Biolaw - AHR and New Genetics Flashcards
Ethics and AHR
- Extent of individual’s right to exercise their choices about reproduction
o Octomom – woman gave birth to 8 babies after using excessive amounts of fertility drugs
o Sex selection – aborting female foetuses
o Saviour siblings – creating children with certain traits so they can become donor to their sibling
o Posthumous sperm/egg to reproduce
o Designer babies – choosing babies with certain traits
What is infertility?
o Definition: failure to conceive after frequent unprotected sexual intercourse for 1-2 years of couple in the reproductive age group
o NICE guidelines
Woman of reproductive age (under 40) who has not conceived after 1 year of intercourse in the absence of any known case of infertility should be offered clinical assessment with her partner
1 in 7 couples affected by infertility
What is Assisted Human Reproduction? (and types)
o AHR – using technologies to assist conception when natural conception is not possible or desirable
IVF – Egg fertilised by sperm in laboratory. Fertilised egg placed in woman’s womb
Artificial Insemination - a doctor (can also be self administered) inserts sperm directly into a woman’s cervix, fallopian tubes, or uterus
Donor insemination - AI with donated sperm
Egg donation - AI with donated eggs
Embryo donation - AI with donated embryos
Surrogacy - Gestational mother is different than the intended parents.
New Genetics - Techniques used to screen embryos - Preimplantation genetic screening
Find out if embryos have a specific gene, chromosome or mitochondrion abnormality
- For couples at risk of passing on serious genetic disorder
- Cells removed from embryo and get tested
- Affected embryos discarded or donated for research
- Unaffected embryos implanted
- Can be used to choose compatible tissue donor for older sibling or to choose sex to avoid transmission of condition
- Regulated by HFE Act 1990 Schedule 2
- Ethical issues
o Defining severity of disease
o Should we include adult onset conditions
o Parents have a right not to know if they have disease
o Some parents wish to positively select for a disability
o Designer baby – slippery slope?
Will we actually slip? – the area is highly regulated
o What about unused embryos? - Testing for disability
o Positive selection of embryos affected by a particular condition is prohibited
o Section 13(9) HFEA 1990
o Thus provision is highly criticised by disability community
New genetics - techniques used to screen embryos - tissue typing
- ‘saviour siblings’ – cannot create a child to be an organ donor but a child can be used as a tissue donor
- Involves taking cell from an early embryo to see if the resulting child would be a good tissue match for the existing child
- Used for bone marrow transplant
- Applies to treating siblings only (no other family member)
- Schedule 2 1990 Act – 1ZA(1)(d)
- Ethical issues:
o Deontological - Child as a means not an end, child is used and created for a purpose – problematic for the child if they know they were created with only purpose to be a donor
o Utilitarian – would benefit existing child, and donor child is not actually losing their life - R (on application of Quintavalle) v HFEA
o HFEA issued licence to parents on 6 year old boy suffering from rare and potentially fatal blood disorder to enable them to ‘create’ a sibling whose tissue would match and offer hope of treatment
o Claimant, a campaigner opposed to such interference, claimed whole concept of creating and selecting life for instrumental purposes was against law
o Held: tissue typing to create babies to help siblings could by authorised by Human Fertilisation and Embryology Authority
New genetics - techniques used to screen embryos - sex selection
- Non-medical sex selection is prohibited
- Widespread hostility to it from the welfare of the child aspect
- Demographic imbalances would exacerbate sex discrimination because women would not have political power to change the status quo
- Only those in middle/upper class can afford sex selection technology
- Jodi Danis – ‘future masculinization’ of wealth
New genetics - techniques involving genetic modification - mitochondrial replacement techniques
Used to create babies without mitochondrial disease
- Three-parent babies
o If mitochondrial disease comes from mother’s line, can ask for donated egg.
o Mother’s egg shell and nucleus is used but the mitochondria are replaced by donated egg.
o Dad’s sperm fertilises the embryo - Safety concerns
o Procedure relatively new and has not been tested in humans
o However benefits may outweigh possible harms – refusing to act may result in greater harm
o If unexpected harm did manifest, it need not be passed on to future generations - Regulations on MRT
o HFEA 1990 s3ZA
o Human Fertilisation and Embryology (Mitochondrial Donation) Regulations 2015, No 572
Specifies the prescribed process
Permits HFEA to grant licences
New genetics - techniques involving genetic modification - germline editing
New techniques used to create babies without a certain disease or with desired traits
- Genome editing – cutting and reforming DNA strand
- Somatic genome editing – ‘body’ cells
- Germline genome editing – gametes
- Ethical arguments
o Modifying the genome is ‘a violation of human dignity’
However what about the human genome confers dignity?
The human genome as it exists today has already been modified through evolution, natural modification
o It is unnatural
However somatic and germline modifications DO happen naturally
We already accepted modern medicine which may be ‘unnatural’ so what if the difference
o Common heritage – human genome must be preserved
What is special about the current genome?
