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EMA Pilot Project on Adaptive Licensing

Building on the earlier work at MIT and elsewhere, in March 2014, the European Medicines Agency (EMA) started inviting companies to submit ongoing medicine-development programs for prospective case studies in a pilot project on adaptive licensing. The agency received 26 applications and recently selected the first two ‘live assets’ for the pilot.

Why did the EMA decide to launch this pilot trial?

We knew that we needed to do something to address the trade-offs between timely access and evidence requirements. We can theorize, we can conduct retrospective studies, but ultimately in order to see what is feasible and what is not, we have to get into the water and run prospective pilots. There were concerns from industry, as well as within our own ranks, so we decided to make the pilot a ‘safe harbor’ environment, without fear of failure, either for the companies or for us. Companies are assured that there are no commitments for us or for them, and no positive or negative consequences. This is outside of the usual interactions between the regulators and industry.

Were you pleased with response from sponsors?

We received 26 submissions from companies large and small and were pleased with that response. We knew that there was a considerable amount of interest within the drug development community, but we couldn’t gauge whether there was a difference between that theoretical interest and a practical willingness to take part!

What are the next steps?

That will depend on each individual product. We will engage in these discussions and bring on board other stakeholders, particularly payers or HTA bodies. We also want to involve patients and, where possible, healthcare providers. We want to see whether we can design alternative, intelligent scenarios to bring these drugs to market. It will be a case-by-case decision as to how deeply we will drill down. We have set no timelines – it will take as long as it takes. We also have set no limit on the amount of pilots either – we will consider as many products as needed to fully understand what is feasible and what is not.

Read more about adaptive licensing here.

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