Quintavalle: The quandary in bioethics.

• Author: Cherkassky, Lisa
• Position: United Kingdom

1. INTRODUCTION 164 II. THE NEED FOR A SAVIOUR SIBLING 165 III. MR & MRS HASHMI AND THE HIGH COURT 167 IV. QUINTAVALLE IN THE COURT OF APPEAL 170 V. QUINTAVALLEIN THE HOUSE OF LORDS 179 VI. THE LEGAL LANDSCAPE AFTER QUINTAVALLE 186 VII. CONCLUSION 188 I. INTRODUCTION

   The case of R. (Quintavalle) v. Human Fertilisation Embryology authority (and Secretary of State for Health) [2005] 2 A.C. 561 (1) ("Quintavalle") presents a handful of legal problems. The provisions of the Human Fertilisation and Embryology Act 1990 (as amended, the "1990 Act") (2) were interpreted very widely to allow a mother to select embryos for implantation according to her tissue-match preferences. This right is now enshrined into law:

   Human Fertilisation and Embryology Act 2008

   Schedule 2: Activities that may be licenced under the 1990 Act.

   Paragraph 1ZA(1): A licence... cannot authorise the testing of an embryo, except for one or more of the following purposes:

   (d) in a case where a person ("the sibling") who is the child of the persons whose gametes are used to bring about the creation of the embryo (or of either of those persons) suffers from a serious medical condition which could be treated by umbilical cord blood stem cells, bone marrow or other tissue of any resulting child, establishing whether the tissue of any resulting child would be compatible with that of the sibling. (3)

   The biggest legal query to arise from the case is the inevitable harvest of babies, toddlers and very young children for their bone marrow. This non-therapeutic procedure has never been authorised by the courts and the welfare test under section 1(3) of the Children Act 1989 would no doubt require some form of physical or psychological benefit to the donor child (which is not easy to prove in a baby or a toddler). (4) There is an additional ethical problem in that embryos can now be created specifically for the purposes of harvest. There is nothing new in conceiving children to meet the desires of their parents (e.g. to take over the family business, to keep the older sibling company, etc.) but the screening technology was not designed to create embryos specifically for participation in non-therapeutic medical procedures after birth. In addition, the 1990 Act was composed strictly in light of its controversial nature but its wide interpretation by the lords surprised many, and what of the embryos that do not provide a tissue match? There is an embryo wastage issue that was not addressed by the lords despite embryos enjoying a good deal of protection in law. (5)

   This article unpacks the judicial story behind Quintavalle to reveal how the strict provisions of the Human Fertilisation and Embryology Act 1990 - namely 'suitable condition' under schedule 2 paragraph 1(1)(a) and 'treatment services' and 'assisting' under section 2(1) - were widely misinterpreted to introduce the social selection of embryos into law. (6) The legal loopholes created by the judgment (embryo wastage, welfare, eugenics and the legality of child harvest in particular) are also identified. It will be concluded that screening for a tissue match is social selection despite arguments to the contrary and that parents are not yet entitled in law to harvest a very young child for bone marrow, making the creation of a saviour sibling under the 1990 Act as a result of Quintavalle ultimately futile.

2. THE NEED FOR ASAVIOUR SIBLING

   The judgment in Quintavalle came about as a result of the swift technological developments in fertility treatment. Preimplantation Genetic Diagnosis (PGD) was developing during the eighties to screen embryos created for genetic diseases. (7) The early embryo is biopsied (i.e. one or two cells are removed) and examined for the presence of x-linked genetic diseases. The first live birth occurred in 1990. (8) The breakthrough was heralded as an end to the stressful combination of fertility treatment and abortion due to defective embryos. (9) PGD has now developed to detect non-gender related genetic diseases and more recently, late-onset adult diseases such as cancer. (10) Screening for a Human Leukocyte Antigen (HLA) tissue match was added to the process to allow parents to find a cure for an existing child (often referred to as Preimplantation Tissue Typing or PTT). (11) Adam Nash became the first ever tissue matched sibling to be born in Chicago, USA in 2001 when his umbilical cord blood cured his sister of the autosomal recessive disorder fanconi anaemia. (12) Dr Yury Verlinsky explained the advantages of the treatment in his project report:

   These new indications make PGD a genuine alternative to conventional prenatal diagnosis, providing patients with important prospects not only to avoid an inherited risk without facing termination of pregnancy, but also to establish a pregnancy with particular genetic parameters that benefit an affected member of the family. (13) The introduction of Preimplantation Tissue Typing (PTT) (14) changed everything. Fertility treatment was no longer a means to conceive a healthy baby, it was an opportunity to place an order for a particular baby. The academic commentary was littered with concerns about sex selection and eugenics (such as perfect pitch or intelligence) (15) but no such 'master race' has emerged despite PGD/PTT being largely unregulated in the United States. (16) The United Kingdom was due to jump on the bandwagon, and the one thing it can do better than any other country is regulate.

