martes, 5 de octubre de 2010

Europa vota a favor de una mayor acceso a información para el paciente


The vote by the European Parliament’s Environment Committee could be a breakthrough on a controversial issue which has been deadlocked for a decade.

Many MEPs have been opposed to relaxing European community laws on information to patients, fearing it would allow pharma companies to use US-style direct-to-consumer (DTC) advertising of medicines.

The European pharma body EFPIA has always distanced itself from US DTC, saying it only wants to provide relevant information to patients, and has welcomed the vote.

The Environment Committee seems to have been persuaded that change is needed, and the legislation will now be voted on by the full European Parliament in December.

The committee has made it clear, however, that only “objective, unbiased information” should be supplied to patients, and says it wants to protect them from “unsolicited information” on medicines.

Pharmaceutical companies would be included among those allowed to supply this information, but what information can be supplied, and through which channels will be hotly contested.

The MEPs propose that at least the following should be made available:

  • A summary of product characteristics, a labelling and package leaflet and a publicly accessible version of the assessment report of the medicinal product
  • The diseases and health conditions which are to be treated with the medicinal product
  • Information on how to prevent such diseases and conditions.
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