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Рынок лекарств переделят и монополизируют — 9 новаций нового законопроекта

Рынок лекарств переделят и монополизируют — 9 новаций нового законопроекта

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by Июль 22, 2018 Новости

Украинский рынок лекарств собираются серьезно перестроить и переделить. В Верховной Раде зарегистрирован проект изменений (№1199) в закон «О лекарственных средствах». Далеко не все законопроекты, попадающие в парламент, становятся законами, но тот факт, что среди инициаторов этого документа замечены такие «реформаторы», как Мусий, Геращенко и Кужель, и поддерживает их не кто иной, как сама глава профильного комитета ВР Ольга Богомолец, говорит о том, что за проектом стоит серьезное лобби.

Документ готовился ударными темпами. Впервые о нем стало известно в тот же день, когда состоялось первое заседание только что созданной рабочей группы при комитете Верховной Рады по охране здоровья — 18 апреля 2018 года. У экспертов фармакологического сообщества эта спешка вызвала недоумение, все-таки реформы в такой чуткой сфере, как здравоохранение, требуют взвешенного и содержательного подхода. Критики выражали сомнения, не отразится ли принятие непродуманных изменений на доступности лекарств для населения.

Опубликованный на сайте Рады законопроект №1199 предполагает 9 наиболее важных нововведений:

Запрет на продажу лекарств в неположенных местах. Их позволяют реализовывать исключительно в аптеках и аптечных пунктах.

Сокращение количества аптек путем обязательного территориального регулирования: они не должны быть ближе 500 метров друг от друга.

Держателям аптек запрещается заниматься другими видами хозяйственной деятельности, кроме продажи лекарств.

Физлицо-предприниматель (ФЛП) для продажи медпрепаратов обязано иметь высшее образование не ниже второго уровня (магистр) в категории «Фармация».

ФЛП для работы с лекарствами обязано иметь сертификат провизора-специалиста от заведения последипломного образования.

Предпринимателю запрещены подработки: он не имеет права одновременно работать в другой аптеке.

ФЛП не имеет права на аптечные сети, оно не может открывать более одной аптеки.

В составе юридического лица, продающего медпрепараты, должно быть не менее трех основателей (акционеров), не представленных в других компаниях и ФЛП, причем все должны выполнять вышеуказанные образовательные требования.

Юрлицо не может иметь более 4 аптек розничной торговли на область и более 8, если оно занимается производством лекарств.

В пояснительной записке авторы обрисовали благие цели законопроекта: это и адаптация законодательства к нормам Евросоюза, и борьба с монополизмом и недобросовестной конкуренцией. Но в Украине уже немало хороших законов, которые не выполняются или выполняются в чьих-то персональных интересах. Так что ключевой момент — в чьих интересах будет выполняться этот закон в случае его принятия.

Главные факты

Законопроект бьет по малым предприятиям, хотя в преамбуле говорится как раз об их защите. ФЛП предлагается в течение 3 месяцев привести свою деятельность «в соответствии с требованиями к индивидуализации субъектов розничной торговли лекарственными средствами и мест для осуществления ими деятельности», а в течение года экстренно стать провизорами. Для тех, кто не является провизором, это требование означает закрытие. В целом положительный момент — продажей медпрепаратов займутся профессионалы. В городе требования будут выполнимы, однако непонятно, что будет в сельской местности, где лекарства чаще всего продают именно «необразованные» ФЛП. Захотят ли крупные аптечные сети погружаться в небольшие населенные пункты — вопрос.

Бизнес сможет легко обойти ограничение по владельцам аптечных сетей. Схем для этого хватает. И, скорее всего, предприниматели поступят очень просто — закроют действующие предприятия и тут же откроют новые на новых основателей. Ничего сложного в этом нет.

Расстояние между аптеками в 500 метров — это хорошо. Не будет аптек на каждом углу и бешеной конкуренции. Но, конечно же, если кто-то будет за этим следить. Непонятно, чьей обязанностью станет данный контроль, будет ли фактически осуществляться или увязнет в коррупции.

Новые требования и борьба с мелкими сетями аптек со ссылкой на европейские стандарты, могут сыграть на руку крупным сетям, и вылиться в монополизацию рынка. И как следствие — в рост цен на рядовых потребителей.

Чем все обернется

Благие цели законопроекта отметили и представители фармацевтического сообщества. Ассоциация представителей международных фармацевтических производителей в своем сообщении назвала необходимыми положения, которые направлены на определение и улучшение профессионального уровня специалистов в сфере фармацевтики, однако выделила и подводные камни законопроекта.

«Отметим, что действительно в странах Европейского Союза установлены различные механизмы обеспечения конкурентной среды в аптечной сфере, в том числе путем установления минимального расстояния между аптечными учреждениями, повышенными требованиями к их учредителям, возможному количеству открытых точек. Однако считаем, что установление любых ограничений в возможности законного ведения экономической деятельности требуют предварительного широкого диалога со всеми заинтересованными лицами, о чем нам неизвестно, а также анализа их последствий», — подчеркнули в Ассоциации.

С этим согласен и президент Всеукраинского совета защиты прав и безопасности пациентов Виктор Сердюк.

«АМКУ признал, что уже идет монополизация рынка, и аптечные сети играют в этом большую роль. Это создает риски, препараты будут дороже, недоступнее, все идет в максимизацию прибыли. Все равно, что продавать, — тапочки, туфли, лекарства… Аптечный бизнес все-таки должен быть обращенным к человеку. У нас достаточно хороших законов. Но для людей они пишутся редко, они пишутся для кого угодно. В основном, чтобы заработать деньги», — отметил он в разговоре с UBR.ua.

Сердюк обратил внимание, что в Украине отсутствуют 30% лекарств, которые используются европейскими врачами, но в законопроекте Богомолец задача исправить это положение не ставится.

«В законе нет ни слова о том, что каждое лекарство должно иметь подтверждение терапевтической эквивалентности. Хлеба, зрелищ и таблетки — это три кита, на которых держится государство», — заметил эксперт.

На пробелы в законопроекте обратила внимание и Ассоциация представителей международных фармацевтических производителей.

«Считаем, что на данный момент актуальным является вопрос урегулирования порядка доступа пациентов к лекарственным средствам через современные электронные технологии — онлайн торговлю. К сожалению, сфера электронной торговли лекарственными средствами остается в стороне от фокуса внимания законодателей. Именно данный вопрос требует в текущей ситуации законодательного регулирования, так как, с одной стороны, отсутствуют ясные механизмы обеспечения безопасности получаемых пациентом лекарственных средств (с точки зрения их хранения, транспортировки, легальности происхождения), а с другой — именно онлайн-торговля может значительно улучшить скорость и доступ пациентов к лекарственным средствам, в том числе маломобильных групп граждан», — говорится в сообщении организации.

Первое прочтение показывает ориентацию законопроекта на защиту интересов крупного бизнеса и на вытеснение мелкого — ФЛП оттираются с аптечного рынка. Чего не делает документ — не защищает потребителя, на него он вообще не ориентирован. Не на снижение или хотя бы на уравновешивание цен, не на повышение доступности лекарств и расширение их ассортимента.

Алексей Ермоленко

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