England and Wales High Court (Administrative Court) Decisions

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

		CO/7457/13 Cardiff Civil Justice Centre 2 Park Street Cardiff CF10 1ET
		19/12/2013

Judge Jarman QC :

1. The claimant seeks a judicial review of the refusal by the defendant of her application for funding of treatment which she received in Germany during October 2012. She did so originally, when representing herself, upon many grounds including alleged breaches of her rights under the European Convention of Human Rights. His Honour Judge Denyer QC when granting on 13 August 2013 limited permission to bring the claim observed that many of the grounds were vague and without merit, including such alleged breaches and he did not give permission in respect of these. He gave permission on the basis that it is arguable that funding should have been provided because:

i) There was a broad equivalence between treatment in the UK and treatment in Germany;

ii) The application was not dealt with speedily or within the time periods set out in policy adopted by the defendant;

iii) Given the need for treatment the defendant has failed to consider retrospective funding.

2. Shortly before the substantive hearing of the claim the claimant instructed solicitors and counsel, Miss Beattie. She and Mr Jones for the defendant have each filed skeleton arguments and Miss Beattie handed in at the start of the hearing a supplemental argument. These in the main follow broadly the arguments identified by Judge Denyer with some refinements.
3. The background is that the claimant has a number of complex health issues following a L5/S1 discectomy which she underwent at Llandough Hospital in 2007. During the procedure there was a rupture of the spinal cord membrane which developed into a psuedomeningocoele. She underwent two surgical repairs in 2007 and 2009. Her health deteriorated and she developed symptoms of headache, neck pain, leg weakness, dizziness, nausea and general weakness. She continued to receive unsuccessful treatment and tests here until February 2012 when she was discharged. The discharge summary of the consultant neurosurgeon at the National Hospital for Neurology and Neurosurgery set out the diagnoses which included low cervical spine fluid and arachnoiditis. The summary indicated that there is no established treatment for arachnoiditis, apart from corticosteroids, and a trial of those had produced only marginal improvement in symptoms. Since tests did not show any surgical remediable cause for ongoing symptoms, the summary continued that it was likely that further treatment would involve a programme of medical management supervised by neurological and/or pain management consultants and that further appointments had been arranged in such clinics.
4. The claimant was not content to let matters rest there and sought help in the United States of America and then in Germany in the clinic of Professor Warnke in Zwickau. On the 25 September 2012, she made an application in due form for prior authorisation for treatment in an EEA county and/or reimbursement of costs. The application was expressed to be for what is now known as S2, for which prior approval is needed. The nature of the treatment for which funding was requested was specified to be surgical procedure, therapy and diagnostic testing, and details were given as a lumbar subarachnoid endoscopy (thecaloscopy) to treat the pathology of adhesive arachnoiditis/nerve compression, surgical repair of enlarged subarachnoid space, restore CSF flow and further investigation of neurological symptoms. The reasons given for requesting the treatment outside the UK were that there is no established surgical treatment for arachnoiditis in the UK, that neurological consequences of loss of CSF is poorly understood in the UK, and surgical treatment for arachnoiditis can restore CSF flow. In response to a question "What is (was) the current waiting time for you to receive this treatment in Cardiff and the Vale?" the claimant inserted "N/A." In covering letters, the claimant stated that Professor Warnke is a pioneering surgeon specialising in thecaloscopy to treat arachnoiditis. In a supporting letter, her GP confirmed that in terms of treatment in the UK all options and avenues appeared to have been exhausted and that Professor Warnke had a procedure to treat adhesive arachnoiditis which is not available in the UK.
5. The claimant discussed these matters with Professor Warnke and it was indicated that thecalosopic diagnostic investigation and subsequent intrathecal procedures would require the removal of fixators which had been implanted in her spine. She gave her consent and underwent that procedure on 5 October 2012. As the claimant was complaining of stabbing occipital pain, attempts were then made to block the greater occipital nerve, which reduced the pain. However, a feeling of pressure in the region of the occiput persisted. Accordingly on 11 October 2012 a diagnostic thecaloscopy was carried out, during which the filum terminale was observed to be lipomatously thickened and prefixed, with obvious axial traction on the spinal cord and thus a secondary tethered cord. To Professor Warnke and his team, that provided an explanation for the majority of the claimant's symptoms. In his operation report, he indicated that the discovery of such thickening came as a surprise to the investigator. After further discussions with the claimant, on 17 October 2012 surgical lysis of the filum terminale was undertaken, during which there was an obvious release of the spinal cord with visible increase in height. Thereafter the stabbing pain persisted, but the symptoms of headache disappeared. The claimant was discharged from the clinic on 26 October 2012.
6. The above details of the procedures carried out at the clinic were included in Professor Warnke's discharge summary which was forwarded to the defendant by covering letter dated 6 November 2012. In a letter dated 13 November to the defendant, the claimant's brother stated that the treatment received in Germany was available on the NHS. A reply, dated 23 November 2012, was written by Dr Hopkins, the chair of the defendant's Individual Patient Funding Requests (IPFR) panel. Dr Hopkins noted this new information, that it differed from the information in the application, and stated that she was seeking to verify whether such treatment is provided by the NHS. She further stated that the claimant's application would be reviewed in light of the information. No express confirmation was then forthcoming but Dr Hopkins must have been satisfied of such availability because the panel went on to consider the application on 17 December 2012.
7. The application was not approved, but that was not communicated to the claimant until a letter dated 15 January was sent by Dr Hopkins, in which she indicated that the panel considered all the information in Professor Warnke's discharge summary. She said that although that summary did not indicate any level of urgency, the panel understood that with any ongoing chronic condition patients would wish to receive treatment as soon as they can. She continued that the panel also discussed the issue of undue delay and noted the ongoing distressing and chronic nature of the claimant's condition and the treatment history, but could see no evidence of undue delay.
8. The decision record sheet of the panel, signed by Dr Hopkins, gives a short explanation for the decision, in which it was recorded that the application had been considered through the Article 56 route. This is a reference to Article 56 of the Treaty on the Functioning of the European Union, which so far as relevant provides:

