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Judicial review: are your procedures fair?
4 July 2008
NHS Trusts must have fair procedures in place when exercising
their decision-making functions. But what is "a fair procedure" in
today's demanding society?
NICE, the National Institute for Health and Clinical Excellence,
has recently faced this very point, with the Court of Appeal
deciding that its consultation process was procedurally unfair.
R (on the application of Eisai Limited) v NICE
highlights the principles of procedural fairness and provides
useful guidance to NHS Trusts.
Background
NICE is responsible for appraising the clinical benefits and
cost effectiveness of healthcare interventions and for making
recommendations as to their use in the NHS.
NICE had previously issued guidance about the use of
acetylcholinesterase inhibitors for the treatment of Alzheimer's
Disease. The guidance recommended that patients with mild to
moderately severe Alzheimer's should receive these drugs. In 2006,
following a lengthy consultation process with the pharmaceutical
companies responsible for these drugs, NICE changed its guidance.
It recommended that only patients with moderately severe
Alzheimer's should receive the drugs.
Challenge and outcome
One pharmaceutical company, Eisai, issued Judicial Review
proceedings against NICE on the grounds that its consultation
process was unfair. NICE had made available to consultees a
read-only version of an economic model in the form of an Excel
spreadsheet, which was used to assess the cost-effectiveness of the
drugs. Eisai requested a fully executable version of the model but
this was refused. Eisai contended that non-disclosure of that model
prevented it from checking NICE's assumptions and challenging the
reliability of the model. Therefore, Eisai was not in a position to
comment on a central part of the appraisal process. The Court of
Appeal agreed.
The case highlights the following principles:
- The consultation process must be fair, even if the organisation
is undertaking it on a voluntary basis. A procedure cannot be "less
fair" simply because the organisation is not required to carry it
out by law
- Context and circumstances will dictate the level of fairness
required. Decisions that would have either a substantial effect on
quality of life or would save
life, will require a high degree of transparency with an
exceptional degree of disclosure and consultation
- Any reasons that justify the procedure must be consistent. NICE
had originally stated that while it had no objection to disclosing
a fully working model, disclosure was prevented because of
confidentiality. It subsequently argued that scrutiny and testing
of the model by Eisai would cause the consultation process to be
substantially delayed. The force of this argument was weakened
because of NICE's previous statement
Judicial review proceedings are costly to defend and can
paralyse an organisation. NHS Trusts must act with caution when
making significant decisions, such as those which affect patient
services, particularly when they choose to withhold any information
from a party who might be entitled to challenge the decision. If
your organisation's decision-making processes are challenged, it is
important to consider your response carefully and take legal advice
as necessary, since the approach taken at this stage may be closely
scrutinised by a Court in any subsequent proceedings.
For advice or to discuss these or any other issues,
please contact Barbara Anthony.