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Cite as: [2017] EWHC 659 (Admin)

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		Neutral Citation Number: [2017] EWHC 659 (Admin)
		Case No: CO/3482/2016

IN THE HIGH COURT OF JUSTICE
QUEEN'S BENCH DIVISION
ADMINISTRATIVE COURT

Royal Courts of Justice
Strand, London, WC2A 2LL

30/03/2017

B e f o r e :

MRS JUSTICE O'FARRELL DBE
____________________

Between:

	THE QUEEN On the application of THE ASSISTED REPRODUCTION AND GYNAECOLOGY CENTRE	Claimant
	- and –
	THE HUMAN FERTILISATION AND EMBRYOLOGY AUTHORITY	Defendant

____________________

Jenni Richards QC, Rose Grogan and Catherine 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
____________________

HTML VERSION OF JUDGMENT APPROVED
____________________

Mrs Justice O'Farrell :

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 under which regulatory activities should be transparent, accountable, proportionate, consistent and targeted only at cases in which action is needed)."

Statistical presentation of success rates in assisted reproduction

Pursuant to its statutory duties, the HFEA has published information and performance related data about licensed clinics every year since 1995. For prospective patients, the success rates of a clinic are material when choosing whether to proceed with treatment and, if so, where. Most patients receiving IVF treatments in the UK pay for such treatments. Therefore, the publication of success rates has a major impact on the business of a clinic.

The Act does not stipulate the content or format of the information to be published by the HFEA. Therefore, the HFEA has discretion as to publication of any performance related data about licensed clinics, provided it meets the objectives of its statutory obligations.

A 'live birth' is defined as the delivery of one or more babies. The 'live birth rate' is the number of live births achieved from every 100 treatment cycles commenced.

'Live birth per treatment cycle' shows the number of live birth events out of all those who started a treatment cycle. This includes all relevant treatments (fresh stimulated IVF/ICSI using patients' own eggs) given by a clinic. This gives the lowest live birth rate of the three stages of IVF summarised above as it includes cycles where patients failed to produce eggs or treatment cycles that were abandoned before eggs were recovered due to the risk of OHSS or other complications.

The advantage of the 'live birth per treatment cycle' measure is that it is easy to generate the data and it is easy to understand. It incorporates all stages of IVF treatment. However, it does not take into account the differences in policies between clinics regarding the number of embryos transferred in any one cycle. A live birth resulting from multiple embryo transfer is counted the same as a live birth resulting from single embryo transfer.

'Live birth per egg collection' shows the chances of success from all embryo transfers from a single egg collection. It reflects factors such as ovarian stimulation, the number of eggs recovered, fertilisation rates, the quality of the embryology and the embryo transfer technique.

It is difficult to present cumulative data on 'live birth per egg collection' because some eggs collected might be frozen for future use, in which case the outcome will not be known for some time. However, the value of this rate is that it shows how likely patients are to conceive over the full cycle of treatment from one egg collection, taking into account all fresh and frozen embryo transfers.

'Live births per embryo transfer rate' (regardless of the number of embryos implanted) reflects only the quality of the embryology and the embryo transfer technique.

'Live births per embryo transferred' shows the number of live birth events from each embryo transferred. If clinics transfer two embryos in any one cycle, that will halve the 'live births per embryo transferred' for that cycle.

The advantage of 'live births per embryo transferred' is that it focuses on clinical skills because it identifies the number of live births for each embryo as the final product of a clinic's IVF laboratory. However, it cannot give an indication of the quality of the whole clinical service because it does not take into account the stages of the IVF process prior to the transfer of the embryos. It does not provide any indication of the quality of the clinic's stimulation protocols by using fertility drugs to maximise ovarian response, nor does it account for cycles where no eggs are collected during the egg collection procedure or where there is failed fertilisation and no embryos are created in the laboratory. These are additional factors which may reflect the quality of embryological skills or clinical practice.

Maternal age is the biggest single factor in assisted reproduction success rates. Currently, the success rate declines significantly at aged 38 years but there are material differences in other age bands above and below 38 years. Therefore, prospective patients have an interest in ascertaining the success rate for their particular age group. However, there are difficulties in publishing meaningful statistics for every age group because each increase in the number of groups results in a reduction in the size of each group. Some clinics perform very few cycles of treatment each year. If the performance tables were split into multiple age bands, this could reduce the numbers in each group to a level where they became statistically unreliable.

