Longstaff, R (on the application of) v Newcastle NHS Primary Care Trust

In these proceedings the Claimant challenges a composite decision made by the Defendant (the Care Trust) which was communicated in two letters to a Dr Hanley dated 18 February 2003 and 18 March 2003. Dr Hanley is a consultant haematologist and the Haemophilia Centre Director at the Freeman Hospital Newcastle-upon-Tyne.

The Claimant has from birth suffered from haemophilia. Since May 2000 he has refused to be treated with plasma derived Factor VIII products (plasma Factor VIII).

The requests of Dr Hanley which led to the decisions that are challenged concerned the treatment of the Claimant with recombinant Factor VIII.

The requests of Dr Hanley and the replies thereto are self-explanatory.

The first request is in a letter of 17 February 2003 which is in the following terms:

“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.”

The reply is dated 18 February 2003.

“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.”

The next letter from Dr Hanley is dated 11 March 2003 and is in the following terms:

“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.”

The response to that letter is dated 18 March 2003.

“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.”

This correspondence refers to current criteria and to new phased criteria. For that one needs to turn to documents which were before the decision makers at the Care Trust when they made the decisions that are challenged.

The documents are

I pause to record that is was common ground before me that in addition to these three documents the only other relevant documents that were before the decision makers at the Care Trust was the correspondence I have set out between Dr Hanley and the Care Trust.

The 1998 circular provides (amongst other things) as follows:

“Summary

This HSC

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.

Context

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).”

The 2003 press release includes the following:

“Wednesday 12^th 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.””

The UKHDCO document of the same day includes the following:

“. . .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.”

At this stage I should refer to some other documents. The first is the minute of the decision communicated by the letter of 18 February 2003, it is in the following terms:

“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”

The press statement referred to therein was apparently not issued but it contained the following:

“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.”

I was also referred to an earlier press release issued in January 2001 stating the conclusions of a panel convened by the Board of Newcastle-upon-Tyne Hospital NHS Trust which consisted of people with knowledge and expertise concerning haemophilia. I was particularly referred to the final two paragraphs of the conclusions of that panel. They are as follows:

“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.”

The claim form was filed on 15 May 2003. It focused on and challenged the grounds or reasons for the decision of the Care Trust as set out in the numbered paragraphs of its letter dated 18February 2003.

The first challenge was thus to the ground that:

“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.

This was therefore a challenge by reference to the view of the Care Trust on the clinical effectiveness of plasma Factor VIII.

The second challenge related to the alleged interpretation by the Care Trust of the 1998 circular. The third challenge related to the third ground in the letter of 18 February 2003 namely:

“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.

In addition there were challenges based on the Disability Discrimination Act 1995 (the DDA) and on the Human Rights Act 1998.

Permission to bring the proceedings was refused on the papers by Sullivan J. In doing so he commented as follows:

“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 Claimant renewed his application for permission before Owen J. As the challenge to the first reason or ground given by the Care Trust in its letter of 18 February 2003 (ie the availability of clinically effective treatment) Owen J concluded that the challenge was unsustainable. In his judgment he set out the view of the Department of Health with regard to the clinical case as expressed in paragraph 2 of the 1998 circular (see above) and continued in the following terms:

“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.

Although this ground is not pursued before me I mention it because in my judgment it should be remembered that the Claimant has sought to bring a challenge based on the view of the Care Trust concerning clinical effectiveness and this challenge has been held to be unsustainable.

It follows that if on a proper analysis a different line of attack and challenge is in effect a challenge to the view of the Care Trust on the clinical effectiveness of plasma Factor VIII, it too is unsustainable because the view of the Care Trust thereon is in accordance with that of the Department of Health and is well within the ambit of the discretion of the Care Trust. The fact that the Claimant and others hold a different view on the clinical effectiveness of plasma Factor VIII and/or the clinical effectiveness of recombinant Factor VIII and/or the comparison of the clinical effectiveness of these two treatments and thus of the risks involved in their use, and/or the research and evidence as to the collection of blood and safety procedures, and do so reasonably, is not a sound basis of challenge in public law to the decisions of the Care Trust.

In my view correctly and properly leading counsel for the Claimant accepted and asserted that it was no part of his case to seek to challenge the decisions of the Care Trust only on, or effectively only on, the first ground advanced in the claim form and thus only on the basis that the view of the Care Trust on clinical effectiveness was open to challenge in public law.

