Aspects For Consideration
Ethical issues in reproductive medicine should take four key aspects into consideration:-
  • Autonomy of the mother
  • Interests of the fetus/future child
  • State interests
  • Duties of a doctor to preserve life
Autonomy of the Mother
The rights and choice of the mother is often the one which is followed given her responsibility for carrying the fetus to term with her own body.

Two major conflicts of interests can occur between mother and child:-

  • Mother who wishes to abort despite child being healthy and completely viable or does not suffer from any long term disability.
  • Severe problems with the fetus or pregnancy which poses a significant risk to the mother but the mother does not wish to abort.
Interests of the Fetus or the Future Child
The killing of a child or adult is unquestionably wrong, but for a developing fetus in the womb, determining the point at which it attains the human rights that adults and children share stirs much debate.

  • Timing - when the embryo becomes "human"
  • When sperm meets egg (conception).
  • When an embryo is certain to be one person and not twins (at 14 days).
  • First fetal heart beat.
  • Ability to think for itself & some degree of consciousness. Widely thought that pain is most basic perception, which occurs at 24 weeks.
  • Viability -
  • The ability of the fetus to survive indepentely outside the mother.
  • Currently a percentage do survive at 23 weeks, but the newborn subsequently suffers from severe lifelong disabilities.
Abortions
Definition:-The intention to terminate a pregnancy resulting in the death of the fetus or embryo.

Much of the controversies arise when determining as under what circumstances, if any, it is acceptable to abort a fetus.

Legality of Abortions

Clarification over what circumstances were justified as reasons for abortion came about firstly by The Abortion Act in 1967 which was later amended by The Human Fertilisation and Embryology Act in 1990.

The Abortion Act 1967

Agreement is needed between two registered medical practitioners on at least one of the following:-

  • The pregnancy is less than 24 weeks gestation and that continuing with the pregnancy poses a greater risk than termination to the physical or mental health of the mother, or any of her existing children or family.
  • The termination is necessary to prevent grave permanent injury to the physical or mental health of the pregnant woman.
  • Continuing the pregnancy involves risk to the life of the woman than if the pregnancy was terminated.
  • That the child is at substantial risk of carrying physical or mental abnormalities as to be seriously handicapped.

The last three points is aimed at covering pregnancies over 24 weeks and where the pregnancy poses a serious risk of morbidity or mortality to the mother, or to the long term health of the future child.



Human Fertilization and Embryology Act 1990

  • The Abortion Act was amended in 1990 to allow abortions up to birth where there was a risk of serious foetal handicap, or where continuance of the pregnancy would involve risk to the life of the pregnant woman (or to prevent grave permanent injury to her physical or mental health.
  • In late abortions, a doctor should terminate the foetus within the uterus. If the foetus is alive outside the uterus it may acquire the legal protection of any newborn baby. Killing it may be murder
  • The Act also allowed selective abortion (i.e. multiple foetuses from superovulation)

Under common law

  • Paton vs BPAS (1978): The father does not have any rights to prevent an abortion.
  • Re F (in utero) (1988): The courts cannot violate the autonomy of the mother even if her actions may damage the foetus.

Infertility Ethics
It is estimated that fertility issues occurs in 1/5th of all heterosexual couples in the UK.

  • IVF (In-vitro fertilisation) is a procedure that attempts to replicate what occurs naturally, with fertilisation happening in vitro rather than in a woman's body.

    Oocytes (eggs) are recovered from the female via hormonal stimulation, and are mixed with sperm in the laboratory. The resultant embryos are then implanted into the female uterus allowing them to gestate.

  • ICSI (Intracytoplasmic sperm injection) involves the injection of single spermatozoa into the cytoplasm of the oocyte, and thus allowing more control over which sperm fertilizes which oocyte. The fertilised egg is then transferred into the woman as in traditional IVF techniques. ICSI is used when sperm quality/quantity is low thus decreasing IVF chances.

IVF/ICSI can be used with egg donation or surrogacy (where the woman providing the donated egg) isn't the birth mother. IVF can also the combined with PGD (pre-implantation genetic diagnosis) to rule out genetic disorders.

