England and Wales High Court (Administrative Court) Decisions

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

		Royal Courts of Justice Strand London WC2A 2LL
		4th July 2008

1. MR JUSTICE BURNETT: This is a rolled-up application for permission to apply for judicial review of a decision of the Commissioning Panel of Salford Primary Care Trust given on 24th April 2008. They refused an application for funding of a drug for treating cancer. The matter comes before me today as one of extreme urgency for reasons that will become apparent. The papers were lodged on 6th June 2008 and came before Mitting J on 19th June 2008.
2. The background to this application is a very sad one indeed. The claimant, Mrs Murphy, suffers from cancer which developed in her kidney and which has now spread. This is not the first serious medical problem from which she has suffered because unfortunately she has a longer history of breast cancer. However, that is well controlled.
3. The position so far as the kidney cancer is concerned is that, following its diagnosis, Mrs Murphy was in due course introduced to Interferon, a treatment very commonly attempted in such cases. Unfortunately, she suffered a particularly strong adverse reaction to Interferon. It is a drug which has the known side effect of causing depression, and the results for Mrs Murphy were particularly unfortunate. In the result, her Interferon dosage was reduced and, in due course, treatment with Interferon was stopped in about February 2008. Of note also in the treatment and development of this aspect of Mrs Murphy's cancer is the fact that the affected kidney was removed, but regrettably that has not stopped the onward march of the tumour, nor has it affected the secondary problems from which she now suffers.
4. It is in those circumstances that Professor Hawkins, Mrs Murphy's consultant oncologist, considered the possibility of treating her with an alternative drug, named Sunitinib. The hospital at which Professor Hawkins is based was not itself prepared to recommend the use of this drug, but in due course Professor Hawkins put forward a submission on behalf of Mrs Murphy to the defendant ("the PCT") for them exceptionally to make available funding for that drug to be prescribed. I say "exceptionally" because it is common ground that the drug is not one ordinarily available within that area, or others, on the NHS.
5. The decision that is challenged by Mrs Murphy is the decision of the Commissioning Panel, chaired by Dr Tankel, which decided not to make that drug available. In considering whether to do so, the Panel was concerned to apply a policy that the PCT shares with a number of others in the Manchester area. The essence of the claim advanced by Mr Gearty on behalf of Mrs Murphy is that the Panel misapplied its own policy and came to a decision which was, in legal terms, irrational. Additionally, he submits that they fell into error in considering a series of material factors individually, but failed, having performed that exercise, to look at them in the round to enable them to make their decision.
6. The legal principles that are in play are not controversial. They derive from a number of cases, but principally R v Cambridge Health Authority, ex parte B [1995] 1 WLR 898, R (Rogers) v Swindon NHS Primary Care Trust [2006] EWCA Civ 392 and R (Otley) v Barking and Dagenham NHS PCT [2007] EWHC 1927 (Admin). The principles are extremely helpfully collected together in paragraph 32 of the skeleton argument of Miss Morris, who appears on behalf of the PCT, and they are as follows:

"32. It is submitted that the following principles may be derived from the relevant case law (R v Cambridge Health Authority ex p B [1995] 1 WLR 898, R (Rogers) v Swindon NHS PCT [2006] EWCA Civ 392 and R (Otley) v Barking and Dagenham NHS PCT [2007] EWHC 1927 (Admin):

a. When an NHS body makes a decision about whether to fund a treatment in an individual patient's case it is entitled to take into account the financial restraints on its budget as well as the patient's circumstances (paragraph 58 Rogers).

b. Decisions about how to allocate scarce resources between patients are ones with which the Courts will not usually intervene absent irrationality on the part of the decision-maker (page 991 B). There are severe limits on the ability of the Court to intervene (paragraph 25 Otley).

c. The Court's role is not to express opinions as to the effectiveness of medical treatment or the merits of medical judgment (page 905 B).

d. It is lawful for an NHS body to decide to decline to fund treatment save in exceptional circumstances, provided that it is possible to envisage such circumstances (paragraphs 59, 62 and 65 Rogers)."

