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The Legal Frameworks that Govern Fetal Surgery in the United Kingdom, European Union and the United States

Authors:
  • UCL Great Ormond Street Institute of Child Health

Abstract

WHAT'S ALREADY KNOWN ABOUT THIS TOPIC? Fetal surgery is entering mainstream clinical care as a specialty that introduces an exciting range of new treatments for mothers and their unborn babies. The conflict between maternal autonomy and interests in fetal health is relatively well‐known. How does fetal surgery affect this issue? WHAT DOES THIS STUDY ADD? Clarify the legal frameworks that govern fetal surgery in the UK, EU and USA. Examine how fetal surgery may influence the legal position. Discuss clinical best practice and how physicians can influence future laws that govern this specialty. The specialty of fetal surgery or fetal intervention is one of the most exciting emerging fields of modern medicine. It is made possible by decades of major developments in antenatal imaging, obstetric anaesthesia, fetal medicine, paediatric surgery and of course by the bold and novel practitioners willing to take new steps to advance the field. Beginning in the 1970s it has now reached a stage of maturity where there are several established in‐utero procedures and countless clinical trials and studies to develop more. But what is the legal situation that fetal surgeons find themselves in? What are the rights and legal protections for the fetus and the mother, both of which are arguably the patient? This article will address this question, discussing and summarising the current legal frameworks governing fetal surgery in the jurisdictions of the United Kingdom, European Court of Human Rights and the United States of America as well as discuss what the future may hold and how researchers and physicians in the specialty can best navigate the legal environment.
REVIEW
The legal frameworks that govern fetal surgery in the United
Kingdom, European Union, and the United States
Kevin X. Cao
1
|Alice Booth
2
|Sebastien Ourselin
3
|Anna L. David
4,5
|
Richard Ashcroft
6
1
Department of Urology, Great Ormond
Street Hospital, London, UK
2
Leicester De Montfort Law School, Leicester, UK
3
UCL Centre for Medical Image Computing,
London, UK
4
UCL Institutefor Women's Health, London,UK
5
Department of Development and
Regeneration, Katholieke Universiteit Leuven,
Leuven, Belgium
6
School of Law, Queen Mary University,
London, UK
Correspondence
Kevin Cao, Department of Urology, Great
Ormond Street Hospital for Children, Great
Ormond Street, London WC1N 3JH, UK.
Email: kevxcao@gmail.com
Funding information
Engineering and Physical Sciences Research
Council (EPSRC), Grant/Award Number: NS/
A000027/1; Wellcome Trust, Grant/Award
Number: WT101957
Abstract
The specialty of fetal surgery or fetal intervention is one of the most exciting emerg-
ing fields of modern medicine. It is made possible by decades of major developments
in antenatal imaging, obstetric anaesthesia, fetal medicine, paediatric surgery, and of
course by the bold and novel practitioners willing to take new steps to advance the
field. Beginning in the 1970s, it has now reached a stage of maturity where there
are several established in utero procedures and countless clinical trials and studies
to develop more. But what is the legal situation that fetal surgeons find themselves
in? What are the rights and legal protections for the fetus and the mother, both of
which are arguably the patient? This article will address this question, discussing
and summarising the current legal frameworks governing fetal surgery in the jurisdic-
tions of the United Kingdom, European Court of Human Rights, and the United States
of America as well as discuss what the future may hold and how researchers and phy-
sicians in the specialty can best navigate the legal environment.
1|INTRODUCTION
In this article, we examine the parallel evolution of the legal status of
the fetus in the United Kingdom, the transnational institutions of
Europe and the United States, the growing specialty of fetal surgery
(fetal intervention/therapy) and discuss the potential interaction
between the two. To date, in all these various legal systems, there
has been no direct reference to fetal intervention in legislation or case
law. The legal position must therefore be inferred from the positions
taken in each legal system with respect to other issues relating to
pregnancy and assisted reproduction. We begin by summarising the
legal status of the fetus and then assess how the current legal
positions impact upon maternal rights and on fetal therapy. Finally,
we consider what the future holds for the specialty and how clinicians
can shape the way society views the practice both in ethics and in law.
2|METHODS
We searched for all relevant case law and statutes in the jurisdictions
of the United Kingdom (England and Wales, Scotland, and Northern
Ireland), the European Court of Human Rights (ECHR), and the United
States on NexisLexis, WestLaw, JustCite, and directly from the data-
bases of the ECHR and the US Library of Congress. We also searched
for English language academic articles from those sources and
Medline. In all cases, articles were examined for reference to fetal
surgery, consent, abortion rights, forced medical interventions, defini-
tions of legal status, and any other terms deemed relevant to fetal
maternal therapy.
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This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided
the original work is properly cited.
© 2018 The Authors Prenatal Diagnosis Published by John Wiley & Sons Ltd
This work has been discussed at the Patient Public Engagement Group of the
GIFTSURG project (www.giftsurg.ac.uk), which is supported by several grants
(see end of manuscript) but has itself not been supported by any specific grants
from the public, private, or nonforprofit sectors
Received: 31 July 2017 Revised: 3 April 2018 Accepted: 5 April 2018
DOI: 10.1002/pd.5267
Prenatal Diagnosis. 2018;38:475481. wileyonlinelibrary.com/journal/pd 475
2.1 |A brief overview of legal traditions in the three
jurisdictions
Laws in England, Wales, Scotland, and Northern Ireland have a complex
historical tradition.In England, the CommonLawsystem has ancient his-
toric roots in local customary laws and over time through the Medieval
and Enlightenment period, increasing introduction of statutory law
through parliamentary legislation. A key principle of common law is the
importance of judgemade law or local court decisions. This is case law,
which builds over time with judgments setting precedent over future
decisions. Statutory law, in some cases, were codifications and, in others,
expressions of unwritten common law. This tradition has been applied to
Wales since the 16th century and has influence on the jurisdiction of
Northern Ireland, in particular in some shared statutory laws, although
Northern Ireland has many common law traditions of its own to draw
from.
