Under the scheme, the Medicines and Healthcare products Regulatory Agency (MHRA) will provide a scientific opinion on the benefit/risk balance of the medicine, based on the data available at the time of the EAMS submission. The opinion will support the prescriber and patient to make a decision on whether to use the medicine before its licence is approved.
MHRA is responsible for the scientific aspects of the scheme and the scientific opinion will be provided after a two-step evaluation process.
Step I - Promising innovative medicine (PIM) designation
The PIM designation will give an indication that a product may be eligible for the Early Access to Medicines Scheme (based on early clinical data).
Step II - Early access to medicines scientific opinion
The scientific opinion will describe the benefits and risks of the medicine, based on the information submitted to MHRA by an applicant. Following a positive EAMS scientific opinion, MHRA will publish a Public Assessment Report (PAR) and the EAMS treatment protocol on the MHRA website. The PAR will include:
- how the product is used and how it works
- summary of the key clinical studies
- the risks and benefits of the product
- the reason for the positive EAMS scientific opinion
- any uncertainties
- information about ongoing clinical studies
- measures in place to monitor and manage risk.
UK Life Sciences Minister George Freeman said: "The designation of the PIM is the first, crucial step in developing cutting-edge medicines sooner, giving real hope to patients and their families."
NHS = National Hope Service?
The first PIM was awarded to DCVax-L - a personalised immunotherapy that targets malignant gliomas – in September. Another was awarded in October, but its name – nor those of any subsequent drugs – will be made public.