HFEA publication of information

The format and content of the information published by the HFEA has changed over time, including publication of performance data for clinics.

From 1995 the HFEA started to publish information on individual clinics. Between 1996 and 1998, the HFEA published "the Patients' Guide to DI and IVF Clinics" ("the Patient Guide"), in which the headline figure was given for each clinic's live birth rate for stimulated fresh IVF treatment per cycle started for all patients treated in a 12 month period.

Between 1998 and 2001, the Patient Guide published the above performance information, broken down into two age groups: (i) below aged 38 and (ii) all ages. Further information was also made available in respect of other treatments and by reference to a more detailed breakdown into age groups.

From 2002, the Patient Guide published the above performance information by reference to four age groups: (i) below 35, (ii) 35-37, (iii) 38-39 and (iv) 40-42.

In 2005 the HFEA published "the Guide to Infertility" in which the headline figure was given for each clinic's live birth rate for stimulated fresh IVF and ICSI treatment per cycle started, broken down into four age groups: (i) below 35, (ii) 35-37, (iii) 38-39 and (iv) 40-42.

In 2009 the CaFC App was launched, following public consultation and engagement with key stakeholders and experts. The feedback from the consultation indicated that patients generally favoured the publication of success data by 'live birth rate per cycle started' as the most instinctive way of presenting data and of most relevance to them, whereas clinicians generally favoured 'live birth rate per embryo transferred' as the most meaningful measure of success.

In a peer reviewed paper entitled "Is meaningful reporting of national IVF outcome data possible?" (Hossam I. Abdalla of the Lister Fertility Clinic, Siladitya Bhattacharya of the Aberdeen Maternity Hospital, University of Aberdeen and Yacoub Khalaf of the assisted Conception Unit, Guy's and St Thomas' Hospital Foundation – "Human Reproduction", 9 October 2009), the use of 'live births per cycle' was challenged as potentially misleading. The opinion articulated was that it was uncertain as to whether a single headline outcome measure could capture the complete spectrum of clinical and scientific distinction, regulatory compliance and safety but that 'live births per embryo transferred' provided a more sophisticated measure that would address some of those uncertainties.

As a result of this divergence of opinion, the HFEA decided to publish both sets of data on the CaFC App, i.e. 'live birth per cycle started' and 'live birth per embryo transferred'.

Data was also broken down for different treatments and for six different age groups: (i) under 35, (ii) 35-37, (iii) 38-39, (iv) 40-42, (v) 43-44 and (vi) over 44.

In the current version of the CaFC App, each clinic has an overview page that gives contact details and information about the treatments available, and how the clinic's success rates compare to the national average for births and multiple births. Users can access further detailed statistical information on IVF/ICSI, IUI with partner sperm and donor insemination. For IVF/ICSI, users can see the breakdown of patients treated by the clinic and three data tables, showing:

i) 'live births per treatment cycle started',

ii) 'live births per embryo transferred' and

iii) proportion of single births for different embryo sources (fresh embryo from own eggs, frozen embryo from own eggs, fresh embryo from donor eggs, frozen embryo from donor eggs).

The figures in each table are broken down into the above six age groups.

The CaFC App is used by approximately 15,000 patients each month to research and/or select a licensed clinic for fertility treatment.

In July 2013 the "Review of the Human Fertilisation and Embryology Authority and the Human Tissue Authority" ("the McCracken Report") was published. The McCracken Report recommendations included a fundamental review of the HFEA's data submission, analysis and publication systems.

Pursuant to those recommendations, in October 2013, the Information for Quality ("IfQ") advisory group and a number of sub-groups were set up to consider the views of the stakeholders and make recommendations to the HFEA board in respect of the information collected, held and disseminated by the HFEA. The IfQ programme included the redesign of the website and CaFC App, and the presentation of clinic data on the CaFC App, including publication of success rates in IVF.

Consultation Process

Initial consultation took place with the public and stakeholders by way of an online survey, meetings with stakeholder groups, focus groups with patients and members of the public and workshops.

In May 2014 the HFEA's strategy for 2014-2017 was agreed, including a decision to improve the presentation of clinic comparison information on the CaFC App. The objectives identified included ensuring that patients had access to high quality meaningful information to increase consumer choice and clinic comparability, and making information accessible, engaging and meaningful.

