The Queen (on the application of Ann Marie Rogers) v Swindon NHS Primary Care Trust & Secretary of State for Health [2206] EWHC 171 (Admin)

In this case the claimant, Rogers (R), claimed that the defendant, Swindon NHS Primary Care Trust (the Trust) had unlawfully refused to provide Herceptin to treat her breast cancer.  In particular she claimed that:

(i) the Trust acted unlawfully by failing to follow what is claimed to be a direction from the Secretary of State, and in providing Herceptin only in exceptional circumstances.
(ii) the Trust’s policy was arbitrary and irrational and
(iii) the decision by the Trust to not to provide R with Herceptin was contrary to her rights under Article 2 and 3 ECHR.

R was 54 with 3 adult children and 2 young grandchildren.  Following her diagnosis she underwent a mastectomy and reconstructive breast surgery.  She then underwent chemotherapy and radiotherapy.  During this time it came to R’s attention that there was a type of breast cancer, known as HER2 positive, which could be treated by Herceptin, the trade name given to the drug trastuzumab by its manufacturer.  R spoke to her consultant and was tested positive for this form of breast cancer.  R asked whether she could pay for Herceptin whilst remaining an NHS patient and was told that she could not.  R’s consultant agreed to treat her with the drug on a private basis.  However after two courses of treatment, each of which cost £1,950, she could not afford to pay for her third course.  R sought legal advice.  Her solicitors were informed that Herceptin was not prescribed by the Trust, but it would review any application for treatment.  An application was made but rejected by the Trust.  Permission was granted for judicial review and an interim order was made by the court for the Trust to fund her treatment until the determination of this application.

Herceptin was not licensed for use in early stage breast cancer but was licensed for secondary or late stage breast cancer.  The manufacturer has first to obtain a licence from the European Medicines Agency. (EMA)  The drug is then appraised by the National Institute of Health and Clinical Excellence (NICE).  Trials showed significant benefits to patients who hade been given Herceptin although there were potential cardiac side effects for a small number of patients.  The National Cancer Research Institute (NCRI) published clinical guidelines on the use of Herceptin in the UK, and identified a 50% reduction in the risk of recurrence where it was used in conjunction with or following chemotherapy.  NCRI recommended the criteria that should be satisfied for women to be considered eligible for treatment. R satisfied these criteria.  There was some contrary opinion to the use of Herceptin published in the Lancet which urged caution on its use; however it was already widely used by a number of other NHS Trusts in England and Wales.

When making decisions about the commissioning of drugs, the Trust had 2 main sources of guidance – NICE and the Swindon Clinical Advisory Forum (CAF). CAF look at the merits of prospective treatment judged against other priorities.   Further advice is provided from other local Cancer networks.  At the time of R’s request for the treatment, the Trust had no policy on the use of Herceptin and said it would consider each case on its merits (the ‘exceptional’ cases)  These cases are considered by the Trust’s Clinical Priorities Committee (CPC).  R’s consultant made an application for exceptional funding to be considered by the CPC.  However, he was unable to state that R was an exceptional case – his view was that all of the 20 women in the Swindon who met the eligibility criteria should have their treatment funded by the Trust.  The CPC concluded that in R’s case, there were no exceptional circumstances.  R appealed to an appeals panel who found that R was in a position between exceptional and unexceptional and referred the case to the Trust’s Board for a final decision.  The Board concluded that exceptionality should be considered in the context of women who met the eligibility criteria rather than the population as a whole.  There was nothing exceptional in R’s case other than her poor prognosis and the Board upheld the finding of the CPC.

At the time that R was receiving her treatment privately, the Secretary of State for Health issued a Department of Health (DoH) bulletin to NHS Trusts and local authority Chief Executives in favour of the use of Herceptin as a treatment which should not be declined solely on the grounds of its cost.  R submitted that the bulletin constituted a DoH direction to Trusts that they should prescribe Herceptin to women who had tested positive for HER2.   Under s.17 National Service Act 1977 the Secretary of State may give directions to PCTs about the exercise of any of their functions.  Section 18 states that such directions “shall be given by regulations or by an instrument in writing.”  “Guidance” must be distinguished from “directions.”  If the statement was merely guidance then “the only duty placed upon health authorities was to take it into account in the discharge of their functions.”  R v North Derbyshire Health Authority ex parte Fisher [1998] applied. They would only be susceptible to challenge on Wednesbury principles if they failed to consider the circular or misunderstood or misapplied it.

The High Court held that on this point the statement was not a direction since if this had been the objective of the Secretary of State it would have been easy enough to say so clearly.  It also held that the Trust’s policy of refusing to fund treatment save for undefined exceptional cases was lawful.  R v North West Lancashire Health Authority ex parte A, D & G [2000] applied.  Neither was it unlawful to have a policy that in the absence of regulatory approval, a treatment would not be funded save in undefined exceptional circumstances.  On the question of irrationality, it acknowledged that some may criticise the policy as a “post code lottery” and others may defend it as a principle of local autonomy in decision-making, but that rationality was not determined in this way.  The system of licensing drug treatments was essential and should not be bypassed; medical opinion was moving in R’s direction but it was not yet unanimous.  In the absence of a direction from the Secretary of State that PCTs should fund Herceptin treatment, they were entitled to be cautious and wait for EMA licensing and NICE approval.  The policy was neither irrational nor unlawful.

In relation to R’s human rights, her Article 2 rights would only be infringed if “… a Contracting State put an individual’s life at risk through the denial of healthcare which they have undertaken to make available to the population generally …” R could only succeed in this part of her claim if the DoH bulletin was a direction requiring all PCTs to fund Herceptin treatment to the eligible group, and it had not done so. Nitecki v Poland [2002] applied.   Her Article 3 claim also failed, on the basis that where there was no deliberate infliction of pain or suffering, the threshold to be reached was a high one and was not reached in R’s case.  Limbuela & Others v SS Home Department [2005] distinguished.

Leave a Reply

Your email address will not be published.