Cutting edge medicines for the patients who need them most
On 7 March 2016, the European Medicines Agency (EMA) launched PRIME: Priority Medicines.
PRIME is a new scheme that will provide scientific and regulatory support to researchers and medicine developers with the aim of benefitting patients without treatment options or “unmet medical needs”.
Quick and easy access to safe and effective medicines is a necessary precondition for well-functioning healthcare systems to exist and prosper. PRIME’s primary aim is to make sure that this condition is properly fulfilled, with a particular emphasis on the patients who need it most, such as those with no treatment options.
Nevertheless, the process that leads to the assessment, approval, and launch of new medicines can sometimes be longer than both researchers and patients would like it to be.
A fast-track process to meet patients' needs
This is why PRIME aims to put in place a fast-track process for those medicines that clearly show a potential “to benefit patients with unmet medical needs based on early clinical data”. In practical terms, a medicine that is deemed eligible for the PRIME scheme will benefit from “accelerated assessment” when an application for market authorisation is submitted. This will result in the assessment procedure lasting, on average, 60 days less than outside the PRIME scheme.
In the words of EMA’s Executive Director, PRIME will enable patients with insufficient treatments to benefit from “cutting edge medicines as soon as possible”. PRIME is also expected to ensure more rational and effective use of available resources. In general, this scheme deserves attention because it not only places emphasis on medicine effectiveness, but values easier and faster access to new medicines as an equally important element in determining the quality of 21st century healthcare systems.