Legal issues
Human Fertilisation and Embryology Act 2008
  • All human embryos outside the body - whatever the process used in their creation are subject to regulation.
  • Regulates "human-admixed" embryos created from a combination of human and animal genetic material for research.
  • Ban sex selection of offspring for non-medical reasons. (Sex selection is allowed for medical reasons - for example to avoid a serious disease that affects only males)
  • Same-sex couples as legal parents of children conceived through the use of donated sperm, eggs or embryos. These provisions enable, for example, the civil partner of a woman who carries a child via IVF to be recognised as the child's legal parent.
  • Retain a duty to take account of the welfare of the child in providing fertility treatment. "The need for supportive parenting" - hence valuing the role of all parents.
  • Storage of an embryo requires consent from both parties whose gametes will be used in the formation of the embryo, in writing. The consent must also include specific remits, e.g. the maximum period of time for which embryos or gametes can be stored.
  • At any point before the embryo is used, consent may be withdrawn by either party.
  • If consent is withdrawn from either party, then the embryo should be destroyed.

When disagreement is reached on the future of the stored embryos, the government has proposed (Department of Health review of HFEA act, 2006) the introduction of a 'cooling off' period, of a period of 1 year, to allow time in which the parties involved can reach a decision on the future of the stored embryos.

Ethical issues
  • Previous to the 2008 HFEA Act, civil partners were not allowed to have IVF, but now with the updated provision, there would be non-discrimination against married individuals or people in civil partnerships.
  • Should lesbian couple be allowed to have IVF where childlessness is not an absence of fertility on the NHS? There is a resource allocation issue.
  • Beneficence: Is it better to be born than not be?
  • Pregnancy past menopause: The uterus is capable of carrying out a pregnancy after menopause; and IVF allows menopause not to be a barrier. However it may also be less clinically effective, and may not be justified in limited resource situations.
  • Implantation of an embryo without consent of both parties involved would be unethical.
  • Children born as a result of gamete donations when they reach 18 years old, are able to have basic identifying information about the donor (name, date of birth and last known address). This raises ethical concerns of anonymity to reciepients.
  • The financial and legal issues of the father are unclear in the circumstances of IVF. If the embryo were implanted, the child may claim financial inheritance from the father, who may have other commitments, so this may become financially and psychologically traumatic for the partner.
  • By bringing children into the world, doctors should have a duty to ensure that the welfare of the children should be adequate. i.e. Nadya Suleman in the US had IVF, which resulted in the birth of 8 babies adding to her existing 6 member family.
Clinical issues
  • If the embryo is unable to be implanted, the patient will be unable to have children that are genetically hers. Therefore it is vital that support and advice are provided about the situation and the options available to her.
  • There is no right of access to fertility treatment (like all other medical treatments).
  • NICE is in the current process of revaluating the NICE 2004 guidelines for the assessment and treatment of people with fertility problems. The new guidelines are expected to be published in 2012.
  • The NICE 2004 document are not binding, and there are regional variations in the numbers of IVF cycles offered. NICE suggests 3 IVF cycles be offered on the NHS.
  • The number of sperm donation is limited, to reduce risk of children of same donor meeting and unknowingly considering marriage
Surrogacy
Students should appreciate these key issues:
  • Ethical and legal issues surrounding the status of the embryo and fetus, and areas of contention and debate including possible maternal-fetal conflict
  • Ethical, legal and professional aspects of contraception, artificial reproductive technologies, termination of pregnancy and neonatal care
  • Ethical issues associated with preimplantation/prenatal testing and embryo selection, genetic testing and screening after birth
  • Human Fertilization Embryology Act 2008, Surrogacy Act 1985, Abortion act.

Surrogacy is the arrangement whereby a woman carries and delivers a child for another couple. The rearing parents may arrange a surrogate pregnancy due to female infertility or other medical issues which may make pregnancy or delivery impossible.

It is now possible for a child to have upto 5 parents: a genetic father, a genetic mother, rearing father, rearing mother and gestating mother.


Legal issues

Human Fertilisation and Embryology Act 2008 (major update from HFEA Act 1990)1
  • Regardless of contractual obligations, surrogacy arrangements are not legally enforceable within the UK
  • Relationship between surrogate mother and child is recognised under the HFEA 2008 Act (Section 30). The surrogate mother retains legal right of determination for the child (even if genetically unrelated).

