Medical Ethics is increasingly recognised to be central to Good Medical Practice and the field of reproductive medicine presents some of the most challenging and complex issues of any branch of medecine. Scientific progress in ART has advanced so rapidly that Ethicists struggle to keep pace, but fertility clinicians can help to bridge the gap between clinical care and the sometimes ‘sci-fi’ world of the embryology laboratory. They can help patients benefit from developments that offer would-be parents the chance of a family without the risk of genetic disease and thereby advance one of humanity’s major goals. Society too is entitled to be engaged in the debate: the transition in just 42 years from in vitro fertilisation being a way of by-passing blocked Fallopian tubes to egg donation, egg freezing, womb transplantation, posthumous reproduction and CRISPR gene editing has raised issues that legislators struggle to explain and some faith groups strive to contain. As clinicians, we are confronted with the patient in the consulting room whom we long to help. We face a difficult balancing act between what is technically feasible, what is practically possible and what is ethically acceptable given resource and other restraints.This chapter is intended to help fertility clinicians achieve that balance.
From our current standpoint, it is difficult to imagine that more than 40 years ago, the birth of Louise Brown, the pioneering achievement of Steptoe and Edwards, was hailed not just with admiration and joy but also with hostility. Critics pointed to the ‘low’ success rates (105 embryo transfers before a healthy birth), and many commented on the high cost (which would inevitably limit access to the wealthy few in the richer countries). Some religious authorities forbade its use for their adherents, claiming that it was ‘unnatural’ and morally repugnant. Some social commentators considered it to mark another potential slip down the ‘slope’ that could lead to the commodification and commercialisation of human reproduction.
Clinicians and scientists working in the field of fertility are still confronted by opposition and misunderstanding, and the media frequently misrepresent what has been achieved or may be possible in the future. It is therefore vital that we have a solid grasp of the ethical basis of our work and can explain and justify what we do with conviction. In no other branch of medicine is ‘Primum non nocere (above all, do no harm)’ so central.
Since Beauchamp and Childress published their seminal book on biomedical ethics in 2001, it has become almost conventional wisdom to analyse medical ethical problems and dilemmas in terms of their ‘Four Principles’: Autonomy, Beneficence (the promotion of good), the avoidance of harm (non-maleficence) and Justice. Patient autonomy is considered to be the most important that effectively trumps the other three (Figure 12.1).
This may seem a welcome inversion after centuries of medical ‘paternalism’ meant that patients didn’t expect to question their doctor’s decisions about their care or even to understand the nature of their diagnosis and prognosis. However, given the special circumstances of modern reproductive medicine, it is important to examine how far such ‘principlism’ should be applied to the management of ethical dilemmas in assisted reproductive technology (ART).
The potential for modern fertility treatment to offer the chance of biological parenthood to otherwise infertile couples, in an environment where patients have expectations of achieving all their goals, inevitably raises questions about both the entitlement to treatment and the nature of that provision.
Fertility treatment differs from other branches of medicine in two fundamental respects. First, the fertility patient is not ‘ill’ in any conventional sense even though their infertility may have a pathological basis. Infertility may be a source of significant morbidity causing depression and social dysfunction, but most people, and even most clinicians, would regard infertility more as a disadvantage or handicap such as extreme myopia or low intelligence. However, in some cultures, childlessness (which is still seen as a predominantly female ‘problem’) is a huge social stigma and the failure to ‘produce’ a child may result in divorce or extreme neglect. Second, infertility treatment is perceived as being generally ‘unsuccessful’ and is compared unfavourably with other treatments of acute conditions in surgery or therapeutics. This widespread perception is clearly mistaken, as modern fertility treatments offer cumulative success rates over several cycles of treatment that compare favourably with those of a normally fertile couple trying to conceive naturally.
Even in cases in which extraordinary procedures are required such as ovum donation for premature ovarian failure (POF) or percutaneous epididymal sperm aspiration (PESA) with intracytoplasmic sperm injection (ICSI) for obstructive azoospermia the eventual outcome of treatment is likely to be influenced more by lack of resources to provide the treatments required than by deficiencies in the techniques available.
Philosophical purists often claim that the successful delivery of a baby is not a ‘cure’ for infertility because the couple remain infertile as long as they rely on technology to assist them to procreate. This is sheer sophistry; a baby is a cure of infertility in exactly the same way as a beta blocker is a cure for hypertension. There may be some psychological benefits for the ultimately unsuccessful couple in just undertaking fertility treatment in that they may feel that at least their needs have been recognised and they have taken the opportunity to challenge their fate. However, one significant disadvantage of fertility treatment is that the desired outcome, the safe delivery of a healthy baby, is an ‘all or nothing’ event. Unsuccessful treatment can rarely offer palliation or therapeutic benefit in the way that a less than wholly successful operation may offer an acceptable if suboptimal outcome. Indeed a ‘biochemical’ pregnancy or early miscarriage following treatment may be perceived as ‘worse’ than a negative test.
Long-term follow-up studies of couples who embarked on fertility treatment but were ultimately unable to achieve a successful pregnancy have shown that they do suffer significantly initially in terms of depression and regret, but that over time (five to seven years) they return to levels of life satisfaction that compare favourably with the levels of those who did succeed with fertility treatment and with the spontaneously fertile. As would be expected, individuals who make a ‘positive’ decision to abandon further fertility treatment after repeated failures fare better than those who wished to continue but could not undertake further treatment because of age or resource allocation.
In clinical terms, the decision to offer fertility treatment has significantly different implications from all other (successful) clinical interventions. In treating other medical problems, successful end results clearly affect the patients, their relatives and to some extent the wider society, but a successful fertility treatment involves an additional party in the child who is born. This individual’s very existence inevitably has a significant influence on all other social and family relationships; indeed the arrival of the child may create the family.
To what extent the clinician needs to consider the potential existence of this, as yet un-conceived child, is a complex philosophical issue. The interests of people who may be born as a result of fertility treatment clearly are not as tangible as those of existing people, but legislation governing the application of the new reproductive technologies sets great store by the interests of the (possible) child. The Human Fertilisation and Embryology Act (1991) states that ‘centres considering treatment must take into account the welfare of any child that may be born’. From that standpoint it would seem difficult to justify restricting availability or access to treatments except in the limiting case where the expected quality of life of the child is so low that the child might realistically wish that he or she had never been born. All other children born as a result of fertility treatment (1.5% of all babies born in the United Kingdom and 8 million worldwide since 1987 following in vitro fertilisation [IVF]) represent a significant addition to the sum of human happiness, and this is so even if we ignore the happiness of their parents and relations.
It may seem that adding the interests of the ‘potential person’ to an equation for setting medical priorities in therapies that include fertility treatment involves a significant problem of incommensurability: how do we weigh the interests of ‘potential’ against those of ‘actual’ people? £5000 could ‘buy’ an IVF cycle for a young couple who, with fresh and subsequent, frozen embryo transfers, could realistically achieve the birth of at least one healthy child. That same £5000 would make very little contribution to the cost of providing ‘reprogrammed’ chimeric antigen receptor T cell (CAR T) therapy for a child with leukaemia who had relapsed after conventional treatment and which is currently estimated at £300,000.
The inevitable conclusion must be that withholding fertility treatment on the grounds of the interest of the ‘welfare of the child’ is a philosophically unsustainable position. Whether this is equivalent to claiming that we have a positive duty to ‘make more’ happy people is equally contentious. Perhaps this is a political rather than an ethical decision. Many governments have promoted pro-natalist policies because of concern about declining populations and falling birth rates, and in the era of ART, some governments are actively supporting state-funded fertility treatment as a way of ensuring that their citizens (usually the educated, professional classes who are most likely to be childless) are encouraged and helped to have children.
12.4 Ethical Approaches
Conventional medical ethics theory tends to be divided into consequentialist doctrines that purport to evaluate the outcome of clinical decisions in terms of consequences, good or bad, and rights- or rule-based systems that judge clinical decisions and outcomes in terms of the extent to which a ‘right’ is advanced or a ‘good’ rule applied. In the simplest case, a single successful cycle of IVF for a childless couple resulting in the birth of a healthy baby seems to be a purely positive outcome. On the basis of a cost–benefit analysis, the financial costs are modest (even allowing for the opportunity cost of diverting scarce resources to fertility treatment) and the foreseeable medium- and long-term consequences are equally positive.
Some potential negative consequences may be foreseen. For example, the child may be neglected or abused, or the couple’s relationship may founder under the psychological stress of even a successful cycle, but these are rare cases. As a society we recognise that a significant proportion of births are unplanned and accidental (50% according to some surveys), yet we would be horrified at the prospect of spontaneously fertile people being required to fulfil the criteria of ‘suitability to parent’ that some treatment centres impose on their patients in the name of equity or the ‘interests of the child’. One in five babies born in the United Kingdom grow up in a household with no father, but single women seeking to become mothers in a safe and lawful way face significant obstacles in accessing treatment and the financial burden is high.
