Adaptive Licensing Pilot Scheme, Fast Tracking Orphan Drugs

Adaptive Licensing Pilot Scheme

In Market Access, Regulation & Government by Yolanda King

The EMA announced its Adaptive Licensing pilot scheme on 19th March 2014, inviting companies to participate in the program. With a meeting held recently between key stakeholders, such as the Association of the British Pharmaceutical Industry and the Bioindustry Association, the scheme appears to be well on its way to success.

The Adaptive Licensing scheme aims to speed up access to new treatments, beginning with “early authorisation of a medicine in a restricted patient population, followed by iterative phases of evidence gathering and adaptations of the marketing authorisation to expand access to the medicine to broader patient populations.” The impact this could have for those with rare diseases is large. With the EMA now actively engaging in enabling earlier access, it could mean life saving drugs are released more efficiently and effectively in the next few years to those who are suffering.

As reported in the PharmaTimes Health Minister Lord Howe stated that the adaptive licensing could prove a “golden opportunity” to highlight the ability of the life sciences industry in the UK. Further to this he suggested that the new scheme could demonstrate to people that regulation is “not a noose which stifles but rather a safety mechanism which can release medicines to patients in need”.

With 14 applications already received for the new scheme it would suggest that the pilot could prove highly effective and go on to enable earlier access to drugs for those in need.

Adaptive Licensing forms a topic for discussion at the Fast Tracking Orphan Drugs Briefing on 10th July in London. Join industry leaders from Shire, Trophos, Alexion Pharma and GW Pharmaceuticals to discuss early access for orphan drugs and how new UK and EU schemes will affect your business. Download the brochure now.

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