Pharmaceutical package:

Proposals for a Directive and a Regulation on information to the public on medicines were presented in 2008 as part of the ‘pharmaceutical package’.  The other two parts of the package – Directives on pharmacovigilance and counterfeiting - have largely been agreed by Council and Parliament, but the information to patients proposals remain blocked. The Cyprus EU Presidency has decided not to tackle these proposals, and this is very much in agreement with the views of the other Member States. Despite the Commission’s efforts to progress this controversial file, Member States have decided by mutual agreement to suspend the Council’s discussions on this subject. 

When the proposals first came out, the Commission was accused of being partial to the pharmaceutical industry. Since then, new proposals were presented in 2011, incorporating many of the European Parliament’s amendments.  As a result of the recent Mediator scandal (a medicine used to treat diabetes that led to numerous deaths), a third version was presented, which included a new chapter on pharmacovigilance.