On 16 May 2014 a meeting was held by the IfQ4 data reporting and analytics group at which there was a discussion about information that could be provided to enable comparison between clinics. The group suggested that 'live birth per embryo transfer' was a better metric than 'live birth rate per treatment cycle started'. It was noted that it encouraged single embryo transfer but that it would not indicate success rates in reaching the embryo transfer stage. The group also considered whether there should be simpler reporting for each clinic by comparison with the national average. The action noted against this item was that the group should think about the best way to report success rates and should contact another sub-group, IfQ5, to find out what patients want.

Following further discussions, on 22 August 2014 a meeting was held by the IfQ4 group at which it was agreed that 'live birth per embryo transferred' should be the headline figure. It was also agreed that a second line figure should be a cumulative success rate for 12 months and 3 years. It was agreed that stakeholder views should be sought on the proposed method of reporting.

In October 2014 the IfQ group launched a consultation exercise, inviting views by an online survey. Having referred to the presentation of success rates on the existing CaFC App, the following issues were raised:

"The Advisory Group has concluded the current headline success rate of births per treatment cycle started is not a sufficiently clear indicator of a clinic's performance. We plan to replace the headline figure for clinic success rates to 'births per embryo transferred' (births means a birth event, so that twins are counted as one birth).

"Using this metric will show how good a clinic is at creating good embryos and choosing the best ones to transfer. It will also benefit clinics which carry out a 'freeze all' cycle where no embryos were transferred, either by choice or because the patient was not well enough to continue following egg collection. It will also not disadvantage the presentation of outcome data for cycles in which single embryo transfer is the best option for the patient. It has however, been suggested that using this metric will encourage clinics to culture embryos to blastocyst (an embryo that has developed in the laboratory for five days after fertilisation before it is transferred to the womb) which some stakeholders are concerned about due to risks of extended culture..."

The questions included Question 4(a):

"Should we use births per embryo transferred as the headline figure for the clinic success rate?"

Of the 335 responses to the survey, 234 answered question 4(a). Of those who answered, 102 (43.6%) answered 'yes' and 116 (49.6%) answered 'no'. When the figures were corrected to include those who provided comments, rather than a simple 'yes' or 'no' answer, the responses were 47% in favour of the proposed headline metric and 53% against.

Question 4(c) asked:

"Do you agree that cumulative birth rate should be the second headline figure for clinic success rates and, what would be the ideal duration over which it should be reported?"

Question 4(c) was answered by 227 respondents. Of those who answered, 117 (51%) answered 'yes' and 110 (49%) answered 'no'. As to the duration over which the cumulative birth rate should be reported, 24% recommended 1 year, 35% recommended 2 years and 41% recommended 3 years.

On 25 November 2014 the IfQ4 group met to discuss the consultation findings and agree recommendations for the HFEA advisory group. The minutes recorded the following matters:

"2. The group noted that a slight majority of stakeholders were not supportive of using either live birth per embryo transferred or cumulative birth rate as headline figures. This was partially due to disadvantages with using either measure, and the desire to avoid using headline figures at all.

"3. The group considered some of the comments provided by respondents. They agreed that encouraging single embryo transfers was a positive outcome of using live birth per embryo transferred and that the metric should continue to record birth events, rather than the number of births. Members also noted that this would not 'hide' those cycles that failed before embryo creation as this information would still be available albeit on the second page within a clinic's Choose a Fertility Clinic (CaFC) profile.

"4. Members noted that some stakeholders did not support using headline figures and preferred allowing users to generate their own success rate information based on a number of other metrics. The group agreed that this position was understandable, but noted the findings of the user research, which highlighted that users often wanted to be able to compare clinics like for like, thus the HFEA needed to provide a consistent metric across all clinics. Other metrics of success would still be available on the second page of a clinic's CaFC profile.

"5. Members noted that the findings also showed some concern over the meaning and definition of cumulative birth rate. They agreed there was no international consensus on how to use this metric, but considered it to be useful information for patients, a position which they noted was supported by several professional stakeholder organisations…

"7. Members noted that the findings showed that 3 years was the preferred duration over which cumulative birth rate should be reported. It was agreed that a fixed duration was required to ensure success rate data was up to date and accurate. However, following discussion, members agreed that 2 years was a more suitable time period as it would be unlikely that there are women having two births from one egg collection within this time period…

"10. Members recommended that live births per embryo transferred and cumulative live birth rate (reported over two years) should be the headline success rate figures on CaFC. They noted that the findings showed there was support for this, and that other information would still be available on the second page of a clinic's CaFC profile."