3. MR & MRSHASHMI AND THE HIGH COURT (17)

   Mr. and Mrs. Hashmi in the United Kingdom learnt of the breakthrough in Chicago, USA. (18) Their son Zain, the fourth of five children, was suffering from beta thalassemia major and required a daily combination of drugs and regular blood transfusions. (19) A stem cell transplant from umbilical cord blood or bone marrow was his only chance of a cure. (20) Mrs Hashmi already had three non-compatible children older than Zain, had conceived after Zain for a matching sibling but on finding out it was not a match underwent an abortion, and gave birth to another child who was not a tissue match before she asked the Human Fertilisation and Embryology Authority (HFE Authority) to issue a licence for a course of PTT to create a match for Zain. (21) The HFE Authority announced its historic decision to licence PTT in a press release as long as any embryo created for the purpose of providing cord blood would itself be at risk from the same disorder:

   2001 Policy:

   (a) the condition of the affected child should be severe or life-threatening, of a sufficient seriousness to justify the use of PGD;

   (b) the embryos conceived in the course of this treatment should themselves be at risk from the condition by which the existing child is affected;

   (c) all other possibilities of treatment and sources of tissue for the affected child should have been explored; (22)

   (d) the technique should not be available where the intended tissue recipient is a parent;

   (e) the intention should be to take only blood for the purposes of the treatment, and not other tissues or organs;

   (f) appropriate implications counselling should be a requirement for couples undergoing this type of treatment;

   (g) families should be encouraged to participate in follow up studies and, as with PGD, clinics should provide detailed information about treatment cycles and their outcomes;

   (h) embryos should not be genetically modified to provide a tissue match. (23)

   A licence was granted to Park Hospital in Nottingham. (24) Mr and Mrs Hashmi created a total of 25 embryos in two cycles. (25) The interest group Comment on Reproductive Ethics (CORE) sought permission to apply for a judicial review on the grounds that the HFE Authority had acted ultra vires to the Human Fertilisation and Embryology Act 1990, presenting a unique opportunity for the courts to discuss the creation of saviour siblings. (26) The relevant provisions from the 1990 Act are as follows:

   Section 2(1): In this act, "treatment services" means medical, surgical or obstetric services provided... for the purpose of assisting women to carry children.

   Section 11(1)(a): The Authority may grant licences under paragraph 1 of schedule 2 authorising activities in the course of treatment services.

   Schedule 2. Paragraph 1(1): A licence under this paragraph may authorise any of the following in the course of providing treatment services:

   (d) practices designed to secure that embryos are in a suitable condition to be placed in a woman or to determine whether embryos are suitable for that purpose.

   Paragraph 1(3): A licence under this paragraph cannot authorise any activity unless it appears to the Authority to be necessary or desirable for the purposes of providing treatment services. (27)

   The question to be answered by the High Court was whether the screening of an embryo for a tissue preference was 'necessary or desirable' to ensure that it was 'in a suitable condition' to be placed in a woman for it to be 'in the course of' treatment services. CORE argued that it was not. (28) Mr and Mrs Hashmi temporarily stopped treatment in anticipation of the judgment, handed down in R (on the application of Josephine Quintavalle) on behalf of CORE v Human Fertilisation and Embryology Authority. (29) Mr Justice Maurice Kay began by stating that the case was only about statutory interpretation (at paragraph 7) which seemed strange considering the ethical undertones of the action, (30) but CORE was successful on the grounds that PTT did not assist women to carry children in the literal sense:

   ...section 2(1) expressly defines "treatment services" by reference to a single purpose - that of "assisting women to carry children". The sole purpose of tissue typing is to ensure that any such child would have tissue compatibility with its older sibling. I do not consider that it can be said to be "necessary or desirable" for the purpose of assisting a woman to carry a child. The carrying of such a child after implantation...