Елена Самтынова
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Законопроектом № 912246-7 предлагается внести изменения в Федеральный закон от 12 апреля 2010 г. № 61-ФЗ «Об обращении лекарственных средств» (далее – Закон № 61-ФЗ) и в Федеральный закон от 21 ноября 2011 г. № 323-ФЗ «Об основах охраны здоровья граждан в Российской Федерации».
В Законе № 61-ФЗ планируется1 определить понятия аптечной организации, аптечной сети, передвижного аптечного пункта, услуг по продвижению лекарственных препаратов для медицинского применения. Для оптовой торговли лекарствами законопроект устанавливает максимальный размер платы за услуги по продвижению продукции: совокупный размер вознаграждения, выплачиваемого производителем лекарств аптечным организациям, не должен превышать 5% от цены приобретенных лекарственных средств.
Предполагается введение ограничения на приобретение и аренду дополнительных площадей в границах соответствующего административно-территориального образования для оптовой и розничной торговли лекарственными препаратами для тех организаций, доля которых превышает 20% объема всех реализованных товаров, указанных в ч. 7 ст. 55 Закона № 61-ФЗ, в денежном выражении за предыдущий финансовый год в границах города федерального значения Москвы, Санкт-Петербурга или Севастополя, в границах муниципального района, городского округа. В случае нарушения указанных требований сделки будут признаваться ничтожными. Причем, иск о применении последствий недействительности такой сделки может быть предъявлен в суд любым заинтересованным лицом. Данное положение не планируется распространять на субъекты обращения лекарственных средств, выручка которых от реализации вышеуказанных товаров за последний календарный год не превышает 400 млн руб.
Также законопроект обязывает аптеки, в том числе ИП, имеющих лицензию на фармацевтическую деятельность, обеспечить покупателям доступ к информации о наличии лекарств и их минимальной цене в рамках одного международного непатентованного наименования (МНН) или иного – в случае его отсутствия. Один из авторов законопроекта депутат Госдумы Сергей Неверов пояснил, что для этих целей в аптеках должны выделяться витрины. Оговаривается обязательность обеспечения сторонами договора поставки лекарственных средств (организациями торговли, аптеками, ИП, производителями и поставщиками лекарственных средств) доступа к информации через интернет-сайты об условиях отбора контрагентов для заключения договора и о его существенных условиях.
Предлагается установить запрет для производителей и продавцов лекарственных средств за взимание либо внесение платы за право поставок лекарственных препаратов, за изменение ассортимента лекарств, за возмещение расходов в связи с утратой или повреждением препаратов для медицинского применения после перехода права собственности на такие товары (если это не следствие виновных действий производителя и (или) организации оптовой торговли), за возмещение расходов, не связанных с исполнением договора поставки и последующей продажей конкретной партии таких товаров. Также устанавливается срок оплаты по договору поставки лекарственных препаратов: с условием отложенной оплаты он не может превышать 90 календарных дней со дня фактического получения лекарственных препаратов.
В Федеральный закон от 21 ноября 2011 г. № 323-ФЗ «Об основах охраны здоровья граждан в Российской Федерации» планируется внести изменения, которыми предусмотрено ведение персонифицированного учета лиц, осуществляющих фармацевтическую деятельность. В соответствующем реестре помимо базового образования фармацевта будет отражаться информация о повышении квалификации. По мнению разработчиков законопроекта, ведение единого реестра будет способствовать повышению уровня профессионализма фармацевтов и персональной ответственности руководителей аптечных организаций.
Целью законопроекта является предупреждение и недопущение монополизации рынка розничной торговли лекарствами. Сергей Неверов также пояснил, что данные меры должны предупредить неадекватное завышение цен на ряд лекарств в период эпидемий.
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1 С текстом законопроекта № 912246-7 «О внесении изменений в Федеральный закон «Об обращении лекарственных средств» и Федеральный закон «Об основах охраны здоровья граждан в Российской Федерации» и материалами к нему можно ознакомиться на официальном сайте Госдумы.
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