Bio-law II - AHR and New Genetics Flashcards
Ethics and assisted human reproduction
often construed as a negative right. The state does not normally interfere with natural conception - protected by law e.g. ECHR Art.8
Knecht v. Romania - couple wanted donor insemination and austria doesn’t allow, took it to court saying against right to family life- right they have
those who conceive naturally cannot make babies better with genetic interference but some may arg they do as ppl have babies with ppl who are good looking or who are intelligent
Ethics and assisted human reproduction
ethical issues = designer babies, reproductive cloning, stem cell research, chimeras, sex selection, genetic modification of babies, human enhancement, and recently germline editing, saviour siblings
‘Octomum’- a woman who gave birth to 8 babies after using fertility drugs and having 12 embryos implanted in America - in UK only one or two embryos implanted allowed maximum - very regulated - where do you draw line with reproductive autonomy?
II. AHR (Infertility treatment and New genetics)
Infertility is not uncommon: 1 of 7 couples are affected by infertility.
‘failure to conceive after frequent unprotected sex sexual intercourse for 1-2 years in couple is in the reproductive age group’
getting worse as women now conceive when they get older - focus on career and studies, mens diet and stress lead to sperm morbility dropping and sperm quality being low
NICE - woman of reproductive age (under 40) who has not conceived after 1 year of intercourse in the absence of any know infertility should be offered clinical assessment with partner - if diagnosed with infertility then offered one free cycle of IVF
What is Assisted Human Reproduction?
technologies to assist conception when natural conception is not possible or desirable
- In vitro Fertilisation (IVF): the egg get fertilised with sperm (in a petri dish) in the laboratory. The fertilised egg (embryo) is placed in the woman’s womb. - woman is first injected with any hormones and if enough good eggs then fertilised with sperm and the waited to develop for a few days then implanted back into her - First reported test tube baby – Louise Brown 1978 Initially hostility to treatment (see Michael Mulkay, The Embryo Research Debate, 1997) - Artificial insemination: a doctor (can also be self administered) inserts sperm directly into a woman's cervix, fallopian tubes, or uterus (most popular one is the intrauterine insemination). - 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.
Infertility affects around one in seven couples and today, IVF is a mainstream treatment for infertile couples. 2% + babies born via IVF in UK- 390,000 babies
Over 12 million babies in the world.
AHR and New Genetics
Techniques which can be used to screen embryos (Preimplantation genetic screening to find out if the embryos have a gene, chromosome or mitochondrion abnormality, tissue typing, sex selection) - to choose an embryo which doesn’t carry a disease, choose sex of baby, tissue donor to an existing child, any abnormalities and pick embryo which does not carry abnormality - no genetic modification here simply picking and choosing
Techniques that include genetic modification
Mitochondrial replacement - mitochondrial disease = inherited from mother so take egg and remove the faulty mitochondria and put a healthy mitochondria from and egg donor so there are 2 genetic material inside the egg it is then inseminated with sperm - not nec third parent as only donating mitochondria
Germline editing: - copy and paste genes to eradicate any diseases etc
both ethically controversial involve genetic modification in reproductive cells which will be passed onto next gens - changes we make to our somatic bodily interventions do not pass to next generations but changing reproductive cells do pass to generations
Preimplantation Genetic Diagnosis (PGD)
couples who are at the risk of passing on serious genetic disorder such as mitochondrial disease or Tay-Sach disease which is fatal. Usually, the parents already have an affected child.
Cells are removed from the embryo (this doesn’t harm it) and get tested
Affected embryos can be discarded or donated for research.
Screening embryos for genetic conditions so that only unaffected embryos are implanted
If the child would be a compatible tissue donor for an existing sibling. - many ethical issues
It can be also used to choose sex to avoid transmission of a condition affects only one sex (eg Duchenne muscular dystrophy, which primarily affects males)
Regulated by HFE Act 1990 Schedule 2
Ethical Issues involved in PGD
Defining severity of disease - what kind of disease?
Should we include adult-onset conditions - e.g. mitochondria disease = impact children at early age but some diseases arent activated until they are older - do we eradicate this disease?
Which conditions?
Genetic Test - Susceptibility not certainty
Carrier embryos?
PGD and parents’ right not to know if they have an inheritable disease
Parents wish to positively select for a disability - some deaf ppl wish to have deaf babies as a hearing child would not fit into their community - controversial as taking away a childs hearing limits them so cannot allow negative traits
S. 13(9) HFEA – may not prefer embryos
Designer Baby – slippery slope?
