The House of Commons Select Committee on Health's recent Report on the National Institute for Clinical Excellence ("NICE")1 contains numerous recommendations to improve the functioning and independence of NICE, many of which have been praised by the pharmaceutical industry, physicians and patient groups alike.
However, some of its recommendations are likely to be of concern to the industry, not least of which the recommendation that "all information which NICE uses in its decision-making process [be] made available for public scrutiny".2 The related reasons for this recommendation appear to be:
the need for clarity and transparency as to the basis on which appraisal decisions are made; and
the public credibility of NICE, particularly with clinicians, the wider NHS and patient groups.
The Select Committee states that "if industry or others have previously unpublished data which they want to use to support their case then this should no longer be presented to NICE subject to confidentiality". Moreover, if "pharmaceutical companies insist that unpublished data relating to the indication in question remain confidential, this may mean NICE will be forced to withdraw that treatment from the appraisal process". Whilst this is said to carry the risk that guidance on a treatment will be delayed until published information is available, the Committee believes that pharmaceutical companies are unlikely to use this as an "opt-out" clause because, it is said, their refusal to submit their evidence to public scrutiny would be likely to have a negative impact on commissioners' and clinicians' confidence in their product.
This article addresses some of the issues surrounding the recommended prohibition on the confidentiality of data used by NICE in its decision-making processes. It maps the consequences that such a prohibition would have on existing legal principle and administrative and judicial practice, evaluates the Select Committee's reasons for its recommendation in the light of the potential practical ramifications for industry stakeholders, and suggests that there is insufficient justification for such a prohibition.
Removal of right to confidentiality
The most obvious consequence of the prohibition is that it would strip stakeholders of an existing right to confidentiality in respect of information which is commercially sensitive and could otherwise be categorised as confidential. Whilst under English law a sufficient public interest in disclosure may be a defence to what would otherwise be a breach of confidence,3 that is a case-specific question, not a principle that can be applied universally to all information submitted to a particular authority for a particular purpose so as to justify the release of such information to the world at large.
It is true that in Smith Kline & French Laboratories Ltd v The Licensing Authority4 the House of Lords held that the Licensing Authority was entitled to cross-refer to Smith Kline & French's ("SK&F") data when a generics manufacturer sought a marketing authorisation and claimed that essential similarity could be demonstrated by reference to the research and testing details that had been supplied earlier by SK&F. In other words, the Medicines Control Agency ("MCA") could refer to the data for a purpose other than that for which it had originally been supplied. However, the issue in that case concerned use of the data by the Licensing Authority for the performance of its statutory functions and duties, not release to the public at large. Indeed, Lord Templeman stated that whilst it was "not unconscionable for the licensing authority to make use of that information in the public interest for the purposes of the Act, it would be unconscionable for the licensing authority to disclose that information to third parties for other purposes."5
Arguably, and as addressed further below, the recommended blanket confidentiality prohibition is not necessary for NICE to perform its functions and pursue its purposes.
Surpassing of administrative law principle
The suggested confidentiality prohibition would also take us beyond established administrative law principle as to what types of information consultees are entitled to receive during consultation processes. There is no general rule that one party to a consultation should be given all material submitted by another and no general rule that confidential information may be disclosed as a requirement of consultation processes. Whether such information may and should be disclosed and, if so, how much information should be disclosed, is a case-specific question. Sometimes it may be possible to disclose the gist of information supplied by another, without revealing confidential information, whilst still enabling other consultees sufficiently to comprehend and respond to the matter.
When material not otherwise available to a consultee is of pivotal importance to the decision-maker's final decision, a decision-maker may take the view that it may properly be disclosed to the consultee, even if some of that information was provided by a competitor and is therefore or might otherwise be considered confidential. However, in the author's view, application of this proposition must depend on the particular industry in question, the subject-matter of the particular consultation and the nature of the particular information considered confidential. In other words, it must be case-specific.
Existing regulatory and parliamentary respect for confidentiality