Dr. Lesley Tilson:

There are increasing challenges of early availability of medicines and more limited evidence coming from clinical trials. It is the uncertainty around that. The ideal gold standard would be to have a randomised control trial but we are not always receiving that at the time we are being asked to assess these drugs.

There is a trend of making these drugs available to patients earlier, but then we have less robust evidence and that is a challenge. It is also a concern for patients because we have to look at the safety of the drugs, how long they have been studied for and the quality of the evidence. That is what is being addressed in the additional stages following EMA licensing.