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	England and Wales High Court (Administrative Court) Decisions
You are here: BAILII >> Databases >> England and Wales High Court (Administrative Court) Decisions >> Assisted Reproduction and Gynaecology Centre & Anor v The Human Fertilisation and Embryology Authority [2013] EWHC 3087 (Admin) (18 October 2013) URL: http://www.bailii.org/ew/cases/EWHC/Admin/2013/3087.html Cite as: [2013] EWHC 3087 (Admin), [2014] WLR 2540, [2013] WLR(D) 416, [2014] 1 WLR 2540

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

		Royal Courts of Justice Strand, London, WC2A 2LL
		18/10/2013

Mrs Justice Patterson :

1. The claimants, the Assisted Reproduction and Gynaecology Centre and The Reproductive Genetics Institute, are fertility clinics. The defendant is the Human Fertilisation and Embryology Authority (HFEA) a body corporate established by s.5 of the Human Fertilisation and Embryology Act 1990 (1990 Act).
2. By these proceedings the claimants challenge the decision on the part of the defendant to impose a particular condition (T123) on the licence of each of the claimants. The claimants' case can be summarised as being a challenge on the following grounds:

i) That the 1990 Act does not empower the defendant to impose an effective condition on a licence prior to completion of the statutory reconsideration process;

ii) If there is a power the decision about when a new condition takes effect must be taken by the Licence Committee (LC) or the Executive Licensing Panel (ELP) which was not the case here;

iii) Even if the defendant has the power to impose an effective condition it must exercise that power in accordance with public law principles. Here, the defendant's decision is not rational or fair and it is in breach of a legitimate expectation that the claimant had;

iv) That the requirements of section 16(5) of the 1990 Act have not been complied with.

Background

3. The medical director and Person Responsible for each of the claimant clinics is Mr Mohammed Taranissi. He is a leading consultant obstetrician/gynaecologist who specialises in the provision of IVF and other fertility services. The Assisted Reproduction and Gynaecology Centre (ARGC) was licensed in 1995 and has consistently achieved very high success rates through IVF treatment, often achieving twice the national average rate of success. The Reproductive Genetics Institute (RGI) was licensed in 2003. It has similarly high success rates. Both clinics have been responsible for pioneering many new and ground breaking treatments in IVF. The majority of their work is in assisting couples who have often been unsuccessful in their fertility attempts elsewhere.
4. As set out, the defendant was established under section 5 of the 1990 Act. It is a body corporate and a non departmental government body. Its functions include the grant and administration of licences to fertility clinics. The Act prohibits certain activities connected with embryos except when carried out under a licence. The statutory scheme, which I will deal with in greater detail later, provides a system for granting, revoking, suspending and varying licences. In carrying out its functions the defendant must have regard to the principles of best regulatory practise (so that its regulatory activities should be transparent, accountable, proportionate, consistent and targeted only at cases in which action is needed): s.8 ZA.
5. As a result of increasing concerns about the risks associated with multiple births, in 2005 the defendant set up an independent expert group to review the available data on multiple births after IVF and to investigate the need for a change in response to rising concern. After advice from the expert group and a full consultation process, in 2009 the defendant adopted a "multiple births policy." That had as its objectives annual and progressive birth rates which licensed centres should not exceed. The policy aimed to reduce the UK's multiple birth rate after IVF to 10%.
6. In December 2010 the defendant decided on a policy that a standard licence condition should be added to the licences of all UK fertility clinics. That condition has become known as T123. It provides, "the centre must not exceed the maximum multiple birth rates specified in directions."
7. The defendant is empowered under sections 23 and 24 of the Act to give directions either of a general or specific nature. A person acting pursuant to directions is to be treated as if they were acting under a licence.
8. On the 19^th of May 2011 the ELP decided to vary all treatment and storage licences by adding condition T123. That decision was communicated to all of the licensed centres in August 2011.
9. Under the standing orders of the defendant its licensing functions are delegated. The ELP deals with routine licensing functions. The LC is maintained to deal with "the exercise of novel, complex or controversial licensing functions." If a centre objects to a licensing decision the LC is empowered to hear representations about a proposed decision. A reconsideration of a licensing decision under section 20A is dealt with by a separate appeals committee.
10. On the 30^th August 2011 the defendant formally notified all of its licensed centres, including the claimants, of the proposal to vary their licences by adding condition T123. The claimants were provided with the proposed revised licence including T123 and Mr Taranissi as the Person Responsible ("PR") was invited to sign and return a form which acknowledged the revised licence. At that time ARGC was in possession of a licence which was due to expire on the 30^th June 2012 and RGI was in possession of a licence which was due to expire in October 2011. On the 26^th of September 2011 Mr Taranissi notified the defendant of his intention to make representations on behalf of both claimants about the condition as was his statutory right under section 19(4) and section 19(5) of the 1990 Act.
11. In October 2011 RGI's licence was renewed for 4 years until May 2015 without the addition of condition T123.
12. On the 24^th of November 2011 the LC heard representations by the claimants and rejected them in a decision dated 1^st December 2011. At the hearing in November the claimants had raised concerns about the participation of two members of the LC in the decision making process and asked that they recuse themselves. They refused. A pre-action protocol letter followed the decision of the 1^st December 2011 and judicial review proceedings (JR1^[1]) were issued. On the 23^rd December 2011 the claimants exercised their statutory right to require the defendant to reconsider the decision by means of appeal.
13. On the 16^th February 2012 the defendant agreed to set aside the determination and constitute a new LC to hear the representations anew. Judicial review proceedings were then withdrawn by consent on the 27^th February 2012.
14. On the 22^nd February 2012 Mr Taranissi submitted an application for the renewal of the licence of ARGC which was due to expire on the 30^th June 2012.
15. On the 18^th May 2012 the ELP considered that application. It decided to renew the licence for a period of 4 years and to offer a standard licence which at that time incorporated condition T123. It was sent to Mr Taranissi on the 6^th June 2012 and he was asked to sign and return the acknowledgment form that was sent out with the proposed licence.
16. On the 19^th June 2012 the claimants wrote to the defendant pointing out the invidious position that Mr Taranissi was placed in: there had been no opportunity to make fresh representations and yet ARGC's licence was due to expire at the end of that month.
17. On the 20^th June 2012 Dr Lamb, an HEFE inspector, informed Mr Taranissi that she would recommend to the ELP that they issue special directions that would enable him to continue to operate on the same terms as the current ARGC licence (without condition T123). On the 27^th June 2012 the ELP accepted that recommendation and issued special directions to come into force upon the expiry of the (extant) licence and which were to remain in force until 1^st October 2012 or until a decision was made on representations of Mr Taranissi, or until the date that the PR accepted the offer licence whichever was the sooner.
18. On the 16^th July 2012 the LC convened to hear the representations. A challenge was made to the composition of the committee. The chair recused himself on the ground of appearance of bias. That meant that the committee became inquorate. No decision on Mr Taranissi's representations was able to be made.
19. By that time the claimants had brought a further judicial review claim (JR2) challenging the decision to make directions rather than grant a short term licence. Permission was refused by Mrs Justice Lang on the 13^th July 2012 and the claim was later withdrawn.
20. Around that time, on the 23^rd July 2012 the defendant through Field Fisher Waterhouse, its solicitors, proposed the issue of a short term licence for ARGC without condition T123. The relevant part of the letter reads:

