Accountability for Rationing — Theory into Practice

E.g., Department of Health, The New NHS – Modern, Dependable (London: HMSO, Cm. 3807, 1997): Paragraph 1.5. Yet, in 1999 the UK government told the European Commission under Council Directive 89/105/EEC (the Transparency Directive) that: “A medicinal product … may be excluded (from the NHS) where the forecast aggregate cost … could not be justified having regard to … the priorities for expenditure of NHS resources.” See R. (Pfizer Ltd) v. Secretary of State for Health, [2003] 2 Common Market Law Reports 19.

See the criticism by Kennedy Ian Professor Sir in Learning from Bristol: The Report of the Public Inquiry into Children's Heart Surgery at the Bristol Royal Infirmary, 1984–95 (London: Cm. 5207, 2001): 57, at paragraph 31.

See generally, Newdick C. , Who Should We Treat? Rights, Rationing and Resources in the NHS (Oxford: Oxford University Press, 2005): Chapter 2.

However, QALYs may under-devalue other ethical objectives, such as equality, clinical need and ability to benefit. See Daniels N. , “Four Unsolved Rationing Problems: A Challenge,” Hastings Centre Report 24, no. 4 (1994): 27.

See Klein R. Redmayne S. , Managing Scarcity – Priority Setting and Rationing in the National Health Service (Buckingham: Open University Press, 1996).

See Daniels N. Sabin J. , Setting Limits fairly – Can we Learn to Share Medical Resources? (Oxford: Oxford University Press, 2002); Ham C. Robert G. , Reasonable Rationing – International Experience of Priority Setting in Health Care (Maidenhead: Open University Press, 2003).

See R. v. Birmingham HA, ex p Collier (unreported, Court of Appeal, 1988) discussed in Newdick C. , Who Should We Treat? Rights, Rationing and Resources in the NHS (Oxford: Oxford University Press, 2005): At 98–100.

See National Health Service Act 1977, s 97, as amended.

S1, National Health Service Act 1977. The duty is imposed on the Secretary of State and delegated to PCTs.

Medical Law Reports 327 no. 8 (1997).

See, New Drugs for Multiple Sclerosis , Executive Letter (1995) 97 (Leeds: National Health Service Executive, 1995).

Department of Health Choose and Book – Patient's Choice of Hospital and Booked Appointment (London: Department of Health, 2004).

Department of Health Press Release, February 25 and <www.nice.org.uk/pdf/CG011fullguideline.pdf> (last visited October 27, 2005).

[1999] Lloyd's Reports: Medical 399.

Ibid, at 408.

Ibid, at 412.

See the European Regulation on Orphan Medicinal Products (EC 141/2000) and, in the US, the Orphan Drugs Act 1983. The “opportunity costs” of orphan drugs are discussed in McCabe C. Claxton K. Tsuchiya A. , “Orphan drugs and the NHS: Should we Value Rarity?” British Medical Journal 331 (2005); 1016 and Burls A. Austin D. Moore D. , “Commissioning for rare diseases: View from the Frontline,” British Medical Journal 331 (2005); 1019.

English Web High Court (2001) Admin 535.

Ibid, paragraphs 77 and 80.

Exceptionally, in Simms [2003] 1 All England Reports 669, the court encouraged use of experimental treatment for patients suffering CJD.

Available at, <http://www.berkshire.nhs.uk/priorities/policies/ethical_framework_051104.pdf>.

Available at, <http://www.berkshire.nhs.uk/priorities> (Last visited October 20, 2005).

National Institute for Clinical Excellence (Establishment and Constitution) Order 1999, SI 1999, No 220, amended by SI 1999, No 2219.

National Health Service Act 1977, Section 17.

Secretary of State's Directions of 2003. NICE guidance remains discretionary in Wales.

See Guide to the Technology Appraisal Process (London: NICE, 2004): Paragraph 6.2, 6.1–2.

See Guide to Methods of Technology Appraisal (London: NICE, 2004): Paragraph 6.2.5.

See Technology Appraisal Programme of the National Institute for Clinical Excellence (Geneva: World Health Organisation, 2003): At 32.

Raftery J. , “NICE: Faster Access to Modern Treatments? Analysis of Guidance on Health Technologies,” British Medical Journal 323 (2002): 1300.

See Guide to Methods of Technology Appraisal (London: NICE, 2004): Paragraphs 6.2, 6.10–11.

Appraisal Consultation Document: Imatinib for Chronic Myeloid Leukaemia (London: NICE, 2004).

See Tackling Cancer in England – Saving More Lives (HC 364, Session 2003–04): At 44, discussed in Newdick C. , Who Should We Treat? Rights, Rationing and Resources (Oxford: Oxford University Press. 2005): At 206–11.

See Social Value Judgements – Guidelines for the Institute and its Advisory Bodies (London: NICE draft report, 2005).

Response to the Report of the Bristol Royal Infirmary Inquiry (London: NICE, 2001): At 8.

S11, Health and Social Care Act 2001.

Patient Involvement in Health (London: Department of Health, 2004): At 28.

See The Concern of the Scottish Executive: Consultation and Public Involvement in Service Change – Draft Interim Guidance (Health Department Letter 42, 2002): Annex C, at paragraph 9.

R. v. North and East Devon HA, ex p. Coughlan , Lloyds Reports: Medical 306, at 322 col. 1.

For many of the difficulties associated with extending democracy in the NHS, see Klein R. New B. , Two Cheers? Reflections on the Health of NHS Democracy (London: King's Fund, 1998).

Report of the First Meeting of the NICE Citizens' Council (London: NICE, 2002): At 8.

Ibid, at 14.

Ibid, at 19 and 22.

The transparency debate is led by The Netherlands, the Nordic countries and New Zealand, see generally Jost T. , ed., Health Care Coverage Determinations – An International Comparative Study (Maidenhead: Open University Press, 2005); Ham C. Robert G. , Reasonable Rationing – International Experience of Priority Setting in Health Care (Maidenhead: Open University Press, 2003).

Harrison D. , Desperately Seeking Solutions – Rationing Health Care (London: Longmans, 1997).