"Within the framework of the provisions set out below, restrictions on freedom to provide services within the Union shall be prohibited in respect of nationals of Member States who are established in a Member State other than that of the person for whom the services are intended."

9. The decision record sheet continued:

"With regard to the application through the Article 56 route the panel considered the evidence in respect of 'undue delay' and secondly that the care was required as a matter of urgency. The panel looked particularly at the discharge letter from the German physician and determined that it did not indicate any level of urgency nor evidence of undue delay. Having considered all information the panel did not support the application. The panel agreed that it would be beneficial to offer the patient a case conference noting that the patient has been discharged home from Germany with no ongoing management plan."

10. The claimant made a request for a review of that decision which was received by the defendant on 21 February 2013 and heard by the review panel on 18 March 2013. By a letter dated 19 March 2013, the review panel confirmed that its decision was not to uphold the appeal.
11. The reference to undue delay is at the heart of this claim and comes from legislative changes brought about as a result of a decision of the European Court of Justice in Case C-372/04, The Queen on the application of Yvonne Watts v Bedford Primary Care Trust and Secretary of State for Health [2006] ECR I-4325. In that case the court held the principle now set out in Article 56 applied to a tax-funded national health service. In March 2010 regulations to give effect to that decision by amending the National Health Service (Wales) Act 2006. The National Health Service (Reimbursement of the Cost of EEA Treatment) Regulations 2010/915 inserted section 6A into the 2006 Act which sets out the conditions for reimbursement of qualifying EEA expenditure, and section 6B which provides for when an application for prior authorisation must be made to, and given by, the Welsh Ministers.
12. Section 6B (1) provides that a person may apply to the Welsh Ministers for prior authorisation in relation to the provision of a service to a person ordinarily resident in Wales. Subsection (3) provides that the Welsh Ministers may determine the form in which an application under this section must be made and the information to be provided in support of the application. The subsections then following are:

"(4) The Welsh Ministers—

(a)must authorise the provision of the requested service if it is a special service and the conditions in subsection (5) are met, and

(b)may authorise the provision of the requested service in any other case where the requested service is necessary to treat or diagnose a medical condition of the patient.

(5) The conditions referred to in subsection (4)(a) are—

(a)that the requested service is necessary to treat or diagnose a medical condition of the patient,

(b)that the requested service is the same as or equivalent to a service that the Welsh Ministers or the Local Health Board in whose area the patient usually resides would make available to the patient in the circumstances of the patient's case, and

(c)that the Welsh Ministers or the Local Health Board cannot provide to the patient a service that is the same as or equivalent to the requested service within a period of time that is acceptable on the basis of medical evidence as to the patient's clinical needs, taking into account the patient's state of health at the time the decision under this section is made and the probable course of the medical condition to which the service relates.