1
English common law has only partial influence on the legal tradi-
tion in Scotland, or Scot's Law, which is a hybrid system of common
law with influences from Roman Law that brings it closer to European
civil law traditions. All four nations are under the jurisdiction of the
Supreme Court of the United Kingdom for mattersof civil law and English
Acts of Parliament while they are in union. Finally, all four nations of the
United Kingdom are also obligatory signatories to the laws of the Euro-
pean Union. This format is largely shared with the United States, which,
like other former British colonies, has implemented with adaptations,
the English common law tradition. The origin and application of many
laws are at state level, with most statelegal systems deriving from English
common law, although in some cases such as the State of Louisiana,
French civil law tradition continues to influence modern legal practice.
The main difference in the US law is that the Federal government will
enact and promulgate interstate statutes, overriding some existing state
legislation.
2
The European Court of Human Rights (ECHR) is a judicial
organ whose primary aim is to enforce implementation of the European
Convention on Human Rights, a contractual statement indicating the
Rights and Freedoms under Civil law of European Union citizens. The
legal system of the European Union is complex with a historical heritage
that derives from the predominantly civil law legal practice of European
nations, which trace their roots in national legal traditions as well as
Roman law, the codifications of Justinian I and Napoleon, influences from
Roman Catholic Canon law, and enlightenment and modern revisions.
Civil law critically is based on the principle of codificationand places
greater relative importance on the lawmaker. Importantly, European
lawis characterised byits recognition of the variance among its signatory
states, which include both common law and civil law practices. While dis-
tinct and supranational, it nevertheless recognises state legal autonomy
but also requires participation and implementation of European legal
decisions, particularly of the European Courts of Justice and ECHR.
3
Thus, the jurisdiction of the ECHR is central, governing many nations
including currently the United Kingdom.
3|EVOLUTION OF FETAL RIGHTS
Historically, the legal status of the fetus has been shaped from the per-
spective of criminal law governing abortion and (to a lesser extent) the civil
law of torts relating to prebirth injury. Through advancing technology, the
fetus is increasingly taking on a human formin utero before our eyes.
4
While this focus is evolving, the basis of the law remains the same.
3.1 |The United Kingdom
The status of the fetus in English law is that it is not a legal person
until birth. Abortion or termination of pregnancy was a crime,
although rarely if ever prosecuted, in the common law of England,
as clarified in the Offences Against the Person Act of 1861 (OAPA,
sections 58 and 59).
5
The Infant Life Preservation Act of 1929 made
it a crime to kill or destroy a child who was capable of being born alive
but was not yet existing independently of the body of the mother, thus
closing a loophole in which the act was neither causing a miscarriage (as
defined in the OAPA) nor murder or manslaughter (or infanticide), as
would be the case if the child was delivered. The case of R v Bourne
clarified the law by stating conditions under which the act of causing
an abortion could be lawful (the OAPA defining only unlawful abortion
as a crime).
6
In conjunction with the Infant Life Preservation Act, this
meant that there was an upper gestational age limit on terminations,
which could be deemed lawful. The Abortion Act of 1967,
7
as amended
by the Human Fertilisation and Embryology Act 1990,
8
formalised and
clarified the legal position for lawful abortions and introduced a system
of regulation. But the legal history of abortion does not establish any
legal rights on the part of the unborn child. It is arguable that the law
here does not define a victim, rather it defines a class of wrongful acts
and focusses on the acts and the agent.
9
Of note, this does not apply in
Northern Ireland, where the Abortion Act 1967 has not been applied.
This sets out the main protection of fetal rights in the UK law;
indeed, it was stated in Paton v British Pregnancy Advisory Service that
the fetus cannot, in English lawhave any right of its ownuntil it is
born and has a separate existence from the mother.
10
At this point,
What's already known about this topic?
Fetal surgery is entering mainstream clinical care as a
specialty that introduces an exciting range of new
treatments for mothers and their unborn babies.
The conflict between maternal autonomy and interests
in fetal health is relatively wellknown. How does fetal
surgery affect this issue?
What does this study add?
Clarifies the legal frameworks that govern fetal surgery
in the United Kingdom, European Union, and the
United States.
Examines how fetal surgery may influence the legal
position.
Discusses clinical best practice and how physicians can
influence future laws that govern this specialty.
476 CAO ET AL.
however, the legal position becomes less clear; forced caesarean sec-
tion cases whereby physicians have successfully applied for court
mandated caesarean delivery in cases of impending fetal harm,
11-14
have weakened this stance as they represent instances of doctors, as
argued in RvS, acting primarily for the benefit of a fetus, which by
law has no legal rights.
15
A recent test case exploring the legality of
compensating a child suffering Fetal Alcohol Syndrome was ruled in
line with the stance in Paton;
16
a child cannot sue its mother for in
utero harm. This however is a civil law case. The law here is complex,
but the priority of the mother in ethics and law remain central.