"The HFEA maintains its position that its decision to offer Special Directions to the ARGC, as opposed to a short term licence, was entirely lawful and proportionate, as per Mrs Justice Lang's Order of 13 July 2012. However, the HFEA is mindful that the adjournment on 16 July inevitably means that what was intended as a short term measure may now persist for a longer period. In those circumstances, although you will of course appreciate that the formal granting of any licence would be a matter for a Licence Committee or the Executive Licensing Panel (ELP"), it is prepared to consider offering the ARGC a short term licence without condition T123 on the following terms:

"This licence shall remain in force until the sooner of:

(a) the date the Person Responsible accepts the offer licence offered on 6 June 2012;

(b) until a decision is made in relation to the current representations, or in respect of any appeal subsequently made by the Person Responsible should his representations not be successful and he exercises his right to reconsideration, or

(c) 30 November 2012."

The claimant replied on the 1^st August 2012 stating:

"We fail to see what power your client has to offer the ARGC a licence with such precise terms, dates and conditions, and it is of concern that your client is apparently able to steer the Executive Licensing Panel (or any other committee) in this way. Notwithstanding this, the terms of your speculative proposal are in themselves acceptable but for the proposed date of the 30 November at paragraph (c) of the draft. We do not believe that it is realistic to anticipate that the licensing and appeals process will be resolved by this date (not least because a licence committee is yet to be assembled) and we would propose 31 March 2013 as an alternative. If a licence is offered imminently and with this variation, our clients would be willing to withdraw their claim for judicial review on the condition that the HFEA pays their reasonable costs to date."

21. The defendant responded in a further letter from Field Fisher Waterhouse dated 10^th August 2012 in which they recognised that matters may take longer than initially anticipated to resolve. It continued:

"As our earlier letter made clear, the grant of such a licence is a matter for the Executive Licensing Panel but the Executive is offering to invite ELP to consider granting such a licence.

In view of the issues set out above the HFEA would be willing to agree to suggest that the period be until 31 March 2013 and accordingly the recommendation would be for a licence on the following terms:

"This licence shall remain in force until the sooner of:

a) The date the Person responsible accepts the offer licence offered on 6 June 2012,

b) Until a decision is made by an HFEA Committee in relation to the current representations, including any consideration by the Appeal Committee, or

c) 31 March 2013"

22. On the 12^th September 2012 the defendant amended its standing orders so that non-members of the HFEA could sit on the LC (including when hearing representations made pursuant to section 20 (2) and section 20 (3) of the 1990 Act) to assist in composing a LC which would be able to hear the representations of Mr Taranissi.
23. On the 24^th September 2012 the ELP met and granted a short term licence to ARGC from the 1^st October 2012 until the 31^st March 2013. The decision at paragraph 9 reads:

"9. The Panel agreed to the Inspectorate's recommendation and to offer a short-term licence, based on the conditions applying to the last accepted licence. This short-term licence, if accepted, would apply from the expiry of the current Special Directions on 1 October 2012 to no later than 31 March 2013. The Panel noted that this seemed not to be what either the PR or the Inspectorate wanted. Therefore, this would only be used if needed and would serve to keep the centre licensed should the offer licence not be accepted."

The licence was duly sent to Mr Taranissi.

24. A differently constituted LC met to consider Mr Taranissi's representations on the 3^rd December 2012. Due to injury of one of the committee members that hearing was adjourned until the 10^th December. The hearing was then part heard until 28^th January 2013 when it had to be adjourned again due to illness on the part of counsel. The hearing concluded on the 18^th March. The decision of the LC was issued on the 25^th of March 2013 and sent to Mr Taranissi. It rejected his representations and concluded that:

"Having listened to and weighed all of the arguments including but not limited to those outlined above, we are persuaded that the proposed condition and the policy of the HFEA in imposing it is reasonable as well as being transparent; accountable; proportionate; consistent; and targeted. Further we are of the view that the HFEA has discharged the burden upon it and has established that it is necessary and appropriate that condition T123 should be imposed upon the licences of the two centres under consideration."

25. On the 26^th March 2013 the defendant sent to ARGC a licence for the period from the 1^st April 2013 until the 30^th of June 2016 which contained condition T123 and to RGI a varied licence which also included the condition. The covering letter invited acknowledgment of both licences.
26. On the 28^th of March 2013 the claimants asked the defendant to confirm that ARGC's current licence would be extended so as to allow the statutory 28 day period provided for in section 20(3) of the 1990 Act. That request was refused in an email of the same date which read

"Thank you for your email. The ARGC's current short term licence will not be extended. After the current short term licence expires on 31 March 2013, the ARGC will operate under the licence which has been granted to Mr Taranissi (which was offered to Mr Taranassi on 6 June 2012) I sent a copy of this licence to Mr Taranassi on 26 March 2013..."

