England and Wales High Court (Administrative Court) Decisions

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

		Royal Courts of Justice Strand, London, WC2A 2LL
		1 December 2010

Mr Justice Kenneth Parker :

The Claim

1. This is a claim by Sharon Moore against, first, the Skipton Fund Limited and, second, the Secretary of State for Health ("SSH"), in which she contends that an ex gratia compensation scheme ("the Scheme") established by the SSH to compensate those who received blood or blood products that were contaminated, in particular, with the virus Hepatitis C, when undergoing treatment by the NHS, is unlawful in a respect that adversely affects her and others in her position.

Background

2. Sharon Moore was admitted to Luton and Dunstable Hospital on 8 or 9 June 1987 with severe anaemia. She had been diagnosed in 1985, at the age of 26, with ulcerative colitis. She was treated with steroids and other drugs, and was also transfused with several units of blood.
3. She then gradually improved and on 17 July 1987 was discharged with iron tablets.
4. She was followed up by the General Practitioner during 1987, with her ulcerative colitis remaining active, causing her abdominal pain, as well as blood in the stool.
5. The following year she improved, and in 1989 she became pregnant. However in June this appeared to exacerbate her ulcerative colitis and on 16 August 1989 she had a total colostomy with an ileostomy.
6. On 15 September 1989 the Claimant was readmitted to hospital with severe nausea and vomiting. Twelve hours after admission she suffered a spontaneous miscarriage.
7. Her ulcerative colitis continued to cause problems, but in March 1994 a lump was noticed in the Claimant's right breast which turned out to be cancer. On 21 April 2004 she had a right mastectomy with clearance of the axillary lymph nodes.
8. On 20 February 1998 Dr. D. S. Thompson, Consultant Haematologist, informed Luton and Dunstable Hospital that on 23 May 1987 a unit of whole blood B+ had been issued to the hospital blood bank, and that that unit was presumed to be infected with Hepatitis C, because the donor of the blood had been found to be Hepatitis C antibody positive.
9. Luton and Dunstable Hospital confirmed that that unit of blood had been transfused into the Claimant on 10 June 1987.
10. The Claimant's General Practitioner, Dr. Jain, explained the situation to the Claimant and samples of blood were taken on 14 April and 28 April 1998, almost 11 years after receiving the blood. Both blood samples showed that the Claimant was Hepatitis C antibody positive, but polymerase chain reaction ("PCR") negative, and liver function tests ("LFTs") were normal.
11. This indicated that the Claimant had previously been infected by Hepatitis C, but was no longer carrying the virus.
12. On 22 March 1999 the Claimant was seen by Dr. N. Simmons, Consultant Gastroenterologist, who wrote that:

"She… is aware of the risk of developing chronic liver disease. She is also aware and has discussed with her partner the fact that there is a risk of sexual transmission of hepatitis C, albeit very low… I think the strategy would be to [repeat] her LFTs and alphaprotein."

13. On 23 January 2004 John Reid, Secretary of State for Health, announced that an ex gratia compensation scheme would be set up for those who were infected with NHS blood or blood products prior to September 1991.
14. On 25 March 2004 the Skipton Fund commenced operations. The eligibility criteria, so far as relevant, are as follows:

"a. The scheme will make a lump sum payment of £20,000 to any person who now has Hepatitis C as a result of receiving blood, blood products or tissue from the NHS prior to September 1991.

b. ...

c. People who have cleared the virus as a result of treatment or who have cleared it spontaneously after a period of chronic infection will also be eligible for payments from the scheme.

d. People entitled to the basic £20,000 payment as described above will receive an additional £25,000 payment if they develop or have developed a cirrhosis or liver cancer, or have had a liver transplant or are on a transplant waiting list.

e. ...

f. ...

g. No payments will be made in respect of those who have died before 29 August 2003 or to people who have cleared the virus spontaneously in the acute phase of the disease.....[emphasis added]"

15. The Scheme therefore distinguishes between an "acute phase" and "chronic infection", for Stage 1 payments of £20,000. There is also a Stage 2, triggered by serious deterioration in health, which leads to payment of £25,000.
16. Howard Thomas, Professor of Medicine, Imperial College School of Medicine and Consultant Physician/Hepatologist, St Mary's Hospital, London, in a witness statement made on behalf of the SSH, explained the rationale for the criteria as follows:

