• Home
• Order now
• Prices
• How we help
• Press
• Law marking
• Contact us
• Resources
• Log in

Clinical Legal Regulation

Reproductive Choice Should Not Be Subject to Clinical or Legal Regulation

I - Introduction

When considering the issue of reproductive choice, a straightforward and relatively easy answer can be given. On the whole, such choice is neither the subject of legal nor clinical regulation. The choice to procreate for most of humanity is related to the underlying concept of sexual freedom and autonomy which requires that an individual has complete control over the self.

The main consideration at stake in reproductive decision making is whether an individual wishes to engage in heterosexual intercourse in order to try and achieve a pregnancy. Jackson notes that such people are able to conceive 'without any external scrutiny of the merit or otherwise of their decision.' This is because there is a general acceptance amongst society that truly private decisions are not to be interfered with by the state, unless there is extremely good reason for doing so.

This approach has traditionally been justified by liberal philosophers such as John Stuart Mill, who argue that the only justification for interfering in private decisions is when such decisions cause harm to others. To a certain extent this right is also protected by Article 8 of the European Convention for the protection of Human Rights and Fundamental Freedoms. The essence of these approaches is that the state will not interfere in the scope of private decisions. These approaches therefore encompass negative rights because individuals cannot insist that particular action is taken; only that it is not. In the context of this discussion, private decision making therefore encompasses the right to procreate naturally.

In essence, the issue which arises in relation to the discussion concerns the difficulties that arise in other aspects of reproductive choice concerning more controversial issues. For example, the person seeking an abortion because it was simply unplanned is, to a certain extent, exercising their 'reproductive choice' by choosing not to reproduce. In this context, there are a number of clinical and legal controls.

Similarly, individuals that lack competence do not have complete and unrestricted rights to reproduce, but this is arguably because such decisions are not capable of forming the subject of choice for those people. It is the third category that raises the majority of the discussion in this paper; those who require assistance to procreate because of fertility problems or simply because they require access to assisted reproductive technologies (ART) for some other reason. In all three of these instances, the law and to a certain extent, clinical regulation, stipulates the extent of reproductive choice. This paper will examine those regulations and whether they are justified.

II - Assisted Reproductive Technology

Those who are unable to fulfil their reproductive choices in the sphere of private decision making due to infertility may seek assistance from clinicians in order to procreate. Whilst such choices arguably remain as private decisions, the action or assistance needed to carry out and fulfil those choices take the matter outside the sphere of private decision-making.

Medical advances over the past 40 years have provided methods of conceiving that were not previously possible. Infertility can be caused by a number of reasons, ranging from blocked fallopian tubes, to the male partner's low sperm count. There are a number of techniques that can be performed to deal with these problems. Couples that are able to produce their own genetic material but have had little success in establishing pregnancy can seek assistance in a number of ways. The process of in vitro fertilization (IVF) involves obtaining sperm and eggs (both also referred to as gametes) and mixing them outside of the body in order to create an embryo.

Hormones can be prescribed to the woman to cause her to super-ovulate and this enables clinics to ensure that more than one egg is harvested and multiple embryos formed. The procedure carried out to remove the eggs is invasive and surgical in nature. The most suitable embryos are then implanted in order to achieve a pregnancy. The process can often be stressful for participants because of the relatively low success rate, particularly when embryos are used after cryopreservation (freezing).

Within the process of IVF, there are further methods available to cater for reproductive 'choice'. Where the male partner has a low sperm count, a process known as intracytoplasmic sperm injection (ICSI) can be used which involves injecting a single sperm into the egg. Further, a process known as pre-implantation genetic diagnosis (PGD) can be used to screen for genetic characteristics of an embryo. This process involves conducting a biopsy on the embryo to remove one of its eight cells (or thereabouts).

The removed cell can then be examined in order to establish the genetic characteristics of the created embryos and decide which embryos contain particular genetic conditions or defects, so that the inheritance of genetic disease can be avoided. PGD can also be used to detect the tissue-type of an embryo prior to implantation. This enables parents to create a child of matching tissue type to an existing ill child so that the tissue of the new child can be used to attempt to cure the existing child.

