R (Rogers) v Swindon NHS Primary Care Trust
| Jurisdiction | England & Wales |
| Judge | Sir Anthony Clarke MR |
| Judgment Date | 12 April 2006 |
| Neutral Citation | [2006] EWCA Civ 392 |
| Docket Number | Case No: C1/2006/0312 |
| Court | Court of Appeal (Civil Division) |
| Date | 12 April 2006 |
[2006] EWCA Civ 392
IN THE SUPREME COURT OF JUDICAT
COURT OF APPEAL (CIVIL DIVISI
ON APPEAL FROM
THE HIGH COURT OF JUST
QUEEN'S BENCH DIVIS
ADMINISTRATIVE CO
The Hon Mr Justice Bean
Royal Courts of Justice
Strand, London, WC2A 2LL
Sir Anthony Clarke Mr
Lord Justice Brooke
Vice-President, Court of Appeal (Civil Division) and
Lord Justice Buxton
Case No: C1/2006/0312
David Pannick QC and Ian Wise (instructed by Irwin Mitchell) for the Claimant
Philip Havers QC and Matthew Barnes (instructed by Bevan Brittan LLP, Bristol) for the Defendant
Alison Foster QC and Eleanor Grey (instructed by the Office of the Solicitor for the Dept. of Health) for the Interested Party
Summary
(This Summary forms no part of the Judgment)
This is an appeal by Ms Rogers from an order made by the Administrative Court (Bean J) dismissing her application for judicial review of Swindon Primary Care Trust's decision, refusing her application for funding in respect of treatment with a drug called Herceptin. Ms Rogers has primary breast cancer, for the treatment of which she was prescribed Herceptin. The Primary Care Trust decided, in accordance with its policy with respect to Herceptin, that she was not entitled to funding. The Administrative Court decided that this decision was not irrational and did not breach her human rights.
By the present judgment, which is the judgment of the court, the Court of Appeal has unanimously held that the Primary Care Trust's policy with respect to Herceptin was irrational and so unlawful. The Court of Appeal will order that the Primary Care Trust's decision be quashed. See further under CONCLUSION below.
The judgment is in nine parts.
I. Introduction (para 1)
II. The facts (paras 2–7) sets out the factual background to this appeal
III. Breast cancer and Herceptin (paras 8–15) describes the operation of Herceptin, recent research as to its effectiveness and subsequent commentary on that research and identifies the 'eligible group', being those patients who have been prescribed Herceptin because, in the opinion of their doctors, they satisfy certain clinical criteria so as to be suitable for that treatment.
IV. The statutory framework (paras 16–17) sets out relevant parts of the National Health Act 1977 and its subsidiary legislation and explains the distinction between 'directions' and 'guidance' issued by the Secretary of State.
V. The PCT's general policy (paras 18–25) describes the Primary Care Trust's usual policy with respect to the funding of drugs which are prescribed 'off-licence' and are unapproved by the National Institute for Health and Clinical Excellence ("NICE") . It will not fund such drugs except where a patient has a special healthcare problem that presents an exceptional case for treatment, when it will consider each case on its merits having regard to the funds available.
VI. The position of the Secretary of State (paras 26–30) sets out statements that have been made by the Secretary of State with respect to the off-licence use of Herceptin and identifies the Secretary of State's guidance. If a clinician decides to prescribe Herceptin for a woman who has tested HER2 positive, a PCT should not refuse to fund it solely on the grounds of its cost.
VII. The PCT's consideration of Herceptin (paras 31–39) sets out the policy adopted by the Primary Care Trust with respect to funding of Herceptin, notwithstanding that it is neither licensed nor approved by NICE. The policy was to fund Herceptin, without regard to financial considerations, in those cases where Herceptin was prescribed by a clinician and where it was decided that there were exceptional clinical or personal circumstances.
VIII. The decision (paras 40–54) describes the procedure adopted by the Primary Care Trust in considering Ms Rogers' application for funding and the Trust's reasons for its decision to refuse funding.
IX. The relevant principles of common law (paras 55–66) considers the leading cases dealing with challenges to healthcare providers' funding decisions on the grounds of irrationality. It also identifies the key issue in this case as being whether the underlying policy, rather than the particular decision in Ms Rogers' case, is unlawful. The court concludes in para 66 that, if the policy is lawful, so too is the decision but, if the policy is unlawful, so too is the decision.
