Eu­ro­pean Par­lia­ment adopts phar­ma leg­isla­tive re­vamp by wide mar­gin

Mem­bers of the Eu­ro­pean Par­lia­ment on Wednes­day vot­ed over­whelm­ing­ly in fa­vor of the first phar­ma-re­lat­ed leg­isla­tive over­haul in about two decades. If ul­ti­mate­ly agreed to by the Eu­ro­pean Coun­cil, the leg­isla­tive pack­age will pave the way for slight­ly short­er reg­u­la­to­ry da­ta pro­tec­tion pe­ri­ods and new re­wards to en­tice fur­ther in­vest­ment.

The new di­rec­tive and reg­u­la­tion, tar­get­ed at mak­ing Eu­rope a more at­trac­tive des­ti­na­tion for drug­mak­ers, 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.

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER