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Buying life: The Herceptin case in the Court of Appeal


Charles Foster,
Barrister,
Outer Temple Chambers,
London WC2

This article was first published in The Solicitor’s Journal and is reproduced here by kind permission of the author and publisher.

In the world there is almost infinite relievable suffering: in the NHS coffers there is a distinctly finite amount of money. The courts have traditionally recognised that it is extremely difficult to determine priorities in healthcare spending. Is it ever irrational in the public law sense to say that kidney machines have to give way to cancer care, or vice versa? The courts have recognised, too, that they are ill-equipped to adjudicate on the fine details of NHS Trust expenditure. The NHS bodies themselves, informed by medical and patient representations and by directives from the Department of Health, will generally be better placed than the judges to weigh the various competing claims for funding: see, for example, R v Cambridge HA ex p B [1995] 1 WLR 898.

But anyone reading most of the coverage of the Herceptin judgment (R (on the application of Ann Marie Rogers) v Swindon NHS Primary Care Trust [2006] EWCA Civ 392), could be forgiven for thinking that these time-hallowed principles have been swept away. Much of the coverage implied that the courts are now eager to jump in and trump both policy decisions about resource allocation and decisions about treatment in the cases of individual patients. It is not so.

Herceptin is the trade name of a drug produced by Roche. There is evidence to suggest that it can help some women with some types of early stage breast cancer.

The licensing and approval regime

NHS Trusts have an obligation to provide funding for drugs which are endorsed by the National Institute for Clinical Excellence (NICE). NICE will not give that endorsement unless and until the drug in question has obtained a licence from the European Medicines Agency (EMEA). Herceptin is licensed by the EMEA for the treatment of secondary or late stage breast cancer. It is not yet licensed to treat early stage breast cancer, although an application to EMEA for a licence for this purpose has been made.

The Secretary of State for Health has a power to give directions to NHS Trusts which those Trusts must follow. It was common ground here that the Secretary of State had given no such direction, but had given guidance. That guidance included the following words: “I want to make it clear that PCTs should not refuse to fund Herceptin solely on the grounds of cost.” (emphasis added)

The absence of an EMEA licence and NICE approval for a particular treatment does not mean that NHS bodies cannot fund it. Many unlicensed and NICE unapproved treatments are used in the NHS. Where there is a licence, but not for the particular purpose proposed, drugs used for such purpose are said to be “off-licence”.

The National Cancer Research Institute (NCRI) is a coalition of UK cancer research bodies and charities. It has published a set of criteria which seek to define which patients with early stage breast cancer might benefit from Herceptin.

The claimant’s circumstances

Ann Marie Rogers has early stage breast cancer. She falls within the NCRI criteria. She is a member of what the Court of Appeal called the “eligible group”. She wants to receive Herceptin, but cannot fund the treatment herself. Her treating clinician supports the prescription of Herceptin.

The Trust’s policy

The Trust’s general policy was not to fund unlicensed or off-licence drugs subject to the exception that “where a patient has a special healthcare problem that presents an exceptional need for treatment” it would consider that case on its merits but in doing so would have regard to the funds available.

Did the Trust act unlawfully?

The court held that there was nothing irrational and therefore unlawful about such a policy. Importantly and inevitably, economic considerations can lawfully go into the equation when considering whether funding should be granted. The court said: “…a policy not to fund Herceptin save in exceptional circumstances, where a patient can show that there are exceptional personal or clinical circumstances in her case, is a cautious approach which is entirely rational…..if [the policy adopted in relation to the funding of Herceptin] had involved a balance of financial considerations against a general policy not to fund off-licence drugs not approved by NICE and the healthcare needs of the particular patient in an exceptional case, we do not think that such a policy would have been irrational.”: (paragraphs 68 and 73).

