Reproductive Medicine and Surrogacy PDF

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Summary

Reproductive Medicine Involuntary childlessness is broader than infertility – and reproductive medicine’s purpose should be considered along these lines. For example, fertility may be treated and there are ways in which the child may still be conceived. Reproductive medicine examples include: corre...

Description

Reproductive Medicine 

Involuntary childlessness is broader than infertility – and reproductive medicine’s purpose should be considered along these lines. For example, fertility may be treated and there are ways in which the child may still be conceived. Reproductive medicine examples include: corrective surgery, fertility drugs, medical advice on conceiving, artificial insemination, surrogacy, IVF, ICSI (if sperm cannot penetrate the egg in IVF), GIFT (embryo is created inside the body rather than in a petri dish, especially to alleviate religious concerns – in England and Wales for Roman Catholic). Note that the NHS does not include all reproductive medicine, it only covers IVF up to about 35%.

Legislation 

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The Human Fertilisation and Embryology Act 1990 was criticised by pro-life activists. It was amended. There is also the Human Fertilisation and Embryology Act 2008, which attempted to alleviate the widespread concerns of the 1990 Act. The 2008 Act is normally considered for conditions of parentage, otherwise reference must be made to the 1990 Act as amended. One of the things that the 1990 Act did that survives the 2008 Act is set up the Human Fertilisation & Embryology Authority (HFEA): - It is an independent regulatory authority, was publicly funded but today 80% of its funding comes from the clinics it regulates. There is a potential for conflict of interest – as due to its funding sources it might be disincentivised to close clinics that violate rules. Furthermore, it may be incentivised to readily provide licenses to clinics. - It maintains registers (ss.31, 31A and 31B of the 1990 Act). - It can issue mandatory directions (ss.23-24). - Required to maintain a Code of Practice (ss.25-26). Thus it does not have any legal authority to act, but it can lead to revocation of licenses. It can be used to provide evidence against clinics in civil and criminal actions. - 9th edition of CoP came into force in 2019 (revised in December). There are three regulatory responses to reproductive medicine that the 1990 Act adopts: - Outright prohibition: For example if you try to move human embryos to animals. - Prohibition subject to authorisation by a licence only. - Prohibition subject to authorisation by either a licence or a third party agreement with a licence-holder. Criminal offences (s41): prosecution requires the consent of the DPP (s42). This is to prevent interest groups from prosecuting unless there is public interest in doing so. Four types of licences available: treatment licenses; non-medical fertility services licences; storage licences; research licences. The 1990 Act does not cover all types of reproductive medicine. SS3 and 4 of the statute specify the treatment services that it covers: A licence or third party agreement may authorise: - The creation, storage, use, procurement, or distribution of an embryo outside of the body - The storage of gametes - The use of gametes, “other than partner-donated sperm [s1(5)] which has been neither processed not stored”

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Therefore, medical advice, corrective surgery, or fertility drugs are not covered by the Act. This means a clinic can provide these treatments or services without seeking a licence under the 1990 Act as amended. It remains legal to bypass the NHS when it comes to acquiring reproductive medicine, but the HFEA strongly advices against this due to problems arising due to lack of medical screening and parentage tracing. Clinics need approval and licences for treatments that do not include partner-donated sperm. However, even for partnerdonated sperm, there are licences required for packaging, storing and spermpreparation methods. Online procurement of sperm is also allowed as long as the website is licenced by the HFEA or has a third-party agreement with a licensee.

