title: The concept of exceptionality: a legal farce?
abstract: How do we decide which treatments should be offered by the National Health Service (NHS) when we cannot afford to fund them all? In the absence of a positive appraisal by the National Institute for Health and Clinical Excellence (NICE), which mandates the provision of a treatment by the NHS, Primary Care Trusts (PCTs) are free to decide whether to provide a particular drug to some, or all, of their population. However, as public bodies, it is a well-established principle of Administrative Law that PCTs are not at liberty to fetter the exercise of their own discretion. They must recognise the possibility that some patients will have exceptional circumstances, and as a consequence, any general policy prohibiting the funding of a drug cannot be absolute. In the absence of statutory guidance on what might constitute exceptional, clinicians are left guessing as to whether their patients might be eligible for funding on the grounds of exceptionality. Using the context of expensive cancer drugs, I will examine the concept of exceptionality from clinical, moral, and legal perspectives, focussing particularly on the role of social factors in determining exceptionality. I will review the cases where PCTs' decisions not to fund cancer drugs were subject to legal action and argue that the courts have provided little guidance on interpreting the term exceptional, and that the concept has a limited role to play in the allocation of scarce health resources at a local level.
authors.affiliation: Centre for Social Ethics and Policy, Institute for Science, Ethics and Innovation, University of Manchester, School of Law, Manchester, UK. amy.ford@manchester.ac.uk
authors.forename: Amy
authors.initials: A
authors.lastname: Ford
mesh_terms: D026683:Advisory Committees; D000970:Antineoplastic Agents / Q000191:economics; D003210:Concept Formation; D003657:Decision Making; D015276:Health Care Rationing / Q000941:ethics* / Q000331:legislation & jurisprudence*; D006779:Hospitals, Public; D013222:State Medicine; D006113:United Kingdom
chemical_list: D000970:Antineoplastic Agents