3.2 |Member states of the Council of Europe
This overarching jurisdiction covers signatory states to the European
Convention on Human Rights (ECHR, 1953), which sets out rights
afforded to all legal persons including the Article 2Right to life.
17
Whether this article applies to the fetus was tested in Vo v France.
18
In this case, physicians of a pregnant French woman, Mrs Vo,
attempted to remove a nonexistent intrauterine device due to a
mixup with a similarly named patient, resulting in miscarriage. A claim
was brought forward by her lawyers stating the lack of criminal
charges for loss of fetal life was incompatible with the state duty to
protect the right to life. The ECHR, under great internal pressure, ulti-
mately avoided clarifying the position of the fetus and how much pro-
tection it should be given by refusing to pass judgment.
While many European states share the Napoleonic code as the
foundation of their legal systems, the actual legislation is individual
to each nation. The legislation of traditionally Catholic countries is
generally stricter on abortion than their more secular cousins, which
allow greater access.
19
This difference in attitudes is one source of
the ECHR's reticence in ruling on the fetus; individual member states
have a duty to implement legislation in line with the decisions of the
Court and a duty to change their law if not compatible. Thus, ECHR
decisions demand approval from the social, religious, and political feel-
ings of its member nations; as international law is founded on compro-
mise, when one cannot be found, the best solution to preserve the
overall jurisdiction is sometimes to stay silent on the matter.
3.3 |The United States
The United States has seemingly taken a more proactive approach in
stating its position regarding the fetus. Abortion laws stem from the
Roe v Wade interpretation of the 14th Amendment to the Bill of
Rights,
20
which provides a right to abortion balanced against the
State's interest in prenatal life, a partial, not absolute, right to abortion.
Previously, a civil action for fetal harm was not possible as legal
rights are conferred with personhoodat birth; however, legislation
has shifted perspective so that personhood can be found in the womb,
as evidenced by the Unborn Victims of Violence Act.
21
Although this
only applies to violent crimes, it represents a willingness to award
rights and protections before birth where previously none existed.
Cases of intervention to preserve fetal life have also been decided, one
dramatic example being the case of Marlise Muñoz concerning whether a
pregnant comatose woman should be kept on life support until her fetus
reached viability.
22
The 1990s and 2000s featured cases involving women
being charged with, among other examples, wilfully endangering a child in
Sherriff v. Encoe,
23
criminal abuse in Commonwealth v. Welch,
24
and being
sentencedtoprisoninCommonwealth v. Kemp forconsumingillicitdrugs
during pregnancy.
25
Many of these decisions were criticised and reversed
on appeal.
26
The number of cases of this nature has reduced over the past
decade perhaps indicating that this trend is reversing and the courts are
reasserting the importance of maternal rights.
State interpretation of federal statutes on this emotionally
charged issue is understandably subjective. The US courts appear to
sit in a middle ground between the United Kingdom and ECHR as
the former has seemingly ruled out fetal rights while the latter refuses
to state its position. The United States has attempted to find a method
of implementing both fetal and maternal rights with some success and
failure, resulting in an ambiguous position; earlier cases imply favour
to fetal rights, and subsequent events suggest maternal rights have
returned to primacy.
4|EFFECT ON MATERNAL RIGHTS
A key issue regarding fetal rights is the difficulty in applying legal per-
sonhood rights to the fetus and mother when one is not only part of
the other's body but interconnectedin [so] many intricate and inti-
mate ways.
27
This is known as the fetalmaternal conflict, when act-
ing for one diminishes the rights of the other.
4.1 |The United Kingdom
The effect of fetal rights on maternal rights in the United Kingdom has
been limited; forced caesarean section cases are the best evidence of the
conflict. Almost all the UK cases have revolved around doctorpatient dis-
putes at the time of childbirth rather than courtimposed sanctions arising
from physician concerns earlier in pregnancy about fetal wellbeing.
The court sets out several guiding principles in the case of Re MB,a
landmark case involving a woman with needle phobia refusing caesarean
section. Those principles aimed at reducing the instance of these cases
going to court, denote that in moments of fear or panic, mental capacity
may be lost and the physician may act in the best interest of the patient
and in this case the fetus.
10
Unfortunately, fear and panic are not difficult
to find in many births.
11
Reassuringly for proponents of maternal auton-
omy, most of these decisions were ultimately reversed on appeal.
4.2 |Member states of the Council of Europe
The ECHR has few instances of fetalmaternal conflict, but there are
numerous cases on reproductive rights and autonomy that reveal the
extent to which the Court is willing to protect the mother. The ECHR
has repeatedly ruled in favour of women undergoing forced
sterilisation such as in K.H. and others v. Slovakia,
28
finding a breach
of the women's Article 8right to respect for private and family life.
The most relevant case concerns consent to sterilisation given without
full understanding during labour in VC v Slovakia;
29
here, the court
found in favour of the woman because her understanding was not
secured. As there is little evidence on the Council's position regarding
the fetalmaternal conflict, reaching a conclusion is difficult, but these
cases hint at a promaternal autonomy lean.
CAO ET AL.477
What VC v Slovakia also demonstrates is the focus of the Court on
respecting and protecting the cultural and religious views of each
member nation; a prominent factor in this decision was the social
exclusion the mother endured from the Roma community after
sterilisation. Europe has many cultural and religious differences, which
impact upon public opinion and legislation on the relationship
between mother and fetus, an example being the greater restriction
on maternal autonomy through restriction of access to abortion in
more traditionally religious states.
