
Décret n° 2020-314 du 25 mars 2020 complétant le décret n° 2020-293 du 23 mars 2020 prescrivant les mesures générales nécessaires pour faire face à l’épidémie de covid-19 dans le cadre de l’état d’urgence sanitaire.
Le Premier ministre, Sur le
rapport du ministre des solidarités et de la santé,
Vu la directive (UE) 2015/1535 du Parlement européen et du Conseil du 9 septembre
2015 prévoyant une procédure d’information dans le domaine des réglementations
techniques et des règles relatives aux services de la société de l’information,
et notamment la notification n° 2020/162/F ;
Vu le code de la santé publique, notamment ses articles L. 3131-15, L. 5121-8 et L. 5123-2;
Vu le code de la sécurité sociale, notamment ses articles L. 162-17 et R. 160-8;
Vu la loi n° 2020-290 du 23 mars 2020 d’urgence pour faire face à l’épidémie de covid-19, notamment son article 4 ;
Vu le décret
n° 2020-293 du 23 mars 2020 prescrivant les mesures générales nécessaires
pour faire face à l’épidémie de covid-19 dans le cadre de l’état d’urgence
sanitaire ;
Vu les recommandations émises par le Haut conseil de la santé publique le 24
mars 2020 ;
Vu l’urgence,
Décrète :
Article 1, Chapitre 7 » : Dispositions relatives à la mise à disposition de médicaments
«Art. 12-2. – Par dérogation à l’article
L. 5121-8 du code de la santé publique, l’hydroxychloroquine
et l’association lopinavir/ritonavir peuvent
être prescrits, dispensés et administrés sous la responsabilité d’un médecin
aux patients atteints par le covid-19, dans les établissements de santé
qui les prennent en charge, ainsi que, pour la poursuite de leur traitement si
leur état le permet et sur autorisation du prescripteur initial, à domicile. «Les médicaments mentionnés au premier alinéa
sont fournis, achetés, utilisés et pris en charge par les établissements de
santé conformément à l’article
L. 5123-2 du code de la santé publique. «Ils sont vendus au public et au détail par les pharmacies à usage
intérieur autorisées et pris en charge conformément aux dispositions
du deuxième alinéa de l’article L. 162-17 du code de la sécurité sociale.
Le cas échéant, ces dispensations donnent lieu à remboursement ou prise en charge dans ce cadre sans participation de l’assuré en application des dispositions de l’article R. 160-8 du même code. L’Agence nationale de sécurité du médicament et des produits de santé est chargée, pour ces médicaments, d’élaborer un protocole d’utilisation thérapeutique à l’attention des professionnels de santé et d’établir les modalités d’une information adaptée à l’attention des patients.
« Le recueil d’informations concernant les effets indésirables et leur transmission au centre régional de pharmacovigilance territorialement compétent sont assurés par le professionnel de santé prenant en charge le patient dans le cadre des dispositions réglementaires en vigueur pour les médicaments bénéficiant d’une autorisation de mise sur le marché.
«La spécialité pharmaceutique PLAQUENIL© et les préparations à base d’hydroxychloroquine ne peuvent être dispensées par les pharmacies d’officine que dans le cadre d’une prescription initiale émanant exclusivement de spécialistes en rhumatologie, médecine interne, dermatologie, néphrologie, neurologie ou pédiatrie ou dans le cadre d’un renouvellement de prescription émanant de tout médecin.
«Afin de garantir l’approvisionnement approprié et continu des patients sur le territoire national, en officines de ville comme dans les pharmacies à usage intérieur, l’exportation des spécialités contenant l’association lopinavir/ritonavir ou de l’hydroxychloroquine est interdite. Ces dispositions ne s’appliquent pas à l’approvisionnement des collectivités relevant des articles 73 et 74 de la Constitution et de la Nouvelle-Calédonie. «Pour l’application du présent article, sont considérés comme établissements de santé les hôpitaux des armées, l’Institution nationale des Invalides et les structures médicales opérationnelles relevant du ministre de la défense déployées dans le cadre de l’état d’urgence sanitaire. ».
Article 2
Le ministre des solidarités et de la santé et la ministre des outre-mer sont chargés de l’exécution du présent décret, qui sera publié au Journal officiel de la République française et entrera en vigueur immédiatement.
Fait le 25 mars 2020.
Edouard
Philippe
Par le Premier ministre :
Le ministre des solidarités et de la santé,
Olivier Véran
La ministre des outre-mer,
Annick Girardin
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