The European Commission’s hotly-anticipated “package” of proposed pharmaceutical legislation, which was due to be presented this week, has been delayed, and no date has been given for when it might be released.

Commission spokesmen said that “technical changes” were needed before the legislation could be issued, and Guenter Verheugen, the Commission Vice President and Commissioner for Enterprise and Industry who has responsibility for the pharmaceutical sector, stressed the need to “place quality ahead of speed” in delivering the proposals.

The proposed legislation consists of a Communication on the future of the European Union (EU) single market for human-use pharmaceuticals, a proposal for a Directive on strengthening and rationalising EU pharmacovigilance and a proposal for a Directive on information to patients. This latter initiative has been highly controversial, because it aims to ease the current curbs on pharmaceutical manufacturers communicating directly with patients – with the aim, according to some critics, of lifting the ban on direct-to-consumer advertising (DTCA) of medicines by the back door - and observers believe that a lack of consensus in Brussels on this highly contentious issue is the reason for the delay.

The Commission first announced plans for a legal framework covering the provision of information to patients at the start of the year, after a review concluded that access and quality of information across the EU is currently so unequal and variable that it could be a danger to public health.

The Commission has made it clear that, through the Directive, it wants European citizens to be able to access “understandable, good-quality, objective, reliable and non-promotional information about the benefits and the risks of medicines and treatments.” There will be clear differentiation between advertising and non-promotional information - “basically, communication not covered by the definition of advertisement should be regarded as information,” it says - and the DTCA ban will remain.

However, critics such as the UK patient advocacy group The Picker Institute, which says the Commission’s proposals are “clearly driven by the pharmaceutical industry’s interests, not by the interests of patients,” points out that no groundwork has yet been done to develop such a distinction, even though the initiative will depend on it.

On September 30, the Institute was one of nine UK organisations which once again urged Brussels to drop its plans. “In the absence of a consensus on the distinction between information and advertising, we believe that these proposals will effectively undermine the ban on DTCA,” it said in a letter to the Commission, which was also signed by the consumer group Which?, the British Medical Association, Royal College of Physicians, Royal College of Nurses, British Pharmacological Society, the Family Planning Association, Mind and Diabetes UK.

Commenting on the delay to the legislation’s delivery this week, the European Federation of Pharmaceutical Industries and Associations (EFPIA) said this was “unexpected” and expressed its concern that, without rapid agreement at the Commission, the proposals could be delayed until after the parliamentary elections next June. “This package of measures is an integral part of the process of ensuring and securing the supply of safe, non-counterfeit medicines and to improve health literacy among patients,” said EFPIA president Arthur J Higgins. We hope that the Commission will do whatever is required to get the pharmaceutical package back on track,” he added.

The Federation’s director-general, Brian Ager, added that the package had been a long time in gestation and it was “disappointing to see it further delayed at this late stage.”