Additionally, this is an area in which the courts submit the decision-making process to rigorous scrutiny (paragraph 56 of Rogers).

7. Mr Gearty was at pains to emphasise that the challenge brought on behalf of Mrs Murphy is one to the process applied by the PCT through its Panel, rather than in any way a challenge to a medical assessment made by the PCT. He emphasises that because in the authorities to which I have referred there have been strong dicta to the effect that this court will interfere with such assessments and judgments only in very rare circumstances. Additionally, he emphasises that it is no part of Mrs Murphy's case before this court to seek an order that Sunitinib should be made available to her. What she seeks is a reconsideration of the decision on a basis which Mr Gearty suggests would be lawful.
8. Next, and also to distinguish the case from others that have come before this court, Mr Gearty emphasises that he is not seeking to challenge the policy under which the decision was made and, last he does not seek directly to rely upon Article 2 of the European Convention on Human Rights. He makes those submissions to emphasise, should it not have been clear from the formal pleadings before the court and other documentation, that this is in truth a narrow procedural challenge which he makes on entirely conventional public law grounds.
9. I turn then to the policy that was in play and was applied, in its determination, by the Panel. The policy is one adopted by the Greater Manchester Association of PCTs. It is entitled "Effective Use of Resources (EUR) Policy 2004". It was a policy which followed a good deal of detailed consideration by and on behalf of the relevant PCTs and which was informed by legal advice and a legal opinion provided by Messrs Hempsons, who are a very well-known firm operating in the field of medical law. As its title suggests, one of the overriding features of the policy is to ensure that resources are effectively used within the NHS.
10. As Lord Bingham observed in ex parte B, one of the cases referred to in paragraph 32 of Miss Morris's skeleton argument, it would be nice to think that all treatment that was decided by clinicians to be of benefit to patients might be afforded within the funds made available by Government to the Health Service. Sadly, that is not the reality. Thus those who are charged with running the National Health Service are constantly forced to make difficult decisions about the distribution of competing resources, and in particular about the circumstances in which individual patients may have made available to them treatment not ordinary available, and which is extremely expensive. So this policy, and the guidance it contains, is designed to direct and assist those who have to make those difficult decisions.
11. There are two particular parts of the document upon which argument has focused. The first is section 3, which is headed "Key principles to be adopted by clinicians for making decisions about individual patient treatments". Paragraph 3.1 provides:

"3.1 The following principles are offered as guidance and not intended to be binding in every case. Where appropriate, treatment, procedures or therapies may be authorised that are not included within these principles or that would appear to be excluded by them. The possibility will be especially relevant in, but will not be confined to, the 'exceptional circumstances', referred to in paragraph 4 below."

Paragraph 4 is entitled "Exceptional Circumstances". Paragraph 4.1 provides:

"4.1 Treatments or procedures that would otherwise appear to be excluded by this policy may nevertheless be authorised for a particular patient, where the failure to provide them would be likely to cause significant damage to his/her psychological health or social circumstances."

And paragraph 4.3 enjoins those considering this document as follows:

"4.3 When deciding whether circumstances are 'exceptional', account may be taken of previous decisions made under similar circumstances."

So that was the policy that the decision-makers in this case were following.