"i) These subjects [that is, up to 40 per cent of those infected with Hepatitis C who do not enter the "chronic" stage of infection] are usually asymptomatic and on clearance of the virus have no residual symptoms related to the virus infection and will have no future consequences of this transient infection. Although these cases often cannot be precisely defined in terms of the interval between the defining infected NHS blood or blood product transfusion and clearance of the virus because of the limited frequency of testing, those still positive at 6 or more months after the infecting transfusion can be assumed for practical purposes as very unlikely to clear the virus and thus should be considered as chronically infected having the risks associated with chronic infection. Those who have cleared the virus by the time of the first test, usually longer than 6 months after the infecting transfusion but before they have developed cirrhosis, will not have the risks associated with chronic infection irrespective of whether they have been infected for less than 6 or more than 6 months.

ii) … subjects with chronic Hepatitis C receive £20,000: This applies to around 60% of those infected. These subjects are at risk of developing cirrhosis and then liver cancer if not satisfactorily treated. In addition patients with chronic viraemia have disorders of affect and cognitive function accompanied by MR spectroscopic abnormalities which resolve on clearance of the virus and are therefore directly attributable to the viral infection. We cannot currently predict the 20% that will develop cirrhosis and those with cirrhosis who will develop liver cancer. In addition we cannot predict the 55% of patients with chronic infection who will be cured by anti-viral treatment. 80% of those with chronic infection will not progress to cirrhosis and liver cancer but may have some mental and physical symptoms. They will have a normal or near normal life expectancy; again we cannot identify this group prospectively. Thus all patients with chronic infection (i.e. who are still HCV-RNA positive more than 6 months after the presumed infection, usually the date of first exposure to blood or blood products) stemming from use of NHS blood or blood products prior to September 1991, receive the ex gratia payment of £20,000 until such time as there is evidence that they have cirrhosis or liver cancer when they are eligible for the second level of ex gratia payment in recognition of their additional symptomatology and shortened life expectancy.

iii) … subjects in receipt of the first level payment and have cirrhosis, primary liver cancer, or are awaiting, or already have had a liver transplant, receive an additional £25,000. This applies to around 30% of those with chronic hepatitis C infection within the first 20 years after infection. These patients have additional symptomatology and reduced life expectancy which is most reduced for those with cirrhosis who have in addition developed primary liver cancer. Between 2% and 3% of those with cirrhosis will develop primary liver cancer each year. Because these patients suffer the greatest problems, it is rational that they receive an additional ex gratia payment. These patients can be identified by clinical examination, liver biopsy, fibroscan, other imaging or non-invasive blood tests, with reasonable certainty (as detailed in the Skipton Fund additional payment [stage 2] application form). Thus this approach is practical. The basis of identification of the case with cirrhosis was the APRI test and today this is still the case with the possible additional refinement of a fibroscan." (footnotes omitted)

17. The Skipton Fund Appeal Panel has its own guidance. The issue of natural clearers is addressed at paragraph 5 of the guidance under the heading "Other Reasons for Refusal":

"Natural Clearers – The PCR test detects the presence of hepatitis C virus in the human body. In a minority (15 – 30%) of people infected with hepatitis C, the body's immune system successfully fights the virus and clears it from the body with no long-term ill effects. In these cases the PCR becomes negative and the disease does not progress to a chronic (long term) phase. Patients in whom this occurs are termed "natural clearers". If this happens, in nearly all cases it is within six months of the infection (the acute phase). Natural clearers whose PCR becomes negative within six months of infection with hepatitis C are not eligible for payment from the Skipton Fund. If a natural clearer makes a claim from the fund they will need to show that the PCR test was positive, or that other signs of chronic infection existed, more than six months after eligible exposure to hepatitis C. If the point of PCR conversion from positive to negative cannot be pinpointed (because, for example, a PCR test was not done early enough or frequently enough) then the Appeals Panel will make a judgement on whether the PCR was more likely than not to have remained positive for more than six months. In the absence of other evidence of chronic infection, for example a positive liver biopsy or abnormal liver function tests, the panel is likely to conclude that it was not, since the clearance rate of hepatitis C infection after six months is rare (thought to be less than 1% per annum) as opposed to the much greater likelihood of clearance within 6 months (15 – 30%). "

