Revue Prescrire, article en une, Medicines in Europe Directive May 2003
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Medicines in Europe:
Areas in which the Directive remains to be reinforced
On 2-3 June 2003 the European Council of health ministers will give an opinion on the Directive and Regulation that will form the legal framework for human medicines throughout the European Union in years to come. The wording of these texts will have enormous implications for patients, health professionals, and health insurance systems (social security and mutual insurance).
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The Medicines in Europe Forum demands that the Directive be reinforced in the following areas:

European medicines policy: state the priorities of medicines agencies and provide them with the necessary means (recital 1)
The Directive must ensure that member states apply European principles of independence and transparency to the organisation and functioning of their respective medicines agencies (article 1 - point 68a), and the European Agency must have the necessary means to accomplish its tasks (article 1 - point 24).
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Drug evaluation: towards trustworthy drugs
Rapporteurs appointed by marketing authorisation committees must have a 90-day period in order to analyse the available scientific data (article 1 - point 15); a basic comparative assessment must also be provided (article 1 - points 6 and 66); and the duration of clinical trials must be compatible with the expected treatment period, especially in the case of long term use (article 1 - point 6b).
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Pharmacovigilance: participation of patients and health professionals will improve the system
Drug packaging must bear labels encouraging users to notify unexpected events (article 1 - point 40); as far as possible, all available pharmacovigilance data must be taken into account, and not only those collected within Europe (recital 15).
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Information for patients: distribute reliable information through medicines agencies rather than pretend to control industry advertising
Patient information leaflets must be appropriately worded, and the international non proprietary name (and not only the trade name) must be clearly visible on all information and advertising material (article 1 - points 37, 38a, 55b and 57); the European Commission must withdraw its proposal to authorise de-facto direct-to-consumer advertising of prescription drugs, a proposal resoundingly rejected by the European Parliament at its first reading.
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Transparency of the activities of medicines agency, and access to documents: secrecy is no longer acceptable
Information held by medicines agencies must be publicly available, on the Internet and in readily accessible and well designed registers containing all relevant information on a given product, i.e. results of clinical trials, documents relating to marketing authorisation, and pharmacovigilance data; the European Regulation on public access to administrative documents must serve as a model for individual member states, whose legislations may presently differ (article 1 - points 9, 18, 37, 54, 62 and 64).
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Data protection: ambiguous texts will lead to conflicts
in particular, if distinctions are made between some drug categories, a scientific consensus must first be reached on the definitions and criteria used, before the final texts are adopted (article 10 (3a)). The Forum underlines that the proposed prolongation of data protection will delay generic development and have a negative impact on public health spending.
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Developing countries must not be considered "off-limits" to European texts
Increasing market globalisation means that the European Union must also consider what is happening outside its borders (article 1 - point 7).
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©La revue Prescrire, for the Medicines in Europe Forum 1 May 2003