Assisted Conception – Notes
• The world’s first IVF baby, Louise Brown, born 25th July 1978 in Oldham.
• Bob Edwards received Nobel prize for medicine in 2010
o Took a while for recognition because it was seen as hugely problematic and the
inventors were shunned.
• IVF promotes subsequent developments, e.g. preimplantation genetic diagnosis,
mitochondrial replacement –> It does not solve age-related infertility.
• Daly and Bewley: IVF not designed to overcome egg degeneration. Takes current
younger generation longer to reach milestones which were attainable for previous
generations. Passing through at a later age has itself now become normalised.
o Women no longer think in terms of normative age, but psychological milestones
and feeling ready to have children.
Now IVF is routine:
• More than 5 million babies born worldwide.
• Over 60,000 IVF cycles per year in the UK
• Two per cent of all UK babies conceived via IVF
Less opposition than when it was new:
• BUT still some critics:
o Pro-life (status of embryo)
o Feminist: Male doctors were experimenting on women’s body was one line of
argument.
▪ Pushing the idea that women should be caretakers and birth givers.
▪ Purdy: AC subjugates women due to social pro-natalism that pressurises
women to undertake costly and risky procedures to remedy infertility.
▪ Pro-natalism and the attitude that women are worthless or unfulfilled if
infertile is pervasive in society.
▪ Men run science and medicine, and women’s need for help add to men’s
power over them.
▪ Onus of barrenness makes some women undertake IVF when it is their
husband who suffer from reproductive problem
▪ AC should not be banned though because it would treat women as legal
incompetents that need special protection against themselves.
o State (and commercial) involvement in reproduction?
o Confusion of kinship relations: esp. donated gametes?
▪ You might have complicated kinship relationships
Regulation in the UK
• Human Fertilisation and Embryology Act 1990, amended 2008
o First baby was born in 1978. In the time lap, a gradual recognition that regulation
was necessary and also, a gradual acceptance.
Human Fertilisation and Embryology Authority HFEA:
• Majority are lay persons (not clinicians or scientists)
,• Regulator has 3 duties
o Regulation: Carries out inspections, collects data, incidents, alerts, grants
licences for treatment, storage or research (criminal offence without licence).
▪ Tight regulation, IVF without licence means you are criminally liable.
o Register: Must maintain a register of treatment, donors, children etc.
▪ Registers can give information of who biological parents are.
o Policy: Must maintain a Code of Practice and must advise Secretary of State for
Health on primary legislation.
Code of Practice (9th ed)
• Advantages of using Code and Directions rather than primary legislation: to regulate
fast-moving area of clinical practice/scientific research with shifting evidence base.
• E.g. Single Embryo Transfer (SET) for high risk women due to health risks with multiple
pregnancies for babies and women.
o Higher rates of miscarriage.
o Doubles risk of maternal death
o 48.4% of twins have low or very low birth weight (8.2% of singletons)
o 40-60% of IVF twins are transferred to neonatal intensive care units
o Twins are 4 - 6 times more likely to suffer from cerebral palsy than singletons
o Twins are 6 times more likely to die in the first year of life than singletons.
• E.g. rules on the number of embryos that may be transferred in one cycle of IVF;
• Each centre must have a ‘multiple birth reduction strategy’, needs to have a policy in
reducing strategy.
• Set progressively lower upper multiple birth limit: was 24%, now 10%
o Multiple birth limit used to be 24% (no more than 24% multiple pregnancies in
clinics) it is now 10%.
• Should set out who should receive elective single embryo transfer (eSET) – e.g. younger
women (<35 or <37) and women on their first cycle of treatment.
o Those who have good prognosis (good chance of getting pregnant) should have
one embryo put back, they are more likely to get pregnant (37 years of age or
younger). Older women are less likely so can have multiple embryos put back as
they are unlikely to have multiple births.
• But legal status of Code is unclear – a breach is not a criminal offence. Breaches can be
taken into account by a licence committee on whether to revoke a licence.
Licensing
• Why special regulatory regime compared with other similarly risky medical treatments,
e.g. prescription of fertility drugs (both of which associated with risk of ovarian hyper-
stimulation syndrome.)
o Health risks associated with the treatments like ovarian hyper-stimulation
syndrome? But other potentially risky medical treatment are not subjected to
this sort of special regulatory framework. Some of the risks associated with IVF
also exist for unlicensed treatments like prescription of fertility drugs.
o Special moral concern for embryos created outside female body –> but this
rationale doesn’t apply to other licensed treatments like donor insemination.
