EMA continues its efforts to facilitate early patient access to innovative medicines through initiation of PRIME scheme

The European Medicines Agency (EMA) has published a draft Reflection Paper on a new scheme, PRIME (‘priority medicines’), which it intends to launch in Q1 2016. The intention of the PRIME scheme is to optimise the development of priority medicines and facilitate patient access to them by reinforcing scientific and regulatory support to medicines of major public health interest. Comments on the draft Reflection Paper are being sought through a public consultation which is open until 23 December 2015.

According to EMA, “PRIME aims to strengthen support to medicines that have the potential to benefit patients who presently have no treatment options, or that may offer a major therapeutic advantage over existing treatments”. These are the criteria by which EMA intends to define the priority medicines that will qualify for the scheme. EMA will provide this support by building on their Scientific Advice and Accelerated Assessment procedures. Scientific Advice will be enhanced by providing advice at key development milestones with potential involvement from multiple stakeholders (e.g. health technology assessment bodies and patients, similar to Adaptive Pathways) when relevant. Accelerated Assessment is the EMA’s current mechanism for bringing medicines of major public health interest to patients sooner, and the PRIME scheme is an output of a recent review of this procedure by EMA.

EMA describes the eligibility criteria for medicines to enter the PRIME scheme as those of the accelerated assessment procedure, i.e. “preliminary clinical evidence indicating that [a medicine] has the potential to bring significant benefits to patients with unmet medical needs and hence be of major interest from a public health and therapeutic innovation perspective”.

Of particular interest to the ATMPs community, earlier entry into the scheme on the basis of compelling nonclinical data and tolerability data in initial clinical trials is envisaged for companies registered as SMEs with EMA and applicants from the academic sector. Therefore, SMEs whose medicines are eligible for the PRIME scheme would be able to benefit from the reduced Scientific Advice fees that EMA grants to such companies.

Author: Anthony Lodge

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