Revue Prescrire, article en une, Medicines in Europe January 2003 (8)

Medicines in Europe: Situation update, 31 December 2002. Some successes, much work remaining

Here we examine the state of play, now that the Commission has published its new draft proposals taking into account the amendments made by the Parliament and Council.

More information

Medicines in Europe: campaigning goes on!
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Transparency of the European Medicines Evaluation Agency (EMEA)
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Functioning of the agency
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Drug evaluation
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Pharmacovigilance
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Data protection
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Developing countries
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Pricing
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Download (English, file type: zip)
• thematic.zip

Compassionate use

Rather positive aspects:
• the Commission accepted that companies should provide patients with no therapeutic alternative with drugs that have not yet been authorised, within the framework of compassionate use, until the drug effectively becomes available (and not just until the date marketing authorisation is granted) (amendment 134, article 73-7bis);

• the Commission rejected an amendment arguing that compassionate use be financed by the companies (amendment 133, article 736) and considered that public funding could not be ruled out. We would like to see this point clarified in order to offer such patients real guarantees.




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