18. The Claimant first submitted an application on 26 July 2004, but that was rejected.
19. The Claimant applied again on 11 January 2005, but was again rejected.
20. On 1 September 2006 the Skipton Fund Appeals procedure commenced.
21. The instant application was submitted on 29 January 2009 including for the first time a report from Professor G.M. Dusheiko, Professor of Medicine and Honorary Consultant Hepatologist at the Royal Free and University College hospitals, London. However on 11 March 2009 the application was rejected:

"Unfortunately the letter you were sent dated 2^nd December 2004 still stands since the new information contained within the medical report from Professor Dusheiko merely confirms that a period of chronic infection was possible rather than probable…"

22. The Claimant then appealed, but on 9 June 2009 the Appeal Panel decided to dismiss the appeal, finding that:

"In order to succeed on an appeal the appellant must satisfy the Panel that it is probable, that is more likely than not, that the infection with Hepatitis C for more than six months was indeed caused either directly through NHS treatment before 1 September 1991 or indirectly by contact with a person who was so infected. In order to be satisfied that this is the case the Panel will pay particular attention to the treatment records of the person concerned.

Your appeal was considered by the Panel at its meeting on 8 June 2009.

The Panel reviewed the entire file of papers held by the Skipton Fund in connection with your appeal and the additional information supplied for the purpose of the appeal. The expert advice we have received is that the overwhelming majority of those who are infected but later have negative PCR tests clear the virus in far less than six months. We noted that there was no evidence on the file that your infection with Hepatitis C lasted six months or more, contrary to the experience of that majority. The burden of showing that your case is exceptional rests with you and we regret that there is no evidence upon which we can reach such a conclusion in your favour. Our view was that the very helpful and impressive report from Professor Dusheiko supports our conclusion.

As a result of these considerations we regret that we must refuse your appeal."

23. This claim was issued on 9 September 2009, and on 28 September 2009 the First Defendant offered to reconsider its decision. The First Defendant disclosed that the number of applications which failed the natural clearer test (and were refused payment) amounted to 187 out of 4827 applications to date.
24. Permission was granted against both Defendants on 24 November 2009.
25. On 3 December 2009 a signed consent order disposing of the claim against the First Defendant was filed.
26. On 4 November 2004 the SSH issued guidance as follows:

"The general view is that patients would only be eligible for the first payment if (i) there was evidence that they had developed chronic hepatitis C but this had resolved spontaneously (thought to be a reasonably rare situation)... Patients who had, or were thought to have, eliminated the virus in the acute stage, when they would most likely have been asymptomatic or where any symptoms that did occur would have been short lived because of the transient nature of the infection, would not be eligible for this payment. It should be assumed that the virus had been cleared in the acute phase unless robust medical evidence is cited that proves, on the balance of probabilities, that the patient experienced chronic infection i.e. infection that extended after the first six months of illness."

The Issues

27. The main ground of challenge is in respect of the Scheme's requirement that the burden of proving persistence of Hepatitis C infection beyond the acute phase (that is, six months after infection) is on the Applicant for compensation when, according to the Claimant, such proof is "scientifically impossible". The second ground of challenge is that the SSH's guidance of 4 November 2004 and the Skipton Fund's own Appeal guidance are unlawful because they were not published before the present proceedings and because they refer to the need for "robust" medical evidence and/or for positive liver biopsy or positive liver function tests.

The Applicable Legal Principles

28. Mr Rabinder Singh QC, who appeared on behalf of the Claimant, referred to the description by Professor Lord (Robert) Winston of the contaminated blood transfusion incident, which left 4,670 people with haemophilia infected with HIV and/or Hepatitis C, as "the worst treatment disaster in the history of the NHS", causing the deaths of almost 2000 people.
29. The Skipton Fund is an ex gratia compensation scheme for those infected with Hepatitis C: there was no strict legal obligation to introduce it. However, the very reason why they were infected was through the act of the state. Therefore, submitted Mr Singh – and this did not appear to be disputed – there was a strong moral obligation to make some compensatory payment to recognise the wrong which had been committed.
30. Mr Singh accepted that the starting point was that there was nonetheless no legal obligation at all to make payment, and any such payments do not represent compensation for losses for which the SSH is legally liable. He also recognised that such cases concern the allocation of public resources, and the courts will be cautious before intervening. However, such schemes and their application are reviewable on familiar judicial review grounds, as is shown by, for example:

"(1) Material error of fact infected the decision to reject an independent inquiry's recommendation that ex gratia payments to NHS patients treated with contaminated blood should match the higher level of compensatory payments made by the Irish government: R (March) v Secretary of State for Health [2010] EWHC 765 (Admin).

