The proposal presented by the European Commission sets up that as a general rule the national decisions on pricing and reimbursement of medicines take within 120 days for innovative medicines, and for generic medicinal products within only 30, instead of 180 days today.

The European Commission has presented a new proposal aimed at simplifying and reducing the duration of national decisions on pricing and reimbursement of medicines. The new deadlines would be within 120 days for innovative medicines, as a rule, and for generic medicinal products within only 30, instead of 180 days today. In addition, the proposal also includes strong enforcement measures in case the decisions do not comply with the time limits, as these are often exceeded by Member States. In October 2011, the Commission also presented a proposal to improve the pharmacovigilance.

In particular, the new proposal also includes interim measures with the aim of correcting the alleged infringement or preventing further damage to the interests concerned, awarding damages to the applicant, or/and imposing a penalty payment, calculated by day of delay. It also introduces the obligation for Member States to regularly reporting on their decisions and the time involved, and notifying national pricing and reimbursement draft measures to the Commission to facilitate compliance from the beginning. The proposal also aims at ensuring legal clarity and consistency with the Court of Justice case-law and clarifying the scope of transparency obligations, according to the Commission.

The proposal, which has been presented as a Directive, shall repeal and replace the longstanding Directive from 1989, which no longer reflected the increased complexity of the pricing and reimbursement procedures in the Member States.