EU pharma package delayed again

The European Commission has again postponed by at least a week the publication of draft regulations that could overhaul the pharmaceutical sector, amid rumours that divisions within the Commission are leading to the delays.

The European Commission had been expected to publish proposals on regulations on 26 November on a number of aspects of the industry, including new rules on pharmacovigilance, pharma's ability to communicate with patients and efforts to tackle drug counterfeiting.

A spokesman for the commission said the package would not be published on 26 November as announced because the College (comprising the 27 European Commissioners) "will be pre-occupied with the financial package." However, there are rumours of disagreements within the College over such subjects as banning the repackaging of medicines. The pharma industry has been pushing to ban repackaging, saying it is the only way to stop trade in counterfeit products.

Other measures in the pharmaceuticals package are also controversial, such as a proposal to allow companies to provide information on their drugs to patients, which could be viewed as tantamount to permitting direct-to-consumer advertising.

Greg Perry, director general, European Generic Medicines Association (EGA) said he understood the reason for the delay was lack of agreement on the ITP (information to patients virtual network) proposal.

Perry said the EGA's main concern was now that the proposed legislation will not make it through this session of the European Parliament - particularly the pharmacovigilance package, which is "a good proposal in terms of improving patient safety, harmonisation and better regulation."

A spokesman for the European Commissioner for Enterprise and Industry, Gunter Verheugen, said that the package had been delayed, citing an overloaded agenda. He said he could not give an exact date of when the proposals would be available but a tentative date of 3 December has been suggested by other sources.