– Jasne zarysowanie, w którym miejscu systemu wspierania nauki agencja się znajduje, jest naszym pierwszym celem – mówi prof. Wojciech Fendler z Uniwersytetu Medycznego w Łodzi, nowo powołany prezes Agencji Badań Medycznych. Wśród jego priorytetowych działań jest też rozkręcenie współpracy międzynarodowej i współpracy z biznesem. – Jeżeli będzie chwila spokoju, wolna od politycznych zawirowań, to jest duża szansa na to, że uda się wszystkie założone zadania zrealizować i stworzyć spójny, racjonalny system wspierania nauki w Polsce – mówi.
Jakie ma pan trzy główne cele jako prezes Agencji Badań Medycznych?
Prof. Wojciech Fendler, prezes Agencji Badań Medycznych: – Agencja Badań Medycznych spośród jednostek takich jak: Narodowe Centrum Nauki, Narodowe Centrum Badań i Rozwoju, Narodowa Agencja Wymiany Akademickiej czy Fundacja na rzecz Nauki Polskiej, jest najmłodsza i jej rola zawęża się do dość wąskiego grona beneficjentów. Chcemy jednak, jako agencja, w odpowiedni sposób ułożyć całą układankę wspierania szeroko pojętej nauki w Polsce. Nasza główna idea jest taka, żeby system nauki był spójny. Chcemy, i pewne ruchy w tym kierunku zostały już poczynione, jasno ustalić, która instytucja co robi, które działania których agencji się zazębiają, które są komplementarne i w jaki sposób można zaplanować procesy innowacji czy wspierania odkryć naukowych tak, żeby wiedzieć, w jakiś sposób jest wspierany dany obszar i na jakich etapach.
Jakie ruchy, o których pan wspomniał, w tym aspekcie zostały już zrobione?
– Realizujemy projekty wspólne z NAWĄ i z NCN-em. Niedługo mamy spotkanie z NCBiR-em, które ma na celu ułożenie pewnego rodzaju schematu wspierania sektora biotechnologicznego, żeby łatwiej było dotrzeć do łóżek pacjentów z produktami badań naukowych.
Jasne zarysowanie, w którym miejscu systemu wspierania nauki agencja się znajduje, umocowanie jej w całym ekosystemie wspierania nauki w Polsce, jest naszym – jako agencji – pierwszym celem. To nie jest tak, że wymyślam coś od nowa, bo agencja funkcjonuje już pięć lat i ma dość dobre mechanizmy konkretnego wspierania beneficjentów na froncie badań biomedycznych. Przez ostatnie lata sporo się jednak zmieniło, np. potrzeby jednostek naukowych czy źródła finansowania.
Dlatego chcemy pozmieniać i poukładać inaczej pewne elementy w systemie tak, żeby najlepiej odpowiadały współczesnym potrzebom gospodarki i nauki oraz pozwoliły efektywnie wykorzystać publiczne środki na ten cel.
To pierwszy, główny cel. Jaki jest kolejny?
– Rozkręcenie współpracy międzynarodowej. Agencja w zakresie swoich działań statutowych ma wpisaną współpracę międzynarodową. Tylko była ona zdefiniowana dość szeroko, a zakres działań, który jest niekonkretny, powoduje, że trudno je realizować.
Jedną z międzynarodowych inicjatyw w zakresie edukacyjno-szkoleniowym, która już działa i będziemy chcieli, żeby działała, jest program wspierania kadr medycznych poprzez Polish Clinical Scholar Research Training realizowany przez Harvard Medical School. Jego celem jest przede wszystkim szkolenie kadry naukowej i dążenie do tego, by wyćwiczyć naukowców i lekarzy w prowadzeniu badań klinicznych na wysokim poziomie. W planach jest pięć edycji, w których weźmie udział po stu uczestników. Aktualnie pracujemy nad uruchomieniem rekrutacji do trzeciej edycji. Planujemy też rozpisać projekt dotyczący badań epidemiologicznych, zakładający działania edukacyjne w zakresie ponadnarodowym. Ten aspekt edukacyjno-szkoleniowy ma być pierwszym filarem współpracy międzynarodowej w ramach agencji.