The Parental Orders (Human Fertilisation and Embryology) Regulations 20102

  • After birth, a parental order is required, otherwise the surrogate mother remains the legal mother of the child (order must be applied within 6 months of birth)
  • Applicants can be in civil partnerships or "living as partners in an enduring family relationship" (so unmarried couples can apply)
  • Child must be at the applicants home
  • Either or both of the couple should be resident in the UK
  • Applicants should be 18 years old or over
  • No commercial arrangements should take place

Surrogacy Arrangements Act 19853

  • Under the Act commercial arrangements are illegal (only expenses can be paid for)
  • Surrogacy contracts are unenforceable
  • This Act was amended by HFEA 2008 so that surrogate mothers can keep the child if they change their minds
  • No advertisements regarding surrogacy arrangements can take place

Ethical issues
  • The right of the family to have children
  • Reservations regarding ethical acceptability falls under 2 main considerations, exploitations of women and commodification of children. 4
  • The potential health risks of the surrogate mother in pregnancy and childbirth
  • The virtues of the "work" of carrying a child for an infertile couple, should be paid (for the risk of short-term or long-term well-being). 4; otherwise could be seen as exploitative
  • The risk of commercialisation of surrogacy
  • The risk of "compassionate familial surrogacy". The Ferreira-Jorge surrogacy in South Africa involving a 48 year old surrogate mother (and genetic maternal-grandmother to the triplets born), could be seen as "forced" to accept the pregnancy even when risk to herself is greater at the extremes of reproductive age. 4
  • Issues have been raised that infertile couple should adopt rather than bringing more children into the world
Sterilization
  • In 1999, 47 000 tubal occlusions and 65 000 vasectomies was performed in England.
  • Both women and men have access to sterilization. Consent is only necessary from the patient.
  • Female contraceptives are meant to empower women, to maximise their choices and to give them control over their fertility, and thus their lives.
  • Information on other long acting contraceptives should be provided, including failure rates.
Legal issues
  • Spousal consent is not required for sterilisation.
  • Prior sanction by a high court judge should be sought in all cases of sterilisation when there is doubt over mental capacity to consent.
  • Full consent requires that patients should be informed that reversal operations, IVF and ICSI (intracytoplasmic sperm injections) are rarely provided by the NHS.
Ethical issues
  • Each person has autonomy over their own body.
  • All reproductive issues, including abortion, contraception and sterilization can be performed over the objection of the spouse.
Clinical issues
  • Female sterilization is safe, simple and very effective surgical procedure.
  • Surgery to reverse sterilization is difficult and has a low success rate. Further pregnancy has a higher risk of ectopics.
  • Sterilization should thus be considered permanent.
  • Decision should thus be made by the woman based on voluntary informed choice and should not be made under duress.
  • Similarly the International Federation of Gynaecology and Obstetrics (FIGO) stated that, "no incentives should be given to promote or discourage any particular decisions regarding sterilization".
  • Royal College of Obstetrics and Gynaecology guidelines state that women under the age of 30 (or those without children) should be counselled in case of later regret.
  • Care should be actioned in women who have recently experienced a loss in relationship, or during pregnancy.
Research on Embryos
The research importance of embryos stems from the fact that they could potentially hold a wide range of scientific and clinical value.

Sources of embryos:

  • Surplus embryo created during superovulation for IVF use. Large amounts of ova produced, and surplus embryo can be donated to another couple or for research purposes
  • Embryos created specifically for research
Ethical issues

The human nature of embryos may preclude some from conducting research (demonstrating potential for full person-hood) Potential medical benefits from medical research on embryos (do everything possible to alleviate human suffering).

Pre-implantation Genetic Diagnosis

Background

  • Preimplantation genetic diagnosis (PGD) is a type of embryo screening performed prior to implantation.
  • Requires in vitro fertilisation to obtain the embryos (or oocytes) for evaluation.
  • Aim of PGD is to try to ensure that the baby will be free from that particular disease: we are searching for a specific inherited genetic defect that will give rise to a specific serious disease.
  • PGD is somewhat of a misnomer: diagnosis means to identify an illness. However, at the time at which PGD occurs, the embryo has no symptoms.
  • Can be used to screen for a specific disorder in couples with a high risk of transmitting an inherited condition (determined by previous pregnancies with serious genetic conditions or family history). Different categories of diseases screened for are:
    • Autosomal dominant: Huntington's disease, Charcot-Marie-Tooth
    • Autosomal recessive: Cystic fibrosis
    • X linked: Fragile X, Haemophilia A, Duchenne's
    • Chromosomal structural abberation
  • In addition, there is also a process called preimplantation genetic screening (PGS). This is offered to patients who are undergoing IVF with advanced maternal age/history of recurrent miscarriage/ family history of chromosomal problems/ several unsuccessful IVF cycles. This is to screen for aneuplodies which can cause failure of implantation, miscarriages or diseases (e.g. trisomy 21: Down's syndrome).
  • These examples are just a small fraction of the potential diseases that can be screened for in licensed clinics.
  • The Human Fertilisation & Embryology Authority (HFEA) is the UK body that is in charge of determining whether a condition is serious enough to be included. Most of the conditions on the list can be carried out for any patient who requests it, and the list is regularly updated with other diseases, including Ehlers-Danlos, currently awaiting consideration for inclusion (at the time of writing)1