On 9 December 2014 the IfQ4 group prepared its report to the IfQ advisory group. Its recommendations included the first headline figure as 'live birth event per embryo transferred' and the second headline figure as 'cumulative live birth (at least one live birth) from one egg collection, over a two year period'. In respect of the consultation feedback on Question 4(a), the group noted:

"From the online consultation, a small majority of respondents disagreed with this proposal, with a larger majority when only looking at lay people (patients, donors, parents of donor-conceived children). Some respondents felt that per embryo transferred figure will hide failures prior to reaching embryo transfer stage. The EG acknowledges these comments and confirmed that the current births per cycle figures would still be available, on a second page.

"The EG also acknowledged that some respondents suggested that there should be no headline figure, but multiple metrics available to choose from, but felt that this went against what the user testing from Fluent Interactive reported – that the large numbers of statistics visible was confusing. It will be useful to have one figure which has consistent numerator and denominator, if patients were to compare clinics…"

The IfQ advisory group prepared recommendations for the HFEA board in a report tabled at a meeting held on 21 January 2015. The recommendations included:

i) the first headline figure should be 'live birth per embryo transferred';

ii) the second headline figure should be 'cumulative live birth rate per egg collection', reported over a two year period;

iii) the headline figures should include all types of treatment.

In respect of the first headline figure recommendation, the IfQ advisory group stated:

"8.2 Our user research showed that patients can struggle with success rate data on Choose a Fertility Clinic. The amount of data, over several tables and pages, can be overwhelming and complicated. We also know that some stakeholders think that the current metric for 'success' is not the most appropriate. We wanted to provide a success metric for patients that is easy to understand, whilst still allowing users to dig deeper into the data if they so wished. Therefore, we sought views on whether Live Births per embryo transferred should be the headline figure for each clinic, with a second headline figure of Cumulative live birth rate – we additionally asked over what time period this should be reported…"

A pie chart showed that 47% of the respondents were in favour of the proposed new headline metric and 53% were against.

"Reasons to agree

"8.3 As the pie chart above shows, it was fairly split on whether to accept this proposal. Respondents noted that live births per embryo transferred had some benefits such as excluding scenarios of failed to fertilise, creating a more level playing field by showing the quality of labs and their clinicians, and using a more helpful success rate figure than is currently presented. Whilst not providing further information, some simply stated that this was the most appropriate measure…

"8.6 Of the respondents who identified themselves as being a member of clinic staff, we found that a slight majority (56%) supported using this as the headline figure. Our discussions with clinic staff at the workshops highlighted that they were also fairly supportive of this proposal, particularly as it encouraged single embryo transfer. Responses from several professional organisations were also in favour, including BFS, Association of Clinical Embryologist (ACE), SING, Infertility Network UK (INUK) and Royal college of Nurses Fertility Nursing Forum (RCN).

"Reasons to disagree

"8.7 However, there were just as many respondents who disagreed with presenting births per embryo transferred as the headline figure. It was suggested that this is a complicated metric for patients to understand, but also that it was slightly misleading as a large proportion of patients will not even reach embryo transfer stage.

"8.8 When we analysed by respondent type, we saw that a large proportion of those who identified themselves as a patient, donor, donor conceived person or their parent disagreed with this proposal. The majority did not provide a rationale to explain why, or a suggestion of what would be better, however we received a handful of comments which can be summarised below:

It conceals the rate of failure prior to embryo transfer.

It does not show clinics which are good at creating embryos as the ones that fail are not included.

It could cause clinics to transfer less embryos even though in some cases double embryo transfer may be more effective.

It is too confusing; patients want to know the odds of success from starting a treatment cycle at a clinic.

…

"Conclusions

Both live births per embryo transferred and cumulative live birth rate have a number of advantages and disadvantages.

Some respondents support having multiple metrics to measure success, although going down this path would be contrary to the findings of user research – and such information can still be available but not as the headline figure.