12. The process which triggered consideration under that policy was started, as I understand it, by Professor Hawkins. He is the consultant oncologist with responsibility for Mrs Murphy's care. It was he who wrote to the PCT to encourage them to make available the drug that he considered would assist Mrs Murphy by exercising their powers under this policy. In a short statement dated 4th June 2008, Professor Hawkins sought to summarise, in a way that is particularly useful for the non-doctor, how he saw the advantages to Mrs Murphy if she were to be prescribed this drug. He indicated that in broad terms there would be a 40 per cent a chance of the tumour shrinking, and if that were to happen, then Mrs Murphy's life expectancy would be increased by some months. I put it in that way because none of the material before me pretends to be able to specify precisely what the impact of this drug would be or by how much Mrs Murphy's life expectancy would be increased. The effect of this drug, if positive, will be to extend Mrs Murphy's life by a relatively short period, rather than there being a possibility of its curing the cancer.
13. Professor Hawkins referred to two particular factors which he considered of importance in the decision-making process. It is apparently possible for patients with advanced cancer of the sort from which, sadly, Mrs Murphy suffers to be placed on trials of Sunitinib. That is not possible in Mrs Murphy's case, if I understand Professor Hawkin's evidence correctly, because she suffers from breast cancer, albeit that it is well controlled. The second factor that he particularly adverted to was the very severe side effects from which Mrs Murphy suffered when she was taking Interferon. That is the foundation of the application to the PCT.
14. Although Professor Hawkins was concerned with and focussed on what, understandably, were relatively narrow medical issues, a number of other matters were raised and put before the Commissioning Panel, by Mrs Murphy herself, by her family and by others on her behalf. Those matters formed part of a very large body of material that was made available to those on the Panel. In the course of argument, Mr Gearty recognised that those within the PCT who have dealt with Mrs Murphy's case have devoted a great deal of time, energy and resources in collecting together the relevant material, putting it before the Panel and, generally, in treating her medical case with an enormous amount of care and attention. That is apparent from the evidence of Mr Golby, an official within the PCT who was largely responsible for the administration of the application, and thus collating the information.
15. The papers went before the Panel and they met on 24th April 2008. The papers included very detailed technical medical evidence from Dr O'Shaughnessy. That evidence looked at the efficacy of the drug in general, and also in cases which might be thought similar to Mrs Murphy's. It also dealt with questions of cost and cost benefit analysis, which inevitably substantially informed the sort of decision with which we are concerned.
16. The starting point is that the drug is too expensive to be justified in the ordinary course of cases. So, when considering the policy, important founding considerations include questions concerning the likely efficacy of the drug, how it will improve the condition of the patient concerned, and how much its prescription will cost. There are relatively complex calculations carried out to produce a figure which is called a "quality-adjusted life year". By that mechanism the relative cost of the drug in question, as compared with others, can be evaluated.
17. We have minutes of the meeting that took place on 24th April 2008. It is clear from those minutes that the Panel considered all of the material that was before them. It is unnecessary for me to read the minutes in full, but I draw attention to those parts which indicate the consideration given by the Panel to the particular factors identified by or on behalf of Mrs Murphy as relevant to the question of whether, exceptionally, this drug should be made available. They are as follows:

1. Mrs Murphy suffered from metastatic renal cancer.

2. She was unable to take part in clinical trials of Sunitinib for the reason I have already identified.

3. The fact that she had breast cancer.

4. The fact that Mrs Murphy has suffered from some mental health problems, quite independently of those that overtook her when she was on Interferon.

5. A number of complaints raised in correspondence from Mrs Murphy's son.

6. That whilst being treated with Interferon Mrs Murphy had not been able to take the maximum dose. That is because Professor Hawkins considered it necessary to reduce the dose to try to ameliorate the side effects.

7. The fact that Mrs Murphy, despite suffering serious illness herself, remains the principal carer for her husband, who himself suffers from a number of difficult medical conditions. Those include Crohns disease, in respect of which there has in the past been surgical intervention and a stoma; secondly, psoriasis, which makes the treatment, and dealing with that problem, more difficult; and, thirdly, diabetes and other health problems.