27. A letter before claim was then sent by the claimant on the 28^th March 2013. That was responded to by Field Fisher Waterhouse on the 29^th March. On the 30^th of March 2013 the claimant pointed out to the defendant that section 16 (5) of the 1990 Act required the defendant to obtain written acknowledgment from the clinics before granting new licences. The letter referred to the standard practice of sending an offer of a licence to new clinics and inviting them to accept the proposed licence, or to make representations upon it. The letter continued

"You have offered no explanation as to why the HFEA did not follow their usual practice when they sent offers of licences to the ARGC and RGI on 26^th March 2013. Our client has not accepted or written to acknowledge the proposed licences for ARGC and RGI as required by section 16 (5)"

28. On 31^st March 2013 Field Fisher Waterhouse replied saying that section 16 (5) had been complied with and "the representations process having now been concluded the licence has been varied. There are no issues about a "new" licence simply that the extant licence has now been varied. (Variation is of course a matter against which Mr Taranissi has a right of appeal that does not hold the variation in abeyance)".
29. On the 4^th of April 2013 the claimant notified the defendant that they intended to exercise their statutory right of appeal against the decision to renew the licence on varied terms in the case of ARGC and to vary the licence in the case of RGI.
30. Judicial review proceedings were issued.
31. On the 30^th April 2013 Holman J ordered that the permission application should be listed for an oral hearing as soon as practicable. On the 22^nd May 2013 Keith J granted permission.

Statutory Framework

32. The 1990 Act established the defendant and provides a scheme for, amongst other things, licensing fertility centres. Given the issues that have arisen it is necessary to set out certain parts of the Act in some detail.
33. Under section 11 the defendant may grant four types of licences and no others. That which is relevant to these proceedings is under section 11(1) (a) which reads;

"Licences under paragraph 1 of schedule 2 to this Act authorising activities in the course of providing treatment for services."

Schedule 2 provides, inter alia, that a licence shall be granted for a period not exceeding 5 years as may be specified in the licence: paragraph 1 (5) .

34. Section 12 lays down certain conditions that are to be on every licence that is granted.
35. Section 16 deals with the grant of a licence. The relevant parts read :

"S16(1) The Authority may on application grant a licence to any person if the requirements of subsection (2) below are met."

36. Sub-section 2 deals with the professional qualifications and expertise on the part of the applicant. 16(2)(cb) reads:

"That the Authority is satisfied that the character of that individual is such as is required for the supervision of the activities and that the individual will discharge the duty under section 17 of this Act."

S. 16(3) provides that the grant of a licence to any person may be by way of renewal of a licence granted to that person, whether on the same or different terms.

s.16(5) provides that The Authority shall not grant a licence unless a copy of the conditions to be imposed by the licence has been shown to, and acknowledged in writing by, the applicant and (where different) the person under whose supervision the activities are to be carried on. "

37. Section 17 deals with the duties on the part of the Person Responsible including ensuring under section 17 (1)(e) that the conditions of the licence are complied with.
38. Section 18 provides the authority with the power to revoke a licence on application or otherwise. Section 18 A provides for variation of licences. The relevant part reads;

"s.18 A (5) The authority may vary a licence without an application under subsection (2) by—

a) removing or varying a condition of the licence, or

b) Adding a condition to the licence."

39. Section 19 sets out the procedure in relation to licensing decisions as follows;

"(1) Before making a decision—

(a) to refuse an application for the grant, revocation or variation of a licence, or

(b) to grant an application for a licence subject to a condition imposed under paragraph 1(2), 1A(2), 2(2) or 3(6) of Schedule 2,

the Authority shall give the applicant notice of the proposed decision and of the reasons for it.

(2) Before making a decision under section 18(2) or 18A(3) or (5) the Authority shall give notice of the proposed decision and of the reasons for it to—

(a) the Person Responsible, and

(b) the holder of the licence (if different).

(4) A person to whom notice is given under subsection (1), (2) or (3) has the right to require the Authority to give him an opportunity to make representations of one of the following kinds about the proposed decision, namely—

(a) oral representations by him, or a person acting on his behalf;

(b) written representations by him.

(5) The right under subsection (4) is exercisable by giving the Authority notice of the exercise of the right before the end of the period of 28 days beginning with the day on which the notice under subsection (1), (2) or (3) was given."

40. Section 19 A deals with notification of licensing decisions, the relevant parts read;

"19A Notification of licensing decisions"

(4) In the case of any other decision to vary a licence, the Authority shall give notice of the decision to—

(a) The Person Responsible, and

(b) The holder of the licence (if different)

(6) Subject to subsection (7), a notice under subsection (2), (4) or (5) shall include a statement of the reasons for the decision"

41. Section 19 C gives the authority power to suspend a licence with immediate effect and provides that a licence is of no effect while a notice under sub-section 1 is in force.
42. Section 20 provides the right to reconsideration of a licensing decision. The relevant parts read;

"(2) Where the Authority decides to vary or revoke a licence, any person to whom notice of the decision was required to be given (other than a person who applied for the variation or revocation) may require the Authority to reconsider the decision.

(3) The right under subsections (1) and (2) is exercisable by giving the Authority notice of exercise of the right before the end of the period of 28 days beginning with the day on which notice of the decision concerned was given under section 19A."

If a suspension notice is challenged the Act provides that the suspension will continue in force notwithstanding the giving of any notice: section 20 (6) .

43. Section 20 A provides for the establishment of an appeals committee to carry out the function of reconsideration required when a notice is issued under s. 20. Section 20 B provides for the procedure on reconsideration which is that it is by way of a fresh decision: section 20 B(1). Regulations are to make provision about the procedure in relation to reconsideration.
44. A person aggrieved by a decision on reconsideration under section 20 has the right to appeal to the High Court or, in Scotland, the Court of Session on a point of law by virtue of section 21.
45. It is apparent from that review that the statute is silent on when a decision made on a variation or grant of a licence comes into effect.
46. The Act then proceeds to give the authority power to issue general directions under section 23 and specific directions under section 24. By virtue of section 23(3) anything done by a person pursuant to directions is to be treated for the purposes of the Act as if it was done under a licence. Under section 24(5A):

"Directions may make provision for the purpose of dealing with a situation arising in consequence of—

(a) the variation of a licence, or

(b) a licence ceasing to have effect."

