The National Institute for Health and Clinical Excellence is following in the footsteps of the US Food and Drug Administration and the European Medicines Agency and setting up a scientific advisory service to guide drugmakers in making their regulatory submissions.

NICE chair Sir Michael Rawlins outlined the plans and rationale for the scheme to PharmaTimes at the institute’s annual conference in Manchester. He noted that the FDA has been advising firms for years and very few drugmakers would contemplate setting up a Phase III trial without such input.

Sir Michael noted that he had been thinking of a similar project for some time but following the Cooksey Report last year, which formally suggested NICE should get involved, and this led to a pilot scheme with Novartis.

The Swiss firm designed the process and prepared a real drug coming into Phase II, “this was not a hypothetical product,” Sir Michael stresses, and a briefing book was prepared and a face-to-face meeting with NICE staff set up. “Much of it was about how and when to capture quality of life data, and what sort of comparator Novartis was planning to use”, he added.

At the end of the sessions, Novartis and NICE staff produced a joint report and “the conclusion unanimously was that this was a very good process and we should set it up as a permanent fixture”. However Sir Michael said that as a small agency, it takes a lot of staff time to set up but it will be all systems go from January 1.

When asked by PharmaTimes if there had been much interest from pharmaceutical companies, Sir Michael added that two firms are already signed up and have put in a briefing book. “We haven’t been canvassing at this stage,” he said, though “I’ve talked about it to many companies and they’ve all welcomed it.”