• The Health Innovation Hub, under the strategic coordination of the National Agency for Medicines and Medical Devices of Romania (ANMDMR), is launching its first project in the field of clinical trials.
  Increasing the number of clinical trials conducted in Romania will primarily generate major benefits for patients, who will gain access to the latest treatments and specialized medical services, potentially leading to improved survival rates and quality of life.
• By 2026, the Romanian clinical trial market could triple in size, from €72 million (the 2019 budget) to over €210 million.
• The workshop “Romania: Developing a Competitive Model for Clinical Trials” aimed to analyze the Romanian clinical trial market and identify the necessary directions for building a competitive model in this field over the next three years.

“The clinical trials market in Romania primarily means fast and guaranteed access for patients; it means the advantages of putting Romania back on the map of a major European industry, as well as benefits for the Romanian state, given that we are talking about a regulated and taxable sector. Over the past year, we have managed to solve many long-standing issues. Our target is to triple the number of clinical trials conducted in our country, involving as many Romanian patients as possible, which will also allow for increased budget revenues. To turn this target into a reality for our healthcare system, we need patient information and education, a qualified workforce, and the right infrastructure. The Health Innovation Hub can be an example of what we could achieve together in other fields, equally affected as the clinical trials sector has been.”

— Pharm. Dr. Răzvan Prisada, President of ANMDMR

Prof. Daniel–Ionuț Gheonea, M.D., Ph.D., Rector of the University of Medicine and Pharmacy of Craiova and founding member of the G6-UMF University Alliance, stated: “Universities do not only train doctors, pharmacists, and nurses. Our role, as defined in the University Charter and according to the Education Law, is also to inform society—both patients and the regions we represent. At the same time, we support patients by providing medical services. Looking at the University of Medicine and Pharmacy of Craiova, in just the last three years we have carried out a colon cancer screening project with 50,000 patients tested. In addition, over 60,000 patients have been tested for hepatitis C under another program run by UMF Craiova. Universities can be key players across the entire field of providing healthcare services and caring for patients.”

The direct involvement and increased capacity of the academic environment in the field of clinical research is also supported by Assoc. Prof. Michael Schenker, M.D., President of the Medical Oncology Commission within the Ministry of Health, and one of the most experienced principal investigators at the national level.

“Clinical research must go hand in hand with medical activity. Hospitals, as institutions, need to be promoted and must reclaim their value in conducting clinical research, which we should understand as a way of practicing medicine, of taking care of our patients. A hospital’s performance lies in offering patients new, innovative medicines — treatments that can change the negative course of disease where standard therapies fail. We need health policies developed with a focus on concrete aspects: direct applicability, fair and predictable access to clinical research and innovation, predictable legislation that is coherent and adapted to everyday practice needs, strengthened partnerships between the pharmaceutical industry, hospitals, and universities along the entire patient journey, accessible statistical data that can support proposals, and access to high-performance services.”

— Assoc. Prof. Michael Schenker, M.D.

“Enhancing the capacity of healthcare professionals to carry out clinical research activities is essential, and implementing university programs in this field is a priority for the academic environment.” — Prof. Doina Drăgănescu, M.D., Ph.D., President of the National Commission of Bioethics for Medicines and Medical Devices, Dean of the Faculty of Pharmacy, “Carol Davila” University of Medicine and Pharmacy, Bucharest.

“At UMF, we identified the need for a master’s program that can be pursued by graduates holding a bachelor’s degree, regardless of their field of study — which is essential for clinical trials. Beyond the interest of medical personnel, we can also include other professions that provide crucial support and without which the field cannot develop, especially when we think about the administrative area. The master’s program conducted in Bucharest is a necessary structure and, for it to be viable, a strong relationship with the companies conducting clinical trials is essential, because we do not want to remain purely theoretical, but to be implemented in the reality of the clinical trial industry. Certainly, this evolution will lead to other curricula in the future. We will engage in discussions with companies to see what they need, so that this master’s program is truly useful.”
— Prof. Doina Drăgănescu, M.D., Ph.D.

“At the moment, people’s main source of information is patient associations — provided that those in need know to reach out to us. I hope this will change, as we now have the new European Regulation that allows NGOs and patient associations to promote clinical trials among patients and inform them. A national information platform on clinical trials would help not only patients, but also doctors, who could refer sick individuals to specialized centers. We need information and education campaigns, not only about clinical trials but about everything related to research.”

Access to clinical trials and quality information is also supported by Radu Gănescu, President of the Coalition of Organizations of Patients with Chronic Diseases:

“The patient is the primary beneficiary of the growth of clinical trials in Romania. When we talk about clinical trials, we are referring to trials conducted in hospitals that often lack sufficient staff, in clinics that often do not have enough doctors, and within a population that frequently does not have proper information or education. A first step we should all take — healthcare professionals, authorities, and the pharmaceutical industry — is to inform and educate the population. We must increase the population’s trust in the healthcare system.”

The Local American Working Group (LAWG) is a promoter of healthcare innovation in Romania and supports the development of public policies aimed at creating an efficient, patient-centered healthcare system with increased access to innovation. LAWG brings together the world’s leading pharmaceutical companies in the fields of research and biotechnology, which are dedicated to developing innovative medicines.

According to Frank Loeffler, President of LAWG and General Manager of Roche,
“In addition to increasing patient access to innovative medicines, a well-developed clinical trial ecosystem can also facilitate future genomic research, which will enable the development of precision medicine. Another positive outcome of a robust clinical trial ecosystem in Romania is the facilitation of real-world data collection, which can then be used to measure clinical outcomes and to initiate the introduction of value-based reimbursement mechanisms. Attracting more clinical trials can also serve as an additional means of securing funding for hospitals, thereby diversifying the sources of financing for the healthcare sector.”

The partnership among all healthcare system stakeholders is essential for achieving concrete and sustainable results in the field of clinical trials, emphasizes Dr. Radu Rășinar, Coordinator of the Health Innovation Hub on behalf of LAWG and Country President of AstraZeneca: “The Innovation Hub in Romania has a unique structure, and I do not believe there is any other Hub globally that brings together all six traditional medical and pharmacy universities working within one association. This gives us the foundation to work, alongside research and development companies, and of course with the Ministry of Health and the National Agency for Medicines – who provide the strategic direction – to decisively contribute to the evolution towards a modern and high-performing healthcare system.”

Clinical trial management companies in Romania are another important partner in the country’s specialized activities.

“We will implement the right solutions to make the system operate in line with EU countries. The industry I represent is an important contributor of human resources and ideas. In the first country report (developed with the help of KPMG in 2016), there were approximately 500 employees in the CRO industry in Romania, and now there are over 1,600. The CRO industry in Romania has grown in terms of the number of employees based on regional and global considerations. Our colleagues have influence at both global and regional levels, which matters greatly because that’s where decisions are made that can truly change patients’ lives.”

— Dr. George Tănăseanu, President of the Association of Clinical Research Organizations in Romania (ACCSCR)