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Regulation of Fertility Treatment

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Lecture notes, textbook notes, academic articles and class notes on the regulation of fertility treatment. From the London School of Economics and Political Science. Emily Jackson textbook and lecture notes. Ideal for medical law exams and essays! In-depth notes to succeed :) From a top 2:1/1st c...

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  • 19 mai 2020
  • 16
  • 2019/2020
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Week 7:
Assisted Conception: Regulation of Fertility Treatment:
The History of In Vitro Fertilisation:
- First in vitro fertilisation of an egg achieved in 1969.
- First IVF baby (Louise Brown) born 1978.
IVF Today:
- 5 million IVF babies born world wide!
- 2% of children born in the UK are conceived in vitro
- Generally regarded as an acceptable means for infertile couples to have a child.
- BUT some objections:  sceptical
o Destruction of embryos
 As many more embryos are created than implanted
o Feminist objections
 That women need to be mothers
 That those who can’t have a baby are somehow lesser
o State and commercial involvement in reproduction
 Shouldn’t be a profit-making activity
o Confusing kinship relations – especially with donated gametes.
 Harms to children
But… IVF is not a Panacea!
- Live birth rate per fresh treatment cycle for women
o under the age of 35 = 32%
o aged 38-39 =27%
o age 40-42 =15%
o aged 43 -44 = 11%
 = not an answer to age-related fertility loss!
History of the Regulation of Fertility Treatments:
1969 First report of successful in vitro fertilisation of an egg
1978 First IVF baby born
1982 Warnock Committee appointed
1984 Warnock Report published
1985/6 Unborn Children (Protection) Bills – based on Warnock recommendations
By 1989, a lot of the criticism/fears concerning embryo destruction had softened, resulting in the HFEA Act
1990 Human Fertilisation and Embryology Act
2008 HFE Act amended

Human Fertilisation and Embryology Authority:
- Organisation made up of mainly laypeople
- Functions include
o Regulation: carries out inspections, collects data, incidents, alerts, grants licences for treatment, storage or
research (criminal offence without licence).
o Register: must maintain a register of information about the provision of treatment and its outcome
o Policy: must maintain a Code of Practice and advise the Secretary of State.
- Can respond to changing clinical practice e.g. 9th edition of Code of Practice contained provisions to prevent multiple
births
o So they can respond quickly to scientific changes
o Need to reduce multiple births
Licensing:
- Sections 3 and 4 HFE Act 1990: creation, use, and storage of embryos, and the storage and use of gametes, can only be
carried out under a licence granted by the HFEA.
- Licenses up to 5 years
- HFEA can carry out unannounced inspections on clinics
- Clinics must report incidents and ‘near misses’
- HFEA can vary or withdraw licence.
- HFEA = public body = subject to judicial review and must comply with HRA

Limits on the HFEA’s Powers:
- Cannot control the market in fertility services!
o Cannot control the prices of treatment
- No jurisdiction outside of the UK:
o Reproductive tourism attractive because:
 Cheaper
 Cheaper in India than in the UK
 Quicker e.g. shorter waiting lists, more donor gametes
 In Spain, more egg donors than in the UK

,  Avoids legal restrictions e.g. on sex selection
 Treatment/ care might be better
o … but there are a number of concerns with going abroad!
 Inequality of opportunity
 The rich get to skip the queue while the poor have to wait on the NHS [who only fund one
round of IVF]
 Concerns for health of mother and baby if regulations loose
 E.g. multiple pregnancies rules!
o In the US, it is allowed – e.g. woman who had 8 babies at once
o Cost the NHS ten times the cost to care for triplets than a single baby
 May emboldened countries to enact stricter regulation in their own countries  as they argue that
women can always just go abroad, so wouldn’t be undermining their reproductive rights or autonomy
 E.g. SH v Austria (ECtHR)
o Courts relied, in part, on the cross-border availability of reproductive treatment to
uphold Austria’s strict regulations
Barriers to Accessing Fertility Treatment:
- Assessment of child’s welfare
o HFE Act 1990, as amended, s.13(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.
o Used to have a clause that said including the need for a father, which was later taken
out admist concerns about equality laws
 Concerns about s13[5] – are fathers unimportant?
o Discriminatory?
 No-one assesses whether fertile couples would make good parents?
 Rather, perhaps those who undergo IVF are more committed?
o Do doctors have the information necessary to assess this?
 Adoption takes a lot of analysis before allowing a child to be adopted,
unlike in IVF. Are doctors equipped?
o What are the consequences of breaching s13(5)?
 Could you ever say a child was better off not having been born? 
wrongful life claim!
o In 2008, despite controversies, govt didn’t take out s.13[5] and instead Child Risk Assessment:
 Code of Practice, 8.15
 When considering a child’s need for supportive parenting, centres should consider the
following definition:
o ‘Supportive parenting is a commitment to the health, wellbeing and development of
the child. It is presumed that all prospective parents will be supportive parents, in the
absence of any reasonable cause for concern that any child who may be born, or any
other child, may be at risk of significant harm or neglect. Where centres have concern
as to whether this commitment exists, they may wish to take account of wider family
and social networks within which the child will be raised.’
 Just whether the parents would, for some reason, pose a risk to a child.
 Rare that parents are denied on this basis, and if they are, unlikely to go to
court but rather just another clinic
o Challenging Access to IVF:
 Dickson v United Kingdom (Application no. 44362/04) (2007)
 Grand Chamber:
 SoS prevented prisoner from accessing treatment.
 Claimed this was a breach of article 8 rights
o ECtHR:
 Interference with article 8 rights
 The wife wouldn’t be able to have IVF until she was 51- seems
unnecessarily onerous
o Seen as a disproportionate interference
 They won!
 Public weren’t happy about this
 Offending public opinion is not a valid justification for preventing access to
treatment
 Argued that it would undermine the deterrent impact of prison
[including that while in prison, you cannot have a baby] – this,
while agreed upon, still failed.
- Cost
o One cycle of IVF may cost more than £5,000