Assuming we want to highlight which clinics are good at producing high quality embryos resulting in a birth (the primary aim of Choose a Fertility Clinic), then live births per embryo transferred is the most appropriate headline figure.

The definition of cumulative birth rate is not well understood, but is seen as a useful second headline figure to provide. If chosen, further work is needed to define what it is measuring and conveying this in an accurate and understandable way."

At the meeting held on 21 January 2015, the HFEA board accepted most of the IfQ advisory group's recommendations, including the above recommendations in respect of the headline performance data for clinics.

In a paper dated 15 July 2015, Juliet Tizzard, Director of Strategy and Corporate Affairs for the HFEA, recommended that the age banding for the clinic data should be changed from six groups to two: (i) under 38 years and (ii) 38 years and over), to give larger, more meaningful sample sizes.

In an updating paper presented to the HFEA board at a meeting on 11 November 2015, it was noted that there was concern expressed about reducing the number of age bands from six to two but the proposed presentation of the data for the purpose of beta testing was limited to the two identified groups.

On 24 March 2016 the HFEA held its annual conference, at which Ms Tizzard gave a presentation on the new website and CaFC App. The presentation stated that statistical information on birth rates would be split into three levels:

i) top level data focussing on consistency with national average;

ii) second level data containing births per embryo transferred, births per egg collection and multiple births;

iii) third level data containing the details currently published.

On 15 June 2016 the HFEA sent clinics notification of the proposed changes to the CaFC App, initially in beta form, with a view to obtaining feedback. The stated aim of the changes was to transform the collection, analysis and publication of information for the benefit of clinics and patients. The letter explained that the CaFC App would use performance statistics and patient ratings, prioritising pregnancy and birth data that best indicated the quality of the clinic's service, and stated:

"The new headline rate for IVF (including ICSI) is births per embryo transferred, with each clinic's overall rate presented alongside the national rate. This will be followed by a new cumulative rate, based on births per egg collection, and the multiple birth rate."

The beta testing of the new website and CaFC App commenced on 12 August 2016 and was concluded by 7 October 2016. Further feedback was received, through an online survey, a workshop for clinic staff and one-to-one user testing.

The clinic workshop was held on 29 September 2016. At the workshop, Ms Tizzard indicated that the HFEA's decision to use as a headline metric 'births per embryo transferred' had been decided (and therefore was not under reconsideration) but that the other issues were open to discussion. There was opportunity for the delegates to provide views on the CaFC App. The feedback provided during the workshop included consensus that there should be no aggregation of age groups or treatments in the statistics.

The online survey results included the following:

i) In answer to question Q10 (regarding the inspection, patient rating and IVF birth rate headline): "Do you think it's right to have this headline information at the top of the page?" 127 out of 163 respondents replied: "No" (77.9%).

ii) In answer to question Q12: "We present a headline statistic representing patients of all ages, grouped together. Do you think it's right to group all ages together for the headline figures?" 154 out of 164 respondents replied: "No" (93.9%).

iii) In answer to question Q15: "At this point we split the data into two age categories, to give patients more relevant information whilst keeping the presentation simple. We have chosen age 38 as the cut off because the rate is significantly lower after this age. Data split by six age categories can be found on the detailed statistics page. Do you think we have got the right balance of age detail between this page and the detailed statistics page?" 137 out of 159 respondents replied: "No" (86%).

iv) In answer to question Q16: "Because we use births per embryo transferred as one of our three headline measures, we don't think it's relevant to separate the different treatment types. That's because, once you have an embryo ready for transfer, how it was created is less important. So, we have included IVF, ICSI, PGS and PGD. Do you think it's right to group treatment types together in this way?" 147 out of 159 respondents replied: "No" (91.8%).

v) One of the respondents, a statistician researching IVF outcomes, indicated opposition to the proposed changes, stating that it reduced clarity and transparency, and that the 'live birth per embryo transferred' metric did not provide patients with an informative or useful measure of success.

In October/November 2016 the IfQ advisory group produced recommendations and options for the HFEA board to determine, including:

i) The headline IVF birth rate should be based on 'birth events per embryo transferred' because it reflects good embryology skills and promotes single embryo transfer.

ii) The headline IVF birth rate should only indicate whether a clinic is consistent with, above or below the national average in respect of all patients under 38 years.

iii) The HFEA should use only fresh IVF and ICSI cycles with the patient's own eggs for the headline calculation.

iv) The HFEA should continue to calculate the cumulative rate of births per egg collection for a two-year period.

v) The HFEA should continue to use three age bands (all ages, under 38 years and over 38 years) on the clinic profile page. Other more detailed age bands should be available on the detailed statistics pages.

