Bilateral consent to use sperm/embryos for reproductive purposes

ELAG (07-07) 4HUMAN FERTILISATION AND EMBRYOLOGY AUTHORITYEthics & Law CommitteeCommittee:Ethics & Law Advisory GroupMeeting Date: 10 th July 2007Agenda Item: 8Paper Number: ELAG (07-07) 4Paper Title:Bilateral consent to use of sperm/ embryos forreproductive purposes.Author:Jessica Watkin (Policy Manager)For Information or DecisionDecision?Resource Implications: NoneRecommendation to theCommittee:ELAG is invited to discuss the cases outlined in thispaper and any issues they might raise for the HFEA.This might include the following questions:• Does the HFEA need to consider any additionalguidance for the Code of Practice?• Should the HFEA propose any additionalprovisions to the Human Tissue and Embryos Bill,over and above their previous suggestion of a oneyear ‘cooling off’ period in cases of disputesbetween gamete providers?• More fundamentally, how ethically sound are theethical principles upon which the current UK lawrests in relation to a gamete providers consent/control over their genetic material? What are themerits or disadvantages of alternative consentframeworks of other countries?11.1BackgroundThis paper outlines two legal cases that raise questions about the ethicalbasis of the current law on the need for bilateral consent for the use ofsperm/ embryos for reproductive purposes.Page 1 of 7 TRIM 07/8609

ELAG (07-07) 41.21.31.4The first concerns Natallie Evans, who lost her legal action to allow herfrozen embryos to be implanted against her former partner’s wishes. Thesecond is reminiscent of the Diane Blood case and concerns a woman whohas applied for a Declaration from the High Court in relation to theextraction and storage of her deceased partner’s sperm, for the presumedintention of using it for reproductive purposes. This second case is currentlybefore the court and few details are available at present.In the first case, the man explicitly withdrew his consent. In the second, it ispresumed that the untimely nature of the man’s death meant that thesituation, and therefore the need for discussion in advance about consent toextraction, storage and subsequent use, was not anticipated. Both casesraise questions about whether the UK law adequately addresses theinterests or, arguably, the moral rights of women who wish to have childrenusing ART in special circumstances, without the male gamete provider’sconsent.ELAG is asked to consider whether the Evans case raises any issues theHFEA ought to consider, such as any additions to its guidance or any policyrecommendations relevant to the Human Tissue and Embryos Bill. ELAGmay also wish to comment on the second case which is currently before thecourts. The Executive will keep members abreast of any significantdevelopments in relation to this case.21 st case: Evans v. The United KingdomKey facts2.12.2In October 2001, Ms Evans was diagnosed with ovarian cancer, thetreatment for which would affect her fertility. Thus, before beginning hercancer treatment, she and her then fiancé (Howard Johnston) began IVFtreatment which resulted in the creation and storage of 6 embryos.The couple’s relationship subsequently ended and in the summer of 2002Mr Johnston requested that the embryos be destroyed. Ms Evansembarked on a series of court actions in an attempt to enable the embryosto be implanted. She lost the final stage of her case in the Grand Chamberof the European Court of Human Rights on the 10 th April 2007.Legal issues2.3Under the current law, both gamete donors’ consent is required at everystage of treatment up until implantation. This was the basis for the UKcourts decision to rule against Ms Evans. The European Court of HumanRights considered the case in the context of Articles 2, 8 and 14 of thePage 2 of 7 TRIM 07/8609