18. It is right to observe that whilst there were those seven factors identified by or on behalf of Mrs Murphy in support of her application for funding for the drug, it is the last of the factors which provides an explanation for her real concern and desire to have this drug so that there is an opportunity for her to continue to care for her disabled husband.
19. The Panel considered each and every one of those factors, which the minutes confirm. The conclusion of the Committee, looking at each of them, was that none was an exceptional factor. At the end of the meeting the Committee voted unanimously to decline funding on the basis that exceptional circumstances had not been demonstrated.
20. The reasoning of the members of the Committee is extremely condensed in the minutes that were produced. Dr Tankel has expanded upon the reasons why the Committee considered each of those factors not to give rise, in itself, to an exceptional circumstance which would justify making funding available.
21. Mrs Murphy was not satisfied with the Committee's decision, and she took advantage of a procedure available within the Trust for the decision to be reviewed. On 15th May 2008 the Process Review Panel considered the earlier decision of the Commissioning Panel.
22. In the meantime, solicitors acting on behalf of Mrs Murphy had written a letter to the Trust which set out in short order the legal complaints that they suggested should be considered by the Trust. In particular, they raised the factors that are relied upon before me, namely that the Panel had misapplied the policy, and also that they had failed to consider all of the matters identified in the round, in addition to looking at them one by one. That letter was before the Process Review Panel members when they met on 15th May 2008.
23. The Process Review Panel was concerned to discover whether the suggestion that the Commissioning Panel had looked only at the individual circumstances one by one, rather than as a whole, was an accurate statement. Mr Golby attended the meeting to provide information, but not to take part in the decision. He had also been at the Commissioning Panel. Mr Golby said that the Commissioning Panel had not considered the individual circumstances as a whole; it had considered each circumstance in turn.
24. There followed a relatively lively discussion about whether the Commissioning Panel should have looked at the circumstances as a whole, in addition to doing so individually. The minutes at the bottom of page 109 of file 1 of the trial bundles suggest that there was a difference of view about the matter, but that, even if the procedure should have encompassed looking at the issues as a whole, given the nature of the issues in this case, it simply did not matter. I read from the bottom of page 111 over to the top of page 112. NED is a reference to "non-executive director" and GP is a reference to "general practitioner":

"NED2 stated her view had been that the main issue was whether the 7 issues should have been looked at as a whole rather than each separately. NED1 said he felt the argument made by GP2 was sound — if none was exceptional on its own, collectively they could not be exceptional. GP1 said he felt NED2's question would have been reasonable if there had been a number of 'maybes' with regards exceptional circumstances, however given that so many of the individual issues were 'black or white' it had not been necessary to have gone through the process of considering them together."

It is apparent that within the Process Review Panel there were two views: one, that it simply was not necessary to look at the seven issues in the round if each, individually, was of no real weight; and the other that on the facts of this case there was no need to do so because they were in truth of negligible weight.

25. The conclusion recorded in the minute on page 113 is as follows:

"NED1 said, in summary the PRP believed the CP took into account all the relevant considerations and gave sufficient weight to those considerations. He asked whether the PRP therefore upheld the decision of the CP."

They did so. The reasoning of the Process Review Panel is elaborated a little in the statement of Mr Bertenshaw, its chairman, in paragraph 19 of his statement:

"The PRP also considered the argument advanced by the Claimant's solicitors that even if individually the circumstances referred to in relation to the Claimant were not 'exceptional' their concurrence in one individual's case constituted an exceptional circumstance in itself. The PRP rejected this view as a number of the circumstances highlighted would be common to those with the Claimant's condition and if none of the individual circumstances which remained were exceptional then the totality of those circumstances did not in fact constitute exceptional circumstances in this case."

