MEDICINES : COMMISSION PRESENTS REVISED AND SOFTENED PHARMA PACKAGE.

The pharmaceutical package presented by the European Commission, on 10 December, is very different from the initial proposals put together by Industry Commissioner Gunter Verheugen: it is based more on public health and patients' interests than on competitiveness or the interests of the pharmaceutical industry.

The Commission has tabled: a communication of a political nature to trigger reflection on how to improve market access and the price-setting mechanism; a proposal for a directive on combating counterfeit drugs and illegal distribution of medicinal products; a proposal for a directive on information on prescription-only drugs; and a proposal for a directive on pharmacovigilance.

Verheugen's proposals on information for patients on prescription-only drugs were considerably revised. Drafted years ago by the Pharmaceutical Forum, the idea was to facilitate direct communication between the pharmaceutical industry and patients on prescription drugs through different channels, such as the press and websites. The text had aroused a great deal of suspicion in recent months regarding the intentions of the industry, which could have taken advantage of the directive to engage in hidden advertising. Today, the proposal incorporates most of the amendments sought by Health Commissioner Androula Vassiliou and will only allow information to be published on websites monitored by the authorities and health care professionals. The press has been ruled out if the member states have not first drawn up a list of media specialised in health issues allowed to publish such information. In other words, if the member states do not wish to draw up such a list, the pharmaceutical industry will not be able to provide information on its products, said a source at the health commissioner's cabinet.

There is another disavowal of the German commissioner's proposal on this issue: the general rule for patient information will be prior monitoring and control by health officials, rather than ex post monitoring, as suggested by Verheugen.

Ex post controls will only be allowed when the information released by the industry has already been validated...