London, WC2A 2LL
B e f o r e :
| The Queen on the Application of Longstaff
|- and -
|Newcastle NHS Primary Care Trust
Smith Bernal Wordwave Limited, 190 Fleet Street
London EC4A 2AG
Tel No: 020 7421 4040, Fax No: 020 7831 8838
Official Shorthand Writers to the Court)
Philip Havers QC (instructed by Eversheds) for the Defendant
Paul Nicholls (instructed by the Office of Solicitor to the Secretary of State for Health)
Crown Copyright ©
Mr Justice Charles :
"Recombinant Factor VII Funding
We would be most grateful for your help and advice in relation to some issues of funding for recombinant coagulation factor concentrates for adults with haemophilia. As you know, the Department of Health have announced the phased introduction of funding over the next three years. It is yet to be clarified exactly how funding will be phased in. It is anticipated that this will be mainly on the basis of age.
As you know, there is an individual patient [the Claimant] who has been refusing plasma derived factor VIII for some time. As a result of this, his care at the Haemophilia Centre has been very difficult. He has experienced regular joint bleeds which have not been treated. In addition, he has chronic liver disease which recently has been showing clinical signs of decompensation. He is likely to need invasive therapeutic intervention and invasive investigations in order to manage his progressive liver disease in the near future. These procedures cannot be performed safely without appropriate factor VIII cover. If he continues to decline plasma derived factor VIII then it is likely that it will be impossible to mange his multiple problems safely. If his liver disease continues to decompensate then this is clearly likely to threaten his life.
As you can imagine, the management of this situation has been extremely problematic for all staff at the Haemophilia Centre and many others involved in his care.
Whilst we are strongly in favour of a fair and equitable introduction of recombinant therapy, we think there are already widespread inconsistencies in England, for example [the Claimant] received recombinant factor VIII when he went down to the Liver Transplant Unit in Birmingham to cover a liver biopsy during 2002.
In terms of cost, in the 12 months before [the Claimant] refused to take further plasma derived factor VIII, he used approximately 200,000 units, at a total cost of £58,000. If his utilisation is similar in the future, using recombinant factor VIII (current price 58p per unit), the approximate annual cost will be £116,000 (ie £58,000 greater than plasma derived treatment).
We wonder whether, taking all the circumstances into consideration, it would be possible to fund recombinant factor VIII for [the Claimant] on the basis of clinical need? Our concern is that unless this decision is taken he will continue to deteriorate and possible die. We appreciate that this is an extremely difficult situation and we would be very grateful for your advice about the best way forward."
"Re: Recombinant Factor VIII and patient PL
Thank you for the letter of 18 February regarding your request for patient PL to receive recombinant FVIII. The request has been discussed by the PCT Management Team today. The recent DoH announcement regarding introduction of funding over the next three years was noted.
The decision of the PCT Management Team is based upon the following:
1. Clinically effective treatment (plasma derived FVIII) is available. The current evidence is that this is as clinically effective as recombinant FVIII.
2. The patient does not fit the current criteria for recombinant FVIII and the Department of Health has not established what the new phased criteria will be. However, it is likely to be based on age bands that will not include this patient in the initial tranche.
3. The patient is currently choosing not to have plasma derived FVIII treatment. This is his choice and we understand he is aware of the consequence of his decision.
As a result of the above we feel that the patient should be encouraged to receive plasma derived FVIII as this is the currently available treatment and that he does not fit the current exclusion criteria."
"Recombinant Factor VIII and Patient PL
Thank you very much for your letter. I appreciate that this is a very difficult situation.
I would reiterate that your position does put the staff at the Haemophilia Centre in an almost impossible position in terms of providing care for this particular patient.
I have discussed things further with the patient and he is adamant that he will not consent to treatment with plasma derived products.
In view of this very difficult situation I wondered whether you would be prepared to reconsider things again to enable us to adopt a more flexible approach to his management."
"Recombinant Factor VIII
Thank you for your letter of 11 March asking whether we could reconsider our approach to provision of Recombinant Factor VIII outside current DoH guidelines.
I have discussed this matter at length at today's management team meeting. We have not found sufficient new evidence or information that supports a change in our previous decision. Therefore, the position remains as:
1. Plasma derived FVIII should be used when required or accepted by the patient for prophylaxis or routine treatment of bleeds.
