The applicant pharmaceutical companies challenged the decision of the National Institute for Clinical Excellence (NICE) to to list certain drugs saying that the procedure adopted was unfair. NICE had revealed that results of calculations it had made in order to assess the appropriatenmess of the use of certain drugs, but had not disclosed the mathematical basis of the calculations, and therefore had made it impossible for the companies to see how the answers had been obtained.
Held: The pharmaceutical companies’ appeal was allowed. In this context there is a ‘need for a very high degree of transparency in the process, with an exceptional degree of disclosure and consultation. ‘ The provision of read only models disabled much of the testing which companies would be entitled to carry out.
After citing ex parte Coughlan, Richards LJ said: ‘The mere fact that information is ‘significant’ does not mean that fairness necessarily requires its disclosure to consultees . . nevertheless the degree of significance of the undisclosed material is obviously a highly material factor.
What fairness requires depends on the context and the particular circumstances; see for example, R v Secretary of State for Education, ex-parte M [1996] ELR 162, at pp. 2006-2007, where Simon Brown LJ emphasised the need to avoid a mechanistic approach to the requirements of consultation . . The fact that the material in question comes from independent experts is plainly relevant to the overall assessment, but it was a combination of factors – including the requirement of a high degree of fairness . . the crucial nature of the advice, the lack of good reason for non-disclosure, and the impact on the applicants- which led to what was on the facts a fairly obvious conclusion . .’ and
‘even if one accepts the possibility that release of the fully executable version would add two to three months to the appraisal process, that has to be viewed in the context of an already lengthy process . . I do not think that either the additional time or the additional cost to NICE should weigh heavily in the balance in deciding whether fairness requires release of the fully executable version. If fairness otherwise requires release of the fully executable version, the court should in my view be very slow to allow administrative consideration of this kind to stand in the way of its release . . procedural fairness does require release of the fully executable version of the model. It is true that there is already a remarkable degree of disclosure and of transparency in the consultation process; but that cuts both ways, because it also serves to underline the nature and importance of the exercise being carried out. The refusal to release the fully executable version of the model stands out as one exception to the principle of openness and transparency that NICE has acknowledged as appropriate in this context. It does place consultees . . at a significant disadvantage in challenging the reliability of the model. In that respect it limits their ability to make an intelligent response in something that is central to the appraisal process’
Tuckey LJ, Jacob LJ, Richards LJ
[2008] EWCA Civ 438, Times 07-May-2008
Bailii
England and Wales
Citing:
Cited – Regina v Secretary of State for Education and Employment and Another Ex Parte Morris and Others QBD 15-Dec-1995
There was no need for consultation before a school can be closed as a failing school. Simon Brown LJ emphasised the need to avoid a mechanistic approach to the requirements of consultation. . .
Appeal From – Eisai Ltd v The National Institute for Health and Clinical Excellence Admn 10-Aug-2007
The company sought to challenge the decision of the respondent not to approve its drug for use for the treatment of patients with Alzheimer’s disease.
Held: In requiring all patients to have a certain MMSE score in order to qualify for funding . .
Cited – Regina v North and East Devon Health Authority ex parte Coughlan and Secretary of State for Health Intervenor and Royal College of Nursing Intervenor CA 16-Jul-1999
Consultation to be Early and Real Listening
The claimant was severely disabled as a result of a road traffic accident. She and others were placed in an NHS home for long term disabled people and assured that this would be their home for life. Then the health authority decided that they were . .
Cited – Bushell v Secretary of State for the Environment HL 7-Feb-1980
Practical Realities of Planning Decisions
The House considered planning procedures adopted on the construction of two new stretches of motorway, and in particular as to whether the Secretary of State had acted unlawfully in refusing to allow objectors to the scheme to cross-examine the . .
Cited – Regina v Secretary of State for Health, ex parte United States Tobacco International Inc CA 1991
The applicant company produced oral snuff. It had opened a factory in the United Kingdom after the Government, on advice, had negotiated an agreement with it to restrict the marketing of the product. The committee, basing itself not on new evidence . .
Cited – S, Regina (on the Application of) v Secretary of State for Education CA 15-Jul-1994
. .
Cited – Aravco Ltd and Others, Regina (on the application of) v Airport Co-Ordination Ltd CA 23-Jun-1999
. .
Cited – Aravco Ltd and Others, Regina (on the application of) v Airport Co-Ordination Ltd CA 23-Jun-1999
. .
Cited – Regina (Bedford) v London Borough of Islington 2003
. .
Cited by:
Cited – Savva, Regina (on The Application of) v Royal Borough of Kensington and Chelsea Admn 11-Mar-2010
The claimant challenged the defendant’s policies on caring for elderly people within the community saying that it provided insufficient funds, and the procedures for review were inadequate and infringed her human rights. . .
Cited – AC v Berkshire West Primary Care Trust, Equality and Human Rights Commissions intervening Admn 25-May-2010
The claimant, a male to female transsexual, challenged a decision by the respondent to refuse breast augmentation treatment. The Trust had a policy ‘GRS is a Low Priority treatment due to the limited evidence of clinical effectiveness and is not . .
Cited – Save Our Surgery Ltd, Regina (on The Application of) v Joint Committee of Primary Care Trusts Admn 7-Mar-2013
The claimants sought judicial review of the report prepared by the defendants under which departments providing childrens’ heart surgery at their regional hospital would close. They complained that the consultation had been inadequate and flawed. . .
Distinguished – Easyjet Airline Co Ltd, Regina (on The Application of) v Civil Aviation Authority CA 15-Dec-2009
The claimant appealed against rejection of its challenge to the respondent’s decision on charging structures for the use by airline of Gatwick airport, and in particular the alleged lack of adequate consultation by the respondent. After its own . .
Lists of cited by and citing cases may be incomplete.
Health, Administrative
Leading Case
Updated: 02 November 2021; Ref: scu.267386
