Patient Information – latest information on concerns

Sweden 7-9 October – Current challenges with the Patient Information proposal were shared by the Commission with delegates at the TOPRA annual symposium this week.

Irene Sacristan Sanchez from the European Commission updated delegates on the “Pharma Package” which includes a legal proposal on Patient Information regarding prescription only medicines – to identify and address the challenges to provide safe, innovative and accessible medicines.

Ms Sacristan Sanchez informed delegates that some Member States are not happy with the proposal and certain members have expressed serious concerns. “The Commission’s proposal aimed to balance concerns, and through trying to please everyone, they have pleased no one, because for some member states this is too liberal and for others it is too restricting.”

Ms Sacristan Sanchez continued to say, “while maintaining the ban of advertising, we do need action at community level, to have harmonized rules on the possibility to provide information to patients.” She explained that the ban on advertising for prescription medicines does not mean that there should be a ban on all promotional information, but nevertheless, “we need clear and detailed rules on what and how information is provided to make sure that there is a non-promotional element.”

The Commission has proposed various measures to identify types of information, channels for distribution and quality criteria to provide a framework that clearly distinguishes between advertising and information to patients.

In contrast to the counterfeit and pharmacovigilance proposals, Member States are not satisfied with the Patient Information legislation. There are two angles for concern: Firstly, “there are member states that have a problem with Industry providing information because they understand it will be impossible to distinguish between advertising and information, or they consider that, if it is provided by Industry, by definition it will be promotional, because Industry will always be aiming to increase sales.” And, secondly, “due to the rules on types of information, distribution channels and quality criteria, there will be restriction on freedom of speech” said Sacristan Sanchez.

The Patient Information legislation has been discussed under every presidency, yet it will not be discussed under the Swedish presidency, which has prioritised pharmacovigilance and counterfeits. However, the EU Parliament has been calling on the Commission to put in legal proposals of Patient Information for years and in the past weeks, quite a few MEPs have been making it clear that they want this proposal discussed.

The European Commission vice president, Gunter Verheugen, is also urging that the EU rules on provision of information to patients for prescription only medications be updated.

The proposal will be taken through to parliament with the other two proposals of the “Pharma Package” legislation, as part of the co-decision procedure, ready for a plenary vote next year.

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