Unused embryos? - spare embryos nobody can use and that’s not fair
Testing for disability
Positive selection of embryos affected by a particular condition is prohibited: Section 13 (9)
Persons or embryos that are known to have a gene, chromosome or mitochondrion abnormality involving a significant risk that a person with the abnormality will have or develop
- (a)a serious physical or mental disability, - (b)a serious illness, or - (c)any other serious medical condition, must not be preferred to those that are not known to have such an abnormality.
A provision highly criticised by disability community. - makes them feel that they are not worthy
A couple must not ‘prefer’ a gamete donor who suffers from a condition like congenital
deafness. (But if the donor is selected for a reason but he also happens to be deaf that is fine!) - parents cannot lawfully choose an embryo with deafness and cannot bring donated sperm which has deafness
Tissue typing (‘saviour siblings’)
Ethical issues:
- Child as a means not an end? - created for a purpose of being a donor - What happens if the treatment fails? Or if child says they don’t want to be a donor? - Converse: child welfare arguments - will feel compelled to be a donor not out of love but because parents created her for this purpose so a lot of pressure on child which is unfair
different use of PGD which involves taking a cell from an early embryo (same as PGD), to see if the resulting child would be a good tissue match for the existing child.
Used for bone marrow transplant (if the baby is a good tissue match the blood from her umbilical cord, her bone marrow or other tissue can be used to treat her sibling.)
Applies to treating siblings only (no other family member).
Schedule 2, 1990 Act as amended - 1ZA(1)(d)
Cannot be used for harvesting an organ. -only a tissue donor
R (on the application of Quintavalle) v HFEA
- D, the HFEA issued a licence to parents of six-year old boy suffering from a rare and potentially fatal blood disorder (beta thalassaemia] to enable them to ‘create’ a sibling whose tissue would match and offer hope of treatment. - couple created child which was approved - C, Josephine Quintavalle a campaigner opposed such interference, claimed the whole concept of doing this and creating and selecting life for instrumental purposes was against the law and did not help with infertility. - Held: Tissue typing to create babies to help siblings could be authorised by the Human Fertilisation and Embryology Authority (HFEA), which issues a licence to create or keep an embryo. - The carrying of a child who would not suffer the same defect as an existing child was capable of assisting the mother to bear a child. ‘The fact that some practices (e.g. a biopsy) designed to determine the suitability of embryos to be placed in a woman involve use of an embryo does not mean that all practices for such a purpose involve ‘use’ of the embryo, or therefore require to be licensed as activities under paragraph 1(1) of Schedule 2.’ - only case in UK about saviour siblings - very rare - The testing of the embryos was proper for that purpose. - Put on statutory footing in 2008: HFEA 1990 Sch 2 para 1ZA(d)
Non-medical sex selection
- (sex selection for social reasons) is prohibited.
- Result of the 2003 public consultation: there is a widespread hostility to it from the welfare of the child aspect.
- Demographic imbalances would exacerbate sex discrimination because women would not have the political power to change the status quo - sex selection is done in favour of boys not girls so could reduce women population
- Only those who in middle or upper class can afford sex selection technology - only through IVF not naturally
- ‘Future masculinization’ of wealth (Jodi Danis) - more boys so boys will have more power - not allowed unless there is a disease for example
Mitochondrial Replacement Techniques - ‘Three Parent IVF’?
- Replacing unhealthy mitochondria
- Affects 1 in 6,500 children born in UK Embryo – genetic material from three sources
- Regulatory change - Approved in UK - The Human Fertilisation and Embryology (Mitochondrial Donation) Regulations 2015
Ethical Issues:
- Safety concerns - if baby will be safe as changing genetic material - Modification of genetic identity - Future generations - Parentage – Media Reports of Three genetic parents?
MRT and Safety Concerns and regulations
relatively new and not tested in humans - dont know if safe so arg shouldnt be allowed but ppl willing to undertake risks
benefits may outweigh poss harms
If an unexpected harm did manifest, it need not be passed on to future generations
- HFEA 1990 s 3ZA(2/3/4): no nuclear or mitochondrial DNA of any cell of the egg/ sperm/ embryo has been altered - HFEA 1990 s 3ZA(5): A permitted egg/ permitted embryo can have undergone a prescribed process to prevent mitochondrial disease - you cannot genetically modify an egg or sperm but this is an exception - not modifying DNA only replacing mitochondria - very controlled - look into every case to assess the risk - New Technology: Maternal spindle transfer/Pro-nuclear transfer - No alteration of DNA itself Human Fertilisation and Embryology (Mitochondrial Donation) Regulations 2015, No 572
Human genome Editing: CRISPR-Cas9
Genome editing involves cutting & reforming the DNA strand
Somatic GE vs Germline GE
- ‘body’ cells vs gametes
- Human germline editing or heritable human genome editing
Genome as ‘common heritage of humanity’
- Protected by international instruments (eg Oveido convention)
ethical issues:
There is some inherent moral proscription against modifying the human genome
- Variation of argument: modifying the genome is “a violation of human dignity” - Argument: “Unnatural” - Argument: Common heritage- must be preserved
What is it about the human genome in exactly its current state that confers dignity?
