by Nick Hudson
LONDON, Nov 18 (APM) - Pressure from patients brought about early access to drugs under the so-called adaptive licensing, a conference heard from a senior clinician at the European Medicines Agency.
Dr Hans-Georg Eichler, senior medical officer at the EMA, and a key proponent of adaptive licensing, told the FT Global Pharmaceutical and Biotechnology Conference in London on Monday, patient pressure was a driving force in bringing about this new licensing model in Europe.
"We have to listen and respond and we have done that. This is why we have started on this adaptive pathway."
Addressing the conference, Michael Doherty, global head of regulatory affairs at Hoffman La-Roche, said drugs were being approved faster in the U.S. following the introduction by the U.S. Food and Drug Administration of the 'breakthrough therapy' model.
This had created a "divergence" between the U.S. and Europe. "With adaptive licensing, we can close that gap. It is a great step forward."
He described adaptive licensing as being in its infancy, having "a toe in the water". However, he said it would evolve and depend on evidence-based information. Much would depend on having access to a large, continual patient database. "It will change the way we innovate."
Andrew Dillon, chief executive of Britain's NICE, told the conference, the cost-effectiveness body was willing to talk to companies about "life-cycle pricing". He added: "We just need to pick the opportunities for those conversations."
He emphasised NICE's willingness to be a flexible participant in the regulatory process. Products which offer incremental benefits needed to be "explored and realised", he added. Doherty said he was "very interested" to hear Dillon's comments on life-cycle pricing.
Dillon said NICE has no intention ever to "trick or surprise" companies and is keen to foster a "partnership" relationship, involving constructive conversations. Addressing delegates he said: "I can see a few wry smiles on people's faces, but that is the truth."
While a number of speakers spoke of their enthusiasm for moves to get drugs to market faster,
Shire's CEO Dr Flemming Ornskov said those ambitions were secondary to a drug's safety. "That is the most important and number one thing."
Shire's CEO Dr Flemming Ornskov said those ambitions were secondary to a drug's safety. "That is the most important and number one thing."
Quick approvals necessitate long and costly follow-up studies, he said. "If you want to hold companies accountable, you have to have a tangible, measurable outcome."
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