Seriously ill patients in UK will have access to unlicensed drugsBMJ 2014; 348 doi: https://doi.org/10.1136/bmj.g2161 (Published 14 March 2014) Cite this as: BMJ 2014;348:g2161
- Nigel Hawkes
Patients in the United Kingdom are to be given access to some drugs before they have been formally licensed, in an effort to speed up access.
The early access scheme, which was first proposed in 2006 and has been under active discussion for the past two years,1 will apply to life threatening and seriously debilitating conditions.
The first step is for the Medicines and Healthcare Products Regulatory Agency to designate a new drug as a “promising innovative medicine” (PIM) on the basis of early trial data and as long as the agency is satisfied the drug meets an unmet …