EU Parliament Report Calls For Nine-Year Data Protection Period

The rapporteur for the draft directive that is part of the proposed EU legislative revision package says the pharmaceutical industry needs certainty and long-term predictability regarding the expected level of regulatory data protection. But her proposal to increase the RDP period is not shared by the rapporteur for the draft regulation.

Paths
The EU parliament rapporteurs see different routes for data protection • Source: Shutterstock

Fears that the European Commission’s proposed overhaul of the pharmaceutical legislation will have a tortuous journey through the EU legislative machinery appear well grounded after the two rapporteurs for the European Parliament’s environment and public health committee (ENVI) took very different positions in their draft reports on the revision package.

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