Member states stall on information to patients
By Sophie Petitjean | Tuesday 24 July 2012
The decision by the Cyprus EU Presidency not to tackle legislative proposals on information on medicines during this half-year is anything but isolated: all the member states have decided by mutual agreement to suspend the Council’s discussions on this subject, in spite of the European Commission’s efforts. The EU executive has already floated three trial balloons.
The proposals for a directive and a regulation on information to the public on medicines were presented in 2008 as part of a package on medicines. The co-legislators agreed on the pharmacovigilance component in 2010 (Regulation 1235/2010 and Directive 2010/84/EC, supplemented by a new directive being finalised) and on the counterfeiting aspect in 2011 (Directive 2011/62/EU). They have so far failed, on the other hand, to wrap up the third and last aspect, namely information on prescription medicines. At the time, the Commission was accused of being partial to the pharmaceutical industry. It consequently presented new proposals, in 2011, that incorporated many of the European Parliament’s amendments.
In the wake of the Mediator scandal (a medicine used to treat diabetes that led to numerous deaths), it added a new chapter on pharmacovigilance. However, this third version has still failed to convince the delegations, which are particularly concerned about exorbitant implementing costs, the lack of added value compared with existing rules and the risk of confusion between information and advertising. According to a diplomatic source, the member states are thought to be waiting for the Commission to simply withdraw its proposal.