2. In the event of actual life threatening bleeds recombinant FVIII could be used as previously agreed by Dr Laker and Dr Freake.
We realise that option 1 will be unacceptable to the patient, however this is within DoH guidelines and is clinically effective treatment.
As always we are keen to work together with you in this matter and if in future there are new concerns we would be keen to discuss these with you in order to be part of the decision making process."
i) A circular issued in 1998 (the 1998 circular).
ii) A press release of 12 February 2003 (the 2003 press release).
iii) A document issued by the United Kingdom Haemophilia Centre Directors organisation (the UKHDCO document).
i) sets out the background to the decision by the Secretary of State relating to the provision of recombinant Factor VIII for specific patients with Haemophilia A;
ii) outlines the financial arrangements for this provision (full details of the proposed mechanism for delivery the additional funding will be provided in due course); and
iii) summarises the steps which Health Authorities and Trusts will be expected to take in order to support a claim for additional funding.
1. Over the past two years there have been representations from the Haemophilia Society, the UK Haemophilia Centre Directors Organisation (UKHCDO) and a number of patients and their families for recombinant Factor VIII to be used as the treatment of choice for individuals with Haemophilia A. These are largely on the ground that they regard the recombinant product as free from the risk of transmission of as yet unknown viruses, and therefore safer than plasma derived products.
2. The Department of Health's view remains that the clinical case for recommending the general use of recombinant Factor VIII has not been made. Plasma derived Factor VIII has had a very good safety record since the introduction of viral inactivation processes in the manufacture of blood products in 1985. Further, there is no evidence that the recombinant product is more effective.
3. Many Health Authorities have examined this issue in depth, on the basis of the clinical evidence of effectiveness and safety relative to cost, decided not to fund this treatment as a general policy. The Department recognises the difficult decisions which this has involved.
4. However, the recent concerns about the theoretical risk of human to human transmission of nvCJD have raised particular anxieties in the haemophilia community about the possibility of blood borne infections through plasma-derived products. While fully recognising that the risk of nvCJD transmission through blood products is theoretical and unquantifiable, given their past experience of HIV and hepatitis C transmission through plasma-derived Factor VIII, the Secretary of State considers that this new fear had raised particular concerns for people with Haemophilia A. Accordingly, in response to strong representations from the Haemophilia Society, particularly in relation to the affect with such fears have on families with haemophiliac children, the Secretary of State decided that recombinant Factor VIII should be made available to all those under the age of 16 who are not already receiving it, and to new patients (those previously untreated with plasma derived products)."
"Wednesday 12th February 2003
GOVERNMENT INVESTS AN EXTRA £88 MILLION
IN HAEMOPHILIA TREATMENTS
New funding will secure synthetic clotting products for haemophilia patients
Public Health Minister Hazel Blears today announced an extra £88 million over the next three years to provide synthetic clotting factors for haemophilia patients.
In 1998 the Government provided funding to place all haemophilia patients under 16 on synthetic clotting factors. These patients have continued to receive synthetic products as they have grown older. The extra funding announced today will extend the availability of synthetic products to adult haemophilia patients.
Over the next few months the Government will work with key stakeholders including the Haemophilia Society to design a programme for rolling out access to these products to older age groups. The rollout will take time to achieve because of the large volumes of product involved but by March 2006 the vast majority of patients should be receiving the new treatments.
Haemophilia is a genetic blood condition in which an essential clotting factor is either partly or completely missing. This causes a person with haemophilia to bleed for longer than normal. The main problem is bleeding into joints, muscles and soft tissues.
Treatment of haemophilia is usually by replacing the missing clotting factor through regular injections which helps the blood to clot and minimises the likelihood of long term joint damage. For many years clotting factors used to treat people with haemophilia have been made from human blood plasma. As a precaution against theoretical risk from vCJD, plasma from UK donors is no longer used to make these products.
In recent years synthetic alternatives to clotting factors from human plasma have become increasingly available. These are usually known as recombinant clotting factors and are regarded as free from the risk of blood borne infections as well as the theoretical risk from vCJD.
