The Assisted Reproduction And Gynaecology Centre, R (On the Application Of) v The Human Fertilisation And Embryology Authority

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:

The Clinic seeks a declaration that the above decisions were unlawful and an order quashing the same, on the following grounds:

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:

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.

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:

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.

The HFEA is established by section 5 of the Act. The statutory purposes of the HFEA under the Act are:

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).”

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.

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:

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.

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:

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:

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:

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

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:

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

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.

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:

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:

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 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:

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.”

The Clinic’s case is that the decision to use ‘live births per embryo transferred’ and not ‘live births per treatment cycle’ is unreasonable and irrational in that it:

Firstly, the metric fails to reflect material factors, such as age, type of treatment, reproductive history and cancelled cycles, all of which contribute significantly to a clinic’s performance. In particular, it fails to reflect the fact that eSET is not appropriate for patients who are older or who have had other failed treatments and centres that treat such patients, such as the Clinic, may be disadvantaged.

Secondly, the decision does not highlight good embryological and clinical practice, it does not allow patients, who are the class of persons for whose benefit the HFEA powers are exercised, to make an informed choice about their chances of success, and does not allow patients to compare the performance of clinics throughout all stages of the IVF process.

Thirdly, there was no opportunity for users to provide feedback on this metric during the 2016 beta testing phase and the HFEA failed to take into account the overwhelmingly opposing views expressed by patients in earlier consultations in 2009 and 2014.

Fourthly, the paper presented to the HFEA board on which it made its decision did not set out the relevant information in a fair and balanced way. The assertion was made that the current headline was no longer supported by the sector whereas in fact most respondents were opposed to the new metric. The views of clinicians were presented wrongly as a majority. There was no proper attempt to address the counter-arguments; in particular, those of the statistician and the Clinic were not given adequate consideration.

There is no rational explanation for the HFEA’s decision to depart from the presentation of clinic performance currently used.

The HFEA’s position is that this challenge is an improper attempt by the Clinic to dispute the substance of the decision and there are no proper grounds for judicial review.

It is accepted that the ‘live births per embryo transferred’ metric does not reflect all material factors but it is contended that neither does the ‘live births per cycle started’, which does not take account of reproductive history. The board considered the limitation of the new metric, including the fact that it does not reflect cancellations prior to embryo transfer, but decided that this was outweighed by the arguments in favour of the metric. The other relevant factors are reflected in the detailed breakdowns on other pages in the CaFC App.

It is disputed that the metric is misleading or fails to highlight good embryological and clinical practice. The current CaFC App displays both ‘live births per embryo transferred’ and ‘live births per cycle started’ and no complaint has been made by the Clinic that this is misleading. The metric does highlight good embryological and clinical practice although, as for all metrics, it does not cover every aspect of such practice. The issue of the best measure of success for IVF clinics has been the subject of much debate but since at least 2009 the majority of clinicians has favoured the use of ‘live birth per embryo transferred’ in preference to ‘live birth per cycle started’.

It is accepted that the HFEA did not invite reconsideration of the ‘live births per embryo transferred’ in the 2016 beta feedback but it had consulted on this issue of principle in the 2014 consultation and further consideration of it was discussed in the 2016 workshop and in the HFEA paper.

It is disputed that the material provided to the HFEA board was partial or unfair. The arguments for and against the use of the ‘live births per embryo transferred’ metric were set out in the paper and given proper consideration by the board.

The HFEA decision on the metric was within the range of reasonable decisions open to it.

It is clear from the wealth of material produced in these proceedings that there is no single measure of IVF success that has universal support or acceptance. The debate has centred around which metric, if any, provides the most appropriate indication of clinic performance. There is a tension between the information patients might instinctively want and the information that is clinically significant.

The ‘live births per embryo transferred’ metric doesn’t take account of issues such as age and reproductive history of patients, ovulation stimulation or embryo creation skills of the clinic. It does reflect embryology selection and transfer skills and promotes the single embryo transfer policy. The ‘live births per cycle started’ metric includes all cancelled treatments during the cycle but doesn’t take account of reproductive history or the policy of the clinic on embryo transfer. It is no answer to the Clinic’s complaint that neither of those metrics fails to reflect all material factors. The complaint is that there should not be a single headline success metric for that very reason.

However, these issues were identified and considered in the IfQ4 discussion in November 2014, its report to the advisory group in December 2014, the advisory group report to the HFEA board in January 2015, the advisory group recommendations to the HFEA board in November 2016, the paper prepared by Ms Tizzard and Ms Crutcher and the presentation to the board at the November 2016 meeting. It is clear from the above documents and the minutes of the November 2016 meeting that the HFEA board considered all those relevant factors but, having weighed them, made the Metric Decision on the basis that:

I reject the Clinic’s submission that the Metric Decision does not logically support the HFEA policy of promoting good embryological and clinical practice. A factor in the number of live births per embryo transferred will be the skill of the clinic in creating and selecting the best embryo for transfer. The majority of professionals and clinicians who have expressed views supports this metric as promoting good embryological practice. The ‘live births per embryo transferred’ metric has been used on the CaFC App since 2009 without complaint.

