Les vaccins : l’épée de Damoclès pour les laboratoires

FlickR - Vaccin H1N1, il est obligatoire de connaître vos droits - gillesroyÁ quelques jours du lancement de la campagne de vaccination en France contre la grippe H1N1, se pose véritablement la question de la responsabilité des laboratoires dans la mise sur le marché de tels vaccins. En effet, face à une éventuelle pandémie, les laboratoires ont dû resserrer le calendrier de la production des vaccins et de la libération des lots.

Cette accélération du processus de fabrication a fait oublier aux laboratoires pharmaceutiques de prendre les mesures et les précautions juridiques nécessaires pour éviter toute mise en cause ultérieure de leur responsabilité en cas de survenance d’effets indésirables non prévus.

La responsabilité des laboratoires du fait des produits défectueux est un sujet d’actualité, comme l’illustre la décision de la Première Chambre civile de la Cour de cassation en date du 9 juillet 2009 dans le contentieux de la vaccination contre l’hépatite B. En effet, tout laboratoire peut voir sa responsabilité civile engagée du fait des produits défectueux sur le fondement de l’article 1386-4 du Code civil, si la notice de présentation du vaccin commercialisé ne contient pas au nombre des effets secondaires indésirables du produit, celui qui est à l’origine du dommage ((Articles R.5121-137 à R.5121-149 du Code de la santé publique)).

Il appartient au laboratoire fabricant ou exploitant du médicament immunologique, en cas d’effets indésirables rapportés par un patient, de démontrer qu’il a parfaitement rempli son obligation d’information à l’égard de ce dernier dès lors que le lien causal entre le médicament défectueux et le dommage subi par le patient peut-être déduit de faits que la jurisprudence qualifient de «présomptions graves, précises et concordantes» ((Cass.civ.1ère, 9 juillet 2009, n°08-11.073.)).

Cette décision se révèle très sévère pour les laboratoires pharmaceutiques lorsqu’il n’est pas contesté que l’administration d’un médicament s’accompagne parfois d’effets indésirables. Une AMM (autorisation de mise sur le marché) est délivrée sur la base d’une étude du rapport bénéfice/risque. Certains effets indésirables sont révélés lors des essais précliniques, mais d’autres ne le sont qu’après leur mise en circulation, grâce à la pharmacovigilance ((Article R.5121-150 du Code de la santé publique.)).

Toutefois, en l’état actuel de la législation, le laboratoire pharmaceutique fabricant, exploitant ou titulaire de l’AMM restent responsables des effets indésirables du médicament commercialisé. En conséquence, les laboratoires pharmaceutiques ont tout intérêt à renforcer leur vigilance et s’assurer que les notices de présentation des médicaments et notamment des vaccins qu’ils commercialisent, contiennent bien tous les effets indésirables relevés lors des essais précliniques, ce qui en l’état actuel de la science est très difficile à réaliser.

Doit-on pour autant prendre exemple sur les Etats-Unis qui ont accordé une protection juridique totale aux laboratoires dans le cadre de la campagne de vaccination contre la grippe H1N1 ?

En France, l’article L.3131-3 du Code de la santé publique prévoit une « immunité juridique » pour les laboratoires pharmaceutiques dans des cas exceptionnels mais s’empresse de rappeler que ces dispositions ne les «exonèrent pas de l’engagement de leur responsabilité dans les conditions de droit commun en raison de la fabrication ou de la mise sur le marché du médicament», sauf à démontrer, sur le fondement de l’article 1386-11 du code civil, que «l’état des connaissances scientifiques et techniques, au moment où il (le laboratoire) a mis le produit en circulation, n’a pas permis de déceler l’existence du défaut».

L’exonération de responsabilité des laboratoires en cas de menace sanitaire grave n’est donc pas près de voir le jour…

Sophie Tatot, avocat au barreau de Paris

Cabinet Lefèvre Pelletier & associés.

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