The human genome as it exists today has already been modified through evolution, natural mutation
First HHGE
- The most controversial use of CRISPR to date has been the modification of human embryos to produce two genetically altered children - edited embryos as man had HIV and didn’t want to risk babies having HIV so they would be resistance to HIV but there were other issues like they became prone to catching a cold
- In November 2018, a Chinese researcher, He Jiankui, announced that he had used CRISPR/Cas9 to create embryos resistant to HIV culminating in the birth of a set of twins.
- He Jiankui claimed to have altered a gene (called CCR5), with the hope of offering people living with HIV a chance to have a genetically related child without HIV.
- Response He Jiankui’s announcement was met with outrage.
- ‘Even if the modifications are verified, the procedure was irresponsible and failed to conform with international norms. Its flaws include an a poorly designed study protocol, a failure to meet for protecting the welfare of and a lack of transparency in the and conduct of the clinical procedures.’ (Baltimore et al. 2018, emphasis added) - not in accordance with government he did it all by himself
- Chinese authorities had suspended Jiankui’s research activities and he was jailed
- Chinese Academy of Medical Sciences condemned Jiankui’s work and declared that it was not in accordance with government regulations and guidelines in China
Enhancement
- Should we have the right to create the best possible child? (Harris 1995) - not a recognised right
- Are we obliged to create the best possible child? (Savulescu 2010)
- How far does the positive right to reproductive autonomy extend?
- Right to not just be assisted to reproduce but also have genetically related children? MtDNA vs egg donation - egg donation = right to have a baby but MtDNA = right to have a healthy child
Law and AHR
whether AHR should be regulated?
If natural reproduction is not regulated what is the rationale for regulating AHR? - ppl decide what partner to have babies with e.g. what race, intelligence etc
- What interests/principles are protected within regulations? - Whose interests are protected? - What principles should be key to the regulatory framework? - A compromise: Consent and welfare of the child principles - whether couple consents to create a baby and whether it is in best interests for baby to be born
Legal Regulation of AHR in the UK
Warnock Report 1984 - recommendations - new regulatory auth needs to be formed to regulate new technologies - desirable and necessary to ensure safe and ethical use of AHR which led to HFE Act 1990
anyone born before 2008 regulations will be regulated with the 1990 act
1990 act amended in 2008 ensure creation and use of all in vitro embroys subejct to regulation, ban sex selection for not. med reasons and take into account welfare of child without specific ref to need for a father
Functions of the 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 e.g. cannot use fertility drugs
- Maintains Code of Practice on conduct of activities – s. 25 HFEA 1990 Flexibility for regulatory framework not very detailed, flexible function = code of practice so they can catch up with highly paced fertility sector - act itself is very general but the code of practice is more detailed
Licensing function – s. 11 HFEA 1990, see also Schedule 2, 1990 Act
- Provide treatment services - Provide non medical fertility services - The storage of gametes - Reproductive Research - Licences - not open-ended -5 years max - Revocation of Licences – s. 18 HFEA 1990
Role in the Formation of Policy
Advises the Secretary of State for Health
Annual Report – s. 7 HFEA 1990
- Register of Information from licenced clinics – s.31 HFEA 1990, as amended
- Can require collection of information about donors, recipients etc. so HFEA have all donors registered in system so if you were conceived and born after 2008 can go to auths website and request access to donor info and they will provide it, if born prior may still have info if donor voluntarily provided it - Rules on disclosure of information – s. 33 HFEA 1990, as amended - There are limits on the HFEA’s powers. For example, the prescription of super-ovulatory hormones does not require a license form HFEA. - may not be able to control what happens in every clinic - As Brazier points out HFEA exercises little control over the market in fertility services. Most fertility treatment is provided by the private clinics, and the prices are charged outside the HFEA’s regulatory ambit. - Also, the fertility services overseas are not in HFEAs remit.