This can occur by the provision of blood stem cells from the placenta after birth or bone marrow from the child. The implications of these latter treatments take the focus of ART away from the provision of services to relieve clinical and medical problems associated with infertility, to the provision of services on the basis of need or choice. The underlying justification for making ART services available was traditionally to provide treatments to those who were medically infertile or at risk of passing on genetic disease through natural conception, and many jurisdictions have not departed from the strict regulatory approach.

As will be discovered, the UK approach is more liberal. However, the developments in the use of ART have raised a number of ethical concerns and this has recently provided stronger argument for the imposition of clinical and legal regulation. This section of the paper will examine the nature of ART regulation and whether it is justified.

Aside from IVF procedures, there are other options to cater for reproductive choice, such as gamete intra-fallopian transfer (GIFT) which involves placing sperm and eggs (apposed to a fertilised embryo) inside the woman in order to try and achieve a pregnancy. Not all cases will require the provision of IVF or alternative techniques and some women can achieve pregnancy through artificial insemination (AI). There are a number of scenarios in this context, some more ethically problematic than others.

For example, where the procedure is carried out using the sperm of the woman's partner, there are fewer ethical concerns involved compared to when a woman is inseminated with the sperm of a donor (referred to as donor insemination (DI)). Furthermore, there are questions that arise in relation to whether single and lesbian women should be granted access to fertility services in order to fulfil their reproductive choices.

One further issue that raises profound moral concerns is the practice of surrogacy. The practice of surrogacy may enable a woman to have a genetically related (or also a non-genetically related) child without carrying the pregnancy to term herself. Thus, in this scenario, another woman is implanted with the embryo created from the gametes of another couple to try and achieve a pregnancy (the process can also involve a woman being inseminated by another man's sperm to create a non-genetically related child to the commissioning mother).

These controversial techniques are all subject to some form of regulation in the UK and the remainder of this paper will now consider two issues. First, the reasoning and justifications put forward to intervene in reproductive choices of individuals will be considered, followed by an analysis of the regulatory structure overseeing the provision of ART. Finally, in context of developing uses of ART, the specific issue of using IVF and PGD to create tissue-matched children will be considered.

III - Justifying Intervention

As was discussed in the preceding paragraphs, the range of ART procedures mentioned raises concerns and each may offend some of the moral and ethical beliefs of members of the community. With regards to the range of issues mentioned in this paper alone, a significant number of people are involved other than simply those seeking to carry out their reproductive choices, whilst on the other hand some issues can be decided purely by the woman alone (such as using contraception and undergoing a sterilisation procedure).

In the latter case, the law does not interfere, and to a certain extent cannot interfere. Skene comments that the 'law will not intervene unless she places her child at risk by abuse or neglect and even then, the law will not intervene until the child is actually born.' Skene goes on to note that it is misleading to say there are no laws regulating some of these activities:

Hospitals and day centres, for example, are required to provide safe premises and properly trained staff. Health professionals are required by the law of contract and negligence to take reasonable care in looking after their patients. This includes providing sufficient information to the patient about medical procedures to enable her to make an informed decision about them. And there are rules for determining who has responsibility for looking after children and maintaining them financially. These laws apply however the child is conceived.

Despite the initial statement in this paper that most individuals seeking to carry out their reproductive choices will not be subject to regulation, it is clear that any deviation from standards imposed by society will be dealt with by the law. However, the scope of reproductive choices outlined above which require assistance by the medical profession (such as IVF) are monitored and heavily regulated in the UK (this will be discussed further below). This occurs for a number of reasons.

Primarily, the interests of the child to be born are considered as paramount (this too will be considered below). Secondly, other parts of the regulatory regime are aimed at protecting the health and interests of the prospective parents. For example, regulation may impose requirements in relation to counselling so that the difficulties faced in establishing pregnancy using ART are adequately addressed. A further clear example of regulation placing the safety of participants as a priority within the regulatory regime is evident from the requirement that clinics do not transfer multiple embryos to a woman seeking treatment, because of the risks associated to the woman's health with multiple pregnancies.

Other clinical practices may be regulated so that the safety and impact of fertility procedures is maintained and this may involve setting detailed and comprehensive clinical guidelines on issues such as storage of gametes and other reproductive material. Thus, the latter may be aimed at preventing mishaps and mix-ups in treatment procedures such as those experienced in the case of Leeds Teaching Hospital NHS Trust v A.

