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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here
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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here
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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here
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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here
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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here
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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here
©La revue Prescrire, for
the Medicines in Europe Forum 1 May 2003
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