(6) The matters to which the Welsh Ministers are to have regard in determining for the purpose of subsection (5)(c) whether the length of any delay is acceptable include—

(a)the patient's medical history,

(b)the extent of any pain, disability, discomfort or other suffering that is attributable to the medical condition to which the service is to relate,

(c)whether any such pain, disability, discomfort or suffering makes it impossible or extremely difficult for the patient to carry out ordinary daily tasks, and

(d)the extent to which the provision of the service would be likely to alleviate, or enable the alleviation of, the pain, disability, discomfort or suffering."

13. Health boards in Wales, including the defendant, then adopted an All Wales Procedure (the procedure) to ensure that such boards have a clear and open mechanism for making requests under Article 56 that is fair, open and transparent. Undue delay is dealt with in paragraphs 4.7-9, which after setting out the requirements of section 6B(6) of the 2006 Act continue as follows:

"4.7 The European Court has stressed that judgments on 'undue delay' must be based on a clinical assessment of what is a medically acceptable period to the individual clinical circumstances of the patient, and this assessment needs to be kept under review while the patient is waiting for treatment. .4.8 'Undue delay' might also be relevant to the decision of whether to refund treatment costs to patients who have gone abroad without first seeking prior authorisation where it is required, since retrospective applications are allowable under the cases law established by the European Court. If a health board decides that 'undue delay' applied to the individual circumstances of the patient in this situation, they should consider reimbursing the patient in the normal way."