The case involved a white woman, Mrs A who sought IVF treatment with her eggs and the sperm of her husband (Mr A) who was also white. She became pregnant and later gave birth to mixed race twins because her eggs had been fertilised with the wrong sperm, that of Mr B, whose wife was also receiving IVF treatment in the same clinic.

In absence of regulation, it would be necessary to consider how individual disputes would be settled and the impact this would have on the provision of services overall. Firstly, it should be noted that even with a statutory system of regulation in place, the courts have had to address issues as they have arisen.

Thus, in absence of a system of regulation (either legal or clinical) the potential for disputes in the field of ART would be increased because of the uncertainty of policies and procedures, and a significant number of issues would have to be decided by the courts. Szoke comments:The process of the common law, which relies on judges responding to cases which come before them, is piecemeal and does not take into account the complexities of issues associated with the development of science and technology, and how they may have an impact on private actions.

A detailed system of regulation takes away this problem and the conflict of values that might otherwise occur in an unregulated context of ART services is therefore better dealt with by the elected representatives in an open, transparent way. Others however, argue that 'the regulation of ART has become a political issue out of proportion to its real significance'. Thus, Baker comments:

It should be unacceptable in a democratic society with a broad spectrum of views on the ethics of ART for one section to dictate its moral requirements to all and to crusade successfully for restrictive legislation that affects the whole community.

In response to Bakers comment, even in absence of regulation ART standards would be left to one section of the community; the medical profession. Some may argue that as many medical issues are currently left to the realms of the doctor-patient relationship, the subject of ART should be no different. However, there are a number of areas of medical practice that involve at least some legal regulation, and a significantly higher number that are subject to clinical regulation.

Medical bodies and hospitals will quite often set their own standards of clinical practice on a wide range of issues. In addition, legal regulation is also formed to compliment many of these guidelines. Thus, traditional concepts of medical ethics and regulation that were historically decided by the profession alone have been rejected. Beauchamp and Walters note that this 'conception has collapsed in the face of pressures of the modern world. Such a professional morality has been judged not adequately comprehensive, coherent, or sensitive to conflicts of interest.' Other commentators also note that there is need for regulation from outside the fertility industry. Black comments:

Regulation has an important role to play in connecting the arguments of participants, in facilitating the integration of the wide range of views as to the appropriate course that technology and its regulation should take.

Black's article comments on the competing views of science and the layperson, recognising that at present, it is the views of science that are granted objectivity, and that lay views are therefore viewed as irrational, based on ignorance and mere emotions or prejudices.

On this account, 'it is that the languages of science, commerce, ethics, ecology, law are foreign to each other; neither can hardly understand what the other is saying, let alone why they are saying it.' Therefore, on Black's approach, regulation can act as an interpreter of these different languages in order to facilitate communication in to an understandable medium understood by all participants which is sufficiently transparent.

Thus, the argument for regulation becomes more compelling. The current regulatory framework in place in the UK is comprehensive for dealing with many areas of ART practice.

IV ART Regulation in the UK

The regulation in the United Kingdom covers the use of embryos in vitro for both treatment and research, the storage and use of gametes (including the use of donated gametes), some limited aspects of surrogacy, and also the legal status of children born as a result of ART. Petersen and Johnson describe the UK legislation as being 'relatively permissive, containing a limited number of express prohibitions, but is otherwise facilitative of a flexible regime administered by the Human Fertilisation and Embryology Authority' (HFEA).

The HFEA has a number of functions outlined under the legislation. One of fundamental importance, is to produce the Code of Practice (currently in its seventh edition), which goes beyond the statutory provisions outlined under the UK legislation. It elaborates on the provisions, providing clinics with advice as to what constitutes good practice. The most recent edition of the Code of Practice contains two divisions, outlining standards that are required of licensees, as well as guidance as to how licensed activities are to be carried out.

The provisions in the HFEA's Code of Practice form the basis of clinical guidelines in the UK because they are not legal guidelines as such. However, the legislation overseeing the regulation contains mechanisms of enforcing the Code and also sets out the categories of licence applicable to clinics. The first category deals with activities that are illegal and cannot be licensed (such as some instances of cloning).

Second, there are activities that are illegal unless carried out pursuant to a licence granted by the HFEA and it is under this heading which most fertility procedures (including IVF) would fall. Third, there are activities which were not originally covered by the 1990 legislation and therefore did not need to be performed under a licence, such as artificial insemination of a woman using 'fresh' gametes (this included artificial insemination by either a male partner or a donor, and GIFT).

