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Assisted Reproduction: Is it Appropriate for the Law to Intervene?

In this article, Anna Nelson (4th Year LLB ), looks at whether the use of Artificial Reproductive Technologies justifies moving the act of reproduction out of the private sphere and into the public one, thus allowing for regulatory intervention.

Assisted Reproduction: Is it Appropriate for the Law to Intervene? 

 

Personal medical decisions are largely considered to be individual in nature. For this reason, the law generally tends not to intervene in medical matters, however assisted reproduction is subject to arguably intense regulation.  It must thus be asked what about assisted reproduction is so notably different so as to warrant this intervention. Natural reproduction is seen by most as an inherently private matter with little justifiable scope for legal

intervention, however, legal intervention within the realms of what we understand to be assisted reproduction is a more contentious issue.  The central question in this article will be whether there is sufficient justification to support the regulatory approach of the UK, which brings assisted reproduction into the public sphere while leaving natural reproduction unregulated.

 

 

The Law: An Overview

The UK is not alone in singling out reproductive medicine as an area requiring regulatory concern, however, UK regulation in this area is considered to be amongst the world’s most comprehensive.[1]  The Human Fertilisation and Embryology Authority (HFEA) was established by the Human Fertilisation and Embryology Act 1990, following the Warnock Commission’s report on matters pertaining to assisted reproduction.  The HFEA is designed to act as an impartial body, with the primary purpose of monitoring and licensing fertility clinics and embryonic research.  In 2008 an updated Human Fertilisation and Embryology Act was passed; this retained the same framework and primary purpose, whilst attempting to update and modernise some specific provisions. 

When considering whether seeking medical assistance in reproduction takes us outwith private realm and into the public sphere, there are a number of contrasting views and moral and ethical standpoints which must be assessed and evaluated in light of the UK’s regulatory approach.

 

Reproduction: An Inherently Private Matter?

                                                                                                   

Some regard any intervention in assisted reproduction as simply wrong on the basis that reproduction is, and ought to remain, an inherently private matter. Those who subscribe to this view often suggest that deregulation of assisted reproduction is the only approach which can adequately reflect the appropriate role of the State in this intimate area.[2]    However, there are many who disagree with this proposition.  The most radical disagreement is voiced by Dillard who describes procreation as the ‘antithesis of the personal’.[3]  This strong assertion stems from his belief that the creation of another person changes our legal relationships and creates new legal obligations to a greater extent than any other act does, and thus cannot be protected by privacy.[4]    Another attack on the proposition that assisted reproduction must remain a private matter is that the area of reproduction as a whole is actually not as free from legal ‘interference’ as some suggest.  This can be seen by the fact that an non-therapeutic sterilisation of a person with incapacity must be judicially approved. This can be seen to demonstrate that protection of the patient can provide sufficient justification for interference with the privacy of reproductive matters, especially in cases where a third party (generally a doctor) is involved.  

 

A final point raised specifically against the privacy of assisted reproduction is the impact this has on public services.  There is a greater risk of dangerous multiple pregnancies when reproductive techniques are applied,[5] and English notes that the NHS takes on the ‘financial burden’ of dealing with these.[6]  Thus, given the impact that assisted reproduction can have on public services, in a way not generally caused by natural conception, it can be suggested that these techniques must appropriately be brought outwith the realm of the private and regulated in order to control their financial impact.  

 

Whilst clearly rejecting the opinion that deregulation is the only appropriate step, the system in the UK nonetheless strikes an appropriate balance in this matter.  It focuses on licensing clinics, with a view to ensure safety.  Thus, it revokes reproductive privacy only when aiming to ensure that minimal medical harm occurs to patients, and resultantly ensuring that the cost of any medical mishaps in minimized.

 

 

Procreative Liberty: Should this Always Prevail?

 

The primacy of procreative liberty is often used to assert states ought not interfere with assisted reproduction.  Many argue that this is a principle embedded in ‘any democratic culture’[7] and that the denial of this based on what people may disapprove of, short of the existence of any actual harm, would amount to allowing ‘tyranny of the majority’,[8] which is an ideology incompatible with today’s rights-based society.  For this reason, some believe that only deregulation adequately respects the liberties of citizens.[9]  There is a slightly milder view expressed by some commentators, such as Robertson, that as reproductive autonomy is a ‘widely recognized prima facie right’ it ought not be limited ‘except for very good reason’.[10]  This acknowledgement that interference may be justified strikes a good balance, and thus it must be evaluated whether the reasons espoused for inference attain the standard required for justification.

 

Generally, the British regulatory system is considered to be a facilitative one which arguably recognizes the importance of procreative liberty.  It is permissive - it allows rather than prohibits access to assisted reproduction, stepping in only to license clinics and try and ensure safety for both service users and doctors.  Thus, a balance is struck where a person still has the liberty to access and chose from a number of techniques, while attempting to ensure safety.  

