Canada: Les Effets Du Projet De Loi 92 Sur Les Ententes Entre Les Fabricants Et Les Pharmacies Et Sur Le Soutien Aux Patients

Le 6 décembre 2016, l'Assemblée nationale du Québec a adopté le Projet de loi 92 intitulé « Loi visant à accroître les pouvoirs de la Régie de l'assurance maladie du Québec, à encadrer les pratiques commerciales en matière de médicaments ainsi qu'à protéger l'accès aux services d'interruption volontaire de grossesse ».

Le Projet de loi 92 accroît les pouvoirs de la Régie de l'assurance maladie du Québec (RAMQ) afin de lui permettre de mieux coordonner les divers secteurs se trouvant sous son égide. Le Projet de loi 92 interdit notamment certaines pratiques commerciales entre les fabricants de médicaments, les grossistes et les pharmacies ainsi que le soutien financier ou le remboursement des patients par les fabricants. Quant aux produits prévus à la Liste des médicaments de la RAMQ, le projet de loi prévoit des restrictions relatives au remboursement du prix des médicaments par les fabricants ainsi que des restrictions quant aux ententes contractuelles possibles entre les fabricants, les grossistes et les pharmacies. La plupart des dispositions du Projet de loi 92 sont déjà en vigueur, sous réserve de certaines exceptions importantes.

Ce que vous devez savoir

  • Il est interdit aux fabricants et aux grossistes de payer ou de rembourser (en tout ou en partie) à un patient le prix des médicaments listés, sauf pour des motifs « humanitaires ». Cette disposition entrera en vigueur au même moment que le règlement qui prévoira les critères définissant l'exception applicable aux motifs humanitaires.
  • De nouvelles restrictions sont imposées aux fabricants, aux grossistes et aux pharmacies quant aux ententes d'exclusivité ou de préférence relatives à l'achat des médicaments listés.
  • Le Projet de loi 92 permet à la RAMQ de retirer des médicaments de la liste dans plusieurs circonstances, notamment si :
    • un fabricant ne se conforme pas aux obligations prévues par règlement ou par entente avec le ministre;
    • un médicament concurrent fait l'objet d'une entente d'inscription avec le ministre; ou
    • L'Institut national d'excellence en santé et en services sociaux (INESSS) recommande de retirer ce médicament de la liste.

Cartes de fidélité et soutien aux patients

En vertu du Projet de loi 92, les fabricants ne peuvent payer ou rembourser, en tout ou en partie, le prix d'un médicament couvert par le régime provincial d'assurance maladie. En conséquence, il sera donc interdit aux fabricants de mettre en place des programmes de fidélisation aux termes desquels ils payent pour le compte d'un patient la différence entre le prix d'un médicament innovateur et celui d'un produit générique. Les fabricants seront également dans l'impossibilité de proposer des paiements conjoints, du financement temporaire ou d'autres types de soutien financier. Cette disposition sera toutefois sujette à exception pour des raisons « humanitaires », qui seront définies dans un règlement adopté en vertu de la Loi. Ces interdictions entreront en vigueur au même moment que le règlement relatif aux motifs « humanitaires » sera adopté. Le gouvernement n'a pas encore indiqué la date à laquelle ce règlement sera décrété.

Ententes commerciales

Le Projet de loi 92 interdit certaines ententes commerciales entre les fabricants, les grossistes et les pharmacies, ce qui implique ce qui suit :

  • Les fabricants ne peuvent exiger qu'un pharmacien s'approvisionne exclusivement auprès d'eux, tout comme ils ne peuvent encourager ou exiger, de manière directe ou indirecte, qu'un pharmacien vende de manière préférentielle une marque de médicaments donnée;
  • Les fabricants ne peuvent donner ou recevoir d'un pharmacien un quelconque avantage relié à la vente de médicaments et ce, directement ou indirectement, sauf tel qu'autorisé par règlement. Par exemple, les bénéfices et les allocations professionnelles déjà autorisés en vertu des lois québécoises existantes vont continuer à être autorisés.

Ces interdictions pourraient avoir une incidence sur les ententes de fournisseur privilégié ou les ententes de distribution spécialisée au Québec.

Retrait d'un médicament de la liste

Le Projet de loi 92 permet à la RAMQ de retirer un produit de la Liste des médicaments dans les cas suivants :

  1. Le fabricant ne respecte pas une des conditions ou un des engagements prévus par règlement, une disposition d'une entente d'inscription ou une disposition d'un contrat conclu à la suite d'un appel d'offres.
  2. Le prix de vente garanti par le fabricant pour un médicament est supérieur au montant maximum payable par le régime général.
  3. Un médicament ou un produit concurrent fait l'objet d'une entente d'inscription.
  4. L'Institut national d'excellence en santé et en services sociaux (INESSS) recommande le retrait ou le ministre est d'avis que l'intérêt public l'exige.

Les fabricants de produits innovateurs devront garder en tête ces dispositions en négociant une entente d'inscription de produit, attendu que la RAMQ fera valoir qu'elle détient le pouvoir de retirer un médicament de la liste si une alternative à meilleur coût devient disponible.

Obligations des pharmaciens

Afin de favoriser la transparence quant à la fixation du coût des médicaments, les pharmaciens auront une obligation d'information plus lourde à l'endroit des patients en ce qui a trait aux frais de délivrance des médicaments et ce, dès le 15 septembre 2017. Tout patient doit recevoir un reçu qui indique séparément le prix du médicament, le montant couvert par le régime général, la marge du grossiste, les frais professionnels du pharmacien et le montant qui devra être payé par le patient.

Pouvoirs d'application accrus

Sous l'égide de la nouvelle législation, la RAMQ aura des pouvoirs d'application accrus quant au recouvrement des rabais illégaux payés par les fabricants et grossistes de médicaments aux pharmacies. Lorsque les dispositions d'application entreront en vigueur, le 7 mars 2017, la RAMQ aura également l'autorité d'exiger une amende administrative monétaire représentant 15 % du montant de tels rabais. Les amendes pour la non-conformité d'un fabricant ou d'un grossiste avec la nouvelle législation peuvent s'élever à 1 million $ et être doublées en cas de récidive.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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