47. Section 25 provides for the maintenance of a code of practice.

The Claimant's Case

Ground One

48. Has the HFEA power under the 1990 Act to impose a condition on a licence which takes effect prior to completion of the statutory reconsideration process?
49. The claimants submit that sections 18-20 of the 1990 Act set a statutory process which not only entitles clinics to make representations about proposed variation or revocation of their licences but which requires the defendant to reconsider the decision afresh through its appeal committee if requested within the statutory period. It is only after any determination by the appeals committee or the time for making the application for reconsideration by the committee has expired that a final decision can take effect. There is no explicit provision in the Act which empowers the authority to impose new or varied conditions prior to completion of that process. The condition does not come into effect by necessary implication and it is inconsistent with the statutory scheme to imply a power to impose a fresh condition before a final decision is taken.
50. Further, section 19 C and section 20(6) underline that position. When a situation is serious enough to warrant revocation, a licence can be suspended with immediate effect notwithstanding the reconsideration process. There is no equivalent express statutory provision for variation of the licence. It could be that the appeals committee would decide that the condition was wholly unwarranted so that it would be absurd and unfair to enable the condition to come into effect prior to completion of the statutory appeal process.
51. The defendant submits that the licences including condition T123 have been in effect since the 1^st April 2013 (for ARGC) and 26^th March 2013 (for RGI) respectively. Those licences provide the lawful authority for the claimants' ongoing provision of fertility treatment.
52. The defendant submits that the 1990 Act draws the distinction between the position before the determination of any representations about a proposed variation of the licence and the stage which follows after the representations. That is evident in the statutory language with section 19 (1) requiring the authority to give notice of "a proposed decision". After representations have been heard and determined by a LC notification of the decision is given by the defendant to, amongst others, the Person Responsible for the licence under section 19A (4) (a). Albeit, the defendant recognises that the claimants have a right of appeal against the claim under section 20 which is dealt with as a re-hearing.
53. The defendant submits that its interpretation is supported by the terms of the applicable regulations. Under the Human Fertilisation and Embryology (Procedure for Revocation, Variation and Refusal of Licences) Regulations 2009 the burden of establishing that the licence should be revoked, varied or suspended rests on the defendant: regulation 11(1). After the decision is made the committee, under regulation 17(1), provide notice of its decision together with a statement of its reasons no later than 7 days after the date on which it made its decision and may serve a notice of its decision and statement of reasons on any other person whom it considers in the public interest ought to be informed of the committee's decision: see paragraph 17(2).
54. In contrast, on an appeal under section 20, the Human Fertilisation and Embryology (Appeals) Regulations 2009 require that the Appellant shall bear the burden of establishing to the committee that the decision of the HFEA being reconsidered shall be overturned: see regulation 23(1). The defendant submits that "the shift in the burden of proof reflects the fact that the burden has shifted to the party seeking to overturn what has become the new status quo." Indeed, once the first decision has been made and given effect a centre that wishes to appeal can obtain interim relief from the effect of the decision pending appeal through seeking appropriate directions under section 24(5A) of the 1990 Act. Accordingly, the defendant submits that it was entitled to issue the claimants copies of the licences as varied (and in the case of ARGC renewed) with the addition of condition T123. The giving of the notice under section 19A was an administrative act which gave effect to the decision to add condition T123 to the licence

Discussion

55. It is a sad fact that this is the fourth Judicial Review which the claimants have had to bring due to the uncertainties of the statutory processes under the 1990 Act. It is notable that, apart from stipulating certain time periods within which appeals are to be lodged (28 days under section 20) or within which notification has to be given of its decision (see regulation 17(1) of the Human Fertilisation and Embryology (Procedure for Revocation, Variation and Refusal of Licences Regulations) 2009) there is limited reference to time limits and no reference to when decisions take effect within the statutory scheme. It took some 20 months from the decision of the defendant to impose condition T123 as a standard condition in August 2011 until a decision was made on the part of the LC on the representations made by the claimants and there remains an appeal outstanding. I was told that the appeal is now anticipated to take place in January 2014 but that is not yet certain. Such protracted periods of uncertainty cannot be in the interest of either party.
56. The statutory scheme dealing with the imposition or variation of licences starts out initially with a "proposed licence" under section 19. Notification of that decision and the reasons for it are given to the Person Responsible or the holder of the licence, if different, to enable them to require the authority to give them the opportunity to make representations on the proposed decision within 28 days of being given notice of the proposed decision.
57. After consideration of those representations and determination as to whether to accept or reject them by the LC a decision is reached. There is no dispute between the parties thus far.
58. The dispute is as to when that decision takes effect.
59. The defendant submits that the decision takes effect when it is notified to the parties in accordance with regulation 17 of the Human Fertilisation and Embryology (Procedure for Revocation, Variation and Refusal of Licences) Regulations 2009.
60. A consequence of that interpretation would be that the centres would operate for a period of time in compliance with an imposed condition which may eventually be overturned by the appeals committee. One would have expected the appeals committee to meet within a reasonable period of time and as soon as practicable after the appeal had been lodged. When, as here, a considerable time will have elapsed before the appeals committee can convene that could lead to an absurd and unfair position over a protracted period so far as any challenging claimant is concerned. The claimant may have to amend their clinical process to accommodate the condition only to have to revert to what is now their current practice if successful on appeal some time later. In that eventuality there would have been an unwarranted and unnecessary interference in clinical practice. Further, the Person Responsible would have to ensure that the conditions of the licence were complied with at the very time when those conditions were disputed and under appeal.
61. To meet that position the defendant points to the powers under section 24(5A) which enable directions to be given for the purpose of dealing with the consequence of a variation of a licence. It seems to me that there are two obvious problems with that course. First, directions can only be given by the defendant. All that a centre who appeals a decision can do is to request the defendant to make special directions. There is no guarantee and, indeed, given the prior decision by the LC some considerable uncertainty as to whether directions would be issued in that circumstance. Without the certainty of a direction the claimant would be left in the unsatisfactory position that I have set out in paragraph 60 above.
62. Second, the statutory provisions do make express provision for a licence to be of no effect when dealing with the powers of suspension of licences under section 19C (4). That provides the defendant with a power of intervention, if necessary, to suspend the original licence or part of it prior to any appeal hearing. It makes clear that if some form of interim action is necessary it is expressly provided for in the statutory scheme. Further, section 20 (6) makes it clear in relation to suspension notices that the giving of any notice requiring reconsideration does not affect the suspension of the notice. Again, express and particular provision is made on the face of the statute.
63. On the other points made by the defendant

i) The requirement under regulation 17(2) of the Human Fertilisation and Embryology (Procedure for Revocation, Variation or Refusal of Licences) Regulations 2009 is, in my judgment, one of notification of the decision made by the LC only. It is a procedural step. It does not deal with the coming into effect of the decision made.