Legislative Requirements of the 1990 Act CONSENT: 

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The 1990 Act is a consent-based regime. Consent is required for most things except “basic partner treatment services” (s12(1)(c) and s1(2)): treatments not involving donor gametes outside of the body. Every other activity must comply with Schedule 3 of the 1990 Act, which stipulates requirement for valid consent. Before consent is given, there is the element of counselling and relevant information. This is because it makes consent more meaningful. This stage has also been described as a suitable opportunity to discuss and come to terms with treatments that might be more difficult for couples to accept: donor gametes, donor embryos and in vitro embryos. Counselling must be offered for particular types of parenthood, such as fatherhood or female parenthood conditions. These are found in s13(6) and Schedule 3ZA, Part 1/ss37 or 44: s13(6A) and Schedule 3ZA, Part 2/ Storage: Schedule 3, para 3 of the 2008 Act. Consent must be given in writing and signed (para 1(1)) and not withdrawn (“effective consent”) (para 3 of Schedule 3 of the 1990 Act). The consent documents must specify the purposes for which an embryo may be used (para 2(1)) and, for embryos and gametes, the maximum storage period and what is to be done if the person giving consent loses capacity or dies (para 2(2)). This will be relevant to posthumous use of gametes, which would require consent of the mother prior to death. The consent can be withdrawn or varies “by notice” (para 4(1)). Consent to the use of an embryo cannot be varied or withdrawn once it has been “used” for treatment, training or research (para 4(2)). There is some uncertainty around the meaning of the word “used”, which has resulted in litigation in Evans [2003], which involved the discussion of consent as defined in the 1990 Act Schedule 3 and 4, which allows both parties to withdraw consent until embryo implantation: FACTS: Evans was diagnosed with a precancerous condition that would require both her ovaries to be removed. Subsequent to this, her and her partner sought treatment at a clinic for IVF treatment. This treatment resulted in the creation for six embryos. Then, their relationship ended and the father withdrew his consent for the use of their embryos. He was still fertile and had a new partner, he didn’t want Evans to have his child as he did not want the financial or emotional burden of being a father to a child he would not himself bring up. For Evans, this was her only chance of having a genetically-related child, which she very much wanted. When they commenced the IVF treatment, both parents were well-informed that they may withdraw their consent at any point and cause the embryos to be destroyed – as required by the Act. Natalie’s argument rested on the definition of the word ‘used’. If it could be shown that the embryos had been ‘used’, then consent could not longer be revoked and the embryos

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would not be destroyed. To this end, she argued that freezing them, i.e. ‘storage’ constituted their use. DECISION: The Court of Appeal rejected Evans’ argument and found that freezing the embryos or storage did not mean that they had been ‘used’. Embryos are not used until implanted. Given that her ex-partner withdrew his consent before that, embryos should be destroyed. Natalie’s use of Article 8 of the ECHR in line with HRA 1998 was dismissed too. This was because it was found that Mr Johnston also had a right under Article 8 to withdraw consent – after all Article 8 requires a balance between competing interests. The case reached the Grand Chamber of the Strasbourg court, where Natalie argued breaches of Article 2, 8 and 14. Evans again lost this case. Under Article 2, embryos do not have a right to life – that falls under the margin of appreciation afforded to contracting State parties. Article 8 was applicable, but by majority the ECtHR found that based on Article 1 the interference was proportionate to protect Mr Johnston’s rights. With respect to Article 14 discrimination against those that require IVF, the Grand Chamber found that there was a reasonable justification to make such a distinction in the law. Despite the much-criticised decision and to the chagrin of pro-life activists pointing out what they perceived to be inherent flaws with the 1990 Act, the chance to change the law was not taken by the government in enacting the 2008 Act. The only change that the latter marked from the former was to add a “cooling off period” of 12 months before destruction (Schedule 3, para 4A of the 2008 Act). This would not have made any difference in the Evans case. If either party now withdraws their consent, the embryo will be destroyed after 12 months, in an attempt to see if the withdrawer would change the minds. Thus, the law is trying to balance the competing Article 8 rights of the mother and father. The State has a broad margin of appreciation in his instance as well. The question however arises that if this is to be viewed as a conflict between the Article 8 rights of the father and the mother, then the embryo has no legal status and as such receives no protection. If it did, it would create a broader and more easily advanced argument for non-destruction. The only case in which the embryo could be saved from destruction in a case where either parent withdraws consent is if undue influence is found. This principle is found in the UN Reproductive Medicine case, although not enough evidence was found there to constitute undue influence.