A paper was prepared for the HFEA board meeting by Ms Tizzard and Helen Crutcher, Policy Manager. The paper considered the headline metric of 'live births per embryo transferred'. It was noted that the beta feedback survey did not ask about this IVF headline measure. It identified arguments raised against this measure in the feedback, namely, that it acts as a disincentive to replace the number of embryos that are clinically indicated, it is difficult for patients to understand, it doesn't give them a picture of their overall chance of success and it does not show the clinic's performance around safe ovarian stimulation practices. It also identified arguments raised in these legal proceedings, namely:

it is a more complex measure than live births per cycle started and is harder for patients to understand;

it relates to a smaller subset of patients who reach the embryo transfer stage;

it can be confusing for patients if a multiple embryo transfer results in the birth of twins or triplets; and

it makes it difficult for patients to identify a successful clinic which uses double embryo transfers when clinically indicated.

However, the advisory group restated its support for the proposed new metric for the following identified reasons:

it promotes good clinical practice around embryo transfer, namely the transfer of one good quality embryo with the aim of producing a birth event, preferably a singleton baby;

as such, it reinforces the HFEA policy to minimise multiple births following IVF, thereby reducing significant risks to IVF mothers and their babies;

it is possible to explain the rate and the reasons for using it to patients;

births per embryo transferred is supported by a majority of professionals in the field and by the British Fertility Society.

The paper considered the age aggregation issue in the presentation of the headline data. It identified the desire by patients for more specific information relating to their age group and the fact that age affects the chance of success. However, it noted that presenting many age bands would result in small sample sizes, leading to relatively meaningless rates and wide reliability ranges, causing confusion. The advisory group recommended using under 38 years for the headline rate since the birth rate generally declines after this age.

HFEA Decisions

On 16 November 2016 the HFEA held a meeting to consider the feedback and make decisions as to the presentation of information on the CaFC App. At the meeting Ms Tizzard gave a presentation, including the following information:

i) Births per embryo transferred – arguments for and against this measure:

Against

It acts as a disincentive to replace the clinically indicated number of embryos

It makes it difficult to identify a successful clinic which transfers two embryos

It is difficult for patients to understand and only shows those who reach transfer

It does not reflect safe stimulation practices

For

It promotes good practice around embryo transfer

It reinforces our policy to reduce multiple births

It is understandable to patients, if explained well

It is supported by the majority of professionals, the Advisory Group and the BFS

Other measures are available elsewhere on CaFC

ii) Presenting the headline statistic at the top of the page

Thoughts about a headline measure at the top of the page:

Most people at the workshop supported a headline measure, so long as it is less aggregated

It should be something which enables comparison between clinics

A few suggested showing more than one age group at this point

The Advisory Group thought that a simple 'consistent with the national average' tick would be more meaningful

iii) What should be included in the headline birth rate calculation?

Points to consider:

Age aggregation and treatment aggregation as done in beta CaFC are very unpopular

Because of the impact of age on success, grouping all ages may disadvantage some clinics treating more older patients

Some treatments are used for different reasons to standard IVF, maybe also on different patients

Both may make the birth rate less meaningful to patients.

Based on advice from the IfQ advisory group, the HFEA made the decisions that are the subject of challenge in these proceedings, as recorded in the minutes of the meeting.

Firstly, the HFEA decided that the primary headline birth rate for IVF should be 'births per embryo transferred' ("the Metric Decision"). Adopting this rate would place greater emphasis on the clinical and embryological practices of the clinic and would promote the HFEA policy on single embryo transfer. It was noted that some respondents during the beta feedback survey argued against this metric on the basis that it would act as a disincentive to replace the number of embryos clinically indicated and it would be difficult for patients to understand, as it does not give them a picture of their overall chance of success. The HFEA considered those views but stated its view that there was no case for changing the headline measure because:

i) it promotes good practice around embryo transfer;

ii) it reinforces the HFEA's policy to reduce multiple births;

iii) it is understandable to patients if explained well; and

iv) it is supported by the majority of professionals, the advisory group and the BFS.