Key Principles in the Regulation of AHR in UK
i. Welfare of the Child - s. 13(5) HFEA 1990. as amended
ii. Consent – Autonomy
- Initially discussion of access only for married couples - No restrictions on age, sexual orientation, marital status, etc. in terms of access to fertility services - but clinics will have own criteria to meet and will have limits to prevent ppl wasting their time and money
i. Welfare of the Child – s. 13(5)
Originally HFEA included ‘need for a father’ clause – removed in 2008
Replaced with ‘need for supportive parenting’
Section 13(5) HFEA 1990, as amended:
decided this clause should be removed to allow same sex couples and single mothers to become parents so no need for a father clause now it is supported parenting - woman cannot bring father or brother as father - avoid incest
The clinic’s refusal based on welfare grounds must be in writing, para. 8.17
ii. Role of Consent
central principle in the HFEA Acts:
Schedule 3, 1990 Act
must be written, specify what happens to gametes on donors death/incapacity, maximum storage period, consent may be withdrawn/varied before use
every time clinic wants to use embryos for new research need to call donors and get consent - difficult as ppl change address and ppl may not want to be reminded they donated embryos
Legal Issues:
- Posthumous donation
- Disputes over use of embryos
Consent : Posthumous Use of Gametes
R v Human Fertilisation and Embryology Authority, ex parte Blood
Mr Blood in coma (due to meningitis) – sperm extracted at wife’s request
Mrs Blood wished to use sperm – no effective consent Schedule 3 so denied use of sperm
Permission to export sperm for use sought cant use in Uk so asks to go to belgium with sperm in order to get baby as belgium does not require consent but HFEA said no as no consent to import or export sperm
CA: HFEA is entitled to place restrictions, but public interest is not served regarding Mrs Blood’s rights under EU law to receive treatment elsewhere – remitted to HFEA to reconsider - she has right to access treatment anywhere in EU
HFEA subsequently changed position – sperm exported and used in Belgium
Ms Blood had two babies despite the absence of consent.
L v Human Fertilisation and Embryology Authority
- Man died suddenly – out of hours application for removal and storage of sperm dies in clinic and wife wants to retrieve sperm as they were in process of treatment obvious man wanted to have a baby but no written consent - he consented to treatments not use of sperm after his death - HFEA did not approve it - No written consent for use - Charles J: HFEA wide discretion to permit export, but storage and use in UK unlawful - retrieval would be justifiable in common law as knew he wanted baby but he died - in the end she was allowed to use the sperm
Statutory scheme: Section 39-41 HFEA 2008
◦ Essential element: written consent for use before man’s death
◦ No special relationship required
◦ Woman must elect within 42 days of birth that man be treated as father
Jennings v Human Fertilisation And Embryology Authority
lawful for him to use an embryo created using his sperm and the eggs of his late wife, Fern-Marie Choya, in treatment with a surrogate. She was already pregnant and died during an accident so J said had spare embryo created and wanted to use surrogate but no consent but he said that is because you did not put it in the forms by the clinics
- The embryo was created in 2018 when Mr Jennings and Ms Choya were undergoing fertility treatment to fulfil their wish to have children of their own. - Ms Choya passed away during her pregnancy with twins. There is one remaining embryo which Mr Jennings wishes to use with a surrogate. - The HFEA oppose the declaration sought on the basis that there was not a valid written consent by Ms Choya at the relevant time to use the remaining embryo in the way sought by the declaration in the event of her death. We don’t know if she would consent to her embryo being used in a surrogate - The court ruled that Jennings can use the embryo, in what could be the UK’s first case of posthumous surrogacy. - The couple had not been given adequate opportunity to consent to this scenario. Mrs Justice Theis, a family division judge, said: “I am satisfied that, in the circumstances of this case, the court can infer from all the available evidence that Ms Choya would have consented to Mr Jennings being able to use their partner- created embryo in treatment with a surrogate in the event of her death. This is being considered in the context where, in my judgment, she had not been given relevant information and/or a sufficient opportunity to discuss it with the clinic.” HFEA to review consent procedures. Court said this was HFEA and clinics mistake as didn’t consider womans consent if die
Consent : Disputes over use of Embryos
Evans the withdrawal of consent avoided Evans becoming a mother using the embryos created with her ex-fiance
FEA 1990 –Right of veto for either gamete provider Evans v United Kingdom [2004] EWCA Civ 727
- Ovarian cancer – underwent IVF natalia gets cancer so clinic recommended to freeze eggs to use later - Storage of 6 embryos - Couple separated – Mr Johnston withdrew consent he was with someone else and she wants to have a baby but cannot because she is infertile so asks to use embryos courts says no as he withdrew consent - Ms Evans challenged – Art. 8 ECHR - UK ‘bright line’ rule – need for both parties to consent - No European consensus – deference to Contracting States - The applicant emphasised that, since her ovaries had had to be removed to combat cancer, the embryos created with her eggs and J's sperm represented her only chance to have a child to whom she was biologically related. - The Court was not persuaded by the applicant's argument that the situation of the male and female parties to IVF treatment cannot be equated. - The Court did not accept that the Art.8 rights of the male donor would necessarily be less worthy of protection than those of the female.