Po drugie pracujemy nad reorganizacją wydziałów merytorycznych agencji. Chcemy stworzyć wydział, który odpowiadałby m.in. za włączanie agencji w projekty międzynarodowe, np. realizowane wspólnie z National Institutes of Health, czy w ramach inicjatywy EU4Health, w których agencja występuje jako podmiot koordynujący na poziomie krajowym i będzie mieć za zadanie spajanie konsorcjów albo wspieranie naszych beneficjentów w projektach europejskich. I to jest druga część współpracy międzynarodowej.
W ramach trzeciej chcemy, by inwestycje, które poczyniliśmy w centra wsparcia badań klinicznych, czy centra medycyny cyfrowej, przełożyły się na widoczność naszych jednostek w badaniach międzynarodowych. Polska jest atrakcyjnym rynkiem dla badań klinicznych. Każdego roku rejestrowane i uruchamiane jest w Polsce kilkaset badań klinicznych. W większości rola polskiego ośrodka jest w nich jednak ograniczona do rekrutowania pacjentów i realizowania badań według protokołu. Taka usługowa rola jest cenna i ważna, bo dostarcza nowej wiedzy i zwykle zapewnia pacjentom lepsze leczenie, ale nie jest to rola kreatywna i kluczowa, realnie zmieniająca światową praktykę medyczną. Mamy poczucie, że nie przekłada się ona na podwyższenie prestiżu i rozpoznawalności polskich ośrodków w badaniach klinicznych. Chcielibyśmy to zmienić.
W jaki sposób?
– Rozmawiamy z firmami farmaceutycznymi z obszarów badań klinicznych, które dostrzegają nasz potencjał. Zachęcamy sponsorów do zwrócenia uwagi na Polskę. Jest to trudne, ale przykłady lokowania CentrumOperacyjnego Badań Klinicznych firmy Astra Zeneca w Warszawie pokazuje, że jest to możliwe. Rozpoznawalność naszego państwa wzrasta i agencja chciałaby ten nurt jeszcze podbić tak, by Polska stała się regionalnym hubem, z którego można inicjować badania i zapraszać ośrodki z innych krajów, w szczególności ze środkowej i wschodniej Europy.
Jaki jest trzeci cel na najbliższe lata?
– Chcemy odczarować, zracjonalizować obawę naukowców, instytucji, rządu przed współpracą z biznesem. Przyjęło się u nas, że biznes to raczej ci, którzy przychodzą z lepszymi lub gorszymi pomysłami głównie po to, by wykorzystać publiczne pieniądze do ich realizacji. Oczywiście możemy znaleźć kilka przypadków nietrafionych projektów komercyjnych, natomiast logika badań naukowych, proces innowacji oraz wdrażania nowych leków na rynek pokazuje, że bez udziału biznesu np. cały czas chodzilibyśmy w maseczkach. Nie byłoby szczepionek ani leków na COVID-19, dlatego że żaden kraj nie jest w stanie podjąć ryzyka i kosztów samodzielnego wytworzenia nowego leku czy szczepionki. Wdrożenie tych produktów na rynek i później zarządzanie nimi jest na tyle dużą i ryzykowną inicjatywą, że mogą to robić tylko wyspecjalizowane podmioty. W związku z czym musimy i powinniśmy współpracować z biznesem na różnych poziomach, docenić jego rolę i znaczenie w procesie wytwarzania i wdrażania innowacji w medycynie.
Wspierając badania komercyjne i niekomercyjne oraz różnego rodzaju inicjatywy szkoleniowe, widzimy, czego potrzebuje strona biznesowa i co oferują uczelnie medyczne i instytuty naukowe. Wiemy, gdzie te światy się rozmijają. Np. kształcimy farmaceutów, ale nie do końca w takim zakresie, w którym oczekiwałyby obecnie firmy. Te z kolei nie za bardzo mogą się przebić do uczelni i zasugerować im, jak mają kształcić. Trzeba by więc ustalić, jakie są realne i perspektywiczne potrzeby firm po to, by zwinnie wprowadzić zmiany w programie studiów, żeby za kilka lat mieć odpowiednie kadry do podtrzymania i rozwijania innowacji, a nie nieustająco doszkalać absolwentów w zakresie praktycznych umiejętności, których brakuje w krytycznych obszarach. Uczelnie dzięki temu mogą lepiej poznać potrzeby rynku i, wprowadzając nowe i atrakcyjne programy studiów, konkurować o najlepszych absolwentów.