Hazel Blears said:
"We have taken a number of steps to make clotting factors used to treat people with haemophilia as safe as possible. We hope this extra £88 million will ultimately give all haemophilia patients access to synthetic treatments, where these are recommended by clinicians."
Karin Pappenheim Chief Executive of the Haemophilia Society welcomed today's announcement. She said:
"As the national patient group, the Society welcomes this move. It show that the Government has listened to the wishes of patients with haemophilia who want the choice of being treated with synthetic recombinant, which is now seen as the safest modern treatment for this incurable bleeding disorder. We look forward to working with the Department of Health, NHS managers and clinicians on the implementation of this positive improvement to patient care.""
". . .it is anticipated that patients with haemophilia A and B will be using recombinant Factor VIII/IX by March 2006. The D.O.H. anticipates that the complete roll-out will take at least four years . . .
A working party will be formed by the DoH to devise an orderly strategy for changing the patient over the recombinant FVIII/IX. This working party will include representatives of the DoH, UKHDCO, purchases, The NHS Purchasing and Supplies Agency and the Haemophilia Society. It is anticipated that patients will be changed to recombinant FVIII/IX in age bands yet to be decided, but starting with those in their 20's as soon in the forthcoming financial year as possible. This working party will also consider increasing access to rVIIIa (Novoseven, Novo). This working party will need to confer urgently because most centres are already at an advanced stage in their contractual negotiations for the next financial year, and will require further guidance to amend their contracts.
Although the broad details of this agreement have been widely anticipated, many patients will be disappointed because it is likely that most patients currently using plasma derived FVIII/IX will not be changed to recombinant until 2005/2006. Patients should be made aware of this so that they have realistic expectations."
"a) Recombinant Factor VIII Funding
Claire tabled a letter she had received from John Hanley and Kate Talks asking for a decision re a patient who has refused to take further plasma derived factor and wishes to receive recombinant factor VIII. As the patient does not fit the criteria for recombinant factor VIII the management team agreed that this request be refused. Gina to be made aware of this decision and a press statement prepared.
Clare advised the Trust will be setting up a complex case panel with a robust appeals panel. Action CB"
"It is anticipated that patients will be changed over to recombinant Factor VIII in age bands, although this has yet to be decided, as soon as possible in the next financial year. Newcastle Primary Care Trust will work the Newcastle upon Tyne Hospitals Trust to implement the working group recommendations as these are made available. The roll out will take time to achieve because of the large volumes of products but by March 2006 the vast majority of patients should be receiving recombinant treatment. In the meantime, the Primary Care Trust has agreed with the Newcastle upon Tyne Hospitals Trust that all patients requiring treatment will be treated on the basis of clinical need, and on an individual case by case basis."
"9) The Panel recommends to the Board that it support the universal availability of recombinant Factor VIII. This recommendation should be conveyed to Health Authorities for funding.
10) If this recommendation is accepted it is likely that, initially, supplies will not meet demand. The more widespread use of recombinant Factor VIII may therefore need to be phased according to clinical guidelines."
A brief history of the proceedings.
"Clinically effective treatment (plasma-derived FVIII) is available. The current evidence is that this is as clinically effective as Recombinant Factor VIII"
It was asserted that this was an insufficient and therefore improper ground. It was further asserted that it was illogical for the Care Trust to maintain that plasma Factor VIII was "clinically effective" if it carries with it the risk of aids and/or hepatitis and/or Creuzfelt Jacobs Disease in those to whom it is administered, and that there is cogent evidence that human blood plasma itself lowers the immune system and cannot therefore be suitable for those who are HIV Positive and are therefore immuno-suppressed.
"The patient is currently choosing not to have plasma derived Factor VIII. This is his choice and we understand he is aware of the consequence of his decision."
It was asserted that by giving this reason the Care Trust were taking into account an irrelevant matter and were therefore acting unreasonably.
"For the reasons set out in the Defendant's Summary Grounds this Claim is not arguable. The reasons given for the Defendant's decision in its letters dated 18 February and 18 March 2003 are not arguably irrational and/or unfair. The Defendant has a very broad discretion when determining questions of this kind. It has to balance the exercise of clinical judgment and the application of finite resources. While I sympathise with the Claimant, it cannot be said that there is any judicially reviewable error in the Defendant's exercise of that broad discretion. If a renewed application for permission is made the Secretary of State should be served as an Interested Party."