30,31
4.3 |The United States
The effect of the fetus on maternal rights can be seen most clearly in
the law of the United States, which has the largest number of cases of
maternal rights being infringed in favour of the fetus; state legislation
ranges from classifying pregnant recreational drug use as assault,
32-39
imprisoning mothers to prevent recreational drug use,
40
to making the
fetus a ward of court.
41
What these cases represent is the conflict in the US legal system
between various pressure groups, public opinion, and legislation; while
some cases show a preference to protecting the fetus sometimes at
the cost of maternal rights, most of these cases were ultimately
repealed. Legislation such as the Unborn Victims of Violence Act,
21
which although does not affect maternal rights directly, does show a
willingness in the US law to transfer legal personhood into the womb,
the implications of which may affect maternal rights.
5|THE LEGAL POSITION ON FETAL
INTERVENTION
Fetal intervention has advanced tremendously since the 1970s with
many new therapies translating from research into clinical practice as
research trials demonstrate efficacy.
42-44
Fetal intervention under-
taken for research is protected legally by robust research ethical coda,
but as the specialty becomes established outside of research, it will
attract observation and interest from the law.
A pivotal question is how treatment of the fetus affects the
rights proscribed to it. Patienthoodis a status that awards an indi-
vidual the right to medical treatment, and this comes from the
individual's legal personhood’—usually awarded after birth. The ques-
tion is, does this also have the reverse effect? Does treating the fetus
as a patient mean that personhood and its accompanying rights will
be awarded in the womb?
5.1 |The United Kingdom
In the United Kingdom, this is a grey area, as performing medical treat-
ment on a person without consent is to commit assault.
45
As the inter-
vention is for the benefit of the fetus rather than the mother, this
appears in contradiction with the law. Currently, there is little impetus
to legislate on the matter and no case has been brought before the
courts so judgment has simply not been passed; until this is resolved,
fetal intervention exists in a grey area that for now is considered legal
in so much as the law protects and enshrines maternal rights of auton-
omy over their bodies.
Fetal intervention is currently governed by existing medical negli-
gence frameworks with the fetus treated as an organ of the mother.
This position satisfies the legality question but does not adequately
consider the psychosocial burden this places on the mother. There is
considerable personal, familial, and societal pressure on pregnant
women to act selflessly for their unborn child; she may feel she has
no choice.
46,47
When assessing a prenatal therapy, many pregnant
women consider their fetus as a baby, even if they have not attained
aviablegestational age.
48
As fetal intervention moves increasingly
into the mainstream, placing safeguards to prevent diminution of
maternal autonomy may protect mothers in the long run. Furthermore,
the fetus's lack of rights prevents its classification as a patient, so it is
not supported by the personhood/patienthood structure. However,
this is not necessarily relevant; to deduce the status of a being from
the treatment given to them is to forget the fundamental[ly] different
nature of law and medicine.
49
Although medical practice can help
understand these issues, ultimately, it is for the law to decide the sta-
tus of the fetus.
What is more relevant is that fetal surgery is now established as
an effective and successful medical therapy that has brought about
an exciting new array of treatments for the fetus. Medical law has
throughout history had to adapt with evolving practices, so it seems
unlikely that the law will not do so here.
5.2 |Member states of the Council of Europe
The position regarding the member states of the European Council is
much less clear as each is governed by its own domestic legislation.
As the law stands currently, the legality of fetal intervention is not
explicitly confirmed, as the European Court will not state whether
the Convention applies to the fetus. If the Convention were to apply,
it is likely that the fetus's right to life would carry a corresponding right
to medical treatment making intervention legal, and the reverse would
be true if the Convention did not apply.
Were the Court to pass a ruling either way on the Convention's
applicability the impact would be far reaching: All domestic legislation
that does not treat the fetus as a full rightsholder would need to be
reviewed if not abandoned. This seems unlikely as the Court has found
nations culpable for not offering access to abortion.
31,50
It seems most
likely that the Court will simply continue to abstain from judgment to
avoid the disruption that such a decision would bring.
5.3 |The United States
As with the other jurisdictions, the United States has no current legal
position on fetal intervention but seems closer to arriving at one.
Steps have been taken in protecting the fetus legally, demonstrating
that the United States has declared its legal interest in fetal life. This
means that the framework for legal intervention has already been laid
in embryonic form at least.
This does not guarantee that intervention will be formally
legalised; the influence of pressure groups on both the Prolife and
Prochoice side of the debate is considerable and has had an impact
on legislation in the past. Moreover, the reversal of many of the prom-
inent fetalmaternal conflict cases has made the US position equally
478 CAO ET AL.
ambiguous. In this area, cultural and public opinion plays a great role,
so if the trend has indeed shifted to favour maternal rights, then per-
haps regulating fetal intervention will be more challenging.
6|FUTURE TRENDS FOR THE SPECIALTY
How the practice of fetal intervention could affect future laws regulat-
ing the relationship between mother and fetus is under debate. A cen-
tral question is whether ascribing patienthood to the fetus also
confers personhood in the womb. This would result in two individual
rightsholders occupying the same body, an eventuality in which the
instruments that award these rights are not prepared for at present.
There have been sensational concerns that awarding the fetus rights
could reduce women to ambulatory wombs,
51
although this contrasts
with other views that interventions can extend maternal choice and
autonomy.
46
Removing the opportunity to undergo therapy for the
benefit of the fetus closes off valuable treatment routes that may
improve fetal outcomes and indirectly maternal and familial psychoso-
cial wellbeing. It is often forgotten in these debates that the psycho-
social burden of raising a child is mainly a private one,
52
so limiting
choice may have farreaching consequences for fetus and parents.