26. I turn now to the submissions that were advanced by Mr Gearty. He submits that it is quite clear when one looks at the minute of the meeting of the Commissioning Panel, coupled with the evidence of its chairman, that the Commissioning Panel did not look first at paragraph 4.1 of the policy, make a decision on paragraph 4.1 one way or the other, and then proceed, if necessary, to consider paragraph 3.1. He submits that, as a matter of law, the only way in which the policy can properly be applied is for that two-stage process to be introduced. In saying that, Mr Gearty recognises that it would be necessary for the Commissioning Panel to look at all the circumstances before them in their papers and distill from the voluminous information those facts which fell within the strict language of paragraph 4.1.
27. Paragraph 4.1 is concerned with psychological harm and social impact. It does not, for example, appear to encompass psychiatric harm, which might strictly speaking be the point prayed in aid by Mrs Murphy. Nonetheless, submits Mr Gearty, having done that, the Commissioning Panel should ask itself whether exceptional circumstances have been made out under paragraph 4.1. Only if they have not, submits Mr Gearty, should the Commissioning Panel then go on to look at any other factors that are within their purview, which might lead them to exercise what is a discretion under paragraph 3.1 to provide funding, even if the more specific principles set out under the guidance are not established.
28. In my judgment, in circumstances where the Commissioning Panel is faced with a large body of material that identifies a wide range of factors for its consideration, to expect it to strip down its decision-making process in the rather legalistic way suggested is unreal. It seems to me that there can be no legal objection, where the Commissioning Panel is faced with (as here) seven factors, for them effectively to consider paragraphs 4.1 and 3.1 together. After all, the issue the Commissioning Panel is there to decide is whether, exceptionally, funding should be made available.
29. So far as the second point is concerned, namely that the Commissioning Panel did not look at the factors in the round, it seems to me that there is more in that argument. When one looks at paragraph 3.1 of the policy it is to my mind plain that the document envisages that funding might be made available on a wide range of grounds which are not further specified within the document. Paragraph 3.1 does not itself speak in terms of exceptional circumstances, save through reference to paragraph 4, but it is plainly directed towards exceptional circumstances, otherwise it would have no sensible meaning.
30. Thus when any decision-maker is concerned to decide whether a policy exceptionally should be departed from, there will inevitably come a stage in the decision-making process when a general, all-round question must be asked and answered. The way Mr Gearty put it was to suggest that factors that have been advanced, in this case on behalf of Mrs Murphy, but in any case, should be looked at holistically. The Review Panel spoke of looking at all the factors in the round. Miss Morris used a different phrase, which was to the same effect, namely the question being whether the decision-maker must look at "a constellation of factors".
31. All of those expressions are really directed towards the same point. As a matter of general principle when considering a series of factors which might inform the overall decision, it is of course necessary to look at them individually. That is because there are many factors which on their own might be sufficient to persuade a decision-maker to exercise a discretion exceptionally. Indeed, in this case Mr Gearty submitted that the circumstances surrounding Mrs Murphy's care of her husband might well be such a factor. But having looked at all factors individually, it seems to me that it is necessary to consider them in the round, to use the phrase of the Review Panel. That is because the overall decision that is engaged under paragraph 3.1 is plainly one that requires the whole circumstances of the case before the Commissioning Panel to be taken into account.
32. I did not understand Miss Morris to disagree with the general proposition that when a body such as the Commissioning Panel is faced with a panoply of arguments all directed towards a single outcome, that the time should come in the decision-making process for the constellation of factors to be looked at as a whole. But, submits Miss Morris, in this case it was not necessary to do so because the weight of the individual factors, save for the last, namely the care of Mrs Murphy's husband, were in truth so vestigial that they could not possibly have affected the outcome, had the Panel gone on to deal with it in the round.
33. Miss Morris developed arguments by reference to each one of the seven factors that I have sought to summarise a little earlier in this judgment, and which are more fully explained in the witness statement from Dr Tankel. I am unable to agree with her submission that all six of the other factors were necessarily irrelevant or obviously of such trivial weight that they could safely have been ignored. It seems to me that there are three which, on analysis, are of no help at all to Mrs Murphy. The fact that she has the cancer which needs treating seems to me to be an irrelevant factor. That is a necessary background factor. It also seems to me that the fact that she also suffers from breast cancer is not something that could weigh in the balance. And it is now accepted that the fifth point, that is to say various matters raised in correspondence from Mrs Murphy's son, were in truth mistaken. But so far as the others are concerned, it does seem to me that a Commissioning Panel, properly directing itself, might attach some weight to them in the consideration of the all-round question.