"The first ground for the refusal of the request reflects that view, and it cannot sensibly be suggested that the Defendant was not entitled to take the same view as the Department of Health, or that the ground is insufficient or improper"
I respectfully agree.
"On the face of the documentary evidence currently available, it is, in my judgment, open to argument that the Defendant misapplied the guidance in [the 1998 circular] by treating the category specified in it as exclusive."
"The refusal of blood plasma derived factor VIII by the Claimant cannot have been an irrelevant factor. But the weight to be attached to that factor must depend upon the reasons for the refusal. Whilst it is not for this court to undertake the exercise of evaluating the weight to attach to that factor, there is nothing in the material before me to indicate that the reasons for the decision by the Claimant were taken into account by the Defendant in arriving at its decision. In those circumstances I am satisfied that it is arguable on the material presently available -- and I emphasis, on the material presently available -- that the Defendant erred in its approach to the Claimant's decision not to receive plasma derived factor VIII treatment."
The alleged misapplication of the 1998 circular
The Second Ground as re-formulated by Owen J
"Of course, in assessing any request for funding, it is important to consider the particular circumstances of the patient in question and the Management Team did so in this case. (In no sense did we regard the criteria set out in the Department of Health's circular as preventing us from providing funding for recombinant factor VIII in an exceptional case if we concluded that it was appropriate to do so because of the particular circumstances of that case). The position so far as the Management Team understood it was that although [the Claimant] had been exposed to all known viral infections which had been found to be transferred by using the plasma derived product, he was concerned about the risk of additional viral infection and for that reason refused to accept plasma derived treatment and wanted to receive what he regarded as treatment from a safe source, namely recombinant factor VIII. We discussed and carefully considered [the Claimant's] position but we considered that the risk in question was purely theoretical, that huge steps had been taken to improve the safety of the plasma derived product and that recombinant factor VIII still carried a theoretical risk for viral infections. In those circumstances we did not consider that [the Claimant's] refusal to accept plasma derived treatment was reasonable and this was, I believe, implicit in my reference to "his choice" in paragraph three of my letter."
"20. I can no longer naively believe that I am not currently at risk from taking human plasma products. I believe it is only a matter of time before a known virus mutates or a new virus emerges that cannot be eliminated via current inactivation methods. This is also the opinion of many experts in the blood safety field."
(a) the Care Trust failed to act fairly in not seeking information from the Claimant as to the reasons why he had refused and was refusing, treatment with plasma Factor VIII and that the Care Trust had a duty to seek such further information; and
(b) the approach of the Care Trust to the reasonableness of the Claimant and its decision thereon was wrong as a matter of public law.
Fairness / duty to seek further information
(a) to seek further information from the Claimant as to his reasons for refusing treatment with plasma Factor VIII, or
(b) to inform the Claimant that it had reached the conclusion expressed at the end of paragraph 12 of the statement of Dr Bradford or that it was of the view that he had effectively gone on a "treatment strike" as Dr Bradford asserts in paragraph 5 of her statement and thereby give him an opportunity to comment on these points.
(1) The relevant request was put to the Care Trust by Dr Hanley on the basis of clinical need and the refusal of the Claimant to be treated with plasma Factor VIII was put by Dr Hanley as part of the history and the reason why the care of the Claimant had been, and was, so difficult.
(2) When read in context the Claimant and his advisers seek to make far too much of the assertion in paragraph 12 of the statement of Dr Bradford that the Care Trust did not consider the refusal of plasma Factor VIII by the Claimant to be reasonable. In its context, and having particular regard to the preceding sentence, the final phrase in paragraph 12 and the information before the Care Trust, this is not an expression of the conclusion reached by the Care Trust on, or by reference to, the individual circumstances and history of the Claimant or his decision making process. Rather it relates to the general medical debate and arguments relating to the clinical effectiveness of plasma Factor VIII that were at the heart of the first ground of challenge that was correctly rejected by both Sullivan J and Owen J.
