The Assisted Reproduction and Gynaecology Centre v The Human Fertilisation and Embryology Authority
| Jurisdiction | England & Wales |
| Judge | Mrs Justice O'Farrell |
| Judgment Date | 30 March 2017 |
| Neutral Citation | [2017] EWHC 659 (Admin) |
| Docket Number | Case No: CO/3482/2016 |
| Court | Queen's Bench Division (Administrative Court) |
| Date | 30 March 2017 |
[2017] EWHC 659 (Admin)
IN THE HIGH COURT OF JUSTICE
QUEEN'S BENCH DIVISION
ADMINISTRATIVE COURT
Royal Courts of Justice
Strand, London, WC2A 2LL
Mrs Justice O'Farrell DBE
Case No: CO/3482/2016
The Queen on the application of
Jenni Richards QC, Rose GroganandCatherine Dobson (instructed by Hempsons) for the Claimant
Kate Gallafent QC (instructed by Fieldfisher) for the Defendant
Hearing dates: 19th December 2016, 20th December 2016, 10th January 2017
Approved Judgment
Introduction
This is a claim for judicial review of decisions of the Human Fertilisation and Embryology Authority ("the HFEA") to change the information and statistical data about licensed clinics which it publishes in the discharge of its duties under section 8 of the Human Fertilisation and Embryology Act 1990, as amended by the Human Fertilisation and Embryology Act 2008 ("the Act").
The claimant ("the Clinic") is a fertility clinic which has been licensed by the HFEA since 1995. The HFEA is the UK's independent regulator of fertility treatment and research using human embryos, established by the Act.
Pursuant to its statutory obligation to provide advice and information for those involved in providing or receiving assisted reproductive treatments, the HFEA procured the establishment of a website and application program entitled "Choose a Fertility Clinic" ("the CaFC App").
Following a consultation exercise and public beta testing between 2014 and 2016, on 16 November 2016 the HFEA decided to make changes to the presentation of data on the clinic profile pages in the CaFC App, including the following:
i) the current success rates for IVF births are expressed as (a) live births per cycle started, (b) live births per embryo transferred and (c) multiple births;
the new success rates will be expressed as (a) live births per embryo transferred, (b) live births per egg collection and (c) multiple births;
ii) the current headline IVF birth rate on each clinic profile page is expressed as a comparison with the national average for (a) patients aged under 35 years and (b) patients aged 35–37 years;
the new headline IVF birth rate will be based on all patients aged under 38 years;
iii) the current success rates for IVF births are divided into six different age bands: (a) under 35, (b) 35–37, (c) 38– 39, (d) 40–42, (e) 43–44 and (f) over 44;
the new success rates for IVF births will be given for (a) patients aged under 38 years, (b) patients aged over 38 years and (c) all patients.
The Clinic seeks a declaration that the above decisions were unlawful and an order quashing the same, on the following grounds:
i) the proposed presentation of data using the CaFC App is illogical, potentially misleading and unreasonable;
ii) the proposed changes to the presentation of data are contrary to the HFEA's obligations to provide information, advice and transparency under the Act;
iii) the HFEA's decisions are not justified by reference to relevant considerations;
iv) the HFEA failed to consult and/or consider consultation responses adequately or at all in respect of its decisions.
The HFEA's position is that its decisions were lawful and the Clinic is attempting to use the judicial review process inappropriately to attack the underlying merits of the decisions:
i) the proposed presentation of data using the CaFC App is within the range of reasonable decisions open to the HFEA and it is not for the court to substitute its own decisions;
ii) there has been no breach of the HFEA's obligations under the Act;
iii) the HFEA had regard to all legally relevant considerations when reaching its decisions;
iv) the HFEA complied with its obligations to consult, including a formal consultation exercise, workshops, beta testing and conscientious consideration of the consultation responses.
These proceedings were commenced on 8 July 2016.
On 14 July 2016 Mr Justice Wyn Williams granted an interim injunction prohibiting the HFEA from publishing to the public at large the revised CaFC App.
On 3 August 2016 the interim injunction was discharged by Mr Justice Green, who ordered that this hearing should be fixed as a rolled up hearing of the application for permission and the substantive hearing of the claim.
Assisted reproduction
In vitro fertilisation ("IVF") is the process of putting collected eggs and sperm together to achieve fertilisation outside the body. Intra cytoplasmic sperm injection ("ICSI") is a variation of IVF treatment where a single sperm is injected into the inner cellular structure of the egg.