34. Mrs Murphy would not be before them if she had been able to take advantage of the clinical trial. It is for reasons connected with her other medical problems that she cannot take advantage of the clinical trial. Whilst it seems to me right, indeed obvious, that in itself would not found an exceptional reason for making funds available, it might have some bearing on a global question. Similarly, the mental health problems which she relies upon are not limited to the adverse impact of Interferon but, although not very clearly expressed and explained in the papers before me, stretch back to a rather deeper and longer history. Whether there is anything in that is not for me to say, but it is not a point that, in my judgment, can be dismissed out of hand. Similarly, the impact on her of Interferon: the side effects and the fact that for some time she had a reduced dosage before she was taken off it altogether.
35. The reality in this case is that the social question, that is to say Mrs Murphy's care of her husband, was not sufficient to carry her into the territory where the Commissioning Panel would fund her treatment. It is no longer suggested that the Commissioning Panel was irrational in coming to that conclusion. There have been previous instances where they have funded Sunitinib, where young patients have young children. Although Mr Gearty, in his skeleton argument and in the paperwork, was inclined to argue that to distinguish between family circumstances such as those, and the circumstances of the Murphys was irrational, he did not press that in argument, in my judgment correctly.
36. Having said that, it does seem to me that the Commissioning Panel made an error when it failed to look at the circumstances in the round. It is only if I could be satisfied that the decision, if retaken, would inevitably be the same, that I should refuse this application. I have come to the conclusion that I am not able to say that the decision would necessarily have been the same if the matter had been looked at in the round. I am conscious of the fact that, as I indicated earlier, this is an environment where I am enjoined by the Court of Appeal in Rogers to subject decision-making processes to rigorous and anxious scrutiny. That is not to say that the arguments advanced by Miss Morris, and which essentially found favour in the reasoning of the Process Review Panel, are not powerful arguments. They are. Whether the legal error that I have identified was such that it should lead to some relief was not a clear cut question. I make that point clear because, as I am sure Mrs Murphy will understand, the consequences of the reasoning that I have sought to explain, albeit rather inadequately extempore, is that this decision will have to be taken again. I have been told that the decision can be taken next week. It will be a matter for the Commissioning Panel, looking at the matter in the round, to determine whether the exceptional grant of funding envisaged by paragraphs 3.1 and 4.1 should flow. The fact that, having looked at the matter, I hope with some care, I have concluded that there was a legal error in the decision-making process, does not, and I emphasise this, lead to the conclusion that the decision will necessarily be different.
37. For those reasons, I grant permission and quash the decision of the Commissioning Panel of 24th April 2008. I remit it to the Commissioning Panel. There is no suggestion it should be comprised of different people, is there, Mr Gearty? It would be unrealistic.
38. MR GEARTY: I think it might be unrealistic. I am not instructed to that effect, but I imagine it would be unrealistic, and we have confidence.
39. MR JUSTICE BURNETT: Yes, so it will be remitted to the Commissioning Panel for the decision to be taken again. The reason, as you will appreciate, that I felt that I should extemporise my reasons so immediately was to make clear the very narrow basis upon which, as it seems to me, the Commissioning Panel fell into the error so that there would be no confusion when the matter went back to them.
40. MR GEARTY: May I make an application for costs, my Lord?
41. MR JUSTICE BURNETT: Yes, you may. You can make an application for costs. Let me just float with you a thought that goes through my mind straightaway. The point on which you have succeeded is not one that was in the grounds. It has come and gone in the course of these proceedings. It came back with a bit of a vengeance today, and it was probably obvious from the outset that it was the point that I was concerned about, but I do wonder whether in those circumstances it is right that there should be costs, because most of the energy on paper has gone into matters which, in the end, you have not succeeded on, and my inclination, but please try to persuade me to the contrary, is that this is a case for no order.
42. MR GEARTY: Can I take brief instructions? My Lord, that is fine.
43. MR JUSTICE BURNETT: You would want a detailed assessment? You have community funding?
44. MR GEARTY: Yes.
45. MR JUSTICE BURNETT: So you want an assessment? You may have that.
46. MR GEARTY: Thank you, my Lord.
47. MR JUSTICE BURNETT: Are you content with no costs?
48. MS MORRIS: Certainly, my Lord.
49. MR JUSTICE BURNETT: Well, can I say that I am enormously grateful to both of you for the help you gave in what is a very difficult case, in circumstances where everybody involved has had to move at great speed to ensure that it is dealt with at a time which is of some value to Mrs Murphy. Thank you very much.
50. Are there any other consequential applications, Miss Morris?
51. MS MORRIS: I have not confirmed that, but I doubt that there are. May I just check? (Pause). No, my Lord, there are not, thank you.