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Judgment

Neutral Citation Number: [2003] EWHC 2091 (Admin)

IN THE HIGH COURT OF JUSTICE

QUEEN'S BENCH DIVISION  

THE ADMINISTRATIVE COURT

Royal Courts of Justice

Strand

London WC2

 

Thursday, 17 July 2003

 

B E F O R E:

 

MR JUSTICE OWEN

 

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THE QUEEN ON THE APPLICATION OF LONGSTAFF

(CLAIMANT)

 

-v-

 

NEWCASTLE UPON TYNE NHS PRIMARY CARE TRUST

(DEFENDANT)

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Computer-Aided Transcript of the Stenograph Notes of

Smith Bernal Wordwave Limited

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MR GRIME QC (instructed by EVERSHEDS) appeared on behalf of the CLAIMANT

MR HAVERS QC (instructed by NEWCASTLE UPON TYNE NHS PRIMARY CARE TRUST) appeared on behalf of the DEFENDANT

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J U D G M E N T

(As Approved by the Court)

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Crown copyright�

 

1.          MR JUSTICE OWEN:  This is a renewed application for permission to apply for judicial review, permission having been refused by Sullivan J on 16th June 2003.  The claimant seeks permission to challenge the decision of the Newcastle NHS Primary Care Trust to refuse his request for treatment of his haemophilia A with recombinant factor VIII. 

2.          The facts that give rise to the application are succinctly summarised in section 5 of the detailed statement of grounds.  The claimant, who was born on 5th February 1958, has haemophilia A and requires treatment with a clotting factor, factor VIII.  Initially, the claimant was treated with factor VIII manufactured from human blood products.  But as a result of receiving such factor VIII at the Royal Victoria Infirmary, Newcastle, the claimant has acquired the following infections: hepatitis B, diagnosed in the mid-1980s; hepatitis C, diagnosed in 1994, and HIV and AIDS virus, diagnosed in about 1985.  Of the 95 haemophiliac patients who have tested positive for HIV at the Royal Victoria Infirmary in Newcastle in recent years, it appears that 78 have died.  The claimant is in the surviving group of 17. 

3.          In about 2000 and as a result of the infections that he had acquired, the claimant took the decision to refuse further treatment from factor VIII derived from human blood plasma on the basis that it had proved impossible to guarantee the safety of this product. 

4.          On 17th February 2003, Dr Hanley, a consultant haematologist, wrote to the defendant on behalf of the claimant, requesting funding for recombinant factor VIII on the basis of clinical need.  The letter set out the factual situation in terms similar to those that I have already recited.  It went on to point out that the claimant had received recombinant factor VIII in 2002 when he went to the liver transplant unit in Birmingham to undergo a liver biopsy.  The letter went on to set out the costs, which are considerable, of recombinant factor VIII, and concluded with the following paragraph:

"We wonder whether, taking all the circumstances into consideration, it would be possible to fund recombinant factor VIII for Mr Longstaff on the basis of clinical need.  Our concern is that unless this decision is taken, he will continue to deteriorate and possibly die.  We appreciate that this is an extremely difficult situation and we would be very grateful for your advice about the best way forward."

5.          Dr Bradford, the defendant's Director of Public Health, replied on 18th February, saying that the request had been discussed by the management team, and that the decision to refuse funding for recombinant factor VIII was 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."

6.          Dr Hanley wrote again on 11th March, asking for the question to be reconsidered, and explaining that he had discussed the situation with the claimant, who was adamant that he would not consent to treatment with plasma derived products. 

7.          Dr Bradford replied to that letter on 18th March.  The relevant paragraphs of the letter read as follows:

"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 acute life threatening bleeds Recombinant Factor VIII could be used as previously agreed by Dr Laker and Dr Freake."

8.          The claimant advances a number of grounds for the proposed challenge to the defendant's decision.  First, it is submitted that the first ground for refusing the request, as set out in the paragraphs above, is an insufficient and therefore improper ground.  In my judgment that argument is unsustainable.  In the Department of Health Health Service Circular, HSC 1988/033, the view of the Department of Health with regard to the clinical case for recommending the general use of recombinant factor VIII was set out in the following terms:

"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." 

9.          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. 

