Судебные тяжбы фармкомпаний из-за срока «эксклюзивности данных» в Казахстане нечасты. Как, например, громкое дело вокруг лекарств для лечения рака, которое рассмотрел Верховный суд РК, о чем Zakon.kz рассказал руководитель патентно-юридической компании «Шабалина и партнеры» Асылбек Абдыкулов.
Предметом конфликта интересов стали два противоопухолевых лекарственных средства для онкобольных. Одно – оригинальное, под названием «Кстанди», производства компании «Astellas Pharma Europe B.V.». Другое – генерик, который под наименованием «Биденза» выпускает фирма «BDR Pharmaceuticals International Pvt. Ltd.».
В обоих препаратах активным веществом является «Энзалутамид», которое и обеспечивает терапевтический эффект. Люди у нас в медицине искушены и наверняка знают разницу между оригинальными лекарственными средствами и генериками. Коротко говоря, первые намного дороже, ибо, придумывая новое лекарство, фармкомпании должны доказать его эффективность и безопасность, для чего проводят доклинические исследования и клинические испытания.
Генерики – аналоги уже придуманных ранее лекарств, которые в своей основе имеют такое же количество и качество активного вещества, что и в оригинальном средстве, но не уступающие им по эффективности.
Людям нужны доступные лекарства, оттого генерики разрешены. Однако, чтобы защитить коммерческие интересы изобретателей новых медицинских технологий, используется так называемая концепция «эксклюзивности данных» («Data exclusivity»). В фармацевтике правовой режим «эксклюзивности данных» направлен на защиту данных клинических исследований. В течение срока «эксклюзивности данных» информация по клиническим исследованиям по новому лекарству считается конфиденциальной, разглашение и использование которой не допускается. Для Казахстана понятие и институт «эксклюзивности данных» (data exclusivity) лекарственных средств является новеллой, и в законодательстве страны юридического определения не содержится.
При этом одни считают, что в Казахстане срок «эксклюзивности данных» определен пунктом 15 статьи 23 Кодекса «О здоровье народа и системе здравоохранения» и расширительно полагают, что закон установил шестилетний запрет на регистрацию генериков с момента регистрации оригинального препарата. Нет открытой информации об исследованиях – не может быть и генериков. Но только шесть лет.
Оппоненты полагают, что статья 23 Кодекса регламентирует только охрану от разглашения закрытой информации в течение 6 лет и больше ничего. Статья не запрещает регистрацию генерика в случае использования конфиденциальной информации.
Именно этот нюанс и стал причиной спора.
Компания из Нидерландов, производитель оригинального лекарственного средства «Кстанди» подала в суд иск о признании незаконной регистрацию генерика «Биденза». Незаконной эта регистрация была, по мнению истца, из-за невыдержанного срока. Так, Национальный центр экспертизы лекарственных средств и медицинских изделий Минздрава зарегистрировал «Кстанди» в Казахстане 23 сентября 2015 года, тогда как препарат «Биденза» – 26 мая 2021 года, то есть когда установленный шестилетний срок еще не истек.
Казахстанская судебная практика по спорам, связанным с правовым режимом «эксклюзивности данных» и их защитой, находится на этапе становления. Поэтому за спором оригинаторов с генериками следили не только юристы и фармкомпании. Тем более, что судебное разбирательство длилось долго – с ноября 2021 года до марта 2023 года. И на первых этапах, надо отметить, решения выносились в пользу истца. Специализированный межрайонный административный суд Астаны 15 февраля 2022 года иск удовлетворил. Затем апелляционной инстанцией это решение было оставлено в силе.
Здесь надо отметить, что создатель оригинального препарата подал иск не против производителя генерика. Ответчиками выступали казахстанские государственные предприятие и учреждение, в том числе Национальный центр экспертизы и Комитет фармконтроля Минздрава, которые зарегистрировали генерик в РК.
Потому, собственно, дело и разбиралось не в гражданском, а в административном судопроизводстве. Однако в качестве заинтересованного лица к суду был привлечен и изготовитель генерика – индийская компания «BDR Pharmaceuticals International Pvt. Ltd.». Интересы которой в суде представляла казахстанская юридическая компания «Шабалина и партнеры». Юристы этой компании и нашли именно те аргументы, которые решили дело в пользу генерика.
Изюминка дела заключается именно в том, что, где бы не была совершена первичная регистрация оригинального лекарства, именно от этой даты и считается шестилетний срок «эксклюзивности данных». Вообще первой, а не конкретно в какой-то стране, в данном случае, в Казахстане. Это следует из норм международного законодательства, которые ратифицированы Казахстаном.
Дело в том, что любая конфиденциальная информация рано или поздно становится раскрытой. Как только оригинальное лекарство регистрируется в какой-либо стране мира, то оно там же вводится в гражданский оборот, распространяется по всему миру и информация об этом препарате, его составе и активном веществе перестает быть закрытой. Причем информация перестает быть конфиденциальной для всего мира, а не для отдельно взятой страны. Территориальный принцип здесь не действует.