(3) The Care Trust correctly identified the conclusion upon which the Claimant's decision to refuse treatment with plasma Factor VIII was based. In my view, when they are read in context, there is effectively no difference between the descriptions contained in paragraph 12 of Dr Bradford's statement and paragraph 20 of the Claimant's statement of the conclusion upon which the Claimant's refusal of treatment with plasma Factor VIII is based. I pause to comment that it follows that I reject the contention that the description of that conclusion in paragraph 12 of Dr Bradford's statement was inaccurate or misrepresents the Claimant's position having regard to the reasons for that conclusion which he now alleges the Care Trust should have informed itself about and thus the Claimant's personal history, his circumstances, his research, his views, his decision making process and the other matters set out in his statements and advanced in argument on his behalf.
(4) It follows that the Care Trust had a correct understanding of the conclusion upon which the Claimant's refusal of treatment with plasma Factor VIII is based and the Care Trust did not, and indeed on the information it had could not, take into account the reasons for that conclusion and thus the Claimant's personal history, etc which he now alleges the Care Trust should have informed itself about.
(5) It was open to the Claimant and Dr Hanley to put the reasons for the conclusion upon which the Claimant's decision to refuse treatment with plasma Factor VIII was based to the Care Trust initially, or when further consideration was sought from and given by the Care Trust, or after the decision in the letter of 18 March 2003. The willingness of the Care Trust to reconsider the Claimant's position is shown by its further consideration of his case leading to the letter of 18 March 2003 and the last paragraph of that letter.
(6) The second paragraph of Dr Handley's letter of 17 February indicates that the Care Trust knew that the Claimant had for some time refused treatment with plasma Factor VIII. Further as Dr Bradford explains in her statement she (and thus the Care Trust) were aware that (i) both the Claimant and his partner actively campaign in respect of the treatment they believe patients with haemophilia should receive and in general terms of their views thereon, and (ii) as she puts it the Claimant had effectively gone on a "treatment strike" until such time as he was offered recombinant Factor VIII. Additionally as I have already mentioned (i) the Care Trust had a correct understanding of the conclusion upon which the Claimant's decision to refuse treatment with plasma Factor VIII was based, and (ii) the Claimant had (and has) not expressly dealt with his decision making process in balancing the damage to his health that flows from lack of treatment with plasma or recombinant Factor VIII and the risks of treatment with plasma Factor VIII. In those circumstances it would place an unrealistic and impractical burden on the Care Trust to say that as an aspect of its duty to act fairly it had an obligation to think of various ways in which the Claimant could, or might, put his case for the funding of his treatment with recombinant Factor VIII having regard to his refusal of treatment with plasma Factor VIII and to conclude that he was, or might be, seeking to rely on the matters he now seeks to advance by reference to his personal history etc. and to ask him about those matters. In my view against the background of the 1998 circular "the ball was in the Claimant's court" (or that of his treating doctors) to advance by reference to his particular circumstances the reasons why it was asserted the Care Trust should exercise its discretion to fund the Claimant's treatment with recombinant Factor VIII.
(7) I add that it seems to me that the following support the views expressed in paragraph (6) namely: (i) the knowledge and research carried out by the Claimant had the result that he was very familiar with the 1998 circular and therefore he should, at least, have appreciated that it would be sensible for him, or someone on his behalf, to advance reasons based on his particular circumstances in support of the request that his treatment with recombinant Factor VIII be funded, and (ii) the point that the initial stance of the Claimant after legal advice in these proceedings was that his refusal to accept treatment with plasma Factor VIII was irrelevant.
The next stage of the argument
(a) the arguments advanced on behalf of the Claimant to the effect that if after taking the additional points now advanced into account the Care Trust decided not to fund the treatment of the Claimant with recombinant Factor VIII that decision would be quashed on public law grounds (as I understood it because such a decision would be Wednesbury unreasonable) were wrong, but
(b) the decision maker was the Care Trust and if the Claimant succeeded on the grounds I have already dealt with I should remit the Claimant's request for further consideration by the Care Trust.
It seemed to me that there was considerable force in point (b) particularly because at that stage the Care Trust was not indicating what it would decide having regard to the additional points being made by the Claimant.
(a) Dr Bradford is not the sole decision maker on behalf of the Care Trust, (indeed the draft press release that was not sent out indicates that an internal appeal panel may be set up). The arguments developed during the oral hearing and although I accept that Dr Bradford is likely to be right about the reaction of her colleagues to those developments, she was not able to test this with them.
