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EF: Can you elaborate on the Agency’s mission when it was created, and after all this time, what progress and spill-over have you achieved?
RS: We've accomplished substantial work in Poland over the past four years. It all began with the recognition of a significant issue by the Polish government: a lack of non-commercial clinical trials. In Western Europe, the standard value of non-commercial to all clinical trial number ratio was 40% . Still, in 2013 in Poland there were only two such trials out of almost 500 total , making it less than 1% initiated by academia. So, we decided to establish the Medical Research Agency, taking inspiration from institutions like the NIHR in Great Britain and the National Institutes of Health in the USA.
In 2019, our mission began, and we saw a drastic change. Back then, only 11 non-commercial clinical trials were initiated annually in Poland. Fast forward to today, after investing almost 0.9 billion U.S. dollars, we now see more than 50 non-commercial clinical trials starting each year. This has been a remarkable achievement, and it involved launching 17 grant calls, particularly in oncology, cardiology, and hematology. We also introduced the CAR-T technology for hematological diseases. We also address the challenges of rare diseases by supporting non-commercial clinical trials to improve patient access to Orphan drugs.
The impact has been remarkable. Non-commercial clinical trials now make up almost 8% of all clinical trials in Poland, with a notable increase in quality. In 2015 - 2022, the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL) reported a significant increase in the number of applications for the approval of clinical trials – from 466 applications submitted in 2015 to a peak 686 in 2022, which is an overall increase by nearly 50% within 7 years. As of 2021, innovative pharmaceutical companies directly contributed to the creation of 3.5 billion PLN in value-added, and the total gross value added due to their activities amounted to 10 billion PLN, equivalent to 0.38% of the entire GDP, and they generated 68.2 thousand jobs in the Polish economy.
The Polish government and Prime Minister have recognized the importance of this sector in building a smart economy. We aim to create a welcoming and predictable environment for investment, making Poland an attractive destination for big pharma companies to establish commercial trials, Research and Development, and digital centers and further contribute to our economy. This journey has been transformative and is a step toward a brighter future.
The Medical Research Agency's mission extends beyond simply creating a financing model for clinical trials. We've invested around half a billion Polish Zloty to establish 23 clinical trial support centers in Poland's best hospitals, universities, and Institutes of Health. These centers serve as central hubs where experts from Contract Research Organizations (CROs), legal professionals, statisticians, and scientists collaborate to assist physicians in applying for European grants and conducting clinical trials. From our perspective, these centers also offer a comfortable and welcoming environment for Polish patients participating in clinical trials, whether commercial or non-commercial. If someone has to travel several kilometers to participate in a clinical trial, they must find a pleasant setting with comfortable amenities. We took inspiration from Switzerland, where patients traveling to Zurich for clinical trials enjoy excellent conditions. This makes us more attractive from an international perspective.
EF: Do you see the framework as a challenge or an opportunity, and how can this benefit everyone?
RS: From a legal perspective, the Polish government recently introduced new legislation on clinical trials in March. This has led to a fresh approach to organizing clinical trials in our country. We've established the National Ethics Committee under the Medical Research Agency. Experts from various fields now evaluate all commercial clinical trials worldwide to ensure ethical standards are met. Notably, we've introduced patient representatives to this committee, giving them a voice in assessing clinical trials, which adds a valuable perspective.
We see two essential aspects of clinical trials. First, they provide access to novel therapies and innovations that might not reach the reimbursement system for several years. This is crucial for lung or breast cancer patients, as clinical trials can offer better treatment options. The more clinical trials conducted in Poland, the greater the access to these novel therapies for our patients.
Secondly, clinical trials are a significant part of our economy. They offer well-paid job opportunities and attract additional funds from the pharmaceutical industry. We're committed to creating a more welcoming environment for this sector in Poland. The Warsaw Health Innovation Hub, a public partnership platform, brings together key players in the pharmaceutical industry. We're working on legislation and projects to make Poland a major player in healthcare and innovation, with 35 companies currently involved in this initiative. It's a unique effort to showcase our reliability as an economic partner in biomedicine.
EF: How would you assess Poland’s potential as a healthcare industry to become a clinical trials hub in the European sector?
RS: As a governmental institution, our primary role is to foster a welcoming environment for companies and support the growth of clinical trials in our country. We have all the necessary tools to become a key player in Europe despite being a nation of almost 38 million people. Our advantage lies in having a single-payer, the National Health Fund, responsible for all patient clinical pathways, which makes managing patient data more straightforward.
To make it easier for patients to access information about clinical trials, we've launched a platform called "Patient in Clinical Trials" (www.patientinclinicaltrials.com). Here, Polish patients can find reliable information on participating in trials, safety measures, data handling, and open enrollment strategies. We want to be a trusted partner for companies looking to conduct clinical trials in Poland.
We're also investing in our specialists and recently began a collaboration with the Harvard Medical School to elevate the skills of our primary investigators. Our government introduced e-prescriptions and digitalized medical records. We believe that time is of the essence in clinical trials, and with these advancements, we're quick and flexible in organizing trials.