This is because the 1990 legislation only partially covered the dealing with human gametes. Storage of eggs or sperm in any case requires a licence, but prior to the implementation of the European Union Tissues and Cells Directive (EUTCD), where storage was not involved a licence was not required.

This could include cases where gametes are used for research purposes (where the gametes are not stored) and for procedures involving fresh gametes that are used to inseminate a woman immediately (the gametes are again not stored), or processes which did not involve the creation of an embryo in vitro (such as GIFT). Some commentators have criticised the ambit of authority afforded to the HFEA with respect to some of the procedures falling under this third category:

... the HFEA's ability to comprehensively ensure the safe and ethical provision of infertility treatment in the UK is undoubtedly undermined by the existence of a few largely unregulated techniques.

As a result of the EUTCD, any donation, procurement, testing, processing or storage of human gametes for the purposes of assisted reproduction must be licensed by the HFEA or be subject to an agreement with a licensed service. Furthermore, as a condition of licence, all donated sperm or eggs must be screened for diseases and quarantined for six months, requiring the gametes to be frozen.

The only exception to this requirement applies to a woman being inseminated by her partner's sperm. Even in the latter instance, if sperm from a partner is to be stored, it must also be screened. The EUTCD has been incorporated into the framework of the 1990 legislation.

The EUTCD has tightened the level of regulation in the UK requiring nearly all cases of artificial insemination to be performed under licensed conditions. This may act to ensure the safety of those using donated gametes by preventing the transmission of communicable when using donated sperm.

The EUTCD also encompasses procedures such as GIFT, surgical procedures carried out to collect sperm and eggs, and preservation and testing of sperm for human application (including sperm washing, sperm sorting and sperm viability tests). All of these procedures must now be carried out under a license granted by the HFEA.

Whilst the EUTCD has dealt with some of the issues not covered by the 1990 legislation, the use and storage of embryos ex utero (whether for treatment or research purposes), has always been comprehensively dealt with by the legislation. This means that all cases of IVF can only be provided by licensed centres.

The licensing requirements are set out in detail under the legislation. According to the HFEA's Second Annual Report, '[o]ne of the most important aspects of the whole inspection and licensing process is to promote and sustain good practice and, in doing so, to ensure a consistent approach.'

Once a license is granted, there are a number of conditions automatically attached to the licence. Licensed centres must ensure that the consent provisions contained under Schedule 3 of the legislation are complied with, that the welfare of the child to be born as a result of the treatment is taken into account in accordance with section 13(5) of the legislation, and that storage periods for gametes stipulated are not exceeded. Licence committees are also able to attach specific conditions to a licence and also make recommendations aimed at improving practice within the centre seeking the licence.

1 Gaining Access to Fertility Services

The main assessment which is to be made by any clinic operating under the legislation is that:

A woman shall not be provided with treatment services unless account has been taken of the welfare of any child who may be born as a result of the treatment (including the need of that child for a father) and of any other children who may be affected by the birth.

This provision does not limit access to fertility treatment on the grounds of the individual per se, but imposes a principle in determining whether treatment should be granted based on the considerations of the welfare of any child to be born. The requirement under section 13(5) was formulated as a result of the recommendations in the Warnock Report that it was 'better for children to be born into a two-parent family, with both father and mother.'

Furthermore, following the failure of an effort to limit treatments to married couples, section 13(5) could be viewed as a compromise for those who were pressing for a narrower drafting of the eligibility criteria when the Bill was progressing through Parliament. As was discovered above, one of the justifications for imposing regulation in this field is because of the need to protect children born as a result of ART and this is the fundamental aim of the welfare principle.

The imposition of a risk assessment of the child to be born based on welfare criteria has received significant criticism. Jackson notes that the effect of this provision is that centres must take 'into account the prospective patient's aptitude for parenthood.' Factors required to be taken into account include previous criminal convictions, family protection measures taken regarding existing children, and incidents of domestic violence.