The IVF process can be summarised as follows:
i) Stage 1 is the start of the cycle. In most cases, this involves stimulation of the ovaries using hormones, such as clomifene citrate or human chorionic gonadotrophin ("hCG"), to produce an increased number of eggs (usually between 8 and 12 eggs).
ii) Stage 2 is the collection of the eggs. In most cases a hormone such as hCG is administered to help the eggs to mature. The eggs are collected from the follicles on each ovary using ultrasound guidance, usually whilst the patient is sedated.
iii) Stage 3 is embryo transfer. When the eggs have been fertilised and grown (between 2 and 6 days after collection), one, two or three of the embryos are transferred into the uterus. At this stage some or all of the embryos may be frozen for future use.
Not all patients who start the IVF process will reach the egg collection stage or embryo transfer stage. Patients may fail to produce eggs or may be forced to postpone or abandon treatment due to the risk of ovarian hyperstimulation syndrome ("OHSS") or other complications. The risk of cancellation before embryo transfer is higher with older patients.
The ideal outcome in an IVF cycle is a healthy, singleton baby born at full gestation.
In certain cases, the chance of achieving pregnancy is increased by the transfer of more than one embryo. If more than one embryo is transferred during IVF treatment, there is an inherent risk of multiple pregnancy. The risks from multiple birth are significant and higher than the risks from singleton births. Mothers face increased health risks, including hypertension, pre-eclampsia and gestational diabetes. Twins are more likely to die during pregnancy, more likely to die shortly after birth and more likely to have cerebral palsy. At least half of all twins are premature and weigh less than singletons.
The risk of multiple birth can be reduced by elective single embryo transfer ("eSET").
However, a negative effect of increased use of eSET can be the use of blastocyst culture, whereby embryos are cultured in the laboratory for up to five or six days, rather than the traditional two or three days, allowing the selection of the best embryo for transfer. There are concerns that extended IVF culture could affect epigenetic changes during the preimplantation period and impact fetal and childhood growth and long term disease. Blastocyst transfer has been found to lead to an increased incidence of monozygotic twinning, a more complex and serious form of multiple pregnancy than that which arises from the transfer of two embryos.
Further, eSET is not suitable for every patient. Fertility and success rates decline with increasing maternal age. Older women, those who have a difficult obstetric and gynaecological history and/or those who have had previous failed IVF treatments may be at a lower risk of multiple birth because of reduced fertility. Double embryo transfers may be appropriate for those patients to give them a better prospect of a successful pregnancy.
The HFEA Code of Practice 2004 (Eighth Edition) provides that if the patient is under 40 years of age, one or two embryos may be transferred in a treatment cycle; if the patient is 40 years or over, up to three embryos may be transferred. The decision as to the number of embryos to transfer is a clinical one, based on factors such as maternal age, obstetric and gynaecological history, number of previous failed IVF attempts, ovarian reserve or previous response to stimulation, and the number and quality of the embryos available.
Statutory Framework
The HFEA is established by section 5 of the Act. The statutory purposes of the HFEA under the Act are:
i) to license and monitor clinics carrying out IVF and donor insemination;
ii) to license and monitor establishments undertaking human embryo research;
iii) to maintain a register of licences held by clinics, research establishments and storage centres;
iv) to regulate storage of gametes (eggs and sperm) and embryos; and
v) to implement the requirements of the European Union Tissue and Cells Directive to re-license IVF clinics and to license intrauterine insemination ("IUI"), gamete intrafallopian transfer ("GIFT") and other services.
Section 8 of the Act provides:
"The Authority shall –
(a) keep under review information about embryos and any subsequent development of embryos and about the provision of treatment services and activities governed by this Act, and advise the Secretary of State, if he asks it to do so, about those matters;
(b) publicise the services provided to the public by the Authority or provided in pursuance of licences;
(c) provide, to such extent as it considers appropriate, advice and information for persons to whom licences apply or who are receiving treatment services or providing gametes or embryos for use for the purposes of activities governed by this Act, or may wish to do so."
Section 8ZA(2) of the 1990 Act further provides:
"In carrying out its functions, the Authority must, so far as relevant, have regard to the principles of best regulatory practice (including the principles...
To continue reading
Request your trial
-
The Electronic Collar Manufacturers Association (an Unincorporated Association) v The Secretary of State for Environment, Food and Rural Affairs
...obligation to adopt that view: R (Assisted Reproduction and Gynaecology Centre) v The Human Fertilisation and Embryology Authority [2017] EWHC 659 (Admin) 152 As to the information placed before the decision-maker, the decision-maker must know enough to ensure that nothing that is necessar......
-
The Chief Fire Officer v Elizabeth Felix-Phillip and Others
...and R (on the application of the Assisted Reproduction and Gynaecology Centre) v The Human Fertilisation and Embryology Authority [2017] EWHC 659 (Admin) at paragraph 62 The holding in Tesco Stores is to the effect that weight is a matter for the decision maker. Tesco remains good law. In ......