safeguarding of the genetic father – similarly
to with
HI – remains problematic in the case of lesbian couples or single women.
Ethical issues
In principle, the creation of huge numbers of unneeded embryos should be avoided if
at all
possible. However, even if this principle is recognised, the issue of what to do with
the excess
embryos created in the context of reproductive medicine procedures still needs to
be addressed.
If embryo donation is conceived as an alternative to throwing the embryos away, this
simultaneously broadens the therapy options available to women and men who are unable
to have
children. The most important point here is that embryo donation must always be completely
voluntary and not for oneʼs own profit. Neither the argument that the embryo must
be “rescued”,
nor that of the desire of another couple to have children, nor the interests of reproductive
medicine may be allowed to lead to a moral or legal duty to make a donation. For this
reason,
couples should only consider donating embryos or impregnated egg cells once it is
absolutely
certain that they will not be needed for further treatments for the donor couple themselves.
In
terms of the rights of the prospective child and the taking into account of its wellbeing,
the
requirements are similar to those involved in sperm/egg donation, while it should
be emphasised
that the prospective child is not genetically related to either of its parents, but
possibly to
siblings. In this case, the guarantee that the child can find out about his/her origins
must
involve the right to contact oneʼs own siblings – but: also other relatives?
On the Ethics of Responsible Parenthood
Reproductive medical practice in terms of sperm/egg and embryo donation results in
diverse forms of
shared parenthood, which involve new challenges for the current laws regulating assisted
reproduction as
included in the amended (Draft) Directive of the German Medical Association. Not only
innovations in
medical technology, but also changing social attitudes to wanting to have children
and the make-up of
families have resulted in the fact that the perception of what constitutes responsible
ethics of
parenthood is currently undergoing a transformation. If one focuses on the wellbeing
of the prospective
child when considering all these questions, as the German Medical Association rightly
does, then we
should nonetheless discuss whether this task of relationship ethics should rather
be more the
responsibility of the parents who are living together with their child [13].
The presumption that permanence and stability, which are central to our understanding
of marriage and
parenthood, will play a lesser role in same-sex relationships is disproved not least
by the interest of
more or less all same-sex couples in striving towards marriage-like forms of having
their relationships
recognised as binding by the law. But even if one – as demanded here – gives the ethics
of responsible
parenthood central importance in the perception of parental duties, this should not
encourage people to
underestimate the profound effects that traditional ideas of family can have on how
people can construct
an individual opinion of what kind of parents a couple would make. This is, of course,
to a certain
extent in conflict with the fundamental liberal character of the Augsburg-Munich Draft
of a Reproductive
Medicine Act, for which the perspective someone has of the parents does not represent
an argument of
constitutional law which justifies limiting the right to procreation. In this context,
it is worth
noting the judgment passed by the Grand Chamber of the European Court of Human Rights
(ECHR) on the
03. 11. 2011 egg donation ban in Austria. The judgment did not confirm the condemnation of
Austria by the judgment of a subordinate chamber, however it nonetheless criticised
the lack of openness
to change in terms of societal consensus in the field of reproductive medicine [14]. This is why, as pointed out by Hartmut Kreß, the “‘ordre public’, the opinions
of state
and society about good morals and public order […] [are] not unchanging constants.
Socio-cultural
assessments change” [15]. This does not, however, mean that one should simply
privatise the orientational function of traditional expectations of family and parenthood
by no longer
focussing on anything other than rights to “negative” freedom. In this way, the effort
made by the GMA
to interpret a consensus on ethical questions of the stability of relationships which
orients itself
towards the traditional idea of a family should not be underestimated, even if this
consensus is
changing – albeit slowly.