, o Availability within NHS patchy! Despite NICE guidelines…
 61% of CCGs provided one full cycle
 12% of CCGs provided three full cycles
 3% of CCGs provided no NHS services at all
o GCC can impose their own conditions
 Turns it into a postcode lottery  dependent on your area of living
 Tension with the idea that this is some fundamental right
o Should the NHS be funding fertility treatment?
 Women not being able to have children is having a profound effect on their mental health and
wellbeing  so they ought to be funded in the same way that other things that impact our wellbeing are
 But, others argue that it shouldn’t be awarded special treatment it should be treated in the same way
as other things that impact our wellbeing are. Not just a medical question. There are things like
education that have a similar impact.
Consent: [Regulation of gametes]
- Consent must be given for storage and use of one’s gametes in writing (Sch 3)
- Consent must state what should be done with stored gametes in the event of the donor’s death or incapacity
- Gametes can be used posthumously but only if the gamete provider has explicitly consented to this.
Posthumous use of Gametes:
- R v Human Fertilisation and Embryology Authority ex.parte Blood [1996] 3 WLR 1176
o Facts:
 Mrs Blood asked for sperm cells to be extracted while her husband was in a coma
 Following discussions they had where he had consented to his sperm being used after death but this
hadn’t been put down in writing.
 The sperm couldn’t lawfully be used in the UK
 Wanted to export them to Belguim where the sperm could be used under their legislation. HFEA
refused her. She appealed this decision and won
 Even though it was unlawful in UK, she has a right under EU law to do so [as they had taken
the sperm already]
o Lord Woolf MR
 … the reasons given by the authority, while not deeply flawed, confirm that the authority did not take
into account two important considerations. The first being the effect of article 59. The second being
that there should be, after this judgment has been given, no further cases where sperm is preserved
without consent….
- L v Human Fertilisation and Embryology Authority [2008] EWHC 2149 (Fam)
o Charles J:
 the evidence that H would have wanted his sperm used posthumously by L was ‘at least as compelling
as that advanced by Mrs Blood’: L and H already had a child together and six days before H’s death
they had enquired about the possibility of using IVF, due to L’s age.
 both storage and use of H’s sperm in the UK would be unlawful, but the HFEA had a wide discretion to
permit export. (permitted December 2008)
- R (on the application of M) v HFEA [2016] EWCA Civ 611
o in stating that there was no evidence to support the view that A wanted her mother to carry her child if she died,
the Committee waved aside the conversation between A and her mother in January 2010. This explicitly dealt
with this situation. Yet the HFEA continued to say on this appeal that the January 2010 conversation was simply
a general discussion. However, A did say “I want you to carry my babies.” …
- Y v A Healthcare NHS Trust [2018] EWCOP 18,
o Knowles J:
 My order declared that, by reason of his traumatic brain injury, Z lacked capacity to provide his written
consent for fertility treatment for the purposes of the HFE Act, such written consent being required for
the storage and use (but not for the retrieval) of his gametes. Notwithstanding that Z lacked capacity, I
declared that it was lawful for a doctor to retrieve his gametes and lawful for those gametes to be stored
both before and after his death on the signing of the relevant consents storage and use and that it was
lawful for his gametes and any embryos formed from his gametes to be used after his death. I also
declared that the court was satisfied that the requirements of Schedule 3 to the HFE Act in relation to
consent were met in those circumstances.
Storage and Use of Embryos:
- Both contributors must provide their consent for the embryo to be thawed and implanted = either party has a veto.
- What happens if they disagree?
o Evans v UK (Application no. 6339/05):
 The Grand Chamber does not consider that the applicant's right to respect for the decision to become a
parent in the genetic sense should be accorded greater weight than J's right to respect for his decision
not to have children
o Is the impact on the woman far greater than on the man? She cannot have any
children [as she had ovarian cancer and the embryos made were the only option she
had]

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