Contribution of clinical trials to gross domestic product in Hungary

Aim

To determine the contribution of clinical trials to the gross domestic product (GDP) in Hungary.

Methods

An anonymous survey of pharmaceutical companies and clinical research organizations (CROs) was conducted to estimate their clinical trial-related employment and revenues. Clinical trial documents at the National Institute of Pharmacy (NIP) were analyzed to estimate trial-related revenues at health care institutions and the value of investigational medical products (IMPs) based on avoided drug costs. Financial benefits were calculated as 2010 US $ purchasing power parity (PPP) values.

Results

Clinical trials increased the revenue of Hungarian health care providers by US $165.6 million. The value of IMPs was US $67.0 million. Clinical trial operation and management activities generated 900 jobs and US $166.9 million in revenue among CROs and pharmaceutical companies.

Conclusions

The contribution of clinical trials to the Hungarian GDP in 2010 amounted to 0.2%. Participation in international clinical trials may result in health, financial, and intangible benefits that contribute to the sustainability of health care systems, especially in countries with severe resource constraints. Although a conservative approach was employed to estimate the economic benefits of clinical trials, further research is necessary to improve the generalizability of our findings.Active participation in international clinical trials may provide health benefits to patients and financial and professional benefits to health care providers. In lower income economies, such as those in Central-Eastern Europe (CEE), the relative benefits of clinical trials are even greater than in the high income countries of Western Europe and North America. Consequently, the contribution of emerging markets to international clinical trials is growing substantially (1). This phenomenon is especially visible in CEE, where the number of clinical trials has increased significantly over the past 15 years and is expected to increase even further in the near future (2). In CEE, international clinical trials offer opportunities for site personnel to improve their professional networking and be remunerated on higher-than average income level. For health care institutions with substantial budget constraints, trial-related payments can represent an important source of liquid cash. A supportive attitude of hospital management toward clinical trial activities, in terms of providing better working environment or increased remuneration, may help to prevent the migration of qualified professional staff to higher income countries. In CEE countries, the health status of the population is worse than in higher income Western European countries (3) and the accessibility of new medicines is relatively limited (4). Therefore, through clinical trials, CEE patients can obtain access to standardized modern health care services, technologies, and investigational drugs without waiting lists or co-payments. However, investigational medical products (IMPs) may represent considerable health risks for patients.The societal gain associated with clinical trials is multifactorial. Clinical trials contribute to the evolution of evidence-based medicine. They systematically investigate side effects and health outcomes not only for IMPs but also for the control treatment arms. Therefore, safety information, even about marketed therapies, is captured and no public investment is necessary.The most tangible benefit may be the financial impact, including the contribution of trials to the revenues of health care providers and clinical research organizations (CROs). However, there are also indirect benefits, such as avoided health care expenses due to the free delivery of IMPs and services.Few scientific publications have addressed the financial benefits of clinical trials. These publications examined avoided drug costs and additional revenues primarily from the viewpoint of health care institutions (5-9). There is also one Polish study on the national economic impact of clinical trials, but the approach was not comprehensive enough to capture all direct and indirect financial benefits (10).Hungary currently has a favorable position for implementation of clinical trials (11). It has high-level professionalism at investigational centers, rapid regulatory and ethical endorsements of applications, complex but manageable contracting processes at clinical sites, sufficient contributions to patient recruitment, and high Good Clinical Practice (GCP) quality according to Food and Drug Administration (FDA) inspections (12). However, similarly to other CEE countries, the capacity for clinical trial participation in Hungary has not been maximized. The aim of this study was to determine the contribution of clinical trials to the national economy in Hungary. We estimated the clinical trial-related revenues of CROs, investigators, and health care institutions and the financial benefits of avoided drug costs due to IMPs as the percentage of the gross domestic product (GDP).