The QMN Weekly Bulletin

EU Parliament Votes for Faster Generic Drug Pricing Decisions, Leaves New Drug Timelines Alone

Feb. 8, 2013

The European Parliament Wednesday voted overwhelmingly in favor of a draft law that would require member states to decide on the pricing and reimbursement of generic medicines within 60 days of an application.

EU Parliament members voted 559-54 in favor of the draft law, which is designed to speed up the availability of generic drugs. There were 72 abstentions. The legislation would revise the transparency rules for pricings and reimbursement of medicines, Directive 89/105/EEC, which have not been updated since 1989.

“It is unacceptable that delays in the pricing and reimbursement of medicines can sometimes reach more than 700 days,” Antonyia Parvanova, who is steering the legislation through Parliament, said. She must now negotiate an agreement with EU ministers.

The new legislation would leave the timeline for decisions concerning pricing of new drugs at 180 days. This decision drew criticism from the European Federation of Pharmaceuticals Industries and Associations (EFPIA). EFPIA wanted shorter maximum time limits for innovative drugs.

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