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\n
" } }, "LEGIARTI000006740842": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L162-16-1", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "1999-07-28", "DATE_DEBUT": "1998-12-27" } }, "META_COMMUN": { "ID": "LEGIARTI000006740842", "URL": "article/LEGI/ARTI/00/00/06/74/08/LEGIARTI000006740842.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SSAXXXXXXXX1X162L16BXXAB" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000866621", "#text": "Décret 85-1353 1985-12-17", "@sens": "source", "@cidtexte": "JORFTEXT000000866621", "@numtexte": "85-1353", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1985-12-17" }, { "@id": "JORFTEXT000000333548", "#text": "Ordonnance 86-1243 1986-12-01", "@sens": "source", "@cidtexte": "JORFTEXT000000333548", "@numtexte": "86-1243", "@typelien": "CITATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "1986-12-01" }, { "@id": "LEGIARTI000034405848", "@num": "69", "#text": "Décret n°90-1215 du 20 décembre 1990 - art. 69 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000717193", "@nortexte": "SPSS9001980D", "@numtexte": "90-1215", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1990-12-20" }, { "@id": "LEGIARTI000048701807", "@num": "20-4", "#text": "Ordonnance n°96-1122 du 20 décembre 1996 - 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Le prix de vente au public de chacun des médicaments mentionnés au premier alinéa de l'article L. 162-17 est fixé par convention entre l'entreprise exploitant le médicament et le comité économique du médicament conformément à l'article L. 162-17-4 ou, à défaut, par arrêté des ministres chargés de la sécurité sociale, de la santé et de l'économie, après avis du comité. La fixation de ce prix tient compte principalement de l'amélioration du service médical rendu apportée par le médicament, des prix des médicaments à même visée thérapeutique, des volumes de vente prévus ou constatés ainsi que des conditions prévisibles et réelles d'utilisation du médicament.

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Ce prix comprend les marges prévues par l'arrêté interministériel mentionné à l'article L. 162-38 ainsi que les taxes en vigueur.

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Un décret en Conseil d'Etat détermine les conditions d'application du présent article, et notamment les procédures et délais de fixation des prix.

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Sont constatées et poursuivies, dans les conditions fixées par le titre VI de l'ordonnance n° 86-1243 du 1er décembre 1986 relative à la liberté des prix et de la concurrence, les infractions aux conventions et arrêtés mentionnés ci-dessus.

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I. - Il est créé, auprès des ministres compétents, un Comité économique du médicament. Le comité contribue à l'élaboration de la politique économique du médicament. Il met en oeuvre les orientations qu'il reçoit des ministres compétents, en application de la loi de financement de la sécurité sociale.
\n
Ces orientations portent notamment sur les moyens propres à assurer le respect de l'objectif national de dépenses d'assurance maladie mentionné à l'article LO 111-3. En particulier, le comité applique ces orientations à la fixation des prix des médicaments à laquelle il procède en application de l'article L. 162-17-4.
\n
La composition et les règles de fonctionnement du comité sont déterminées par décret.
\n
II. - Le Comité économique du médicament assure un suivi périodique des dépenses de médicaments en vue de constater si l'évolution de ces dépenses est compatible avec le respect de l'objectif national de dépenses d'assurance maladie.
\n
Ce suivi comporte au moins deux constats à l'issue des quatre et huit premiers mois de l'année.
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En application des orientations qu'il reçoit annuellement des ministres compétents, le Comité économique du médicament peut conclure avec des entreprises ou groupes d'entreprises des conventions d'une durée maximum de quatre années relatives à un ou à des médicaments visés au premier alinéa de l'article L. 162-17. Ces conventions déterminent les relations entre le comité et chaque entreprise, et notamment :
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1° Le prix de ces médicaments et, le cas échéant, l'évolution de ces prix, notamment en fonction des volumes de vente ;
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2° Le cas échéant, les remises prévues en application de l'article L. 162-18 ;
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3° Les engagements de l'entreprise visant à la maîtrise de sa politique de promotion permettant d'assurer le bon usage du médicament ainsi que le respect des volumes de vente précités ;
\n
4° Les modalités de participation de l'entreprise à la mise en oeuvre des orientations ministérielles précitées ;
\n
5° Les dispositions conventionnelles applicables en cas de non-respect des engagements mentionnés au 3° et au 4°.
\n
Lorsque les orientations reçues par le comité ne sont pas compatibles avec les conventions précédemment conclues, lorsque l'évolution des dépenses de médicaments n'est manifestement pas compatible avec le respect de l'objectif national de dépenses d'assurance maladie ou en cas d'évolution significative des données scientifiques et épidémiologiques prises en compte pour la conclusion des conventions, le comité demande à l'entreprise concernée de conclure un avenant permettant d'adapter la convention à cette situation. En cas de refus de l'entreprise, le comité peut résilier la convention ou certaines de ses dispositions. Dans ce cas, le comité peut proposer aux ministres chargés de la sécurité sociale, de la santé et de l'économie de fixer le prix de ces médicaments par arrêté, en application de l'article L. 162-16-1.
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Lorsqu'une mesure d'interdiction de publicité a été prononcée par l'Agence du médicament dans les conditions prévues à l'article L. 551-6 du code de la santé publique, le Comité économique du médicament peut demander à l'entreprise concernée, dans le délai d'un mois à compter de la date de publication de la décision d'interdiction au Journal officiel, la modification des prix des médicaments fixés par convention faisant l'objet de l'interdiction de publicité ou le versement, en application de l'article L. 162-18, de remises sur le chiffre d'affaires de ces médicaments. Si l'avenant correspondant n'a pas été signé dans un délai de deux mois à compter de la même date, le comité peut résilier la convention ; ces prix sont fixés par arrêté des ministres chargés de la sécurité sociale, de la santé et de l'économie, après avis du comité. Cette modification des prix ne peut entraîner une dépense supplémentaire pour l'assurance maladie.
\n
Lorsque la mesure d'interdiction de publicité mentionnée à l'alinéa précédent porte sur un médicament dont le prix est fixé par arrêté, le Comité économique du médicament peut, dans le délai d'un mois à compter de la date de publication de la décision d'interdiction au Journal officiel, proposer à l'entreprise concernée de conclure une convention modifiant les prix des médicaments faisant l'objet de l'interdiction de publicité ou prévoyant, en application de l'article L. 162-18, le versement de remises sur le chiffre d'affaires de ces médicaments. A défaut de conclusion d'une telle convention dans un délai de deux mois à compter de la même date, ces prix sont modifiés par arrêté des ministres chargés de la sécurité sociale, de la santé et de l'économie, après avis du comité. Cette modification des prix ne peut entraîner une dépense supplémentaire pour l'assurance maladie.
\n
Les modalités d'application du présent article, et notamment les conditions de révision et de résiliation des conventions, sont définies par décret en Conseil d'Etat.
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Article 30 ENTIEREMENT_MODIF (LOI no 98-1194 du 23 décembre 1998 de financement de la sécurité sociale pour 1999 (1))