Clinical Trials in Hungary: Reversing a Downward Trend

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Hungary has long been one of the leading countries in Central and Eastern Europe for clinical trials. However, a downward trend in the number of research projects being conducted in the country since 2015 has some stakeholders concerned about the future of Hungary as a regional clinical trials hub. 

 

Clinical drug trials are a major driver of growth for the Hungarian economy, producing an average of nearly USD 300 million per year

Hungary’s research and development sector is among the most active in Central and Eastern Europe. There are a plethora of multinational pharma companies conducting research in the country, and some have established partnerships with universities, such as the agreement between Hungarian champion Gedeon Richter and Semmelweis University. 

 

Developing a new active ingredient takes more than ten years and costs more than USD 1 billion, and a large percentage of this cost is spent on clinical trials. Clinical drug trials are a major driver of growth for the Hungarian economy, producing an average of nearly USD 300 million per year. They create jobs for thousands of medical professionals, generating tax revenues and income for the researchers and institutions. Additionally, nearly 20,000 patients per year benefit from receiving access to advanced personalised medicinal products free of charge. Hungary’s involvement in clinical trials has traditionally been strong, ranking 10th in Europe in the number of trials and 4th when taking into account the population size. In recent years, many pharma companies have been moving clinical trials from northern and western Europe into central and eastern Europe as well as Asia and Latin America due to higher treatment-naive patient populations and more cost-effective access to these populations. 

 

However, since 2015 clinical trials in Hungary have been declining rapidly, not only the number of approved trials but also the authorisation for new trials. Approved clinical trials in 2015 totalled 337, while in 2018 the number dropped to 290, and new trial authorisations decreased by 18 per cent. Some reasons for the decline are increasing competition, rising costs, and new EU regulations set to take effect in 2020.

 

To reverse the downward trend, the Hungarian Association for Innovative Pharma Manufacturers (AIPM) recommends four actions.

 

Firstly, the AIPM recommends financial considerations such as encouraging investment in clinical trials and strengthening the regulatory and reimbursement environment to once again make Hungary an attractive clinical trial destination.

 

Secondly, AIPM suggests that a central database should be established which would allow research data to be collected in one place and offer tremendous value to research institutions.

 

Thirdly, the AIPM believes government support should include tax deductions, counting the cost of clinical trials under research and development expenditure, and deducting these costs from the special taxes on the pharmaceutical industry.

 

Finally, a commitment to cooperation and unity across sectors and systems would allow for a smoother flow of communication and increase Hungary’s appeal in the European clinical trials space.

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