 

The Welfare Justification: A Consistent Principle?

 

It is generally accepted that the law can intervene to protect the welfare of the patient, but a more contentious question arises in procreative matters: can the welfare of the future child act as a justification for intervention?  The protection of subsequent offspring was one of the major reasons established by the Warnock Committee for the creation of a regulatory system however there are two key questions raised by this:

 

  1. Should the welfare of a potential person should outweigh an existing person’s reproductive autonomy?
  2. Why should welfare considerations be restricted only to those seeking assistance to conceive?

 

When discussing justification for the regulation of assisted reproduction, one possible response is that it is appropriate to regulate the area in order to protect the welfare of a child which will be born as a result.  English suggests that the fact that there is  ‘at least a potential person, whose interests must be considered’ as well as those of the parents, ‘legitimises’ the state’s involvement.[11]  This is a view which has been met with strong criticism.  Walker is particularly vehement in his opinion that potential persons have “no standing” – be it moral, legal or ethical – in relation to those who exist.[12]  He suggests that the idea of the welfare of a person requires that that person is able to value this to some degree; thus they must first be in existence in order to be a ‘valuer’.  Thus, as potential persons cannot actually be harmed – and so their welfare need not be protected – they are unable to appreciate any maleficence or any protection from this.  Given the current climate shift of medico-legal jurisprudence towards the protection of patient autonomy, the temptation is to lean favorably towards the position of Walker and suggest that it ought to be up to the parents – the existent persons – alone to decide how they wish to proceed in their reproductive choices.

 

 Regardless of whether the welfare of a potential person is accepted as appropriate justification, however, protection of society and of patients themselves from coercion or abuse by clinics remain valid justification for intervention.  Our society is such that the law will intervene to protect people in circumstances of risk, even if this restricts autonomy to an extent. Thus, in line with the recommendations of the Warnock Commission, protection of the patient can be viewed as an acceptable justification for interference with reproductive privacy and liberty.

 

In addition, the suggestion that regulation is required to protect the welfare of a future child only in assisted reproduction can seem illogical.  Jackson points out that those seeking such treatments will have ‘invariably given considerable thought to parenthood’[13], which cannot be said for all who conceive naturally.  Surely it follows that if we are to bring assisted reproduction into the public realm with the safety of child as a justification, we ought to do so for all who wish to reproduce?  Harris and Alghrani note that a parental licensing scheme of all reproduction should be implemented if we are to be serious about the welfare of a potential child.[14]  The key rebuttal of this is that the test will always be too speculative and imprecise and will never be sufficiently certain to serve as justification for interference with privacy and reproductive autonomy.[15]  Additionally, the practical difficulties would be huge; how would unlicensed parents be effectively reprimanded? Removal of the child or criminalization of the parent would likely be the only effective punishments but these would also be counterproductive to the aim of ensuring the child’s welfare.  Logically, to reject this scheme for some parents means to reject it for all – including the unfortunately infertile. Thus, absent the desire and will to regulate all parents, perhaps none should be regulated. To regulate only some seems discriminatory and contradictory.  While the welfare of the future child is a commonly cited justification for interference, some question whether it is ever appropriate to consider the potential person before the existing.  It is contended that a potential person has no legal or ethical standing in relation to those in existence[16], and as such the potential of harm to the future child cannot justify intervention.  Only imminent and real harm to a real person or society as a whole can justify the regulatory interference with reproductive liberty.

 

This issue is reflected in the British regulatory system, which makes a ‘welfare consideration’[17] a precondition for access to services.  In addition to the problems demonstrated by consideration of the wider ethical issues there is also a key practical concern.  S13(5) of the Human Fertilisation and Embryology Act 1990 is criticised for being worded excessively vaguely.  Mason suggests it is ‘so imprecise as to be either all-embracing or meaningless’.[18] This means its application can often lead to inconsistent decisions, especially due to the inclusion of ‘subjective social questions’[19] which doctors may be ill-qualified to answer, or whose answers will depend, to some extent, on personal beliefs.  This section was improved by the 2008 Act which replaced the requirement for consideration of a father with the need for supportive parenting, thus removing at least one aspect of discrimination from the test.[20]  It has been suggested that due to its inconsistent nature, and the burden this places upon only non-natural parents, s13(5) is an ‘unjustifiable violation of reproductive liberty”[21] and ought to be abolished.

 

 

Illogical Exclusions?

