Per the MHRA’s plan to provide early access to some unlicensed products, our spy inside that agency reports that:
MHRA put together a proposal two years ago to allow medicines at the end stage of development trials earlier access to the market. The UK government was not interested in this and kicked it into the long grass. This scheme MHRA proposed at the time would be very like the French ATU scheme which has been in operation for the past ten years or so.
(For more on the French compassionate use program, see here.)
But when last year, the UK government started talking about its "growth agenda,” it decided that early access to new medicines was central to that agenda, it came back to the MHRA for help. We dusted down our previous scheme -- which is now out for consultation.
When the dust clears, we’ll be watching.