Saviour siblings

  • For certain life limiting conditions the best available treatments is a transfusion of stem cells from cord blood provided by a tissue-matched donor.
  • In these cases Preimplantation tissue typing (PTT) gives the best chance of having a tissue matched child. This is beneficial because using a tissue matched donor who is a close relative is more likely to be successful than treatment using a tissue matched unrelated donor.
  • PTT is similar to PGD and ensures that the child is free from the disease and is a tissue match for it's older affected sibling. There are 10 diseases that are licensed for PTT including Diamond Blackfan Anaemia, Beta and Alpha Thalassaemia, Fanconi's Anaemia, and Aplastic Anaemia. However, each individual case still needs to considered by HEFA on a case by case basis.2

Ethical issues

  • HEFA determines which serious conditions get included as permissable for PGD.
  • However, some worry that this is just the start of a slippery slope that will enable embryos to be selected on a "trivial" basis. For example, sex selection is currently used to exclude embryos with sex-linked diseases.
  • There are some that argue that couples should be free to choose the sex of their child. By following the trajectory of this argument ("Designer babies") it is clear to see that this could have serious implications for the future of society.3

Inaccuracy of techniques

  • Screening relies on the theory that all of the embryo cells are identical. However, some embryos are mosaic: the cells are non-chromosomally identical. As the embryologist only takes 1-2 cells (blastomeres) from the developing embryo it is possible that something may be identified in that cell which is not present in the rest of the embryo (so causing a viable embryo to be discarded)- a false positive.
  • Alternatively, a serious genetic condition may be missed causing a false negative.
  • Additionally, it is important to note that PGD tests for a specific condition (or conditions) based on what the child is deemed to be at high risk for. It is possible that the child is affected by another disease other than the one that is tested for.
  • Furthermore, the child is still at risk of other complications that are present with every normal pregnancy (e.g. Cerebral palsy)4.

The rights of an embryo

  • Ongoing discussion, particularly from religious figures, over whether an embryo should be afforded the same rights and respect as a child /adult.5
  • For those that hold this view, destruction of an unsuitable embryo is morally objectionable. Potentially, PGD can be seen as less acceptable than a termination because (potentially) more embryos can be discarded.
  • This issue is further compounded by the relatively low success rate: as it currently stands, only about 20% of treatment cycles result in live births.

Impact on those with disabilities

  • There are two facets to this issue. The first is that the practice of PGD can be seen to reinforce negative stereotypes of those with disabilities, possibly suggesting that lives of those affected by such disorders are worth less than those of healthy people.
  • The second issue, although somewhat rarer, is the selection for certain disabilities. For example, PGD can be used to select for deafness or dwarfism. Both can be genetic conditions and can be considered as having their own unique culture and identity. For this reason, a parent may want to select for such an embryo despite a potential negative impact on the child's future life6

Legal

    Given below are some of the most important events deteriming the legal aspects of PGD:
  • 1989: PGD was first used to select a female embryo to be free from Duchenne's musclar dystrophy (a severe sex linked condition)
  • 1990: Human Fertilisation and Embryology Act to set up the HFEA
  • 1999: HFEA carries out public consultation on the use of PGD for couples at risk of genetic diseases.
  • 2000: Reccomendation that PGD should be limited to specific and serious conditions. HFEA grants licence to perform PGS
  • 2001: HFEA grants licence to Mr & Mrs Hashmi (both carriers of thalassaemia). Their first son is affected with thalassaemia and they want to find an embryo free from disease that could serve as a blood donor. They hoped to harvest umbilical stem cells to cure their first son
  • 2002: License issued in 2001 was deemed unlawful, and High Court Judgement that PGD must only be used in interests of child to be concieved
  • 2003: Court of Appeal allows tissue typing under strict conditions


(www.hfea.gov.uk)

References
  • Human Fertilisation and Embryology Act 2008
  • The Parental Orders (Human Fertilisation and Embryology) Regulations 2010
  • Surrogacy Arrangements Act 1985 (c.49)
  • Bromham DR, Journal of Assisted Reproduction and Genetics 12 (8) 1995 "Surrogacy: Ethical, Legal, and Social Aspects"
  • Royal College of Obstetricians and Gynaecologists: Male and Female sterilisation Guidelines 2004
  • Recommendations on Ethical Issues in Obstetrics and Gynaecology (FIGO 2000)