, o Creating children through artificial means raises ethical dilemmas: who should
be permitted to have access to treatment –> but then compare with lax
regulation of surrogacy.
o Most persuasive explanation is the form regulation takes in the UK reflects the
historical context in 1989, when original Bill was drafted. Professional bodies,
such as RCOG had not yet produced practical guidance given the novelty and
controversy of IVF. Better to consolidate rules of best practise within a licensing
regime but now there is extensive professional guidance available to clinicians.
o HFEA increasingly relies on professional bodies to develop guidance: British
Andrology Society’s involvement in setting appropriate age limits for sperm
donors.
• Different types of licence: 1) treatment services; 2) non-medical services; 3) storage of
gametes and embryos; 4) research on embryos.
• Standard licensing conditions:
o Consent provisions (Schedule 3).
o Welfare of child that might be born
o Statutory storage periods for gametes and embryos not exceeded
• Decisions as a public body must comply with Human Rights Act –> must be
proportionate, lawful (within statutory powers), rational (Wednesbury
unreasonableness), take into account relevant factors.
• Judicial review more likely to be successful of procedural grounds.
o R (Assisted Reproduction and Gynaecology Centre) v HFEA [2002]: Court has no
role if Authority’s decision was rational and had not exceeded its powers –>
Disagreements on substance not a concern for court.
o R (Assisted Reproduction and Gynaecology Centre) v HFEA [2013]: successfully
challenged Authority’s power to place a condition on all clinics’ licences before it
had had the chance to contest that decision through representations and an
appeal, and hence interfered with clinical practice –> procedural ground.
Limits on HFEA’s
• Powers are limited
• (a) No control over the market in fertility treatment (Brazier)
o It does not control prices, majority of fertility treatment is privately funded. HFEA
does not control how much private clinics charge.
o Concerns about clinics selling add-ons. Fertility patients are really susceptible to
these. If you are paying 5k in cycle of IVF, you are hugely invested in it working
and are likely to take on the add-ons if advised as something that will increase
their likelihood of success.
o Fertility clinics have a vested interest in the expansion of their business. The
more treatment cycles a woman undergoes, the more people seek treatment,
greater the profit.
• (b) No control over cross border reproductive care
o Increasingly common for patients to go overseas for IVF. Oversea clinics are
marketing to international customer base.
o Those wealthy enough to participate in reproduction markets can readily evade
their domestic constraints.
• The world’s first IVF baby, Louise Brown, born 25th July 1978 in Oldham.
• Bob Edwards received Nobel prize for medicine in 2010
o Took a while for recognition because it was seen as hugely problematic and the
inventors were shunned.
• IVF promotes subsequent developments, e.g. preimplantation genetic diagnosis,
mitochondrial replacement –> It does not solve age-related infertility.
• Daly and Bewley: IVF not designed to overcome egg degeneration. Takes current
younger generation longer to reach milestones which were attainable for previous
generations. Passing through at a later age has itself now become normalised.
o Women no longer think in terms of normative age, but psychological milestones
and feeling ready to have children.
Now IVF is routine:
• More than 5 million babies born worldwide.
• Over 60,000 IVF cycles per year in the UK
• Two per cent of all UK babies conceived via IVF
Less opposition than when it was new:
• BUT still some critics:
o Pro-life (status of embryo)
o Feminist: Male doctors were experimenting on women’s body was one line of
argument.
▪ Pushing the idea that women should be caretakers and birth givers.
▪ Purdy: AC subjugates women due to social pro-natalism that pressurises
women to undertake costly and risky procedures to remedy infertility.
▪ Pro-natalism and the attitude that women are worthless or unfulfilled if
infertile is pervasive in society.
▪ Men run science and medicine, and women’s need for help add to men’s
power over them.
▪ Onus of barrenness makes some women undertake IVF when it is their
husband who suffer from reproductive problem
▪ AC should not be banned though because it would treat women as legal
incompetents that need special protection against themselves.
o State (and commercial) involvement in reproduction?
o Confusion of kinship relations: esp. donated gametes?
▪ You might have complicated kinship relationships
Regulation in the UK
• Human Fertilisation and Embryology Act 1990, amended 2008
o First baby was born in 1978. In the time lap, a gradual recognition that regulation
was necessary and also, a gradual acceptance.
Human Fertilisation and Embryology Authority HFEA:
• Majority are lay persons (not clinicians or scientists)
,• Regulator has 3 duties
o Regulation: Carries out inspections, collects data, incidents, alerts, grants
licences for treatment, storage or research (criminal offence without licence).
▪ Tight regulation, IVF without licence means you are criminally liable.
o Register: Must maintain a register of treatment, donors, children etc.