There is concern about the effect on abortion legislation, as the
legal basis of abortion relies on the fetus's lack of personhood. It is
unlikely to prevent all legal termination but may reduce availability,
especially late gestation abortions if fetal therapy becomes an option.
Another intriguing prospect is that of the artificial placenta, a
potential technical advance whereby a fetus may be delivered from
the mother and subsequently supported outside the womb, complet-
ing its gestational development without biologic support of the
mother.
53
In this scenario, fetal surgery could be performed without
impacting maternal health. It is difficult to predict how the law will
respond to this scenario, but there are numerous potential positions
the law could take, all of which may lead to ethical and social ques-
tions. There is no doubt that there is the clinical desire for these tech-
nologies to develop as a solution to spontaneous or iatrogenic preterm
birth, which already poses a great burden on society.
As fetal therapy advances, legislators will be forced to reach a
decision on the position of the fetus and the rights that it should
be accorded. For all three jurisdictions, this will be difficult, in find-
ing a resolution that sensitively weighs up differences in cultural
values and binds people on such an emotive issue as the treatment
of the fetus.
What is also increasingly clear is that the constantly shifting world
of politics has a great impact on the frameworks of each nation's laws.
Changing political environments and the results of popular move-
ments can have the effect of altering the social perspective on how
new laws should be written or old laws changed. In the case of the
United Kingdom, for example, the jurisdictions themselves will change,
likely to reaffirm the country's native laws rather than those of the
ECHR. In today's state of play, it is as important as ever for physicians
to recognise their role in shaping how their specialty is regulated by
the law.
7|THEROLEOFFETALTHERAPY
PRACTITIONERS
While clinicians are unable to directly dictate legislation, their actions
drive future decisions, and it is largely for clinicians to decide how
this effect will culminate, how and when clinical services are offered,
and the detail of ethical guidelines in this field. As fetal intervention
is driven by research endeavours around the world, the effect that
physicians have on the medical, social, and legal implications of their
study is great. The translation of research could reinforce the spe-
cialty with a solid framework of principles that will shape how future
laws will appear.
The pathway for innovation in fetal therapy was defined many
years ago by the International Fetal Medicine and Surgery Society
(IFMSS). It is suggested that fetal medicine and surgery practitioners
collaborate to produce acceptable indications and outcomes for their
practice while respecting research equipoise. Cooperative agreement
by physicians in the form of a framework is in the long run more read-
ily adopted by legislators (see Table 1).
Medical treatment often advances through the courage to exper-
iment with new techniques, technology, and practice beyond
established standards. This of course should be encouraged, and inno-
vation must be supported in the fetal medicine and surgery commu-
nity. A good standard to follow would be to seek institutional ethical
approval before undertaking a new practice. The outcomes of new
practice should be presented internationally at established academic
meetings at the earliest possible opportunity for peer review. It is also
incredibly important to disseminate information to and involve rele-
vant patient and public interest groups, particularly those that advo-
cate for mothers and for patients living with the conditions that new
fetal interventions are designed to treat. It is as important to report
on negative outcomes, as well as successes. The international commu-
nity of practitioners, armed with a solid body of evidence, is then able
to derive a consensus on successful treatments and to agree on
disengaging in potentially dangerous practice. International commit-
tees should also actively direct treatments with the greatest potential
into properly conducted clinical trials to allow the evaluation of the
innovation against current gold standard clinical practice, or where
no treatment is available, against current untreated clinical outcomes.
These often require registries of natural history data to be set up, to
compare with treated cohorts in clinical trials, examples of these are
emerging in the fetal medicine community.
54
This is especially
TABLE 1 International Fetal Medicine and Surgery Society (IFMSS) mission statement
International Fetal Medicine and Surgery Society mission statement
1. To promote and encourage the development and advancement of the field of fetal diagnosis and therapy
2. To advance the cause of education and scientific research relating to the field of fetal diagnosis and therapy or other reasonably related medical or
scientific pursuits
3. To promote the establishment of a mutually beneficial relationship among its members
CAO ET AL.479
important as the specialty is still small and patient numbers limited rel-
ative to the greater practice of medicine. This approach, taken as the
individual practitioner and a member of the growing collective body
of fetal physicians, supports the frontiersman attitudein a safe and
legally defensible manner.
Ultimately, the law, like the medical profession, wishes to see
advances occur and for patients to have greater choice and better
care. Having learned historical lessons from other specialties and seen
its own rise from obscurity to prominence, fetal surgery should now
take stock of these lessons and understand the nature of law. What
the law would like to see is unity in opinion, whether it is a firm stance
on a treatment or the clear indication that the scientific community is
heading in that direction.
ACKNOWLEDGEMENT
Many thanks to Hannah Booth for her diligent efforts and helping to
create this piece of work.
CONFLICTS OF INTEREST
None declared
FUNDING SOURCES
The concepts in this work were discussed at the Patient Public
Engagement Group of the GIFTSurg project www.giftsurg.ac.uk),
which is supported by an Innovative Engineering for Health award
by the Wellcome Trust (WT101957) and the Engineering and Physical
Sciences Research Council (EPSRC) (NS/A000027/1). A.L.D. is sup-
ported by the UCL/UCLH NIHR Comprehensive Biomedical Research
Centre.