EF: What tangible uses stand out when it comes to interoperability in the clinical trial sector?
RS: In the context of international healthcare legislation, data is becoming increasingly valuable, especially in clinical trials. Poland is investing almost half a billion Polish Zlotys in creating eighteen regional digital medicine centers at the top medical universities and clinical hospitals. These centers will collect patient data from clinical trials in a secure biobank, including genomics and proteomics. This initiative aims to position Poland as a leader in biomedicine within Europe. Regardless of where patients participate in clinical trials in Poland, their data will be standardized and stored in the biobank. This uniformity will promote high-quality scientific research from clinical trials and pave the way for integrating AI and algorithms into healthcare. As a physician, I can attest that patients are eager for digital solutions and AI assessments to enhance their healthcare. This presents an excellent opportunity for Poland to lead in this development with minimal errors.
EF: What makes you a strategic partner to the sector?
RS: After 2 years of organizing the Warsaw Health Innovation Hub and playing a central role in financing clinical trials in Poland, we've become a trusted partner for international players like medical device and pharmaceutical companies. Initially, we focused on financial support, patient access, and collaborative projects. However, we've realized that our true value is a vital platform for dialogue.
Our institution fosters important discussions on healthcare, the Polish context, and government involvement. With 35 global partners, we've created a unique setting. We bring together key figures from the Ministry of Health, the registration agency, health technology, and the National Health Fund. This public-private forum enables productive talks on effective partnerships, patient priorities, and government acceptability. We also emphasize international benchmarks, learning from successful practices in other countries like Romania, Germany, and the UK. Global companies share insights with us, helping us adapt and personalize strategies for Poland, avoiding reinventing the wheel. Our core mission is to facilitate fruitful discussions between government and pharma companies, charting the way forward.
EF: How do you keep your role’s importance to other stakeholders and the relevance of the value you're bringing over the long run, and how can we prioritize this?
RS: Over the past eight years, the government in Poland has prioritized healthcare and innovation. This commitment led to the creation of our Agency with strong government support and funding. This direction will continue regardless of the government in power because science and medical progress should go beyond politics. Medical science can be a form of diplomacy, free from political affiliations. Institutions like the Medical Research Agency aim to lead in healthcare innovation. We have the advantage of strong connections with the best scientists in Poland. When pharmaceutical companies approach us with new technologies, our role is to facilitate collaboration and create a consortium for the benefit of Polish healthcare. Our mission is to shape the scene, introduce innovations in Poland, and take responsibility for the future of healthcare.
EF: How do you see the role of education evolving for physicians within Poland?
RS: When we started the Medical Research Agency, there was a widespread belief among Polish patients that clinical trials were risky experiments. People were worried about the safety and potential harm to their loved ones. This fear is a common concern. We collaborated with the Association of Good Clinical Practice, which includes CROs in Poland and worldwide. We also partnered with global patient associations to emphasize the importance of clinical trials. These trials provide access to novel therapies and, in some cases, a lifeline, particularly for terminal illnesses like cancer.
While at a top hospital in Houston, USA, I witnessed a comprehensive system for patients, including assessments for clinical trial eligibility. Patients there believe that clinical trials offer a chance for a longer and better life. Our role is to demonstrate the significance of clinical trials, their safety, and the added value they bring to treatment.
EF: What decisions will you make today that you think will significantly impact the SDG goals a decade from now?
RS: Looking ahead to the next decade, it's important to build on the progress in Poland's biotechnology and biomedical sectors. The focus should remain on innovative therapies and the development of this field, as it brings numerous benefits. Firstly, innovation in healthcare leads to the creation of new treatments and therapies, ultimately advancing healthcare. It addresses unmet medical needs, especially for diseases lacking effective therapies. Additionally, managing the wealth of knowledge from countless medical journals can be transformed through AI and innovative models.
Boosting the intellectual property landscape is another vital step. Demonstrating innovation in the nation can lead to more patents in Poland. Lastly, the future of medicine lies in personalized treatments driven by genomics, proteomics, and biomarkers. Tailoring treatments to an individual's genetic makeup is the path every country should follow, which promises economic growth and a global health impact. It's a direction we should wholeheartedly embrace.
EF: Is there anything else you think we should focus on, any areas of interest, or any partnerships you are excited about now?
RS: Poland has made significant strides in healthcare management in the past four years. We've created a welcoming environment for clinical trials, R&D in medicine, and innovation. This ideal landscape allows scientists to explore new ideas, conduct clinical trials, and research new molecules. We're also supporting our national pharmaceutical companies in developing cutting-edge drugs using arena technology, a unique asset globally. It's crucial to continue in this direction, with stable government partnerships demonstrating our trustworthiness in the pharmaceutical and medical device sectors. I believe fostering collaboration between entities involved in clinical trials is the key to success. Open discussions and working together can bring significant added value to our efforts.