The metric does not take account of egg collection and fertilisation but that information is available in the ‘cumulative live births per egg collection’ metric as a second headline figure.

The ‘live births per embryo transferred’ metric does not take account of cancellations prior to embryo transfer. However, the cancellation group was considered by the board at the meeting on 21 January 2015. The board decided that including this group in success rates would be unhelpful on the basis that it disadvantaged clinics who received patients with a poor prognosis, a factor over which the clinics had no control. In any event, that information is available on the second page of the clinic profile.

Although the ‘live births per embryo transferred’ metric does not allow comparison of clinic performance throughout all stages of IVF treatment, it does not follow that patients are deprived of the opportunity of making an informed choice about their treatment or clinic. The HFEA makes a valid point that no information that could be made available on the CaFC App would indicate the chances of success for any individual patient. It was stated in the discussions and papers that users wanted a consistent metric to be able to compare clinics. That had to be weighed against the disadvantage of any single metric. The HFEA noted that it remained open to patients to see the overall success rates and compare clinics by reference to the identified material factors, through the detailed information available on the clinic pages.

The HFEA consulted on its proposal to use the ‘live births per embryo transferred’ metric as the main headline figure in 2014/2015. The results were that 47% of respondents were in favour of the proposal and 53% were against. When combined with the response to the proposed cumulative headline figure, the results were 49% in favour of this headline information and 51% against the proposals.

The IfQ4 group correctly noted that a slight/small majority of respondents did not agree with the proposal but, in providing their recommendation to the IfQ advisory group, balanced that against the fact that more detailed information would be available elsewhere on the CaFC App and the user research which supported a simple, consistent metric for clinic comparison.

The IfQ advisory group identified the results and the arguments as part of their recommendations for the HFEA board. The Clinic contends that there was a clear majority against the proposed metric and the report by the IfQ advisory group wrongly states that the results were “fairly split”. I agree that it is not accurate to describe a 47:53 response as a fair split but the actual response figures, the percentages and pie chart were all clearly set out directly above the relevant text so that there was no risk that the board would be misled.

The Clinic further contends that the IfQ report wrongly states that a slight majority of clinic staff supported the proposal. I reject that complaint because it was a correct reflection of the responses by clinic staff to the proposal. The breakdown shows that most professional organisations (9:2), embryologists (28:15) and clinic members (10:3) were in favour of the ‘births per embryo transferred’ metric.

The IfQ advisory group report of December 2014 contained a balancing exercise, fairly setting out the arguments for and against the proposal. The conclusion on this issue was expressed in fair and measured terms, accepting that both metrics under consideration had advantages and disadvantages.

The HFEA did not invite reconsideration of the ‘live births per embryo transferred’ metric during the beta testing in 2016. Given the full consultation in 2014/2015 on this issue, in my judgment it was not necessary for the HFEA to re-consult on this matter. However, the paper prepared for the HFEA board and the presentation by Ms Tizzard at the meeting in November 2016 reiterated the arguments for and against the proposed metric.

There was no obligation on the part of the HFEA to adopt the majority view based on the feedback during the consultation processes. The obligation was to give conscientious consideration to the views expressed, taking into account majority views on the issue. However, having taken those views into account, the HFEA was entitled to give greater weight to the views of the clinicians and professional bodies who favoured the ‘live births per embryo transferred’ metric.

The minutes of the HFEA board meeting identify the consideration given to the arguments and record the reasons for the decision. The decisive factors identified by the HFEA were that the ‘live births per embryo transferred’ metric promotes good practice around embryo transfer, reinforces the HFEA’s policy to reduce multiple births, is understandable if explained well, and is supported by the majority of professionals, the advisory group and the BFS. The decision is supported logically by the reasons given and constitutes one out of the available rational responses to the arguments.

It is not for this court to decide whether either metric, neither or both should be used as headline figures. This court must consider whether the HFEA’s decision was within the range of reasonable decisions open to it in all the circumstances. In my judgment, the decision was not irrational or outside the range of reasonable decisions available.

The Clinic’s case is that the decision to present the IVF birth rate by reference to whether a clinic is consistent, above or below the national average, using data relating to the under 38 age group was illogical, unfair and irrational.

Firstly, the use of a single figure to compare a clinic’s success rate against the national average (as opposed to the use of different age groups for the comparison) was not part of the consultation. Therefore, the HFEA failed in its duty to make reasonable inquiry in respect of the headline.

Further, the executive summary of the feedback paper wrongly stated that many people agreed with the use of headline information, which was contrary to the survey results showing that most respondents objected to a headline figure. Therefore, the HFEA failed to inform itself of the views and preferences of stakeholders to enable it to make a rational decision.

Finally, the advisory group was divided on this issue. It stated that this was the most important message for patients but failed to provide any evidential, rational foundation for its decision and the HFEA board provided no reasons for accepting the recommendation of the advisory group.