Accordingly, all members of the board agreed to retain 'live births per embryo transferred' as the headline IVF birth rate on the CaFC App.

Secondly, the HFEA decided to accept the recommendation of the IfQ advisory group to present a headline birth rate at the top of the clinic page, indicating whether the clinic was consistent with the national average, using age aggregation but not all treatment aggregation ("the Headline Decision"). It was noted that in the feedback most people supported a headline measure. Age aggregation and treatment aggregation were very unpopular because the impact of age on success meant that grouping all ages might disadvantage some clinics treating older patients, and some treatments are used for different reasons to standard IVF, making the birth rate less meaningful to patients. The decision made was to present the headline birth rate based on stimulated, fresh IVF and ICSI cycles, using the patient's eggs for all patients under 38 years.

Thirdly, the HFEA decided that further down each clinic page, the IVF birth rate should be shown for three age categories: (i) all ages, (ii) under 38 years and (iii) 38 years and over ("the Age Group Decision").

In addition, the HFEA decided that the presentation of the births per egg collection data should be calculated for a two-year period as recommended by the IfQ advisory group. This decision is criticised by the Clinic but it is not the subject of the challenge.

The HFEA's intention is to make the website and CaFC App live following the outcome of this judicial review application.

The Issues

The Clinic has had the highest pregnancy and live birth rates since it was established in 1995. This includes lower cancellation rates between the start of a treatment cycle to embryo transfer. It treats a higher proportion of older patients and those who have had unsuccessful previous IVF treatment than the national average. Therefore, it is more likely to use, with clinical justification, the transfer of more than one embryo per cycle. The decisions by the HFEA will have an adverse impact on the success rates shown on its clinic profile page.

The Clinic's complaint is that the HFEA's decision fails to achieve its stated objective, the simple, clear and transparent presentation of data, and is thus unlawful. The public is a class for whose benefit the HFEA exists but the HFEA failed to take into account the views and preferences of patients expressed during the consultations. The material presented to the HFEA board was incomplete and skewed in favour of the outcomes that the HFEA had already selected. There was no adequate attempt to address the counter-arguments or concerns in respect of its chosen course. The decisions are irrational and unreasonable.

The HFEA's position is that there has been full consultation, the feedback has been considered and all counter-arguments have been expressed clearly on many occasions. The HFEA's decisions are rational, satisfy the statutory objective to provide more meaningful and reliable information, and are supported by embryologists and peer reviewed papers.

The Clinic's challenge to each of the above HFEA decisions requires the court to consider:

i) whether the decision promotes the policy and objects of the Act;

ii) whether the HFEA carried out a sufficient inquiry in reaching its decision and had regard to all legally relevant considerations;

iii) whether the HFEA carried out adequate consultation and/or conscientiously considered the responses of those consulted before reaching its decision;

iv) whether the decision was rational and within the range of reasonable decisions open to the HFEA.

Principles applicable

A public authority's power must be exercised within the object and purpose of the statute. The HFEA's discretion is not unfettered. Regard must be had to the person or class of persons for whose benefit the power was intended to be conferred: Padfield v Minister of Agriculture, Fisheries and Food [1968] AC 997 per Lord Reid at pages 1030, 1033. The purpose for which the information is provided to the public must not extend to unlawful attempts to persuade the public of a particular view held by the HFEA: R (Westminster City Council) v Inner London Education Authority [1986] 1WLR 28 per Glidewell J pp.44-45.

Public bodies must take into account all legally relevant considerations and avoid taking into account those that are irrelevant. That requires reasonable steps to be taken to provide the decision maker with the relevant information to enable it to make a rational decision: Secretary of State for Education and Science v Tameside MBC [1977] AC 1014 per Lord Wilberforce at pp.1047-8, Lord Diplock at pp.1064-5; R (B) v Worcestershire County Council [2009] EWHC 2915 per Stadlen J at Paras.94-95; Law Society of England and Wales v Legal Services Commission [2010] EWHC 2550 per Moses LJ at Para.109.

Fairness requires that the issues are put to the decision maker in a balanced way so that they are able to arrive at a decision that has a rational basis. That requires identification of the arguments both for and against the recommendations: R (Hindawi) v Secretary of State for Justice [2011] EWHC 830 per Thomas LJ at Paras.73-75.

