EU anticounterfeiting proposals - update

Last month I reported on activity by the European pharma industry to pilot a scheme for verifiying the identity of medicines at the point of dispensing as part of the moves to combat trade in counterfeits.

On the regulatory front, at its meeting in early June 2009, the Council of The European Union reviewed the progress of discussions on last year's "Pharmaceutical Package" that included proposals for combating the circulation of "falsified" medicinal products, which includes counterfeit medicines.

Member states" delegates on the Council working party discussing the detail of the proposal have welcomed it and there is general agreement that there is a need for legislation in this area to reduce the risk of falsified medicines reaching the EU market.

Nonetheless, as might be expected with such a complex issue, there are questions and reservations about certain elements of the proposal and these are the subject of ongoing discussion. Among the issues to be resolved are:

the actual definition of "falsified medicinal product"

the scope of the proposal - particularly whether or not it should extend to excipients and intermediate products

questions around the safety features to be incorporated into products - their efficiency and practical application, and

the practical aspects of applying the controls on APIs envisaged in the proposals.

Details of the current state of play can be found in a Commission document The proposals are subject to the co-decision procedure for EU legislation and as such will have to be considered by the European Parliament, but it is envisaged that the first reading of this proposal in that forum will not be until at least the autumn of this year.