EU pharmaceutical package talks stall

European Union discussions on new pharmaceutical legislation will not be concluded this year according to the Swedish presidency.

The negotiations between the EU's 27 member states on how to combat counterfeiting and how to improve pharmacovigilance are certain to spill over into 2010, said Johan Lindberg, the Swedish official who is chairing the talks in the Council of Ministers working party on pharmaceuticals.

Lindberg said there are still many areas to be debated on the proposals that were presented last December by the European Commission (EC). In any case, the Council cannot complete its work until it receives the views of the European Parliament, and even a draft report on the proposals is unlikely to emerge from there until December.

"We can try to solve problems and reach as much agreement as possible on both areas during the autumn," said Lindberg.

Sweden will make no attempt to make progress on opening up the provision of information to the public on prescription medicines. "There was just too much opposition in council," said Lindberg.

EU members are now determined to widen the composition of the proposed new European committee on pharmacovigilance to include representatives from all member states, instead of the restricted membership proposed by the EC.

The subjects still to be tackled in the working group include the reporting system for adverse effects, the link between the new committee and the European Medicines Agency (EMEA), the definition of adverse events, and proposals for intensive monitoring of suspect medicines.

Lindberg acknowledged that the proposal deals only with the legal distribution chain and does not tackle the questions raised by the sale of medicines over the internet, a gap that needs to be filled by further proposals in the next few years.

All member states have agreed that a definition of a counterfeit medicine is necessary. Discussion has focused on the borderline between the regulatory action proposed by the EC, and the possibility of imposing legal sanctions on counterfeiters.

"It is important to have a clear boundary between what we are doing and questions of criminal legislation," said Lindberg. "All member states agree that we shouldn't be tackling the question of criminality."

A similar approach is being taken to questions of ownership of data generated by pharmacies. "This also needs boundaries and we have made clear that this proposal will be without prejudice to intellectual property," said Lindberg.