The decision maker must have regard to all relevant information and the decision must be logical: R (A) v Liverpool City Council [2007] EWHC 1477 per Walker J at Paras.39-40. Where reasons are given for a decision, the court is entitled to examine them to determine whether the decision maker has taken into account relevant considerations and weighed those relevant considerations in a way that a reasonable decision maker should do: R (Gallagher) v Basildon DC [2010] EWHC 2824 per Parker J at Para.33.

The question of what is a material or relevant consideration is a question of law, but the weight to be given to it is a matter for the decision maker: R (Sainsbury's Supermarkets Ltd) v Wolverhampton City Council [2010] UKSC 20 per Lord Collins Para.70. If the decision maker wrongly takes the view that some consideration is not relevant, and therefore has no regard to it, his decision cannot stand and he must be required to think again. But it is entirely for the decision maker to attribute to the relevant considerations such weight as he thinks fit and the courts will not interfere unless he has acted unreasonably in the Wednesbury sense: Tesco Stores Ltd v Secretary of State for the Environment [1995] 1WLR 759 per Lord Keith of Kinkel p.764; R (Lynch) v Secretary of State for the Home Department [2012] EWHC 1597 per King J Para.10.

Where a public authority exercises its discretion, it must follow fair procedures, including consulting and receiving representations. The basic requirements of a fair consultation are that: (a) consultation must be at a time when proposals are still at a formative stage, (b) sufficient reasons must be given for any proposal to enable intelligent consideration and response, (c) adequate time must be given for such consideration and response and (d) the product of consultation must be conscientiously taken into account in finalising any proposals: R (Gunning) v Brent LBC (1985) 84 LGR 168; R (Morris) v Newport City Council [2009] EWHC 3051 per Beatson J at Para.2; R (Moseley) v Haringey LBC [2014] 1 WLR 3947 per Lord Wilson JSC at Para.25.

It is implicit in the obligation to consult that the consultation must be genuine i.e. that the HFEA must be willing to take into account the representations made as a result of the consultation: R re Liverpool City Council v The Secretary of State for Health [2003] EWHC 1975 Burnton J at Para.47.

A decision maker must afford the opportunity for stakeholders to express potentially relevant views as part of the consultation process. There may be some matter so obviously material to a decision on a particular issue that anything short of direct consultation and consideration would not be in accordance with the HFEA's obligations: In re Findlay [1985] 1 AC 318 per Lord Scarman at pages 333-334. However, not every change between the proposals consulted on and the proposals the authority wishes to adopt demands further consultation. When considering whether a consultation process is unlawful on the grounds of unfairness, the court will take into account the fact that any consultation has to come to an end and decisions have to be taken: Devon County Council v Secretary of State for Communities and Local Government [2010] EWHC 1456 per Ouseley J at Paras.70-72.

Any discretion must be exercised reasonably. There must be a rational connection between the decision and the objective: R (Trafford) v Blackpool Borough Council [2014] EWHC 85 per HHJ Davies Para.77. In this case, given that the HFEA's new approach represents a departure from its previous position as to the appropriate metrics to use for performance rates of clinics, it must be able to demonstrate that there is good reason for such change: R (Assisted Reproduction Centre) v HFEA [2013] EWHC 3087 per Patterson J Paras.93-96.

However, the court must not substitute its own decision for that of the Authority's. The court will only interfere with the decision reached by a decision maker pursuant to its statutory power if it is unreasonable in that it is outside the range of reasonable responses open to the decision maker: Associated Provincial Picture Houses Ltd v Wednesbury Corporation [1948] 1 KB 223 per Lord Greene MR at pages 228 – 231; R (Crawford) v The Legal Ombudsman [2014] EWHC 182 per Popplewell J at Para.21; R (ARGC) v HFEA [2002] EWCA Civ 20 per Wall J at para.15:

"This is an area of rapidly developing scientific knowledge and debate, in which the Authority, as the licensing body established by Parliament, makes decisions and gives advice. It is not the function of the court to enter the scientific debate, nor is it the function of the court to adjudicate on the merits of the Board's decisions or any advice it gives. Like any public authority, the board is open to challenge by way of judicial review, but only if it exceeds or abuses the powers and responsibilities given to it by Parliament."

Metric Decision

Clinic's case