(2) Eligibility criteria based on the country of birth and imposed by the Secretary of State for Defence on an ex gratia compensation scheme for British civilians who were prisoners of the Japanese during the Second World War were quashed on the basis that they constituted indirect racial discrimination under the Race Relations Act 1976: Secretary of State for Defence v Elias [2006] EWCA Civ 1293 [2006] 1 WLR 3213.

(3) The decision by the Home Secretary to exclude judicial misconduct from deciding whether it could constitute exceptional circumstances within his statement on 29 November 1985 for ex gratia payments to persons who had wrongfully been detained in custody as a result of wrongful conviction constituted an unlawful fettering of discretion: R v Home Secretary, ex parte Garner (Divisional Court, 19 April 1999)"

The Claimant's Submissions: First Issue

31. Mr Singh submitted as his starting point that the scheme intended that natural clearers in whom Hepatitis C persists beyond six months should be compensated.
32. However, he contended that, as a matter of reality, it was impossible for any natural clearer to prove persistence beyond six months (or for any particular period). Geoffrey Dusheiko, Professor of Medicine and Honorary Consultant Hepatologist at the Centre of Hepatology and University College School of Medicine, made a witness statement on behalf of the Claimant. He stated in his report, first whole paragraph:

"It is, however, in the absence of any stored serum samples, exceedingly difficult to prove that there was a period of progression or prolonged viraemia during the acute phase. It is not possible to either deny or prove the supposition that persistence occurred for a period…"

33. In practice, contended Mr Singh, proof was impossible because cogent evidence was required to rebut the working hypothesis that the Hepatitis C virus had persisted in any natural clearer beyond six months. A positive PCR test at six months would be sufficient – but it was not generally available during the relevant time period for Skipton Fund payments. It would be unethical to require a liver biopsy. Liver function tests would be insufficient, for they are not sufficiently specific to identify Hepatitis C. Symptoms alone are also too non-specific. Even clinical symptoms suggestive of hepatitis, raised liver function tests, and the absence of hepatitis A or B in serum at six months would be insufficient to justify a specific diagnosis of hepatitis C.
34. Even if suitable tests performed at six months were capable of discharging the burden of displacing the working hypothesis that natural clearance occurred within six months, applicants were only informed of the fact of infection many years after they were infected – in the Claimant's case, over 10 years later.
35. Furthermore, Mr Singh contends that the Appeal guidance is positively misleading, in suggesting that positive liver biopsy or positive liver function tests are required. It would be unethical to insist on a liver biopsy in order to make a successful claim; and positive liver function tests are highly unlikely to be able to prove persistent hepatitis C. In any case, Professor Thomas accepted in his statement that it was not normal practice after a blood transfusion to offer liver function tests routinely at the time of Claimant's infection (1987).
36. In summary, the Claimant's case is that, although applicants were in theory entitled to payment from the Skipton Fund if they could prove persistence of Hepatitis C at six months, placing the burden of proof on them meant that even those who in fact fell within that category were unable to prove it – which was contrary to the express purpose of the scheme and/or irrational.

Decision

37. It is important not to lose sight of two fundamental points in this case. The first fundamental point is that the probability of spontaneous clearance of the virus after six months is very low indeed. As Professor Thomas observed:

"…that if patients are to spontaneously clear the virus they will do so in the first 6 months of infection and thereafter spontaneous clearance is rare."

