Out-Law News | 17 Sep 2014 | 4:13 pm | 1 min. read
The drug, called DCVax-L, has received a PIM designation under the Early Access to Medicines Scheme (EAMS).
UK minister for life sciences George Freeman said: "This 'promising innovative medicine' designation is the first crucial step in accelerating access to new medicines, giving real hope to patients and their families. This scheme is helping to secure a better future for people and proves that our country is leading the world in life sciences. I hope more companies – big and small – and medical charities, will nominate products to be part of this scheme."
Under the EAMS, drug companies have the chance to follow a fast-track process for bringing their products to market. They can first apply for a PIM designation from the UK's Medicines and Healthcare products Regulatory Agency (MHRA).
A PIM designation signifies the potential of a drug for treating patients with life threatening or seriously debilitating conditions for which there is either no cure or where existing treatments are unsatisfactory during a stage at which the drug is still being developed and has not been finalised.
On obtaining a PIM designation, drugs manufacturers can then apply to the MHRA for a scientific opinion on whether available data shows that doctors should be able to prescribe the drug to patients before the product has gone through the full licensing process. For that to happen, the potential benefits must outweigh the risks.
Drug companies would not be able to charge for the use of their drugs under the scheme until they obtain a license for the drug, although they would be able to recover costs. It is intended, however, that medicines developed and brought into unlicensed use under the EAMS programme will stand a better chance of receiving marketing authorisation and, following this and other licence approvals, will be commissioned for use by the National Institute for Health and Care Excellence (NICE) across the NHS in England.
Expert in life sciences Helen Cline of Pinsent Masons, the law firm behind Out-Law.com, said: "The EAMS sits alongside the existing early access and early licensing European framework but can be distinguished from existing compassionate use schemes as it is intended to facilitate accelerated licensing by the European Medicines Agency and rapid commissioning by NICE. However, it is disappointing that the scheme itself is unfunded and that currently there is no special fund to pay for these medicines once licensed although cancer treatments such as DCVax-L could qualify for funding under the Cancer Drugs Fund."