▪ Registers can give information of who biological parents are.
o Policy: Must maintain a Code of Practice and must advise Secretary of State for
Health on primary legislation.
Code of Practice (9th ed)
• Advantages of using Code and Directions rather than primary legislation: to regulate
fast-moving area of clinical practice/scientific research with shifting evidence base.
• E.g. Single Embryo Transfer (SET) for high risk women due to health risks with multiple
pregnancies for babies and women.
o Higher rates of miscarriage.
o Doubles risk of maternal death
o 48.4% of twins have low or very low birth weight (8.2% of singletons)
o 40-60% of IVF twins are transferred to neonatal intensive care units
o Twins are 4 - 6 times more likely to suffer from cerebral palsy than singletons
o Twins are 6 times more likely to die in the first year of life than singletons.
• E.g. rules on the number of embryos that may be transferred in one cycle of IVF;
• Each centre must have a ‘multiple birth reduction strategy’, needs to have a policy in
reducing strategy.
• Set progressively lower upper multiple birth limit: was 24%, now 10%
o Multiple birth limit used to be 24% (no more than 24% multiple pregnancies in
clinics) it is now 10%.
• Should set out who should receive elective single embryo transfer (eSET) – e.g. younger
women (<35 or <37) and women on their first cycle of treatment.
o Those who have good prognosis (good chance of getting pregnant) should have
one embryo put back, they are more likely to get pregnant (37 years of age or
younger). Older women are less likely so can have multiple embryos put back as
they are unlikely to have multiple births.
• But legal status of Code is unclear – a breach is not a criminal offence. Breaches can be
taken into account by a licence committee on whether to revoke a licence.
Licensing
• Why special regulatory regime compared with other similarly risky medical treatments,
e.g. prescription of fertility drugs (both of which associated with risk of ovarian hyper-
stimulation syndrome.)
o Health risks associated with the treatments like ovarian hyper-stimulation
syndrome? But other potentially risky medical treatment are not subjected to
this sort of special regulatory framework. Some of the risks associated with IVF
also exist for unlicensed treatments like prescription of fertility drugs.
o Special moral concern for embryos created outside female body –> but this
rationale doesn’t apply to other licensed treatments like donor insemination.
, o Creating children through artificial means raises ethical dilemmas: who should
be permitted to have access to treatment –> but then compare with lax
regulation of surrogacy.
o Most persuasive explanation is the form regulation takes in the UK reflects the
historical context in 1989, when original Bill was drafted. Professional bodies,
such as RCOG had not yet produced practical guidance given the novelty and
controversy of IVF. Better to consolidate rules of best practise within a licensing
regime but now there is extensive professional guidance available to clinicians.
o HFEA increasingly relies on professional bodies to develop guidance: British
Andrology Society’s involvement in setting appropriate age limits for sperm
donors.
• Different types of licence: 1) treatment services; 2) non-medical services; 3) storage of
gametes and embryos; 4) research on embryos.
• Standard licensing conditions:
o Consent provisions (Schedule 3).
o Welfare of child that might be born
o Statutory storage periods for gametes and embryos not exceeded
• Decisions as a public body must comply with Human Rights Act –> must be
proportionate, lawful (within statutory powers), rational (Wednesbury
unreasonableness), take into account relevant factors.
• Judicial review more likely to be successful of procedural grounds.
o R (Assisted Reproduction and Gynaecology Centre) v HFEA [2002]: Court has no
role if Authority’s decision was rational and had not exceeded its powers –>
Disagreements on substance not a concern for court.
o R (Assisted Reproduction and Gynaecology Centre) v HFEA [2013]: successfully
challenged Authority’s power to place a condition on all clinics’ licences before it
had had the chance to contest that decision through representations and an
appeal, and hence interfered with clinical practice –> procedural ground.
Limits on HFEA’s
• Powers are limited
• (a) No control over the market in fertility treatment (Brazier)
o It does not control prices, majority of fertility treatment is privately funded. HFEA
does not control how much private clinics charge.
o Concerns about clinics selling add-ons. Fertility patients are really susceptible to
these. If you are paying 5k in cycle of IVF, you are hugely invested in it working
and are likely to take on the add-ons if advised as something that will increase
their likelihood of success.
o Fertility clinics have a vested interest in the expansion of their business. The
more treatment cycles a woman undergoes, the more people seek treatment,
greater the profit.
• (b) No control over cross border reproductive care
o Increasingly common for patients to go overseas for IVF. Oversea clinics are
marketing to international customer base.
o Those wealthy enough to participate in reproduction markets can readily evade
their domestic constraints.