ELAG (07-07) 4European Convention on Human Rights. Again, the Court found against MsEvans.2.42.52.6The judgement stated that: ‘States were entitled to a broad margin ofappreciation in this field, given the complexity of the moral and ethicalissues to which IVF treatment gave rise, on which opinions within ademocratic society might reasonably differ widely. There was nointernational or European consensus as to the point at which a sperm donorshould be allowed effectively to withdraw his consent and prevent the use ofhis genetic material.’Legal regimes similar to the UK’s apply in Denmark, France, Greece, theNetherlands, Switzerland, Belgium, Finland and Iceland.However, as outlined in the Grand Chamber judgement, other countrieshave adopted different approaches. These include, for example, onlyallowing the male to veto ongoing treatment up until the point of fertilisation(rather than implantation) or honouring the prior advance agreement ofparties who anticipate the possibility of a future dispute in relation to the fateof embryos created using their gametes. Extracts from the judgement are atAnnex A.Human Tissue and Embryos Bill2.7In response to these sorts of cases, the Government has proposedintroducing legislative provisions in a Human Tissue and Embryos Bill thatwould allow for a one year ‘cooling off’ period ‘following the withdrawal ofconsent to embryo storage by one of the persons whose gametes wereused in the creation of the embryo’ 1 . This provision is in line with an HFEAsuggestion to the Department of Health’s consultation paper: ‘Review of theHuman Fertilisation and Embryology Act’ 2 .HFEA Code of Practice2.8The HFEA’s Code of Practice (7 th edition) provides the following guidance:Providing proper informationG.5. 2: Informed consentG.5.2.1. Before any person gives consent to:1Draft Human Tissues and Embryos Bill2Cm 6989, December 2006Page 3 of 7 TRIM 07/8609

ELAG (07-07) 4…the storage or use of embryos created using their gametes,the person seeking their consent should give them information about thefollowing:…b) the right to vary or withdraw the terms of consent at any time up to the pointwhere the gametes or embryos have been transferred to a patient in the courseof fertility treatment or in a project of research; and…d) in the case of embryos, the consequences of a variation or withdrawal ofconsent by either gamete provider where the wishes of the gamete providers, orwhere she is not one of these people, those of either gamete provider and thewoman to be treated, do not coincide…33.12 nd case: AL v a hospital NHS Trust and the HFEAThe second case concerns a deceased male patient in relation to whom aHigh Court Declaration was sought and obtained out of hours. It wasdeclared that it was lawful for doctors to retrieve his sperm and for hissperm to be stored. It is assumed that the declaration was sought becausethe deceased man had not given his consent before he died. The HFEA isparty to the proceedings, but does not intend to take an active part.44.1ConclusionELAG is invited to discuss the cases and any implications they may raisefor the HFEA. This might include the following questions:• Does the HFEA need to consider any additional guidance for theCode of Practice?• Should the HFEA propose any additional provisions to the HumanTissue and Embryos Bill, over and above their previous suggestionof a one year ‘cooling off’ period in cases of disputes betweengamete providers?• More fundamentally, how ethically sound are the ethical principlesupon which the current UK law rests in relation to a gameteproviders consent/ control over their genetic material? What are themerits or disadvantages of alternative consent frameworks of otherPage 4 of 7 TRIM 07/8609

ELAG (07-07) 4countries?Page 5 of 7 TRIM 07/8609

ELAG (07-07) 4ANNEX AExtracts from ‘Evans v.The United Kingdom’ judgment. (Grand Chamber,European Court of Human Rights)’42. A number of countries have, however, regulated the consent issuedifferently. In Hungary, for example, in the absence of a specific contraryagreement by the couple, the woman is entitled to proceed with the treatmentnotwithstanding the death of her partner or the divorce of the couple. In Austriaand Estonia the man’s consent can be revoked only up to the point of fertilisation,beyond which it is the woman alone who decides if and when to proceed. InSpain, the man’s right to revoke his consent is recognised only where he ismarried to and living with the woman. In Germany and Italy, neither party cannormally withdraw consent after the eggs have been fertilised. In Iceland, theembryos must be destroyed if the gamete providers separate or divorce beforethe expiry of the maximum storage period.’In addition, case law from the United States (where there is no federal law on theissue) and Israel illustrates other alternatives. For example,’44. In Davis v.Davis, (842 S.W.2d 588, 597; Tenn.1992), the Supreme Court ofTennessee held in 1992:“… disputes involving the disposition of pre-embryos produced by in vitrofertilization should be resolved, first, by looking to the preferences of theprogenitors. If their wishes cannot be ascertained, of if there is dispute, then theirprior agreement concerning disposition should be carried out. If no prioragreement exists, then the relative interests of the parties in using the preembryosmust be weighed. Ordinarily, the party wishing to avoid procreationshould prevail, assuming that the other party has a reasonable possibility ofachieving parenthood by means other than use of pre-embryos in question…’…‘1. In Kass v. Kass (98 N.Y. Int. 0049), the couple had signed an agreementwith the clinic which stipulated that, “in the event that we ... are unable to make adecision regarding the disposition of our frozen pre-zygotes”, the embryos couldbe used for research. When the couple separated, Mrs Kass sought to overturnthe agreement and proceed to implantation. Although she prevailed at firstinstance (the court reasoning that just as a woman has exclusive control over herreproduction so should she have the final say in the area of IVF), the New YorkCourt of Appeal decided that the existing agreement was sufficiently clear andshould be honoured.2. In A.Z. v. B.Z, (2000, 431 Mass. 150 ; 725 N.E. 2d 1051) there was again aprevious written agreement, according to which, in the event of separation, theembryos were to be given to the wife, who now wished to continue with thePage 6 of 7 TRIM 07/8609