10.        The second ground of refusal was directed to the current criteria for treatment with recombinant factor VIII.  It also refers to HSC 1988/033.  Paragraph 4 of the circular provides as follows:

"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 born infections though 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 considered that this new fear had raised particular concern for people with haemophilia A.  Accordingly, in response to strong representations from the Haemophilia Society, particularly in relation to the effect which 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)."

11.        The claimant addresses a number of criticisms in relation to this ground; but in essence submits that the defendant appears to have resolved the issue on the basis that the claimant did not fall within the categories specified in the circular. 

12.        The circular does not exclude the treatment of those falling outside those categories with recombinant factor VIII.  In the face of the documentary evidence currently available, it is, in my judgment, open to argument that the defendant misapplied the guidance in HSC 1988/033 by treating the categories specified in it as exclusive. 

13.        The third ground for refusal relates to the claimant's own refusal to receive treatment by plasma derived factor VIII.  At paragraph 12 of the grounds for the application, it is submitted on behalf of the claimant that:

"The Defendants appear here to be using the Claimant's personal decision about one type of treatment (blood plasma derived Factor VIII) as an actual ground or factor in deciding against funding a different treatment for him (Recombinant Factor VIII).  The Defendants are purporting therefore to take account of an irrelevant matter; and are therefore acting unreasonably."

14.        The ground as formulated is, in my judgment, misconceived.  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 emphasise, 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. 

15.        There are two further strands to the claimant's application.  The first, a claim under the Disability Discrimination Act 1995, is closely related to the case advanced in relation to the second of the grounds on which funding for treatment with recombinant factor VIII was refused.  It adds little to that ground but, in my judgment, does give rise to an arguable case.  Permission is also given in relation to it. 

16.        The second, a claim under the Human Rights Act, is, in my judgment, without any substance for the reasons set out in the defendant's skeleton argument: namely, that Article 2 of the Convention is not engaged in the present case, and that the claim based on discrimination contrary to Article 14 is unsustainable since Article 14 of the Convention has no freestanding life, but applies only in conjunction with one of the other substantive rights guaranteed by the Convention. 

17.   Accordingly, there will be permission to apply for judicial review of the decision of the defendant refusing funding for recombinant factor VIII, on the grounds set out in paragraphs 8 to 12 of the detailed statement of grounds, modified in the manner that I have indicated, and in relation to the arguments advanced under the Disability Discrimination Act. 

18.        Mr Grime, that leaves the question of interim relief.

19.        MR GRIME:  Yes.  The application for interim relief is on page 3 of the claim form, as your Lordship has seen.  I do maintain that application.  I do not understand it to be the case that there is any disadvantage, save a financial one, to temporary treatment with recombinant factor VIII.  In other words, it will not do the defendant any harm if, for example, his claim eventually fails, if in the meantime he is receiving.

20.        MR JUSTICE OWEN:  Yes.  Mr Havers, I need not address you as to that.

21.        The claimant also seeks a mandatory order that the defendant fund recombinant factor VIII treatment pending the resolution of his application.  I do not propose to grant such interim relief for two reasons.  Firstly, the defendant has agreed that the treatment of recombinant factor VIII may be provided if the claimant presents with a life threatening bleed.  Secondly, and as is submitted by Mr Havers, to grant such interim relief will be to pre-empt the substantive hearing. 

22.        Mr Grime, that leaves the question of an expedited hearing.

23.        MR GRIME:  Yes.  Your Lordship has just indicated the willingness of the authority to fund treatment for a bleed of specific sorts of treatment.  But as Dr Hanley's letter made clear, this is a gradually deteriorating patient, so in fact time is important even absent --

24.        MR JUSTICE OWEN:  Yes.  Well, I will hear Mr Havers on that.

25.        MR HAVERS:  I do not oppose the application.

26.        MR JUSTICE OWEN:  Very well.  I will order that there should be an expedited hearing of your application, Mr Grime.

27.        MR GRIME:  The matter of costs?

28.        MR JUSTICE OWEN:  Yes.

29.        MR HAVERS:  In my submission, costs ought to await the substantive hearing.

30.        MR JUSTICE OWEN:  Yes.  The costs will be reserved.

31.        MR GRIME:  I do not seek any further directions from your Lordship.

32.        MR JUSTICE OWEN:  Thank you both very much for your assistance.