 

With this in mind questions can be raised over the procedures which have been left unregulated.  Self-insemination with fresh sperm is not covered, thus no safeguards exist to ensure the quality of donor consent, nor is the sperm subjected to testing to prevent HIV transmission.[22] However, obvious practical issues would arise if this were regulated – how do we adequately control what happens in the privacy of people homes?  There are also a number of supra-ovulatory drugs available, unregulated by HFEA, even though these carry a high-risk of multiple pregnancies, with potentially tragic results.[23]  It would be fairly easy to bring these within the regulatory scope, although this may be more costly and complex than the current system of GP prescription. For a long time Gamete Intra-Fallopian Transfer (GIFT) was perhaps the most controversial, unregulated procedure. It requires invasive medical intervention in order to place the sperm and eggs together in the fallopian tube.  There is currently no limit on the number of eggs which can be transferred and the risk of multiple pregnancy is higher than with IVF.  Given that this already involves a specialist, and carries more risk than the (regulated) IVF, the exclusion of GIFT from HFEA’s remit made little sense.  However, this particular illogicality was rectified, as paragraph 7 of the HFEA Code of Practice[24] now regulates the number of eggs which can be transferred in these circumstances. While this may be seen as a move signifying awareness in the UK about the seeming illogicality of the regulatory framework, one ought to be wary of taking this opinion as the change was actually enacted following the European Union Tissue and Cells Directives 2007, which obliged the UK to regulate the use of GIFT.[25]

 

The exclusion of these techniques can be considered a ‘regulatory lacuna’[26] and it is a prolifically-expressed concern that the risks of these procedures ought to place them within the reach of regulation. The illogicality of the situation is captured by Brazier when she notes: ‘paradoxically it seems that procedures more likely to cause harm are beyond the reach of regulation’.[27]  It is also noted that one should be wary as seeing the regulation of GIFT as too big a step forward in this area, due to the fact that this only occurred once it was necessitated by an EU Directive, rather than as a result of parliamentary debate or reasoning.  Thus the justification for regulation seems to have been contradicted, and a clear inadequacy in the current legislation exposed.  Though this could be seen as an argument in favour of de-regulation, this is a conclusion we ought to be wary of.  English encourages us not to risk ‘throwing the baby out with the bath water[28] and it is contended that this is an apt assessment of the situation.  Simply because the regulation which currently exists is not perfect does not mean that the situation would be improved by its removal.  In fact, the inadequacy exposed may be best dealt with by extension of the current regulatory scheme.

 

Conclusion

 

English asks whether we can still justify prioritisation of protection over individual autonomy in today’s individual rights-based political climate.[29]  Following examination of the issues on each side of the argument, the conclusion has been reached that where protection of the patient is the justification, intervention with a person’s reproductive liberty and autonomy may be acceptable.  However, those arguments favouring the welfare of the potential child over the existing person’s autonomy are less convincing.  The British regulatory system works fairly well when considered in light of this: its licensing system works to ensure that clinics are safe and do not take advantage of patients. That said, the current framework in the UK has some issues regarding illogicality which ought to be addressed and it is proposed that reform be enacted which removes the welfare test and which brings, at least, GIFT within the scope of the regulation. 

 

 

[1] English, V.  Autonomy versus protection—who benefits from the regulation of IVF? 2006 Human Reproduction Journal

[2] McLean, S.  Modern Dilemmas; Choosing Children 2006 Capercaillie Publishing

[3] Dillard, C. Rethinking the Procreative Right 2016, Yale Human Rights & Development Journal p50

[4] Dillard C (See No3)

[5] Jackson, E. Regulating Reproduction: Law, Technology & Autonomy 2001 Hart Publishing p184

[6] English, V (See No1)

[7] R. Dworkin, Life's Dominion 1993. Harper Collins.  p166.

[8] J. Mill, On Liberty in M. Warnock  Utilitarianism 1962. Collins. p129.

[9] Jackson, E (See No 5)

[10] Robertson, J. Children of Choice; Freedom & the New Reproductive Technologies (1994)

[11] English, V (See No1)

[12] Walker, S.E.P., Potential Persons and the Welfare of the (Potential Child) Test 2014 Medical International Law

[13]  Jackson, E (See No5)

[14] Alghrani, A and Harris, J.  Reproductive Liberty: Should the Foundation of Families be Regulated? 18 Child & Fam L.Q. 191 2006

[15] Ibid.,

[16] Walker, S.E.P (See No12)

[17] 1990 Act S13(5)

[18] Laurie, J. Mason, A. Law & Medical Ethics 9th Ed. Oxford 2013

[19] Elliston, S. The welfare of the child principle and the use of PGD 2012 Routledge p166

[20] Human Fertilisation and Embryology Act 2008, s14(2)(b)

[21] Algrhani & Harris (See No14) p5

[22] Jackson, E (See No5) P184

[23] Ibid.,

[24] Human Fertilisation and Embryology Authority Code of Practice 8th Edition 2016 s7

[25] Directive (2004/23/EC)

[26] Jackson, E (See No5) p185

[27] Brazier, M. Regulating the Reproductive Business? Medical Law Review 1999 p1

[28] English, V (See No1)

[29] English, V (See No1)

 

 
 

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