ii) It is quite right that there is a distinction between an initially proposed decision notified under s 19(1) and the final decision notified under section 19A but the sections deal with the procedural development of the decision making process and not with the coming into effect of the decision made.

iii) It was submitted that upon the claimants' case the completion of the statutory process must be upon determination of a challenge in the High Court when that is made under section 21. I disagree. The nature of such an appeal to the High Court is entirely different. It is on a point of law only and by way of a review hearing. It is a different form of challenge to that which is invoked under section 20 which is a complete rehearing on the merits.

iv) It was submitted, further, that the claimants' construction led to uncertainty as if an appeal was lodged and then withdrawn under section 16 (4), how did one know when the first instance decision took effect? There was no mechanism in the Act for it doing so. That strikes me as an illusory point. Upon withdrawal of an appeal all the statutory steps have been taken by way of notification of the first instance decision and the appeal process had been engaged but aborted. Upon that event the post representations decision will become final. That is entirely different to when there is the prospect of an appeal process to be invoked with all the uncertainty that that entails.

v) It was submitted that the shift in the burden of proof in the appeals process on a rehearing so that the appellant has to demonstrate why the condition should not be imposed was supportive of the defendant's interpretation. I do not see that where the burden of proof lies in the appeal is relevant to when the final decision becomes absolutely final and takes effect. The regulations are dealing with the processes to be followed on appeal and no more and no less than that.

64. Further, although not matters of interpretation, it is worthy of observation that until March 2013 the defendant itself appeared to regard the appeal process under section 20 as the final stage in the statutory process. That is evident from letters from Field Fisher Waterhouse of the 23^rd July 2012 and the 10^th August 2012 set out above which both referred to the original licence remaining in force until after the claimants have exercised their right to any consideration by the appeal committee.
65. For all of those reasons the claimants succeeds on ground one. In my judgment the defendant has no power to impose a condition which takes effect on a licence prior to completion of the full statutory process up to and including the appeal process provided for in section 20 of the 1990 Act. In the light of my finding on ground one, the other grounds fall away. For the sake of completeness though I deal with them below.

Ground Two

66. If, contrary to the above, the defendant does, by virtue of the 1990 Act, have power to impose a condition that decision would have to be made by the LC and not by the Chief Executive. As the decision was made by the Chief Executive here it was an unlawful one.
67. The claimants submit that the defendant's Standing Orders are part of the corporate governance framework which the defendant must comply with as set out in their foreword. Section 6 of the Standing Orders deals with the arrangements for the exercise of the HFEA functions by delegation. Section 6(3) deals with the licensing functions. It reads:

"6.3 Licensing Functions

6.3.1 The authority shall establish and maintain an ELP composed of staff employed by the Authority.

6.3.2 The Authority delegates to the Executive Licensing Panel:

a) The exercise of its routine licensing functions, as set out in annex B to these Standing Orders as amended from time to time by the Authority; and

b) The power to issue directions under section 24(5A) to (5E) and section 24(13) of the Act.

6.3.3 The Executive Licensing Panel shall be constituted and shall operate in accordance with the Executive Licensing Panel Protocol set out in annex C to these Standing Orders.

6.3.4 In accordance with Section 9A(2) of the Act, the Authority shall establish and maintain a Licence Committee which will include Member(s) of the Authority and such additional Committee Member(s) as the Authority considers necessary.

6.3.5 The Authority delegates to the Licence Committee:

a) The exercise of its novel, complex or controversial licensing function, as set out in annex B to these Standing Orders as amended from time to time by the Authority; and

b) The power to issue directions under section 24(5A) to (5E) and section 24(13) of the Act

6.3.6 Save when considering representations under Section 19(4) of the Act, the Licence Committee shall be constituted and shall operate in accordance with the Licence Committee Protocol set out in annex D to these Standing Orders.

6.3.7 When considering representations under Section 19(4) of the Act, the Licence Committee shall be constituted and shall operate in accordance with the Human Fertilisation and Embryology (Procedure for Revocation, Variation or Refusal of Licences) Regulation 2009 (as amended)."

Reconsideration of licensing decisions is considered within section 6(4) of the Standing Orders which reads:

"6.4 Reconsideration of licensing decision

6.4.1 In accordance with section 20A of the Act, the Authority shall establish and maintain an Appeals Committee.

6.4.2 The Authority delegates to the Appeals Committee the power to carry out its functions under section 20 of the Act.

6.4.3 The Appeals Committee shall be constituted and shall operate in accordance with the Human Fertilisation and Embryology (Appeals) Regulation "

68. It is submitted that the Standing Orders provide a comprehensive scheme of delegation.
69. Annex B to the standing orders contains part 1 (headed "Routine Licensing Decisions Delegated to Executive Licensing Panel") and expressly includes the exercise of the authority's power to vary licences under section 18A of the Act. It includes also proposals to place additional conditions on licences and the exercise of the authority's power to issue notices under section 19 of the Act. Under part 3 of Annex B the matters delegated to the LC include consideration of executive proposals to revoke/suspend licences and exercise of the authority's powers to revoke/suspend licences in accordance with sections 18 (1) and (2) and 19C of the Act. They include also the exercise of the authority's power to vary a licence in accordance with section 18A of the Act. Annex C and D of the Standing Orders deal with the protocol for the conduct of meetings by the ELP and by the LC respectively.
70. The claimants submit that a decision to do something different from that which had been done previously and to impose a condition which took effect should have been considered by the LC or the ELP and it was not. There was general confusion about who took the decision.
71. The defendant submits that the issue as to who took the decision demonstrates the fundamental misunderstanding by the claimants as to how the Act works. The decision to impose condition T123 was taken by the ELP. In the case of the claimants that would not crystallise until the claimants' representations had been considered by the LC in March 2013. Section 19A of the 1990 Act is there to provide specifically for notification. That section provides an administrative mechanism for communication of the decision.
72. Peter Thompson is the Chief Executive of the defendant authority. His witness statement deals, in paragraphs 53 to 60, with the decision making process. They read:

"53. On 25 March 2013, the parties received the Licence Committee decision, which rejected Mr Taranissi's representations and decided that Condition T123 should be imposed upon the ARGC and RGI's licences.

