A new European scheme that aims to improve patient access to medicines has been put out to consultation.
The European Medicines Agency’s (EMA) Priority Medicines scheme, or PRIME, builds on existing regulatory tools, in particular scientific advice from the accelerated assessment procedure, and aims to strengthen support to medicines that have the potential to benefit patients who have no treatment options, or medicines that may offer a therapeutic advantage over existing treatments.
The regulator believes that “by providing enhanced supported to medicines that address unmet medical needs, [it] will encourage developers to focus their resources on those candidate medicines that are likely to make a real difference to a patient’s life”.
Additionally PRIME also aims to strengthen the design of clinical trials so that patients participate in trials that have a greater chance of providing the necessary data for a drug approval application.
The EMA will now bring together a multidisciplinary group of experts from relevant scientific committees to give preliminary guidance on the overall development plan and recommended regulatory pathway of drugs.
Medicines that receive support from the PRIME scheme will nevertheless still have to demonstrate that their benefits outweigh their risks, which is the same standard applied to all medicines seeking approval in the EU.
In order to enter PRIME medicines would have to meet the same standards set for the accelerated assessment procedure. This means clinical evidence needs to be presented indicating that the medication has the potential to bring significant benefits to patients with unmet medical needs.
The actual launch date of PRIME is set for the beginning of 2016 and ahead of then pharmaceutical companies are able to provide comment until 23 December.
• More information on the EMA’s Priority Medicine (PRIME) Scheme