The European Commission’s widely 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,PharmaTimes writes.
An EC spokesman says that "technical changes” were needed before the legislation could be issued, and Guenter Verheugen, the EC vp and Commissioner for Enterprise and Industry who has responsibility for the pharmaceutical sector, stresses the need to "place quality ahead of speed” in delivering the proposals, according to PharmaTimes.
The proposed legislation consists of a 'communication' on the future of the European Union single market for pharmaceuticals, a proposal for a directive on strengthening and rationalizing EU pharmacovigilance, and a proposal for a directive on information to patients, the mag reminds us.
This last initiative is very controversial, because it would ease the current curbs on drugmakers communicating directly with patients, PharmaTimes writes. Some critics say the goal is to lift the ban on DTC advertising of prescription meds 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, PharmaTimes writes.
The EC wants European citizens to be able to access "understandable, good-quality, objective, reliable and non-promotional info about risks and benefits," and there will be clear differentiation between advertising and non-promotional info. "Basically, communication not covered by the definition of advertisement should be regarded as information,” it says. And the DTC 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, PharmaTimes writes.
On September 30, the Institute was one of nine UK organizations that 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 EC, 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.
The European Federation of Pharmaceutical Industries and Associations says the delay was "unexpected” and expressed concern that, without rapid agreement at the EC, 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,” EFPIA president Arthur Higgins, tells PharmaTimes. "We hope that the Commission will do whatever is required to get the pharmaceutical package back on track."
The Federation’s director-general, Brian Ager, adds that the package had been a long time in gestation and it was "disappointing to see it further delayed at this late stage.”