38. A figure of 0.5 per cent per annum is mentioned in the expert witness statements, but Professor Thomas and his colleagues, with their vast combined experience, had never observed an actual case of spontaneous clearance after six months.
39. In those circumstances, in principle I see nothing irrational or unfair in requiring those in the relevant position and claiming an ex gratia payment from public funds to show that an event, spontaneous clearance of the virus after six months, that was statistically very unlikely indeed to occur, had in fact occurred. Indeed, as Miss Grey, who appeared on behalf of the SSH, perceptively pointed out, there would be no practical difference if the burden of proof had formally been assumed by the Skipton Fund to show, on a balance of probability, that the infection, which ex hypothesi had spontaneously cleared, had not moved into the chronic phase. Faced with that reverse burden, the Skipton Fund would simply have relied on the statistical improbability of such an event – spontaneous clearance after six months – having occurred. In practice, on that alternative scenario, the Applicant, facing such a very unlikely probability, would have to bring some medical evidence to show that the statistically remote contingency had occurred in his or her case.
40. The second point is that the Claimant, and those in her position, are not now at risk of illness or disease by reason of the fact that they had become infected with Hepatitis C as a result of receiving contaminated blood or blood products. The Claimant, and those in her position, have cleared their Hepatitis C infections so that they are not at risk of the consequences of infection, particularly serious liver disease and liver cancer. As Professor Thomas puts the matter:

"Once the virus has cleared there is general agreement that there is then no risk of morbidity or mortality from chronic liver disease or hepatocellular cancer so long as the infection is cured before the patient has developed cirrhosis." (witness statement, paragraphs 23 and 24)"

41. Professor Thomas, perhaps straying from the strict terms of his remit, certainly saw no obvious medical justification for compensating persons in that category:

"If the [date of the] blood test used to define that clearance of the virus (HCV-RNA negativity by sensitive assay) is greater than 6 months after infection these patients should not receive a payment in that, even if they have been infected for more than 6 months, the negative HCV-RNA indicates that they are now recovered and not therefore at risk of cirrhosis and HCC. Those that are still infected would receive a payment because they are still infected with less than 0.5 per cent per year subsequently clearing the virus [without specific medical intervention]."

42. Nonetheless the scheme did make provision for payment of compensation to those who could show, on a balance of probability, that they had not cleared the virus within six months and had moved into the chronic phase of infection, even if they subsequently cleared the virus and, not having developed cirrhosis of the liver, were not at risk of cirrhosis or liver cancer. Miss Grey suggested that the inclusion of this category within the Scheme could be justified principally on the basis that, if the infection persisted beyond six months the risk at the relevant time of the infected person suffering liver cirrhosis or cancer increased exponentially, even if it could be shown at a later time (after clearance without the incidence of liver cirrhosis) that such risk had been eliminated entirely. It seems to me that such a rationale for the inclusion of such persons within the Scheme is well understandable, but it does suggest that the justification is weaker than for some other categories and that this group is at the margin of the Scheme's objectives.
43. She submitted that the inclusion within the Scheme of a category of persons who were not now at risk of liver cirrhosis or liver cancer was a generous provision. I agree with that submission. The corollary would be that a Scheme that absolutely excluded that category would not have been irrational or manifestly unjust.
44. Looking at the purposes of the scheme as a whole, and appreciating the favourable treatment of those who were in the position that I have just described, again I see, in principle, nothing irrational or unjust in the provisions of a Scheme that placed the burden on those who claimed such treatment to show, on a balance of probability, that the infection had persisted into the chronic phase.
45. However, the core of the Claimant's case is that the Scheme in effect created an "empty category" of potential beneficiary, and was, therefore, illogical and unlawful. In other words, the Scheme proceeded on the basis that there would be persons who remained infected with Hepatitis C after six months (so entering the chronic phase of infection), and who would be able to show that they had entered the chronic phase even if subsequent reliable tests showed that at some point they had spontaneously cleared the virus.
46. To test that case it is necessary to look carefully at the medical evidence. At paragraph 14 of his witness statement Professor Dusheiko states:

"However, even those in whom hepatitis C in fact persisted beyond 6 months (as is possible in the Claimant's position) will, as a matter of reality, be quite unable to prove that it did not clear within 6 months. This is because they did not know at the time (in this case, December 1987) that a history and examination needed to be performed and blood tests (including serum ALT and AST, and tests to exclude hepatitis A and hepatitis B) needed to be taken at 6 months or later to confirm that they still had hepatitis C at 6 months."