LEGAL REFERENCE KEY
EWHC QB/KB : High Court of England and Wales Queen's/King's
Bench Division
EWHC Fam : High Court of England and Wales Family Division
EWCA Crim : High Court of England and Wales Court of Appeal
Criminal Division
UKHL : United Kingdom House of Lords
ECHR : Council of Europe, European Court of Human
Rights
ORCID
Kevin X. Cao http://orcid.org/0000-0002-9494-0946
Sebastien Ourselin http://orcid.org/0000-0002-5694-5340
Anna L. David http://orcid.org/0000-0002-0199-6140
Richard Ashcroft http://orcid.org/0000-0001-6065-4717
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How to cite this article: Cao KX, Booth A, Ourselin S, David
AL, Ashcroft R. The legal frameworks that govern fetal surgery
in the United Kingdom, European Union, and the United
States. Prenatal Diagnosis. 2018;38:475481. https://doi.org/
10.1002/pd.5267
CAO ET AL.481
... Some jurisdictions might have legal frameworks governing pregnancy care and restricting pregnancy termination. A recent example from the United States in the Dobbs vs. Jackson case shows that cancer treatment options might be restricted for pregnant patients [38,67], despite the historic trend denying foetuses a legal entity status until they are born [68]. ...
... This could lead to cancer treatment and pregnancy decisions that might not be treatment and care paths that the pregnant cancer patient genuinely wants to follow [87]. Some extensive studies have been carried out in exploring the vulnerabilities of pregnant women, such as when their developing foetus requires an intervention (e.g., foetal surgery) [68], suggesting that pregnant patient's interest should not be overlooked [88]. ...
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Simple Summary Cancer treatment during pregnancy can raise many difficult questions. Currently available clinical practice guidelines offer very limited ethical guidance for healthcare professionals. This article offers a theoretical framework and a practical ethics checklist for ethical and patient-centred care. It takes a holistic view to patient treatment, care and counselling that emphasises the need to recognise the relational context of individual patient’s autonomy; balance maternal and foetal beneficence obligations; balance maternalistic and relational approaches to evidence-based personalised patient care; consider protection of the vulnerable in light of responsibilities towards the unborn; and ensure reasonable and just resource allocation. At the moment, very few studies have explored clinicians’ attitudes and patients’ experiences when cancer treatment is delivered during pregnancy. Therefore, future work will require patient engagement to develop ethical guidance in this setting. Abstract (1) Background: Caring for pregnant cancer patients is clinically and ethically complex. There is no structured ethical guidance for healthcare professionals caring for these patients. (2) Objective: This concept paper proposes a theoretically grounded framework to support ethical and patient-centred care of pregnant cancer patients. (3) Methodological approach: The framework development was based on ethical models applicable to cancer care during pregnancy—namely principle-based approaches (biomedical ethics principles developed by Beauchamp and Childress and the European principles in bioethics and biolaw) and relational, patient-focused approaches (relational ethics, ethics of care and medical maternalism)—and informed by a systematic review of clinical practice guidelines. (4) Results: Five foundational discussion themes, summarising the key ethical considerations that should be taken into account by healthcare professionals while discussing treatment and care options with these patients, were identified. This was further developed into a comprehensive ethics checklist that can be used during clinical appointments and highlights the need for a holistic view to patient treatment, care and counselling while providing ethical, patient-centric care. (5) Conclusion: The proposed framework was further operationalised into an ethics checklist for healthcare professionals that aims to help them anticipate and address ethical concerns that may arise when attending to pregnant cancer patients. Further studies exploring clinicians’ attitudes towards cancer treatment in the course of pregnancy and patient experiences when diagnosed with cancer while pregnant and wider stakeholder engagement are needed to inform the development of further ethical, patient-centred guidance.
... Cao and colleagues (2018) traced legal conceptions of the fetus in the U.K., U.S., and European Court of Human Rights (ECHR), observing that fetal status attracted legal interest as cases of forced cesarean section and unintended fetal harm arose. U.K. law maintains that the fetus has no rights of its own, while the ECHR has avoided ruling on cases where fetal and maternal interests seem to conflict (Cao et al., 2018). The U. S., however, has encoded fetal "rights" into law with the Unborn Victims of Violence Act (Cao et al., 2018), consistent criminalization of maternal behavior deemed unhealthy for the fetus (Paltrow and Flavin, 2013;Kavattur et al., 2023), and the 2022 Supreme Court decision (Dobbs v. Jackson Women's Health Organization) that overturned federal protection for abortion. ...
... U.K. law maintains that the fetus has no rights of its own, while the ECHR has avoided ruling on cases where fetal and maternal interests seem to conflict (Cao et al., 2018). The U. S., however, has encoded fetal "rights" into law with the Unborn Victims of Violence Act (Cao et al., 2018), consistent criminalization of maternal behavior deemed unhealthy for the fetus (Paltrow and Flavin, 2013;Kavattur et al., 2023), and the 2022 Supreme Court decision (Dobbs v. Jackson Women's Health Organization) that overturned federal protection for abortion. Roe v Wade (1973) identified a gradient by which to assess increasing state interest in fetal life, allowing maternal rights to be infringed upon only at the point of viability (Lifshitz Aviram and Margalit, 2023), but Dobbs permits states to prohibit abortion from the time of conception, effectively disenfranchising the pregnant person from the right to make decisions about their own bodily integrity. ...