The HFEA’s position is that there was no duty to consult about the proposal to change the headline information to identify one age group, namely under 38 years. The clinic profile page on the current CaFC App sets out the IVF birth rate by reference to whether a clinic is consistent, above or below the national measure, calculated only by reference to those aged under 38. Although it is broken down into two sub-groups: (i) under 35 years and (ii) 35-37 years, it does not provide the information that the Clinic now contends for, namely for patients over 38 years.

The question posed in the beta feedback questionnaire was ambiguous in that it did not explain what “headline information” was referred to. The comments provided by respondents indicated that they agreed with the concept of headline information but not the form proposed.

The current clinic page in the CaFC App states whether the clinic’s IVF/ICSI birth rate is consistent, above or below the national measure. The material issues raised with stakeholders in respect of the proposed headline measure were age aggregation and treatment aggregation. There was adequate opportunity given to the stakeholders to provide feedback addressing those issues, during the beta testing, in the online survey responses and in the workshop.

The responses were overwhelmingly against age aggregation (93.9% in the online feedback) and treatment aggregation (91.8% in the online feedback).

At the advisory group meeting on 26 October 2016, there was clear disagreement on the issue of age aggregation. Various different views were expressed with explanation as part of the discussion. The recommendation was that the under 38 age group should be used. The reason given was that the birth rate generally declines after this age, meaning the under 38 average results would be more comparable between clinics. On treatment aggregation, the advisory group considered various alternatives but recommended that only fresh IVF/ICSI treatment with the patient’s eggs should be included in the headline success rate.

The paper produced for the HFEA board meeting on 16 November 2016 and the presentation given by Ms Tizzard at the meeting identified the fact that both age aggregation and treatment aggregation were very unpopular. The arguments for various alternatives were clearly and fairly set out. In relation to age aggregation, the paper identified the problem caused by splitting data, namely statistical unreliability. The reason stated for the advisory group’s recommendation was that the birth rate generally declines after 38 years and the cohort of patients in this age group is larger across most clinics, making comparison more meaningful.

The HFEA board had before it the beta feedback responses and was asked to consider them in making its decisions, as recorded in the transcript of the meeting at page 3 and the minutes of the meeting at item 8.4.

The board decision was to change the proposed headline in response to the feedback. Treatment aggregation was modified to include only stimulated, fresh IVF and ICSI cycles using the patient’s eggs. Age Aggregation was modified to include only those aged 38 and under. Having taken into account the stakeholder feedback, it was not necessary for the HFEA to consult further on these modifications.

Although it did not set out its reasons, the relevant considerations and arguments in favour of the decision were adequately set out in the papers before the board.

In my judgment there was adequate consultation on the change in presentation of the headline birth rate and conscientious consideration was given by the HFEA board to the responses. The Headline Decision is not materially different to the current CaFC App headline and there are reasoned arguments in favour of age aggregation to ensure meaningful group sizes. It is not objectively irrational and it falls within the range of reasonable decisions available.

The Clinic submits that the use of a reduced number of age bands is contrary to the views of the patients from the consultation process and was rejected some years ago. Feedback from the consultation exercise was overwhelmingly opposed to age aggregation. No rational explanation has been given for ignoring the wishes of the patients.

Age is the most important factor in determining success for IVF. Although more detailed statistics, including the preferences identified in the consultation exercise, can be found through the CaFC App, it is not easy or obvious to access that information, which defeats the objectives of the HFEA exercise.

The HFEA has failed conscientiously to take into account the outcome of the consultation on this issue. No reason was given by the HFEA board for the decision.

The current clinic profile page on the CaFC App sets out the birth rate for two groups: (i) under 35 years and (ii) 35-37 years. It does not provide the information that the Clinic now contends for, namely the IVF birth rate for patients broken down into six age bands. The current approach of presenting more detailed statistics on the second page, using the existing six age groups, has been maintained.

The HFEA conscientiously considered the consultation feedback on age aggregation. There was clear discussion about the unpopularity of age aggregation and the disadvantage to clinics treating more older patients. These matters were expressly identified by Ms Tizzard in her presentation to the board.

Although the HFEA board did not set out its reasons for the decision to use three age groups for the IVF birth rate on the first clinic page in the portal, the online feedback results were before it and the arguments in favour of each option were fairly set out in the papers and presentation to the board. Given the strength of opposition from stakeholders, it was incumbent on the board to consider them carefully and to explain its decision to reject their views.

The paper before the board identified the main disadvantage of age grouping, namely, the resulting small sample sizes, leading to meaningless rates and wide reliability ranges. The paper set out the arguments in favour of various alternatives as well as the recommended option. There was discussion at the board meeting and different views were canvassed. It is clear from the transcript and minutes of the meeting that the board exercised conscientious consideration of the responses.

There was no obligation on the part of the HFEA to adopt the majority view based on the feedback during the consultation processes. The board was entitled to weigh the clear majority opposition to age aggregation in the beta feedback against the argument for statistical reliability.

It is not a matter for the court to determine what the correct decision should have been. The decision was within the range of rational and reasonable decisions available.

In conclusion:

For the reasons set out above, permission to apply for judicial review is granted but the claim for judicial review and relief is dismissed.