ACCESS: WELFARE OF THE CHILD 

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S13(5): “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 supportive parenting), and of any other child who may be affected by the birth.” On the face of it, it seems easy to understand that before providing fertility treatments to a woman, the clinic must account for welfare of the child. This is a vital provision as it restrains assisted reproduction by placing a condition on a woman seeking reproductive medicine. Depending on the interpretation of this condition, access can be restricted. Why should we take account of the interests of the future child whose existence depends on the treatment taking place, especially considering the embryo is not even considered worthy of Article 2 right to life protections under English law? Derek Partfit calls this a ‘non-identity problem’ and advances three possible justifications: - Utilitarian: Child’s welfare interests are relevant to overall utility. - Virtue theory: Assessment can reveal non-virtuous motives. - Rights and duty-based theories: Can reveal an intention to violate the rights of the child in the future, but there can be no right not be brought into existence.

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Treatment services as defined for the purposes of s13(5) as per s2(1) of the 1990 Act: ‘medical, surgical or obstetric services provided to the public or a section of the public for the purpose of assisting women to carry children’. Note then the definition of ‘treatment services’ is much broader than the Act’s categories of licence-regulated treatments. This means that if you are a licenced clinic, you must take the interests and welfares of the unborn child even if you are provided services that do not require licences. From a legal point of view, there is not much clarity of what is meant by the welfare of the child. However, the Code of Practice provides some guidance. Historically, the 1990 Act mentions that a child’s need for a father must be taken into account. However, the 2008 Act amends this to remove the bias in favour of heteronormative families. The statutory bias against single women or Lesbian couples seeking reproductive medicine has now been alleviated and replaced with the need for clinics to account for future ‘supportive parenting’. Is it appropriate for the Code of Practice of the HFEA to provide the guidance around gauging the welfare of the child rather than the law? This seems reflective of the Abortion Act 1967, which was a medical framework that emphasised the medical decision-making of professionals rather than stressing the autonomy of the woman. The Code of Practice has changed over time. What used to be a very broad interpretation of S13(5) is now interpreted more liberally and narrowly. The key features of the guidance: - “[T]he assessment must be done in a non-discriminatory way” (para 8.6). Despite its intentions, the implementation of this guidance varies from clinic to clinic, with single women finding it difficult to access reproductive medicine in some areas. - “The centre should consider factors that are likely to cause a risk of significant harm or neglect to any child who may be born or any existing child of the family” (para 8.14). The Court therefore interprets the welfare requirement in a narrow way – asking whether there is risk of significant harm or neglect – instead of a broader welfare analysis. - “Supportive parenting is a commitment to the health, well being and development of the child. It is presumed [that any parents will be supportive parents]…in the absence of any reasonable cause for concern…” (para 8.15). Thus, there is an evidential burden to show that a group of parents or a parent will not be supportive for the purposes of S13(5), which can limit prejudice. This means that clinics cannot without a good reason refuse to provide treatment to parents. The type of examples of ‘reasonable cause for concern’ that the CoP provides to clinics wanting to refuse treatment includes: previous convictions for harming children, child protection measures taken with respect to existing children, drug or alcohol abuse, etc. - If treatment is refused, the clinic should explain the decision in writing (para 8.20). NB that the Code of Practice does not have a strictly binding formulation and does not remove discretion from the hands of clinics. As expected, there has been litigation challenging the discretion exercised by clinics to refuse treatment: (NB that the case law timeline below predates the now revised S13(5) of the 1990 Act as amended, but nevertheless demonstrates how limited opportunities are to challenge this discretion) - R v Ethics Committee of St Mary’s Hospital ex parte Harriott [1988] (pre-1990 Act case). FACTS: The patient had a criminal record relating to prostitution and the clinic claimed that she did not have an understanding that was required to fulfil the parental role she sought to take on. She and her husband were rejected adoption or foster services, so now they sought IVF. When the clinic learnt the reasons for denial of adoption, the physician took them off the waiting list.

