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EU Rapporteur Slams Commission’s ‘Regulatory Sandbox’ & Antimicrobial ‘Voucher’ Proposals

 
• By Ian Schofield

Tiemo Wölken has proposed a public “European Medicines Facility” to elaborate R&D projects focusing on the development of priority antimicrobials and medicines for other unmet medical needs. He also disagrees with his fellow rapporteur’s support for an increase in the regulatory data protection period.

Roadblock
The EU pharma legislation revision may hit a few obstacles along the way • Source: Shutterstock

The European Parliament’s rapporteur for the draft regulation that is part of the planned overhaul of the EU pharmaceutical legislation has confirmed his support for European Commission’s proposal to reduce the “baseline” regulatory data protection from eight years to six.

In his draft report for the parliament’s environment and public health committee (ENVI), Tiemo Wölken says he welcomes the “stepping away from the model of ‘one-size-fits-all’ towards a stepwise approach of

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