47. However, with respect to Professor Duscheiko, that statement does not rule out the real possibility that some persons may nonetheless have in fact been examined and been subject to relevant blood tests. Before 1991 (when a positive PCR test became available) the diagnosis was admittedly difficult to make. Once symptoms of Hepatitis had been detected and serum amino-transferases had been shown to be raised, the serum could be tested for the presence of Hepatitis A and Hepatitis B. If there were symptoms of Hepatitis, raised serum amino-transferases, and neither Hepatitis A nor Hepatitis B were present, the diagnosis of suspected Hepatitis C could, by a logical process of exclusion, be made. (See statement of Professor Dusheiko at paragraph 10). It is, therefore, not unlikely that such diagnosis, following relevant symptoms and testing, did occur in certain cases; and the possibility cannot be ruled out that some persons falling within the Claimant's category of applicant to the Scheme (that is, those who are now shown to be spontaneously clear of the virus but who might have been infected at the chronic phase) would be able to rely upon such diagnosis as part of their clinical history as some evidence of having entered the chronic stage of infection.
48. It would, of course, be to some extent fortuitous whether a particular applicant had suffered relevant symptoms and had been tested and then diagnosed with suspected Hepatitis C, so creating a clinical history that could now be relied on to make an application to the Scheme. However, the longer the infection continued into the chronic phase, the more likely would it be that relevant symptoms would have appeared and that the diagnosis would have been made. If there was no such clinical history, the greater would be the probability that the infection had cleared spontaneously within the six month period and that it had not entered the chronic phase. The absence of such a clinical history, over an extended period, would strongly suggest that, for the purposes of the Scheme, the person should be appropriately equated with those who are known to have cleared spontaneously within the six month period.
49. Furthermore, to proceed on the putative footing that those with no such relevant clinical history should be treated as if they had (against a very unlikely statistical probability) entered the chronic phase of infection would create unfairness to another group, namely, those who could be shown to have cleared the infection spontaneously within the six month period. That latter group is not eligible for compensation; but the first group, with no relevant clinical history who, statistically, would have been most unlikely to have cleared the infection within six months would be eligible for compensation on the putative footing assumed above.
50. As to the PCR test, that test was not widely available until 1991. Plainly, this Claimant, and many other applicants in her position, could not at a time six months after infection in 1987 have received a PCR test, for no such test then existed. However, the Scheme applied to "people who had contracted Hepatitis C as a result of receiving blood or blood products from the NHS prior to September 1991." (Emphasis added). Those persons, therefore, who had contracted Hepatitis C during 1991, and probably also a short time before 1991, would have been able to obtain a PCR test; and if, following the appearance of symptoms, they had been so tested six months after infection, and the test had proved positive, they would now have conclusive proof of having entered the chronic phase of infection, even if they had subsequently cleared the infection.
51. As to positive liver biopsy, there is agreement between the medical experts that liver biopsy is a risky, invasive procedure and that it would be medically unacceptable to carry out such a procedure for the diagnosis of Hepatitis C. However, the real point is that such a test might have been carried out for a legitimate medical purpose, and the result could help demonstrate that the patient had been infected with Hepatitis C at the relevant time. In my view, it would be inaccurate to conclude that a category of claimant was empty of any eligible candidates when there was a possibility that some persons might have undergone liver biopsy and might therefore be able to furnish relevant evidence that the infection entered the chronic phase.
52. As to LFTs which (as mentioned) were available before 1991, Professor Dusheiko stated that "they are not diagnostic of [Hepatitis C]; merely indicators of chronic liver infection" (witness statement, paragraph 31). He points out that during chronic Hepatitis, ALTs may fluctuate over time, and may be intermittently or consistently normal. ALT and AST levels falling within the normal range are frequently actually high, relative to healthy individuals. He concluded that LFTs alone (my emphasis) would not prove persistence of infection beyond six months. He stated the same conclusion in respect to clinical symptoms, which, in particular, include jaundice.
53. However, it appears to me undeniable that positive LFTs combined with relevant clinical symptoms could properly lead the Skipton Fund, or on appeal, the Appeal Panel, to conclude that it was more probable than not that infection had persisted into the chronic phase. Given the statistical improbability of such a contingency, I do not underestimate the difficult nature of showing that to be the case, even with the benefit of positive LFTs and a corroborating clinical history. However, on the evidence before me I cannot dismiss such a prospect as unreal.
54. In short, I am not able to accept Mr Singh's submission that the relevant category of applicants (those clearing spontaneously after six months infection) is empty or illusory. It may be that the Claimant, for reasons particular to her, is unable to show that she falls within that category. But, in my view, there are others who may well be able to show that they do so.
55. I should add for the sake of completeness that I am not entirely satisfied that even if the relevant category were "empty" in the sense intended by Mr Singh that the Scheme would be logically defective or irrational. The decision to include the relevant category within the ambit of the Scheme was taken as a matter of principle (see paragraph 42 above). It does not seem to me to be irrational or unlawful, within the context of an ex gratia compensation scheme entailing the expenditure of public funds, to require those claiming to be within the relevant category to show that that is the case, even if, in the current state of medical science, such demonstration may, as a practical matter, turn out to border on the impossible. The moral obligation of the State, emphasised throughout by Mr Singh, would putatively be recognised by the inclusion of the deserving category within the Scheme. The difficulty, or practical impossibility, of showing that a particular applicant fell within the relevant category is a purely contingent matter. The need for proof remains justified by the principle that only those who can be shown to fall within the relevant category should receive payment of public funds to which, it is accepted, they are not strictly legally entitled in the absence of the compensation scheme. That principle has, in my view, all the greater force if the moral justification for the inclusion of the particular category in the Scheme is relatively weak compared to the justifiable claims of other categories, as appears to be the present case.

