A further delay has been announced for the European Commission's proposed pharmaceutical legislation which was set to be presented last week. In addition to a Communication on the future of the European Union single market for human-use pharmaceuticals, the proposed legislation also contains two Directives: a Directive relating to strengthening and rationalising pharmacovigilance; and a Directive relating to information communicated to patients.
According to the Commission, further technical changes are responsible for this unexpected delay. It is speculated, however, that the legislation has been delayed due to the controversial proposed Directive relating to information to patients. Critics of this legislation continue to maintain that this proposed Directive will undermine the European ban on direct consumer advertising. In particular, lobby groups claim that a lack of distinction between "information" and "advertising" is particularly problematic.
It remains uncertain how long the legislation has been delayed and proponents of the legislation have expressed concern that the much needed Directives could be delayed until after the parliamentary elections next June.
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