PHARMACEUTICALS PACKAGE : INTERNAL MARKET COMMITTEE SEEKS FINE-TUNING ON SEVERAL POINTS.

Two draft opinions on the pharmaceuticals package were debated, on 26 January, by the European Parliament's Committee on Internal Market (IMCO)(1). They are set for adoption in February. According to MEPs, certain points of the European Commission's proposals on drug monitoring and on combating counterfeit drugs need to be fine-tuned.

On the update of drug monitoring rules(2), Philippe Juvin (EPP, France) observed that the existing system does not work well, primarily due to a tendency to under-declare the undesirable side effects of drugs. For rapporteur Claude Turmes (Greens-EFA, Luxembourg), it is useful for patients to be able to participate in identifying unwanted effects, but they are not experts. It is therefore necessary to put in place a system based on regional and national centres to filter information provided by patients.

Article 21(a) setting simpler rules for the authorisation of release on the market of certain drugs also drew MEPs' attention. Although the rapporteur recommends deleting the article on the grounds that EU and national provisions already exist and that this measure could lead to the general use of simplified procedures, other MEPs are calling for limited application to exceptional situations. Opinions are divided on patient information leaflets, and more specifically the Environment Committee's proposal to affix a black triangle on drugs whose authorisation is matched with an obligation to conduct a post-authorisation safety study. Some...

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