EFPIA: One Fifth Of Future Products ‘Unviable’ Under EU’s Plans To Modulate Regulatory Data Protection
The European Commission’s pharmaceutical legislation overhaul could result in a loss of 50 expected new products by 2035 and an annual fall in R&D spending of €2bn, the European pharma industry federation EFPIA claims.
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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.
Drug manufacturing in the EU would grind to a halt in under three years if a proposal to restrict per- and polyfluoroalkyl substances in the European Economic Area is implemented in its current form, says industry group EFPIA.
The European Commission will have a fight on its hands when it comes to the data protection part of its proposals for EU pharma legislative reform.