- step 1, the promising innovative medicines (PIM) designation
- step 2, the early access to medicines scientific opinion.
Friday, 21 March 2014
The Early Access to Medicines Scheme (EAMS)
Announcement from the UK's Medicines and Healthcare Products Regulatory Agency:
"The Early Access to Medicines Scheme (EAMS) aims to give patients with life threatening or seriously debilitating conditions access to medicines that do not yet have a marketing authorisation when there is a defined unmet medical need.
Under the scheme, Medicines and Healthcare products Regulatory Agency (MHRA), will give a scientific opinion on a new medicine or indication that has demonstrated a positive risk/benefit balance.
The scheme will begin taking applications from companies from early April 2014. MHRA will provide advice on the scheme when it is launched and we look forward to receiving applications from then.
The scheme is voluntary and the opinion from MHRA does not replace the normal licensing procedures for medicines.
MHRA is responsible for the scientific aspects of the scheme and the scientific opinion will be provided after a two-step evaluation process:
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). The PIM designation will be issued after an MHRA scientific meeting and could be given several years before the product is licensed.
Companies who want to move to step 2 must hold a PIM designation and provide further relevant data on quality, safety and efficacy.
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 after sufficient data have been gathered from the patients who will benefit from the medicine. The opinion will support the prescriber and patient to make a decision on whether to use the medicine before its licence is approved".
Announcing the scheme on 14 March, Dr Ian Hudson, Chief Executive of the Medicines and Healthcare Products Regulatory Agency said:
“We are delighted that the Early Access to Medicines Scheme will be launched in April 2014. The scheme is intended to enable patient access to medicines for treatment of life threatening or seriously debilitating conditions where there is an unmet need. This is a major new development in medicines policy in the UK.
“The scheme offers a way by which unlicensed medicines can be available to patients before approval of a licence to benefit public health. It will also enable companies to gain additional knowledge and experience of these medicines in clinical use.”
That's got to be good news for people with mesothelioma, especially those who have had the standard treatment of Alimta and cisplatin (or carboplatin) and whose cancer starts to grow again. When you each the stage of second, third, fourth line treatment (or more), few people have the time or the option to take part in a clinical trial, especially where there is a 50-50 chance of getting a placebo, rather than the trial drug.
I do hope that the drug companies take up this option if the initial results in a clinical trial look promising.