Jako agencja chcemy działać w formie brokera. Przez platformę, którą już posiadamy, czyli Warsaw Health Innovation Hub, rozwijamy środowisko do dialogu. W ten sposób pokażemy szanse, możliwości i mechanizmy współpracy, jednocześnie sprawiając, by towarzystwa naukowe, czy inne instytucje stały się partnerami dla biznesu, a biznes uwierzył, że mamy dobre kadry, a działania akademickie są solidne i wydajne. Musimy zachęcić biznes do działania w Polsce. Tylko w ten sposób pojawiają się nowe miejsca pracy, szybciej trafiają do nas nowe leki, a decydentom łatwiej będzie decydować, które firmy i w jaki sposób wspierać.
Co w takim razie pozostanie bez zmian?
– Oczywiście nie chcę zburzyć tego, co agencja już osiągnęła, czyli mechanizmów przyznawania dofinansowania w ramach konkursów na niekomerycyjne badania kliniczne. Te konkursy są systematycznie ogłaszane. Mamy już kolejne zaplanowane na następny rok. Rozszerzamy ofertę o badania translacyjne. Jak najbardziej chcę więc tę działalność zachować i podtrzymać. Jeśli chodzi o wspieranie badań realizowanych w uczelniach czy instytutach, zmiany kursu w zakresie tego, co agencja dotychczas robiła, będą niewielkie.
Jaka jest największa trudność w realizacji celów, które pan przedstawił?
– Największym wyzwaniem jest kwestia danych medycznych, ich dostępności i wymiany. Z jednej strony napotykamy na nieścisłości pomiędzy przepisami, które regulują obieg danych medycznych, ale z drugiej strony blokują nas stare przyzwyczajenia i irracjonalne obawy uczelni i szpitali klinicznych na temat tego, co można z danymi robić.
Czyli bariera mentalna, najtrudniejsza do zmiany.
– Tak, ale o ile możemy mieć różne poglądy i opinie na ten temat, o tyle wymagania dotyczące wdrożenia Rozporządzenia Europejskiej Przestrzeni Danych Medycznych, czyli EHDS, obligują nas do konkretnych działań w tym temacie. Lepiej podjąć je szybciej i postawić Polskę w awangardzie operacji na dużych danych medycznych niż dopuścić do sytuacji, jaką mieliśmy np. z RODO. Odkąd przepisy te weszły w życie, niemal każdy, gdy nie chciał czegoś robić z danymi, zasłaniał się zdaniem, że nie wie, czy może, bo jest RODO.
Teraz byłoby dobrze wyprzedzić zmiany, które nas nieuchronnie czekają. Agencja już wcześniej podejmowała działania w tym kierunku. Teraz jeszcze bardziej je zintensyfikowaliśmy. Od lipca rozmawiamy z ministerstwem, NFZ-em, Urzędem Rejestracji Produktów Leczniczych i Urzędem Ochrony Danych Osobowych o tym, gdzie są potrzebne zmiany prawne. Widzimy, że problem zaczyna być dostrzegany przez decydentów. Zależy nam na szybkim działaniu, dlatego że odblokuje to szereg innych inicjatyw kluczowych dla rozwoju medycyny. Te dane są potrzebne wszystkim, i ministerstwu, i NFZ-owi, i naukowcom, i biznesowi. Jeżeli przegapimy właściwy moment, to trudno go będzie nadrobić.
Co w pana wizji rozwoju agencji najbardziej mogło przekonać komisję konkursową?
– Wszystkich dziewięciu kandydatów dostało te same pytania. Rozmowa była dość długa i wnikliwa. Dotyczyła zarówno systemu działania nauki w Polsce, jak i sposobu funkcjonowania agencji, jej ram prawnych i aspektów finansowych. Wizja, którą przedstawiłem, dotyczyła spójności systemu i tego, że agencja nie powinna być wyłącznie mechanizmem wydatkowania środków, tylko jednostką naukową podległą Ministerstwu Zdrowia, narzędziem, które służy do realizacji ambitnych, czasem ryzykownych projektów naukowych, do wytwarzania nowej wiedzy. W tym momencie nie ma komórki, która potrafiłaby odpowiedzieć merytorycznie np. na pytanie, czy dana procedura naukowa działa. W aspekcie finansowym ocenia to AOTMiT, ale ocena merytoryczna, ocena systemowych rozwiązań jest trudna do przeprowadzenia. Agencja posiada narzędzia do tego, żeby przeprowadzać takie analizy, żeby zebrać panel specjalistów, czy zrealizować badanie własne, które na takie pytania odpowie.