Owen J gave permission to the challenge the decisions on the second ground namely that the Care Trust had misapplied the 1998 circular. As to this Owen said:

“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.”

As to the third ground Owen J was of the view that as formulated the challenge based on the reference to the Claimant’s refusal of plasma Factor VIII was misconceived. Owen J commented on and reformulated this ground as follows:

“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.”

Owen J also gave permission for the challenge based on the DDA but he refused permission for the challenge based on the Human Rights Act 1998.

The challenge based on the DDA is a discrete one and was primarily dealt with by the Secretary of State in argument because it was based on the 1998 circular. I shall deal with this challenge separately.

Although this ground of challenge was maintained in the skeleton argument it was not pursued orally.

In my view leading counsel for the Claimant was correct not to press this point because in my judgment having regard to the evidence of Dr Bradford on behalf of the Care Trust and the documents now before the Court it is unsustainable.

The argument was primarily based on the minute of the decision communicated in the letter of 18 February 2003 and was that the Care Trust interpreted the 1998 circular as excluding persons falling outside the categories referred to therein for treatment with recombinant factor VIII. I accept that the minute introduces the possibility of that argument but in my view the terms of the two decision letters and the press statement referred to in the minute (which as I have said was not issued) point strongly, if not conclusively, to the conclusions (i) that the Care Trust was not of the view that the categories referred to in the 1998 circular were exclusive, and thus (ii) that the Care Trust did not misinterpret the 1998 circular as alleged (or at all). In my judgment, any lingering doubts as to this are removed by Dr Bradford’s statements.

Accordingly this ground of challenge fails.

This ground flows from a correct interpretation of the 1998 circular and thus from the point that the funding of treatment with recombinant factor VIII of a person like the Claimant who is not in one of the categories referred to in the 1998 circular is to be considered on an individual basis.

In written and oral argument this ground was expanded and developed.

The main expansion and development of the ground as formulated by Owen J was based on paragraph 12 of the statement of Dr Bradford dated 19 September 2003 and in particular the last sentence of that paragraph. Paragraph 12 of that statement is in the following terms:

“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.”

There is a distinction between a challenge based on whether the reasons of the Claimant for using treatment for plasma factor VIII were taken into account and a challenge based on a conclusion that this decision of the Claimant was not reasonable. There is also a distinction between a challenge based on the conclusion that founded the Claimant’s decision to refuse treatment with plasma Factor VIII and one based on the matters he took into account in reaching that conclusion.

In paragraph 20 of the Claimant’s statement in response to that of Dr Bradford he said:

“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.”

In my view this paragraph in the Claimant’s statement identifies the conclusion upon which his decision to refuse treatment with plasma Factor VIII is based.

In his statements the Claimant sets out the reasons for this conclusion by reference to his history and other matters and thus the “reasons for the reason” upon which his decision to exercise his right as a person of full age and capacity to refuse treatment, or a type of treatment, was based (see in Re: T (Adult: Refusal of Treatment) [1993] Fam 95 and St George’s Health Care NHS Trust v S [1999] Fam 26).

The focus and thrust of the Claimant’s statements is directed towards the reasons why he maintains that his conclusions on the clinical effectiveness of plasma Factor VIII, and thus the risks he asserts would result from his treatment with it, are reasonable or well founded. The statements do not go on to deal expressly with the Claimant’s reasons for deciding to take the risks that flow from his refusal of plasma Factor VIII rather than the risks that he maintains would flow from such treatment. Therefore he does not expressly indicate whether and, if so, how his personal circumstances and experience etc. play a part in the balancing of those risks and thus his decision to suffer (or risk suffering) the known consequences to his health (which he refers to in his statements) of not being treated with plasma or recombinant Factor VIII to avoid the risks he refers to in paragraph 20 of his statement.

In written and oral argument the Claimant accepted that the Care Trust took into account the reason for his refusal of plasma Factor VIII as set out in paragraph 12 of Dr Bradford’s statement. However it was asserted that:

I was not referred to any authority to support the proposition that in circumstances such as exist here the Care Trust owes a general duty to seek further information as to the reasons why a patient, or his doctor, seek a decision to fund a particular type of treatment.

In my judgment no such general duty exists.