И значит, отсчитывать шесть лет следует не с момента регистрации в Казахстане – 23 сентября 2015 года, а с 21 июня 2013 года, когда впервые в мире состоялась регистрация «Кстанди» голландской компанией в Европейском союзе, и когда данные об оригинальном лекарстве перестали быть конфиденциальными.
То есть законные шесть лет прошли, и генерик зарегистрирован правильно.
Это было неожиданно и юридически очень красиво. Сказался и профессиональный опыт юристов фирмы «Шабалина и партнеры» в делах именно подобного рода.
В итоге 16 марта 2023 года Верховный Суд РК удовлетворил кассационную жалобу представителей компании и признал действия государственных органов по регистрации генерика «Биденза» правомерными. Суды не установили использование конфиденциальной информации государственными органами, доказательств этому истец не представил. Суд установил, что экспертиза и регистрация лекарства касается вопросов безопасности, эффективности и качества лекарства, а иные вопросы, в т.ч. интеллектуальной собственности и «эксклюзивности данных» не входят в компетенцию Национального центра экспертизы и Комитета фармконтроля Минздрава. При этом всеми судами не установлено несоответствие генерика требованиям надлежащих фармацевтических практик или законодательства РК в области здравоохранения или неблагоприятные пороки этого лекарства.
Со слов Асылбека Абдыкулова «Проблема правового режима «эксклюзивности данных» (data exclusivity) и его применения в Казахстане осталась открытой. Верховный Суд страны для отмены нижестоящих судебных актов использовал лишь часть аргументов из десятка, которые были приведены в кассационной жалобе. Остались без оценки вопросы интеллектуальной собственности, в частности положение «Болар» (Bolar exemption), вопросы использования компанией своих собственных клинических исследований, а не чужих эксклюзивных сведений, вопрос, что «эксклюзивность» данных не действует для ситуации их использования в некоммерческих целях без цели извлечения прибыли, и прочее».
Но, как говорит Асылбек Абдыкулов, остальные поводы и основания не пропадут – будут использованы в аналогичных кейсах, которых появляется все больше и больше. Верховный суд лишь в данном конкретном деле поставил точку, вообще же это скорее многоточие…
Как рассказал Асылбек Абдыкулов «За последние три года компания «Шабалина и партнеры» закончила несколько дел, связанных с «data exclusivity», по которым удалось добиться успеха с использованием собственной эксклюзивной методики и системы охраны и защиты. Режим «эксклюзивности данных» заключается в том, что он не исключает гражданский оборот в Казахстане оригинальных лекарственных средств, а позволяет выйти на рынок генерическим препаратам, конкурируя на локальном рынке. Законы не предусматривают запрет на проведение экспертизы и регистрацию генериков, не предусматривают признание регистрации генерика недействительной, и не запрещают обращение на территории страны, лекарственных средств, даже зарегистрированных с нарушением».
По мнению Асылбека Абдыкулова «Данный спор относится не к спору о защите конфиденциальной информации, а является спором в сфере государственных закупок лекарственных средств, где проглядывается желание не допустить конкурентный продукт на рынок Казахстана. Многие лекарственные средства обеспечивают высокую эффективность при лечении тех или иных заболеваний, однако их высокая стоимость ограничивает доступ к лечению народа Казахстана, в т.ч. социально уязвимых слоев населения. При этом желание запретить регистрацию генериков в Казахстане, в конечном итоге отразится на национальном потребителе, который будет ограничен в ассортименте лекарственных средств».
Товары медицинского назначения относятся к чувствительному сектору экономики любого государства, что предполагает разумное стимулирование выхода генериков на рынок, что приводит к существенному снижению цен на препараты, и, следовательно, выгоден конечным потребителям и государству, реализующему государственные программы здравоохранения.
Законы страны должны отвечать парадигмам и реалиям настоящего периода, а также целям поставленным Главой государства в Послании народу Казахстана от 1 сентября 2021 года, в части расширения объемов и номенклатуры контрактов с отечественными производителями, а также доведения доли лекарственных средств и медицинских изделий отечественного производства.
Выход на рынок новых препаратов и конкуренция со стороны препаратов-генериков приносит выгоду потребителям за счет появления дополнительной мотивации для фармацевтических компаний к осуществлению разработок и производству новых эффективных и инновационных препаратов, с одновременным снижением цен на существующие препараты, что отвечает интересам потребителей, предоставляя в их распоряжение современные лекарственные препараты.
В таких условиях Казахстану следует обеспечить оптимальный баланс между справедливыми и разумными интересами общественного здравоохранения и участниками оборота лекарственных средств.
P.S. И, кстати, пока готовилась эта статья, Верховный суд РК рассмотрел еще одно аналогичное дело касательно «data exclusivity», которыми занимались юристы компании «Шабалина и партнеры». Суд признал экспертизу и регистрацию лекарственного средства «Андролиз» законной и обоснованной.
Андрей Губенко
Источник: Zakon.kz
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