Drug industry says EMA’s PRIME scheme useful but could be improved

Regulatory NewsRegulatory News | 14 March 2022 |  By 

Eligibility criteria for admission to the European Medicines Agency’s (EMA) priority medicines (PRIME) scheme are too strict to facilitate innovation in Europe according to the European Federation of Pharmaceutical Industries and Associations (EFPIA).
The drug industry group made the comments to Regulatory Focus in response to the publication of a report on the first five years of the PRIME scheme. (RELATED: EMA lauds PRIME priority meds scheme and outlines potential revisions, Regulatory Focus 8 March 2022)
In the report the EMA said PRIME has had a positive impact on “authorisation of new medicines that address patients’ unmet medical needs,” explaining that 18 PRIME products have been authorised since 2016.
EFPIA spokeswoman Lavinia Meloni told Focus that although the scheme is an important development tool, it would be more effective if it was better aligned with fast-track mechanisms in other markets.
“The PRIME scheme is important in the regulatory eco-system as a development tool to fast-track development and registration of promising products that fulfil a major public health interest, including unmet medical needs: it is a critical regulatory tool for innovation and promising medicines,” she said. “The overall eligibility rate of PRIME appears to be too stringent in the global environment to facilitate innovation in Europe. Industry is concerned of a too narrow interpretation on unmet medical need while scoping PRIME closer to similar regulatory tool in other regions would allow Europe to be part of the global development with no delay in clinical trials.”
In its first five years, only about 25% of the 384 PRIME eligibility requests that EMA received were granted. Of the 95 requests that were granted, 24 have progressed to the evaluation stage or beyond.
In addition to making it easier to be accepted on to the scheme, EFPIA suggested interactions with scientific advisors provided through PRIME should be more flexible and allow for the involvement of health technology assessment (HTA) bodies.
EFPIA also said the provision of scientific advice through PRIME could be made more efficient by using iterative submission to support and ease the accelerated assessment.

This view is shared by Simone Boselli, public affairs director at the European Organisation for Rare Diseases (EURODIS) who told Focus, “The PRIME process would benefit from early and adequate engagements from HTA and payers bodies."
“This would add greater consistency in achieving the stated objectives of addressing unmet needs sustainably,” she said.
PRIME is similar US Food and Drug Administration’s (FDA) fast track and breakthrough therapy designations. However, as the US agency points out there are some differences, including in relation to eligibility.
To be accepted into PRIME a candidate must be new medicine has the potential to benefit patients with unmet medical needs, based on early clinical data.
In contrast, drugs are eligible for fast track designation if they are designed to treat a serious condition and can, through nonclinical or clinical data, demonstrate the potential to address unmet medical need.
Likewise for breakthrough therapy status the candidate must treat a serious condition and have preliminary clinical evidence indicating it may offer substantial benefit on clinically significant endpoints over available therapies.
Regulatory framework
But while closer alignment with other accelerated approval schemes would help Industry, the availability of resources is what will determine whether PRIME is effective in the longer term according to EFPIA.
“In the long-term vision, and depending on the outline and regulatory provisions, industry generally sees a value of the incorporation of PRIME into the pharmaceutical regulatory framework through legislative means to secure resources, expertise needed from the EU regulatory network with permanent EMA staff to support enhancements and specifically along of SA provision but to also to broaden the opportunities to support promising therapies in Europe,” Meloni said.
“A future-proof PRIME will allow the right balance between consistency and predictability with the agility that the scheme needs to foster innovation. PRIME benefits depend on the combination of mind-set and expertise of the entire EU network,” she added.


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