Successful Challenge to NICE on Access to Alzheimer's Drugs
10 August 2007
Today the High Court handed down judgment in the case of R (Eisai Ltd) (Alzheimer's Society & Shire Ltd, Interested Parties) v. the National Institute for Health and Clinical Excellence.
In her judgment, Mrs Justice Dobbs ruled that NICE had failed in its duty to ensure that its guidance was not discriminatory and that there was a need for NICE to clarify its position as to the circumstances when doctors may exercise their own clinical judgment about whether a patient should have access to drug treatments, overriding NICE's recommendations when it is appropriate to do so.
The court did not find that the NICE guidance itself (which recommends Alzheimer's drugs only for patients in the moderate stage of Alzheimer's disease) or the way in which NICE had calculated benefits of the drugs for carers was irrational. The Judge also dismissed an argument by drug manufacturer Eisai that the decision-making process was unfair because NICE's cost effectiveness model was not made public.
However, ordering NICE to amend its Guidance, Mrs Justice Dobbs made strong criticisms of NICE's failure to comply with its statutory equality duties under the Race Relations Act and the Disability Discrimination Act. Upholding the challenge by Eisai and the Alzheimer's Society, the Judge found that "no proper consideration was given to NICE's duties as a public authority to promote equal opportunities and to have regard to the need to eliminate discrimination" and that, at the stage of formulating its Guidance, NICE had not considered or complied with its "due diligence" equality duties, and it did not appear that any thought was given to present or imminent obligations under anti-discrimination law.
The Alzheimer's Society, representing the interests of people with dementia and their carers, acted as one of a number of separate interested parties in this challenge.
Tim Ward and Gerry Facenna were junior counsel to the Alzheimer's Society.