A mere reference in the policy to unidentified exceptional circumstances did not render the policy arbitrary and thus unlawful. That was what the Court of Appeal had said in R v North West Lancashire HA ex p A, D & G [2000] 1 WLR 977. The Court of Appeal inserted a crucial caveat – a caveat which it said was anyway implicit in the North West Lancashire case. “A policy of withholding assistance save in unstated exceptional circumstances ….will be rational in the legal sense provided that it is possible to envisage, and the decision-maker does envisage, what such exceptional circumstances might be.”: (Paragraph 62).

In the claimant’s case, however, the Trust had departed from its general policy. It would have been entitled to say that having regard to the funds available, and to its other funding demands, it was not going to fund Herceptin. But it did not say that. It expressly said that it was not refusing funding on grounds of cost. Nor did it say as it would have been entitled to, that it would fund whatever was rubber-stamped by NICE, and nothing else. What then were the grounds of refusal? They could only have been that the claimant could not show exceptional personal or clinical circumstances.

Go back now to the test articulated in the court’s gloss on the North West Lancashire case. What “exceptional circumstances” did the Trust envisage might justify the prescription of Herceptin to early stage breast cancer patients? The Trust tried to wriggle out of answering: in the end it gave only one example - a woman with a child with a life-limiting condition might fall into an exceptional class, it said. The Court of Appeal was robustly dismissive: “…we cannot see how that fact can possibly justifying providing funding for that woman but not another when each falls within the eligible group and there are available funds for both. After all, once financial considerations are ruled out, and it has been decided not to rely on NICE without exception, then the only concern which the PCT can have must relate to the legitimate clinical needs of the patient. The non-medical personal situation of a particular patient cannot in these circumstances be relevant to the question whether Herceptin prescribed by the patient’s clinician should be funded for the benefit of the patient. Where the clinical needs are equal, and resources are not an issue, discrimination between patients in the same eligible group cannot be justified on the basis of personal characteristics not based on healthcare.” (Paragraph 79) So much for personal circumstances. What about clinical circumstances? The situation there was the same:

“….it was suggested in argument that one woman in the eligible group might have a greater clinical need for Herceptin than another. We can see that that might be theoretically possible but there is no indication that any such possibility in fact exists….there is no rational basis for distinguishing between patients within the eligible group on the basis of exceptional clinical circumstances any more than on the basis of personal, let alone social, circumstances.” (Paragraphs 80 and 81).

If you can’t say rationally whether and why somebody should be a member of a particular class, you can’t rationally say whether and why not they should not be. The Trust had accordingly acted unlawfully in saying that the claimant should not get Herceptin.

This did not mean that the Court could or should force the Trust to fund the claimant’s Herceptin. It did mean that the Trust should be ordered to formulate a lawful policy upon which to base decisions in particular cases, including that of the claimant.

The effect of the judgment

So where does all this leave the law relating to the challengability of decisions about NHS funding? For all the fuss in this case, more or less exactly where it was before. It is just as difficult to be Wednesbury unreasonable as it was before. The courts are no more ready to second-guess Trust decisions about funding than they were, but they will be ruthless with the sort of intellectual sloppiness that oozed from the minutes of the Swindon PCT’s meetings. Reliance on “exceptional circumstances” is fine, as long as someone can stand up and demonstrate that cogent thought has been given to what those circumstances might be. Appeals to poverty or different priorities will be listened to sympathetically by courts reviewing the rationality of funding decisions. The Herceptin judgment probably won’t save many lives, but it is likely to improve the quality of funding committee memos.

Articles 2 and 14 of the ECHR are plainly potentially relevant to these issues. It would have been very interesting to know what the Court of Appeal said about this. But unfortunately it did not think it necessary to consider the point. It would be nice to think that the issue of the Articles’ relevance can’t be dodged for ever, but the English courts have a hugely impressive record of avoiding them.

Summary

“A policy of withholding assistance save in unstated exceptional circumstances ….will be rational in the legal sense provided that it is possible to envisage, and the decision-maker does envisage, what such exceptional circumstances might be.”

  • It is rational and therefore lawful to take economic considerations into account in deciding whether or not to fund treatment not endorsed by NICE.

Solicitors Journal, 5 May 2006, p. 558 (Vol 150: No. 17; 558)