X. Rationality (paras 67–82) addresses the rationality of the policy adopted by the Primary Care Trust, as set out in VI above. It notes that the Trust had recognised that Herceptin could be provided in "exceptional" cases even though NICE had not approved it, and had also decided to disregard financial considerations. But in considering what might be such an exceptional case, 'personal circumstances' are irrelevant as soon as financial considerations are disregarded, and the Trust was unable to identify any 'clinical circumstances' that might provide a rational justification for distinguishing between different members of the eligible group. The stated policy was thus not capable of being rationally explained, and therefore was unlawful, as was the decision in Ms Rogers' case that applied that policy.
XI. CONCLUS (paras 83–84) sets out the court's conclusion that the policy and therefore the decision applying the policy was unlawful and should be quashed. Subject to further submissions, the court expresses its present view that it cannot and should not order the PCT to fund Ms Rogers' treatment. Rather it is for the PCT to formulate a lawful policy upon which to base decisions in particular cases, including that of Ms Rogers, in the future.
IN
Part Paragraph
I. Introduction 1
II. The facts 2
III. Breast cancer and Herceptin 8
IV. The statutory framework 16
V. The PCT's general policy 18
VI. The position of the Secretary of State 26
VII. The PCT's consideration of Herceptin 31
VIII. The decision 40
IX. The relevant principles at common law 55
X. Rationality 67
XI. CONCLUS 83
This is the judgment of the court to which all members of the court have contributed.
I. Introduction
This is an appeal from an order of Bean J dated 15 February 2006 dismissing an application by Ms Ann Rogers for judicial review of a decision of the Swindon NHS Primary Care Trust ("the PCT") refusing to provide her with Herceptin to treat her breast cancer. In this appeal, which is brought with the permission of the judge, she says that the PCT's refusal was unlawful on the ground that it was arbitrary or irrational and in the relevant sense unreasonable and/or that it involved a failure to give proper consideration to the relevant facts and/or that it infringed her rights under article 2 and/or 14 of the European Convention on Human Rights ("the Convention") . In granting permission to appeal the judge said that the case raises issues of public interest and importance which should be considered by the Court of Appeal.
II. The facts
This is a somewhat shortened version of the facts taken from the judgment of the judge. They are not in dispute. The appellant is 54 and lives in Swindon. She has three adult children and two young grandchildren. Prior to her diagnosis of breast cancer she had run the restaurant side of her sister's public house but since her treatment has been unable to carry on working. She first noticed a lump in her breast in October 2004. She went to her general practitioner the following day and was given an appointment for a mammogram at her local hospital in Swindon which was conducted on 24 November 2004. The mammogram result was initially thought to be normal but subsequent biopsies revealed invasive carcinoma.
In January 2005 the appellant underwent a mastectomy, breast reconstruction and auxiliary surgery. Following a period of recovery from this surgery she commenced chemotherapy in March 2005. This course of chemotherapy lasted until 4 July 2005. She found the treatment very difficult due to its gruelling side-effects. Following the course of chemotherapy she embarked on a course of radiotherapy at the Churchill Hospital in Oxford in August and September 2005. At this time she also had adjuvant hormone therapy.
In the meantime the appellant's son had discovered on the internet that there was a type of breast cancer known as HER2 positive which could be treated by a drug called Herceptin. Towards the end of her chemotherapy she accordingly asked her consultant, Dr Cole, if she could be tested for HER2 and on 30 June 2005 was tested positive. In August 2005 Dr Cole wrote to the medical director of the Swindon and Marlborough NHS Trust informing him of the "exciting" results of the Herceptin trials that had been presented to the American Society of Oncology in May 2005 and asked whether Ms Rogers could pay for Herceptin whilst remaining an NHS patient. The answer was that she could not. In due course Dr Cole agreed to treat the appellant with Herceptin on a private basis and on 27 October 2005 began treatment at the Ridgeway Hospital, Swindon. Although she had to pay for the drug she did not have to pay for the medical input because Dr Cole waived his fees.
Herceptin is given by a loading dose followed by a further 17 doses given at three week intervals. The estimated cost (including VAT) of the course of treatment was £26,328.22, which the appellant was unable to pay. She borrowed £5,000 from which she paid for her first...
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