In an updated drug appraisal guide released this month, the institute strengthened its 2009 stance and now requires companies submitting to NICE to sign a declaration that they have disclosed all clinical trial data.
The guide follows a public consultation with more than 50 organisations, including pharmaceutical companies and the Association of the British Pharmaceutical Industry (ABPI).
NICE (National Institute for Health and Care Excellence), which decides which drugs are clinically and cost-effective for adoption in England and Wales, said it will only approach European regulators if drugmakers do not provide the necessary data.
A ‘more muscular’ NICE?
At the House of Commons Health Select Committee on NICE earlier this month, NICE Chairman David Haslam told MPs (Members of Parliament) that he and CEO Andrew Dillon were signatories of the AllTrials.net campaign, which called for open access to trial data:
“We ask for a signature from the UK medical director of pharmaceutical companies that we have all the data relevant to the topic – the drug that we’re considering. Again it’s an area that we do take extremely seriously.”
The Committee asked if NICE should go further “be a bit more muscular in its approach” by encouraging pharma companies to make all their trial data public, and not just to provide it to NICE:
“Campaigners have suggested that adds to the secrecy behind decisions, that you can’t see what the pharmaceutical companies are supplying to you and whether that data is accurate or could be contested by other bodies.”
The committee proposed “other trusted bodies, like Cochrane” could also be allowed to examine data.
Haslam told MPs, “my personal view on this is I can see no reason whatsoever not to publish all the data, and I think there’s a moral imperative from the point of view of the patients who’ve been part of the trials that their time, their effort shouldn’t be ignored.
“I think everything should be in the public domain and I’ve always felt that way very strongly.”
The move follows calls for increasing transparency from pharmaceutical companies and comes after Roche was criticised for its handling of Tamiflu data. The UK government spent nearly £500m (€624m) on stockpiling the pandemic flu drug.
Carole Longson, Director for the Health Technology Evaluation Centre at NICE, said full data sets are necessary for NICE to make accurate decisions.
“We strongly believe that all clinical trial data should be made available so that those with responsibility for developing guidance and making treatment decisions have all the necessary information to hand to help them do so safely and efficiently.”
Separately, NICE outlined plans for bringing forward meetings with drug companies “so that companies can get advice early on and address any potential issues with the methodology or presentation of clinical trial data, to help speed up the appraisal process.”