Furthermore, any history affecting the ability of those seeking treatment to care for their children in the future, such as psychological disorders or alcohol/substance abuse, or any medical conditions having the same effect, must also be taken into account. Where factors are apparent to the centre, they are required to seek the patient's consent before obtaining information from third parties such as the patient's GP, or any agencies or authorities. It seems clear based upon the guidance given by the HFEA's Code of Practice that the assessment is mostly based upon the suitability as parents of those seeking treatment services.

Jackson's analysis begins by focusing on a comparison between the ability of fertile people to procreate without any intrusion by the state, with the situation faced by infertile people when they seek assistance in carrying through their reproductive choices. The latter find themselves judged by clinicians who are required by law to assess their 'suitability' as parents. This comparison is the basis of Jackson's arguments and is evaluated against the backdrop of decisional privacy:

My claim is that we should refrain from scrutinising the pre-conception decisions of adults who intend to bring about a child's creation just as we would if they had happened to be able to conceive naturally. Notice that this is not the same as saying that people have a right to be provided with infertility treatment. On the contrary, my argument here is much more modest. It is simply that we should each have the liberty to shield certain personal decisions from public scrutiny.

Jackson goes on to argue that the imposition of the welfare principle is incoherent, disingenuous and illegitimate. The importance of Jackson's argument is that this difference in approach may be more justified in cases where those seeking treatment are arguing that they are entitled to have their desire to have a child fulfilled, which would require some positive action by the state.

However, the fundamental issue is that those seeking treatments should be free to fulfil their own goals and wishes, without intervention from the state. This approach is an issue relating to negative rights or liberty. Jackson does note however, that the concept of privacy (which is central to her argument) does not cover all of the issues at stake in the debate surrounding ART, but it is one that has become heavily obscured by the application of the welfare principle.

The second criticism of the principle is that it is disingenuous. The reasoning put forward for this claim is that the principle is, in practice, incapable of distinguishing between adequate and inadequate parents. Accordingly, clinicians are not trained to assess parenting ability and do not have access to adequate information in order to make the decisions that are required of them under the welfare principle. Jackson points out the obvious example that is incorporated directly into the UK legislation, requiring clinics to favour two parent families, and notes that single parenthood does not necessarily equate to risk of harm to a potential child.

The recent proposal to amend section 13(5) of the UK legislation would take away the duty to consider the need of the potential child for a father. This is a controversial proposal and it could be argued that the removal of such a requirement throws into question the exact reasoning behind the welfare principle applicable to ART.

If passed, the reformed legislation would suggest that single parents are capable of being 'suitable' parents, and therefore, what further factors will berelevant when assessing the welfare of a child who is not yet born in light of a divergence of opinion on those who make suitable parents? Furthermore, it could be argued that in light of the recent changes to the HFEA's Code of Practice, Jackson's arguments are strengthened.

Thus, the changes imply a presumption in favour of providing treatment and rely on the honesty of those seeking treatments to reveal past circumstances which may be relevant to parental suitability and provide consent for any contact with third party agencies.

Jackson's is essentially arguing that the welfare principle be removed. As the suitability for parenting of those seeking to reproduce naturally is not regulated; the same should apply to those who need assistance to reproduce because of medical problems. This latter proposition is different to saying that all people should be granted access to IVF.

Further, Jackson's arguments are narrower than the proposal that ART should be completely unregulated. The latter is a more contentious proposition because of the fact that there are so many more issues at stake. The welfare principle on the other hand, relates to one particular part of the current legislation. It should be noted that Jackson does raise some valid points that apply to the general discussion of whether ART should be subject to regulation.

Other commentators have heavily criticised Jackson's evaluation of the welfare principle. Laing and Oderberg argue that the proposal to remove the welfare principle would leave open the opportunity for other types of practices such as cloning, sex selection and the creation of animal-human hybrids leaving such issues unregulated. However, this proposition misses the crucial point that these alternative practices are in fact regulated aside from the general provision of ART.

The difficulty faced in the context of regulation is that if a system of regulation is in fact implemented (which seems inevitable following the current discussion), then the priorities of the regime need to be established. The current approach recognises the welfare of the child to be born as paramount, but arguably the welfare principle does not achieve such aim.

Other factors are also placed as significant, such as the health of participants undergoing treatments is also protected under the system of regulation. Regulation (in any form) will never succeed in protecting these factors absolutely because there is always room for human errors and errors of judgment. However, the systems can aim to reduce and minimise such concerns.