54. Given the terms of the ARGC's short term licence, as approved by the ELP on 24 September 2012, I understood that the ARGC's short term licence would expire on 31 March 2013. This was Easter Sunday and so it was important to address the ARGC's licence position urgently and by Thursday 28 March 2013 at the latest, as Friday 29 March was not a working day. (I would note that there was no such urgency in December 2011 following the Licence Committee's earlier, quashed decision.)

55. I discussed the matter with the Authority's Legal Adviser and its Director of Compliance on the morning of 26 March 2013. Given the decision of the Licence Committee, I understood that the proposal to vary the RGI's licence had now been determined so as to now include Condition T123.

56. In relation to the ARGC I also considered that the issue of the inclusion of Condition T123 in its licence had been resolved. I understood that the four year licence which had been offered to Mr Taranissi in June 2012 could now take effect as the outstanding dispute about Condition T123 had been dealt with via the representations process. My view was that licences in the terms offered to both centres in 2011 (and again to the ARGC in 2012) should now apply to the two centres. Confirming this in writing to the centres appeared to be the appropriate and lawful way of dealing with the impending expiry of the short term licence.

57. There was no reason to think that the Authority was compelled to do anything else. We were not obliged under the Act or the terms of the short term licence) to offer the ARGC another short term licence without Condition T123. I understood that the Authority would have had power to offer either a further short term licence or Special Direction in these terms but I did not believe this was the appropriate route.

58. Mr Taranissi had not given notice of his intention to exercise his right to appeal by this stage, nor had he indicated that he would not accept the Licence Committee's decision. Whilst I realised that he might well exercise his right to appeal, I did not consider our decision making should presume an appeal was inevitable and I did not consider that there was any obligation on the Authority to make an arrangement covering the 28 day period in which he could exercise his right to appeal, or covering any period pending the determination of any appeal.

59. The internal discussion which took place on March 26 2013 included consideration of whether we needed to schedule an ELP meeting. (There was no ELP meeting scheduled that week.) My view was that this was unnecessary as the decision that Condition T123 should be included in the licence of the ARGC and the RGI had already been taken by the Licence Committee. I could not see what the ELP could be asked to do in the light of this. The task now was to put the decision of the Licence Committee into administrative effect by issuing the licences.

60. In reaching this decision, Nick Jones (Director of Compliance) and I were also conscious that the rest of the sector had been operating with Condition T123 on their licences since 2011 and that there were important public policy reasons for this condition. Weighing up our responsibilities to act in the public interest, whilst considering the interest of Mr Taranissi's clinics, Nick and I were firmly in the view that the balance now tipped in the favour of the need to have the condition in place. "

The defendant submits that that shows no error of approach.

Discussion

73. It is clear from the record of the determination of the HFEA LC of the 18^th March 2013 that the decision made to reject the representations of Mr Taranissi on behalf of both of the centres for which he was the Person Responsible was made by that committee. That determination was communicated to the parties on the 25^th March 2013.
74. Regulation 17 of the Human Fertilisation and Embryology (Procedure for Revocation, Variation and Refusal of Licences) Regulations 2009 states as follows

"17.— Decision of the committee"

(1) The committee shall provide the notice referred to in section 19A (2) to (5) of the Act, in writing, together with a statement of its reasons for the decision, no later than 7 days after the date on which it has made its decision.

(2) The committee may serve notice of its decision, and the statement of its reasons for that decision, on any other person whom it considers, in the public interest, ought to be informed of the committee's decision.

(3) When serving the notice referred to in section 19A of the Act, the committee shall at the same time serve a written record of—

(a) Any advice tendered by a legal, clinical, scientific or specialist adviser;

(b) any rulings on admissibility of evidence made by the committee.

75. In my judgment paragraph 17 (1) of the regulations is setting out an administrative step whereby the committee provides the notice of its decision together with the reasons for reaching that decision within a specific and short period of time after the date upon which it has made its decision. Read together with section 19A of the 1990 Act the committee is obliged to provide the notice within the 7 day period after the date upon which it has made its decision. The authority is obliged then to give notice of the decision to the relevant person. It follows that the fact that the notice came through the aegis of Mr Thompson does not mean that there was any error in approach on behalf of the defendant.
76. The issuing of the licence as opposed to consideration of representations or the powers of variation of a licence is not a function which is required to be carried out by the LC under the Act, the regulations or the Standing Orders.
77. Paragraph 6.7 of the Standing Orders deals with delegation to officers. Paragraph 6.7.1 reads:

"Those functions of the authority which have not been reserved by the authority or delegated to the chair or committee or working group of the authority shall be exercised by the chief executive on behalf of the authority"

6.7.2:

"The Chief Executive shall determine which functions he/she will perform personally and shall nominate officers to undertake the remaining functions for which he/she will retain accountability to the authority."

78. In setting out his actions in his witness statement what Mr Thompson was doing, in my judgment, was acting within the powers that were available to him by virtue of the Standing Orders. How he then exercises his function is not prescribed. It is, therefore, a matter for his discretion provided he exercises it in a way that is reasonable and in accordance with public law principles. Dealing with this very narrow issue of whether the Chief Executive had the power to authorise the issue of the licences I find that Mr Thompson had the power to organise the issue of the licences and acted reasonably in so doing.
79. Whether that act was lawful so as to give effect to the condition is a different matter. That goes to the issue of lawfulness of the decision as opposed to the mechanics as to how the decision was transmitted. In ground (1) I have dealt with the issue of statutory interpretation. I now turn to deal with ground (3).

Ground Three

80. Whether, if there was a power on the part of the defendant to impose a condition which took effect prior to the completion of the statutory process, that power was exercised in accordance with public law principles or whether it breached those principles and legitimate expectations held by the claimant?
81. The claimants submit that there are eight fundamental principles in the approach to legitimate expectations. The principles are not in dispute with the defendant albeit there is a slight difference of emphasis between the parties. The agreed principles are

i) There must be an undertaking which is clear, unambiguous and devoid of relevant qualification;

ii) The undertaking can derive from a representation or a course of conduct;

iii) Whether there is such an undertaking is ascertained by asking how, on a fair reading, the representation or course of conduct would be reasonably understood by those to whom it is made. That involves a consideration of the context;

iv) The smaller the group of recipients the better the chance of establishing a legitimate expectation : see R (on the application of Bhatt Murphy and others) v Secretary of State [2008] EWCA Civ 755 paragraph 46;

v) Detrimental reliance is not an essential component, see Paponette and Others v Attorney General of Trinidad and Tobago [2010] UK PC 32 at paragraph 27;

vi) To justify frustration of a legitimate expectation the decision maker must take it into account as a legitimate expectation: see Paponette (supra at paragraphs 45-47);

vii) Once an expectation is established the burden switches to the public authority to identify the public interest which justifies overriding that expectation: see Paponette (at paragraphs 37, 38 and 42);

viii) The question of whether there is a public interest which overrides the legitimate expectation is for a court to decide, it is not a matter of Wednesbury review.