ELAG (07-07) 4treatment, contrary to the wishes of the husband. However, the Supreme Courtof Massachusetts considered that the arrangement should not be enforcedbecause, inter alia, as a matter of public policy “forced procreation is not an areaamenable to judicial enforcement”. Rather, “freedom of personal choice inmatters of marriage and family life” should prevail.3. This judgment was cited with approval by the Supreme Court of NewJersey, in J.B. v. M.B. (2001 WL 909294). Here, it was the wife who sought thedestruction of the embryos while the husband wanted them either to be donatedto another couple or preserved for use by him with a future partner. Althoughconstitutional arguments were advanced on behalf of the wife, the court declinedto approach the matter in this way, reasoning that it was in any event not surethat enforcing the alleged private contract would violate her rights. Instead,having taken into account the fact that the father was not infertile, the courtsubscribed to the view taken in the A.Z. case regarding public policy and orderedthat the wife's wishes be observed.4. Finally, in Litowitz v. Litowitz, (48 P. 3d 261, 271) the woman, who had hadchildren before undergoing a hysterectomy, wished to use embryos created withher ex-husband's sperm and donor eggs for implantation in a surrogate mother.The ex-husband, however, wished the embryos to be donated to another couple.At first instance and on appeal the husband's view prevailed, but in 2002 theSupreme Court of Washington decided by a majority to adopt a contractualanalysis and to honour the couple's agreement with the clinic not to store theembryos for more than five years.3. Israel5. In Nachmani v. Nachmani (50(4) P.D. 661 (Isr)) a childless Israeli coupledecided to undergo IVF and then to contract with a surrogate in California to beartheir child because the wife would not be able to carry the foetus to term. Thecouple signed an agreement with the surrogate, but not with the IVF clinicregarding the disposal of the embryos in the event of their separation. The wifehad her last eleven eggs extracted and fertilised with her husband's sperm. Thecouple then separated, before the embryos could be implanted in the surrogate,and the husband, who had gone on to have children with another woman,opposed the use of the embryos.The District Court found in favour of the wife, holding that the husband couldno more withdraw his agreement to have a child than a man who fertilises hiswife's egg through sexual intercourse. A five-judge panel of the Supreme Courtreversed this decision, upholding the man's fundamental right not to be forced tobe a parent. The Supreme Court reheard the case as a panel of eleven judgesand decided, seven to four, in favour of the wife. Each judge wrote a separateopinion. The judges in the majority found that the woman's interests and inparticular her lack of alternatives to achieve genetic parenthood outweighedthose of the man. Three of the minority judges, including the Chief Justice,reached the opposite conclusion, emphasising that the wife had known that herPage 7 of 7 TRIM 07/8609

ELAG (07-07) 4husband's consent would be required at every stage and that the agreementcould not be enforced after the couple had become separated. The fourth of thedissenters held that the man's consent was required before the obligation ofparenthood could be imposed on him.’Page 8 of 7 TRIM 07/8609