The Second Issue: Unpublished Guidance

56. The Claimant contends that the SSH issued guidance to the Skipton Fund in respect of its decision-making under the Scheme that was unpublished, and that the Appeal Panel used guidance that also was unpublished. The Claimant relies upon R (WL Congo) v Home Secretary EWCA Civ 111 [2010] 1 WLR 2168 at [70]-[78] for the proposition that it is unlawful to operate an unpublished policy in a manner inconsistent with the published policy.
57. However, as to the latter guidance, it appears from the evidence that the Appeal Guidance was sent to the Claimant on 11 March 2009, when she was informed by the Skipton Fund that she had a right of appeal against the Fund's adverse decision. The letter in question stated that a copy of the appeal panel's guidance notes was enclosed for the Claimant's reference. The Claimant was, therefore, able to consider the contents of the guidance, to make any representations about the terms of the guidance if appropriate, and to formulate any appeal with the benefit of the guidance. Nothing here was unfair or unlawful.
58. As to the guidance of 4 November 2004, the critical part of the relevant e-mail from the SSH to the Skipton Fund read:

"… It should be assumed that the virus has been cleared in the acute phase unless robust medical evidence is cited that proves, on the balance of probabilities, that the patient experienced chronic infection i.e. infection that extended after the first six months of illness."

59. In a letter on behalf of the SSH dated 26 October 2010 it was sated that the Skipton Fund had in effect incorporated the essence of this guidance into the Skipton Fund application form, the guidance notes and the letter informing those who clear the virus in the acute phase that they are not entitled to a payment. That appears to me what in substance has taken place, and the guidance cannot, therefore, be meaningfully described as "unpublished".
60. The Claimant specifically takes issue with the language of the document, insofar as it refers to an "assumption" and to "robust evidence", contending that such language is at odds with the published criteria of the Scheme. I do not agree. The published criteria do not deal explicitly with the question of how applicants should show that they fall within any relevant category of entitlement. However, it is plain that the Skipton Fund and, on any appeal, the Appeal Panel would have to decide whether or not any particular applicant did so. It appears to me to be no more than common sense that, given the statistical improbability of an infected person clearing the virus spontaneously after six months' infection, any decision-maker would begin with an "assumption" that the applicant did not fall within that statistically small category, unless medical evidence showed that he or she was more likely than not to have cleared the virus spontaneously after such period. Nor do I believe that the epithet "robust" adds much, if anything, in this context. It does no more than remind the decision-maker that, given the statistical improbability of the asserted contingency, he or she should look with care at the particular medical evidence put forward to ensure that (a) it was accurate and reliable and (b) that it was in fact probative of what was assented. That again, in the present context, seems no more than common sense.
61. I, therefore, reject the contention both that the guidance contained in the e-mail of 4 November 2004 was "unpublished" in any relevant sense and that such guidance was in conflict with, or inconsistent with, the published criteria.
62. For these reasons both grounds of challenge fail and I dismiss this application for judicial review against SSH.