Agencja realizuje teraz dwa własne projekty, które odpowiadają na tego typu problemy. Żeby to robić dobrze, żeby tę wiedzę można było w jak najlepszy sposób dostarczać, a ministerstwo mogło te dane wykorzystywać do racjonalnego zarządzania, potrzebujemy jednak dobrego systemu zarządzania danymi, dlatego ten obszar jest kluczowy.
Agencja Badań Medycznych odpowiada za rozwój badań, budowanie innowacyjnego systemu opieki zdrowotnej, ocenia, które nowe technologie medyczne powinny być stosowane, zajmuje się programem dofinansowania badań klinicznych. Będzie się pan starał działać na wszystkich tych płaszczyznach? Czy będzie położny większy nacisk na któryś z tych elementów?
– Działamy we wszystkich tych sferach, natomiast dwie są w tym momencie najważniejsze. To kwestia danych medycznych i obszar badań własnych. Agencja ma unikalne umocowanie prawne w systemie, dzięki któremu może realizować projekty, których nie podjąłby się żaden pojedynczy instytut, czy uczelnia, bo np. temat jest mocno kontrowersyjny, albo wymaga wielu skomplikowanych zabiegów przygotowawczych. Stąd będziemy się starać wzmacniać obszar badań własnych.
Pozostałe zadania, jak finansowanie projektów naukowych, wciąż się toczą. Pieniądze z Krajowego Planu Odbudowy i Wzmacniania Odporności zwielokrotnią budżet grantów na lata 2025-2026. Uczelnie, firmy, szpitale złożyły teraz bardzo dużo wniosków o dofinansowanie, więc lekko obawiamy się, czy w przyszłym roku tych zgłoszeń nie będzie mniej, ale być może będzie wtedy można przyznać większe sumy dofinansowania. 2025 rok będzie priorytetowy, jeśli chodzi o pełną realizację projektów w ramach KPO. Trzeba jednak będzie mocno zwracać uwagę na zasadne wydatkowanie tych pieniędzy, żeby nie było ryzyka zwrotu czy nieuznania dofinansowania przez Unię Europejską.
Wspomniał pan o 2025 roku, czyli wciąż na początku pana pracy w ABM. A jakby miała wyglądać Agencja Badań Medycznych na końcu pana kadencji?
– Jeżeli będzie kilka lat na spokojne poukładanie tych wszystkich puzzli z obszaru medycyny i opieki zdrowotnej i ten system wspierania nauki w Polsce się domknie i będzie spójny, to liczę, że zacznie to wyglądać jak rozwinięty kraj zachodni, a nie jak naukowe safari, w którym każdy próbuje zająć najfajniejsze dla siebie miejsce, coś tam zobaczyć, zabrać to, czego potrzebuje i potem przeskoczyć do kolejnego projektu.
Mechanizmy, które agencja już ma, są dobrze ustawione, team merytoryczny, który tutaj pracuje, jest na wysokim poziomie i wie, co robi, więc naprawdę nie potrzeba wiele, żeby ten system domknąć. Jeżeli będzie chwila spokoju, wolna od politycznych zawirowań, kontroli i oskarżeń, to jest duża szansa na to, że uda się te wszystkie zadania zrealizować i stworzyć komplementarny, spójny, racjonalny system wspierania nauki w Polsce, w którym agencja będzie wspierać badania mające największe i bezpośrednie przełożenie na zdrowie i bezpieczeństwo pacjentów.
Kierownik Zakładu Biostatystyki i Medycyny Translacyjnej Uniwersytetu Medycznego w Łodzi, pełnomocnik ds. badań klinicznych, dyrektor szkoły doktorskiej medycyny molekularnej. Wszystkie te funkcje dalej pan pełni i będzie pełnił?
– Nie, kieruję jedynie wciąż Zakładem Biostatystyki i Medycyny Translacyjnej, ale tylko na jedną piątą etatu wymaganą do realizacji projektów Narodowego Centrum Nauki oraz zadań dydaktycznych. Pozostały czas teraz będę poświęcał Agencji Badań Medycznych.
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