... 13 In the UK, the fetus does not have any legal rights of its own, at least until it is born and has a separate existence from the mother. 14 In practice, ethical guidance focuses on the autonomy of the woman, and her unique position as patient and pregnant woman. Whatever the theoretical basis may be for making judgements about the interests of the future child, it is arguable that only the woman herself is in a position to make those judgements, and it is clear in law and ethics that her informed consent is essential to authorising any clinical trial of a treatment during her pregnancy, regardless of whether the aim of that treatment is to benefit her, her fetus, or both. ...
... Modern medicine has clearly shown that foetal surgery or foetal intervention is an emerging field 3 . ...
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Foetal interventions are the direct result of developments in the field of medicine. The scientific advancements opened the way for pregnant women to select the treatment of the foetus ‘in utero’. This is an option available when the pregnant woman is reluctant to terminate the pregnancy on the grounds of congenital abnormalities of the foetus. Further, treatment of the foetus is considered a psychological relief to pregnant women who otherwise had to wait until the birth of the child to remedy the defects. The predominant method of treatment of the foetus is ‘foetal surgery’ which facilitates the treatment of the foetus in the womb. This demarcates the treatment of the fatal conditions of the foetus through invasive procedures or open surgery. The problem that arises in this context is whether the foetal surgeons exercise a medical duty of care towards the foetus. The problem is aggravated when the viable foetuses become patients as such patients have the potential to survive outside the womb (ex-utero) irrespective of the destruction of the life of the mother. Medical negligence and a course of action for medical malpractice litigation are established only upon the proof of the existence of a medical duty of care and the breach of it. This paper aims to provide insight into legislation on the medical negligence of surgeons performing surgeries on foetuses. The methodology adopted in the paper is qualitative in nature and a comparative legal analysis with the jurisdiction of the United States of America (USA). The paper's conclusion holds that foetal surgeons legally undertake to act for the benefit of foetal patients and have an obligation to avoid negligence.
... The use of primary fetal organoids offers many unprecedented benefits to study human development and congenital diseases. Access to fetal tissues, however, has ethical and legal restrictions in many parts of the world that prohibit their use in research 27 . Until now, primary fetal organoids have only been derived with destructive methods, limiting their use for autologous disease modelling, prenatal functional diagnostics and personalised therapeutics 28 . ...
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Despite advances in prenatal diagnosis, it is still difficult to predict severity and outcomes of many congenital malformations. New patient-specific prenatal disease modelling may optimise personalised prediction. We and others have described the presence of mesenchymal stem cells in amniotic fluid (AFSC) that can generate induced pluripotent stem cells (iPSCs). The lengthy reprogramming processes, however, limits the ability to define individual phenotypes or plan prenatal treatment. Therefore, it would be advantageous if fetal stem cells could be obtained during pregnancy and expanded without reprogramming. Using single cell analysis, we characterised the cellular identities in amniotic fluid (AF) and identified viable epithelial stem/progenitor cells of fetal intestinal, renal and pulmonary origin. With relevance for prenatal disease modelling, these cells could be cultured to form clonal epithelial organoids manifesting small intestine, kidney and lung identity. To confirm this, we derived lung organoids from AF and tracheal fluid (TF) cells of Congenital Diaphragmatic Hernia (CDH) fetuses and found that they show differences to non-CDH controls and can recapitulate some pathological features of the disease. Amniotic Fluid Organoids (AFO) allow investigation of fetal epithelial tissues at clinically relevant developmental stages and may enable the development of therapeutic tools tailored to the fetus, as well as to predicting the effects of such therapies.
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Over the past several decades in which access to abortion has become increasingly restricted, parents' autonomy in medical decision-making in the realms of fetal care and neonatal intensive care has expanded. Today, parents can decide against invasive medical interventions at gestational ages where abortions are forbidden, even in cases where neonates are expected to be seriously ill. Although a declared state interest in protecting the lives of fetuses and newborns contributes to justifications for restricting women's autonomy with regards to abortion, it does not fully explain this discrepancy. We believe that social portrayals of women as complying with or shirking their reproductive function play a major role in explaining it. The growing divide between a woman's rights as a reproductive being and as a parent suggest that abortion restriction is rooted in a historical societal desire for women to serve as reproducers and in the corresponding fear of them abandoning this allotted role in pursuit of social equality. The Dobbs v. Jackson (2022) decision is not based in a view of abortion as a medical act occurring between a doctor and patient, as Roe v. Wade (1973) did, but decision-making about fetal therapy or NICU care is still viewed as occurring between a doctor and patient or surrogate because in this act a woman is seen as fulfilling her role as mother.
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Objective: To evaluate the ethical and social acceptability of a proposed clinical trial using maternal uterine artery vascular endothelial growth factor (VEGF) gene therapy to treat severe early-onset fetal growth restriction (FGR) in pregnant women. Methods: We conducted a literature review on the ethics and legality of experimental treatments in pregnant women, in particular advanced therapeutics. Issues that were identified from the literature helped develop interview guides for semistructured, qualitative interviews, carried out in four European countries, with 34 key stakeholders (disability groups, professional bodies and patient support groups) and 24 women/couples who had experienced a pregnancy affected by severe early-onset FGR. Results: The literature review identified two main questions: 'is it ethical to give a pregnant woman a potentially risky treatment from which she does not benefit directly?' and 'is it ethical to treat a condition of the unborn child, who may then be born with a serious disability when, without treatment, they would have died?'. The review concluded that there were no ethical or legal objections to the intervention, or to a trial of this intervention. Overall, respondents viewed the proposed trial in positive terms. Women were generally interested in participating in clinical trials that conferred a potential benefit to their unborn child. The risk of disability of the premature child was a concern, but not considered a major stumbling block for maternal VEGF gene therapy. Conclusions: This study did not identify any fundamental or insurmountable objections to a trial of maternal gene therapy for severe early-onset FGR. Copyright © 2016 ISUOG. Published by John Wiley & Sons Ltd.