14. Paragraph 5.1 provides, so far as relevant, that a patient is only entitled to reimbursement for treatment where the treatment was necessary to treat or diagnose a medical condition of the patient; and was the same as or equivalent to a service that a responsible authority would make or have made available to the patient under the Act in the circumstances of the patient's case; and was a special service for which prior authorisation was required but not granted and the health board concludes that 'undue delay' applies. Paragraph 5.5 provides that retrospective applications are allowable under case law "..where it was not reasonable to expect the patient to have applied for prior authorisation before receiving the service in another EEA country (or where the patient does not await the outcome of such an application)."
15. Thus, although there is no reference to retrospective authorisation in the 2006 Act as amended, it is clear that the defendant as matter of policy may grant such authorisation where the conditions, including that of undue delay, are met.
16. It seems plain that the particular circumstances of the claimant's application is somewhat different to the usual case which the procedure contemplates, namely a case where treatment is available in an EEA country which will not be available in the UK within an acceptable period of time. The concept of 'undue delay' is central in such a case. In the claimant's case, in terms of the diagnosis of arachnoiditis, surgical treatment is not available here which is why the claimant attended the clinic in Germany where it was available. However, when investigations were undertaken there, to the surprise of the investigator in the words of Professor Warnke, the thickened filum terminale was discovered and surgical lysis of the filum terminale was carried out. The IPFR panel did not reject the application on the basis that this procedure was not available on the NHS and the inference must be that it is. Mr Jones on behalf of the defendant submits that even if reimbursement should have been provided, it should be limited to this procedure. The reason this was not carried out in the UK was not because of an unacceptable waiting time but because the condition was not diagnosed until investigation by Professor Warnke's team.
17. Whether that diagnosis should have been discovered earlier in the UK may be an issue for other proceedings, but it is not an issue before this court. Nor should this court substitute its assessment or judgment for that of the panel, to which Parliament has entrusted the task. What this court must consider is whether in coming to its decision, the panel acted in a way that is unlawful on public law grounds. Miss Beattie on behalf of the claimant has emphasised that it is for the defendant to justify the refusal of an Article 56 right, which refusal must also satisfy the principle of proportionality. She submitted that the decision is flawed on 3 grounds and it is to those I now turn.
18. The first ground is procedural unfairness. It is not in dispute that the decision letter and the review of the panel's decision was not within the timescales set out in the procedure, namely that the panel will normally meet at least once and month, and the decision letter will be sent within 5 working days of the panel (paragraph 6.5). Miss Beattie submitted that this of itself renders the decision unlawful, although she properly conceded that it could not be said that it is likely the decision would have been any different had these timescales been adhered to.
19. Mr Jones submitted that the decision was in the event taken, and the delay is not such as to render the decision unlawful. He pointed to the further information submitted in November including translated medical documents, and the change in the nature of the application as a result of what was discovered during the thecaloscopy on 11 October 2012. The treatment which the application was changed to cover was carried out a week later.
20. In my judgment, those factors are sufficient to justify the delay in this case and do not render the decision unlawful. Even if it were, it is difficult to see what relief is appropriate. Quashing the decision on the basis of delay, so as to necessitate a further decision would not appear to be appropriate, and declaratory relief is unnecessary as the defendant accepts that timescales set out in the procedure were not adhered to.
21. Miss Beattie also submitted that the procedure was not easily accessible. Because the claimant's case was complex, it did not fit easily into the categories of application. Moreover, no email address was provided for the claimant and her family to keep the defendant informed of the progress of her diagnosis and treatment in Germany, and there were difficulties in telephone contact.
22. Whilst these difficulties must have been frustrating for the claimant and her family, in my judgment they do not render the decision unlawful. As Mr Jones submitted, it would be unrealistic to expect the defendant to deal with this application between the date of diagnosis and treatment in Germany, a period of some 6 days. Once the latter had been undertaken, and the application became a retrospective one, then difficulties of communication for themselves do not amount to public law grounds of challenge.
23. The second ground of challenge is that the defendant failed to make sufficient inquiry into whether 'undue delay' applied and failed to consider that test in the individual circumstances of the claimant's case. Miss Beattie submitted that the likely time which the claimant would face if the treatment was provided on the NHS was not referred to in the decision of the panel or the review panel, and there is no evidence that the likely waiting time was identified. The defendant did not know, therefore, whether the treatment which was carried out in Germany could have been available in the UK within, days weeks months or years. Moreover the defendant had no regard to the matters set out in section 6B (b), (c) or (d) of the 2006 Act.
24. In my judgment, whilst the review decision and the covering letter is each very brief in its terms, each confirms that the panel expressly took into account the discharge summary of Professor Warnke, and in my judgment that summary adequately sets out each of these matters, and the delay in diagnosis. That in my judgment was part of the medical history which had to be taken into account and was taken into account.
25. Once the treatment was carried out, as Mr Jones submitted, the grounds of challenge focus on an exercise of finding out the waiting time of treatment in the UK which was not going to be carried out, because the claimant had already had the treatment in Germany. That it may be understandable for her to undergo the treatment as quickly as possible was something which the panel expressly considered and accepted. The fact remains that the treatment had been carried out. The decision to undergo this was not taken in light of any information of how long the claimant might have to wait for similar treatment in the UK. I do not accept, therefore that this was a material consideration which the panel ought to have considered in the particular and unusual circumstances of the claimant's case.
26. Mr Jones also pointed to the procedure in setting out guidance for the completion of the application form makes it clear that it was the responsibility of the claimant's clinicians to provide a comprehensive picture of medical history, medical condition, and the nature of the treatment requested and the anticipated benefits of the treatment. It is clear that the application was originally submitted on the basis that there is no established surgical procedure for the treatment of arachnoiditis in the UK, and that the change in the nature of the application came about after the treatment on 17 October 2013. It is not surprising in these circumstances that the claimant provided no details of how long she may have to wait for the latter treatment in the UK. Nor, however, I am satisfied, was it perverse of the panel or the review panel not to make inquiries as to such a time. In my judgment the decision is justified and proportionate.
27. The third ground is that the defendant took an immaterial consideration into account, namely whether the treatment which was undertaken on 17 October 2013 was required urgently to be carried out. It is common ground that urgency is not a factor which is expressly referred to in the 2006 Act as amended or the procedure, but that this factor was expressly referred in the claimant's letter dated 25 September 2012 sent with her application. Nevertheless, Miss Beattie submitted that the defendant has taken an irrelevant matter into account and its decision should be quashed accordingly.
28. I do not accept that submission. As Mr Jones pointed out, paragraph 5.5 of the procedure refers to whether it was reasonable for a patient to await prior authorisation before having treatment in another EEA country. In retrospective applications therefore, which the claimant's application became after 17 October 2013, in my judgment this was a material factor for the defendant to consider. Even if it was not however, as Mr Jones submitted in the alternative, it is clear that the defendant did not apply the criterion of urgency in place of undue delay, but considered each as an independent basis to justify funding. Once the defendant had made its decision on undue delay, as I have found it was entitled to, then if urgency was not a relevant consideration that should have been the end of the matter. The defendant went on to consider urgency, but in the event decided that issue also against the claimant. It does not render the decision unlawful.
29. It is difficult not to feel sympathy for the claimant, as the panel clearly did, but in the end that is not enough to justify the interference by this court with the clinical assessment of the defendant. Accordingly the claim is dismissed.