82. The claimants submit that the legitimate expectation here arose because of the course of conduct and statements made to the claimants.
83. On the 1^st December 2011, after the first hearing by the LC on Mr Taranissi's representations on condition T123, the committee rejected those representations but took no steps to impose the disputed condition on the licence of ARGC. That was consistent with what had happened with RGI. No notice was served by the defendant under s 19A.
84. The next representations relied upon by the claimants are those set out in the correspondence from Field Fisher Waterhouse in their letter of the 23^rd July 2012. It is submitted that the representation was clear and to the clinics only and, therefore, to a very small group. Although there was reference to an end date which was eventually agreed at March 2013 it was submitted that was not a relevant qualification as the licence had to be for a defined period and the 31^st March 2013 was the best guess as to when the statutory processes would be complete at that time. Other than that the date had no significance. The end date did not detract from the fact that the defendant was making representations consistent with what it had done previously, namely, that the status quo would continue until the statutory process was completed.
85. At no stage did the defendant draw any distinction between the making of representations on the decision before the LC and the appeal process before the appeals committee. As a result there was a clear legitimate expectation that the status quo would be retained until the whole process was completed.
86. Having accepted that was the position in 2012 it was submitted that it would take a significantly different position to provide justification for an altered stance. On that, no good or rational reason had been advanced at any time by the defendant. In fact, the defendant had not taken into account its previously indicated course of conduct and so could not demonstrate that there was any public interest to outweigh the legitimate expectation that had been created. There was no suggestion that there were any unsafe practices on the part of the claimants which in any event were subject to regular inspections and the code of practice.
87. The claimants subjected Mr Thompson's witness statement, in particular those paragraphs which I have set out above, to detailed scrutiny. Overall, the submission was that his statement failed to demonstrate a balanced consideration by the defendant of all the relevant factors. In the instant case that included the likelihood of an appeal, fairness to the claimants, the impact on the clinic and on the Person Responsible of the imposition of the condition half way through the statutory process, the impact on patients and, in particular, the defendant's own previous practice and stance which ought to have been, in the claimants' submission, the starting point to the decision making process. As a result Mr Thompson focused on the wrong question of whether there was any obligation on the defendant to make an arrangement covering the 28 day period in which Mr Taranissi could exercise his right to appeal, or covering any period pending determination of any appeal. In that context reliance was placed on R v Secretary of State For Education ex parte Tameside Borough Council [977] AC 1014 at 1065 per Diplock J.
88. The defendant, having accepted the general principles of the approach to legitimate expectations, draws specific attention to paragraph 43 in R on the application of Bhatt Murphy ( supra). In that paragraph Laws LJ says:

"Authority shows that where a substantive expectation is to run the promise or practice which is its genesis is not merely a reflection of the ordinary fact (as I have put it) that a policy with no terminal date or terminating event will continue in effect until rational grounds for its cessation arise. Rather it must constitute a specific undertaking, directed at a particular individual or group, by which the relevant policy's continuance is assured. Lord Templeman in Preston referred (866 – 867) to "conduct [in that case, of the Commissioners of Inland Revenue] equivalent to a breach of contract or breach of representations"."

89. The defendant emphasised the pressing and focused nature of the kind of assurance required if a substantive legitimate expectation is to be upheld and enforced. The defendant submits that it never agreed, promised or indeed represented that the clinics would be licensed without condition T123 until any appeal under s.20 had been concluded. On the contrary, the parties had agreed the existing licence would expire by the 31^st March 2013. There was no basis, therefore, to submit that there was any representation in place beyond that date. In particular, here, any representations that had been made, such as in the letter from Field Fisher Waterhouse of the 23^rd July 2012, were for a limited period.
90. Furthermore, there was nothing unfair and no abuse of power by the defendant if (which is denied) there had been a regular and consistent practice on their part. There were good public interest reasons for over-riding any legitimate expectation. First, due to the imminent expiry of ARGC's licence it was in the interests of ARGC for the defendant to issue a new licence immediately. Second, the amount of time that had elapsed since the authority's initial proposal in May 2011 to vary all the centres' licences to include condition T123 and the fact that the whole of licensed clinics apart from the claimants had agreed to the variation of licences since August 2011 made it in the public interest to ensure parity across the field by requiring the claimants to comply with the condition once their representations had been rejected by the LC.

Discussion

91. I concur with the agreed principles to the approach to legitimate expectations.
92. It is quite clear from the history of events set out above that until the 31^st March 2013 there was a clear and unambiguous promise to a small group, namely the claimant clinics, that there would be no change to their licences until after any appeal had been determined by the appeals committee. Thereafter, the claimants rely upon the conduct which had been established over the previous 21 months or so as a basis for their legitimate expectation. They accept that there was no express agreement on the part of the defendant as to the position beyond the 31^st March 2013. The case of Paponette (supra) dealt with the position where there was a promise for a limited period. In paragraph 44 Lord Dyson said:

"The position is different where, properly understood, a promise is only for a limited period. If it is for a specified limited period then once that period has expired the promise ceases to bind. The promise may also be subject to an implication that it is for no more than a reasonable period. In that event once a reasonable period of time has elapsed the promise ceases to bind."

He continued in paragraph 46:

"Where an authority is considering whether to act inconsistently with a representation or a promise which it has made and which has given rise to a legitimate expectation, good administration as well as elementary fairness demands that it takes into account the fact that the proposed act will amount to a breach of the promise. Put in public law terms, the promise and the fact that the proposed act will amount to a breach of it are relevant factors which must be taken into account."