Consider the analogy that is often drawn between allocating access to fertility treatment and authorities ‘choosing’ the best possible adoptive parents for a baby who has been given up at birth by its mother. Given the ‘shortage’ of healthy newborns available for adoption in the United Kingdom, and the large number of couples who would like to adopt a baby, it is generally accepted that the authorities must ‘choose’ the ‘best’ possible would-be parents for that child. But given the large number of children taken into our care homes, whose life outcomes are recognised to be very compromised, do we, as a society, accept that possibly ‘lower’ standards of potential parenting may be acceptable for prospective adoptive parents in these cases? Caring though half-competent parenting is infinitely preferable for ‘looked after’ children who have been rescued from neglect and abuse to them remaining in Institutions.
This is clearly a false analogy to make with decisions about the provision of fertility treatment. The child who may, or even will, be born as the result of successful fertility treatment can be born only to the would-be parents who came to the fertility clinic. They may not be, potentially, the ‘best’ parents, but they are the only parents that this, as yet unconceived, child can have.
Rights-based systems are ethically more contentious. Article 12 of the European Convention on Human Rights does protect the right to ‘found a family’, but this legislation was drawn up at a time when an individual’s right not to be compulsorily sterilised was the issue at stake, and in the era before ART was even envisaged. There can be no right to have a child, in the sense that somebody, possibly society, has a corresponding duty to provide successful fertility treatment. Demand for medical treatment, including fertility treatment, is theoretically unlimited because even in wealthy countries there will always be a disparity between what individuals could theoretically benefit from and what society can afford to provide. For this reason, the concept of rationing in healthcare, including fertility treatment, is accepted and the issue becomes one of ensuring justice, equity of distribution or simply rationing ‘fairly’.
‘Justice as Fairness’ requires a balancing of needs and deserts. In an acute or progressive clinical situation, the condition itself generates its own therapeutic agenda. Responsible clinicians treat the life-threatening and rapidly deteriorating conditions before the mild and stable, and little or no consideration is given either to the cost of the intervention, the responsibility of the patients for their condition or even the likelihood of a successful outcome. A computer algorithm that could predict the outcome of admission of a patient to an ITU with 98% accuracy (and therefore save the pain, anguish and expense of often a prolonged and ultimately futile time spent in intensive care) was condemned as inhumane. Yet, decisions about access to funded (or even private) fertility treatment are made on criteria with much less statistical rigour such as anti-mullerian hormone (AMH) levels or body mass index (BMI).
However, infertility patients are generally not perceived to be in this position, however great their distress. The condition itself does not deteriorate except in the sense that advancing female age may eventually make it less likely to succeed. Funding commissioners may feel entitled to consider the issue of desert and responsibility in the field of infertility treatment when they would not in any other medical arena. Diabetics who smoke or transplant patients who do not comply with their medication will still be treated, unlike fertility patients who are often held to be ‘responsible’ for their childlessness. Patients report, through tears, of being asked, ‘Why didn’t you start trying for a baby when you were younger?’ or ‘How do you think you got the Chlamydia that has blocked your tubes?’! Even when the needs of all infertile people are recognised, allocation of resources is often made on the basis of personal desert or utility. A 30-year-old childless married woman with tubal blockage due to peritonitis will be offered IVF on the NHS whereas a 36-year-old, previously sterilised, mother of two cannot get the treatment she needs to have a baby with her new partner. When discussing questions of need in this context, the issue is one of how to allocate limited resources so that utility is maximised and injustice is minimised. The sheer complexity of human motivation is such that the calculation of needs and deserts is fraught with difficulty, and that is assuming that we can answer the fundamental question of whether the fertile five-sixths of the population or the decision makers (i.e. the clinicians or commissioners who control access to treatment) are entitled to make judgments about the lifestyles, needs and deserts of the one-sixth of the population who cannot reproduce spontaneously.
Some authorities have claimed that if guidelines for access to fertility treatments can be agreed, then justice demands only that the guidelines are applied impartially: that is, the content of the guidelines is relatively unimportant. This type of ‘procedural’ justice is exemplified by the ‘post-code lottery’ that has prevailed in England and Wales notwithstanding the National Institute for Health and Care Excellence (NICE) guideline of 2004 which recommended three ‘full’ (including frozen embryo transfers) for all eligible childless couples.
A clinician may meet in her NHS fertility clinic, 10 consecutive couples from 10 different Care Commissioning Groups (CCGs), who will all have different criteria for eligibility for treatment (age, BMI, AMH, time-trying, age of partner, parity, smoking history …) and different treatment options (one, two or possibly even three cycles which may include freezing and frozen transfers, may include donor gametes, may even include funded transfer of frozen embryos for a sibling pregnancy).