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All books in this flagship series contain carefully selected substantial extracts from key cases, legislation, and academic debate, providing students with a stand-alone resource. The seventh edition of EU Law: Text, Cases, and Materials provides clear analysis of all aspects of European law in the post Lisbon era. This edition looks in detail at the way in which the provisions of the Lisbon Treaty have worked since the Treaty became operational, especially innovations such as the hierarchy of norms, the different types of competence, and the legally binding Charter of Rights. The coming into effect of the new Treaty was overshadowed by the financial crisis, which has occupied a considerable part of the EU’s time since 2009. The EU has also had to cope with the refugee crisis, the pandemic crisis, the rule of law crisis and the Brexit crisis. There has nonetheless been considerable legislative activity in other areas, and the EU courts have given important decisions across the spectrum of EU law. The seventh edition has incorporated the changes in all these areas. The book covers all topics relating to the institutional and constitutional dimensions of the EU. In relation to EU substantive law there is detailed treatment of the four freedoms, the single market, competition, equal treatment, citizenship, state aid, and the area of freedom, security and justice. Brexit is the rationale for the decision to have a separate UK version of the book. There is no difference in the chapters between the two versions, insofar as the explication of the EU law is concerned. The difference resides in the fact that in the UK version there is an extra short section at the end of each chapter explaining how, for example, direct effect, supremacy or free movement are relevant in post-Brexit UK. Law students in the UK need to know this, law students in the EU and elsewhere do not.
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This book provides a coherent framework for addressing bioethical issues in which the moral status of embryos and fetuses is relevant. It is based on the "interest view," which ascribes moral standing to beings with interests, and connects the possession of interests with the capacity for conscious awareness or sentience. The theoretical framework is applied to up-to-date ethical and legal topics, including abortion, prenatal torts, wrongful life, the crime of feticide, substance abuse by pregnant women, compulsory cesareans, assisted reproduction, and stem cell research. Along the way, difficult philosophical problems, such as identity and the nonidentity problem are thoroughly explored. © Oxford University Press, Inc. 2011, 1992. All rights reserved.
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Monochorionic twin pregnancies have a perinatal mortality rate of 11%. The complication of twin-to-twin transfusion syndrome (TTTS) is preferably treated with fetoscopic laser coagulation of the vascular anastomoses, although intertwin vascular connections can remain patent and cause severe complications. This open-label, multicenter, randomized controlled trial was performed to compare the efficacy and safety of the newly developed Solomon technique and standard laser coagulation. Parturients with monochorionic, diamniotic twin pregnancies of 26 weeks’ gestation or less complicated by TTTS were randomly assigned to undergo either the Solomon technique or standard laser coagulation. A cannula was introduced transabdominally into the amniotic cavity of the recipient twin. After the vascular anastomoses were identified, all visible anastomoses were coagulated. For the Solomon technique, after coagulation of all visible anastomoses, a thin line of tissue at the placental surface was coagulated from 1 edge of the placenta to the other, to connect white areas that resulted from coagulation of the anastomoses. This was done to completely separate the 2 parts of the chorionic surface of the placenta at the level of the vascular equator. Both groups received identical postoperative monitoring and peripartum management. Available placentas were examined for the presence of residual anastomoses by color dye injection within 1 week. The primary outcome was a composite of the incidence of twin anemia polycythemia sequence, recurrence of TTTS, perinatal mortality, or severe neonatal morbidity. Secondary outcomes were residual anastomoses, gestational age at birth, birth weight, and complications. Of 393 eligible women, 274 were enrolled; after exclusions, 137 and 135 women were included in the Solomon and standard groups, respectively. The groups were similar in maternal age, gestational age at treatment, placenta localization, and Quintero stage. The primary outcome was identified in 94 (34%) of 274 fetuses in the Solomon group compared with 133 (49%) of 270 fetuses in the standard group (odds ratio, 0.54; 95% confidence interval, 0.35–0.82). Survival did not differ significantly between the 2 groups (overall rates of 74% for the Solomon group and 73% for the standard group). Gestational ages at birth were a mean (SD) of 32.4 (3.3) weeks in the Solomon group and 32.3 (3.3) weeks in the standard group (P = 0.89); birth weights were 1754 (594) g and 1762 (611) g, respectively (P = 0.82). In the Solomon group, the surgeon perceived complete separation of the placental parts in 118 women (86%). None of the procedure-related complications differed between the groups. With colored dye injection, residual anastomoses were present in 14 (19%) of 74 and 23 (30%) of 77 of the placentas in the Solomon and standard treatment groups, respectively (P = 0.12). Other than the well-known complications of TTTS and its treatment, no serious adverse events occurred. The mean surgical time for the procedure was not clinically or statistically different between the 2 procedures (23 minutes for Solomon vs 22 minutes for standard, P = not significant). The Solomon technique significantly reduced the incidence of twin anemia polycythemia sequence and recurrent TTTS without showing adverse outcomes or complications. The overall primary outcome as well as individual comparison of morbidity and mortality showed no increased risks related to the Solomon technique. Fetoscopic surgeons should consider using the Solomon technique for parturients with TTTS.