Les citoyens, patients et professionnels de santé,
peuvent faire entendre leur voix auprès des instances européennes.
En témoignent les propositions d'amendements du Collectif Europe
et Médicament (en anglais), élaborés dans le
but de défendre une politique du médicament dans l'intérêt
de la santé publique.
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Certains des points défendus par le Collectif, l'Association
Mieux Prescrire et la revue Prescrire sont soutenus par des députés
européens, et ont des chances d'être retenus.
D'autres points ne sont pas acquis. Le lobbying des firmes pharmaceutiques
s'amplifie.
À titre d'exemple, voici deux propositions d'amendements
élaborés par le Collectif (propositions en gras dans
le texte), dans deux domaines essentiels.
Exemple 1 :
indépendance des institutions
(dans les considérants)
Recital 4 (Directive 2001/83/CE)
(4) The main purpose of any regulation on the production and distribution
of medicinal products for human use should be to safeguard public
health. However, this objective should be achieved by means which
do not hinder the development of the pharmaceutical industry or
trade in medicinal products in the Community.
Amendment 2
(4) The main purpose of any regulation on the production and distribution
of medicinal products for human use is to
safeguard public health. The development of the pharmaceutical industry
or trade in medicinal products in the Community must
not compromise public health objectives. The highest level of human
health and consumer protection has to be insured, as stated in articles
152 and 153 of the Treaty.
Justification
The proposed article 4 must be in accordance with articles 152 and
153 of the Treaty.
Exemple 2 :
nécessité de la réévaluation régulière
des autorisations de mise sur le marché
(dans le corps de la Directive)
Article 24, paragraph 1 (Directive 2001/83/CE)
1. Without prejudice to paragraphs 2 and 3, a marketing authorisation
shall be valid indefinitely.
Amendment 18
1. Marketing authorisation shall be valid for
five years and shall be renewable for five-year periods, after reevaluation
by the competent authorities of the risk/ benefit balance in the
light of the new efficacy and safety data internationally available.
Justification
The role of medicines cannot be assessed without comparing their
added therapeutic value to existing treatments.
The 5-year renewal of marketing authorisation is meant to protect
citizen's health. Provided it is scientifically applied, the 5-year
renewal allows benefits and risks of medicines to be regularly reassessed.
It allows the EU market to be cleared of medicines with poorly proven
efficacy, poor benefit/risk ratio compared to others, or medicines
whose companies fail to provide requested pharmacovigilance data.
©La revue Prescrire 1er octobre 2002
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