R (on the application of Rogers) v Swindon NHS Primary Care Trust ...

36. As we read the note of the meeting, it was agreed that, pending approval byNICE, the PCT should adopt the process of managing Herceptin requests proposedby ASWCS and quoted above. The note added:"[Jane Leaman] informed the meeting that, in accordance with the ASWCS'spolicy, the PCT's standard process for assessing requests for treatments notnormally funded would be invoked for any applications received for trastuzumabfor early breast cancer. This would mean each individual application would bereviewed by the Clinical Priorities Committee to ascertain if the patient's casedemonstrated any exceptionality."The meeting also agreed that work was required further to clarify the PCT'sposition on the commissioning of off-licence drugs.37. It is clear from the documents to which we have just referred that the PCT'spolicy was intended to follow the guidance given by the Secretary of State, whichMs Deborah Lee, the Director of Commissioning and Primary Care at the PCT, saidin her statement she viewed in this way. She did not regard it as in effectrequiring the PCT to fund treatment, merely that it should review individual casesand not have a blanket policy or use cost alone as a determinant. Both Ms Leeand Ms Leaman say that in effect the decision made was that the PCT would nottreat Herceptin as an exception to its general policy that it does not fundunlicensed drugs. Ms Lee says that the key factor was that Herceptin was notlicensed or approved by NICE and that it would be wrong to introduce what shedescribes as a dangerous precedent of disregarding the contribution made by thelicensing and appraisal process. She adds:"Given the widely reported safety profile of this drug concerning cardio-toxicity,and the concerns raised in the medical press regarding the methodology throughwhich trial results were generated (that the two reports in the New EnglandJournal of Medicine have different variables therefore comparison is difficult andfurther, one paper combines data from two different trials sponsored by Genetech- the biotechnology company that developed Herceptin), I believe it would beirresponsible to introduce this drug in advance of licensing and NICE appraisal."38. It is common ground between the appellants and the PCT that neither thepolicy decided upon at the meeting of 18 November and a subsequent meeting ofthe executive board of the PCT, nor the decision taken in the appellant's case,was affected by the cost of Herceptin itself or of treatment involving Herceptin.Thus it is not said that the PCT decided, either wholly or partly for budgetary orfinancial reasons, not to fund Herceptin treatment save in exceptional cases.Pending licensing and approval, its policy was (and remains) to disregardconsiderations of cost and not to fund such treatment requested by a clinician onbehalf of a patient save in exceptional circumstances.39. As Ms Lee says in her statement, the PCT has not adopted a policy whichinvolves a blanket ban on funding Herceptin. It follows that it involves fundingHerceptin treatment in some cases but not in others. The cases in which fundingwill be provided must be exceptional cases. The critical question in this appeal, asit was before the judge, is whether such a policy (and the decision whichdepended upon it) is arbitrary and/or irrational and unlawful, as Mr Pannicksubmits on behalf of the appellant, or whether it is rational and lawful, as MrHavers submits on behalf of the PCT. Before addressing that question, we shouldrefer to the decision made in the case of the appellant. We can do socomparatively shortly (based on paragraphs 33 to 46 of the judgment) because itis not in dispute that the decision followed from the policy. As appears below itseems to us to follow that if the policy was unlawful, so was the decision and, if