The “Early Access to Medicines” scheme will enable limited numbers of promising medicines to be fast-tracked to offer some hope for patients in England with illnesses for which there are no other treatment options. The Medicines and Healthcare Products Regulatory Agency (MHRA) will oversee the scheme, from April 2014 onwards.
Patients with otherwise untreatable conditions might be allowed access to certain drugs before they become licensed formally, outside of the usual clinical trials procedures, if there are no alternative treatment options and provided there is sufficient data to indicate the proposed treatments look promising and innovative.
The MHRA will assess the benefits and risks of each unlicensed treatment. The early access scheme is not intended to replace or undermine the existing system of bringing drugs to market via clinical trials.
Walsh, F. (2014). ‘Early access’ drugs scheme launched for severely ill. London: BBC Health News, March 14th 2014.
This relates to:
Early Access to Medicines Scheme (EAMS) to launch in April 2014. London: Medicines and Healthcare Products Regulatory Agency, March 14th 2014.