(b) It is likely that the background situation relating to the health of the Claimant, and the availability of funding pursuant to the programme for rolling out the availability of recombinant Factor VIII referred to in the press releases mentioned in paragraphs 13 and 14, above will change.
(c) The decision maker is the Care Trust not the court and the Care Trust has a wide knowledge of the relevant factors relating to decisions of this kind. If, as he indicates he would like to, the Claimant makes a further request by reasoning informed by the arguments and exchanges in court (possibly against a changed background situation) it seems to me that a conclusion of the court based only on the arguments presented, and my knowledge of the background situation, may well cause more problems than it solves, although it is likely that a new request will include points made in these proceedings.
(1) In my view there is a difference in kind between a refusal of treatment based on an informed opinion on clinical effectiveness, and thus the risks of infection involved in the proposed and possible treatments, and one based on religious belief, irrationality, phobia or physical condition.
(2) It is apparent from the information before me that different views are held on the clinical effectiveness of plasma Factor VIII and that the view thereon expressed in the 1998 circular and adopted by the Care Trust is within the range of decisions open to a public law decision maker.
(3) I have considerable sympathy for the Claimant and note the recognition in paragraph 4 of the 1998 circular of the fear referred to therein. But in my view a finding that his views on clinical effectiveness, and thus as to the risk of infection from plasma Factor VIII, are reasonable (whatever test is applied to ascertain reasonableness), or understandable, cannot be determinative of the question whether a decision of the Care Trust not to fund his treatment with recombinant Factor VIII should be quashed in public law. This goes back to the rejection of the challenge based on clinical effectiveness and that the view of the Care Trust thereon is within the range of conclusions open to it Rather, in my view, the nature and effect of the reasons for (i) the Claimant's conclusions on clinical effectiveness, and (ii) his decision based thereon to refuse treatment, are factors which he can put to the Care Trust in support of a request that it funds his treatment with recombinant Factor VIII. But if the points made by reference to the personal history etc. of the Claimant (and thus for example the death of his brother and his treatment with batches of concentrate made in part with plasma from a donor who subsequently developed new variant CJD) go only to establishing or confirming his views on the clinical effectiveness of plasma Factor VIII in my view it is difficult to see how they add much.
(4) As the cases make clear even when his, or her, life depends on receiving medical treatment a person of full age and capacity is entitled to refuse it. In my view this applies to a refusal of a type of treatment. It reflects the autonomy of each individual and the right of self determination. It follows that an adult who exercises that right of self determination to refuse treatment, or a type of treatment, takes the risks that flow therefrom including the risk that the refusal may result in his, or her, death. It seems to me that the risks which the Claimant has decided to take by his continued refusal of treatment with plasma Factor VIII include the risk that his treatment with recombinant Factor VIII will not be funded (or will only be funded in the circumstances set out in the letter of 18 March 2003) and thus that his care will be difficult and his health will deteriorate. I add that it seems to me that the position taken by the Care Trust in its letter of18 March 2003 is not as the Claimant alleged a glaring illogicality, rather it is an understandable human reaction to the present situation.
(5) The reasoning of the Claimant in respect of the balancing of the risks he asserts would exist if he was treated with plasma Factor VIII and the risks referred to in paragraph (4), and the effect on that balancing or judgmental exercise of, for example:
(i) his personal history etc. and other points that might distinguish him from others who hold similar views on the clinical effectiveness of, and the risks of treatment with, plasma Factor VII, and
(ii) his work as a campaigner in respect of the treatment of patients with haemophilia,
may be matters he would wish to put to the Care Trust in support of a further request for the funding of his treatment with recombinant Factor VIII.
The challenge based on the DDA
(a) whether or not the Claimant (or anyone else over 16 who has been treated with plasma derived products) suffers from HIV / HCV and their effects (or some other disability) is irrelevant to the application of the 1998 circular,
(b) it cannot be said that the reason for the Claimant's previous treatment is the disability, and
(c) if the position of two people over 16 who both suffer from the effects of HIV / HCV, but who have had different treatment regimes in the past, is examined the one who has had treatment with plasma derived products would not be entitled to treatment with recombinant Factor VIII whereas the one who has not in the past been treated with plasma derived products would.