That is not to say that in some cases a public law decision maker in a similar position to the Care Trust would not be obliged to seek further information from the person seeking a decision from it. For example, an obligation to do so may arise from the provisions of a particular statutory scheme, and in the circumstances of a given case such an obligation may arise from the duty of a public law decision maker to act fairly.

Naturally it was accepted that the Care Trust as a public law decision maker had a duty to act fairly in reaching its decision. In this context I was referred to a decision of my own in R v P Borough Council ep S [1999] Fam 188. That case was concerned with different circumstances but at page 220 I set out general principles relating to the duty to act fairly by reference to earlier authority. I add that what steps need to be taken to satisfy the requirements of fairness will vary from case to case (see for example in Re: L (a minor) [1997] AC 16 in the speech of Lord Nichols as 32 B/D).

In my judgment, in the circumstances of this case the duty on the Care Trust to act fairly did not require it before reaching its decisions either

My reasons for this are as follows:

If the remedy for success on the challenge thus far was remission to the Care Trust for further consideration it can be said that the Claimant could have achieved this by putting the additional points he now seeks to rely on to the Care Trust and inviting them to further consider whether it will fund his treatment with recombinant Factor VIII. The willingness of the Care Trust to do this is expressed at the end of its letter of 18 March 2003.

Thus the next stage of the argument advanced on behalf of the Claimant based on the approach of the Care Trust to the reasonableness of the Claimant was not confined to showing that the matters he now seeks to advance relating to his personal history etc were relevant but was also directed to obtaining a mandatory order that the Care Trust do fund his treatment with recombinant Factor VIII. Unsurprisingly in submission the stance of the Care Trust was that:

Whether the request was remitted by the court, or having failed to have the existing decisions quashed the Claimant made a further request, the Care Trust could decide to fund the Claimant’s treatment with recombinant Factor VIII even though a refusal to do so could not be successfully attacked on public law grounds. Any such reconsideration of a request by the Claimant would have regard to this judgment.

Having regard to these points I sought clarification from the parties as to their positions relating to remission and the findings I was being invited to make on the points raised by the Claimant relating to the approach of the Care Trust to the reasonableness of the Claimant. This resulted in a change of positions. Leading counsel for the Care Trust told me that having taken instructions from Dr Bradford she was confident that if the Care Trust reconsidered its position in the light of the points raised by the Claimant in these proceedings it would reach the same conclusion and therefore counsel invited me to consider and decide whether such a decision would be quashed as being Wednesbury unreasonable. However leading counsel for the Claimant told me that the Claimant would prefer to be able to put any further request to the Care Trust without any such findings being made and thus, in effect, that he was no longer seeking a mandatory order that the Care Trust do fund the treatment of the Claimant with recombinant Factor VIII.

Having heard the arguments and knowing that time and money has been spent in preparing and advancing them I have been tempted to accede to this request by the Care Trust. But I have concluded that I should not do so because:

I therefore confine myself to the following comments in connection with the arguments I heard::

The basis of this was developed during the hearing and was an attack on the 1998 circular. It is important to remember that as explained in Clark v Novacold [1999] ICR 951 (at 959C and 964B) the DDA does not draw the distinction between direct and indirect discrimination on specified grounds and was drafted in such a way that indirect as well as direct discrimination can be dealt with under the statutory test.

With my emphasis for present purposes the crucial part of the statutory test in both s. 5 (which was the relevant section in Clark v Novacold) and s. 20 (the relevant section here) is that: “an employer / provider of services discriminates against a disabled person if (a) for a reason which relates to the disabled person’s disability he treats him less favourably than he treats or would treat others to whom that reason does not or would not apply”. The true construction of that phrase is dealt with in Clark v Novacold (see 961H to 965D).

I agree with the submission made on behalf of the Secretary of State that the reasons why, under the 1998 circular, the Claimant is not required to be treated with recombinant Factor VIII are not reasons which relate to the Claimant’s disability and thus that the DDA does not apply.

Those reasons are that (i) the Claimant is over 16, and (ii) he has previously received plasma derived products. They are thus a combination of age and previous treatment. The Claimant asserts that his disability is the effects of HIV / HCV and that it is the direct consequence of viral infections from his treatment with blood products in the past. For present purposes I accept these assertions.

Accordingly the challenge based on the DDA fails.

For the reasons set out above this application is dismissed.