93. In that regard consideration of Mr Thompson's witness statement is required. When he became involved the discretion to be exercised was whether or not what appeared to be a revised interpretation of the statutory provisions on the part of the defendant should affect the choice that had to be made as to whether to give effect to the decision of the LC. There is no evidence that Mr Thompson took into account the previous representations or conduct of his own authority. Further, there is no sufficient explanation for taking a different stance from that which it had taken in 2011.
94. Whilst it was clearly in the interest of ARGC to be able to carry out their business under a licence the real issue is not whether that should be the case but whether the licence under which ARGC could operate should be one which contained condition T123. That condition had the potential to interfere with the clinical judgment to be exercised on behalf of ARGC. Not to take those factors into account does, in the circumstance of this case, constitute a notable omission of relevant material considerations.
95. Whether, once the agreed time had expired there was sufficient by way of the previous conduct to amount to a legitimate expectation in the way the law has developed is a moot point. It is not one that I have to finally decide as, in my judgment, what is evident is that, in the context of this case, and with its particular history it was only fair to allow the claimants time within which to have their appeal determined before effect was given to the decision to impose a condition.
96. In his witness statement Mr Thompson refers to confirming the decision in writing to the claimants and says there was no reason to think the authority was compelled to do anything else. He recites that the authority was not obliged under the Act or the terms of the short term licence to offer ARGC another short term licence without condition T123 or to issue it with special directions allowing it to operate without condition T123. He records that he realised that Mr Taranissi might well exercise his right of appeal, but fails to put that into the context of this case, namely, what Mr Taranissi had done previously by way of earlier judicial review applications, the authority's conduct in correspondence with Mr Taranissi and its earlier actions. In my judgment that means that Mr Thompson failed to take into account and balance against the requirements which he did consider the issue of fairness and previous conduct in relation to the claimants. In particular, given that there was a departure from the conduct on the part of the defendant from when the representations had been rejected at the end of 2011 it was incumbent on the defendant to provide good public interest reasons for so doing.
97. In his witness statement Mr Thompson refers to the fact that the rest of the sector had been operating with condition T123 on their licences since 2011 and that there were important public policy reasons for this condition. Mr Thompson then continued "weighing up our responsibilities to act in the public interest whilst considering the interests of Mr Taranissi's clinics Nick and I were firmly of the view that the balance now tipped in favour of the need to have the condition in place."
98. It is important to note that Mr Taranissi's clinics have throughout been supportive of the multiple births policy. Their dispute is whether condition T123 is the proper way to achieve the agreed objective. Their concern is shared by other professionals in the field including Dr Allan Thornhill (a member of HFEA, Consultant Clinical Research St. Guys Hospital Assisted Conception Unit) and Professor Alison Murdoch (Professor Reproductive Medicine, at the Institute of Reproductive Medicine at the Institute of Genetic Medicine, former Person Responsible and former chair of British Fertility Society.) There appears, therefore, to be an ongoing legitimate debate the resolution of which cannot be determined until the appeal committee convenes and adjudicates. In the ordinary course of events one would have expected the appeal committee to have convened within a reasonable period of time after the decision finally made in March 2013. As it is there is only a tentative date of January 2014 for the appeal committee hearing. A 10 month period of time before, at the earliest, an appeal can be heard in the context of this case cannot be regarded as satisfactory.
99. All of these factors impinge upon whether the stance of the defendant towards the claimants on this matter is one which is fair, applying public law principles.
100. The other factor relied upon by the defendants is that of parity with the other clinics which have operated with the additional condition since 2011. I fail to see the substance in that argument given that there remains outstanding a dispute of substance to be resolved as to the efficacy of the condition.
101. In my judgment, and for reasons which I have set out, the conduct of the defendant towards the claimants has not been fair. A fair outcome would have been to have retained the status quo until the end of the appeals process. It is not adequate to say that in 2013 a Section 19 Notice was served which is different from the position in 2011 given that I have already found that a notice under section 19 is a procedural requirement only. In looking at the case overall, and taking into account the history since the policy was decided by the defendant I find that the defendant's conduct towards the claimants and explanation as to its change of stance was lacking.

Section 16(5)

102. The claimants submit that section 16(5) of the 1990 Act provides that a licence cannot be granted unless the applicant or Person Responsible has acknowledged the conditions in writing. As a result the defendant cannot require a clinic to accept a new licence against the wishes of the Person Responsible and the licence holder. The claimants accept that a clinic is not entitled to pick and choose what conditions it will accept but, it submits, it is entitled to elect whether to accept or reject a licence. If it rejects the licence then it will cease to provide licensed treatment. The claimants submit that is an unfair position to be placed in halfway through the statutory process.
103. The defendant submits that section 16(5) appears to relate only to ARGC and not RGI. That is because the section appears to relate simply to the grant or renewal of licences and not to variation of licences which are dealt with under section 18A. On any view the requirements of section 16 have been satisfied as it is clear from the course of correspondence that Mr Taranissi is well aware of the contents of the licence. It is far from clear that section 16 (5) applies at all but, if it does, the revised licence including condition T123 have been acknowledged by Mr Taranissi or through his solicitor.

Discussion

104. Section 16(5) prohibits the grant of a licence unless a copy of the conditions to be imposed upon it have been shown to and have been acknowledged in writing by the applicant (and where different the person under whose supervision the activities are to be carried on.) It is a provision which seeks to register on the part of the licence holder knowledge of the conditions under which it is to act. The statutory language does not require acceptance or rejection of the conditions by the licence holder but simply an acknowledgment in writing.
105. I am not convinced that section 16 (5) has any greater significance than that. If it does, and if the claimant were to have to make an election halfway through the statutory process I would regard that as a supplementary factor to those which I have found above constitute unfairness on the part of the defendant. However, I regard the subsection as a statutory requirement directed towards safeguarding the position of the HFEA from allegations by clinics who claim that they were not aware of the conditions imposed on their licence. I consider it to be a necessary, but procedural, safeguard. In those circumstances I do not think the arguments about section 16(5) take this matter any further. Any challenge on that basis fails.

Conclusion

106. The challenge succeeds on Grounds 1 and 3. I invite submissions from the parties as to consequential orders and costs.

Note 1   Strictly JR2 as an earlier challenge CO/2025/2011 was brought which challenged the defendant’s on going failure to conclude a review of its actions against the claimants and the PR and to provide a copy of the investigation report. The action was withdrawn by consent on 18.2.13.    [Back]