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DECISION: The patient challenged this decision through the use of judicial review but she lost. The Court said that the decision of the physician was not unreasonable under Wednesbury unreasonableness criterion. Thus, the clinic could not be compelled to reconsider. - R v Sheffield Health Authority ex parte Seale [1994] (related to NHS funding but still has some relevance. FACTS: Applicant was 37 years old and Sheffield Health Authority had a policy of not funding IVF for anyone above the age of 35. She sought judicial review. DECISION: The Court found that the Health Authority’s decision was not unreasonable as at the patient’s age it becomes less likely that IVF would be successful. - R (Mellor) v Secretary of State for the Home Department [2002]. FACTS: Mellor was serving a life sentence and argued against the refusal of the Home Office to allow him and his wife artificial insemination so that he may conceive a child while he was still in prison. He argued that this was a disproportionate interference with his Article 12 right to have a family. DECISION: The Court rejected Mellor’s argument. They concluded that the restriction of rights here was part and parcel of the deprivation of liberty that imprisonment sought to achieve. - Dickson v Premier Prisons [2004]; Dickson v UK (2007). FACTS: Prisoner who wished to undergo artificial insemination. He wished to have a baby with a woman he married while he was still in prison, they had never met in person. She would be in her fifties by the time Dickson got out, and she wanted to start a family now. She sought judicial review. The case reached Strasbourg. DECISION: The High Court and subsequently the Court of Appeal rejected the application for three particular reasons: a) the relationship has never taken place outside of a penal environment; b) there was insufficient provision of the child’s material interests; c) the restriction was a proportional interference with the nature of the punishment for Dickson’s crimes. At Strasbourg it was found that this was not a disproportionate interference with the applicant’s Article 12 rights due to the lack of a blanket ban – the Home Office decided each case individually on its merits and that was within the State party’s margin of appreciation. The lower Chamber of the Court, however, did not agree with the government that losing freedom through imprisonment is equated to losing the ability to have children, unless there were other security threats. The Grand Chamber however upheld that appeal – saying that the State’s policy was based on a threshold that was too high and did not strike the right balance between private and public interest. The Grand Chamber said that the welfare of the child is relevant here and that the State has a positive obligation to guarantee it. Notwithstanding that duty, the State cannot use it as an excuse to prevent prisoners from trying to conceive a child. That is because the Home Office’s current methodology did not allow for proportionality assessments on a case-bycase basis, and thus effectively served as a disproportionate blanket ban. The conclusion that can be drawn from this case is that as long as there is no blanket ban on welfare grounds or any restriction does not operate effectively as a blanket ban, it is very difficult, though not impossible, to challenge a decision not to provide reproductive medicine to parents.

Donor Anonymity

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Those who want access to assisted reproduction can require a donor sperm or donor egg. It is relatively easy for those willing to donate sperm, but donating eggs is much more challenging from a medical point of view as the medical intervention required is more invasive. As per S31 of the 1990 Act, the HFEA is to maintain a Register to store the information of those who donate. Historically, the young men who donated sperm for spare cash could choose to remain anonymous to the child that was eventually born. This is a challenge, as it is emotionally hard for a child to never be able to find out who their genetic father is. Arguments against donor anonymity drew upon adoption, where the adopted children after growing up would still have access to details about their biological parents. A case was brought in the UK arguing that donor anonymity is contrary to rights of the child under the ECHR. What the UK did before the case was that definitively concluded that the law should be changed. Since 31 March 2005, there is a method to find information about the donor – with donor anonymity no longer completely accepted. As a result, when the child turns 16, they are entitled to non-identifying information, as specified by the regulations: HFEA (Disclosure of Donor Information) Regulations 2004/1511, Reg. 2(2). This includes donor age, ethnic group, place of birth, etc. The children are also entitled to find out about the number and age of their half-siblings. When the child turns 18, they are entitled to identifying information such as name, last name, the last known address and date of birth of the donor, as specified by regulations: Reg. 2(3) (provided after 31st March 2005). This means that the law is not retroactive – it only applies for donors whose children have been conceived after April 1 2005. The first child who will be able to benefit from these regulations will be able to do so in 2023 – as that is when they will turn 18. There is no legal requirement for the birth certificate to...