Phar­ma com­pa­nies ques­tion new EU in­cen­tives as re­vamp ad­vances

Mem­bers of a com­mit­tee for the Eu­ro­pean Par­lia­ment on Tues­day signed off on a new leg­isla­tive over­haul that aims to make their con­ti­nent more at­trac­tive for phar­ma com­pa­nies, but that drug com­pa­nies have said may end up do­ing the op­po­site.

The new di­rec­tive and reg­u­la­tion would make phar­ma com­pa­nies el­i­gi­ble for a min­i­mum reg­u­la­to­ry da­ta pro­tec­tion pe­ri­od — where oth­er com­pa­nies can’t ac­cess their prod­uct da­ta — of sev­en and a half years. They’d al­so re­ceive two years of mar­ket pro­tec­tion dur­ing which gener­ics or biosim­i­lars couldn’t be sold.

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