IV Novel and Controversial Techniques and Reproductive Choice

The last part of this paper will examine the development of policy on the use of PGD for the purpose of establishing the tissue-type of an embryo. There are essentially, two categories of case that are relevant in this instance. The first involves couples who seek to use the technology because of need: they are at risk of transmitting a genetic disease through natural conception and therefore need to ensure that an implanted embryo is free from that disease.

They also utilise the technology for tissue typing to ensure the new child created is of a matching tissue type to an existing sick child. Thus, tissue typing is ancillary to avoiding disease. The second couple have no need to use IVF; they choose to use IVF so they can utilise PGD solely for the purpose of establishing tissue type. Even if it can be argued that they need to use IVF to cure their existing child, the distinction is that this need comes from the child and not those seeking IVF.

As a licence is required by clinics carrying out PGD, one condition of such licence is that permission is sought in particular cases, such as using PGD for this purpose. The HFEA has developed policy on a case-by-case basis, and originally required that the primary purpose for using PGD was to prevent the transmission of a genetic disease. Tissue-typing was permitted where it would be ancillary to the main purpose of PGD: prevention of transmitting the genetic disease from which the existing ill-child is suffering.

This affirms a view that ART services can be provided where there is medical need but not choice. In subsequent decision making, the HFEA asserted that those seeking to use PGD solely for the purpose of tissue typing were not able to meet this requirement and therefore unable to gain access to the technology for that purpose. During the cases presented before it, the HFEA began to build up policy on when it was, and was not permissible to use PGD for the purpose of tissue-typing leading to the current policy contained in the Code of Practice.

The initial distinctions made between using the process primarily for the purpose of preventing genetic disease (tissue-typing is ancillary to this purpose), and using it solely for the purpose of tissue-typing were based on legal, welfare and ethical grounds, and have received heavy criticism. The HFEA's Licensing Committee originally held that the UK legislation enabling clinics to conduct 'practices designed to secure that embryos are in a suitable condition to be placed in a woman' did not include suitability for the sole purpose of tissue typing. However, as was confirmed by the Court of Appeal, 'suitability' is a matter for the woman seeking treatment to decide.

Aside from the legal issues faced by the HFEA, some of the other reasons raised for distinguishing between PGD for detecting genetic disease and tissue type, and using it solely for establishing tissue type, were based on the welfare principle and ethical reasoning. Thus, when using PGD for detecting genetic disease and establishing tissue type, the possible physical risk of harm to the child to be born arising from the biopsy procedure itself (which was not known at the time the policy was formulated), was justified because the procedure would ensure that the child to be born was free of the genetic disease being tested for.

In such case, establishing the tissue type of the embryo could be done by examining the same cell that was removed to detect the presence of genetic disease. However, in the case where PGD is conducted solely for tissue typing, the risk of harm present in the biopsy procedure was not considered justified. In the latter case, the possible risk of harm to the child to be born was not in that child's benefit, but for the benefit of the existing ill-child.

This demonstrates that in the context of creating tissue-matched children, the welfare principle was applied in a different way which was not concerned with the 'suitability' of parents. In examining the ethical issues involved, the HFEA had used the potential for harm to the child as a justification for preventing use of the technology solely for establishing tissue type. Joining the welfare considerations with the precautionary principle in relation to possible harm to the child was considered confusing in the development of policy in this context. Furthermore, the use of ethical reasoning to justify the distinction originally drawn has received criticism.

In this context, regulation has been decided on a case-by-case basis where individuals are seeking to exercise reproductive choice. Whilst it is clear that there are profound ethical implications for those seeking to exercise reproductive choice (consider alternatives such as social sex selection, reproductive cloning etc), it could be argued that a more justified and consistent approach is needed for a respectable system or regulation to prevail. The way in which the HFEA developed its policy has received considerable criticism. It is accepted that the need for regulation per se is justified, but it is the way in which regulation is developed and applied that needs further consideration.

Secure your law degree, order your law essay today!

Order Now. It takes less than 2 minutes.

1. * Name   
2. * Email   
3. * Phone   

1. * Your essay question 
   (please give as much detail as possible)  

Copyright © 2012 All Answers Ltd. All Answers Ltd is a company registered in England and Wales with Company Registration No: 4964706 VAT Registration No: 842417633 - Law Teacher - The law essay professionals