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UK - Court of Appeal - Rogers, R (on the application of) v Swindon NHS Primary Care Trust & Anor: farmaci off-label e accesso alle cure
12 aprile 2006

 La Court of Appeal, rovesciando la decisione di primo grado, ha ritenuto arbitrario e irragionevole il provvedimento del Swindon NHS Primary Care Trust con cui veniva negato alla ricorrente (Ms Rogers) l'accesso gratuito off-licence al farmaco Herceptin, già disponibile per la cura del cancro al seno allo stadio avanzato, ma ancora in corso di valutazione per la terapia nelle prime fasi della malattia.

EWCA Civ 392

La ricorrente, una donna inglese di 54 anni, residente a Swindon, soffriva di un carcinoma mammario in fase iniziale. In seguito alla mastectomia e alle prime cure chemioterapiche, le fu consigliato l'utilizzo del farmaco Herceptin, del quale si erano appena scoperti gli effetti benefici anche per la cura del cancro al seno in fase iniziale, oltre che per gli stadi più avanzati. Tale farmaco non era però finanziato all'interno del NHS dal Primary Care Trust (PCT) dove la donna risiedeva e la spesa prevista per la terapia ammontava a 26,328.22 sterline, spesa insostenibile per Ms Rogers.

Il ricorso prende avvio dalla richiesta della paziente di ottenere l'accesso al farmaco all'interno del NHS, sulla base della policy del PCT per cui, anche ove un farmaco non fosse adottato entro l'area di riferimento, il PCT stesso avrebbe potuto rivedere la propria decisione tenendo in considerazione le circostanze di ogni singolo caso. Il rigetto dell'istanza costituisce il motivo del ricorso per judicial review ai giudici britannici.

In primo grado il provvedimento fu ritenuto legittimo, mentre in secondo grado venne rilevata l'irragionevolezza e l'arbitrarietà della decisione dell'autorità sanitaria locale, poiché in essa non era ravvisabile quale tipo di paziente potesse soddisfare le circostanze eccezionali per ottenere l'accesso al farmaco.

Si riportano alcuni passaggi della sentenza di secondo grado (.pdf completo e decisione di primo grado nel box download – fonte: Bailii).


«52 In relation to the four points raised by the appeal panel, the Board concluded as follows: (i) exceptionality should be considered in the context of women who met the eligibility criteria, rather than the population as a whole; (ii) the risk of the patient dying, as in the case of the appellant's cousin, had been taken into account in the assessment of prognosis; (iii) a number of women would have a poor prognosis, so that the prognosis could not therefore be described as individual exceptionality, but might inform eligibility in any further policy; and (iv), there was insufficient evidence to support the conclusion of Dr Cole that patients with a poorer prognosis are likely to benefit more from this treatment. There was unanimous support for upholding the decision of the CPC.

53 The judge noted in paragraph 46 of his judgment that many authorities and trusts have taken a different view from that of the PCT and have funded Herceptin treatment for all applicants in the eligible group. These include Cheshire and Merseyside; Greater Manchester; Hampshire and Isle of Wight; Leicestershire, Northamptonshire and Rutland; North and East Yorkshire and North Lincolnshire; Northumberland and Tyne and Wear; South West Peninsular; and South Yorkshire Health Authorities, together with Lancashire and South Cumbria Cancer Network; all Primary Care Trusts in Norfolk and in Northern Ireland; and many PCTs in London, Staffordshire, Cambridgeshire, Somerset and elsewhere».

«58. Mr Pannick accepts, in our view correctly, that this case would be very different if the PCT had decided that as a matter of policy it would adopt the Secretary of State's guidance that applications should not be refused solely on the grounds of cost but that, as a hard-pressed authority with many competing demands on its budget, it could not disregard its financial restraints and that it would have regard both to those restraints and to the particular circumstances of the individual patient in deciding whether or not to fund Herceptin treatment in a particular case. In such a case it would be very difficult, if not impossible, to say that such a policy was arbitrary or irrational».

«63. Thus we would not hold that the policy was arbitrary because it refers to unidentified exceptional circumstances. The essential question is whether the policy was rational; and, in deciding whether it is rational or not, the court must consider whether there are any relevant exceptional circumstances which could justify the PCT refusing treatment to one woman within the eligible group but granting it to another. And to anticipate, the difficulty that the PCT encounters in the present case is that while the policy is stated to be one of exceptionality, no persuasive grounds can be identified, at least in clinical terms, for treating one patient who fulfils the clinical requirements for Herceptin treatment differently from others in that cohort».

«68. […] Thus 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».

«78. […] the PCT developed a policy which treated financial considerations as irrelevant. It thus had funds available for all women within the eligible group whose clinician prescribed Herceptin. Yet its policy is to refuse funding save where exceptional personal or clinical circumstances can be shown».

«81 All the clinical evidence is to the same effect. The PCT has not put any clinical or medical evidence before the court to suggest any such clinical distinction could be made. In these circumstances 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. In short, we accept Mr Pannick's submission that once the PCT decided (as it did) that it would fund Herceptin for some patients and that cost was irrelevant, the only reasonable approach was to focus on the patient's clinical needs and fund patients within the eligible group who were properly prescribed Herceptin by their physician. This would not open the floodgates to those suffering from breast cancer because only comparatively few satisfy the criteria so as to qualify for the eligible group.

82. For these reasons we have reached the conclusion that the policy of the PCT is irrational, unless it can properly be said that it is not necessary to identify individual characteristics which might justify distinguishing between one patient within the eligible group and another. […] Here the evidence does not establish the possibility of there being relevant clinical circumstances relating to one patient and not another and, in the case of personal characteristics, there is no rational basis for preferring one patient to another».

Lucia Busatta
Pubblicato il: Mercoledì, 12 Aprile 2006 - Ultima modifica: Giovedì, 30 Maggio 2019
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