Assisted Conception Flashcards
Warnock Committee
Established in order to make recommendations on the regulation of fertility treatment and medical/research use of embryos.
Led to the Human Fertilisation and Embryology Bill 1990 (HFEA).
s 5 HFEA
Set up the HFEA body. Functions of the HFEA:
- Regulates fertility and embryology research.
- Issues licences and maintains register about treatments and outcomes.
s 25 HFEA
Statute provides that the HFEA must publish a Code of Practice which gives guidance to clinicians about proper conduct of licensable activities.
HFEA can also issue Directions on specific issues, which licensed clinics must comply with.
Flexible model of regulation because it is primarily governed by soft law, rather than primary legislation. HFEA can respond to a shifting evidence base (= good) as unlike legislation it can constantly update its practices by amending its Code of Practice and issuing Decisions.
Legal status of Code of Practice
Legal status is unclear. It is not a criminal offence to break the HFEA Code of Practice, but HFEA can take into account any breaches when deciding to revoke or vary licences.
ss 3-4 HFEA
Creation and storage of embryos requires licence granted by the HFEA. This imposes a special framework for the use of embryos/AI.
Reason = context of 1990s Act. This was a new and morally controversial field. RCOG had not at the time of the Warnock Commission developed its own best practice guide. Therefore, Parlt. felt this area justified additional regulation.
R (Assisted Reproduction and Gynaecology Centre) v HFEA)
CA said that provided HFEA’s decision in granting, varying or revoking a licence was rational and within its powers, the courts have no role. HFEA’s licensing decisions therefore subject to standard irrationality public law test - Wednesdbury unreasonableness.
Current context of assisted conception
- Primarily a private market since NHS treatment is limited.
- HFEA can issue licences to private entities which then charge very large sums of money for treatment. HFEA cannot control their prices.
- Reproductive tourism is possible, particularly in Europe and increasing in demand -> Shenfield et al estimate that there are 24-30,000 cycles of cross-border IVF in Europe each year.
s 13(5) HFEA 1990
Restriction on access to IVF treatment - welfare clause. Originally enacted in HFEA 1990 as a requirement that there must also be a prospective father in addition to the prospective mother.
In light of legislation e.g. Adoption and Children Act 2002, it was clear that this was discriminatory to same sex couples.
Therefore it was amended but the welfare clause was retained - account needs to be taken of welfare of prospective child, and any other child affected by the birth, before a woman can access treatment.
Problems with s 13(5) HFEA
1) Fertility clinics do not have access to relevant information about personal lives of prospective parents, unlike adoption agencies e.g.
2) Subjective assessment is problematic and difficult to make, leading to unfairness. Subject to individual biases - what makes a ‘good’ parent?
3) Discriminatory against infertile couples - fertile couples are not subject to this additional legal requirement.
HoC Science and Technology Committee thus recommended removing it, but govt. chose not to adopt this change.
HFEA 8th Code of Practice
Clinicians should focus on whether there are any specific risk factors met. Presumption in favour of treatment, unless any of the risk factors are present.
Risk factors include:
- drug/alcohol dependence of either parent
- conviction for child abuse or violent domestic history
NICE guidance
NICE guidance states that there should be three cycles of IVF treatment provided to women under the age of 40. One cycle should be provided to women aged 40-42.
NHS treatment
In reality, NHS does not comply with the NICE guidance/recommendations.
2015 - 57% of CCGs only funded one course of IVF treatment, in stark contrast to NICE standards. Therefore, depends considerably on postcode lottery whether women get access to appropriate IVF provision.
Limits on rights of patients in fertility treatment
1) s 13(5) HFEA 1990 (welfare clause).
2) Limited NHS resources.
Clear that NHS resources are very limited for IVF treatment - means that the majority of fertility treatment is provided by private clinics. This makes regulation more difficult and restricts access for many women who simply cannot afford private treatment.
R v HFEA, ex p Blood
B challenged HFEA’s refusal to give her husband’s sperm to her for use in a Belgian fertility clinic. HFEA refused since her husband lacked capacity and thus could not give his written consent.
Court held that B was entitled to her dying husband’s sperm for use in treatment in Belgium, despite the fact he could not consent. Although HFEA were correct that she could not use it in the UK, they failed to account for her rights under EU law which allowed her to use the sperm in another EU MS.
Evans v Amicus Healthcare
E and J both consented to storage of embryos. However, J later withdrew consent for them to be used. E sought an injunction requiring J to restore his consent so that she could legally use the embryos to become pregnant.
CA dismissed appeal. Their consent required both parties and therefore E’s withdrawal was valid under HFEA. Interference with E’s Art 8 rights was lawful since there were no alternative means of achieving the proportionate aim of respect for consent.
