EU Report Calls to Minimise Amount of Data Generated by Sponsors

The European Parliament’s policy department published a report recommending regulators and health technology assessment (HTA) bodies take steps to minimise the amount of data demanded of drug developers. The report also makes connections between pharmaceutical R&D models and access to affordable medicines.

The report describes the current drug R&D and market access situation, as well as initiatives already in place to try to optimise the process. This information will support discussions at the Committee on Environment, Public Health and Food Safety (ENVI), the European Parliament group for which the report was written. In the final few pages, the authors put forward some policy proposals for ENVI members and their peers. The suggestions include ideas that could affect regulators in Europe.

“Attention must be paid to commercially unattractive medicines with a valuable unmet medical need. However, regulators should avoid making any additional requirements for data collection for new medicines as this could result in a decline in productivity of new medicines,” the authors wrote. “This means that when [randomised controlled trials] aiming for more subgroups to demonstrate patient benefit are combined with increasing data requirements to demonstrate safety and efficacy, pharmaceutical companies have to collect more data on more patients.”

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Published 29. November 2016 in News EU