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Here is the link to a short consultation from MHRA on a proposal to introduce early access to medicines.It is proposed that to speed things up unlicensed meds could be available after phase 3 trials while awaiting their marketing authorisation (MA). The scheme would be available for promising new meds to treat,diagnose or prevent life threatening chronic or seriously debilitating conditions currently without adequate treatment options. It will be limited to meds representing a significant advance in treatment in an area of unmet need . They expect only one or two meds /annum would qualify .
They have not ruled out reviewing meds at phase 2 in exceptional circumstances . The scheme would be self funding as they would charge for the extra reviews required and would mean access approx one year before the licence was granted.
Questions are raised as to what happens to patients if the MA is not granted but they see this as unlikely under the arrangements .
I would be grateful for any comments and for you to bring this to the attention of anyone within your networks who might have an opinion .
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