Under new Regulations, severely ill patients and those with rare debilitating conditions could be given new medicines years before they are licensed. The idea is to help patients in England with severe illnesses who have no other treatment options.
The Medicines and Healthcare Products Regulatory Agency (MHRA) will oversee the Early Access to Medicines scheme when it is launched this April.
The scheme would enable a small number of promising medicines to be fast-tracked. Health Secretary Jeremy Hunt said,“what patients want is sometimes to try medicines that may not be clinically proven to be effective but are clinically safe. We are streamlining the process so these medicines can be used much earlier – particularly if they have early promise – and that is something which will bring hope to a lot of patients.”
The MHRA stressed that the early access scheme would in no way replace the system of bringing drugs to market via clinical trials.
It can take a decade of patient trials and assessments before a licence is granted and the early access scheme could resolve this. The MHRA stressed that the early access scheme would in no way replace the system of bringing drugs to market via clinical trials.
For unlicensed drugs to be used under the early access scheme, sufficient data from several years of clinical trials would be needed to show that it looks like a promising and innovative treatment. The MHRA will also carry out an assessment of the benefits and risks, which will be available for doctors and patients.
Harpal Kumar, chief executive of Cancer Research UK, said, “time is of the essence for many cancer patients, particularly those with more advanced disease. It can mean the difference between life and death. Therefore this scheme, which has at its heart the potential to bring promising new medicines to patients faster, is to be warmly welcomed.”
Department of Health officials said the scheme would benefit pharmaceutical companies by enabling them to gain experience of their medicines being used in the NHS.
The Early Access to Medicines scheme will work alongside and not replace the current system of clinical trials.