The E.U. releases its new Pharma Regulation: Invest in the U.S. and China
28 April 2023
Wednesday, the European Commission published the E.U. Pharmaceutical Package, revising how the pharmaceutical system is regulated in the Europe. With more sticks than carrot in the proposal, E.U. is undermining its pharma/biotech potential.
The E.U. arrives first in the regulation space but last in the innovation space. Although not all the implications of this E.U. Pharmaceutical Package are straightforward to comprehend, the overall picture is not of an increased attractiveness for the E.U as a base for Pharma and Biotech.
The industry's worries focus mainly on the reduced length of drug IP protection, lower protection against generics and biosimilar market entry, added uncertainty in the rare disease space, and "extended" market protection being limited to antibiotic developers.
Even top CEOs of European pharma are saying that today's second-biggest market will soon swap its place in the ranking with APAC.
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