We are already the product of evolutionary change - First human germline modification
o Nov 2018 – He Jiankui created embryos resistant to HIV
o However by eliminating HIV, he may the children susceptible to any kind of cold – by editing one kind of disease out of genetics, you could create another problem
o Met with outrage
Regulation of AHR (4)
o Warnock Report 1984
Recommended formal regulation was desirable and necessary to ensure safe and ethical use of AHR
Led to HFE Act 1990 (amended in 2008)
o Human Fertilisation and Embryology Act 1990
Established the Human Fertilisation and Embryology Authority
o HFE Act (as amended in 2008)
Ensured creation and use of all in vitro embryos are subject to regulation
Banned sex selection for non medical reasons
Takes into account the ‘welfare of the child’
Removes specific reference to ‘the need for a father’
Controlled scope of embryo research
o Functions of Human Fertilisation and Embryology Authority
Inspect clinics to assess compliance with HFEAs – Schedule 3B HFEA 1990 as amended
Power to issue specific directions to clinics
Maintains Code of Practice on conduct of activities – s.25 HFEA 1990
Licensing Function – s.11 HFEA 1990
Advises Secretary of State for Health – Annual Report s.7 HFEA 1990
Register of information from licensed clinics – s.31 HFEA 1990
Key principles in regulation of AHR in UK - Welfare of the child
o Welfare of the Child – s.13(5) HFEA 1990, as amended
Originally HFEA included ‘need for a father’ clause – this was removed in 2008
Replaced with ‘need for supportive parenting’
S 13(5) HFEA 1990, as amended:
* 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
Para 8.11:
* Supportive parenting – commitment to the health, wellbeing and development of the child
Key principles in regulation of AHR in UK - Consent
Central principle – Schedule 3 1990 Act
Consent must be in writing – s.1 Schedule 3 HFEA 1990
* Must specify what happens to gametes on donor’s death/incapacity
* Maximum storage period must be specified f less than maximum of 10 years
* Consent may be withdrawn/varied before use
Posthumous use of gametes
- Ex parte Blood
o Mr Blood in coma – sperm requested at wife’s request
o Mrs Blood wished to use sperm – no effective consent Schedule 3
o Mrs B sought permission to export sperm for use – was initially refused
o Later HFEA changed position – sperm was exported and used in Belgium
o Ms Blood had two babies despite the absence of consent - L v HFEA
o Man died suddenly – out of hours application for removal and storage of sperm
o No written consent for use
o Court held: HFEA have wide discretion to permit export, but storage and use in the UK is unlawful - Section 39-41 HFEA 2008
o Essential element is WRITTEN CONSENT for use before man’s death
o No special relationship required
o Woman must elect within 42 days of birth that man be treated as father - Jennings v HFEA
o Application made by Jennings who sought declaration that it was lawful for him to use embryo created using his sperm and eggs of late wife, to be placed in surrogate
o Embryo created when Mr Jennings and wife were undergoing fertility treatment – wife later passed away after embryos had been created
o Initially, HFEA opposed the use of the embryo as there was not valid written consent by late wife at the relevant time to use of remaining embryo in event of her death
o However, court ruled Jennings could use embryo – UKs first posthumous surrogacy
o Couple had not been given adequate opportunity to consent to this scenario – court assumed that wife would have consented to Mr Jennings using the embryo in the event of her death
Dispute over use of embryos
- Evans v United Kingdom
o Couple underwent IVF – stored 6 embryos
o Couple later separated and Mr Johnston withdrew his consent to the use of the embryos
o Ms Evans challenged this using Art 8 argument – she had ovarian cancer and so this was the only way for her to have children
o ECtHR held: there was no consent as both parties have the option to withdraw their consent at any point so could not use the embryos
o UK ‘bright line’ rule – need for both parties to consent
o Court did not accept that the Art 8 rights of the male donor would be less worthy of protection that those of the female
Academic commentary on reproductive autonomy
Deech (2017)
* Reproductive autonomy is a societal responsibility
* Absolute respect for autonomy does not and ought not to exist in the field of fertility – it involves more than just one person or couple, it involves the general practitioner, clinicians, professional organisations, lawyers, politicians, philosophers, nurses, researchers, drug companies, theologians, religious groups, patient groups, the interests of the prospective child, existing children and other family members
* Thorough regulation of this area of medic ine and science allows these conflicting interests to be resolved, providing a foundation for the successful introduction of innovation in fertility treatments
Johnston and Zacharias (2017)
* Society has a version of reproductive autonomy that is open and responsive to the demands of a reproductive justice framework
* Has the capacity to be broad in scope and attentive to context
* Reproductive autonomy cannot exist without attention to context – once constraining contextual factors are identified, bioethicists, clinicians, and policy-makers can begin to address them and work to create the preconditions for people to be truly able to act in accordance with their values and priorities – to attain a reproductive autonomy worth having
* An approach to reproductive autonomy that is broad in scope and deeply attentive to context is necessary for a future in which economic and social inequalities continue to shape individual decisions and a future that includes ever more technologies
Priaulx (2008)
* If reproductive autonomy is of such critical value to us all in the pursuance of our own vision of the good life, then what cases like Evans demand is less attention to the resolution of disputes, and actively seeking to avoid them. Such a solution is only likely to be found if we look towards the future in evaluating how we can shape the current legal, social and indeed, technological landscape to best serve all of our needs.
* Focus on autonomy rather than rights – Although Mr Johnston and Ms Evans reproductive rights are competing, they are equal
